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Global blood supply runs low

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Mon, 10/28/2019 - 15:36

 

Nearly two-thirds of countries worldwide have an insufficient supply of blood for transfusion, according to findings from a recent modeling study including 195 countries and territories.

Tomasz Gierygowski/Thinkstock

Low- and middle-income countries are most often affected, reported lead author Nicholas Roberts of the University of Washington in Seattle and colleagues. Among all countries in Oceania, south Asia, and eastern, central, and western sub-Saharan Africa, not one had enough blood to meet estimated needs, they noted.

Shortages are attributable to a variety of challenges, including resource constraints, insufficient component production, and a high prevalence of infectious diseases, according to investigators. And existing guidelines, which call for 10-20 donations per 1,000 people in the population, may need to be revised, investigators suggested.

“These estimates are important, as they can be used to guide further investments in blood transfusion services, for analysis of current transfusion practices, and to highlight need for alternatives to transfusions such as antifibrinolytics, blood saving devices, and implementation of blood management systems,” the investigators wrote in Lancet Haematology.



Blood availability was calculated using the 2016 WHO Global Status Report on Blood Safety and Availability, in which 92% of countries participated. Blood needs were calculated using multiple databases, including the (U.S.) National Inpatient Sample datasets from 2000-2014, the State Inpatient Databases from 2003-2007, and the Global Burden of Disease 2017 study.

The global blood need was almost 305 million blood product units, while the supply totaled approximately 272 million units. These shortages, however, were not distributed equally across the globe. Out of 195 countries, 119 (61%) had an insufficient supply of blood to meet anticipated demand. Within this group, the shortage equated to about 102 million blood product units.

Denmark had the greatest supply of blood products (red blood cell products, platelets, and plasma), at 14,704 units per 100,000 population, compared with South Sudan, the least prepared to meet transfusion needs, with just 46 blood product units available per 100,000 population. This pattern was echoed across the globe; high-income countries were usually better stocked than those with low or middle income.

To meet demands, some of the most affected countries would need to raise their collection goals from single-digit figures to as high as 40 donations per 1,000 population, the investigators advised.

“Many countries face critical undersupply of transfusions, which will become more pronounced as access to care improves,” the investigators wrote.

The study was funded by the National Institutes of Health. The investigators reported having no other financial disclosures.

SOURCE: Roberts N et al. Lancet Haematol. 2019 Oct 17. doi: 10.1016/ S2352-3026(19)30200-5.

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Nearly two-thirds of countries worldwide have an insufficient supply of blood for transfusion, according to findings from a recent modeling study including 195 countries and territories.

Tomasz Gierygowski/Thinkstock

Low- and middle-income countries are most often affected, reported lead author Nicholas Roberts of the University of Washington in Seattle and colleagues. Among all countries in Oceania, south Asia, and eastern, central, and western sub-Saharan Africa, not one had enough blood to meet estimated needs, they noted.

Shortages are attributable to a variety of challenges, including resource constraints, insufficient component production, and a high prevalence of infectious diseases, according to investigators. And existing guidelines, which call for 10-20 donations per 1,000 people in the population, may need to be revised, investigators suggested.

“These estimates are important, as they can be used to guide further investments in blood transfusion services, for analysis of current transfusion practices, and to highlight need for alternatives to transfusions such as antifibrinolytics, blood saving devices, and implementation of blood management systems,” the investigators wrote in Lancet Haematology.



Blood availability was calculated using the 2016 WHO Global Status Report on Blood Safety and Availability, in which 92% of countries participated. Blood needs were calculated using multiple databases, including the (U.S.) National Inpatient Sample datasets from 2000-2014, the State Inpatient Databases from 2003-2007, and the Global Burden of Disease 2017 study.

The global blood need was almost 305 million blood product units, while the supply totaled approximately 272 million units. These shortages, however, were not distributed equally across the globe. Out of 195 countries, 119 (61%) had an insufficient supply of blood to meet anticipated demand. Within this group, the shortage equated to about 102 million blood product units.

Denmark had the greatest supply of blood products (red blood cell products, platelets, and plasma), at 14,704 units per 100,000 population, compared with South Sudan, the least prepared to meet transfusion needs, with just 46 blood product units available per 100,000 population. This pattern was echoed across the globe; high-income countries were usually better stocked than those with low or middle income.

To meet demands, some of the most affected countries would need to raise their collection goals from single-digit figures to as high as 40 donations per 1,000 population, the investigators advised.

“Many countries face critical undersupply of transfusions, which will become more pronounced as access to care improves,” the investigators wrote.

The study was funded by the National Institutes of Health. The investigators reported having no other financial disclosures.

SOURCE: Roberts N et al. Lancet Haematol. 2019 Oct 17. doi: 10.1016/ S2352-3026(19)30200-5.

 

Nearly two-thirds of countries worldwide have an insufficient supply of blood for transfusion, according to findings from a recent modeling study including 195 countries and territories.

Tomasz Gierygowski/Thinkstock

Low- and middle-income countries are most often affected, reported lead author Nicholas Roberts of the University of Washington in Seattle and colleagues. Among all countries in Oceania, south Asia, and eastern, central, and western sub-Saharan Africa, not one had enough blood to meet estimated needs, they noted.

Shortages are attributable to a variety of challenges, including resource constraints, insufficient component production, and a high prevalence of infectious diseases, according to investigators. And existing guidelines, which call for 10-20 donations per 1,000 people in the population, may need to be revised, investigators suggested.

“These estimates are important, as they can be used to guide further investments in blood transfusion services, for analysis of current transfusion practices, and to highlight need for alternatives to transfusions such as antifibrinolytics, blood saving devices, and implementation of blood management systems,” the investigators wrote in Lancet Haematology.



Blood availability was calculated using the 2016 WHO Global Status Report on Blood Safety and Availability, in which 92% of countries participated. Blood needs were calculated using multiple databases, including the (U.S.) National Inpatient Sample datasets from 2000-2014, the State Inpatient Databases from 2003-2007, and the Global Burden of Disease 2017 study.

The global blood need was almost 305 million blood product units, while the supply totaled approximately 272 million units. These shortages, however, were not distributed equally across the globe. Out of 195 countries, 119 (61%) had an insufficient supply of blood to meet anticipated demand. Within this group, the shortage equated to about 102 million blood product units.

Denmark had the greatest supply of blood products (red blood cell products, platelets, and plasma), at 14,704 units per 100,000 population, compared with South Sudan, the least prepared to meet transfusion needs, with just 46 blood product units available per 100,000 population. This pattern was echoed across the globe; high-income countries were usually better stocked than those with low or middle income.

To meet demands, some of the most affected countries would need to raise their collection goals from single-digit figures to as high as 40 donations per 1,000 population, the investigators advised.

“Many countries face critical undersupply of transfusions, which will become more pronounced as access to care improves,” the investigators wrote.

The study was funded by the National Institutes of Health. The investigators reported having no other financial disclosures.

SOURCE: Roberts N et al. Lancet Haematol. 2019 Oct 17. doi: 10.1016/ S2352-3026(19)30200-5.

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Consider treating ovarian torsion with conservative surgery in young women

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Changed
Tue, 10/22/2019 - 11:26

 

– Women with ovarian torsion had a lower rate of perioperative complications when treated with conservative surgery, compared with oophorectomy, according to results from a retrospective study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News
Dr. Rachel S. Mandelbaum

The effectiveness of laparoscopy and conservative surgery has increased in recent years, but over 75% of women with ovarian torsion in the study were treated with oophorectomy and 60% underwent a laparotomy, said Rachel S. Mandelbaum, MD, of the department of obstetrics & gynecology at the University of Southern California, Los Angeles.

“We believe that conservative surgery should be performed whenever possible in young women with ovarian torsion regardless of the appearance of the ovary intraoperatively,” said Dr. Mandelbaum.

The researchers performed a retrospective, observational study of 89,801 women in the Nationwide Inpatient Sample who were younger than age 50 years, were diagnosed with ovarian torsion during Jan. 2001–Sept. 2015, and were treated with conservative surgery or oophorectomy. Patients were excluded if they had malignancy, were older than 50 years of age, or their surgery information was unavailable. The majority of patients in the study were white (46%), nonobese (91%), without comorbidities, privately insured (59%), and were seen at a large (61%) urban hospital (51% teaching; 38% nonteaching).

Dr. Mandelbaum and colleagues found 78% of patients received a cystectomy, 19% had cyst drainage, 11% had detorsion alone, and 0.5% had an oophoropexy, with less than 10% of patients having a combination of cystectomy, cyst drainage, and oophoropexy. According to a multivariable analysis, patients who were treated with conservative surgery were more likely to be young, have a high income, live in the northeastern United States, be treated with laparoscopy, and be seen at a large hospital or teaching hospital (P less than .001). Oophorectomy was more common in patients with a high number of comorbidities and in patients with morbid obesity (P less than .001).

Between 2001 and 2015, the rate of conservative surgery increased from 19% to 25% (P less than .001); however, the rate of conservative surgery by age was nearly 40% in pediatric patients up to 15 years old, while the rate of conservative surgery declined by almost half until 35 years, followed by a further decline until age 50 years, said Dr. Mandelbaum. Use of laparoscopy also increased from 31% in 2001 to 42% in 2015 (P less than .001).

Overall, 20,643 patients underwent conservative surgery and 69,157 patients received an oophorectomy. Patients in the conservative surgery group were more likely to undergo a conservative surgery with a laparoscopic surgical approach (51%) than a laparotomy (41%), while patients receiving an oophorectomy were more likely to have a laparotomy (67%) than a laparoscopic surgical approach (33%). In 1,663 conservative surgeries (8%), the approach was unknown.

Postoperative complications were higher in the oophorectomy group (12%) than the conservative surgery (8%) group (odds ratio, 0.57; 95% confidence interval, 0.57-0.78; P less than .001), but there was a similar rate of venous thromboembolism (0.3% vs. 0.2%; P equals .568) and sepsis (0.3% vs. 0.3%; P equals .865) in each group.

Dr. Mandelbaum attributed the high rate of oophorectomies in the study to “differential uptake of evidence” in different areas of the United States, fear of complications from leaving an infected ovary in situ, or the surgeon’s belief that the ovary is not viable because of its color intraoperatively. “We know from animal and human studies that the intraoperative appearance of the ovary does not correlate to viability, and that 90% of black or blue ovaries regain function and subsequently appear normal on both transvaginal ultrasound or on a second look grossly,” she said. Oophorectomy rates also vary by surgeon, and gynecologists are more likely to perform conservative surgery, she added.

The researchers said they were unable to obtain data on specific surgical variables such as the size of the mass, time to surgery, intraoperative appearance, laterality, fertility wishes of the patient, and surgeon type. There were also no postdischarge data, or information on the timing of complications.

Dr. Mandelbaum reported no relevant conflicts of interest.

SOURCE: Mandelbaum RS et al. ASRM 2019. Abstract O-96.

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– Women with ovarian torsion had a lower rate of perioperative complications when treated with conservative surgery, compared with oophorectomy, according to results from a retrospective study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News
Dr. Rachel S. Mandelbaum

The effectiveness of laparoscopy and conservative surgery has increased in recent years, but over 75% of women with ovarian torsion in the study were treated with oophorectomy and 60% underwent a laparotomy, said Rachel S. Mandelbaum, MD, of the department of obstetrics & gynecology at the University of Southern California, Los Angeles.

“We believe that conservative surgery should be performed whenever possible in young women with ovarian torsion regardless of the appearance of the ovary intraoperatively,” said Dr. Mandelbaum.

