Cardiology

AstraZeneca has announced that the phase 3 DAPA-CKD trial for dapagliflozin (Farxiga) in patients with chronic kidney disease has been halted early because of overwhelming efficacy of the drug, at the recommendation of an independent data monitoring committee.

DAPA-CKD is an international, multicenter, randomized, double-blinded trial in 4,245 patients with stage 2-4 chronic kidney disease. Patients received either 10 mg of the dapagliflozin once-daily or a placebo. The primary composite endpoint is worsening of renal function, defined as a composite of an estimated glomerular filtration rate decline of at least 50%, onset of end-stage kidney disease, and death from cardiovascular or renal cause.

The decision to stop the trial came after a routine assessment of efficacy and safety that showed dapagliflozin’s benefits significantly earlier than expected. AstraZeneca will initiate closure of the study, and results will be published and submitted for presentation at a forthcoming medical meeting.

Dapagliflozin is a sodium-glucose transporter 2 inhibitor currently indicated for the treatment type 2 diabetes patients with inadequately controlled type 2 diabetes and for reduction of the risk of hospitalization for heart failure. In August 2019, the drug was granted Fast Track status by the Food and Drug Administration for the treatment of chronic kidney disease. In January 2020, the agency also granted Fast Track status for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients, regardless of diabetes status, with heart failure with reduced ejection fraction.

“Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in the press release.

lfranki@mdedge.com

AstraZeneca has announced that the phase 3 DAPA-CKD trial for dapagliflozin (Farxiga) in patients with chronic kidney disease has been halted early because of overwhelming efficacy of the drug, at the recommendation of an independent data monitoring committee.

DAPA-CKD is an international, multicenter, randomized, double-blinded trial in 4,245 patients with stage 2-4 chronic kidney disease. Patients received either 10 mg of the dapagliflozin once-daily or a placebo. The primary composite endpoint is worsening of renal function, defined as a composite of an estimated glomerular filtration rate decline of at least 50%, onset of end-stage kidney disease, and death from cardiovascular or renal cause.

The decision to stop the trial came after a routine assessment of efficacy and safety that showed dapagliflozin’s benefits significantly earlier than expected. AstraZeneca will initiate closure of the study, and results will be published and submitted for presentation at a forthcoming medical meeting.

Dapagliflozin is a sodium-glucose transporter 2 inhibitor currently indicated for the treatment type 2 diabetes patients with inadequately controlled type 2 diabetes and for reduction of the risk of hospitalization for heart failure. In August 2019, the drug was granted Fast Track status by the Food and Drug Administration for the treatment of chronic kidney disease. In January 2020, the agency also granted Fast Track status for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients, regardless of diabetes status, with heart failure with reduced ejection fraction.

“Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in the press release.

lfranki@mdedge.com

AstraZeneca has announced that the phase 3 DAPA-CKD trial for dapagliflozin (Farxiga) in patients with chronic kidney disease has been halted early because of overwhelming efficacy of the drug, at the recommendation of an independent data monitoring committee.

DAPA-CKD is an international, multicenter, randomized, double-blinded trial in 4,245 patients with stage 2-4 chronic kidney disease. Patients received either 10 mg of the dapagliflozin once-daily or a placebo. The primary composite endpoint is worsening of renal function, defined as a composite of an estimated glomerular filtration rate decline of at least 50%, onset of end-stage kidney disease, and death from cardiovascular or renal cause.

The decision to stop the trial came after a routine assessment of efficacy and safety that showed dapagliflozin’s benefits significantly earlier than expected. AstraZeneca will initiate closure of the study, and results will be published and submitted for presentation at a forthcoming medical meeting.

Dapagliflozin is a sodium-glucose transporter 2 inhibitor currently indicated for the treatment type 2 diabetes patients with inadequately controlled type 2 diabetes and for reduction of the risk of hospitalization for heart failure. In August 2019, the drug was granted Fast Track status by the Food and Drug Administration for the treatment of chronic kidney disease. In January 2020, the agency also granted Fast Track status for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients, regardless of diabetes status, with heart failure with reduced ejection fraction.

“Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in the press release.

lfranki@mdedge.com

From the University of North Carolina at Wilmington School of Nursing (Dr. Smith and Dr. Turrise), the New Hanover Regional Medical Center Heart Center (Mr. Jordan), the Coastal Carolinas Health Alliance and Coastal Connect Health Information Exchange (Ms. Robertson), and Coastal Thoracic Surgical Associates (Dr. Kane), Wilmington, NC.

Abstract

Objective: Cardiothoracic (CT) surgeons at our medical center were not receiving timely notification when their coronary artery bypass graft (CABG) surgery patients were admitted to the medical center or to other hospitals. The CT surgical team worked with a health alliance in southeastern North Carolina to implement health information exchange (HIE) real-time electronic notifications for their CABG patients who presented to the hospital’s emergency department (ED) or any ED affiliated with the medical center. The alert tool notifies team members about patient encounters, driving timely clinical engagement.

Methods: The CT team provided the HIE team with the names of CABG surgery patients, which were loaded into the alert tool. When a patient on the list presented to the hospital ED or its affiliates, the alert tool sent a real-time electronic notification to the Cardiac Surgical Services nurse coordinator. This intervention prompted the assessment and disposition of CABG patients, while in the ED, by the CT surgical team.

Results: Over a 16-month period (September 2017-December 2018), the names of 614 post-CABG patients were input into the HIE for tracking. Of these patients, 47 were treated and discharged from the ED; 31 were admitted for observation; 44 were readmitted for inpatient care; and 492 did not have a qualifying event requiring a notification alert. Following implementation of this practice change, the 30-day readmission rate for patients who underwent CABG at our institution decreased from 10% to 7.2%.

Conclusion: Utilizing a real-time alert tool resulted in immediate notification of the CT team when 1 of their patients presented to the ED. This afforded the CT surgical team an opportunity to intervene in the care of their patients, which in turn led to improved quality of care, physician communication and collaboration, and patient outcomes, such as preventable 30-day readmissions.

Keywords: electronic health record; real-time electronic notification; CABG; process improvement.

Unplanned 30-day hospital readmissions of patients who have undergone coronary artery bypass graft (CABG) surgery contribute to higher overall health care costs. CABG is 1 of the conditions/procedures that the Centers for Medicare and Medicaid Services (CMS) monitors for excess readmissions.¹ Readmission rates for CABG-related conditions at 30 days post-surgery are reported to be between 16% and 20% for US hospitals.² Readmissions are not only financially costly, but also have been associated with worse patient outcomes and decreased patient satisfaction.³ Common diagnoses for post-CABG admission include atrial fibrillation, pleural effusion, and wound infection.

The facility where this project was implemented had a 10% post-CABG admission rate for patients across all payers. While this rate is below the national average of 13.2%, the cardiothoracic (CT) surgical team was not being notified in a timely manner when their post-CABG patients were readmitted. The Lean team used the A3 problem-solving process to develop strategies that would reduce these readmissions and improve the care of their patients.

We explored the use of electronic alerts in managing post-CABG patients by conducting a literature search using the terms electronic alerts in patient care, patient engagement in the emergency department, electronic alerts in CABG, real-time notifications to prevent readmission, and CABG readmission. Databases searched were PubMed, Google Scholar, Cumulative Index of Nursing and Allied Health Literature, ProQuest, and ScienceDirect. This search resulted in studies focused on the use of electronic health record (EHR) alerts as a clinical decision-support tool; for example, patient demographic and assessment data are entered into the EHR, and the clinician is prompted with “performance” recommendations (eg, consider electrocardiogram and aspirin).⁴ In a paper by Engelman and Benjamin,⁵ the authors discuss the importance of the engaged physician and note that, in their emergency department (ED), an electronic notification is sent when a postoperative patient presents; however, the notification goes to the inpatient service for timely review and disposition. There was no literature that discussed the use of an electronic alert tool as a real-time patient engagement strategy that resulted in a practice change specific to the CT surgical team.

Our process improvement project focused on alerting the CT surgical team when a post-CABG patient presented to the ED, allowing them to evaluate the patient in real time and determine whether the chief complaint was related to the CABG and whether further evaluation by the CT surgeon was required. Specifically, we wanted to determine whether a real-time electronic alert that notified the CT surgical team about post-op CABG patients presenting to the ED would result in timely patient engagement, avoidance of readmissions, and an enhanced patient experience. During this project, alerts were sent to the CT surgical team notifying them of a post-CABG patient presenting to the ED or being directly admitted from home on physician orders, a provider’s office, or inpatient rehabilitation; however, the focus of this article is specifically on the notification regarding post-CABG patients presenting to the ED.

Prior to implementing the electronic notification project, the team developed and implemented several internal and external readmission reduction and prevention strategies for CABG patients. An in-house strategy involved a process whereby patients would receive their discharge medications prior to being discharged from the hospital post-CABG, thereby avoiding potential delays in the patient obtaining medications. When examining post-CABG patient readmissions, the primary conditions that led to readmission were fluid overload, pleural effusion, and atrial fibrillation. As such, a second in-house strategy was developed for post-CABG patients presenting to the ED with atrial fibrillation. The newly established protocol allowed patients to be monitored and treated in the cardiac observation unit. In addition, external strategies, including an outpatient furosemide protocol for home health nurses and an outpatient thoracentesis program and order set, were established (eg, for patients with congestive heart failure, shortness of breath).

Methods

Setting

The regional medical center where this project was implemented is the ninth largest hospital in North Carolina and the largest county-owned public hospital in the state. It is a tertiary care center and teaching hospital with 3 hospital campuses and 855 licensed beds. The medical center was included in the 100 Safecare Hospitals list by the Safecare Group; received a grade “A” Hospital Safety Score from the Leapfrog Group; and is 1 of America’s Top 100 Hospitals for Patient Experience.

Real-Time Notification Project

A regional hospital alliance in southeastern North Carolina established a health information exchange (HIE) with its member hospitals and office-based physicians to enable electronic exchange of patient information to improve quality, safety, and efficiency in health care delivery. Our medical center is part of this alliance. The HIE is a digital platform that facilitates the sharing of information between disparate connected EHR systems, and offers a portal for practices and hospitals to access patient information across North Carolina, South Carolina (via SC HIE), and nationwide (select dialysis centers). More specifically, approved providers and team members are able to access, in real time, patient-care encounter documents from other care settings (eg, acute, post-acute, ambulatory) via the HIE. Additionally, approved care entities can query-retrieve web portal information to support patient outcome improvement strategies. A partnership discussion highlighted the opportunity to utilize the HIE’s capabilities, such as real-time notification, to facilitate workflow (eg, when a patient presents to the ED, the HIE can provide access to health information at the point of care). In this capacity, the alert tool notifies care team members about patient encounters to drive timely clinical engagement for care transitions.

In January 2017, we began discussions on using the HIE to facilitate real-time electronic tracking in the Cardiac Surgical Services department at our medical center. Persons involved in these discussions included the cardiovascular (CV) team (comprised of case managers, department managers and coordinators, program coordinators, administrators, and support services [eg, pre-admission testing and home health staff]) and CT surgeons. At that time, CABG readmissions were manually tracked, and the real-time notification tool was being used in other departments (eg, in case management for tracking readmissions). The entire team was part of the initial decision meeting to pursue this possibility. The CV team reached consensus in June 2017 and proposed extending the use of the alert tool to the post-CABG population presenting to the ED (or any ED affiliated with the medical center) or admitted directly to the medical center.

The HIE staff met with the Cardiac Surgical Services team to tailor and develop the logistics of the project, such as who would be notified and how. The goals of the project were to support appropriate care intervention, reduce preventable hospital readmissions, and improve quality of care through enhanced provider communication and engagement. To achieve these goals, on the day of discharge the Cardiac Surgical Services coordinator provided the HIE team with the names of patients who had undergone CABG surgery. This patient list was loaded into the alert tool and continually updated. At 31 days, patient names were removed from the list. When a patient on the list presented to the hospital ED, the alert tool sent 2 real-time electronic notifications, an email and a text message, to the Cardiac Surgical Services coordinator, noting that a patient event occurred. Personal information was not included in the alert in order to protect patient information and comply with Health Insurance Portability and Accountability Act regulations.

The alert prompted the Cardiac Surgical Services coordinator to securely access patient information to identify and, if necessary, visit the patient. Then, based on the information gathered by the Cardiac Surgical Services coordinator, a Situation-Background-Assessment-Recommendation report was relayed to the CT surgeon, who then determined whether intervention by the CT surgical team was warranted. This process, on average, took approximately 30 minutes to complete. This was a key change in processes, one that allowed post-CABG patients to be seen by the CT surgical team while in the ED. If the issue was related to the CABG surgery, the CT surgeons could then determine an appropriate course of action, including admission or implementation of another protocol, such as the home furosemide protocol. For patients directly admitted, the surgeon contacted the admitting provider to discuss the level of care required (ie, observation or inpatient admission and treatment).

Biweekly CV team meetings were conducted during the implementation of the real-time notification alert tool. At each meeting, updates were provided on notifications received, patients who were missed by the notification process, and how well the real-time alerts were working to enhance care and appropriate disposition.

Measurements

Clinical performance data included total notifications, total number of ED visits, ED disposition (inpatient admission, observation, discharge), total number of direct admissions, direct admissions to observation, direct inpatient admissions, and patients missed by the notification process (eg, due to data entry errors, omissions of information [suffix of junior or senior], as well as programming bugs). Finally, the number of observation admissions converted to inpatient admissions was collected and further analyzed to inform needed process changes.

The Cardiac Surgical Services coordinator collected, entered, and maintained data using Excel. Data were obtained from the EHR, recorded in Excel, and analyzed using basic descriptive statistics in an ongoing fashion. Particular attention was focused on problems with the notification process (eg, patients being missed due to errors in data entry) and summarizing information to keep the Cardiac Surgical Services team updated on the progress of the process improvement. This project did not require staff protections or considerations, and because this was not a research study Institutional Review Board approval was not required.

Results

This practice change was implemented in September 2017 and led to improvements in care quality, as evidenced by improved physician communication and collaboration. In the 16-month period from implementation through December 2018, the names of 614 post-CABG patients were input into the HIE for tracking. Of these patients, 47 were treated and discharged from the ED; 31 were admitted for observation; and 44 were readmitted for inpatient care. The remaining 492 patients did not have a qualifying event requiring a notification alert. Clinical performance data from this period included 70 ED visits, 21 direct admissions, 19 direct admissions to observation, 5 patients missed by the notification process, and 4 observation admissions converted to inpatient admissions. A reduction in the CABG readmission rate from 10% in September 2017 to 7.2% in December 2018 was also noted.

Discussion

The aim of this process improvement project was to determine whether a real-time electronic alert that notified the CT surgical team about post-op CABG patients presenting to the ED would result in timely patient engagement, avoidance of readmissions, and an enhanced patient experience. This practice change has been successful, following 16 months of implementation and process refinement. Integrating a real-time electronic alert with a supporting action plan and care protocols resulted in timely patient engagement and avoidance of readmission of post-CABG patients.

Early notification of possible post-CABG readmissions became a standard-of-care process within the Cardiac Surgical Services department, with expansion to all CT post-op patients. Leveraging HIE technology to support quality improvement processes was also viewed by other departments as relevant and beneficial. For example, the hospital stroke and orthopedic-spine teams established their own processes for receiving real-time alerts.

There were several lessons learned during this project. First, gaining 100% physician buy-in to collaborative communication proved to be critical to the project’s success. The CV team was surprised by the length of time (approximately 8-10 months) it took for the practice change to be adopted by the physicians. In part, some of this delay in adoption resulted from medical staff turnover, primarily in the medical resident training rotations. Collaborative communication was key. The CT surgeons spoke with ED leadership and hospitalist services to explain the readmission reduction project and the use of an electronic alert tool. The CT surgeons also communicated to the ED physicians, hospitalists, and cardiologists that the Cardiac Surgical Services coordinator would be involved in the process and discussions regarding patientss care. Additionally, the CT surgeons authored the furosemide protocol and then committed to its use in the home health setting, further highlighting the role of collaborative communication in avoiding readmissions.

Another key step in this quality improvement project was determining who should receive the alert notifications. At the onset of the project, all notifications were sent to 1 person, the Cardiac Surgical Services coordinator. While this seemed logical in the initial stage of the project, it was unsustainable, as the receipt of the alert and the subsequent notification of the CT surgeon depended on 1 person and their availability. Approximately 10 months into the project, the notification process was further refined, with the cardiovascular intensive care unit charge nurse becoming the point of contact for the alerts. The Cardiac Surgical Services coordinator, in collaboration with nursing leaders and CT surgeons, completed a Lean Standard Work template outlining the major steps and the associated responsibilities (for the cardiovascular intensive care unit charge nurse, CT surgeon and on-call surgeon, Cardiac Surgical Services coordinator) in the process of receiving notifications, collecting patient assessment data, and reporting notifications to the CT surgeons.

Establishing adequate support mechanisms during a practice change is also important. For instance, we had to dedicate personnel time for data collection and analysis and involve additional nursing or other qualified personnel in the new process to avoid depending on a single person for the project’s success. Additional considerations were establishing criteria for surgeon notification and defining an appropriate time frame for notification (eg, urgent versus next-day notifications). We accomplished these activities approximately 10 months into the project, after it became apparent at CV team meeting discussions that further clarification of criteria and timelines was needed.

Some aspects of the project unfolded as planned, while others presented opportunities for improvement. For example, the alert notification process worked as envisioned; however, as previously mentioned, the process needed to be more inclusive to ensure there is always a charge nurse on duty to receive the alert notification, rather than just the Cardiac Surgical Services coordinator, who may not always be at the hospital. The outpatient thoracentesis program was well planned and effectively implemented. This program provided an avenue for patients who had symptoms of pleural effusion to be treated in an outpatient setting, rather than requiring an inpatient stay. Opportunities for improvement included addressing the inconsistent use of the home health furosemide protocol (developed in 2016), and the need for continued interprofessional and interdepartmental communication and coordination. For example, we had to inform the ED physicians and staff who rotate or are new to the ED about established processes and protocols in place for managing post-CABG patients who present to the ED.

The primary limitation of this project was the inability to measure the enhanced patient experience, which was 1 of the stated project goals. This goal became secondary because of more pressing issues, specifically, interorganizational collaboration (eg, hospital EHR, HIE, and CT surgical team) and tailoring the functionality of the electronic alert tool to the project. Developing and implementing measures of enhanced patient experience were not feasible during this implementation. Additionally, because this was not a research study, it was not possible to determine cause and effect or to control for confounders, such as a sicker, older cohort with more comorbid conditions, during the comparison period. Finally, although this process improvement project was conducted at a regional medical center that is the only facility performing CABG within the region, patients may have presented to another facility for an event that led to a readmission. Because readmissions to other facilities could not be captured, it is possible that the actual readmission rate was higher than the rate reported here.

Conclusions and Implications

Utilizing a real-time alert from the HIE to the CT surgical team resulted in CT surgeons being immediately made aware when their patients presented to the ED, allowing the CT surgical team the opportunity to intervene, as appropriate, in the care of their patients. Furthermore, this real-time notification and intervention resulted in timely patient engagement and, in some cases, avoidance of readmissions. Currently, patients are monitored for readmission within 30 days of discharge. In the future, the time will expand to 91 days, in preparation for participation in the CMS bundle payment program for CABG surgery.

This practice change can be used in organizations that do not have or participate in a HIE. In fact, these real-time alert applications may be available through an EHR already in use within the organization. The use of the alert requires collaborative communication and having supporting protocols in place to guide decision-making and care of post-CABG patients presenting to the ED.

There appears to be a gap in the literature discussing the use of an electronic alert tool as a real-time patient engagement strategy for post-CABG patients presenting to the ED. As such, this project contributes important results and lessons learned for other hospital service lines/departments that might consider implementing a similar process. Next steps include designing and conducting methodologically rigorous research studies based on this process improvement project to examine mortality rates as an outcome, and designing a more specific measure of patient experience, as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey only provides hospital-level data.

Corresponding author: Stephanie D. Smith, PhD, RN, UNCW School of Nursing, 601 South College Road, Wilmington, NC 28403; smithsd@uncw.edu.

Funding disclosures: None.

From the University of North Carolina at Wilmington School of Nursing (Dr. Smith and Dr. Turrise), the New Hanover Regional Medical Center Heart Center (Mr. Jordan), the Coastal Carolinas Health Alliance and Coastal Connect Health Information Exchange (Ms. Robertson), and Coastal Thoracic Surgical Associates (Dr. Kane), Wilmington, NC.

Abstract

Objective: Cardiothoracic (CT) surgeons at our medical center were not receiving timely notification when their coronary artery bypass graft (CABG) surgery patients were admitted to the medical center or to other hospitals. The CT surgical team worked with a health alliance in southeastern North Carolina to implement health information exchange (HIE) real-time electronic notifications for their CABG patients who presented to the hospital’s emergency department (ED) or any ED affiliated with the medical center. The alert tool notifies team members about patient encounters, driving timely clinical engagement.

Methods: The CT team provided the HIE team with the names of CABG surgery patients, which were loaded into the alert tool. When a patient on the list presented to the hospital ED or its affiliates, the alert tool sent a real-time electronic notification to the Cardiac Surgical Services nurse coordinator. This intervention prompted the assessment and disposition of CABG patients, while in the ED, by the CT surgical team.

Results: Over a 16-month period (September 2017-December 2018), the names of 614 post-CABG patients were input into the HIE for tracking. Of these patients, 47 were treated and discharged from the ED; 31 were admitted for observation; 44 were readmitted for inpatient care; and 492 did not have a qualifying event requiring a notification alert. Following implementation of this practice change, the 30-day readmission rate for patients who underwent CABG at our institution decreased from 10% to 7.2%.

Conclusion: Utilizing a real-time alert tool resulted in immediate notification of the CT team when 1 of their patients presented to the ED. This afforded the CT surgical team an opportunity to intervene in the care of their patients, which in turn led to improved quality of care, physician communication and collaboration, and patient outcomes, such as preventable 30-day readmissions.

Keywords: electronic health record; real-time electronic notification; CABG; process improvement.

Unplanned 30-day hospital readmissions of patients who have undergone coronary artery bypass graft (CABG) surgery contribute to higher overall health care costs. CABG is 1 of the conditions/procedures that the Centers for Medicare and Medicaid Services (CMS) monitors for excess readmissions.¹ Readmission rates for CABG-related conditions at 30 days post-surgery are reported to be between 16% and 20% for US hospitals.² Readmissions are not only financially costly, but also have been associated with worse patient outcomes and decreased patient satisfaction.³ Common diagnoses for post-CABG admission include atrial fibrillation, pleural effusion, and wound infection.