The researchers performed a retrospective, observational study of 89,801 women in the Nationwide Inpatient Sample who were younger than age 50 years, were diagnosed with ovarian torsion during Jan. 2001–Sept. 2015, and were treated with conservative surgery or oophorectomy. Patients were excluded if they had malignancy, were older than 50 years of age, or their surgery information was unavailable. The majority of patients in the study were white (46%), nonobese (91%), without comorbidities, privately insured (59%), and were seen at a large (61%) urban hospital (51% teaching; 38% nonteaching).

Dr. Mandelbaum and colleagues found 78% of patients received a cystectomy, 19% had cyst drainage, 11% had detorsion alone, and 0.5% had an oophoropexy, with less than 10% of patients having a combination of cystectomy, cyst drainage, and oophoropexy. According to a multivariable analysis, patients who were treated with conservative surgery were more likely to be young, have a high income, live in the northeastern United States, be treated with laparoscopy, and be seen at a large hospital or teaching hospital (P less than .001). Oophorectomy was more common in patients with a high number of comorbidities and in patients with morbid obesity (P less than .001).

Between 2001 and 2015, the rate of conservative surgery increased from 19% to 25% (P less than .001); however, the rate of conservative surgery by age was nearly 40% in pediatric patients up to 15 years old, while the rate of conservative surgery declined by almost half until 35 years, followed by a further decline until age 50 years, said Dr. Mandelbaum. Use of laparoscopy also increased from 31% in 2001 to 42% in 2015 (P less than .001).

Overall, 20,643 patients underwent conservative surgery and 69,157 patients received an oophorectomy. Patients in the conservative surgery group were more likely to undergo a conservative surgery with a laparoscopic surgical approach (51%) than a laparotomy (41%), while patients receiving an oophorectomy were more likely to have a laparotomy (67%) than a laparoscopic surgical approach (33%). In 1,663 conservative surgeries (8%), the approach was unknown.

Postoperative complications were higher in the oophorectomy group (12%) than the conservative surgery (8%) group (odds ratio, 0.57; 95% confidence interval, 0.57-0.78; P less than .001), but there was a similar rate of venous thromboembolism (0.3% vs. 0.2%; P equals .568) and sepsis (0.3% vs. 0.3%; P equals .865) in each group.

Dr. Mandelbaum attributed the high rate of oophorectomies in the study to “differential uptake of evidence” in different areas of the United States, fear of complications from leaving an infected ovary in situ, or the surgeon’s belief that the ovary is not viable because of its color intraoperatively. “We know from animal and human studies that the intraoperative appearance of the ovary does not correlate to viability, and that 90% of black or blue ovaries regain function and subsequently appear normal on both transvaginal ultrasound or on a second look grossly,” she said. Oophorectomy rates also vary by surgeon, and gynecologists are more likely to perform conservative surgery, she added.

The researchers said they were unable to obtain data on specific surgical variables such as the size of the mass, time to surgery, intraoperative appearance, laterality, fertility wishes of the patient, and surgeon type. There were also no postdischarge data, or information on the timing of complications.

Dr. Mandelbaum reported no relevant conflicts of interest.

SOURCE: Mandelbaum RS et al. ASRM 2019. Abstract O-96.

 

– Women with ovarian torsion had a lower rate of perioperative complications when treated with conservative surgery, compared with oophorectomy, according to results from a retrospective study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News
Dr. Rachel S. Mandelbaum

The effectiveness of laparoscopy and conservative surgery has increased in recent years, but over 75% of women with ovarian torsion in the study were treated with oophorectomy and 60% underwent a laparotomy, said Rachel S. Mandelbaum, MD, of the department of obstetrics & gynecology at the University of Southern California, Los Angeles.

“We believe that conservative surgery should be performed whenever possible in young women with ovarian torsion regardless of the appearance of the ovary intraoperatively,” said Dr. Mandelbaum.

The researchers performed a retrospective, observational study of 89,801 women in the Nationwide Inpatient Sample who were younger than age 50 years, were diagnosed with ovarian torsion during Jan. 2001–Sept. 2015, and were treated with conservative surgery or oophorectomy. Patients were excluded if they had malignancy, were older than 50 years of age, or their surgery information was unavailable. The majority of patients in the study were white (46%), nonobese (91%), without comorbidities, privately insured (59%), and were seen at a large (61%) urban hospital (51% teaching; 38% nonteaching).

Dr. Mandelbaum and colleagues found 78% of patients received a cystectomy, 19% had cyst drainage, 11% had detorsion alone, and 0.5% had an oophoropexy, with less than 10% of patients having a combination of cystectomy, cyst drainage, and oophoropexy. According to a multivariable analysis, patients who were treated with conservative surgery were more likely to be young, have a high income, live in the northeastern United States, be treated with laparoscopy, and be seen at a large hospital or teaching hospital (P less than .001). Oophorectomy was more common in patients with a high number of comorbidities and in patients with morbid obesity (P less than .001).

Between 2001 and 2015, the rate of conservative surgery increased from 19% to 25% (P less than .001); however, the rate of conservative surgery by age was nearly 40% in pediatric patients up to 15 years old, while the rate of conservative surgery declined by almost half until 35 years, followed by a further decline until age 50 years, said Dr. Mandelbaum. Use of laparoscopy also increased from 31% in 2001 to 42% in 2015 (P less than .001).

Overall, 20,643 patients underwent conservative surgery and 69,157 patients received an oophorectomy. Patients in the conservative surgery group were more likely to undergo a conservative surgery with a laparoscopic surgical approach (51%) than a laparotomy (41%), while patients receiving an oophorectomy were more likely to have a laparotomy (67%) than a laparoscopic surgical approach (33%). In 1,663 conservative surgeries (8%), the approach was unknown.

Postoperative complications were higher in the oophorectomy group (12%) than the conservative surgery (8%) group (odds ratio, 0.57; 95% confidence interval, 0.57-0.78; P less than .001), but there was a similar rate of venous thromboembolism (0.3% vs. 0.2%; P equals .568) and sepsis (0.3% vs. 0.3%; P equals .865) in each group.

Dr. Mandelbaum attributed the high rate of oophorectomies in the study to “differential uptake of evidence” in different areas of the United States, fear of complications from leaving an infected ovary in situ, or the surgeon’s belief that the ovary is not viable because of its color intraoperatively. “We know from animal and human studies that the intraoperative appearance of the ovary does not correlate to viability, and that 90% of black or blue ovaries regain function and subsequently appear normal on both transvaginal ultrasound or on a second look grossly,” she said. Oophorectomy rates also vary by surgeon, and gynecologists are more likely to perform conservative surgery, she added.

The researchers said they were unable to obtain data on specific surgical variables such as the size of the mass, time to surgery, intraoperative appearance, laterality, fertility wishes of the patient, and surgeon type. There were also no postdischarge data, or information on the timing of complications.

Dr. Mandelbaum reported no relevant conflicts of interest.

SOURCE: Mandelbaum RS et al. ASRM 2019. Abstract O-96.

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Surgery better than medical therapy in some GERD patients

Surgery for heartburn, but not for everyone
Article Type
Changed
Thu, 10/17/2019 - 11:52

Surgery may be more effective than medical therapy, according to results from a randomized trial in 78 patients with reflux-related heartburn refractory to proton pump inhibitors (PPIs).

Stuart J. Spechler, MD, from Baylor University Medical Center, Dallas, and coauthors wrote in the New England Journal of Medicine that, for these patients, there were no medical treatment options that had been shown to have long-term benefit, so PPIs were often continued despite not offering adequate symptom relief. Other medical options such as baclofen and neuromodulators often have unacceptable side effects, and studies of their efficacy were few and of short duration.

In this study, patients were randomized either to laparoscopic Nissen fundoplication, treatment with omeprazole plus baclofen with desipramine depending on symptoms, or a control treatment of omeprazole plus placebo.

At 1 year, researchers saw a significantly higher rate of treatment success – defined as 50% or greater improvement in gastroesophageal reflux disease health-related quality of life score – in the surgery group (67%), compared with the medical-treatment group (28%) and control-medical group (12%).

This translated to an unadjusted 138% greater chance of treatment success with surgery, compared with active medical treatment, and a greater than 400% increase for surgery, compared with the control medical treatment.

Researchers also did a prespecified subgroup analysis among people with reflex hypersensitivity or abnormal acid reflux, and found the incidence of success with surgery was 71% and 62%, respectively.

They described this finding as “noteworthy,” given that reflux hypersensitivity was considered a functional disorder that would not be expected to improve with a procedure that didn’t alter abnormal esophageal pain perception.

However, they acknowledged that, as the study did not include a sham-surgery group, they couldn’t determine how much the placebo effect might have contributed to the treatment success of surgery.

They also stressed that the randomized group was a highly selected group of patients, and that the systematic work-up including esophageal multichannel intraluminal impedance pH monitoring could identify a subgroup that might have a better response to surgery than to medical treatment.

Four patients in the surgery group experienced a total of five serious adverse events, including one patients who had a herniated fundoplication treated with repeat surgery; four patients in the active-medical group experienced four serious adverse events; and three patients in the control-medical group experienced five serious adverse events.

The authors noted that 366 patients with PPI-refractory heartburn were originally enrolled in the study, then treated with 20 mg of omeprazole twice daily for 2 weeks with strict instructions to take 20 minutes before breakfast and dinner. Of these patients, 42 had their symptoms relieved by the omeprazole treatment and so were excluded from the randomization.

The “strict instructions” on how to take omeprazole were important, because PPIs only bind to gastric proton pumps that are actively secreting acid, the authors wrote. They also commented that the relative potencies of individual PPIs can vary, so patients not on omeprazole before the study may have responded better to this than other PPIs.

Before randomizations, patients also underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance pH monitoring. This excluded another 23 patients who were found to have non–gastroesophageal reflux disease, including eosinophilic esophagitis, other endoscopic or histologic abnormalities, and manometric abnormalities.

“This trial highlights the critical importance of systematic evaluation, similar to that recommended by Gyawali and Fass for managing the care of patients with PPI-refractory heartburn,” they wrote. “Many patients would not complete this rigorous evaluation, and among those who did, the cause of heartburn in most of them was not [gastroesophageal reflux disease].”

The study was funded by the Department of Veterans Affairs Cooperative Studies Program. Four authors declared consultancies with and/or grants from the pharmaceutical sector.

SOURCE: Spechler SJ et al. N Engl J Med. 2019 Oct 16. doi: 10.1056/NEJMoa1811424.

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Around 40% of troublesome heartburn fails to respond to proton pump inhibitor therapy, which may reflect a diverse range of underlying causes of the condition. Therefore we cannot treat it as a single disease process that will respond to higher and higher doses of acid suppression.

The results of a study of surgical intervention in a carefully selected group of patients are striking in showing surgery’s superiority to medical treatment, but it is important to note that 79% of patients enrolled in the study did not meet the criteria for surgery. Therefore these findings cannot be generalized to all patients with refractory heartburn, and each case should only be considered for surgery after extended trials of medical therapy.

Nicholas J. Talley, MD, PhD, is from the faculty of health and medicine at the University of Newcastle (Australia) and Hunter Medical Research Institute, also in Newcastle. These comments are adapted from an accompanying editorial (N Engl J Med. 2019 Oct 17. doi: 10.1056/NEJMe1911623). Dr. Talley declared a range of consultancies, grants, personal fees, and patents unrelated to the study.

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Around 40% of troublesome heartburn fails to respond to proton pump inhibitor therapy, which may reflect a diverse range of underlying causes of the condition. Therefore we cannot treat it as a single disease process that will respond to higher and higher doses of acid suppression.