The facility where this project was implemented had a 10% post-CABG admission rate for patients across all payers. While this rate is below the national average of 13.2%, the cardiothoracic (CT) surgical team was not being notified in a timely manner when their post-CABG patients were readmitted. The Lean team used the A3 problem-solving process to develop strategies that would reduce these readmissions and improve the care of their patients.

We explored the use of electronic alerts in managing post-CABG patients by conducting a literature search using the terms electronic alerts in patient care, patient engagement in the emergency department, electronic alerts in CABG, real-time notifications to prevent readmission, and CABG readmission. Databases searched were PubMed, Google Scholar, Cumulative Index of Nursing and Allied Health Literature, ProQuest, and ScienceDirect. This search resulted in studies focused on the use of electronic health record (EHR) alerts as a clinical decision-support tool; for example, patient demographic and assessment data are entered into the EHR, and the clinician is prompted with “performance” recommendations (eg, consider electrocardiogram and aspirin).⁴ In a paper by Engelman and Benjamin,⁵ the authors discuss the importance of the engaged physician and note that, in their emergency department (ED), an electronic notification is sent when a postoperative patient presents; however, the notification goes to the inpatient service for timely review and disposition. There was no literature that discussed the use of an electronic alert tool as a real-time patient engagement strategy that resulted in a practice change specific to the CT surgical team.

Our process improvement project focused on alerting the CT surgical team when a post-CABG patient presented to the ED, allowing them to evaluate the patient in real time and determine whether the chief complaint was related to the CABG and whether further evaluation by the CT surgeon was required. Specifically, we wanted to determine whether a real-time electronic alert that notified the CT surgical team about post-op CABG patients presenting to the ED would result in timely patient engagement, avoidance of readmissions, and an enhanced patient experience. During this project, alerts were sent to the CT surgical team notifying them of a post-CABG patient presenting to the ED or being directly admitted from home on physician orders, a provider’s office, or inpatient rehabilitation; however, the focus of this article is specifically on the notification regarding post-CABG patients presenting to the ED.

Prior to implementing the electronic notification project, the team developed and implemented several internal and external readmission reduction and prevention strategies for CABG patients. An in-house strategy involved a process whereby patients would receive their discharge medications prior to being discharged from the hospital post-CABG, thereby avoiding potential delays in the patient obtaining medications. When examining post-CABG patient readmissions, the primary conditions that led to readmission were fluid overload, pleural effusion, and atrial fibrillation. As such, a second in-house strategy was developed for post-CABG patients presenting to the ED with atrial fibrillation. The newly established protocol allowed patients to be monitored and treated in the cardiac observation unit. In addition, external strategies, including an outpatient furosemide protocol for home health nurses and an outpatient thoracentesis program and order set, were established (eg, for patients with congestive heart failure, shortness of breath).

Methods

Setting

The regional medical center where this project was implemented is the ninth largest hospital in North Carolina and the largest county-owned public hospital in the state. It is a tertiary care center and teaching hospital with 3 hospital campuses and 855 licensed beds. The medical center was included in the 100 Safecare Hospitals list by the Safecare Group; received a grade “A” Hospital Safety Score from the Leapfrog Group; and is 1 of America’s Top 100 Hospitals for Patient Experience.

Real-Time Notification Project

A regional hospital alliance in southeastern North Carolina established a health information exchange (HIE) with its member hospitals and office-based physicians to enable electronic exchange of patient information to improve quality, safety, and efficiency in health care delivery. Our medical center is part of this alliance. The HIE is a digital platform that facilitates the sharing of information between disparate connected EHR systems, and offers a portal for practices and hospitals to access patient information across North Carolina, South Carolina (via SC HIE), and nationwide (select dialysis centers). More specifically, approved providers and team members are able to access, in real time, patient-care encounter documents from other care settings (eg, acute, post-acute, ambulatory) via the HIE. Additionally, approved care entities can query-retrieve web portal information to support patient outcome improvement strategies. A partnership discussion highlighted the opportunity to utilize the HIE’s capabilities, such as real-time notification, to facilitate workflow (eg, when a patient presents to the ED, the HIE can provide access to health information at the point of care). In this capacity, the alert tool notifies care team members about patient encounters to drive timely clinical engagement for care transitions.

In January 2017, we began discussions on using the HIE to facilitate real-time electronic tracking in the Cardiac Surgical Services department at our medical center. Persons involved in these discussions included the cardiovascular (CV) team (comprised of case managers, department managers and coordinators, program coordinators, administrators, and support services [eg, pre-admission testing and home health staff]) and CT surgeons. At that time, CABG readmissions were manually tracked, and the real-time notification tool was being used in other departments (eg, in case management for tracking readmissions). The entire team was part of the initial decision meeting to pursue this possibility. The CV team reached consensus in June 2017 and proposed extending the use of the alert tool to the post-CABG population presenting to the ED (or any ED affiliated with the medical center) or admitted directly to the medical center.

The HIE staff met with the Cardiac Surgical Services team to tailor and develop the logistics of the project, such as who would be notified and how. The goals of the project were to support appropriate care intervention, reduce preventable hospital readmissions, and improve quality of care through enhanced provider communication and engagement. To achieve these goals, on the day of discharge the Cardiac Surgical Services coordinator provided the HIE team with the names of patients who had undergone CABG surgery. This patient list was loaded into the alert tool and continually updated. At 31 days, patient names were removed from the list. When a patient on the list presented to the hospital ED, the alert tool sent 2 real-time electronic notifications, an email and a text message, to the Cardiac Surgical Services coordinator, noting that a patient event occurred. Personal information was not included in the alert in order to protect patient information and comply with Health Insurance Portability and Accountability Act regulations.

The alert prompted the Cardiac Surgical Services coordinator to securely access patient information to identify and, if necessary, visit the patient. Then, based on the information gathered by the Cardiac Surgical Services coordinator, a Situation-Background-Assessment-Recommendation report was relayed to the CT surgeon, who then determined whether intervention by the CT surgical team was warranted. This process, on average, took approximately 30 minutes to complete. This was a key change in processes, one that allowed post-CABG patients to be seen by the CT surgical team while in the ED. If the issue was related to the CABG surgery, the CT surgeons could then determine an appropriate course of action, including admission or implementation of another protocol, such as the home furosemide protocol. For patients directly admitted, the surgeon contacted the admitting provider to discuss the level of care required (ie, observation or inpatient admission and treatment).

Biweekly CV team meetings were conducted during the implementation of the real-time notification alert tool. At each meeting, updates were provided on notifications received, patients who were missed by the notification process, and how well the real-time alerts were working to enhance care and appropriate disposition.

Measurements

Clinical performance data included total notifications, total number of ED visits, ED disposition (inpatient admission, observation, discharge), total number of direct admissions, direct admissions to observation, direct inpatient admissions, and patients missed by the notification process (eg, due to data entry errors, omissions of information [suffix of junior or senior], as well as programming bugs). Finally, the number of observation admissions converted to inpatient admissions was collected and further analyzed to inform needed process changes.

The Cardiac Surgical Services coordinator collected, entered, and maintained data using Excel. Data were obtained from the EHR, recorded in Excel, and analyzed using basic descriptive statistics in an ongoing fashion. Particular attention was focused on problems with the notification process (eg, patients being missed due to errors in data entry) and summarizing information to keep the Cardiac Surgical Services team updated on the progress of the process improvement. This project did not require staff protections or considerations, and because this was not a research study Institutional Review Board approval was not required.

Results

This practice change was implemented in September 2017 and led to improvements in care quality, as evidenced by improved physician communication and collaboration. In the 16-month period from implementation through December 2018, the names of 614 post-CABG patients were input into the HIE for tracking. Of these patients, 47 were treated and discharged from the ED; 31 were admitted for observation; and 44 were readmitted for inpatient care. The remaining 492 patients did not have a qualifying event requiring a notification alert. Clinical performance data from this period included 70 ED visits, 21 direct admissions, 19 direct admissions to observation, 5 patients missed by the notification process, and 4 observation admissions converted to inpatient admissions. A reduction in the CABG readmission rate from 10% in September 2017 to 7.2% in December 2018 was also noted.

Discussion

The aim of this process improvement project was to determine whether a real-time electronic alert that notified the CT surgical team about post-op CABG patients presenting to the ED would result in timely patient engagement, avoidance of readmissions, and an enhanced patient experience. This practice change has been successful, following 16 months of implementation and process refinement. Integrating a real-time electronic alert with a supporting action plan and care protocols resulted in timely patient engagement and avoidance of readmission of post-CABG patients.

Early notification of possible post-CABG readmissions became a standard-of-care process within the Cardiac Surgical Services department, with expansion to all CT post-op patients. Leveraging HIE technology to support quality improvement processes was also viewed by other departments as relevant and beneficial. For example, the hospital stroke and orthopedic-spine teams established their own processes for receiving real-time alerts.

There were several lessons learned during this project. First, gaining 100% physician buy-in to collaborative communication proved to be critical to the project’s success. The CV team was surprised by the length of time (approximately 8-10 months) it took for the practice change to be adopted by the physicians. In part, some of this delay in adoption resulted from medical staff turnover, primarily in the medical resident training rotations. Collaborative communication was key. The CT surgeons spoke with ED leadership and hospitalist services to explain the readmission reduction project and the use of an electronic alert tool. The CT surgeons also communicated to the ED physicians, hospitalists, and cardiologists that the Cardiac Surgical Services coordinator would be involved in the process and discussions regarding patientss care. Additionally, the CT surgeons authored the furosemide protocol and then committed to its use in the home health setting, further highlighting the role of collaborative communication in avoiding readmissions.

Another key step in this quality improvement project was determining who should receive the alert notifications. At the onset of the project, all notifications were sent to 1 person, the Cardiac Surgical Services coordinator. While this seemed logical in the initial stage of the project, it was unsustainable, as the receipt of the alert and the subsequent notification of the CT surgeon depended on 1 person and their availability. Approximately 10 months into the project, the notification process was further refined, with the cardiovascular intensive care unit charge nurse becoming the point of contact for the alerts. The Cardiac Surgical Services coordinator, in collaboration with nursing leaders and CT surgeons, completed a Lean Standard Work template outlining the major steps and the associated responsibilities (for the cardiovascular intensive care unit charge nurse, CT surgeon and on-call surgeon, Cardiac Surgical Services coordinator) in the process of receiving notifications, collecting patient assessment data, and reporting notifications to the CT surgeons.

Establishing adequate support mechanisms during a practice change is also important. For instance, we had to dedicate personnel time for data collection and analysis and involve additional nursing or other qualified personnel in the new process to avoid depending on a single person for the project’s success. Additional considerations were establishing criteria for surgeon notification and defining an appropriate time frame for notification (eg, urgent versus next-day notifications). We accomplished these activities approximately 10 months into the project, after it became apparent at CV team meeting discussions that further clarification of criteria and timelines was needed.

Some aspects of the project unfolded as planned, while others presented opportunities for improvement. For example, the alert notification process worked as envisioned; however, as previously mentioned, the process needed to be more inclusive to ensure there is always a charge nurse on duty to receive the alert notification, rather than just the Cardiac Surgical Services coordinator, who may not always be at the hospital. The outpatient thoracentesis program was well planned and effectively implemented. This program provided an avenue for patients who had symptoms of pleural effusion to be treated in an outpatient setting, rather than requiring an inpatient stay. Opportunities for improvement included addressing the inconsistent use of the home health furosemide protocol (developed in 2016), and the need for continued interprofessional and interdepartmental communication and coordination. For example, we had to inform the ED physicians and staff who rotate or are new to the ED about established processes and protocols in place for managing post-CABG patients who present to the ED.

The primary limitation of this project was the inability to measure the enhanced patient experience, which was 1 of the stated project goals. This goal became secondary because of more pressing issues, specifically, interorganizational collaboration (eg, hospital EHR, HIE, and CT surgical team) and tailoring the functionality of the electronic alert tool to the project. Developing and implementing measures of enhanced patient experience were not feasible during this implementation. Additionally, because this was not a research study, it was not possible to determine cause and effect or to control for confounders, such as a sicker, older cohort with more comorbid conditions, during the comparison period. Finally, although this process improvement project was conducted at a regional medical center that is the only facility performing CABG within the region, patients may have presented to another facility for an event that led to a readmission. Because readmissions to other facilities could not be captured, it is possible that the actual readmission rate was higher than the rate reported here.

Conclusions and Implications

Utilizing a real-time alert from the HIE to the CT surgical team resulted in CT surgeons being immediately made aware when their patients presented to the ED, allowing the CT surgical team the opportunity to intervene, as appropriate, in the care of their patients. Furthermore, this real-time notification and intervention resulted in timely patient engagement and, in some cases, avoidance of readmissions. Currently, patients are monitored for readmission within 30 days of discharge. In the future, the time will expand to 91 days, in preparation for participation in the CMS bundle payment program for CABG surgery.

This practice change can be used in organizations that do not have or participate in a HIE. In fact, these real-time alert applications may be available through an EHR already in use within the organization. The use of the alert requires collaborative communication and having supporting protocols in place to guide decision-making and care of post-CABG patients presenting to the ED.

There appears to be a gap in the literature discussing the use of an electronic alert tool as a real-time patient engagement strategy for post-CABG patients presenting to the ED. As such, this project contributes important results and lessons learned for other hospital service lines/departments that might consider implementing a similar process. Next steps include designing and conducting methodologically rigorous research studies based on this process improvement project to examine mortality rates as an outcome, and designing a more specific measure of patient experience, as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey only provides hospital-level data.

Corresponding author: Stephanie D. Smith, PhD, RN, UNCW School of Nursing, 601 South College Road, Wilmington, NC 28403; smithsd@uncw.edu.

Funding disclosures: None.

From the University of North Carolina at Wilmington School of Nursing (Dr. Smith and Dr. Turrise), the New Hanover Regional Medical Center Heart Center (Mr. Jordan), the Coastal Carolinas Health Alliance and Coastal Connect Health Information Exchange (Ms. Robertson), and Coastal Thoracic Surgical Associates (Dr. Kane), Wilmington, NC.

Abstract

Objective: Cardiothoracic (CT) surgeons at our medical center were not receiving timely notification when their coronary artery bypass graft (CABG) surgery patients were admitted to the medical center or to other hospitals. The CT surgical team worked with a health alliance in southeastern North Carolina to implement health information exchange (HIE) real-time electronic notifications for their CABG patients who presented to the hospital’s emergency department (ED) or any ED affiliated with the medical center. The alert tool notifies team members about patient encounters, driving timely clinical engagement.

Methods: The CT team provided the HIE team with the names of CABG surgery patients, which were loaded into the alert tool. When a patient on the list presented to the hospital ED or its affiliates, the alert tool sent a real-time electronic notification to the Cardiac Surgical Services nurse coordinator. This intervention prompted the assessment and disposition of CABG patients, while in the ED, by the CT surgical team.

Results: Over a 16-month period (September 2017-December 2018), the names of 614 post-CABG patients were input into the HIE for tracking. Of these patients, 47 were treated and discharged from the ED; 31 were admitted for observation; 44 were readmitted for inpatient care; and 492 did not have a qualifying event requiring a notification alert. Following implementation of this practice change, the 30-day readmission rate for patients who underwent CABG at our institution decreased from 10% to 7.2%.

Conclusion: Utilizing a real-time alert tool resulted in immediate notification of the CT team when 1 of their patients presented to the ED. This afforded the CT surgical team an opportunity to intervene in the care of their patients, which in turn led to improved quality of care, physician communication and collaboration, and patient outcomes, such as preventable 30-day readmissions.

Keywords: electronic health record; real-time electronic notification; CABG; process improvement.

Unplanned 30-day hospital readmissions of patients who have undergone coronary artery bypass graft (CABG) surgery contribute to higher overall health care costs. CABG is 1 of the conditions/procedures that the Centers for Medicare and Medicaid Services (CMS) monitors for excess readmissions.¹ Readmission rates for CABG-related conditions at 30 days post-surgery are reported to be between 16% and 20% for US hospitals.² Readmissions are not only financially costly, but also have been associated with worse patient outcomes and decreased patient satisfaction.³ Common diagnoses for post-CABG admission include atrial fibrillation, pleural effusion, and wound infection.

The facility where this project was implemented had a 10% post-CABG admission rate for patients across all payers. While this rate is below the national average of 13.2%, the cardiothoracic (CT) surgical team was not being notified in a timely manner when their post-CABG patients were readmitted. The Lean team used the A3 problem-solving process to develop strategies that would reduce these readmissions and improve the care of their patients.

We explored the use of electronic alerts in managing post-CABG patients by conducting a literature search using the terms electronic alerts in patient care, patient engagement in the emergency department, electronic alerts in CABG, real-time notifications to prevent readmission, and CABG readmission. Databases searched were PubMed, Google Scholar, Cumulative Index of Nursing and Allied Health Literature, ProQuest, and ScienceDirect. This search resulted in studies focused on the use of electronic health record (EHR) alerts as a clinical decision-support tool; for example, patient demographic and assessment data are entered into the EHR, and the clinician is prompted with “performance” recommendations (eg, consider electrocardiogram and aspirin).⁴ In a paper by Engelman and Benjamin,⁵ the authors discuss the importance of the engaged physician and note that, in their emergency department (ED), an electronic notification is sent when a postoperative patient presents; however, the notification goes to the inpatient service for timely review and disposition. There was no literature that discussed the use of an electronic alert tool as a real-time patient engagement strategy that resulted in a practice change specific to the CT surgical team.

Our process improvement project focused on alerting the CT surgical team when a post-CABG patient presented to the ED, allowing them to evaluate the patient in real time and determine whether the chief complaint was related to the CABG and whether further evaluation by the CT surgeon was required. Specifically, we wanted to determine whether a real-time electronic alert that notified the CT surgical team about post-op CABG patients presenting to the ED would result in timely patient engagement, avoidance of readmissions, and an enhanced patient experience. During this project, alerts were sent to the CT surgical team notifying them of a post-CABG patient presenting to the ED or being directly admitted from home on physician orders, a provider’s office, or inpatient rehabilitation; however, the focus of this article is specifically on the notification regarding post-CABG patients presenting to the ED.

Prior to implementing the electronic notification project, the team developed and implemented several internal and external readmission reduction and prevention strategies for CABG patients. An in-house strategy involved a process whereby patients would receive their discharge medications prior to being discharged from the hospital post-CABG, thereby avoiding potential delays in the patient obtaining medications. When examining post-CABG patient readmissions, the primary conditions that led to readmission were fluid overload, pleural effusion, and atrial fibrillation. As such, a second in-house strategy was developed for post-CABG patients presenting to the ED with atrial fibrillation. The newly established protocol allowed patients to be monitored and treated in the cardiac observation unit. In addition, external strategies, including an outpatient furosemide protocol for home health nurses and an outpatient thoracentesis program and order set, were established (eg, for patients with congestive heart failure, shortness of breath).

Methods

Setting

The regional medical center where this project was implemented is the ninth largest hospital in North Carolina and the largest county-owned public hospital in the state. It is a tertiary care center and teaching hospital with 3 hospital campuses and 855 licensed beds. The medical center was included in the 100 Safecare Hospitals list by the Safecare Group; received a grade “A” Hospital Safety Score from the Leapfrog Group; and is 1 of America’s Top 100 Hospitals for Patient Experience.

Real-Time Notification Project

A regional hospital alliance in southeastern North Carolina established a health information exchange (HIE) with its member hospitals and office-based physicians to enable electronic exchange of patient information to improve quality, safety, and efficiency in health care delivery. Our medical center is part of this alliance. The HIE is a digital platform that facilitates the sharing of information between disparate connected EHR systems, and offers a portal for practices and hospitals to access patient information across North Carolina, South Carolina (via SC HIE), and nationwide (select dialysis centers). More specifically, approved providers and team members are able to access, in real time, patient-care encounter documents from other care settings (eg, acute, post-acute, ambulatory) via the HIE. Additionally, approved care entities can query-retrieve web portal information to support patient outcome improvement strategies. A partnership discussion highlighted the opportunity to utilize the HIE’s capabilities, such as real-time notification, to facilitate workflow (eg, when a patient presents to the ED, the HIE can provide access to health information at the point of care). In this capacity, the alert tool notifies care team members about patient encounters to drive timely clinical engagement for care transitions.

In January 2017, we began discussions on using the HIE to facilitate real-time electronic tracking in the Cardiac Surgical Services department at our medical center. Persons involved in these discussions included the cardiovascular (CV) team (comprised of case managers, department managers and coordinators, program coordinators, administrators, and support services [eg, pre-admission testing and home health staff]) and CT surgeons. At that time, CABG readmissions were manually tracked, and the real-time notification tool was being used in other departments (eg, in case management for tracking readmissions). The entire team was part of the initial decision meeting to pursue this possibility. The CV team reached consensus in June 2017 and proposed extending the use of the alert tool to the post-CABG population presenting to the ED (or any ED affiliated with the medical center) or admitted directly to the medical center.

The HIE staff met with the Cardiac Surgical Services team to tailor and develop the logistics of the project, such as who would be notified and how. The goals of the project were to support appropriate care intervention, reduce preventable hospital readmissions, and improve quality of care through enhanced provider communication and engagement. To achieve these goals, on the day of discharge the Cardiac Surgical Services coordinator provided the HIE team with the names of patients who had undergone CABG surgery. This patient list was loaded into the alert tool and continually updated. At 31 days, patient names were removed from the list. When a patient on the list presented to the hospital ED, the alert tool sent 2 real-time electronic notifications, an email and a text message, to the Cardiac Surgical Services coordinator, noting that a patient event occurred. Personal information was not included in the alert in order to protect patient information and comply with Health Insurance Portability and Accountability Act regulations.

The alert prompted the Cardiac Surgical Services coordinator to securely access patient information to identify and, if necessary, visit the patient. Then, based on the information gathered by the Cardiac Surgical Services coordinator, a Situation-Background-Assessment-Recommendation report was relayed to the CT surgeon, who then determined whether intervention by the CT surgical team was warranted. This process, on average, took approximately 30 minutes to complete. This was a key change in processes, one that allowed post-CABG patients to be seen by the CT surgical team while in the ED. If the issue was related to the CABG surgery, the CT surgeons could then determine an appropriate course of action, including admission or implementation of another protocol, such as the home furosemide protocol. For patients directly admitted, the surgeon contacted the admitting provider to discuss the level of care required (ie, observation or inpatient admission and treatment).

Biweekly CV team meetings were conducted during the implementation of the real-time notification alert tool. At each meeting, updates were provided on notifications received, patients who were missed by the notification process, and how well the real-time alerts were working to enhance care and appropriate disposition.

Measurements

Clinical performance data included total notifications, total number of ED visits, ED disposition (inpatient admission, observation, discharge), total number of direct admissions, direct admissions to observation, direct inpatient admissions, and patients missed by the notification process (eg, due to data entry errors, omissions of information [suffix of junior or senior], as well as programming bugs). Finally, the number of observation admissions converted to inpatient admissions was collected and further analyzed to inform needed process changes.

The Cardiac Surgical Services coordinator collected, entered, and maintained data using Excel. Data were obtained from the EHR, recorded in Excel, and analyzed using basic descriptive statistics in an ongoing fashion. Particular attention was focused on problems with the notification process (eg, patients being missed due to errors in data entry) and summarizing information to keep the Cardiac Surgical Services team updated on the progress of the process improvement. This project did not require staff protections or considerations, and because this was not a research study Institutional Review Board approval was not required.

Results

This practice change was implemented in September 2017 and led to improvements in care quality, as evidenced by improved physician communication and collaboration. In the 16-month period from implementation through December 2018, the names of 614 post-CABG patients were input into the HIE for tracking. Of these patients, 47 were treated and discharged from the ED; 31 were admitted for observation; and 44 were readmitted for inpatient care. The remaining 492 patients did not have a qualifying event requiring a notification alert. Clinical performance data from this period included 70 ED visits, 21 direct admissions, 19 direct admissions to observation, 5 patients missed by the notification process, and 4 observation admissions converted to inpatient admissions. A reduction in the CABG readmission rate from 10% in September 2017 to 7.2% in December 2018 was also noted.

Discussion

The aim of this process improvement project was to determine whether a real-time electronic alert that notified the CT surgical team about post-op CABG patients presenting to the ED would result in timely patient engagement, avoidance of readmissions, and an enhanced patient experience. This practice change has been successful, following 16 months of implementation and process refinement. Integrating a real-time electronic alert with a supporting action plan and care protocols resulted in timely patient engagement and avoidance of readmission of post-CABG patients.

Early notification of possible post-CABG readmissions became a standard-of-care process within the Cardiac Surgical Services department, with expansion to all CT post-op patients. Leveraging HIE technology to support quality improvement processes was also viewed by other departments as relevant and beneficial. For example, the hospital stroke and orthopedic-spine teams established their own processes for receiving real-time alerts.

There were several lessons learned during this project. First, gaining 100% physician buy-in to collaborative communication proved to be critical to the project’s success. The CV team was surprised by the length of time (approximately 8-10 months) it took for the practice change to be adopted by the physicians. In part, some of this delay in adoption resulted from medical staff turnover, primarily in the medical resident training rotations. Collaborative communication was key. The CT surgeons spoke with ED leadership and hospitalist services to explain the readmission reduction project and the use of an electronic alert tool. The CT surgeons also communicated to the ED physicians, hospitalists, and cardiologists that the Cardiac Surgical Services coordinator would be involved in the process and discussions regarding patientss care. Additionally, the CT surgeons authored the furosemide protocol and then committed to its use in the home health setting, further highlighting the role of collaborative communication in avoiding readmissions.

Another key step in this quality improvement project was determining who should receive the alert notifications. At the onset of the project, all notifications were sent to 1 person, the Cardiac Surgical Services coordinator. While this seemed logical in the initial stage of the project, it was unsustainable, as the receipt of the alert and the subsequent notification of the CT surgeon depended on 1 person and their availability. Approximately 10 months into the project, the notification process was further refined, with the cardiovascular intensive care unit charge nurse becoming the point of contact for the alerts. The Cardiac Surgical Services coordinator, in collaboration with nursing leaders and CT surgeons, completed a Lean Standard Work template outlining the major steps and the associated responsibilities (for the cardiovascular intensive care unit charge nurse, CT surgeon and on-call surgeon, Cardiac Surgical Services coordinator) in the process of receiving notifications, collecting patient assessment data, and reporting notifications to the CT surgeons.

Establishing adequate support mechanisms during a practice change is also important. For instance, we had to dedicate personnel time for data collection and analysis and involve additional nursing or other qualified personnel in the new process to avoid depending on a single person for the project’s success. Additional considerations were establishing criteria for surgeon notification and defining an appropriate time frame for notification (eg, urgent versus next-day notifications). We accomplished these activities approximately 10 months into the project, after it became apparent at CV team meeting discussions that further clarification of criteria and timelines was needed.

Some aspects of the project unfolded as planned, while others presented opportunities for improvement. For example, the alert notification process worked as envisioned; however, as previously mentioned, the process needed to be more inclusive to ensure there is always a charge nurse on duty to receive the alert notification, rather than just the Cardiac Surgical Services coordinator, who may not always be at the hospital. The outpatient thoracentesis program was well planned and effectively implemented. This program provided an avenue for patients who had symptoms of pleural effusion to be treated in an outpatient setting, rather than requiring an inpatient stay. Opportunities for improvement included addressing the inconsistent use of the home health furosemide protocol (developed in 2016), and the need for continued interprofessional and interdepartmental communication and coordination. For example, we had to inform the ED physicians and staff who rotate or are new to the ED about established processes and protocols in place for managing post-CABG patients who present to the ED.

The primary limitation of this project was the inability to measure the enhanced patient experience, which was 1 of the stated project goals. This goal became secondary because of more pressing issues, specifically, interorganizational collaboration (eg, hospital EHR, HIE, and CT surgical team) and tailoring the functionality of the electronic alert tool to the project. Developing and implementing measures of enhanced patient experience were not feasible during this implementation. Additionally, because this was not a research study, it was not possible to determine cause and effect or to control for confounders, such as a sicker, older cohort with more comorbid conditions, during the comparison period. Finally, although this process improvement project was conducted at a regional medical center that is the only facility performing CABG within the region, patients may have presented to another facility for an event that led to a readmission. Because readmissions to other facilities could not be captured, it is possible that the actual readmission rate was higher than the rate reported here.

Conclusions and Implications

Utilizing a real-time alert from the HIE to the CT surgical team resulted in CT surgeons being immediately made aware when their patients presented to the ED, allowing the CT surgical team the opportunity to intervene, as appropriate, in the care of their patients. Furthermore, this real-time notification and intervention resulted in timely patient engagement and, in some cases, avoidance of readmissions. Currently, patients are monitored for readmission within 30 days of discharge. In the future, the time will expand to 91 days, in preparation for participation in the CMS bundle payment program for CABG surgery.

This practice change can be used in organizations that do not have or participate in a HIE. In fact, these real-time alert applications may be available through an EHR already in use within the organization. The use of the alert requires collaborative communication and having supporting protocols in place to guide decision-making and care of post-CABG patients presenting to the ED.

There appears to be a gap in the literature discussing the use of an electronic alert tool as a real-time patient engagement strategy for post-CABG patients presenting to the ED. As such, this project contributes important results and lessons learned for other hospital service lines/departments that might consider implementing a similar process. Next steps include designing and conducting methodologically rigorous research studies based on this process improvement project to examine mortality rates as an outcome, and designing a more specific measure of patient experience, as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey only provides hospital-level data.

Corresponding author: Stephanie D. Smith, PhD, RN, UNCW School of Nursing, 601 South College Road, Wilmington, NC 28403; smithsd@uncw.edu.

Funding disclosures: None.

Catheter-based renal denervation took a step closer to attaining legitimacy as a nonpharmacologic treatment for hypertension with presentation of the primary results of the SPYRAL HTN-OFF MED pivotal trial at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Mohammed Haneefa Nizamudeen/Getty Images

“We saw clinically meaningful blood pressure reductions at 3 months,” reported Michael Boehm, MD, chief of cardiology at Saarland University Hospital in Homburg, Germany.

That’s encouraging news, as renal denervation (RDN) was nearly abandoned as a potential treatment for hypertension in the wake of the unexpectedly negative results of the SYMPLICITY HTN-3 trial (N Engl J Med. 2014;370:1393-401). However, post hoc analysis of the trial revealed significant shortcomings in design and execution, and a more rigorous development program for the percutaneous device-based therapy is well underway.

The SPYRAL HTN-OFF MED pivotal trial was designed under Food and Drug Administration guidance to show whether RDN reduces blood pressure in patients with untreated hypertension. The prospective study included 331 off-medication patients in nine countries who were randomized to RDN or a sham procedure, then followed in double-blind fashion for 3 months.

The primary outcome was change in 24-hour ambulatory systolic blood pressure from baseline to 3 months. From a mean baseline 24-hour ambulatory blood pressure of 151.4/98 mm Hg, patients in the RDN group averaged a 4.7 mm Hg decrease in 24-hour SBP, which was 4 mm Hg more than in sham-treated controls. Statistically, this translated to a greater than 99.9% probability that RDN was superior to sham therapy. The RDN group also experienced a mean 3.7–mm Hg reduction in 24-hour DBP, compared with a 0.8–mm Hg decrease in controls.

Office SBP – the secondary endpoint – decreased by a mean of 9.2 mm Hg with RDN, compared with 2.5 mm Hg in controls.

These results probably understate the true antihypertensive effect of RDN for two reasons, Dr. Boehm noted. For one, previous studies have shown that the magnitude of blood pressure lowering continues to increase for up to 1-2 years following the procedure, whereas the off-medication assessment in SPYRAL HTN-OFF MED ended at 3 months for ethical and safety reasons. Also, 17% of patients in the control arm were withdrawn from the study and placed on antihypertensive medication because their office SBP reached 180 mm Hg or more, as compared to 9.6% of the RDN group.

A key finding was that RDN lowered blood pressure around the clock, including nighttime and early morning, the hours of greatest cardiovascular risk and a time when some antihypertensive medications are less effective at blood pressure control, the cardiologist observed.

The RDN safety picture was reassuring, with no strokes, myocardial infarctions, major bleeding, or acute deterioration in kidney function.

A surprising finding was that, even though participants underwent blood and urine testing for the presence of antihypertensive drugs at baseline to ensure they were off medication, and were told they would be retested at 3 months, 5%-9% nonetheless tested positive at the second test.

That elicited a comment from session chair Richard A. Chazal, MD, of Fort Myers, Fla.: “I must say, as a clinician who sometimes has trouble getting his patients to take antihypertensives, it’s fascinating that some of the people that you asked not to take the medications were taking them.”

While the primary outcome in SPYRAL HTN-OFF MED was the 3-month reduction in blood pressure while off of antihypertensive medication, the ongoing second phase of the trial may have greater clinical relevance. At 3 months, participants are being placed on antihypertensive medication and uptitrated to target, with unblinding at 6 months. The purpose is to see how many RDN recipients don’t need antihypertensive drugs, as well as whether those that do require less medication than the patients who didn’t undergo RDN.

Dr. Boehm characterized RDN as a work in progress. Two major limitations that are the focus of intense research are the lack of a predictor as to which patients are most likely to respond to what is after all an invasive procedure, and the current inability intraprocedurally to tell if sufficient RDN has been achieved.

“Frankly speaking, there is no technology during the procedure to see how efficacious the procedure was,” he explained.

Discussant Dhanunaja Lakkireddy, MD, deemed the mean 4.7–mm Hg reduction in 24-hour SBP “reasonably impressive – that’s actually a pretty good number for an antihypertensive clinical trial.” He was also favorably impressed by RDN’s safety in a 44-site study.

“The drops in blood pressure are not enough to really make a case for renal denervation to be a standalone therapy. But adding it as an adjunct to standard medications may be a very reasonable strategy to adopt. This is a fantastic signal for something that can be brought along as a long-term add-on to antihypertensive medications,” commented Dr. Lakkireddy, chair of the ACC Electrophysiology Council and medical director of the Kansas City Heart Rhythm Institute.

Simultaneous with Dr. Boehm’s presentation, the SPYRAL HTN-OFF MED Pivotal Trial details were published online (Lancet 2020 Mar 29. doi: 10.1016/S0140-6736(20)30554-7).

The study was sponsored by Medtronic. Dr. Boehm reported serving as a consultant to that company and Abbott, Amgen, Astra, Boehringer-Ingelheim, Cytokinetics, Novartis, ReCor, Servier, and Vifor.

bjancin@mdedge.com

SOURCE: Boehm M. ACC 2020, Abstract 406-15.

Catheter-based renal denervation took a step closer to attaining legitimacy as a nonpharmacologic treatment for hypertension with presentation of the primary results of the SPYRAL HTN-OFF MED pivotal trial at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Mohammed Haneefa Nizamudeen/Getty Images

“We saw clinically meaningful blood pressure reductions at 3 months,” reported Michael Boehm, MD, chief of cardiology at Saarland University Hospital in Homburg, Germany.

That’s encouraging news, as renal denervation (RDN) was nearly abandoned as a potential treatment for hypertension in the wake of the unexpectedly negative results of the SYMPLICITY HTN-3 trial (N Engl J Med. 2014;370:1393-401). However, post hoc analysis of the trial revealed significant shortcomings in design and execution, and a more rigorous development program for the percutaneous device-based therapy is well underway.

The SPYRAL HTN-OFF MED pivotal trial was designed under Food and Drug Administration guidance to show whether RDN reduces blood pressure in patients with untreated hypertension. The prospective study included 331 off-medication patients in nine countries who were randomized to RDN or a sham procedure, then followed in double-blind fashion for 3 months.

The primary outcome was change in 24-hour ambulatory systolic blood pressure from baseline to 3 months. From a mean baseline 24-hour ambulatory blood pressure of 151.4/98 mm Hg, patients in the RDN group averaged a 4.7 mm Hg decrease in 24-hour SBP, which was 4 mm Hg more than in sham-treated controls. Statistically, this translated to a greater than 99.9% probability that RDN was superior to sham therapy. The RDN group also experienced a mean 3.7–mm Hg reduction in 24-hour DBP, compared with a 0.8–mm Hg decrease in controls.

Office SBP – the secondary endpoint – decreased by a mean of 9.2 mm Hg with RDN, compared with 2.5 mm Hg in controls.

These results probably understate the true antihypertensive effect of RDN for two reasons, Dr. Boehm noted. For one, previous studies have shown that the magnitude of blood pressure lowering continues to increase for up to 1-2 years following the procedure, whereas the off-medication assessment in SPYRAL HTN-OFF MED ended at 3 months for ethical and safety reasons. Also, 17% of patients in the control arm were withdrawn from the study and placed on antihypertensive medication because their office SBP reached 180 mm Hg or more, as compared to 9.6% of the RDN group.

A key finding was that RDN lowered blood pressure around the clock, including nighttime and early morning, the hours of greatest cardiovascular risk and a time when some antihypertensive medications are less effective at blood pressure control, the cardiologist observed.

The RDN safety picture was reassuring, with no strokes, myocardial infarctions, major bleeding, or acute deterioration in kidney function.

A surprising finding was that, even though participants underwent blood and urine testing for the presence of antihypertensive drugs at baseline to ensure they were off medication, and were told they would be retested at 3 months, 5%-9% nonetheless tested positive at the second test.

That elicited a comment from session chair Richard A. Chazal, MD, of Fort Myers, Fla.: “I must say, as a clinician who sometimes has trouble getting his patients to take antihypertensives, it’s fascinating that some of the people that you asked not to take the medications were taking them.”

While the primary outcome in SPYRAL HTN-OFF MED was the 3-month reduction in blood pressure while off of antihypertensive medication, the ongoing second phase of the trial may have greater clinical relevance. At 3 months, participants are being placed on antihypertensive medication and uptitrated to target, with unblinding at 6 months. The purpose is to see how many RDN recipients don’t need antihypertensive drugs, as well as whether those that do require less medication than the patients who didn’t undergo RDN.

Dr. Boehm characterized RDN as a work in progress. Two major limitations that are the focus of intense research are the lack of a predictor as to which patients are most likely to respond to what is after all an invasive procedure, and the current inability intraprocedurally to tell if sufficient RDN has been achieved.

“Frankly speaking, there is no technology during the procedure to see how efficacious the procedure was,” he explained.

Discussant Dhanunaja Lakkireddy, MD, deemed the mean 4.7–mm Hg reduction in 24-hour SBP “reasonably impressive – that’s actually a pretty good number for an antihypertensive clinical trial.” He was also favorably impressed by RDN’s safety in a 44-site study.

“The drops in blood pressure are not enough to really make a case for renal denervation to be a standalone therapy. But adding it as an adjunct to standard medications may be a very reasonable strategy to adopt. This is a fantastic signal for something that can be brought along as a long-term add-on to antihypertensive medications,” commented Dr. Lakkireddy, chair of the ACC Electrophysiology Council and medical director of the Kansas City Heart Rhythm Institute.

Simultaneous with Dr. Boehm’s presentation, the SPYRAL HTN-OFF MED Pivotal Trial details were published online (Lancet 2020 Mar 29. doi: 10.1016/S0140-6736(20)30554-7).

The study was sponsored by Medtronic. Dr. Boehm reported serving as a consultant to that company and Abbott, Amgen, Astra, Boehringer-Ingelheim, Cytokinetics, Novartis, ReCor, Servier, and Vifor.

bjancin@mdedge.com

SOURCE: Boehm M. ACC 2020, Abstract 406-15.

Catheter-based renal denervation took a step closer to attaining legitimacy as a nonpharmacologic treatment for hypertension with presentation of the primary results of the SPYRAL HTN-OFF MED pivotal trial at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Mohammed Haneefa Nizamudeen/Getty Images

“We saw clinically meaningful blood pressure reductions at 3 months,” reported Michael Boehm, MD, chief of cardiology at Saarland University Hospital in Homburg, Germany.

That’s encouraging news, as renal denervation (RDN) was nearly abandoned as a potential treatment for hypertension in the wake of the unexpectedly negative results of the SYMPLICITY HTN-3 trial (N Engl J Med. 2014;370:1393-401). However, post hoc analysis of the trial revealed significant shortcomings in design and execution, and a more rigorous development program for the percutaneous device-based therapy is well underway.

The SPYRAL HTN-OFF MED pivotal trial was designed under Food and Drug Administration guidance to show whether RDN reduces blood pressure in patients with untreated hypertension. The prospective study included 331 off-medication patients in nine countries who were randomized to RDN or a sham procedure, then followed in double-blind fashion for 3 months.

The primary outcome was change in 24-hour ambulatory systolic blood pressure from baseline to 3 months. From a mean baseline 24-hour ambulatory blood pressure of 151.4/98 mm Hg, patients in the RDN group averaged a 4.7 mm Hg decrease in 24-hour SBP, which was 4 mm Hg more than in sham-treated controls. Statistically, this translated to a greater than 99.9% probability that RDN was superior to sham therapy. The RDN group also experienced a mean 3.7–mm Hg reduction in 24-hour DBP, compared with a 0.8–mm Hg decrease in controls.

Office SBP – the secondary endpoint – decreased by a mean of 9.2 mm Hg with RDN, compared with 2.5 mm Hg in controls.

These results probably understate the true antihypertensive effect of RDN for two reasons, Dr. Boehm noted. For one, previous studies have shown that the magnitude of blood pressure lowering continues to increase for up to 1-2 years following the procedure, whereas the off-medication assessment in SPYRAL HTN-OFF MED ended at 3 months for ethical and safety reasons. Also, 17% of patients in the control arm were withdrawn from the study and placed on antihypertensive medication because their office SBP reached 180 mm Hg or more, as compared to 9.6% of the RDN group.

A key finding was that RDN lowered blood pressure around the clock, including nighttime and early morning, the hours of greatest cardiovascular risk and a time when some antihypertensive medications are less effective at blood pressure control, the cardiologist observed.

The RDN safety picture was reassuring, with no strokes, myocardial infarctions, major bleeding, or acute deterioration in kidney function.

A surprising finding was that, even though participants underwent blood and urine testing for the presence of antihypertensive drugs at baseline to ensure they were off medication, and were told they would be retested at 3 months, 5%-9% nonetheless tested positive at the second test.

That elicited a comment from session chair Richard A. Chazal, MD, of Fort Myers, Fla.: “I must say, as a clinician who sometimes has trouble getting his patients to take antihypertensives, it’s fascinating that some of the people that you asked not to take the medications were taking them.”

While the primary outcome in SPYRAL HTN-OFF MED was the 3-month reduction in blood pressure while off of antihypertensive medication, the ongoing second phase of the trial may have greater clinical relevance. At 3 months, participants are being placed on antihypertensive medication and uptitrated to target, with unblinding at 6 months. The purpose is to see how many RDN recipients don’t need antihypertensive drugs, as well as whether those that do require less medication than the patients who didn’t undergo RDN.

Dr. Boehm characterized RDN as a work in progress. Two major limitations that are the focus of intense research are the lack of a predictor as to which patients are most likely to respond to what is after all an invasive procedure, and the current inability intraprocedurally to tell if sufficient RDN has been achieved.

“Frankly speaking, there is no technology during the procedure to see how efficacious the procedure was,” he explained.

Discussant Dhanunaja Lakkireddy, MD, deemed the mean 4.7–mm Hg reduction in 24-hour SBP “reasonably impressive – that’s actually a pretty good number for an antihypertensive clinical trial.” He was also favorably impressed by RDN’s safety in a 44-site study.

“The drops in blood pressure are not enough to really make a case for renal denervation to be a standalone therapy. But adding it as an adjunct to standard medications may be a very reasonable strategy to adopt. This is a fantastic signal for something that can be brought along as a long-term add-on to antihypertensive medications,” commented Dr. Lakkireddy, chair of the ACC Electrophysiology Council and medical director of the Kansas City Heart Rhythm Institute.

Simultaneous with Dr. Boehm’s presentation, the SPYRAL HTN-OFF MED Pivotal Trial details were published online (Lancet 2020 Mar 29. doi: 10.1016/S0140-6736(20)30554-7).

The study was sponsored by Medtronic. Dr. Boehm reported serving as a consultant to that company and Abbott, Amgen, Astra, Boehringer-Ingelheim, Cytokinetics, Novartis, ReCor, Servier, and Vifor.

bjancin@mdedge.com

SOURCE: Boehm M. ACC 2020, Abstract 406-15.

The long-sought goal of measuring the quality of U.S. transcatheter aortic valve replacement (TAVR) programs by patient outcomes rather than by the surrogate measure of case volume is about to be realized.

Starting more or less immediately, the U.S. national register for all TAVR cases that’s mandated by Food and Drug Administration labeling of these devices and run through a collaboration of the American College of Cardiology and the Society of Thoracic Surgeons will start applying a newly developed and validated five-item metric for measuring 30-day patient outcomes and designed to gauge the quality of TAVR programs.

At first, the only recipients of the data will be the programs themselves, but starting in about a year, by sometime in 2021, the STS/ACC TVT (transcatheter valve therapy) Registry will start to make its star-based rating of TAVR programs available to the public, Nimesh D. Desai, MD, said on March 29 at the joint scientific sessions of the ACC and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic. These societies already make star-based ratings of U.S. programs available to the public for several other types of cardiac interventions, including coronary artery bypass surgery and MI management.

The new, composite metric based on 30-day outcome data “is appropriate for high-stakes applications such as public reporting,” said Dr. Desai, a thoracic surgeon and director of thoracic aortic surgery research at the University of Pennsylvania in Philadelphia. “We’re confident this model can be used for public reporting. It’s undergone extensive testing of its validity.” The steering committee of the STS/ACC TVT Registry commissioned development of the metric, and it’s now “considered approved,” and ready for use, he explained.