The results of a study of surgical intervention in a carefully selected group of patients are striking in showing surgery’s superiority to medical treatment, but it is important to note that 79% of patients enrolled in the study did not meet the criteria for surgery. Therefore these findings cannot be generalized to all patients with refractory heartburn, and each case should only be considered for surgery after extended trials of medical therapy.

Nicholas J. Talley, MD, PhD, is from the faculty of health and medicine at the University of Newcastle (Australia) and Hunter Medical Research Institute, also in Newcastle. These comments are adapted from an accompanying editorial (N Engl J Med. 2019 Oct 17. doi: 10.1056/NEJMe1911623). Dr. Talley declared a range of consultancies, grants, personal fees, and patents unrelated to the study.

Body

 

Around 40% of troublesome heartburn fails to respond to proton pump inhibitor therapy, which may reflect a diverse range of underlying causes of the condition. Therefore we cannot treat it as a single disease process that will respond to higher and higher doses of acid suppression.

The results of a study of surgical intervention in a carefully selected group of patients are striking in showing surgery’s superiority to medical treatment, but it is important to note that 79% of patients enrolled in the study did not meet the criteria for surgery. Therefore these findings cannot be generalized to all patients with refractory heartburn, and each case should only be considered for surgery after extended trials of medical therapy.

Nicholas J. Talley, MD, PhD, is from the faculty of health and medicine at the University of Newcastle (Australia) and Hunter Medical Research Institute, also in Newcastle. These comments are adapted from an accompanying editorial (N Engl J Med. 2019 Oct 17. doi: 10.1056/NEJMe1911623). Dr. Talley declared a range of consultancies, grants, personal fees, and patents unrelated to the study.

Title
Surgery for heartburn, but not for everyone
Surgery for heartburn, but not for everyone

Surgery may be more effective than medical therapy, according to results from a randomized trial in 78 patients with reflux-related heartburn refractory to proton pump inhibitors (PPIs).

Stuart J. Spechler, MD, from Baylor University Medical Center, Dallas, and coauthors wrote in the New England Journal of Medicine that, for these patients, there were no medical treatment options that had been shown to have long-term benefit, so PPIs were often continued despite not offering adequate symptom relief. Other medical options such as baclofen and neuromodulators often have unacceptable side effects, and studies of their efficacy were few and of short duration.

In this study, patients were randomized either to laparoscopic Nissen fundoplication, treatment with omeprazole plus baclofen with desipramine depending on symptoms, or a control treatment of omeprazole plus placebo.

At 1 year, researchers saw a significantly higher rate of treatment success – defined as 50% or greater improvement in gastroesophageal reflux disease health-related quality of life score – in the surgery group (67%), compared with the medical-treatment group (28%) and control-medical group (12%).

This translated to an unadjusted 138% greater chance of treatment success with surgery, compared with active medical treatment, and a greater than 400% increase for surgery, compared with the control medical treatment.

Researchers also did a prespecified subgroup analysis among people with reflex hypersensitivity or abnormal acid reflux, and found the incidence of success with surgery was 71% and 62%, respectively.

They described this finding as “noteworthy,” given that reflux hypersensitivity was considered a functional disorder that would not be expected to improve with a procedure that didn’t alter abnormal esophageal pain perception.

However, they acknowledged that, as the study did not include a sham-surgery group, they couldn’t determine how much the placebo effect might have contributed to the treatment success of surgery.

They also stressed that the randomized group was a highly selected group of patients, and that the systematic work-up including esophageal multichannel intraluminal impedance pH monitoring could identify a subgroup that might have a better response to surgery than to medical treatment.

Four patients in the surgery group experienced a total of five serious adverse events, including one patients who had a herniated fundoplication treated with repeat surgery; four patients in the active-medical group experienced four serious adverse events; and three patients in the control-medical group experienced five serious adverse events.

The authors noted that 366 patients with PPI-refractory heartburn were originally enrolled in the study, then treated with 20 mg of omeprazole twice daily for 2 weeks with strict instructions to take 20 minutes before breakfast and dinner. Of these patients, 42 had their symptoms relieved by the omeprazole treatment and so were excluded from the randomization.

The “strict instructions” on how to take omeprazole were important, because PPIs only bind to gastric proton pumps that are actively secreting acid, the authors wrote. They also commented that the relative potencies of individual PPIs can vary, so patients not on omeprazole before the study may have responded better to this than other PPIs.

Before randomizations, patients also underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance pH monitoring. This excluded another 23 patients who were found to have non–gastroesophageal reflux disease, including eosinophilic esophagitis, other endoscopic or histologic abnormalities, and manometric abnormalities.

“This trial highlights the critical importance of systematic evaluation, similar to that recommended by Gyawali and Fass for managing the care of patients with PPI-refractory heartburn,” they wrote. “Many patients would not complete this rigorous evaluation, and among those who did, the cause of heartburn in most of them was not [gastroesophageal reflux disease].”

The study was funded by the Department of Veterans Affairs Cooperative Studies Program. Four authors declared consultancies with and/or grants from the pharmaceutical sector.

SOURCE: Spechler SJ et al. N Engl J Med. 2019 Oct 16. doi: 10.1056/NEJMoa1811424.

Surgery may be more effective than medical therapy, according to results from a randomized trial in 78 patients with reflux-related heartburn refractory to proton pump inhibitors (PPIs).

Stuart J. Spechler, MD, from Baylor University Medical Center, Dallas, and coauthors wrote in the New England Journal of Medicine that, for these patients, there were no medical treatment options that had been shown to have long-term benefit, so PPIs were often continued despite not offering adequate symptom relief. Other medical options such as baclofen and neuromodulators often have unacceptable side effects, and studies of their efficacy were few and of short duration.

In this study, patients were randomized either to laparoscopic Nissen fundoplication, treatment with omeprazole plus baclofen with desipramine depending on symptoms, or a control treatment of omeprazole plus placebo.

At 1 year, researchers saw a significantly higher rate of treatment success – defined as 50% or greater improvement in gastroesophageal reflux disease health-related quality of life score – in the surgery group (67%), compared with the medical-treatment group (28%) and control-medical group (12%).

This translated to an unadjusted 138% greater chance of treatment success with surgery, compared with active medical treatment, and a greater than 400% increase for surgery, compared with the control medical treatment.

Researchers also did a prespecified subgroup analysis among people with reflex hypersensitivity or abnormal acid reflux, and found the incidence of success with surgery was 71% and 62%, respectively.

They described this finding as “noteworthy,” given that reflux hypersensitivity was considered a functional disorder that would not be expected to improve with a procedure that didn’t alter abnormal esophageal pain perception.

However, they acknowledged that, as the study did not include a sham-surgery group, they couldn’t determine how much the placebo effect might have contributed to the treatment success of surgery.

They also stressed that the randomized group was a highly selected group of patients, and that the systematic work-up including esophageal multichannel intraluminal impedance pH monitoring could identify a subgroup that might have a better response to surgery than to medical treatment.

Four patients in the surgery group experienced a total of five serious adverse events, including one patients who had a herniated fundoplication treated with repeat surgery; four patients in the active-medical group experienced four serious adverse events; and three patients in the control-medical group experienced five serious adverse events.

The authors noted that 366 patients with PPI-refractory heartburn were originally enrolled in the study, then treated with 20 mg of omeprazole twice daily for 2 weeks with strict instructions to take 20 minutes before breakfast and dinner. Of these patients, 42 had their symptoms relieved by the omeprazole treatment and so were excluded from the randomization.

The “strict instructions” on how to take omeprazole were important, because PPIs only bind to gastric proton pumps that are actively secreting acid, the authors wrote. They also commented that the relative potencies of individual PPIs can vary, so patients not on omeprazole before the study may have responded better to this than other PPIs.

Before randomizations, patients also underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance pH monitoring. This excluded another 23 patients who were found to have non–gastroesophageal reflux disease, including eosinophilic esophagitis, other endoscopic or histologic abnormalities, and manometric abnormalities.

“This trial highlights the critical importance of systematic evaluation, similar to that recommended by Gyawali and Fass for managing the care of patients with PPI-refractory heartburn,” they wrote. “Many patients would not complete this rigorous evaluation, and among those who did, the cause of heartburn in most of them was not [gastroesophageal reflux disease].”

The study was funded by the Department of Veterans Affairs Cooperative Studies Program. Four authors declared consultancies with and/or grants from the pharmaceutical sector.

SOURCE: Spechler SJ et al. N Engl J Med. 2019 Oct 16. doi: 10.1056/NEJMoa1811424.

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Key clinical point: Surgery may be more effective than medical therapy in some patients with treatment-refractory gastroesophageal reflux disease.

Major finding: Patients with treatment-refractory gastroesophageal reflux disease treated with surgery were 2.38 times more likely to respond to surgery than medical treatment.

Study details: A randomized, controlled trial in 78 patients with gastroesophageal reflux disease.

Disclosures: The study was funded by the Department of Veterans Affairs Cooperative Studies Program. Four authors declared consultancies with and/or grants from the pharmaceutical sector.

Source: Spechler SJ et al. N Engl J Med. 2019 Oct 16. doi: 10.1056/NEJMoa1811424.

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Portico system safe, effective for high-risk TAVR patients

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Tue, 10/22/2019 - 11:00

– An investigational device exemption trial of the Portico valve with FlexNav delivery system showed 1-year clinical results on par with commercially available valves, Gregory P. Fontana, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Doug Brunk/MDedge News
Dr. Gregory P. Fontana

In a prospective, open-label study conducted at 52 sites known as PORTICO, Dr. Fontana and colleagues conducted a noninferiority intention-to-treat evaluation of the safety and effectiveness of the self-expanding Portico transcatheter aortic valve replacement system, compared with Food and Drug Administration–approved and commercially available TAVR systems for patients with severe aortic stenosis at high or extreme risk for surgery. Between May 2014 and June 2019, 750 patients from 69 sites were randomized 1:1 to each group. The prespecified primary safety composite endpoint was all-cause mortality, disabling stroke, life-threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days, while the primary effectiveness composite endpoint was all-cause mortality or disabling stroke at 1 year.

The mean baseline age of patients was 83 years, 53% were female, and their mean Society of Thoracic Surgeons score was 6.5%. Dr. Fontana, director and chairman of cardiothoracic surgery at the CardioVascular Institute of Los Robles Regional Medical Center, Thousand Oaks, Calif., reported at the meeting sponsored by the Cardiovascular Research Foundation that procedural success was comparable between groups (96.5% for Portico vs, 98.3% for commercially available TAVR, respectively). In addition, patients in both groups met the prespecified primary safety composite endpoint (13.8% vs. 9.6%; P for noninferiority = .03) and the primary effectiveness composite endpoint (14.9% vs. 13.4%, P for noninferiority = .006).



However, the rate of moderate to severe paravalvular leak at 30 days was 6.3% among patients in the Portico valve group, compared with 2.1% of their counterparts in the commercially available TAVR group, a difference that did not reach noninferiority. Dr. Fontana said that a next-generation valve with design modifications to reduce paravalvular leak is being tested in clinical trials.

PORTICO included a separate cohort of 100 patients who underwent Portico valve implantation using the FlexNav Delivery System, which became available after the trial had launched. The primary safety endpoint for the FlexNav cohort was major vascular complication rate at 30 days. This cohort demonstrated no deaths or strokes, low rates of major vascular complications (7.0%) and new permanent pacemaker implants (14.6%), as well as a safety profile comparable with the commercially available valve group in the randomized study (8.0% vs. 9.6%).

“My sense of this device is that presumably it will be another valve we have available to us in the United States,” Pinak B. Shah, MD, a cardiologist at Brigham and Women’s Hospital, Boston, said during a media briefing. “The challenge to all of us is to figure out where it fits in our armamentarium. Is it going to be worth individuals to learn a whole new device when at this point it’s hard to say if there’s a major difference compared to the other self-expanding devices we have now?”

With the new FlexNav delivery system, the Portico valve is characterized by “a very calm, slow delivery,” said Dr. Fontana, who was the study’s coprincipal investigator, along with Raj R. Makkar, MD, director of interventional cardiology at Cedars-Sinai Medical Center, Los Angeles. “The operator can land the valve exactly where they want it. If they’re not happy, they can make some adjustments. I haven’t yet a system in my hands that is as stable as this. The option of having excellent hemodynamics and large cells to engage the coronary system is a unique combination for us in the United States.”

The Portico valve is not currently FDA approved. The PORTICO study was funded by Abbott. Dr. Fontana disclosed grant/research support from Abbott and Medtronic and consulting fees/honoraria from Abbott, Medtronic, and LivaNova.

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– An investigational device exemption trial of the Portico valve with FlexNav delivery system showed 1-year clinical results on par with commercially available valves, Gregory P. Fontana, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Doug Brunk/MDedge News
Dr. Gregory P. Fontana

In a prospective, open-label study conducted at 52 sites known as PORTICO, Dr. Fontana and colleagues conducted a noninferiority intention-to-treat evaluation of the safety and effectiveness of the self-expanding Portico transcatheter aortic valve replacement system, compared with Food and Drug Administration–approved and commercially available TAVR systems for patients with severe aortic stenosis at high or extreme risk for surgery. Between May 2014 and June 2019, 750 patients from 69 sites were randomized 1:1 to each group. The prespecified primary safety composite endpoint was all-cause mortality, disabling stroke, life-threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days, while the primary effectiveness composite endpoint was all-cause mortality or disabling stroke at 1 year.

The mean baseline age of patients was 83 years, 53% were female, and their mean Society of Thoracic Surgeons score was 6.5%. Dr. Fontana, director and chairman of cardiothoracic surgery at the CardioVascular Institute of Los Robles Regional Medical Center, Thousand Oaks, Calif., reported at the meeting sponsored by the Cardiovascular Research Foundation that procedural success was comparable between groups (96.5% for Portico vs, 98.3% for commercially available TAVR, respectively). In addition, patients in both groups met the prespecified primary safety composite endpoint (13.8% vs. 9.6%; P for noninferiority = .03) and the primary effectiveness composite endpoint (14.9% vs. 13.4%, P for noninferiority = .006).



However, the rate of moderate to severe paravalvular leak at 30 days was 6.3% among patients in the Portico valve group, compared with 2.1% of their counterparts in the commercially available TAVR group, a difference that did not reach noninferiority. Dr. Fontana said that a next-generation valve with design modifications to reduce paravalvular leak is being tested in clinical trials.

PORTICO included a separate cohort of 100 patients who underwent Portico valve implantation using the FlexNav Delivery System, which became available after the trial had launched. The primary safety endpoint for the FlexNav cohort was major vascular complication rate at 30 days. This cohort demonstrated no deaths or strokes, low rates of major vascular complications (7.0%) and new permanent pacemaker implants (14.6%), as well as a safety profile comparable with the commercially available valve group in the randomized study (8.0% vs. 9.6%).

“My sense of this device is that presumably it will be another valve we have available to us in the United States,” Pinak B. Shah, MD, a cardiologist at Brigham and Women’s Hospital, Boston, said during a media briefing. “The challenge to all of us is to figure out where it fits in our armamentarium. Is it going to be worth individuals to learn a whole new device when at this point it’s hard to say if there’s a major difference compared to the other self-expanding devices we have now?”

With the new FlexNav delivery system, the Portico valve is characterized by “a very calm, slow delivery,” said Dr. Fontana, who was the study’s coprincipal investigator, along with Raj R. Makkar, MD, director of interventional cardiology at Cedars-Sinai Medical Center, Los Angeles. “The operator can land the valve exactly where they want it. If they’re not happy, they can make some adjustments. I haven’t yet a system in my hands that is as stable as this. The option of having excellent hemodynamics and large cells to engage the coronary system is a unique combination for us in the United States.”

The Portico valve is not currently FDA approved. The PORTICO study was funded by Abbott. Dr. Fontana disclosed grant/research support from Abbott and Medtronic and consulting fees/honoraria from Abbott, Medtronic, and LivaNova.

– An investigational device exemption trial of the Portico valve with FlexNav delivery system showed 1-year clinical results on par with commercially available valves, Gregory P. Fontana, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Doug Brunk/MDedge News
Dr. Gregory P. Fontana

In a prospective, open-label study conducted at 52 sites known as PORTICO, Dr. Fontana and colleagues conducted a noninferiority intention-to-treat evaluation of the safety and effectiveness of the self-expanding Portico transcatheter aortic valve replacement system, compared with Food and Drug Administration–approved and commercially available TAVR systems for patients with severe aortic stenosis at high or extreme risk for surgery. Between May 2014 and June 2019, 750 patients from 69 sites were randomized 1:1 to each group. The prespecified primary safety composite endpoint was all-cause mortality, disabling stroke, life-threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days, while the primary effectiveness composite endpoint was all-cause mortality or disabling stroke at 1 year.

The mean baseline age of patients was 83 years, 53% were female, and their mean Society of Thoracic Surgeons score was 6.5%. Dr. Fontana, director and chairman of cardiothoracic surgery at the CardioVascular Institute of Los Robles Regional Medical Center, Thousand Oaks, Calif., reported at the meeting sponsored by the Cardiovascular Research Foundation that procedural success was comparable between groups (96.5% for Portico vs, 98.3% for commercially available TAVR, respectively). In addition, patients in both groups met the prespecified primary safety composite endpoint (13.8% vs. 9.6%; P for noninferiority = .03) and the primary effectiveness composite endpoint (14.9% vs. 13.4%, P for noninferiority = .006).



However, the rate of moderate to severe paravalvular leak at 30 days was 6.3% among patients in the Portico valve group, compared with 2.1% of their counterparts in the commercially available TAVR group, a difference that did not reach noninferiority. Dr. Fontana said that a next-generation valve with design modifications to reduce paravalvular leak is being tested in clinical trials.

PORTICO included a separate cohort of 100 patients who underwent Portico valve implantation using the FlexNav Delivery System, which became available after the trial had launched. The primary safety endpoint for the FlexNav cohort was major vascular complication rate at 30 days. This cohort demonstrated no deaths or strokes, low rates of major vascular complications (7.0%) and new permanent pacemaker implants (14.6%), as well as a safety profile comparable with the commercially available valve group in the randomized study (8.0% vs. 9.6%).

“My sense of this device is that presumably it will be another valve we have available to us in the United States,” Pinak B. Shah, MD, a cardiologist at Brigham and Women’s Hospital, Boston, said during a media briefing. “The challenge to all of us is to figure out where it fits in our armamentarium. Is it going to be worth individuals to learn a whole new device when at this point it’s hard to say if there’s a major difference compared to the other self-expanding devices we have now?”

With the new FlexNav delivery system, the Portico valve is characterized by “a very calm, slow delivery,” said Dr. Fontana, who was the study’s coprincipal investigator, along with Raj R. Makkar, MD, director of interventional cardiology at Cedars-Sinai Medical Center, Los Angeles. “The operator can land the valve exactly where they want it. If they’re not happy, they can make some adjustments. I haven’t yet a system in my hands that is as stable as this. The option of having excellent hemodynamics and large cells to engage the coronary system is a unique combination for us in the United States.”

The Portico valve is not currently FDA approved. The PORTICO study was funded by Abbott. Dr. Fontana disclosed grant/research support from Abbott and Medtronic and consulting fees/honoraria from Abbott, Medtronic, and LivaNova.

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Prior maternal gastric bypass surgery tied to fewer birth defects

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The risk of major birth defects was lower for infants whose mothers had gastric bypass surgery prior to the pregnancy than it was for infants of matched controls, according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.

“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.

To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.

In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.

Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.

The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.

Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.

Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
 

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The risk of major birth defects was lower for infants whose mothers had gastric bypass surgery prior to the pregnancy than it was for infants of matched controls, according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.

“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.

To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.

In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.

Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.

The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.

Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.

Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
 

 

The risk of major birth defects was lower for infants whose mothers had gastric bypass surgery prior to the pregnancy than it was for infants of matched controls, according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.

“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.

To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.

In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.

Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.

The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.

Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.

Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
 

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Key clinical point: Infants whose mothers previously underwent gastric bypass surgery had a lower risk of birth defects than did the infants of matched controls.

Major finding: Major birth defects occurred in 3% of infants whose mothers had gastric bypass surgery, compared with 5% of infants born to control women.

Study details: The data come from a cohort study of 2,921 women with history of gastric bypass surgery and 30,573 matched controls.

Disclosures: Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.

Source: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.
 

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New consensus recommendations on bleeding in acquired hemophilia

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New consensus statements, released by a group of 36 experts, provide specific recommendations related to monitoring bleeding and assessing efficacy of treatment in patients with acquired hemophilia.

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A global survey was developed by a nine-member steering committee with expertise in the hemostatic management of patients with acquired hemophilia. The Delphi methodology was used to obtain consensus on a list of statements on the location-specific treatment of bleeding in acquired hemophilia.

“The initial survey was circulated via email for refinement and was formally corroborated at a face-to-face meeting,” wrote Andreas Tiede, MD, PhD, of Hannover (Germany) Medical School and fellow experts. The report is published in Haemophilia.

The key areas outlined include the initial management of bleeding, and management of location-specific bleeding, including urological, gastrointestinal, muscle, and pharyngeal bleeds, as well as intracranial and postpartum hemorrhage.



If an expert hematologist is not available, and the bleeding event is life‐threatening, the emergency physician should initiate treatment in accordance with local or national recommendations, according to the initial management guidelines.

With respect to urological bleeds, the best interval for evaluating successful achievement of hemostasis is every 6-12 hours. The experts also reported that, if first-line hemostatic therapy is not effective, more intensive treatment should be considered every 6-12 hours.

In the management of intracranial hemorrhage, the frequency of clinical evaluation is subject to the particular scenario, and it can vary from every 2 hours (for clinical assessment) to every 24 hours (for imaging studies), they wrote.

If initial hemostatic treatment is not effective, more intensive therapy should be considered every 6 hours, they recommended.

“The statement addressing optimal frequency for assessing hemostasis in intracranial bleeds was the subject of much deliberation among the steering committee regarding timing of assessment,” the experts acknowledged.

The geographic diversity and global representation of expert participants were major strengths of these recommendations. However, these statements did not consider socioeconomic parameters or geopolitical differences that could affect patient care. As a result, they may not be applicable to all patient populations.

The manuscript was funded by Novo Nordisk AG. The authors reported having financial affiliations with Novo Nordisk and several other companies.

SOURCE: Tiede A et al. Haemophilia. 2019 Sep 13. doi: 10.1111/hae.13844.

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New consensus statements, released by a group of 36 experts, provide specific recommendations related to monitoring bleeding and assessing efficacy of treatment in patients with acquired hemophilia.

Svisio/Thinkstock

A global survey was developed by a nine-member steering committee with expertise in the hemostatic management of patients with acquired hemophilia. The Delphi methodology was used to obtain consensus on a list of statements on the location-specific treatment of bleeding in acquired hemophilia.