To create the new metric, Dr. Desai and his associates used data from 52,561 patients who underwent transfemoral TAVR during 2015-2017 at any of 301 U.S. sites. These data came from a total pool of more than 114,000 patients at 556 sites, but data from many sites weren’t usable because they were not adequately complete. The researchers then identified the top four measures taken during the 30 days following intervention (hospitalization included) that best correlated with 1-year survival and patients’ quality-of-life scores on the Kansas City Cardiomyopathy Questionnaire: stroke; major, life-threatening, or disabling bleed; acute kidney injury (stage III); and moderate or severe paravalvular leak. These outcomes “matter most to patients,” Dr. Desai said.

They used these four outcomes plus 30-day mortality to calculate the programs’ ratings. Among the 52,561 patients, 14% had at least one of these adverse outcomes. The researchers then used a logistic regression model that adjusted for 46 measured variables to calculate how each program performed relative to the average performance of all the programs. Programs with outcomes that fell within the 95% confidence intervals of average performance were rated as performing as expected; those outside rated as performing either better or worse than expected. The results showed 34 centers (11%) had worse than expected outcomes and 25 (8%) had better than expected outcomes, Dr. Desai said.

“This is a major step forward in measuring TAVR quality,” commented Michael Mack, MD, a cardiac surgeon with Baylor Scott & White Health in Dallas who has been very active in studying TAVR. “Until now, we used volume as a surrogate for quality, but the precision was not great. This is an extremely welcome metric.” The next step is to eventually use 1-year follow-up data instead of 30-day outcomes, he added.

“With the rapid expansion of TAVR over the past 6-8 years, we’re now at the point to start to do this. It’s an ethical obligation This will be one of the most high-fidelity, valid models for public reporting” of clinical outcomes,” said Joseph Cleveland, MD, a professor of surgery at the University of Colorado at Denver in Aurora. “It’s reassuring that about 90% of the program performed as expected or better than expected,” he added.

“Transparency and outcomes should drive how TAVR is delivered,” commented Ashish Pershad, MD, an interventional cardiologist at Banner-University Medicine Heart Institute in Phoenix who estimated that he performs about 150 TAVR procedures annually. “This is a step forward. I’ve been waiting for this for a long time. Until now, volume has been used as a surrogate outcome, but we know it’s not accurate. I’m confident that this model is a good starting point.” But Dr. Pershad also had concern that this new approach “can lend itself to some degree of gaming,” like a bleeding event getting classified as minor when it was really major, or outlier patients getting dropped from reports.

The temptation to cut corners may be higher for TAVR than it’s been for the cardiac-disease metrics that already get publicly reported, like bypass surgery and myocardial infarction management, because of TAVR’s higher cost and higher profile, Dr. Pershad said. Existing measures “have not been as linked to financial disincentive as TAVR might be” because TAVR reimbursements can run as high as $50,000 per case. “The stakes with TAVR are higher,” he said.

Ultimately, the reliable examination of TAVR outcomes that this new metric allows may lead to a shake-up of TAVR programs, Dr. Pershad predicted. “This is clearly a step toward closing down some programs that [consistently] underperform.”

The STS/ACC TVT Registry receives no commercial funding. Dr. Desai has been a consultant to, speaker on behalf of, and received research funding from Gore, and he has also spoken on behalf of Cook, Medtronic, and Terumo Aortic. Dr. Cleveland, Dr. Mack, and Dr. Pershad had no disclosures.

mzoler@mdedge.com

The long-sought goal of measuring the quality of U.S. transcatheter aortic valve replacement (TAVR) programs by patient outcomes rather than by the surrogate measure of case volume is about to be realized.

Starting more or less immediately, the U.S. national register for all TAVR cases that’s mandated by Food and Drug Administration labeling of these devices and run through a collaboration of the American College of Cardiology and the Society of Thoracic Surgeons will start applying a newly developed and validated five-item metric for measuring 30-day patient outcomes and designed to gauge the quality of TAVR programs.

At first, the only recipients of the data will be the programs themselves, but starting in about a year, by sometime in 2021, the STS/ACC TVT (transcatheter valve therapy) Registry will start to make its star-based rating of TAVR programs available to the public, Nimesh D. Desai, MD, said on March 29 at the joint scientific sessions of the ACC and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic. These societies already make star-based ratings of U.S. programs available to the public for several other types of cardiac interventions, including coronary artery bypass surgery and MI management.

The new, composite metric based on 30-day outcome data “is appropriate for high-stakes applications such as public reporting,” said Dr. Desai, a thoracic surgeon and director of thoracic aortic surgery research at the University of Pennsylvania in Philadelphia. “We’re confident this model can be used for public reporting. It’s undergone extensive testing of its validity.” The steering committee of the STS/ACC TVT Registry commissioned development of the metric, and it’s now “considered approved,” and ready for use, he explained.

To create the new metric, Dr. Desai and his associates used data from 52,561 patients who underwent transfemoral TAVR during 2015-2017 at any of 301 U.S. sites. These data came from a total pool of more than 114,000 patients at 556 sites, but data from many sites weren’t usable because they were not adequately complete. The researchers then identified the top four measures taken during the 30 days following intervention (hospitalization included) that best correlated with 1-year survival and patients’ quality-of-life scores on the Kansas City Cardiomyopathy Questionnaire: stroke; major, life-threatening, or disabling bleed; acute kidney injury (stage III); and moderate or severe paravalvular leak. These outcomes “matter most to patients,” Dr. Desai said.

They used these four outcomes plus 30-day mortality to calculate the programs’ ratings. Among the 52,561 patients, 14% had at least one of these adverse outcomes. The researchers then used a logistic regression model that adjusted for 46 measured variables to calculate how each program performed relative to the average performance of all the programs. Programs with outcomes that fell within the 95% confidence intervals of average performance were rated as performing as expected; those outside rated as performing either better or worse than expected. The results showed 34 centers (11%) had worse than expected outcomes and 25 (8%) had better than expected outcomes, Dr. Desai said.

“This is a major step forward in measuring TAVR quality,” commented Michael Mack, MD, a cardiac surgeon with Baylor Scott & White Health in Dallas who has been very active in studying TAVR. “Until now, we used volume as a surrogate for quality, but the precision was not great. This is an extremely welcome metric.” The next step is to eventually use 1-year follow-up data instead of 30-day outcomes, he added.

“With the rapid expansion of TAVR over the past 6-8 years, we’re now at the point to start to do this. It’s an ethical obligation This will be one of the most high-fidelity, valid models for public reporting” of clinical outcomes,” said Joseph Cleveland, MD, a professor of surgery at the University of Colorado at Denver in Aurora. “It’s reassuring that about 90% of the program performed as expected or better than expected,” he added.

“Transparency and outcomes should drive how TAVR is delivered,” commented Ashish Pershad, MD, an interventional cardiologist at Banner-University Medicine Heart Institute in Phoenix who estimated that he performs about 150 TAVR procedures annually. “This is a step forward. I’ve been waiting for this for a long time. Until now, volume has been used as a surrogate outcome, but we know it’s not accurate. I’m confident that this model is a good starting point.” But Dr. Pershad also had concern that this new approach “can lend itself to some degree of gaming,” like a bleeding event getting classified as minor when it was really major, or outlier patients getting dropped from reports.

The temptation to cut corners may be higher for TAVR than it’s been for the cardiac-disease metrics that already get publicly reported, like bypass surgery and myocardial infarction management, because of TAVR’s higher cost and higher profile, Dr. Pershad said. Existing measures “have not been as linked to financial disincentive as TAVR might be” because TAVR reimbursements can run as high as $50,000 per case. “The stakes with TAVR are higher,” he said.

Ultimately, the reliable examination of TAVR outcomes that this new metric allows may lead to a shake-up of TAVR programs, Dr. Pershad predicted. “This is clearly a step toward closing down some programs that [consistently] underperform.”

The STS/ACC TVT Registry receives no commercial funding. Dr. Desai has been a consultant to, speaker on behalf of, and received research funding from Gore, and he has also spoken on behalf of Cook, Medtronic, and Terumo Aortic. Dr. Cleveland, Dr. Mack, and Dr. Pershad had no disclosures.

mzoler@mdedge.com

The long-sought goal of measuring the quality of U.S. transcatheter aortic valve replacement (TAVR) programs by patient outcomes rather than by the surrogate measure of case volume is about to be realized.

Starting more or less immediately, the U.S. national register for all TAVR cases that’s mandated by Food and Drug Administration labeling of these devices and run through a collaboration of the American College of Cardiology and the Society of Thoracic Surgeons will start applying a newly developed and validated five-item metric for measuring 30-day patient outcomes and designed to gauge the quality of TAVR programs.

At first, the only recipients of the data will be the programs themselves, but starting in about a year, by sometime in 2021, the STS/ACC TVT (transcatheter valve therapy) Registry will start to make its star-based rating of TAVR programs available to the public, Nimesh D. Desai, MD, said on March 29 at the joint scientific sessions of the ACC and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic. These societies already make star-based ratings of U.S. programs available to the public for several other types of cardiac interventions, including coronary artery bypass surgery and MI management.

The new, composite metric based on 30-day outcome data “is appropriate for high-stakes applications such as public reporting,” said Dr. Desai, a thoracic surgeon and director of thoracic aortic surgery research at the University of Pennsylvania in Philadelphia. “We’re confident this model can be used for public reporting. It’s undergone extensive testing of its validity.” The steering committee of the STS/ACC TVT Registry commissioned development of the metric, and it’s now “considered approved,” and ready for use, he explained.

To create the new metric, Dr. Desai and his associates used data from 52,561 patients who underwent transfemoral TAVR during 2015-2017 at any of 301 U.S. sites. These data came from a total pool of more than 114,000 patients at 556 sites, but data from many sites weren’t usable because they were not adequately complete. The researchers then identified the top four measures taken during the 30 days following intervention (hospitalization included) that best correlated with 1-year survival and patients’ quality-of-life scores on the Kansas City Cardiomyopathy Questionnaire: stroke; major, life-threatening, or disabling bleed; acute kidney injury (stage III); and moderate or severe paravalvular leak. These outcomes “matter most to patients,” Dr. Desai said.

They used these four outcomes plus 30-day mortality to calculate the programs’ ratings. Among the 52,561 patients, 14% had at least one of these adverse outcomes. The researchers then used a logistic regression model that adjusted for 46 measured variables to calculate how each program performed relative to the average performance of all the programs. Programs with outcomes that fell within the 95% confidence intervals of average performance were rated as performing as expected; those outside rated as performing either better or worse than expected. The results showed 34 centers (11%) had worse than expected outcomes and 25 (8%) had better than expected outcomes, Dr. Desai said.

“This is a major step forward in measuring TAVR quality,” commented Michael Mack, MD, a cardiac surgeon with Baylor Scott & White Health in Dallas who has been very active in studying TAVR. “Until now, we used volume as a surrogate for quality, but the precision was not great. This is an extremely welcome metric.” The next step is to eventually use 1-year follow-up data instead of 30-day outcomes, he added.

“With the rapid expansion of TAVR over the past 6-8 years, we’re now at the point to start to do this. It’s an ethical obligation This will be one of the most high-fidelity, valid models for public reporting” of clinical outcomes,” said Joseph Cleveland, MD, a professor of surgery at the University of Colorado at Denver in Aurora. “It’s reassuring that about 90% of the program performed as expected or better than expected,” he added.

“Transparency and outcomes should drive how TAVR is delivered,” commented Ashish Pershad, MD, an interventional cardiologist at Banner-University Medicine Heart Institute in Phoenix who estimated that he performs about 150 TAVR procedures annually. “This is a step forward. I’ve been waiting for this for a long time. Until now, volume has been used as a surrogate outcome, but we know it’s not accurate. I’m confident that this model is a good starting point.” But Dr. Pershad also had concern that this new approach “can lend itself to some degree of gaming,” like a bleeding event getting classified as minor when it was really major, or outlier patients getting dropped from reports.

The temptation to cut corners may be higher for TAVR than it’s been for the cardiac-disease metrics that already get publicly reported, like bypass surgery and myocardial infarction management, because of TAVR’s higher cost and higher profile, Dr. Pershad said. Existing measures “have not been as linked to financial disincentive as TAVR might be” because TAVR reimbursements can run as high as $50,000 per case. “The stakes with TAVR are higher,” he said.

Ultimately, the reliable examination of TAVR outcomes that this new metric allows may lead to a shake-up of TAVR programs, Dr. Pershad predicted. “This is clearly a step toward closing down some programs that [consistently] underperform.”

The STS/ACC TVT Registry receives no commercial funding. Dr. Desai has been a consultant to, speaker on behalf of, and received research funding from Gore, and he has also spoken on behalf of Cook, Medtronic, and Terumo Aortic. Dr. Cleveland, Dr. Mack, and Dr. Pershad had no disclosures.

mzoler@mdedge.com

In the COMPASS trial of patients with stable coronary or peripheral artery disease (PAD), the combination of aspirin plus rivaroxaban, 2.5 mg twice daily, provided a larger absolute benefit on cardiovascular endpoints — including a threefold greater reduction in all-cause mortality — in patients with diabetes compared with the overall population.

The results of the diabetes subset of the COMPASS trial were presented by Deepak Bhatt, MD, Brigham and Women’s Hospital Heart & Vascular Center, Boston, Massachusetts, on March 28 at the “virtual” American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC). They were also simultaneously published online in Circulation.

“Use of dual pathway inhibition with low-dose rivaroxaban plus aspirin is particularly attractive in high-risk patients such as those with diabetes,” Bhatt concluded.

The COMPASS trial was first reported in 2017 and showed a new low dose of rivaroxaban (2.5-mg twice-daily; Xarelto, Bayer/Janssen Pharmaceuticals) plus aspirin, 100 mg once daily, was associated with a reduction in ischemic events and mortality and a superior net clinical benefit, balancing ischemic benefit with severe bleeding, compared with aspirin alone for secondary prevention in patients with stable atherosclerotic vascular disease.

But clinicians have been slow to prescribe rivaroxaban in this new and very large population.

“It’s been more than 2 years now since main COMPASS results, and there isn’t a sense that this therapy has really caught on,” chair of the current ACC session at which the diabetes subgroup results were presented, Hadley Wilson, MD, Sanger Heart and Vascular Institute, Charlotte, North Carolina, commented:

He asked Bhatt whether the diabetes subgroup may be “the tipping point that will make people aware of rivaroxaban and then that may trickle down to other patients.”

Bhatt said that he hoped that would be the case. “We as a steering committee of this trial could say the results were positive so rivaroxaban should now be used in everyone with stable coronary or peripheral arterial disease, but that is impractical and as you out point out it hasn’t happened,” he replied.

“In PAD/vascular medicine we have embraced this new therapy. In the broader cardiology world there are a lot of patients with stable coronary arterial disease at high ischemic risk who could take rivaroxaban, but its use is bound to be limited by it being a branded drug and the fact that there is a bleeding risk,” Bhatt explained.

“I think we need to identify patients with the highest ischemic risk and focus drugs such as these with a financial cost and a bleeding risk on those who most likely will derive the greatest absolute reduction in risk,” he said. “The PAD subgroup is one group where this is the case, and now we have shown the diabetes subgroup is another. And there is no incremental bleeding risk in this group over the whole population, so they get a much greater benefit without a greater risk. I hope this helps get rivaroxaban at the new lower dose used much more often.”

A total of 18,278 patients were randomly assigned to the combination of rivaroxaban and aspirin or aspirin alone in the COMPASS trial. Of these, 6922 had diabetes mellitus at baseline and 11,356 did not have diabetes.

Results from the current analysis show a consistent and similar relative risk reduction for benefit of rivaroxaban plus aspirin vs placebo plus aspirin in patients both with and without diabetes for the primary efficacy endpoint, a composite of cardiovascular death, myocardial infarction (MI), or stroke, with a hazard ratio of 0.74 for patients with diabetes and 0.77 for those without diabetes, the researchers report.

Because of the higher baseline risk in the diabetes subgroup, these patients had numerically larger absolute risk reductions with rivaroxaban than those without diabetes for the primary efficacy endpoint at 3 years (2.3% vs 1.4%) and for all-cause mortality (1.9% vs 0.6%).

These results translate into a number needed to treat (NNT) with rivaroxaban for 3 years to prevent one CV death, MI, or stroke of 44 for the diabetes group vs 73 for the nondiabetes group; the NNT to prevent one all-cause death was 54 for the diabetes group vs 167 for the nondiabetes group, the authors write.

Because the bleeding hazards were similar among patients with and without diabetes, the absolute net clinical benefit (MI, stroke, cardiovascular death, or bleeding leading to death or symptomatic bleeding into a critical organ) for rivaroxaban was “particularly favorable” in the diabetes group (2.7% fewer events in the diabetes group vs 1.0% fewer events in the nondiabetes group), they add.

Panelist at the ACC Featured Clinical Research session at which these results were presented, Jennifer Robinson, MD, University of Iowa College of Public Health, Iowa City, asked Bhatt how clinicians were supposed to decide which of the many new agents now becoming available for patients with stable coronary artery disease to prescribe first.

“We often forget about rivaroxaban when we’re thinking about what to add next for our secondary prevention patients,” she said. “You also led the REDUCE-IT trial showing benefit of icosapent ethyl, icosapent ethyl icosapent ethyl icosapent ethyl and there is also ezetimibe, PCSK9 inhibitors and SGLT2 inhibitors. For your patients with coronary disease who are already on a high dose statin which one of these would you add next?”

“That is what physicians need to ponder all the time,” Bhatt replied. “And when a patient has several risk factors that are not well controlled, I guess it’s all important. I go through a checklist with my patients and try and figure what they’re not on that could further reduce their risk.”

“In the COMPASS trial there was an overall positive result with rivaroxaban in the whole population. And now we have shown that patients with diabetes had an even greater absolute risk reduction. That pattern has also been seen with other classes of agents including the statins, PCSK9 inhibitors, and icosapent ethyl,” Bhatt noted.

“In patients with diabetes, I will usually target whatever is standing out most at that time. If their glycemic control is completely out of whack, then that is what I would focus on first, and these days often with a SGLT2 inhibitor or GLP-1 agonist. If the LDL was out of control, I would add ezetimibe or a PCSK9 inhibitor. If the triglycerides were high, I would add icosapent ethyl. If multiple things were out of control, I would usually focus on the number most out of kilter first and try not to forget about everything else.”

But Bhatt noted that the challenge with rivaroxaban is that there is no test of thrombosis risk that would prompt the physician to take action. “Basically, the doctor just has to remember to do it. In that regard I would consider whether patients are at low bleeding risk and are they still at high ischemic risk despite controlling other risk factors and, if so, then I would add this low dose of rivaroxaban.”

Another panel member, Sekar Kathiresan, MD, asked Bhatt whether he recommended using available scores to assess the bleeding/thrombosis risk/benefits of adding an antithrombotic.

Bhatt replied: “That’s a terrific question. I guess the right answer is that we should be doing that, but in reality I have to concede that I don’t use these scores. They have shown appropriate C statistics in populations, but they are not fantastic in individual patients.”

“I have to confess that I use the eyeball test. There is nothing as good at predicting future bleeding as past bleeding. So if a patient has had bleeding problems on aspirin alone I wouldn’t add rivaroxaban. But if a patient hasn’t bled before, especially if they had some experience of dual antiplatelet therapy, then they would be good candidates for a low vascular dose of rivaroxaban,” he said.

“It is not as easy as with other drugs as there is always a bleeding trade-off with an antithrombotic. There is no such thing as a free lunch. So patients need careful assessment when considering prescribing rivaroxaban and regular reassessment over time to check if they have had any bleeding,” he added.

The COMPASS study was funded by Bayer. Bhatt reports honoraria from Bayer via the Population Health Research Institute for his role on the COMPASS trial and other research funding from Bayer to the Brigham & Women’s Hospital.

American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC). Abstract 20-LB-20544-ACC. Presented March 28, 2020.

Circulation. Published online March 28, 2020. Full text.

This article first appeared on Medscape.com.

In the COMPASS trial of patients with stable coronary or peripheral artery disease (PAD), the combination of aspirin plus rivaroxaban, 2.5 mg twice daily, provided a larger absolute benefit on cardiovascular endpoints — including a threefold greater reduction in all-cause mortality — in patients with diabetes compared with the overall population.

The results of the diabetes subset of the COMPASS trial were presented by Deepak Bhatt, MD, Brigham and Women’s Hospital Heart & Vascular Center, Boston, Massachusetts, on March 28 at the “virtual” American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC). They were also simultaneously published online in Circulation.

“Use of dual pathway inhibition with low-dose rivaroxaban plus aspirin is particularly attractive in high-risk patients such as those with diabetes,” Bhatt concluded.

The COMPASS trial was first reported in 2017 and showed a new low dose of rivaroxaban (2.5-mg twice-daily; Xarelto, Bayer/Janssen Pharmaceuticals) plus aspirin, 100 mg once daily, was associated with a reduction in ischemic events and mortality and a superior net clinical benefit, balancing ischemic benefit with severe bleeding, compared with aspirin alone for secondary prevention in patients with stable atherosclerotic vascular disease.

But clinicians have been slow to prescribe rivaroxaban in this new and very large population.

“It’s been more than 2 years now since main COMPASS results, and there isn’t a sense that this therapy has really caught on,” chair of the current ACC session at which the diabetes subgroup results were presented, Hadley Wilson, MD, Sanger Heart and Vascular Institute, Charlotte, North Carolina, commented:

He asked Bhatt whether the diabetes subgroup may be “the tipping point that will make people aware of rivaroxaban and then that may trickle down to other patients.”

Bhatt said that he hoped that would be the case. “We as a steering committee of this trial could say the results were positive so rivaroxaban should now be used in everyone with stable coronary or peripheral arterial disease, but that is impractical and as you out point out it hasn’t happened,” he replied.

“In PAD/vascular medicine we have embraced this new therapy. In the broader cardiology world there are a lot of patients with stable coronary arterial disease at high ischemic risk who could take rivaroxaban, but its use is bound to be limited by it being a branded drug and the fact that there is a bleeding risk,” Bhatt explained.

“I think we need to identify patients with the highest ischemic risk and focus drugs such as these with a financial cost and a bleeding risk on those who most likely will derive the greatest absolute reduction in risk,” he said. “The PAD subgroup is one group where this is the case, and now we have shown the diabetes subgroup is another. And there is no incremental bleeding risk in this group over the whole population, so they get a much greater benefit without a greater risk. I hope this helps get rivaroxaban at the new lower dose used much more often.”

A total of 18,278 patients were randomly assigned to the combination of rivaroxaban and aspirin or aspirin alone in the COMPASS trial. Of these, 6922 had diabetes mellitus at baseline and 11,356 did not have diabetes.