“The initial survey was circulated via email for refinement and was formally corroborated at a face-to-face meeting,” wrote Andreas Tiede, MD, PhD, of Hannover (Germany) Medical School and fellow experts. The report is published in Haemophilia.

The key areas outlined include the initial management of bleeding, and management of location-specific bleeding, including urological, gastrointestinal, muscle, and pharyngeal bleeds, as well as intracranial and postpartum hemorrhage.



If an expert hematologist is not available, and the bleeding event is life‐threatening, the emergency physician should initiate treatment in accordance with local or national recommendations, according to the initial management guidelines.

With respect to urological bleeds, the best interval for evaluating successful achievement of hemostasis is every 6-12 hours. The experts also reported that, if first-line hemostatic therapy is not effective, more intensive treatment should be considered every 6-12 hours.

In the management of intracranial hemorrhage, the frequency of clinical evaluation is subject to the particular scenario, and it can vary from every 2 hours (for clinical assessment) to every 24 hours (for imaging studies), they wrote.

If initial hemostatic treatment is not effective, more intensive therapy should be considered every 6 hours, they recommended.

“The statement addressing optimal frequency for assessing hemostasis in intracranial bleeds was the subject of much deliberation among the steering committee regarding timing of assessment,” the experts acknowledged.

The geographic diversity and global representation of expert participants were major strengths of these recommendations. However, these statements did not consider socioeconomic parameters or geopolitical differences that could affect patient care. As a result, they may not be applicable to all patient populations.

The manuscript was funded by Novo Nordisk AG. The authors reported having financial affiliations with Novo Nordisk and several other companies.

SOURCE: Tiede A et al. Haemophilia. 2019 Sep 13. doi: 10.1111/hae.13844.

 

New consensus statements, released by a group of 36 experts, provide specific recommendations related to monitoring bleeding and assessing efficacy of treatment in patients with acquired hemophilia.

Svisio/Thinkstock

A global survey was developed by a nine-member steering committee with expertise in the hemostatic management of patients with acquired hemophilia. The Delphi methodology was used to obtain consensus on a list of statements on the location-specific treatment of bleeding in acquired hemophilia.

“The initial survey was circulated via email for refinement and was formally corroborated at a face-to-face meeting,” wrote Andreas Tiede, MD, PhD, of Hannover (Germany) Medical School and fellow experts. The report is published in Haemophilia.

The key areas outlined include the initial management of bleeding, and management of location-specific bleeding, including urological, gastrointestinal, muscle, and pharyngeal bleeds, as well as intracranial and postpartum hemorrhage.



If an expert hematologist is not available, and the bleeding event is life‐threatening, the emergency physician should initiate treatment in accordance with local or national recommendations, according to the initial management guidelines.

With respect to urological bleeds, the best interval for evaluating successful achievement of hemostasis is every 6-12 hours. The experts also reported that, if first-line hemostatic therapy is not effective, more intensive treatment should be considered every 6-12 hours.

In the management of intracranial hemorrhage, the frequency of clinical evaluation is subject to the particular scenario, and it can vary from every 2 hours (for clinical assessment) to every 24 hours (for imaging studies), they wrote.

If initial hemostatic treatment is not effective, more intensive therapy should be considered every 6 hours, they recommended.

“The statement addressing optimal frequency for assessing hemostasis in intracranial bleeds was the subject of much deliberation among the steering committee regarding timing of assessment,” the experts acknowledged.

The geographic diversity and global representation of expert participants were major strengths of these recommendations. However, these statements did not consider socioeconomic parameters or geopolitical differences that could affect patient care. As a result, they may not be applicable to all patient populations.

The manuscript was funded by Novo Nordisk AG. The authors reported having financial affiliations with Novo Nordisk and several other companies.

SOURCE: Tiede A et al. Haemophilia. 2019 Sep 13. doi: 10.1111/hae.13844.

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Firearm-related deaths show recent increase

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Mon, 10/21/2019 - 11:24

 

After years of relative stability, firearm-related mortality in the United States rose sharply starting in 2015, according to analysis of a national mortality database.

U.S. firearm mortality was 10.4 per 100,000 person-years during 1999-2014, with the high in that period occurring in 2012 and dropping each of the next 2 years – compared with 11.8 per 100,000 during 2015-2017, an increase of 13.8%, Jason E. Goldstick, PhD, and associates wrote Oct. 8 in Health Affairs.

The majority of the 612,310 firearm deaths over the entire study period were suicides, with the proportion rising slightly from 58.6% in 1999-2014 to 60.0% in 2015-2017. Homicides made up 38.5% of deaths in 1999-2014 and 37.9% in 2015-2017, while the combined share of unintentional and undetermined deaths dropped from 2.9% to 2.1%, the investigators reported.

“What we can see is a worsening epidemic of firearm mortality that is geographically and demographically broad,” Dr. Goldstick of the University of Michigan, Ann Arbor, said in a separate written statement.

The geographic broadness can be seen when the change in mortality from 1999-2014 to 2015-2017 was calculated for each locale: 29 states had an increase of more than 20% and only 3 states (California, New York, and Rhode Island) and the District of Columbia had a decrease of at least 12.5%, they said. The data came from the Centers for Disease Control and Prevention’s Wide-ranging Online Data for Epidemiologic Research tool.

The different trends among states and subpopulations make it difficult to offer policy-based interventions. “The epidemiology of firearm violence is complex and varies based on the mechanism of death, demographic group under study, and regionally specific culture, making a one-size-fits-all solution inappropriate,” Dr. Goldstick and associates wrote.

The study was funded mainly by a grant from the National Institute of Child Health and Human Development. The investigators did not provide any information on conflicts of interest.

SOURCE: Goldstick JE et al. Health Aff. 2019;38(10):1646-52.

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After years of relative stability, firearm-related mortality in the United States rose sharply starting in 2015, according to analysis of a national mortality database.

U.S. firearm mortality was 10.4 per 100,000 person-years during 1999-2014, with the high in that period occurring in 2012 and dropping each of the next 2 years – compared with 11.8 per 100,000 during 2015-2017, an increase of 13.8%, Jason E. Goldstick, PhD, and associates wrote Oct. 8 in Health Affairs.

The majority of the 612,310 firearm deaths over the entire study period were suicides, with the proportion rising slightly from 58.6% in 1999-2014 to 60.0% in 2015-2017. Homicides made up 38.5% of deaths in 1999-2014 and 37.9% in 2015-2017, while the combined share of unintentional and undetermined deaths dropped from 2.9% to 2.1%, the investigators reported.

“What we can see is a worsening epidemic of firearm mortality that is geographically and demographically broad,” Dr. Goldstick of the University of Michigan, Ann Arbor, said in a separate written statement.

The geographic broadness can be seen when the change in mortality from 1999-2014 to 2015-2017 was calculated for each locale: 29 states had an increase of more than 20% and only 3 states (California, New York, and Rhode Island) and the District of Columbia had a decrease of at least 12.5%, they said. The data came from the Centers for Disease Control and Prevention’s Wide-ranging Online Data for Epidemiologic Research tool.

The different trends among states and subpopulations make it difficult to offer policy-based interventions. “The epidemiology of firearm violence is complex and varies based on the mechanism of death, demographic group under study, and regionally specific culture, making a one-size-fits-all solution inappropriate,” Dr. Goldstick and associates wrote.

The study was funded mainly by a grant from the National Institute of Child Health and Human Development. The investigators did not provide any information on conflicts of interest.

SOURCE: Goldstick JE et al. Health Aff. 2019;38(10):1646-52.

 

After years of relative stability, firearm-related mortality in the United States rose sharply starting in 2015, according to analysis of a national mortality database.

U.S. firearm mortality was 10.4 per 100,000 person-years during 1999-2014, with the high in that period occurring in 2012 and dropping each of the next 2 years – compared with 11.8 per 100,000 during 2015-2017, an increase of 13.8%, Jason E. Goldstick, PhD, and associates wrote Oct. 8 in Health Affairs.

The majority of the 612,310 firearm deaths over the entire study period were suicides, with the proportion rising slightly from 58.6% in 1999-2014 to 60.0% in 2015-2017. Homicides made up 38.5% of deaths in 1999-2014 and 37.9% in 2015-2017, while the combined share of unintentional and undetermined deaths dropped from 2.9% to 2.1%, the investigators reported.

“What we can see is a worsening epidemic of firearm mortality that is geographically and demographically broad,” Dr. Goldstick of the University of Michigan, Ann Arbor, said in a separate written statement.

The geographic broadness can be seen when the change in mortality from 1999-2014 to 2015-2017 was calculated for each locale: 29 states had an increase of more than 20% and only 3 states (California, New York, and Rhode Island) and the District of Columbia had a decrease of at least 12.5%, they said. The data came from the Centers for Disease Control and Prevention’s Wide-ranging Online Data for Epidemiologic Research tool.

The different trends among states and subpopulations make it difficult to offer policy-based interventions. “The epidemiology of firearm violence is complex and varies based on the mechanism of death, demographic group under study, and regionally specific culture, making a one-size-fits-all solution inappropriate,” Dr. Goldstick and associates wrote.

The study was funded mainly by a grant from the National Institute of Child Health and Human Development. The investigators did not provide any information on conflicts of interest.

SOURCE: Goldstick JE et al. Health Aff. 2019;38(10):1646-52.

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HCV+ kidney transplants: Similar outcomes to HCV- regardless of recipient serostatus

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Kidneys from donors with hepatitis C virus (HCV) infection function well despite adverse quality assessment and are a valuable resource for transplantation candidates independent of HCV status, according to the findings of a large U.S. registry study.

one kidney in red and blue
Mohammed Haneefa Nizamudeen/Getty Images

A total of 260 HCV-viremic kidneys were transplanted in the first quarter of 2019, with 105 additional viremic kidneys being discarded, according to a report in the Journal of the American Society of Nephrology by Vishnu S. Potluri, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

Donor HCV viremia was defined as an HCV nucleic acid test–positive result reported to the Organ Procurement and Transplantation Network (OPTN). Donors who were HCV negative in this test were labeled as HCV nonviremic. Kidney transplantation recipients were defined as either HCV seropositive or seronegative based on HCV antibody testing.

During the first quarter of 2019, 74% of HCV-viremic kidneys were transplanted into seronegative recipients, which is a major change from how HCV-viremic kidneys were allocated a few years ago, according to the researchers. The results of small trials showing the benefits of such transplantations and the success of direct-acting antiviral therapy (DAA) on clearing HCV infections were indicated as likely responsible for the change.

HCV-viremic kidneys had similar function, compared with HCV-nonviremic kidneys, when matched on the donor elements included in the Kidney Profile Donor Index (KDPI), excluding HCV, they added. In addition, the 12-month estimated glomerular filtration rate (eGFR) was similar between the seropositive and seronegative recipients, respectively 65.4 and 71.1 mL/min per 1.73 m2 (P = .05), which suggests that recipient HCV serostatus does not negatively affect 1-year graft function using HCV-viremic kidneys in the era of DAA treatments, according to the authors.

Also, among HCV-seropositive recipients of HCV-viremic kidneys, seven (3.4%) died by 1 year post transplantation, while none of the HCV-seronegative recipients of HCV-viremic kidneys experienced graft failure or death.

“These striking results provide important additional evidence that the KDPI, with its current negative weighting for HCV status, does not accurately assess the quality of kidneys from HCV-viremic donors,” the authors wrote.

“HCV-viremic kidneys are a valuable resource for transplantation. Disincentives for accepting these organs should be addressed by the transplantation community,” Dr. Potluri and colleagues concluded.

This work was supported in part by the Health Resources and Services Administration of the U.S. Department of Health & Human Services. The various authors reported grant funding and advisory board participation with a number of pharmaceutical companies.

SOURCE: Potluri VS et al. J Am Soc Nephrol. 2019;30:1939-51.

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Kidneys from donors with hepatitis C virus (HCV) infection function well despite adverse quality assessment and are a valuable resource for transplantation candidates independent of HCV status, according to the findings of a large U.S. registry study.

one kidney in red and blue
Mohammed Haneefa Nizamudeen/Getty Images

A total of 260 HCV-viremic kidneys were transplanted in the first quarter of 2019, with 105 additional viremic kidneys being discarded, according to a report in the Journal of the American Society of Nephrology by Vishnu S. Potluri, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

Donor HCV viremia was defined as an HCV nucleic acid test–positive result reported to the Organ Procurement and Transplantation Network (OPTN). Donors who were HCV negative in this test were labeled as HCV nonviremic. Kidney transplantation recipients were defined as either HCV seropositive or seronegative based on HCV antibody testing.

During the first quarter of 2019, 74% of HCV-viremic kidneys were transplanted into seronegative recipients, which is a major change from how HCV-viremic kidneys were allocated a few years ago, according to the researchers. The results of small trials showing the benefits of such transplantations and the success of direct-acting antiviral therapy (DAA) on clearing HCV infections were indicated as likely responsible for the change.

HCV-viremic kidneys had similar function, compared with HCV-nonviremic kidneys, when matched on the donor elements included in the Kidney Profile Donor Index (KDPI), excluding HCV, they added. In addition, the 12-month estimated glomerular filtration rate (eGFR) was similar between the seropositive and seronegative recipients, respectively 65.4 and 71.1 mL/min per 1.73 m2 (P = .05), which suggests that recipient HCV serostatus does not negatively affect 1-year graft function using HCV-viremic kidneys in the era of DAA treatments, according to the authors.

Also, among HCV-seropositive recipients of HCV-viremic kidneys, seven (3.4%) died by 1 year post transplantation, while none of the HCV-seronegative recipients of HCV-viremic kidneys experienced graft failure or death.

“These striking results provide important additional evidence that the KDPI, with its current negative weighting for HCV status, does not accurately assess the quality of kidneys from HCV-viremic donors,” the authors wrote.

“HCV-viremic kidneys are a valuable resource for transplantation. Disincentives for accepting these organs should be addressed by the transplantation community,” Dr. Potluri and colleagues concluded.

This work was supported in part by the Health Resources and Services Administration of the U.S. Department of Health & Human Services. The various authors reported grant funding and advisory board participation with a number of pharmaceutical companies.

SOURCE: Potluri VS et al. J Am Soc Nephrol. 2019;30:1939-51.

 

Kidneys from donors with hepatitis C virus (HCV) infection function well despite adverse quality assessment and are a valuable resource for transplantation candidates independent of HCV status, according to the findings of a large U.S. registry study.

one kidney in red and blue
Mohammed Haneefa Nizamudeen/Getty Images

A total of 260 HCV-viremic kidneys were transplanted in the first quarter of 2019, with 105 additional viremic kidneys being discarded, according to a report in the Journal of the American Society of Nephrology by Vishnu S. Potluri, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

Donor HCV viremia was defined as an HCV nucleic acid test–positive result reported to the Organ Procurement and Transplantation Network (OPTN). Donors who were HCV negative in this test were labeled as HCV nonviremic. Kidney transplantation recipients were defined as either HCV seropositive or seronegative based on HCV antibody testing.

During the first quarter of 2019, 74% of HCV-viremic kidneys were transplanted into seronegative recipients, which is a major change from how HCV-viremic kidneys were allocated a few years ago, according to the researchers. The results of small trials showing the benefits of such transplantations and the success of direct-acting antiviral therapy (DAA) on clearing HCV infections were indicated as likely responsible for the change.

HCV-viremic kidneys had similar function, compared with HCV-nonviremic kidneys, when matched on the donor elements included in the Kidney Profile Donor Index (KDPI), excluding HCV, they added. In addition, the 12-month estimated glomerular filtration rate (eGFR) was similar between the seropositive and seronegative recipients, respectively 65.4 and 71.1 mL/min per 1.73 m2 (P = .05), which suggests that recipient HCV serostatus does not negatively affect 1-year graft function using HCV-viremic kidneys in the era of DAA treatments, according to the authors.

Also, among HCV-seropositive recipients of HCV-viremic kidneys, seven (3.4%) died by 1 year post transplantation, while none of the HCV-seronegative recipients of HCV-viremic kidneys experienced graft failure or death.

“These striking results provide important additional evidence that the KDPI, with its current negative weighting for HCV status, does not accurately assess the quality of kidneys from HCV-viremic donors,” the authors wrote.

“HCV-viremic kidneys are a valuable resource for transplantation. Disincentives for accepting these organs should be addressed by the transplantation community,” Dr. Potluri and colleagues concluded.

This work was supported in part by the Health Resources and Services Administration of the U.S. Department of Health & Human Services. The various authors reported grant funding and advisory board participation with a number of pharmaceutical companies.

SOURCE: Potluri VS et al. J Am Soc Nephrol. 2019;30:1939-51.

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Optimizing a Total Joint Replacement Care Pathway to Reduce Skilled Nursing Facility Utilization

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Optimizing a Total Joint Replacement Care Pathway to Reduce Skilled Nursing Facility Utilization

From Grant Medical Center (Dr. Wasielewski, Dr. Polonia, Ms. Barca, Ms. Cebriak, Ms. Lucki), and OhioHealth Group (Mr. Rogers, Ms. St. John, Dr. Gascon), Columbus, OH.

Abstract

  • Background: Organizations participating in the Centers for Medicare and Medicaid Services (CMS) Bundled Payment for Care Improvement (BPCI) initiative enter into payment arrangements that include financial and performance accountability for episodes of care. There is growing evidence that the use of these payment incentives reduces spending for episodes of care while maintaining or improving quality. A recent study of BPCI and quality outcomes in joint replacement episodes found that nearly all the reduction in spending within BPCI hospitals was generated from the reduced use of institutional post-acute care (eg, skilled nursing facilities [SNF], long-term care facilities, and inpatient rehabilitation facilities).
  • Objective: To describe a pilot program designed to reduce the utilization of institutional post-acute care for total joint replacement surgical patients.
  • Methods: A multidisciplinary intervention team optimized scheduling, preadmission testing, patient communication, and patient education along a total joint replacement care pathway.
  • Results: Among Medicare patients, total discharges to a SNF fell from 39.5% (70/177) in the baseline period to 17.7% (34/192) in the performance period. The risk of SNF utilization among patients in the intervention period was nearly half (0.45; 95% confidence interval, 0.314-0.639) that of patients in the baseline period. Using Fisher’s exact test and a 2-tailed test, this reduction was found to be significant (P < 0.0001). The readmission rate was substantially lower than national norms.
  • Conclusion: Optimizing patient care throughout the care pathway using the concerted efforts of a multidisciplinary team is possible given a common vision, shared goals, and clearly communicated expectations.

Keywords: arthroplasty; readmissions; Medicare; post-acute care; Bundled Payment for Care Improvement.

Quality improvement in health care is partially dependent upon processes that standardize episodes of care. This is especially true in the post–acute care setting, where efforts to increase patient engagement and care coordination can improve a patient’s recovery process. One framework for optimizing patient care across an episode of care is the Centers for Medicare and Medicaid Services (CMS) Bundled Payment for Care Improvement (BPCI) initiative, which links payments for the multiple services patients receive during an episode of care. Organizations participating in the BPCI initiative enter into payment arrangements that include financial and performance accountability for episodes of care. The BPCI initiative provides a framework for episodes of care across multiple types of facilities and clinicians over periods of time (30-day, 60-day, and 90-day episodes).1-5 Evidence that the use of these payment incentives reduces spending for episodes of care while maintaining or improving quality is accumulating. A recent study of BPCI and quality outcomes in joint replacement episodes found that nearly all the reduction in spending within BPCI hospitals was generated from the reduced use of institutional post-acute care, such as skilled nursing facilities (SNF), long-term care facilities, and inpatient rehabilitation facilities.1

Our hospital, the Grant Medical Center, which is part of the OhioHealth system, had agreed to participate in the CMS BPCI–Advanced Model for major joint replacement of the lower extremity, with a start date of October 1, 2018. Prior to adopting this bundled payment and service delivery model for major joint replacement through the BPCI program, we implemented strategic interventions to improve the efficiency of care delivery and reduce post-acute utilization. Although the BPCI program applied only to Medicare patients, the interventions that were developed, implemented, and evaluated in this quality improvement project, which we describe in this article, were provided to all patients who underwent lower-extremity joint replacement, regardless of payer.

Gap Analysis

Prior to developing and implementing the intervention, a gap analysis was performed to determine differences between Grant Medical Center’s care pathway/processes and evidence-based best practice. A steering committee comprised of physician champions, rehabilitation services, senior leadership from the Bone and Joint Center, and care management was gathered. The gap analysis examined the care paths in the preoperative phase, index admission phase, and the post-acute phase of care. Findings of the gap analysis included an underutilized joint education class, overutilization of SNF placement, and lack of key resources to assess the needs of patients prior to surgery.

The Grant Bone and Joint Center offered a comprehensive joint education class in person, but also gave patients the option of utilizing an online learning source. While both were successful, staff believed the in-person class had a greater impact than the online version. Patients who attended the class completed a preoperative assessment by hand, which included a social assessment for identifying potential challenges prior to admission. However, because class attendance was low (< 10%), this assessment tool was not utilized until the patient’s admission in most cases. The gap analysis also identified that the educational content of the class lacked key points to encourage a home-going plan.

 

 

The baseline SNF utilization rate (using data from July 1, 2015–June 30, 2016) within the Medicare population was 39.5% (70/177), with an overall (all payers) rate of 22.9% (192/838). This SNF utilization rate was higher than the national benchmark, underscoring the need to focus on a preoperative “plan for home” message. In addition, review of Medicare fee-for-service data from 2014 to 2016 revealed that Grant Medical Center utilized 83 different SNFs over the course of approximately 2 years. In this context, staff saw an opportunity to develop stronger relationships with fewer SNF partners, as well as OhioHealth Home Care, in order to improve care by standardizing functional recovery in post-acute care management.

In sum, the gap analysis found that a lack of standardization, follow through, and engagement in daily multidisciplinary rounds often led to a plan for SNF discharge instead of home. As such, it was determined that the pilot program would target the preoperative and post-acute phases of care and that its primary endpoint would be the reduction of the SNF discharge rate among Medicare fee-for-service patients.

Literature Review

Targeting the SNF discharge rate as the endpoint was also supported by a recent study that showed that most of the reduction in spending for total joint replacement within BPCI hospitals was linked to reduced use of institutional post-acute care.1 Other studies in the joint replacement literature have delineated the specific aspects of care redesign that allow hospitals to provide more efficient and effective care delivery during an episode of care.6-8 A review of these and similar studies of joint replacement quality improvement interventions yielded a number of actionable findings:

  • Engaging and educating patients and families is critical. Families and other caregivers must be identified preoperatively, actively engaged, and committed to helping the patient recover.
  • Providers must build the expectation in patients that they will return home as soon as it is safe to do so. This includes working to restore physiologic function, managing pain with oral medication, and restoring the physical capability of adapting to a home environment.
  • Relationships must be established with post-acute care providers who are able to demonstrate best practices and be willing partners on performance outcomes.
  • Providers need to invest in personnel to coordinate care transitions initiated preoperatively that continue through the post-acute phase of care.
  • Providers must promote processes that allow patients to more fully own their recovery through coaching and improved communication.