Results from the current analysis show a consistent and similar relative risk reduction for benefit of rivaroxaban plus aspirin vs placebo plus aspirin in patients both with and without diabetes for the primary efficacy endpoint, a composite of cardiovascular death, myocardial infarction (MI), or stroke, with a hazard ratio of 0.74 for patients with diabetes and 0.77 for those without diabetes, the researchers report.

Because of the higher baseline risk in the diabetes subgroup, these patients had numerically larger absolute risk reductions with rivaroxaban than those without diabetes for the primary efficacy endpoint at 3 years (2.3% vs 1.4%) and for all-cause mortality (1.9% vs 0.6%).

These results translate into a number needed to treat (NNT) with rivaroxaban for 3 years to prevent one CV death, MI, or stroke of 44 for the diabetes group vs 73 for the nondiabetes group; the NNT to prevent one all-cause death was 54 for the diabetes group vs 167 for the nondiabetes group, the authors write.

Because the bleeding hazards were similar among patients with and without diabetes, the absolute net clinical benefit (MI, stroke, cardiovascular death, or bleeding leading to death or symptomatic bleeding into a critical organ) for rivaroxaban was “particularly favorable” in the diabetes group (2.7% fewer events in the diabetes group vs 1.0% fewer events in the nondiabetes group), they add.

Panelist at the ACC Featured Clinical Research session at which these results were presented, Jennifer Robinson, MD, University of Iowa College of Public Health, Iowa City, asked Bhatt how clinicians were supposed to decide which of the many new agents now becoming available for patients with stable coronary artery disease to prescribe first.

“We often forget about rivaroxaban when we’re thinking about what to add next for our secondary prevention patients,” she said. “You also led the REDUCE-IT trial showing benefit of icosapent ethyl, icosapent ethyl icosapent ethyl icosapent ethyl and there is also ezetimibe, PCSK9 inhibitors and SGLT2 inhibitors. For your patients with coronary disease who are already on a high dose statin which one of these would you add next?”

“That is what physicians need to ponder all the time,” Bhatt replied. “And when a patient has several risk factors that are not well controlled, I guess it’s all important. I go through a checklist with my patients and try and figure what they’re not on that could further reduce their risk.”

“In the COMPASS trial there was an overall positive result with rivaroxaban in the whole population. And now we have shown that patients with diabetes had an even greater absolute risk reduction. That pattern has also been seen with other classes of agents including the statins, PCSK9 inhibitors, and icosapent ethyl,” Bhatt noted.

“In patients with diabetes, I will usually target whatever is standing out most at that time. If their glycemic control is completely out of whack, then that is what I would focus on first, and these days often with a SGLT2 inhibitor or GLP-1 agonist. If the LDL was out of control, I would add ezetimibe or a PCSK9 inhibitor. If the triglycerides were high, I would add icosapent ethyl. If multiple things were out of control, I would usually focus on the number most out of kilter first and try not to forget about everything else.”

But Bhatt noted that the challenge with rivaroxaban is that there is no test of thrombosis risk that would prompt the physician to take action. “Basically, the doctor just has to remember to do it. In that regard I would consider whether patients are at low bleeding risk and are they still at high ischemic risk despite controlling other risk factors and, if so, then I would add this low dose of rivaroxaban.”

Another panel member, Sekar Kathiresan, MD, asked Bhatt whether he recommended using available scores to assess the bleeding/thrombosis risk/benefits of adding an antithrombotic.

Bhatt replied: “That’s a terrific question. I guess the right answer is that we should be doing that, but in reality I have to concede that I don’t use these scores. They have shown appropriate C statistics in populations, but they are not fantastic in individual patients.”

“I have to confess that I use the eyeball test. There is nothing as good at predicting future bleeding as past bleeding. So if a patient has had bleeding problems on aspirin alone I wouldn’t add rivaroxaban. But if a patient hasn’t bled before, especially if they had some experience of dual antiplatelet therapy, then they would be good candidates for a low vascular dose of rivaroxaban,” he said.

“It is not as easy as with other drugs as there is always a bleeding trade-off with an antithrombotic. There is no such thing as a free lunch. So patients need careful assessment when considering prescribing rivaroxaban and regular reassessment over time to check if they have had any bleeding,” he added.

The COMPASS study was funded by Bayer. Bhatt reports honoraria from Bayer via the Population Health Research Institute for his role on the COMPASS trial and other research funding from Bayer to the Brigham & Women’s Hospital.

American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC). Abstract 20-LB-20544-ACC. Presented March 28, 2020.

Circulation. Published online March 28, 2020. Full text.

This article first appeared on Medscape.com.

In the COMPASS trial of patients with stable coronary or peripheral artery disease (PAD), the combination of aspirin plus rivaroxaban, 2.5 mg twice daily, provided a larger absolute benefit on cardiovascular endpoints — including a threefold greater reduction in all-cause mortality — in patients with diabetes compared with the overall population.

The results of the diabetes subset of the COMPASS trial were presented by Deepak Bhatt, MD, Brigham and Women’s Hospital Heart & Vascular Center, Boston, Massachusetts, on March 28 at the “virtual” American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC). They were also simultaneously published online in Circulation.

“Use of dual pathway inhibition with low-dose rivaroxaban plus aspirin is particularly attractive in high-risk patients such as those with diabetes,” Bhatt concluded.

The COMPASS trial was first reported in 2017 and showed a new low dose of rivaroxaban (2.5-mg twice-daily; Xarelto, Bayer/Janssen Pharmaceuticals) plus aspirin, 100 mg once daily, was associated with a reduction in ischemic events and mortality and a superior net clinical benefit, balancing ischemic benefit with severe bleeding, compared with aspirin alone for secondary prevention in patients with stable atherosclerotic vascular disease.

But clinicians have been slow to prescribe rivaroxaban in this new and very large population.

“It’s been more than 2 years now since main COMPASS results, and there isn’t a sense that this therapy has really caught on,” chair of the current ACC session at which the diabetes subgroup results were presented, Hadley Wilson, MD, Sanger Heart and Vascular Institute, Charlotte, North Carolina, commented:

He asked Bhatt whether the diabetes subgroup may be “the tipping point that will make people aware of rivaroxaban and then that may trickle down to other patients.”

Bhatt said that he hoped that would be the case. “We as a steering committee of this trial could say the results were positive so rivaroxaban should now be used in everyone with stable coronary or peripheral arterial disease, but that is impractical and as you out point out it hasn’t happened,” he replied.

“In PAD/vascular medicine we have embraced this new therapy. In the broader cardiology world there are a lot of patients with stable coronary arterial disease at high ischemic risk who could take rivaroxaban, but its use is bound to be limited by it being a branded drug and the fact that there is a bleeding risk,” Bhatt explained.

“I think we need to identify patients with the highest ischemic risk and focus drugs such as these with a financial cost and a bleeding risk on those who most likely will derive the greatest absolute reduction in risk,” he said. “The PAD subgroup is one group where this is the case, and now we have shown the diabetes subgroup is another. And there is no incremental bleeding risk in this group over the whole population, so they get a much greater benefit without a greater risk. I hope this helps get rivaroxaban at the new lower dose used much more often.”

A total of 18,278 patients were randomly assigned to the combination of rivaroxaban and aspirin or aspirin alone in the COMPASS trial. Of these, 6922 had diabetes mellitus at baseline and 11,356 did not have diabetes.

Results from the current analysis show a consistent and similar relative risk reduction for benefit of rivaroxaban plus aspirin vs placebo plus aspirin in patients both with and without diabetes for the primary efficacy endpoint, a composite of cardiovascular death, myocardial infarction (MI), or stroke, with a hazard ratio of 0.74 for patients with diabetes and 0.77 for those without diabetes, the researchers report.

Because of the higher baseline risk in the diabetes subgroup, these patients had numerically larger absolute risk reductions with rivaroxaban than those without diabetes for the primary efficacy endpoint at 3 years (2.3% vs 1.4%) and for all-cause mortality (1.9% vs 0.6%).

These results translate into a number needed to treat (NNT) with rivaroxaban for 3 years to prevent one CV death, MI, or stroke of 44 for the diabetes group vs 73 for the nondiabetes group; the NNT to prevent one all-cause death was 54 for the diabetes group vs 167 for the nondiabetes group, the authors write.

Because the bleeding hazards were similar among patients with and without diabetes, the absolute net clinical benefit (MI, stroke, cardiovascular death, or bleeding leading to death or symptomatic bleeding into a critical organ) for rivaroxaban was “particularly favorable” in the diabetes group (2.7% fewer events in the diabetes group vs 1.0% fewer events in the nondiabetes group), they add.

Panelist at the ACC Featured Clinical Research session at which these results were presented, Jennifer Robinson, MD, University of Iowa College of Public Health, Iowa City, asked Bhatt how clinicians were supposed to decide which of the many new agents now becoming available for patients with stable coronary artery disease to prescribe first.

“We often forget about rivaroxaban when we’re thinking about what to add next for our secondary prevention patients,” she said. “You also led the REDUCE-IT trial showing benefit of icosapent ethyl, icosapent ethyl icosapent ethyl icosapent ethyl and there is also ezetimibe, PCSK9 inhibitors and SGLT2 inhibitors. For your patients with coronary disease who are already on a high dose statin which one of these would you add next?”

“That is what physicians need to ponder all the time,” Bhatt replied. “And when a patient has several risk factors that are not well controlled, I guess it’s all important. I go through a checklist with my patients and try and figure what they’re not on that could further reduce their risk.”

“In the COMPASS trial there was an overall positive result with rivaroxaban in the whole population. And now we have shown that patients with diabetes had an even greater absolute risk reduction. That pattern has also been seen with other classes of agents including the statins, PCSK9 inhibitors, and icosapent ethyl,” Bhatt noted.

“In patients with diabetes, I will usually target whatever is standing out most at that time. If their glycemic control is completely out of whack, then that is what I would focus on first, and these days often with a SGLT2 inhibitor or GLP-1 agonist. If the LDL was out of control, I would add ezetimibe or a PCSK9 inhibitor. If the triglycerides were high, I would add icosapent ethyl. If multiple things were out of control, I would usually focus on the number most out of kilter first and try not to forget about everything else.”

But Bhatt noted that the challenge with rivaroxaban is that there is no test of thrombosis risk that would prompt the physician to take action. “Basically, the doctor just has to remember to do it. In that regard I would consider whether patients are at low bleeding risk and are they still at high ischemic risk despite controlling other risk factors and, if so, then I would add this low dose of rivaroxaban.”

Another panel member, Sekar Kathiresan, MD, asked Bhatt whether he recommended using available scores to assess the bleeding/thrombosis risk/benefits of adding an antithrombotic.

Bhatt replied: “That’s a terrific question. I guess the right answer is that we should be doing that, but in reality I have to concede that I don’t use these scores. They have shown appropriate C statistics in populations, but they are not fantastic in individual patients.”

“I have to confess that I use the eyeball test. There is nothing as good at predicting future bleeding as past bleeding. So if a patient has had bleeding problems on aspirin alone I wouldn’t add rivaroxaban. But if a patient hasn’t bled before, especially if they had some experience of dual antiplatelet therapy, then they would be good candidates for a low vascular dose of rivaroxaban,” he said.

“It is not as easy as with other drugs as there is always a bleeding trade-off with an antithrombotic. There is no such thing as a free lunch. So patients need careful assessment when considering prescribing rivaroxaban and regular reassessment over time to check if they have had any bleeding,” he added.

The COMPASS study was funded by Bayer. Bhatt reports honoraria from Bayer via the Population Health Research Institute for his role on the COMPASS trial and other research funding from Bayer to the Brigham & Women’s Hospital.

American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC). Abstract 20-LB-20544-ACC. Presented March 28, 2020.

Circulation. Published online March 28, 2020. Full text.

This article first appeared on Medscape.com.

The largest trial to date investigating the clinical utility of using genetic testing to detect clopidogrel loss-of-function genotype to guide antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) missed its primary endpoint of a 50% reduction in cardiovascular events at 1 year.

However, the TAILOR-PCI trial did show a 34% reduction in such events at 1 year, as well as a statistically significant 40% reduction in the total number of events per patient receiving genetically guided treatment compared with patients who received standard treatment.

In addition, a post hoc analysis found a significant 79% reduction in the rate of adverse events in the first 3 months of treatment among patients who received genetically guided therapy compared with those who did not.

The study was presented March 28 during the “virtual” American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology.

“Although these results fell short of the effect size that we predicted, they nevertheless provide a signal that offers support for the benefit of genetically guided therapy, with approximately one-third fewer adverse events in the patients who received genetically guided treatment compared with those who did not,” concluded Naveen L. Pereira, MD, professor of medicine at the Mayo Clinic in Rochester, Minnesota, and co-principal investigator of the study.

Pereira said the post hoc analysis of the first 3 months of treatment was particularly interesting. “This period immediately after PCI is when patients are at the highest risk for adverse events. We now know that antiplatelet drug therapy is critical during the first 3 months after PCI. Our findings suggest that the lion’s share of the benefit of genetically guided therapy may occur during this high-risk period,” he noted.

However, he added, “Because this wasn’t a preplanned analysis, we can’t draw firm conclusions from it, but it merits further study.”

Asked during an ACC virtual press conference how these results may influence clinical practice, Pereira said he hopes it changes practice toward genotyping.

“We set a very high standard in trying to achieve a 50% reduction in events, but we did see a 34% reduction. I think the probability of the results being true is very high,” he said. “I hope people pay attention to that. I’m not sure what the guidelines will do, but I believe if clopidogrel genetic information is made available to the physician, not changing therapy in a patient who has the loss-of-function gene will now be very difficult.”

Discussant of the trial, Roxana Mehran, MD, Mount Sinai Hospital, New York City, said she thought the results were good enough clinically to justify using genotyping to guide therapy.

“The trial showed an absolute 1.8% reduction and a relative 34% reduction in cardiovascular events, which did not quite meet the P value for significance, and they are supported by a significant reduction in multiple events, and a large difference at 3 months, although these are not primary analyses. So, for me this trial has shown that tailoring antiplatelet therapy by genetic testing is beneficial,” she said.

Another outside commentator, Patrick O’Gara, MD, Brigham and Women’s Hospital, Boston, Massachusetts, described TAILOR-PCI as a “terrific study.”

“Together with the study presented last year showing genotype-guided clopidogrel treatment was noninferior to ticagrelor/prasugrel in STEMI [non-ST-segment elevation myocardial infarction] patients, it chips away at the biologic appropriateness of targeting therapies based on genetic risk,” he said.

“I would hate people to focus on the fact the primary endpoint was missed by one hundredth of a percentage point but hope they would rather consider the bigger picture of making this genotype test more available and accessible to inform clinical decision making,” O’Gara added. “It just makes too much sense to ignore this potential.”

The TAILOR-PCI trial enrolled 5302 patients from 40 centers in the United States, Canada, Mexico, and South Korea who had undergone PCI with stenting. They were randomly assigned to genetic testing for the clopidogrel loss-of-function variant or a group that received standard treatment (clopidogrel) without genetic testing.

In the genetic testing group, 35% of patients were found to have the clopidogrel loss-of-function variant and were therefore prescribed ticagrelor, whereas those without the loss-of-function variant received clopidogrel.

After 1 year, the primary endpoint, a composite of cardiovascular death, MI, stroke, definite or probable stent thrombosis, and severe recurrent ischemia, occurred in 35 patients (4%) of the group that received genetically guided treatment, compared with 54 (5.9%) in the conventionally treated group (adjusted hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.43 - 1.02; P = .56).

A prespecified analysis of total events (rather than just analysis of first event per patient) showed a 40% reduction in the genotyped group (HR, 0.60; 95% CI, 0.41 - 0.89; P = .011).

“Multiple adverse events represent a higher burden on the patient, so it is encouraging to see a significant reduction in cumulative events with genetically guided therapy,” Pereira said.

There was no difference in the safety endpoint of TIMI major bleeding or minor bleeding between the two groups: 1.9% in the genetically guided group vs 1.6% in the conventional treatment group.

The results did not differ between various subgroups in the trial, including race or ethnicity. Although Asian patients have a higher occurrence of the clopidogrel loss-of-function gene, the event risk reductions were similar in Asian and white patients in the study.

Pereira said the study may have been underpowered because of recent improvements in care. When the TAILOR-PCI trial was designed in 2012, around 10% to 12% of patients who received a stent could be expected to have a major adverse event, but during the trial, greater use of drug-coated stents and other treatments significantly reduced the expected rate of adverse events and made it more difficult for the trial to reach its goal of a 50% reduction in adverse events with the number of patients enrolled, he explained.

As part of the discussion, Mehran pointed out that more than 80% of the patients in the trial had acute coronary syndrome (ACS) and yet were being sent home on clopidogrel, which she said she found “daunting.”

“This begs the question of whether they were lower-risk patients and not really the hot unstable ACS patients with large thrombus burden where we see higher event rates,” Mehran commented. She also noted the results must be considered in the new era of platelet monotherapy, where aspirin is being withdrawn, and asked whether clopidogrel monotherapy would be considered safe without aspirin on board.

The researchers are planning a cost-effectiveness analysis of genetically guided therapy based on these data, and they are also continuing to follow patients over the longer term.

The TAILOR-PCI study was funded by the Mayo Clinic in collaboration with the National Heart, Lung, and Blood Institute. Spartan Bioscience Inc supplied the genetic tests used. Pereira reports no relevant disclosures.

American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology. Abstract 20-LB-20309-ACC. Presented March 28, 2020.

This article first appeared on Medscape.com.

The largest trial to date investigating the clinical utility of using genetic testing to detect clopidogrel loss-of-function genotype to guide antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) missed its primary endpoint of a 50% reduction in cardiovascular events at 1 year.

However, the TAILOR-PCI trial did show a 34% reduction in such events at 1 year, as well as a statistically significant 40% reduction in the total number of events per patient receiving genetically guided treatment compared with patients who received standard treatment.

In addition, a post hoc analysis found a significant 79% reduction in the rate of adverse events in the first 3 months of treatment among patients who received genetically guided therapy compared with those who did not.

The study was presented March 28 during the “virtual” American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology.

“Although these results fell short of the effect size that we predicted, they nevertheless provide a signal that offers support for the benefit of genetically guided therapy, with approximately one-third fewer adverse events in the patients who received genetically guided treatment compared with those who did not,” concluded Naveen L. Pereira, MD, professor of medicine at the Mayo Clinic in Rochester, Minnesota, and co-principal investigator of the study.

Pereira said the post hoc analysis of the first 3 months of treatment was particularly interesting. “This period immediately after PCI is when patients are at the highest risk for adverse events. We now know that antiplatelet drug therapy is critical during the first 3 months after PCI. Our findings suggest that the lion’s share of the benefit of genetically guided therapy may occur during this high-risk period,” he noted.

However, he added, “Because this wasn’t a preplanned analysis, we can’t draw firm conclusions from it, but it merits further study.”

Asked during an ACC virtual press conference how these results may influence clinical practice, Pereira said he hopes it changes practice toward genotyping.

“We set a very high standard in trying to achieve a 50% reduction in events, but we did see a 34% reduction. I think the probability of the results being true is very high,” he said. “I hope people pay attention to that. I’m not sure what the guidelines will do, but I believe if clopidogrel genetic information is made available to the physician, not changing therapy in a patient who has the loss-of-function gene will now be very difficult.”

Discussant of the trial, Roxana Mehran, MD, Mount Sinai Hospital, New York City, said she thought the results were good enough clinically to justify using genotyping to guide therapy.

“The trial showed an absolute 1.8% reduction and a relative 34% reduction in cardiovascular events, which did not quite meet the P value for significance, and they are supported by a significant reduction in multiple events, and a large difference at 3 months, although these are not primary analyses. So, for me this trial has shown that tailoring antiplatelet therapy by genetic testing is beneficial,” she said.

Another outside commentator, Patrick O’Gara, MD, Brigham and Women’s Hospital, Boston, Massachusetts, described TAILOR-PCI as a “terrific study.”

“Together with the study presented last year showing genotype-guided clopidogrel treatment was noninferior to ticagrelor/prasugrel in STEMI [non-ST-segment elevation myocardial infarction] patients, it chips away at the biologic appropriateness of targeting therapies based on genetic risk,” he said.

“I would hate people to focus on the fact the primary endpoint was missed by one hundredth of a percentage point but hope they would rather consider the bigger picture of making this genotype test more available and accessible to inform clinical decision making,” O’Gara added. “It just makes too much sense to ignore this potential.”

The TAILOR-PCI trial enrolled 5302 patients from 40 centers in the United States, Canada, Mexico, and South Korea who had undergone PCI with stenting. They were randomly assigned to genetic testing for the clopidogrel loss-of-function variant or a group that received standard treatment (clopidogrel) without genetic testing.

In the genetic testing group, 35% of patients were found to have the clopidogrel loss-of-function variant and were therefore prescribed ticagrelor, whereas those without the loss-of-function variant received clopidogrel.

After 1 year, the primary endpoint, a composite of cardiovascular death, MI, stroke, definite or probable stent thrombosis, and severe recurrent ischemia, occurred in 35 patients (4%) of the group that received genetically guided treatment, compared with 54 (5.9%) in the conventionally treated group (adjusted hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.43 - 1.02; P = .56).

A prespecified analysis of total events (rather than just analysis of first event per patient) showed a 40% reduction in the genotyped group (HR, 0.60; 95% CI, 0.41 - 0.89; P = .011).

“Multiple adverse events represent a higher burden on the patient, so it is encouraging to see a significant reduction in cumulative events with genetically guided therapy,” Pereira said.

There was no difference in the safety endpoint of TIMI major bleeding or minor bleeding between the two groups: 1.9% in the genetically guided group vs 1.6% in the conventional treatment group.

The results did not differ between various subgroups in the trial, including race or ethnicity. Although Asian patients have a higher occurrence of the clopidogrel loss-of-function gene, the event risk reductions were similar in Asian and white patients in the study.

Pereira said the study may have been underpowered because of recent improvements in care. When the TAILOR-PCI trial was designed in 2012, around 10% to 12% of patients who received a stent could be expected to have a major adverse event, but during the trial, greater use of drug-coated stents and other treatments significantly reduced the expected rate of adverse events and made it more difficult for the trial to reach its goal of a 50% reduction in adverse events with the number of patients enrolled, he explained.

As part of the discussion, Mehran pointed out that more than 80% of the patients in the trial had acute coronary syndrome (ACS) and yet were being sent home on clopidogrel, which she said she found “daunting.”

“This begs the question of whether they were lower-risk patients and not really the hot unstable ACS patients with large thrombus burden where we see higher event rates,” Mehran commented. She also noted the results must be considered in the new era of platelet monotherapy, where aspirin is being withdrawn, and asked whether clopidogrel monotherapy would be considered safe without aspirin on board.