A total joint replacement initiative undertaken at another hospital within the OhioHealth system, Riverside Methodist Hospital, that incorporated these aspects of care redesign demonstrated a significant reduction in SNF utilization. That success informed the development of the initiative at Grant Medical Center.

 

 

Methods

Setting

This pilot project was conducted from July 2017 through July 2018 at the Grant Bone and Joint Center in the Grant Medical Center, an urban hospital in Columbus, Ohio. The Bone and Joint Center performs more than 7400 surgeries each year, of which 12% are total joint replacements. Grant Medical Center is a Level I Trauma Center that has received a fourth designation in Magnet Nursing status and has attained The Joint Commission Disease-Specific Care Certification for its total knee and hip arthroplasty, total shoulder, and hip fracture programs.

Intervention

The findings from the gap analysis were incorporated into a standardized preoperative care pathway at the Center. Standardization of the care pathway required developing relationships between office staff, schedulers, inpatient work teams, and preadmission testing, as well as physician group realignment with the larger organization.

During this time, the steering committee identified the need for a designated full-time pre-habilitation case manager to support patients undergoing hip and knee replacements at the Center. With the addition of a new role, prehab case manager, attention was directed to patient social assessment and communication. After the surgery was scheduled but prior to the preoperative education class, each patient received a screening phone call from the prehab case manager that included an initial social assessment. The electronic health record (EHR) was utilized to communicate the results of the assessment, including barriers to a home-going plan. The phone call allowed the case manager to reinforce the importance of class attendance for the patient and primary caregiver, and also allowed any specific concerns identified to be addressed and resolved prior to surgery.

A work group consisting of the prehab case manager, office staff, and the bone and joint leadership team focused on improving the core preoperative education content, same-day preadmission clearance, and class attendance. To support these efforts, the work group (1) created a scheduling document to align preadmission testing and the preoperative education class so they occurred on the same day, (2) improved prior authorization of the surgery to support the post-surgical care team, (3) clarified expectations and roles among office staff and care management staff to optimize the discharge process, and (4) engaged the physician team to encourage a culture change towards setting patient expectations to be discharged to home or a preferred SNF location. Regarding prior authorization communications, prior to the intervention, communication was insufficient, paper driven, and lacking in continuity. Utilizing the EHR, an EPIC platform, a designated documentation location was created, which increased communication among the office schedulers, preadmission testing, and surgery schedulers. The consistent location for recording prior authorization avoided canceled surgeries and claim denials due to missing pieces of information. In addition to these process changes, the surgical offices were geographically realigned to a new single location, a change that brought the staff together and in turn allowed for role clarification and team building and also allowed the staff to identify opportunities for improvement.

The core content of the education class was redesigned to support patients’ understanding of the procedure and what to expect during the hospital stay and discharge for home. Staff worked first to align all preadmission patient requirements with the content of the class. In pilot studies, patients were asked to provide feedback, and this feedback was incorporated into subsequent revisions. Staff developed multilingual handouts, including a surgery instruction sheet with a preoperative social assessment, in addition to creating opportunities for 1:1 education when it was medically or socially appropriate.

The work group brought the physicians in the care pathway together for a focused conversation and education regarding the need for including class attendance as part of their practice. They worked with the physicians’ support team to coordinate standardized follow-up care in the post-acute setting and encouraged the physicians to create a “home-going” culture and reset expectations for length of stay. Prior to the start of this project, the rehabilitation department began using the 6-Clicks Inpatient Basic Mobility Short Form, a standardized instrument comprised of short forms created from the Activity Measure for Post-Acute Care (AM-PAC) instrument. The AMPAC score is used to help establish the patient’s functional level; patients scoring 18 or higher have a higher probability of a successful return home (rather than an institutional discharge). Physical therapists at the Center adminster the 6-Clicks tool for each therapy patient daily, and document the AM-PAC score in the appropriate flowsheet in the EHR in a manner consistent with best practices.9-11 The group utilized the AMPAC score to determine functional status upon discharge, offering guidance for the correct post-acute discharge plan.

 

 

The workgroup also established a relationship with the lead home health care service to develop a standard notification process to set volume and service expectations. Finally, they worked with the lead SNFs to explain the surgical procedure and set expectations for patient recovery at the facilities. These changes are summarized in the Figure.

Pre-intervention and intervention tactics

Analysis

Descriptive statistics were used to describe patients and metrics in the baseline and performance periods. The difference in the proportion of patients discharged to a SNF in the baseline and performance periods was examined by a Z-test of proportion and change in relative risk. A Z-test of proportion was also used examine differences in the 90-day all-cause readmission rate and in the average length of stay between the 2 periods.

 

Results

Differences between Medicare fee-for-service patients in the baseline and performance periods are reported in Table 1. While age, sex, diagnoses, and surgical types were similar, AM-PAC scores and the proportion of patients married or living with someone were higher in the performance period. The AM-PAC score in Table 1 represents the last documented score prior to discharge.

Demographic Characteristics of Patients in the Baseline and Performance Periods

The proportion of Medicare patients discharged to a SNF fell from 39.5% (70/177) in the baseline period to 17.7% (34/192) in the performance period (Table 2). The 21.9% difference was significant at the 0.05 level (Z = 4.6586, P = 0.0001). Medicare patients in the intervention period had nearly half (0.45) the risk (95% confidence interval, 0.314-0.639) of SNF utilization compared with patients in the baseline period. Using Fisher’s exact test and a 2-tailed test, this reduction was found to be significant (P < 0.0001).

Discharge Status of Patients in the Baseline and Performance Periods

Concomitantly, the 90-day all-cause readmission rate among Medicare patients rose from 2.8% (5/177) to 4.7% (9/192), but the difference in proportions was not statistically significant (Z = –0.9356, P = 0.3495). Similarly, the average length of stay for Medicare patients was 2.9 days in both the baseline and performance periods.

 

 

Discussion

The intervention was associated with a statistically significant decrease in the SNF discharge rate following total joint replacement. The readmission rate and average length of stay were statistically unchanged. The lack of a statistically significant change in readmissions is important, as previous research has found that total joint replacement patients discharged to a SNF have higher odds of hospital readmission within 90 days than those discharged home.12 Moreover, the readmission rate in the performance period (4.7%) was still substantially lower than the national estimate of 90-day readmission rates associated with total hip arthroplasty (7.7%) and total knee arthroplasty (9.7%).13 For patients, these quality improvements are associated with improved outcomes and lower costs of care.

These outcomes were achieved after a substantial effort at the facility level to onboard new staff; orient them and their colleagues in each step along the care pathway, from scheduling through post-acute care; and build trust among all team members. The critical difference was changing expectations for post-acute recovery and rehabilitation throughout both the new clinical coordination workflow and processes and the existing processes. Orientation of the clinical coordination role was necessary to establish relationships with inpatient team members who were not as intimately involved with the position and expectations. To accomplish this, competing priorities had to be addressed and resolved through standardization efforts developed and implemented by the multidisciplinary team. The team first reviewed reports of such efforts in the initial review of the BPCI literature.1-5 Subsequent analyses of the most germane study3 and related research14 confirmed that a team-based approach to standardization could be successful. The former study used physician and affiliated care teams to build a care pathway that minimized variation in practices across the episode of care, and the latter used a multidisciplinary team approach to develop rapid recovery protocols. Subsequent research has validated the findings that hospital-based multidisciplinary teams have long been associated with improved patient safety, shorter length of stay, and fewer complications.15

Limitations

This quality improvement project was limited to a single facility. As such, adapting the improvements made to Grant Medical Center’s care pathway for implementation throughout the OhioHealth system will take time due to variation of care provided at each campus; scale-up efforts are ongoing. In the Grant facility, the project uncovered instances of unstandardized provider communication pathways, clinical staff workflows, and expectations for patients. Standardization in all 3 instances improved the patient experience. Additionally, data collection requirements for rigorous research and evaluation efforts that had to be done by hand during the project are now being integrated into the EHR.

The improvements described here, which were implemented in anticipation of adopting the CMS BPCI bundled payment model for joint replacement of the lower extremity, were provided to every patient regardless of payer. Patient outcomes varied across payer, as did preoperative education rates and other variables (Table 1). These differences are being tracked and analyzed following the Center’s entry into the CMS BPCI model on October 1, 2018.

Corresponding author: Gregg M. Gascon, PhD, CHDA, OhioHealth Group, 155 E. Broad Street, Suite 1700, Columbus, Ohio 43215; ggascon@ohiohealthgroup.com.

Financial disclosures: None.

References

1. Dummit LA, Kahvecioglu D, Marrufo G, et al. Association between hospital participation in a Medicare bundled payment initiative and payments and quality outcomes for lower extremity joint replacement episodes. JAMA. 2016;316:1267-1278.

2. Urdapilleta O, Weinberg D, Pedersen S, et al. Evaluation of the Medicare Acute Care Episodes (ACE) demonstration: final evaluation report. Centers for Medicare & Medicaid Services. May 31, 2013. http://downloads.cms.gov/files/cmmi/ACE-EvaluationReport-Final-5-2-14.pdf.

3. Froemke C, Wang L, DeHart ML, et al. Standardizing care and improving quality under a bundled payment initiative for total joint arthroplasty. J Arthroplasty. 2015;30:1676-1682.

4. US Department of Health and Human Services. (2015 Better, smarter, healthier: In historic announcement, HHS sets clear goals and timeline for shifting Medicare reimbursements from volume to value. New Release. January 26, 2015.

5. Tsai TC, Joynt KE, Wild RC, et al. Medicare’s Bundled Payment Initiatives: most hospitals are focused on a few high-volume conditions. Health Aff (Millwood). 2015;34;371-380.

6. Mechanic RE. Opportunities and challenges for episode-based payment. N Engl J Med. 2011,365:777-779.

7. Mallinson TR, Bateman J, Tseng HY, et al. A comparison of discharge functional status after rehabilitation in skilled nursing, home health, and medical rehabilitation settings for patients after lower-extremity joint replacement surgery. Arch Phys Med Rehabil. 2011:92:712-720.

8. Froimson M, Deadwiller M, Schill M, Cousineau K. Early results of a total joint bundled payment program: the BPCI initiative. Poster No. 2026. Poster presented at Orthopaedic Research Society Annual Meeting; March 15-18, 2014; New Orleans, LA.

9. Haley SM, Coster WJ, Andres PL, et al. Activity outcome measurement for postacute care. Med Care. 2004;42(1 Suppl):S49-S61.

10. Jette DU, Stilphen M, Ranganathan VK, et al. Validity of the AM-PAC “6-Clicks” inpatient daily activity and basic mobility short forms. Phys Ther. 2014;94;379-391.

11. Jette DU, Stilphen M, Ranganathan VK, et al. AM-PAC “6-Clicks” functional assessment scores predict acute care hospital discharge destination. Phys Ther. 2014;94:1252-1261.

12. Bini SA, Fithian DC, Paxton LW, et al. Does discharge disposition after primary total joint arthroplasty affect readmission rates? J Arthroplasty. 2010;25:114-117.

13. Ramkumar PN, Chu CT, Harris JD, et al. Causes and rates of unplanned readmissions after elective primary total joint arthroplasty: a systematic review and meta-analysis. Am J Orthop. 2015;44:397-405.

14. Klingenstein GG, Schoifet SD, Jain RK, et al. Rapid discharge to home after total knee arthroplasty is safe in eligible Medicare patients. J Arthroplasty. 2017;32:3308-3313.