The researchers are planning a cost-effectiveness analysis of genetically guided therapy based on these data, and they are also continuing to follow patients over the longer term.

The TAILOR-PCI study was funded by the Mayo Clinic in collaboration with the National Heart, Lung, and Blood Institute. Spartan Bioscience Inc supplied the genetic tests used. Pereira reports no relevant disclosures.

American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology. Abstract 20-LB-20309-ACC. Presented March 28, 2020.

This article first appeared on Medscape.com.

The largest trial to date investigating the clinical utility of using genetic testing to detect clopidogrel loss-of-function genotype to guide antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) missed its primary endpoint of a 50% reduction in cardiovascular events at 1 year.

However, the TAILOR-PCI trial did show a 34% reduction in such events at 1 year, as well as a statistically significant 40% reduction in the total number of events per patient receiving genetically guided treatment compared with patients who received standard treatment.

In addition, a post hoc analysis found a significant 79% reduction in the rate of adverse events in the first 3 months of treatment among patients who received genetically guided therapy compared with those who did not.

The study was presented March 28 during the “virtual” American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology.

“Although these results fell short of the effect size that we predicted, they nevertheless provide a signal that offers support for the benefit of genetically guided therapy, with approximately one-third fewer adverse events in the patients who received genetically guided treatment compared with those who did not,” concluded Naveen L. Pereira, MD, professor of medicine at the Mayo Clinic in Rochester, Minnesota, and co-principal investigator of the study.

Pereira said the post hoc analysis of the first 3 months of treatment was particularly interesting. “This period immediately after PCI is when patients are at the highest risk for adverse events. We now know that antiplatelet drug therapy is critical during the first 3 months after PCI. Our findings suggest that the lion’s share of the benefit of genetically guided therapy may occur during this high-risk period,” he noted.

However, he added, “Because this wasn’t a preplanned analysis, we can’t draw firm conclusions from it, but it merits further study.”

Asked during an ACC virtual press conference how these results may influence clinical practice, Pereira said he hopes it changes practice toward genotyping.

“We set a very high standard in trying to achieve a 50% reduction in events, but we did see a 34% reduction. I think the probability of the results being true is very high,” he said. “I hope people pay attention to that. I’m not sure what the guidelines will do, but I believe if clopidogrel genetic information is made available to the physician, not changing therapy in a patient who has the loss-of-function gene will now be very difficult.”

Discussant of the trial, Roxana Mehran, MD, Mount Sinai Hospital, New York City, said she thought the results were good enough clinically to justify using genotyping to guide therapy.

“The trial showed an absolute 1.8% reduction and a relative 34% reduction in cardiovascular events, which did not quite meet the P value for significance, and they are supported by a significant reduction in multiple events, and a large difference at 3 months, although these are not primary analyses. So, for me this trial has shown that tailoring antiplatelet therapy by genetic testing is beneficial,” she said.

Another outside commentator, Patrick O’Gara, MD, Brigham and Women’s Hospital, Boston, Massachusetts, described TAILOR-PCI as a “terrific study.”

“Together with the study presented last year showing genotype-guided clopidogrel treatment was noninferior to ticagrelor/prasugrel in STEMI [non-ST-segment elevation myocardial infarction] patients, it chips away at the biologic appropriateness of targeting therapies based on genetic risk,” he said.

“I would hate people to focus on the fact the primary endpoint was missed by one hundredth of a percentage point but hope they would rather consider the bigger picture of making this genotype test more available and accessible to inform clinical decision making,” O’Gara added. “It just makes too much sense to ignore this potential.”

The TAILOR-PCI trial enrolled 5302 patients from 40 centers in the United States, Canada, Mexico, and South Korea who had undergone PCI with stenting. They were randomly assigned to genetic testing for the clopidogrel loss-of-function variant or a group that received standard treatment (clopidogrel) without genetic testing.

In the genetic testing group, 35% of patients were found to have the clopidogrel loss-of-function variant and were therefore prescribed ticagrelor, whereas those without the loss-of-function variant received clopidogrel.

After 1 year, the primary endpoint, a composite of cardiovascular death, MI, stroke, definite or probable stent thrombosis, and severe recurrent ischemia, occurred in 35 patients (4%) of the group that received genetically guided treatment, compared with 54 (5.9%) in the conventionally treated group (adjusted hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.43 - 1.02; P = .56).

A prespecified analysis of total events (rather than just analysis of first event per patient) showed a 40% reduction in the genotyped group (HR, 0.60; 95% CI, 0.41 - 0.89; P = .011).

“Multiple adverse events represent a higher burden on the patient, so it is encouraging to see a significant reduction in cumulative events with genetically guided therapy,” Pereira said.

There was no difference in the safety endpoint of TIMI major bleeding or minor bleeding between the two groups: 1.9% in the genetically guided group vs 1.6% in the conventional treatment group.

The results did not differ between various subgroups in the trial, including race or ethnicity. Although Asian patients have a higher occurrence of the clopidogrel loss-of-function gene, the event risk reductions were similar in Asian and white patients in the study.

Pereira said the study may have been underpowered because of recent improvements in care. When the TAILOR-PCI trial was designed in 2012, around 10% to 12% of patients who received a stent could be expected to have a major adverse event, but during the trial, greater use of drug-coated stents and other treatments significantly reduced the expected rate of adverse events and made it more difficult for the trial to reach its goal of a 50% reduction in adverse events with the number of patients enrolled, he explained.

As part of the discussion, Mehran pointed out that more than 80% of the patients in the trial had acute coronary syndrome (ACS) and yet were being sent home on clopidogrel, which she said she found “daunting.”

“This begs the question of whether they were lower-risk patients and not really the hot unstable ACS patients with large thrombus burden where we see higher event rates,” Mehran commented. She also noted the results must be considered in the new era of platelet monotherapy, where aspirin is being withdrawn, and asked whether clopidogrel monotherapy would be considered safe without aspirin on board.

The researchers are planning a cost-effectiveness analysis of genetically guided therapy based on these data, and they are also continuing to follow patients over the longer term.

The TAILOR-PCI study was funded by the Mayo Clinic in collaboration with the National Heart, Lung, and Blood Institute. Spartan Bioscience Inc supplied the genetic tests used. Pereira reports no relevant disclosures.

American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology. Abstract 20-LB-20309-ACC. Presented March 28, 2020.

This article first appeared on Medscape.com.

A powerful genetic predisposition to cardiovascular disease was overcome by low lifetime exposure to LDL cholesterol and systolic blood pressure in a naturalistic study conducted in nearly half a million people, Brian A. Ference, MD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Frontline Medical News

This novel finding potentially opens the door to primordial cardiovascular prevention, the earliest possible form of primary prevention, in which cardiovascular risk factors are curtailed before they can become established.

“It’s important to note that the trajectories of lifetime risk for cardiovascular disease predicted by a PGS [polygenic risk score] are not fixed. At the same level of a PGS for coronary artery disease, participants with lower lifetime exposure to LDL and systolic blood pressure had a lower trajectory of risk for cardiovascular disease. This finding implies that the trajectory of cardiovascular risk predicted by a PGS can be reduced by lowering LDL and blood pressure,” observed Dr. Ference, professor of translational therapeutics and executive director of the Center for Naturally Randomised Trials at the University of Cambridge (England).

Together with an international team of coinvestigators, he analyzed lifetime cardiovascular risk as predicted by a PGS derived by genomic testing in relation to lifetime LDL and systolic blood pressure levels in 445,566 participants in the UK Biobank. Subjects had a mean age of 57.2 years at enrollment and 65.2 years at last follow-up. The primary study outcome, a first major coronary event (MCE) as defined by a fatal or nonfatal MI or coronary revascularization, occurred in 23,032 subjects.

The investigators found a stepwise increase in MCE risk across increasing quintiles of genetic risk as reflected in the PGS, such that participants in the top PGS quintile were at 2.8-fold greater risk of an MCE than those in the first quintile. The risk was essentially the same in men and women.

A key finding was that, at any level of lifetime MCE risk as defined by PGS, the actual event rate varied 10-fold depending upon lifetime exposure to LDL cholesterol and systolic blood pressure (SBP). For example, men in the top PGS quintile with high lifetime SBP and LDL cholesterol had a 93% lifetime MCE risk, but that MCE risk plummeted to 8% in those in the top quintile but with low lifetime SBP and LDL cholesterol.

Small differences in those two cardiovascular risk factors over the course of many decades had a big impact. For example, it took only a 10-mg/dL lower lifetime exposure to LDL cholesterol and a 2–mm Hg lower SBP to blunt the trajectory of lifetime risk for MCE in individuals in the middle quintile of PGS to the more favorable trajectory of those in the lowest PGS quintile. Conversely, with a 10-mg/dL increase in LDL cholesterol and 2–mm Hg greater SBP over the course of a lifetime, the trajectory of risk for people in the middle quintile of PGS became essentially superimposable upon the trajectory associated with the highest PGS quintile, the cardiologist explained.

“Participants with low lifetime exposure to LDL and blood pressure had a low lifetime risk of cardiovascular disease at all levels of PGS for coronary disease. This implies that LDL and blood pressure, which are modifiable, may be more powerful determinants of lifetime risk than polygenic predisposition,” Dr. Ference declared.

Discussant Vera Bittner, MD, professor of medicine at the University of Alabama, Birmingham, said that for her this study carried a heartening take-home message: “The polygenic risk score can stratify the population into different risk groups and, at the same time, lifetime exposure to LDL and blood pressure significantly modifies the risk, suggesting that genetics is not destiny, and we may be able to intervene.”

“To be able to know what your cardiovascular risk is from an early age and to plan therapies to prevent cardiovascular disease would be incredible,” agreed session chair B. Hadley Wilson, MD, of the Sanger Heart and Vascular Institute in Charlotte, N.C.

Sekar Kathiresan, MD, said the study introduces the PGS as a new risk factor for coronary artery disease. Focusing efforts to achieve lifelong low exposure to LDL cholesterol and blood pressure in those individuals in the top 10%-20% in PGS should provide a great absolute reduction in MCE risk.

“It potentially can give you a 30- or 40-year head start in understanding who’s at risk because the factor can be measured as early as birth,” observed Dr. Kathiresan, a cardiologist who is director of the Center for Genomic Medicine at Massachusetts General Hospital, Boston.

“It’s also very inexpensive: You get the information once, bank it, and use it throughout life,” noted Paul M. Ridker, MD, director of the Center for Cardiovascular Disease Prevention and professor of medicine at Harvard Medical School, Boston.

“A genome-wide scan will give us information not just on cardiovascular risk, but on cancer risk, on risk of kidney disease, and on the risk of a host of other issues. It’s a very different way of thinking about risk presentation across a whole variety of endpoints,” Dr. Ridker added.

Dr. Ference reported receiving fees and/or research grants from Merck, Amgen, Regeneron, Sanofi, Novartis, Pfizer, Eli Lilly, NovoNordisk, The Medicines Company, Mylan, Daiichi Sankyo, Silence Therapeutics, Ionis Pharmaceuticals, dalCOR, CiVi Pharma, KrKa Pharmaceuticals, Medtronic, and Celera.

bjancin@mdedge.com

A powerful genetic predisposition to cardiovascular disease was overcome by low lifetime exposure to LDL cholesterol and systolic blood pressure in a naturalistic study conducted in nearly half a million people, Brian A. Ference, MD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Frontline Medical News

This novel finding potentially opens the door to primordial cardiovascular prevention, the earliest possible form of primary prevention, in which cardiovascular risk factors are curtailed before they can become established.

“It’s important to note that the trajectories of lifetime risk for cardiovascular disease predicted by a PGS [polygenic risk score] are not fixed. At the same level of a PGS for coronary artery disease, participants with lower lifetime exposure to LDL and systolic blood pressure had a lower trajectory of risk for cardiovascular disease. This finding implies that the trajectory of cardiovascular risk predicted by a PGS can be reduced by lowering LDL and blood pressure,” observed Dr. Ference, professor of translational therapeutics and executive director of the Center for Naturally Randomised Trials at the University of Cambridge (England).

Together with an international team of coinvestigators, he analyzed lifetime cardiovascular risk as predicted by a PGS derived by genomic testing in relation to lifetime LDL and systolic blood pressure levels in 445,566 participants in the UK Biobank. Subjects had a mean age of 57.2 years at enrollment and 65.2 years at last follow-up. The primary study outcome, a first major coronary event (MCE) as defined by a fatal or nonfatal MI or coronary revascularization, occurred in 23,032 subjects.

The investigators found a stepwise increase in MCE risk across increasing quintiles of genetic risk as reflected in the PGS, such that participants in the top PGS quintile were at 2.8-fold greater risk of an MCE than those in the first quintile. The risk was essentially the same in men and women.

A key finding was that, at any level of lifetime MCE risk as defined by PGS, the actual event rate varied 10-fold depending upon lifetime exposure to LDL cholesterol and systolic blood pressure (SBP). For example, men in the top PGS quintile with high lifetime SBP and LDL cholesterol had a 93% lifetime MCE risk, but that MCE risk plummeted to 8% in those in the top quintile but with low lifetime SBP and LDL cholesterol.

Small differences in those two cardiovascular risk factors over the course of many decades had a big impact. For example, it took only a 10-mg/dL lower lifetime exposure to LDL cholesterol and a 2–mm Hg lower SBP to blunt the trajectory of lifetime risk for MCE in individuals in the middle quintile of PGS to the more favorable trajectory of those in the lowest PGS quintile. Conversely, with a 10-mg/dL increase in LDL cholesterol and 2–mm Hg greater SBP over the course of a lifetime, the trajectory of risk for people in the middle quintile of PGS became essentially superimposable upon the trajectory associated with the highest PGS quintile, the cardiologist explained.

“Participants with low lifetime exposure to LDL and blood pressure had a low lifetime risk of cardiovascular disease at all levels of PGS for coronary disease. This implies that LDL and blood pressure, which are modifiable, may be more powerful determinants of lifetime risk than polygenic predisposition,” Dr. Ference declared.

Discussant Vera Bittner, MD, professor of medicine at the University of Alabama, Birmingham, said that for her this study carried a heartening take-home message: “The polygenic risk score can stratify the population into different risk groups and, at the same time, lifetime exposure to LDL and blood pressure significantly modifies the risk, suggesting that genetics is not destiny, and we may be able to intervene.”

“To be able to know what your cardiovascular risk is from an early age and to plan therapies to prevent cardiovascular disease would be incredible,” agreed session chair B. Hadley Wilson, MD, of the Sanger Heart and Vascular Institute in Charlotte, N.C.

Sekar Kathiresan, MD, said the study introduces the PGS as a new risk factor for coronary artery disease. Focusing efforts to achieve lifelong low exposure to LDL cholesterol and blood pressure in those individuals in the top 10%-20% in PGS should provide a great absolute reduction in MCE risk.

“It potentially can give you a 30- or 40-year head start in understanding who’s at risk because the factor can be measured as early as birth,” observed Dr. Kathiresan, a cardiologist who is director of the Center for Genomic Medicine at Massachusetts General Hospital, Boston.

“It’s also very inexpensive: You get the information once, bank it, and use it throughout life,” noted Paul M. Ridker, MD, director of the Center for Cardiovascular Disease Prevention and professor of medicine at Harvard Medical School, Boston.

“A genome-wide scan will give us information not just on cardiovascular risk, but on cancer risk, on risk of kidney disease, and on the risk of a host of other issues. It’s a very different way of thinking about risk presentation across a whole variety of endpoints,” Dr. Ridker added.

Dr. Ference reported receiving fees and/or research grants from Merck, Amgen, Regeneron, Sanofi, Novartis, Pfizer, Eli Lilly, NovoNordisk, The Medicines Company, Mylan, Daiichi Sankyo, Silence Therapeutics, Ionis Pharmaceuticals, dalCOR, CiVi Pharma, KrKa Pharmaceuticals, Medtronic, and Celera.

bjancin@mdedge.com

A powerful genetic predisposition to cardiovascular disease was overcome by low lifetime exposure to LDL cholesterol and systolic blood pressure in a naturalistic study conducted in nearly half a million people, Brian A. Ference, MD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Frontline Medical News

This novel finding potentially opens the door to primordial cardiovascular prevention, the earliest possible form of primary prevention, in which cardiovascular risk factors are curtailed before they can become established.

“It’s important to note that the trajectories of lifetime risk for cardiovascular disease predicted by a PGS [polygenic risk score] are not fixed. At the same level of a PGS for coronary artery disease, participants with lower lifetime exposure to LDL and systolic blood pressure had a lower trajectory of risk for cardiovascular disease. This finding implies that the trajectory of cardiovascular risk predicted by a PGS can be reduced by lowering LDL and blood pressure,” observed Dr. Ference, professor of translational therapeutics and executive director of the Center for Naturally Randomised Trials at the University of Cambridge (England).

Together with an international team of coinvestigators, he analyzed lifetime cardiovascular risk as predicted by a PGS derived by genomic testing in relation to lifetime LDL and systolic blood pressure levels in 445,566 participants in the UK Biobank. Subjects had a mean age of 57.2 years at enrollment and 65.2 years at last follow-up. The primary study outcome, a first major coronary event (MCE) as defined by a fatal or nonfatal MI or coronary revascularization, occurred in 23,032 subjects.

The investigators found a stepwise increase in MCE risk across increasing quintiles of genetic risk as reflected in the PGS, such that participants in the top PGS quintile were at 2.8-fold greater risk of an MCE than those in the first quintile. The risk was essentially the same in men and women.

A key finding was that, at any level of lifetime MCE risk as defined by PGS, the actual event rate varied 10-fold depending upon lifetime exposure to LDL cholesterol and systolic blood pressure (SBP). For example, men in the top PGS quintile with high lifetime SBP and LDL cholesterol had a 93% lifetime MCE risk, but that MCE risk plummeted to 8% in those in the top quintile but with low lifetime SBP and LDL cholesterol.

Small differences in those two cardiovascular risk factors over the course of many decades had a big impact. For example, it took only a 10-mg/dL lower lifetime exposure to LDL cholesterol and a 2–mm Hg lower SBP to blunt the trajectory of lifetime risk for MCE in individuals in the middle quintile of PGS to the more favorable trajectory of those in the lowest PGS quintile. Conversely, with a 10-mg/dL increase in LDL cholesterol and 2–mm Hg greater SBP over the course of a lifetime, the trajectory of risk for people in the middle quintile of PGS became essentially superimposable upon the trajectory associated with the highest PGS quintile, the cardiologist explained.

“Participants with low lifetime exposure to LDL and blood pressure had a low lifetime risk of cardiovascular disease at all levels of PGS for coronary disease. This implies that LDL and blood pressure, which are modifiable, may be more powerful determinants of lifetime risk than polygenic predisposition,” Dr. Ference declared.

Discussant Vera Bittner, MD, professor of medicine at the University of Alabama, Birmingham, said that for her this study carried a heartening take-home message: “The polygenic risk score can stratify the population into different risk groups and, at the same time, lifetime exposure to LDL and blood pressure significantly modifies the risk, suggesting that genetics is not destiny, and we may be able to intervene.”

“To be able to know what your cardiovascular risk is from an early age and to plan therapies to prevent cardiovascular disease would be incredible,” agreed session chair B. Hadley Wilson, MD, of the Sanger Heart and Vascular Institute in Charlotte, N.C.

Sekar Kathiresan, MD, said the study introduces the PGS as a new risk factor for coronary artery disease. Focusing efforts to achieve lifelong low exposure to LDL cholesterol and blood pressure in those individuals in the top 10%-20% in PGS should provide a great absolute reduction in MCE risk.

“It potentially can give you a 30- or 40-year head start in understanding who’s at risk because the factor can be measured as early as birth,” observed Dr. Kathiresan, a cardiologist who is director of the Center for Genomic Medicine at Massachusetts General Hospital, Boston.

“It’s also very inexpensive: You get the information once, bank it, and use it throughout life,” noted Paul M. Ridker, MD, director of the Center for Cardiovascular Disease Prevention and professor of medicine at Harvard Medical School, Boston.

“A genome-wide scan will give us information not just on cardiovascular risk, but on cancer risk, on risk of kidney disease, and on the risk of a host of other issues. It’s a very different way of thinking about risk presentation across a whole variety of endpoints,” Dr. Ridker added.

Dr. Ference reported receiving fees and/or research grants from Merck, Amgen, Regeneron, Sanofi, Novartis, Pfizer, Eli Lilly, NovoNordisk, The Medicines Company, Mylan, Daiichi Sankyo, Silence Therapeutics, Ionis Pharmaceuticals, dalCOR, CiVi Pharma, KrKa Pharmaceuticals, Medtronic, and Celera.

bjancin@mdedge.com

In Part I of our discussion we introduced the concept of person-generated health data (PGHD), defined as wellness and/or health-related data created, recorded, or gathered by individuals. The ubiquity and remarkable technological progress of personal computing devices, including wearables, smartphones, and tablets, along with the multitude of sensor modalities embedded within these devices, enables a continuous connection with individuals wanting to share information about their behavior and daily life.

Such rich, longitudinal information is now being used in combination with traditional clinical information to predict, diagnose, and formulate treatment plans for diseases, as well as understand the safety and effectiveness of medical interventions.
 

Identifying a disease early

One novel example of digital technologies being used for early identification of disease was a promising 2019 study by Eli Lilly (in collaboration with Apple and Evidation Health) called the Lilly Exploratory Digital Assessment Study.

In this study, the feasibility of using PGHD for identifying physiological and behavioral signatures of cognitive impairment was examined for the purpose of seeking new methods to detect mild cognitive impairment (MCI) in a timely and cost-effective manner. The study enrolled 31 study participants with cognitive impairment and 82 without cognitive impairment. It used consumer-grade sensor technologies (the iPhone, Apple Watch, iPad, and Beddit sleep monitor) to continuously and unobtrusively collect data. Among the information the researchers collected were interaction with the phone keyboard, accelerometer data from the Apple Watch, volume of messages sent/received, and sleep cycles.¹

Courtesy of Evidation Health, Inc.

A total of 16 terabytes of data were collected over the course of 12 weeks. Data were organized into a behaviorgram (See Figure 1) that gives a holistic picture of a day in a patient’s life. A machine learning model was used to distinguish between behaviorgrams of symptomatic versus healthy controls, identifying typing speed, circadian rhythm shifts, and reliance on helper apps, among other things, as differentiating cognitively impaired from healthy controls. These behaviorgrams may someday serve as “fingerprints” of different diseases, with specific diseases displaying predictable patterns. In the near future, digital measures like the ones investigated in this study are likely to be used to help clinicians predict and diagnose disease, as well as to better understand disease progression and treatment response.
 

Leading to better health outcomes

The potential of PGHD to detect diseases early and lead to better health outcomes is being investigated in the Heartline study, a collaboration between Johnson & Johnson and Apple, which is supported by Evidation.²

This study aims to enroll 150,000 adults age 65 years and over to analyze the impact of Apple Watch–based early detection of irregular heart rhythms consistent with atrial fibrillation (AFib). The researchers’ hypothesis is that jointly detecting atrial fibrillation early and providing cardiovascular health programs to new AFib patients, will lead to patients being treated by a medical provider for AFib that otherwise would not have been detected. This, in turn, would lead to these AFib patients decreasing their risks of stroke and other serious cardiovascular events, including death, the study authors speculated.

Presenting new challenges

While PGHD has the potential to help people, it also presents new challenges. It is highly sensitive and personal – it can be as identifying as DNA.³

Cortesy of Evidation Health

The vast amount of data that PGHD can collect from interaction with consumer wearable devices poses serious privacy risks if done improperly. To address those risks, companies like Evidation have built in protections. Evidation has an app, Achievement, that has enlisted a connected population of more than 3.5 million members who earn rewards for performing health-related actions, as tracked by wearables devices and apps. Through the Achievement app (See Figure 2.), members are provided opportunities to join research studies. As part of these studies, data collected from sensors and apps is used by permission of the member so that it is clear how their data are contributing to specific research questions or use cases.

This is a collaborative model of data collection built upon trust and permission and is substantially different than the collection of data from electronic health records (EHRs) – which is typically aggregated, deidentified, and commercialized, often without the patients’ knowledge or consent. Stringent protections, explicit permission, and transparency are absolutely imperative until privacy frameworks for data outside of HIPAA regulation catches up and protects patients from discrimination and unintended uses of their data.

Large connected cohorts can help advance our understanding of public health. In one study run on Achievement during the 2017-2018 flu season, a survey was sent to the Achievement population every week asking about symptoms of influenza-like illness and requesting permission to access historical data from their wearable around the influenza-like illness event.⁴ With the data, it was possible to analyze patterns of activity, sleep, and resting heart rate change around flu events.  Resting heart rate, in particular, is shown to increase during fever and at the population level. In fact, through the use of PGHD, it is possible to use the fraction of people with resting heart rate above their usual baseline as a proxy to quantify the number of infected people in a region.⁵ This resting heart rate–informed flu surveillance method, if refined to increased accuracy, can work in near real time. This means it may be able detect influenza outbreaks days earlier than current epidemiological methods.

Health data generated by connected populations are in the early stages of development. It is clear that it will yield novel insights into health and disease. Only time will tell if it will be able to help clinicians and patients better predict, diagnose, and formulate treatment plans for disease.

Neil Skolnik, M.D. is a professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, and associate director of the Family Medicine Residency Program at Abington Jefferson Health. Luca Foschini PhD, is co-founder & chief data scientist at Evidation Health. Bray Patrick-Lake, MFS, is a patient thought leader and director of strategic partnerships at Evidation Health.

References

1. Chen R et al. Developing measures of cognitive impairment in the real world from consumer-grade multimodal sensor streams. KDD ’19. August 4–8, 2019 Aug 4-8.

2. The Heartline Study. https://www.heartline.com.

3. Foschini L. Privacy of Wearable and Sensors Data (or, the Lack Thereof?). Data Driven Investor, Medium. 2019.

4. Bradshaw B et al. Influenza surveillance using wearable mobile health devices. Online J Public Health Inform. 2019;11(1):e249.

5. Radin JM et al. Harnessing wearable device data to improve state-level real-time surveillance of influenza-like illness in the USA: a population-based study. Lancet Digital Health. 2020. doi: 10.1016/S2589-7500(19)30222-5.

In Part I of our discussion we introduced the concept of person-generated health data (PGHD), defined as wellness and/or health-related data created, recorded, or gathered by individuals. The ubiquity and remarkable technological progress of personal computing devices, including wearables, smartphones, and tablets, along with the multitude of sensor modalities embedded within these devices, enables a continuous connection with individuals wanting to share information about their behavior and daily life.

Such rich, longitudinal information is now being used in combination with traditional clinical information to predict, diagnose, and formulate treatment plans for diseases, as well as understand the safety and effectiveness of medical interventions.
 

Identifying a disease early

One novel example of digital technologies being used for early identification of disease was a promising 2019 study by Eli Lilly (in collaboration with Apple and Evidation Health) called the Lilly Exploratory Digital Assessment Study.

In this study, the feasibility of using PGHD for identifying physiological and behavioral signatures of cognitive impairment was examined for the purpose of seeking new methods to detect mild cognitive impairment (MCI) in a timely and cost-effective manner. The study enrolled 31 study participants with cognitive impairment and 82 without cognitive impairment. It used consumer-grade sensor technologies (the iPhone, Apple Watch, iPad, and Beddit sleep monitor) to continuously and unobtrusively collect data. Among the information the researchers collected were interaction with the phone keyboard, accelerometer data from the Apple Watch, volume of messages sent/received, and sleep cycles.¹

Courtesy of Evidation Health, Inc.

A total of 16 terabytes of data were collected over the course of 12 weeks. Data were organized into a behaviorgram (See Figure 1) that gives a holistic picture of a day in a patient’s life. A machine learning model was used to distinguish between behaviorgrams of symptomatic versus healthy controls, identifying typing speed, circadian rhythm shifts, and reliance on helper apps, among other things, as differentiating cognitively impaired from healthy controls. These behaviorgrams may someday serve as “fingerprints” of different diseases, with specific diseases displaying predictable patterns. In the near future, digital measures like the ones investigated in this study are likely to be used to help clinicians predict and diagnose disease, as well as to better understand disease progression and treatment response.
 

Leading to better health outcomes

The potential of PGHD to detect diseases early and lead to better health outcomes is being investigated in the Heartline study, a collaboration between Johnson & Johnson and Apple, which is supported by Evidation.²

This study aims to enroll 150,000 adults age 65 years and over to analyze the impact of Apple Watch–based early detection of irregular heart rhythms consistent with atrial fibrillation (AFib). The researchers’ hypothesis is that jointly detecting atrial fibrillation early and providing cardiovascular health programs to new AFib patients, will lead to patients being treated by a medical provider for AFib that otherwise would not have been detected. This, in turn, would lead to these AFib patients decreasing their risks of stroke and other serious cardiovascular events, including death, the study authors speculated.

Presenting new challenges

While PGHD has the potential to help people, it also presents new challenges. It is highly sensitive and personal – it can be as identifying as DNA.³

Cortesy of Evidation Health

The vast amount of data that PGHD can collect from interaction with consumer wearable devices poses serious privacy risks if done improperly. To address those risks, companies like Evidation have built in protections. Evidation has an app, Achievement, that has enlisted a connected population of more than 3.5 million members who earn rewards for performing health-related actions, as tracked by wearables devices and apps. Through the Achievement app (See Figure 2.), members are provided opportunities to join research studies. As part of these studies, data collected from sensors and apps is used by permission of the member so that it is clear how their data are contributing to specific research questions or use cases.

This is a collaborative model of data collection built upon trust and permission and is substantially different than the collection of data from electronic health records (EHRs) – which is typically aggregated, deidentified, and commercialized, often without the patients’ knowledge or consent. Stringent protections, explicit permission, and transparency are absolutely imperative until privacy frameworks for data outside of HIPAA regulation catches up and protects patients from discrimination and unintended uses of their data.

Large connected cohorts can help advance our understanding of public health. In one study run on Achievement during the 2017-2018 flu season, a survey was sent to the Achievement population every week asking about symptoms of influenza-like illness and requesting permission to access historical data from their wearable around the influenza-like illness event.⁴ With the data, it was possible to analyze patterns of activity, sleep, and resting heart rate change around flu events.  Resting heart rate, in particular, is shown to increase during fever and at the population level. In fact, through the use of PGHD, it is possible to use the fraction of people with resting heart rate above their usual baseline as a proxy to quantify the number of infected people in a region.⁵ This resting heart rate–informed flu surveillance method, if refined to increased accuracy, can work in near real time. This means it may be able detect influenza outbreaks days earlier than current epidemiological methods.

Health data generated by connected populations are in the early stages of development. It is clear that it will yield novel insights into health and disease. Only time will tell if it will be able to help clinicians and patients better predict, diagnose, and formulate treatment plans for disease.

Neil Skolnik, M.D. is a professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, and associate director of the Family Medicine Residency Program at Abington Jefferson Health. Luca Foschini PhD, is co-founder & chief data scientist at Evidation Health. Bray Patrick-Lake, MFS, is a patient thought leader and director of strategic partnerships at Evidation Health.

References

1. Chen R et al. Developing measures of cognitive impairment in the real world from consumer-grade multimodal sensor streams. KDD ’19. August 4–8, 2019 Aug 4-8.

2. The Heartline Study. https://www.heartline.com.

3. Foschini L. Privacy of Wearable and Sensors Data (or, the Lack Thereof?). Data Driven Investor, Medium. 2019.

4. Bradshaw B et al. Influenza surveillance using wearable mobile health devices. Online J Public Health Inform. 2019;11(1):e249.

5. Radin JM et al. Harnessing wearable device data to improve state-level real-time surveillance of influenza-like illness in the USA: a population-based study. Lancet Digital Health. 2020. doi: 10.1016/S2589-7500(19)30222-5.

In Part I of our discussion we introduced the concept of person-generated health data (PGHD), defined as wellness and/or health-related data created, recorded, or gathered by individuals. The ubiquity and remarkable technological progress of personal computing devices, including wearables, smartphones, and tablets, along with the multitude of sensor modalities embedded within these devices, enables a continuous connection with individuals wanting to share information about their behavior and daily life.

Such rich, longitudinal information is now being used in combination with traditional clinical information to predict, diagnose, and formulate treatment plans for diseases, as well as understand the safety and effectiveness of medical interventions.
 

Identifying a disease early

One novel example of digital technologies being used for early identification of disease was a promising 2019 study by Eli Lilly (in collaboration with Apple and Evidation Health) called the Lilly Exploratory Digital Assessment Study.

In this study, the feasibility of using PGHD for identifying physiological and behavioral signatures of cognitive impairment was examined for the purpose of seeking new methods to detect mild cognitive impairment (MCI) in a timely and cost-effective manner. The study enrolled 31 study participants with cognitive impairment and 82 without cognitive impairment. It used consumer-grade sensor technologies (the iPhone, Apple Watch, iPad, and Beddit sleep monitor) to continuously and unobtrusively collect data. Among the information the researchers collected were interaction with the phone keyboard, accelerometer data from the Apple Watch, volume of messages sent/received, and sleep cycles.¹

Courtesy of Evidation Health, Inc.

A total of 16 terabytes of data were collected over the course of 12 weeks. Data were organized into a behaviorgram (See Figure 1) that gives a holistic picture of a day in a patient’s life. A machine learning model was used to distinguish between behaviorgrams of symptomatic versus healthy controls, identifying typing speed, circadian rhythm shifts, and reliance on helper apps, among other things, as differentiating cognitively impaired from healthy controls. These behaviorgrams may someday serve as “fingerprints” of different diseases, with specific diseases displaying predictable patterns. In the near future, digital measures like the ones investigated in this study are likely to be used to help clinicians predict and diagnose disease, as well as to better understand disease progression and treatment response.
 

Leading to better health outcomes

The potential of PGHD to detect diseases early and lead to better health outcomes is being investigated in the Heartline study, a collaboration between Johnson & Johnson and Apple, which is supported by Evidation.²

This study aims to enroll 150,000 adults age 65 years and over to analyze the impact of Apple Watch–based early detection of irregular heart rhythms consistent with atrial fibrillation (AFib). The researchers’ hypothesis is that jointly detecting atrial fibrillation early and providing cardiovascular health programs to new AFib patients, will lead to patients being treated by a medical provider for AFib that otherwise would not have been detected. This, in turn, would lead to these AFib patients decreasing their risks of stroke and other serious cardiovascular events, including death, the study authors speculated.

Presenting new challenges

While PGHD has the potential to help people, it also presents new challenges. It is highly sensitive and personal – it can be as identifying as DNA.³

Cortesy of Evidation Health

The vast amount of data that PGHD can collect from interaction with consumer wearable devices poses serious privacy risks if done improperly. To address those risks, companies like Evidation have built in protections. Evidation has an app, Achievement, that has enlisted a connected population of more than 3.5 million members who earn rewards for performing health-related actions, as tracked by wearables devices and apps. Through the Achievement app (See Figure 2.), members are provided opportunities to join research studies. As part of these studies, data collected from sensors and apps is used by permission of the member so that it is clear how their data are contributing to specific research questions or use cases.

This is a collaborative model of data collection built upon trust and permission and is substantially different than the collection of data from electronic health records (EHRs) – which is typically aggregated, deidentified, and commercialized, often without the patients’ knowledge or consent. Stringent protections, explicit permission, and transparency are absolutely imperative until privacy frameworks for data outside of HIPAA regulation catches up and protects patients from discrimination and unintended uses of their data.

Large connected cohorts can help advance our understanding of public health. In one study run on Achievement during the 2017-2018 flu season, a survey was sent to the Achievement population every week asking about symptoms of influenza-like illness and requesting permission to access historical data from their wearable around the influenza-like illness event.⁴ With the data, it was possible to analyze patterns of activity, sleep, and resting heart rate change around flu events.  Resting heart rate, in particular, is shown to increase during fever and at the population level. In fact, through the use of PGHD, it is possible to use the fraction of people with resting heart rate above their usual baseline as a proxy to quantify the number of infected people in a region.⁵ This resting heart rate–informed flu surveillance method, if refined to increased accuracy, can work in near real time. This means it may be able detect influenza outbreaks days earlier than current epidemiological methods.

Health data generated by connected populations are in the early stages of development. It is clear that it will yield novel insights into health and disease. Only time will tell if it will be able to help clinicians and patients better predict, diagnose, and formulate treatment plans for disease.

Neil Skolnik, M.D. is a professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, and associate director of the Family Medicine Residency Program at Abington Jefferson Health. Luca Foschini PhD, is co-founder & chief data scientist at Evidation Health. Bray Patrick-Lake, MFS, is a patient thought leader and director of strategic partnerships at Evidation Health.

References

1. Chen R et al. Developing measures of cognitive impairment in the real world from consumer-grade multimodal sensor streams. KDD ’19. August 4–8, 2019 Aug 4-8.

2. The Heartline Study. https://www.heartline.com.

3. Foschini L. Privacy of Wearable and Sensors Data (or, the Lack Thereof?). Data Driven Investor, Medium. 2019.

4. Bradshaw B et al. Influenza surveillance using wearable mobile health devices. Online J Public Health Inform. 2019;11(1):e249.

5. Radin JM et al. Harnessing wearable device data to improve state-level real-time surveillance of influenza-like illness in the USA: a population-based study. Lancet Digital Health. 2020. doi: 10.1016/S2589-7500(19)30222-5.

The first data on myocardial injury linked with COVID-19 disease during the start of the pandemic in Wuhan, China serves as a “wake up call” for clinicians and the general public on what the United States and other Western countries can expect as the SARS-CoV-2 virus spreads and case numbers mount: a potentially “daunting” toll of deaths as an infection with a tendency to be most severe in patients with underlying cardiovascular disease hits populations that include large numbers of such patients.

“A consistent picture emerges” from two reports on a total of 603 COVID-19 patients treated at two academic hospitals in Wuhan, which described “remarkably similar characteristics of patients who develop myocardial injury” associated with their infection. “Patients who develop myocardial injury with COVID-19 have clinical evidence of higher acuity, with a higher incidence of acute respiratory distress syndrome and more frequent need for assisted ventilation than those without myocardial injury, and the patients who are more prone to have myocardial injury are “older patients with preexisting cardiovascular complications and diabetes,” Robert O. Bonow, MD, and coauthors wrote in an editorial published online (JAMA Cardiol. 2020 Mar 27. doi: 10.1001/jamacardio.2020.1105).

These new findings have special relevance to the United States and other Western countries because of their substantial numbers of elderly patients with cardiovascular diseases, said Dr. Bonow, professor of medicine at Northwestern University, Chicago, and coauthors.

One of the two reports cited in the editorial reviewed 416 patients hospitalized at Renmin Hospital in Wuhan during the period of Jan. 20 to Feb. 10, 2020, with confirmed COVID-19 disease, and found that 20% of the cohort had evidence of cardiac injury, defined as blood levels of the high-sensitivity troponin I cardiac biomarker above the 99th-percentile upper reference limit, regardless of new abnormalities in electrocardiography and echocardiography.

The analysis also showed that patients with myocardial injury had a significantly higher in-hospital mortality rate, 51%, compared with a 5% mortality rate among patients without myocardial injury, and among patients with myocardial injury those with elevated high-sensitivity troponin I had an even higher mortality rate (JAMA Cardiol. 2020 Mar 25. doi: 10.1001/jamacardio.2020.0950).

A second review of 187 confirmed COVID-19 cases at Seventh Hospital in Wuhan during the period of Jan. 23 to Feb. 23, 2020, showed similar findings, with a 28% prevalence of myocardial injury at admission based on an elevated level of plasma troponin T (TnT), and 35% had cardiovascular disease (CVD) including hypertension, coronary heart disease, and cardiomyopathy. Elevated TnT levels and CVD at entry each linked with substantially increased mortality. The incidence of death among patients with elevated TnT and no underlying CVD was 38% compared with 8% among patients without elevated TnT or underlying CVD. Among patients admitted with underlying CVD those who also had an elevated TnT had a 69% death rate during hospitalization compared with a 13% rate in those without TnT elevation (JAMA Cardiol. 2020 Mar 27. doi: 10.1001/jamacardio.2020.1017).

Dr. Bonow and coauthors noted that patients with chronic coronary artery disease have a heightened risk for developing acute coronary syndrome during acute infection, potentially resulting from a severe increase in myocardial demand during infection, or severe systemic inflammatory stress that could result in atherosclerotic plaque instability and rupture as well as vascular and myocardial inflammation.

In addition, patients with heart failure are prone to hemodynamic instability during severe infection. “Thus it is anticipated that patients with underlying cardiovascular diseases, which are more prevalent in older adults, would be susceptible to higher risks of adverse outcomes and death during the severe and aggressive inflammatory responses to COVID-19 than individuals who are younger and healthier,” they wrote.

They also cited the potential for acute or fulminant myocarditis as well as new-onset heart failure caused by the SARS-CoV-2 virus that causes COVID-19 disease based on experience with the related Middle East respiratory syndrome coronavirus. Another concerning observation is that the SARS-CoV-2 virus binds to the angiotensin-converting enzyme 2 protein on cell surfaces as its main entry receptor, “raising the possibility of direct viral infection of vascular endothelium and myocardium,” a process that itself could produce myocardial injury and myocarditis.

These new findings from COVID-19 patients in Wuhan represent early data from what has become a global pandemic, and raise questions about generalizability, but for the time being a key message from these early cases is that prevention of SARS-CoV-2 infection is paramount. “Until we know more, the populations described in these primary data reports should be most observant of strict hand hygiene, social distancing, and, where available, COVID-19 testing,” the authors said.

Dr. Bonow and coauthors had no disclosures.

mzoler@mdedge.com

The first data on myocardial injury linked with COVID-19 disease during the start of the pandemic in Wuhan, China serves as a “wake up call” for clinicians and the general public on what the United States and other Western countries can expect as the SARS-CoV-2 virus spreads and case numbers mount: a potentially “daunting” toll of deaths as an infection with a tendency to be most severe in patients with underlying cardiovascular disease hits populations that include large numbers of such patients.

“A consistent picture emerges” from two reports on a total of 603 COVID-19 patients treated at two academic hospitals in Wuhan, which described “remarkably similar characteristics of patients who develop myocardial injury” associated with their infection. “Patients who develop myocardial injury with COVID-19 have clinical evidence of higher acuity, with a higher incidence of acute respiratory distress syndrome and more frequent need for assisted ventilation than those without myocardial injury, and the patients who are more prone to have myocardial injury are “older patients with preexisting cardiovascular complications and diabetes,” Robert O. Bonow, MD, and coauthors wrote in an editorial published online (JAMA Cardiol. 2020 Mar 27. doi: 10.1001/jamacardio.2020.1105).

These new findings have special relevance to the United States and other Western countries because of their substantial numbers of elderly patients with cardiovascular diseases, said Dr. Bonow, professor of medicine at Northwestern University, Chicago, and coauthors.

One of the two reports cited in the editorial reviewed 416 patients hospitalized at Renmin Hospital in Wuhan during the period of Jan. 20 to Feb. 10, 2020, with confirmed COVID-19 disease, and found that 20% of the cohort had evidence of cardiac injury, defined as blood levels of the high-sensitivity troponin I cardiac biomarker above the 99th-percentile upper reference limit, regardless of new abnormalities in electrocardiography and echocardiography.

The analysis also showed that patients with myocardial injury had a significantly higher in-hospital mortality rate, 51%, compared with a 5% mortality rate among patients without myocardial injury, and among patients with myocardial injury those with elevated high-sensitivity troponin I had an even higher mortality rate (JAMA Cardiol. 2020 Mar 25. doi: 10.1001/jamacardio.2020.0950).

A second review of 187 confirmed COVID-19 cases at Seventh Hospital in Wuhan during the period of Jan. 23 to Feb. 23, 2020, showed similar findings, with a 28% prevalence of myocardial injury at admission based on an elevated level of plasma troponin T (TnT), and 35% had cardiovascular disease (CVD) including hypertension, coronary heart disease, and cardiomyopathy. Elevated TnT levels and CVD at entry each linked with substantially increased mortality. The incidence of death among patients with elevated TnT and no underlying CVD was 38% compared with 8% among patients without elevated TnT or underlying CVD. Among patients admitted with underlying CVD those who also had an elevated TnT had a 69% death rate during hospitalization compared with a 13% rate in those without TnT elevation (JAMA Cardiol. 2020 Mar 27. doi: 10.1001/jamacardio.2020.1017).

Dr. Bonow and coauthors noted that patients with chronic coronary artery disease have a heightened risk for developing acute coronary syndrome during acute infection, potentially resulting from a severe increase in myocardial demand during infection, or severe systemic inflammatory stress that could result in atherosclerotic plaque instability and rupture as well as vascular and myocardial inflammation.

In addition, patients with heart failure are prone to hemodynamic instability during severe infection. “Thus it is anticipated that patients with underlying cardiovascular diseases, which are more prevalent in older adults, would be susceptible to higher risks of adverse outcomes and death during the severe and aggressive inflammatory responses to COVID-19 than individuals who are younger and healthier,” they wrote.

They also cited the potential for acute or fulminant myocarditis as well as new-onset heart failure caused by the SARS-CoV-2 virus that causes COVID-19 disease based on experience with the related Middle East respiratory syndrome coronavirus. Another concerning observation is that the SARS-CoV-2 virus binds to the angiotensin-converting enzyme 2 protein on cell surfaces as its main entry receptor, “raising the possibility of direct viral infection of vascular endothelium and myocardium,” a process that itself could produce myocardial injury and myocarditis.

These new findings from COVID-19 patients in Wuhan represent early data from what has become a global pandemic, and raise questions about generalizability, but for the time being a key message from these early cases is that prevention of SARS-CoV-2 infection is paramount. “Until we know more, the populations described in these primary data reports should be most observant of strict hand hygiene, social distancing, and, where available, COVID-19 testing,” the authors said.

Dr. Bonow and coauthors had no disclosures.

mzoler@mdedge.com

The first data on myocardial injury linked with COVID-19 disease during the start of the pandemic in Wuhan, China serves as a “wake up call” for clinicians and the general public on what the United States and other Western countries can expect as the SARS-CoV-2 virus spreads and case numbers mount: a potentially “daunting” toll of deaths as an infection with a tendency to be most severe in patients with underlying cardiovascular disease hits populations that include large numbers of such patients.

“A consistent picture emerges” from two reports on a total of 603 COVID-19 patients treated at two academic hospitals in Wuhan, which described “remarkably similar characteristics of patients who develop myocardial injury” associated with their infection. “Patients who develop myocardial injury with COVID-19 have clinical evidence of higher acuity, with a higher incidence of acute respiratory distress syndrome and more frequent need for assisted ventilation than those without myocardial injury, and the patients who are more prone to have myocardial injury are “older patients with preexisting cardiovascular complications and diabetes,” Robert O. Bonow, MD, and coauthors wrote in an editorial published online (JAMA Cardiol. 2020 Mar 27. doi: 10.1001/jamacardio.2020.1105).

These new findings have special relevance to the United States and other Western countries because of their substantial numbers of elderly patients with cardiovascular diseases, said Dr. Bonow, professor of medicine at Northwestern University, Chicago, and coauthors.

One of the two reports cited in the editorial reviewed 416 patients hospitalized at Renmin Hospital in Wuhan during the period of Jan. 20 to Feb. 10, 2020, with confirmed COVID-19 disease, and found that 20% of the cohort had evidence of cardiac injury, defined as blood levels of the high-sensitivity troponin I cardiac biomarker above the 99th-percentile upper reference limit, regardless of new abnormalities in electrocardiography and echocardiography.

The analysis also showed that patients with myocardial injury had a significantly higher in-hospital mortality rate, 51%, compared with a 5% mortality rate among patients without myocardial injury, and among patients with myocardial injury those with elevated high-sensitivity troponin I had an even higher mortality rate (JAMA Cardiol. 2020 Mar 25. doi: 10.1001/jamacardio.2020.0950).

A second review of 187 confirmed COVID-19 cases at Seventh Hospital in Wuhan during the period of Jan. 23 to Feb. 23, 2020, showed similar findings, with a 28% prevalence of myocardial injury at admission based on an elevated level of plasma troponin T (TnT), and 35% had cardiovascular disease (CVD) including hypertension, coronary heart disease, and cardiomyopathy. Elevated TnT levels and CVD at entry each linked with substantially increased mortality. The incidence of death among patients with elevated TnT and no underlying CVD was 38% compared with 8% among patients without elevated TnT or underlying CVD. Among patients admitted with underlying CVD those who also had an elevated TnT had a 69% death rate during hospitalization compared with a 13% rate in those without TnT elevation (JAMA Cardiol. 2020 Mar 27. doi: 10.1001/jamacardio.2020.1017).

Dr. Bonow and coauthors noted that patients with chronic coronary artery disease have a heightened risk for developing acute coronary syndrome during acute infection, potentially resulting from a severe increase in myocardial demand during infection, or severe systemic inflammatory stress that could result in atherosclerotic plaque instability and rupture as well as vascular and myocardial inflammation.

In addition, patients with heart failure are prone to hemodynamic instability during severe infection. “Thus it is anticipated that patients with underlying cardiovascular diseases, which are more prevalent in older adults, would be susceptible to higher risks of adverse outcomes and death during the severe and aggressive inflammatory responses to COVID-19 than individuals who are younger and healthier,” they wrote.

They also cited the potential for acute or fulminant myocarditis as well as new-onset heart failure caused by the SARS-CoV-2 virus that causes COVID-19 disease based on experience with the related Middle East respiratory syndrome coronavirus. Another concerning observation is that the SARS-CoV-2 virus binds to the angiotensin-converting enzyme 2 protein on cell surfaces as its main entry receptor, “raising the possibility of direct viral infection of vascular endothelium and myocardium,” a process that itself could produce myocardial injury and myocarditis.

These new findings from COVID-19 patients in Wuhan represent early data from what has become a global pandemic, and raise questions about generalizability, but for the time being a key message from these early cases is that prevention of SARS-CoV-2 infection is paramount. “Until we know more, the populations described in these primary data reports should be most observant of strict hand hygiene, social distancing, and, where available, COVID-19 testing,” the authors said.

Dr. Bonow and coauthors had no disclosures.

mzoler@mdedge.com

The test-driven world of cardiovascular medicine is rapidly shifting to remote hands-off telemedicine to keep patients and their physicians safe during the COVID-19 pandemic.

During a recent telehealth webinar, Ami Bhatt, MD, director of the adult congenital heart disease program, Massachusetts General Hospital, Boston, said they’ve gone from seeing 400 patients a day in their clinic to fewer than 40 and are trying to push that number even lower and use virtual care as much as possible.

“The reason is we are having to send home physicians who are exposed and it’s cutting into our workforce very quickly. So the more people you could have at home doing work virtually is important because you’re going to need to call them in [during] the next couple of weeks,” she said. “And our PPE [personal protective equipment] is running low. So if we can afford to not have someone come in the office and not wear a mask because they had a cough, that’s a mask that can be used by someone performing CPR in an ICU.”

The hospital also adopted a train-the-trainer method to bring its existing telehealth program to cardiology, said Dr. Bhatt, who coauthored the American College of Cardiology’s recent guidance on establishing telehealth in the cardiology clinic.

“We find that sending people tip sheets and PowerPoints in addition to everything that is happening ... is too much,” Dr. Bhatt observed. “So actually holding your friend’s hand and walking them through it once you’ve learned how to do it has been really great in terms of adoption. Otherwise, everyone would fall back on phone, which is OK for now, but we need to establish a long-term plan.”

During the same March 20 webinar, David Konur, CEO of the Cardiovascular Institute of the South, Houma, La., said they began doing telecardiology more than 5 years ago and now do about 30,000 “patient touches” a month with 24/7 access.

“This is certainly an unprecedented time,” he said. “COVID-19 is shining a very bright light on the barriers that exist in health care, as well as the friction that exists to accessing care for all of our patients.”
 

New mandates

A new Food and Drug Administration policy, temporarily relaxing prior guidance on certain connected remote monitoring devices such as ECGs and cardiac monitors, is part of a shifting landscape to reduce barriers to telehealth during the ongoing pandemic. The increased flexibility may increase access to important patient physiological data, while eliminating unnecessary patient contact and easing the burden on healthcare facilities and providers, the agency said in the new guidance, issued March 20.

As such, the FDA “does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring.”

Modifications could include the addition of monitoring statements for patients with COVID-19 or coexisting conditions such as hypertension and heart failure; a change to the indications or claims related to home use of devices previously cleared for use only in health care settings; and changes to hardware or software to increase remote monitoring capability. The approved devices listed in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximetry, noninvasive blood pressure monitors, respiratory rate/breathing frequency monitors, and electronic stethoscopes.

The FDA policy comes just days after the Centers for Medicare & Medicaid Services expanded telehealth coverage to Medicare beneficiaries and the Office for Civil Rights at the U.S. Department of Health & Human Services said it would not penalize health care providers for using such non–HIPAA compliant third-party apps as Skype or Google Hangouts video. The HHS also signaled that physicians would be allowed to practice across state lines during the COVID-19 crisis.

“All these mandates have come in a time of desperation where we’re doing the best that we can to provide for patients and keep them safe,” Eugenia Gianos, MD, system director of cardiovascular prevention at Northwell Health and director of the Women’s Cardiovascular Center, Lenox Hill Hospital, New York, said in an interview. “Realistically, the whole digital realm has a lot of promise for our patients.” She noted that telehealth programs are still being developed for the department, but that office visits have been purposely scaled back by more than 75% to protect patients as well as health care providers. “In times of need, the most promising technologies we have, have to come to the forefront,” Dr. Gianos said. “So using the data from the home – whether they have a blood pressure cuff or something that tracks their heart rate or their weight – when we don’t otherwise have data, is of great value.”

Andrew M. Freeman, MD, director of clinical cardiology and operations at National Jewish Hospital in Denver, said “in the current situation, telehealth is the most viable option because it keeps patients safe and physicians safe. So it wouldn’t surprise me if every institution in the country, if not worldwide, is very rapidly pursuing this kind of approach.”
Exactly how many programs or cardiologists were already using telehealth is impossible to say, although the ACC is planning to survey its members on their practices during the COVID-19 pandemic, he noted.

The situation is so fluid that ACC is already revising its March 13 telehealth guidance to reflect the recent policy changes. Another document is being prepared to provide physicians with a template for the telehealth space, said Dr. Freeman, who coauthored the telehealth guidance and also serves on the ACC’s Innovation Leadership Council. 
The new FDA policy allowing greater flexibility on remote monitoring devices is somewhat “vaguely worded,” Dr. Freeman noted, but highlights the ability of existing technology to provide essential patient data from home. “I think as we add adjuncts to the things we’re used to in the normal face-to-face visit, it’s going to make the face-to-face visit less required,” he said.

Questions remain, however, on implementing telehealth for new patients and whether payers will follow HHS’s decision not to conduct audits to ensure a prior relationship existed. The potential for telehealth to reach across state lines also is being viewed cautiously until tested legally, Dr. Freeman observed.

“If there’s one blessing in this awful disease that we have received, is that it may really give the power to clinicians, hospital systems, and payers to make telehealth a true viable, sustainable solution for good care that’s readily available to folks,” he said.
 

Fast-tracked research

On March 24, the American Heart Association announced it is committing $2.5 million for fast-tracked research grants for projects than can turn around results within 9-12 months and focus on how this novel coronavirus affects heart and brain health.

Additional funding also will be made available to the AHA’s new Center for Health Technology & Innovation’s Strategically Focused Research Networks to develop rapid technology solutions to aid in dealing with the pandemic.

The rapid response grant is an “unprecedented but logical move for the organization in these extraordinary times,” AHA President Bob Harrington, MD, chair of medicine at Stanford (Calif.) University, said in a statement. “We are committed to quickly bringing together and supporting some of the brightest minds in research science and clinical care who are shovel ready with the laboratories, tools, and data resources to immediately begin work on addressing this emergent issue.”

Dr. Freeman and Dr. Bhatt have disclosed no relevant financial relationships. Dr. Harrington is on the editorial board for Medscape Cardiology.

A version of this article originally appeared on Medscape.com

The test-driven world of cardiovascular medicine is rapidly shifting to remote hands-off telemedicine to keep patients and their physicians safe during the COVID-19 pandemic.

During a recent telehealth webinar, Ami Bhatt, MD, director of the adult congenital heart disease program, Massachusetts General Hospital, Boston, said they’ve gone from seeing 400 patients a day in their clinic to fewer than 40 and are trying to push that number even lower and use virtual care as much as possible.

“The reason is we are having to send home physicians who are exposed and it’s cutting into our workforce very quickly. So the more people you could have at home doing work virtually is important because you’re going to need to call them in [during] the next couple of weeks,” she said. “And our PPE [personal protective equipment] is running low. So if we can afford to not have someone come in the office and not wear a mask because they had a cough, that’s a mask that can be used by someone performing CPR in an ICU.”

The hospital also adopted a train-the-trainer method to bring its existing telehealth program to cardiology, said Dr. Bhatt, who coauthored the American College of Cardiology’s recent guidance on establishing telehealth in the cardiology clinic.

“We find that sending people tip sheets and PowerPoints in addition to everything that is happening ... is too much,” Dr. Bhatt observed. “So actually holding your friend’s hand and walking them through it once you’ve learned how to do it has been really great in terms of adoption. Otherwise, everyone would fall back on phone, which is OK for now, but we need to establish a long-term plan.”

During the same March 20 webinar, David Konur, CEO of the Cardiovascular Institute of the South, Houma, La., said they began doing telecardiology more than 5 years ago and now do about 30,000 “patient touches” a month with 24/7 access.

“This is certainly an unprecedented time,” he said. “COVID-19 is shining a very bright light on the barriers that exist in health care, as well as the friction that exists to accessing care for all of our patients.”
 

New mandates

A new Food and Drug Administration policy, temporarily relaxing prior guidance on certain connected remote monitoring devices such as ECGs and cardiac monitors, is part of a shifting landscape to reduce barriers to telehealth during the ongoing pandemic. The increased flexibility may increase access to important patient physiological data, while eliminating unnecessary patient contact and easing the burden on healthcare facilities and providers, the agency said in the new guidance, issued March 20.

As such, the FDA “does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring.”

Modifications could include the addition of monitoring statements for patients with COVID-19 or coexisting conditions such as hypertension and heart failure; a change to the indications or claims related to home use of devices previously cleared for use only in health care settings; and changes to hardware or software to increase remote monitoring capability. The approved devices listed in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximetry, noninvasive blood pressure monitors, respiratory rate/breathing frequency monitors, and electronic stethoscopes.

The FDA policy comes just days after the Centers for Medicare & Medicaid Services expanded telehealth coverage to Medicare beneficiaries and the Office for Civil Rights at the U.S. Department of Health & Human Services said it would not penalize health care providers for using such non–HIPAA compliant third-party apps as Skype or Google Hangouts video. The HHS also signaled that physicians would be allowed to practice across state lines during the COVID-19 crisis.

“All these mandates have come in a time of desperation where we’re doing the best that we can to provide for patients and keep them safe,” Eugenia Gianos, MD, system director of cardiovascular prevention at Northwell Health and director of the Women’s Cardiovascular Center, Lenox Hill Hospital, New York, said in an interview. “Realistically, the whole digital realm has a lot of promise for our patients.” She noted that telehealth programs are still being developed for the department, but that office visits have been purposely scaled back by more than 75% to protect patients as well as health care providers. “In times of need, the most promising technologies we have, have to come to the forefront,” Dr. Gianos said. “So using the data from the home – whether they have a blood pressure cuff or something that tracks their heart rate or their weight – when we don’t otherwise have data, is of great value.”

Andrew M. Freeman, MD, director of clinical cardiology and operations at National Jewish Hospital in Denver, said “in the current situation, telehealth is the most viable option because it keeps patients safe and physicians safe. So it wouldn’t surprise me if every institution in the country, if not worldwide, is very rapidly pursuing this kind of approach.”
Exactly how many programs or cardiologists were already using telehealth is impossible to say, although the ACC is planning to survey its members on their practices during the COVID-19 pandemic, he noted.

The situation is so fluid that ACC is already revising its March 13 telehealth guidance to reflect the recent policy changes. Another document is being prepared to provide physicians with a template for the telehealth space, said Dr. Freeman, who coauthored the telehealth guidance and also serves on the ACC’s Innovation Leadership Council. 
The new FDA policy allowing greater flexibility on remote monitoring devices is somewhat “vaguely worded,” Dr. Freeman noted, but highlights the ability of existing technology to provide essential patient data from home. “I think as we add adjuncts to the things we’re used to in the normal face-to-face visit, it’s going to make the face-to-face visit less required,” he said.

Questions remain, however, on implementing telehealth for new patients and whether payers will follow HHS’s decision not to conduct audits to ensure a prior relationship existed. The potential for telehealth to reach across state lines also is being viewed cautiously until tested legally, Dr. Freeman observed.

“If there’s one blessing in this awful disease that we have received, is that it may really give the power to clinicians, hospital systems, and payers to make telehealth a true viable, sustainable solution for good care that’s readily available to folks,” he said.
 

Fast-tracked research

On March 24, the American Heart Association announced it is committing $2.5 million for fast-tracked research grants for projects than can turn around results within 9-12 months and focus on how this novel coronavirus affects heart and brain health.

Additional funding also will be made available to the AHA’s new Center for Health Technology & Innovation’s Strategically Focused Research Networks to develop rapid technology solutions to aid in dealing with the pandemic.

The rapid response grant is an “unprecedented but logical move for the organization in these extraordinary times,” AHA President Bob Harrington, MD, chair of medicine at Stanford (Calif.) University, said in a statement. “We are committed to quickly bringing together and supporting some of the brightest minds in research science and clinical care who are shovel ready with the laboratories, tools, and data resources to immediately begin work on addressing this emergent issue.”

Dr. Freeman and Dr. Bhatt have disclosed no relevant financial relationships. Dr. Harrington is on the editorial board for Medscape Cardiology.

A version of this article originally appeared on Medscape.com

The test-driven world of cardiovascular medicine is rapidly shifting to remote hands-off telemedicine to keep patients and their physicians safe during the COVID-19 pandemic.

During a recent telehealth webinar, Ami Bhatt, MD, director of the adult congenital heart disease program, Massachusetts General Hospital, Boston, said they’ve gone from seeing 400 patients a day in their clinic to fewer than 40 and are trying to push that number even lower and use virtual care as much as possible.

“The reason is we are having to send home physicians who are exposed and it’s cutting into our workforce very quickly. So the more people you could have at home doing work virtually is important because you’re going to need to call them in [during] the next couple of weeks,” she said. “And our PPE [personal protective equipment] is running low. So if we can afford to not have someone come in the office and not wear a mask because they had a cough, that’s a mask that can be used by someone performing CPR in an ICU.”

The hospital also adopted a train-the-trainer method to bring its existing telehealth program to cardiology, said Dr. Bhatt, who coauthored the American College of Cardiology’s recent guidance on establishing telehealth in the cardiology clinic.

“We find that sending people tip sheets and PowerPoints in addition to everything that is happening ... is too much,” Dr. Bhatt observed. “So actually holding your friend’s hand and walking them through it once you’ve learned how to do it has been really great in terms of adoption. Otherwise, everyone would fall back on phone, which is OK for now, but we need to establish a long-term plan.”

During the same March 20 webinar, David Konur, CEO of the Cardiovascular Institute of the South, Houma, La., said they began doing telecardiology more than 5 years ago and now do about 30,000 “patient touches” a month with 24/7 access.

“This is certainly an unprecedented time,” he said. “COVID-19 is shining a very bright light on the barriers that exist in health care, as well as the friction that exists to accessing care for all of our patients.”
 

New mandates

A new Food and Drug Administration policy, temporarily relaxing prior guidance on certain connected remote monitoring devices such as ECGs and cardiac monitors, is part of a shifting landscape to reduce barriers to telehealth during the ongoing pandemic. The increased flexibility may increase access to important patient physiological data, while eliminating unnecessary patient contact and easing the burden on healthcare facilities and providers, the agency said in the new guidance, issued March 20.

As such, the FDA “does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring.”

Modifications could include the addition of monitoring statements for patients with COVID-19 or coexisting conditions such as hypertension and heart failure; a change to the indications or claims related to home use of devices previously cleared for use only in health care settings; and changes to hardware or software to increase remote monitoring capability. The approved devices listed in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximetry, noninvasive blood pressure monitors, respiratory rate/breathing frequency monitors, and electronic stethoscopes.

The FDA policy comes just days after the Centers for Medicare & Medicaid Services expanded telehealth coverage to Medicare beneficiaries and the Office for Civil Rights at the U.S. Department of Health & Human Services said it would not penalize health care providers for using such non–HIPAA compliant third-party apps as Skype or Google Hangouts video. The HHS also signaled that physicians would be allowed to practice across state lines during the COVID-19 crisis.

“All these mandates have come in a time of desperation where we’re doing the best that we can to provide for patients and keep them safe,” Eugenia Gianos, MD, system director of cardiovascular prevention at Northwell Health and director of the Women’s Cardiovascular Center, Lenox Hill Hospital, New York, said in an interview. “Realistically, the whole digital realm has a lot of promise for our patients.” She noted that telehealth programs are still being developed for the department, but that office visits have been purposely scaled back by more than 75% to protect patients as well as health care providers. “In times of need, the most promising technologies we have, have to come to the forefront,” Dr. Gianos said. “So using the data from the home – whether they have a blood pressure cuff or something that tracks their heart rate or their weight – when we don’t otherwise have data, is of great value.”

Andrew M. Freeman, MD, director of clinical cardiology and operations at National Jewish Hospital in Denver, said “in the current situation, telehealth is the most viable option because it keeps patients safe and physicians safe. So it wouldn’t surprise me if every institution in the country, if not worldwide, is very rapidly pursuing this kind of approach.”
Exactly how many programs or cardiologists were already using telehealth is impossible to say, although the ACC is planning to survey its members on their practices during the COVID-19 pandemic, he noted.

The situation is so fluid that ACC is already revising its March 13 telehealth guidance to reflect the recent policy changes. Another document is being prepared to provide physicians with a template for the telehealth space, said Dr. Freeman, who coauthored the telehealth guidance and also serves on the ACC’s Innovation Leadership Council. 
The new FDA policy allowing greater flexibility on remote monitoring devices is somewhat “vaguely worded,” Dr. Freeman noted, but highlights the ability of existing technology to provide essential patient data from home. “I think as we add adjuncts to the things we’re used to in the normal face-to-face visit, it’s going to make the face-to-face visit less required,” he said.

Questions remain, however, on implementing telehealth for new patients and whether payers will follow HHS’s decision not to conduct audits to ensure a prior relationship existed. The potential for telehealth to reach across state lines also is being viewed cautiously until tested legally, Dr. Freeman observed.

“If there’s one blessing in this awful disease that we have received, is that it may really give the power to clinicians, hospital systems, and payers to make telehealth a true viable, sustainable solution for good care that’s readily available to folks,” he said.
 

Fast-tracked research

On March 24, the American Heart Association announced it is committing $2.5 million for fast-tracked research grants for projects than can turn around results within 9-12 months and focus on how this novel coronavirus affects heart and brain health.

Additional funding also will be made available to the AHA’s new Center for Health Technology & Innovation’s Strategically Focused Research Networks to develop rapid technology solutions to aid in dealing with the pandemic.

The rapid response grant is an “unprecedented but logical move for the organization in these extraordinary times,” AHA President Bob Harrington, MD, chair of medicine at Stanford (Calif.) University, said in a statement. “We are committed to quickly bringing together and supporting some of the brightest minds in research science and clinical care who are shovel ready with the laboratories, tools, and data resources to immediately begin work on addressing this emergent issue.”

Dr. Freeman and Dr. Bhatt have disclosed no relevant financial relationships. Dr. Harrington is on the editorial board for Medscape Cardiology.

A version of this article originally appeared on Medscape.com