15. Epstein NE. Multidisciplinary in-hospital teams improve patient outcomes: A review. Surg Neurol Int. 2014;5(Suppl 7):S295-S303.

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From Grant Medical Center (Dr. Wasielewski, Dr. Polonia, Ms. Barca, Ms. Cebriak, Ms. Lucki), and OhioHealth Group (Mr. Rogers, Ms. St. John, Dr. Gascon), Columbus, OH.

Abstract

  • Background: Organizations participating in the Centers for Medicare and Medicaid Services (CMS) Bundled Payment for Care Improvement (BPCI) initiative enter into payment arrangements that include financial and performance accountability for episodes of care. There is growing evidence that the use of these payment incentives reduces spending for episodes of care while maintaining or improving quality. A recent study of BPCI and quality outcomes in joint replacement episodes found that nearly all the reduction in spending within BPCI hospitals was generated from the reduced use of institutional post-acute care (eg, skilled nursing facilities [SNF], long-term care facilities, and inpatient rehabilitation facilities).
  • Objective: To describe a pilot program designed to reduce the utilization of institutional post-acute care for total joint replacement surgical patients.
  • Methods: A multidisciplinary intervention team optimized scheduling, preadmission testing, patient communication, and patient education along a total joint replacement care pathway.
  • Results: Among Medicare patients, total discharges to a SNF fell from 39.5% (70/177) in the baseline period to 17.7% (34/192) in the performance period. The risk of SNF utilization among patients in the intervention period was nearly half (0.45; 95% confidence interval, 0.314-0.639) that of patients in the baseline period. Using Fisher’s exact test and a 2-tailed test, this reduction was found to be significant (P < 0.0001). The readmission rate was substantially lower than national norms.
  • Conclusion: Optimizing patient care throughout the care pathway using the concerted efforts of a multidisciplinary team is possible given a common vision, shared goals, and clearly communicated expectations.

Keywords: arthroplasty; readmissions; Medicare; post-acute care; Bundled Payment for Care Improvement.

Quality improvement in health care is partially dependent upon processes that standardize episodes of care. This is especially true in the post–acute care setting, where efforts to increase patient engagement and care coordination can improve a patient’s recovery process. One framework for optimizing patient care across an episode of care is the Centers for Medicare and Medicaid Services (CMS) Bundled Payment for Care Improvement (BPCI) initiative, which links payments for the multiple services patients receive during an episode of care. Organizations participating in the BPCI initiative enter into payment arrangements that include financial and performance accountability for episodes of care. The BPCI initiative provides a framework for episodes of care across multiple types of facilities and clinicians over periods of time (30-day, 60-day, and 90-day episodes).1-5 Evidence that the use of these payment incentives reduces spending for episodes of care while maintaining or improving quality is accumulating. A recent study of BPCI and quality outcomes in joint replacement episodes found that nearly all the reduction in spending within BPCI hospitals was generated from the reduced use of institutional post-acute care, such as skilled nursing facilities (SNF), long-term care facilities, and inpatient rehabilitation facilities.1

Our hospital, the Grant Medical Center, which is part of the OhioHealth system, had agreed to participate in the CMS BPCI–Advanced Model for major joint replacement of the lower extremity, with a start date of October 1, 2018. Prior to adopting this bundled payment and service delivery model for major joint replacement through the BPCI program, we implemented strategic interventions to improve the efficiency of care delivery and reduce post-acute utilization. Although the BPCI program applied only to Medicare patients, the interventions that were developed, implemented, and evaluated in this quality improvement project, which we describe in this article, were provided to all patients who underwent lower-extremity joint replacement, regardless of payer.

Gap Analysis

Prior to developing and implementing the intervention, a gap analysis was performed to determine differences between Grant Medical Center’s care pathway/processes and evidence-based best practice. A steering committee comprised of physician champions, rehabilitation services, senior leadership from the Bone and Joint Center, and care management was gathered. The gap analysis examined the care paths in the preoperative phase, index admission phase, and the post-acute phase of care. Findings of the gap analysis included an underutilized joint education class, overutilization of SNF placement, and lack of key resources to assess the needs of patients prior to surgery.

The Grant Bone and Joint Center offered a comprehensive joint education class in person, but also gave patients the option of utilizing an online learning source. While both were successful, staff believed the in-person class had a greater impact than the online version. Patients who attended the class completed a preoperative assessment by hand, which included a social assessment for identifying potential challenges prior to admission. However, because class attendance was low (< 10%), this assessment tool was not utilized until the patient’s admission in most cases. The gap analysis also identified that the educational content of the class lacked key points to encourage a home-going plan.

 

 

The baseline SNF utilization rate (using data from July 1, 2015–June 30, 2016) within the Medicare population was 39.5% (70/177), with an overall (all payers) rate of 22.9% (192/838). This SNF utilization rate was higher than the national benchmark, underscoring the need to focus on a preoperative “plan for home” message. In addition, review of Medicare fee-for-service data from 2014 to 2016 revealed that Grant Medical Center utilized 83 different SNFs over the course of approximately 2 years. In this context, staff saw an opportunity to develop stronger relationships with fewer SNF partners, as well as OhioHealth Home Care, in order to improve care by standardizing functional recovery in post-acute care management.

In sum, the gap analysis found that a lack of standardization, follow through, and engagement in daily multidisciplinary rounds often led to a plan for SNF discharge instead of home. As such, it was determined that the pilot program would target the preoperative and post-acute phases of care and that its primary endpoint would be the reduction of the SNF discharge rate among Medicare fee-for-service patients.

Literature Review

Targeting the SNF discharge rate as the endpoint was also supported by a recent study that showed that most of the reduction in spending for total joint replacement within BPCI hospitals was linked to reduced use of institutional post-acute care.1 Other studies in the joint replacement literature have delineated the specific aspects of care redesign that allow hospitals to provide more efficient and effective care delivery during an episode of care.6-8 A review of these and similar studies of joint replacement quality improvement interventions yielded a number of actionable findings:

  • Engaging and educating patients and families is critical. Families and other caregivers must be identified preoperatively, actively engaged, and committed to helping the patient recover.
  • Providers must build the expectation in patients that they will return home as soon as it is safe to do so. This includes working to restore physiologic function, managing pain with oral medication, and restoring the physical capability of adapting to a home environment.
  • Relationships must be established with post-acute care providers who are able to demonstrate best practices and be willing partners on performance outcomes.
  • Providers need to invest in personnel to coordinate care transitions initiated preoperatively that continue through the post-acute phase of care.
  • Providers must promote processes that allow patients to more fully own their recovery through coaching and improved communication.

A total joint replacement initiative undertaken at another hospital within the OhioHealth system, Riverside Methodist Hospital, that incorporated these aspects of care redesign demonstrated a significant reduction in SNF utilization. That success informed the development of the initiative at Grant Medical Center.

 

 

Methods

Setting

This pilot project was conducted from July 2017 through July 2018 at the Grant Bone and Joint Center in the Grant Medical Center, an urban hospital in Columbus, Ohio. The Bone and Joint Center performs more than 7400 surgeries each year, of which 12% are total joint replacements. Grant Medical Center is a Level I Trauma Center that has received a fourth designation in Magnet Nursing status and has attained The Joint Commission Disease-Specific Care Certification for its total knee and hip arthroplasty, total shoulder, and hip fracture programs.

Intervention

The findings from the gap analysis were incorporated into a standardized preoperative care pathway at the Center. Standardization of the care pathway required developing relationships between office staff, schedulers, inpatient work teams, and preadmission testing, as well as physician group realignment with the larger organization.

During this time, the steering committee identified the need for a designated full-time pre-habilitation case manager to support patients undergoing hip and knee replacements at the Center. With the addition of a new role, prehab case manager, attention was directed to patient social assessment and communication. After the surgery was scheduled but prior to the preoperative education class, each patient received a screening phone call from the prehab case manager that included an initial social assessment. The electronic health record (EHR) was utilized to communicate the results of the assessment, including barriers to a home-going plan. The phone call allowed the case manager to reinforce the importance of class attendance for the patient and primary caregiver, and also allowed any specific concerns identified to be addressed and resolved prior to surgery.

A work group consisting of the prehab case manager, office staff, and the bone and joint leadership team focused on improving the core preoperative education content, same-day preadmission clearance, and class attendance. To support these efforts, the work group (1) created a scheduling document to align preadmission testing and the preoperative education class so they occurred on the same day, (2) improved prior authorization of the surgery to support the post-surgical care team, (3) clarified expectations and roles among office staff and care management staff to optimize the discharge process, and (4) engaged the physician team to encourage a culture change towards setting patient expectations to be discharged to home or a preferred SNF location. Regarding prior authorization communications, prior to the intervention, communication was insufficient, paper driven, and lacking in continuity. Utilizing the EHR, an EPIC platform, a designated documentation location was created, which increased communication among the office schedulers, preadmission testing, and surgery schedulers. The consistent location for recording prior authorization avoided canceled surgeries and claim denials due to missing pieces of information. In addition to these process changes, the surgical offices were geographically realigned to a new single location, a change that brought the staff together and in turn allowed for role clarification and team building and also allowed the staff to identify opportunities for improvement.

The core content of the education class was redesigned to support patients’ understanding of the procedure and what to expect during the hospital stay and discharge for home. Staff worked first to align all preadmission patient requirements with the content of the class. In pilot studies, patients were asked to provide feedback, and this feedback was incorporated into subsequent revisions. Staff developed multilingual handouts, including a surgery instruction sheet with a preoperative social assessment, in addition to creating opportunities for 1:1 education when it was medically or socially appropriate.

The work group brought the physicians in the care pathway together for a focused conversation and education regarding the need for including class attendance as part of their practice. They worked with the physicians’ support team to coordinate standardized follow-up care in the post-acute setting and encouraged the physicians to create a “home-going” culture and reset expectations for length of stay. Prior to the start of this project, the rehabilitation department began using the 6-Clicks Inpatient Basic Mobility Short Form, a standardized instrument comprised of short forms created from the Activity Measure for Post-Acute Care (AM-PAC) instrument. The AMPAC score is used to help establish the patient’s functional level; patients scoring 18 or higher have a higher probability of a successful return home (rather than an institutional discharge). Physical therapists at the Center adminster the 6-Clicks tool for each therapy patient daily, and document the AM-PAC score in the appropriate flowsheet in the EHR in a manner consistent with best practices.9-11 The group utilized the AMPAC score to determine functional status upon discharge, offering guidance for the correct post-acute discharge plan.

 

 

The workgroup also established a relationship with the lead home health care service to develop a standard notification process to set volume and service expectations. Finally, they worked with the lead SNFs to explain the surgical procedure and set expectations for patient recovery at the facilities. These changes are summarized in the Figure.

Pre-intervention and intervention tactics

Analysis

Descriptive statistics were used to describe patients and metrics in the baseline and performance periods. The difference in the proportion of patients discharged to a SNF in the baseline and performance periods was examined by a Z-test of proportion and change in relative risk. A Z-test of proportion was also used examine differences in the 90-day all-cause readmission rate and in the average length of stay between the 2 periods.

 

Results

Differences between Medicare fee-for-service patients in the baseline and performance periods are reported in Table 1. While age, sex, diagnoses, and surgical types were similar, AM-PAC scores and the proportion of patients married or living with someone were higher in the performance period. The AM-PAC score in Table 1 represents the last documented score prior to discharge.

Demographic Characteristics of Patients in the Baseline and Performance Periods

The proportion of Medicare patients discharged to a SNF fell from 39.5% (70/177) in the baseline period to 17.7% (34/192) in the performance period (Table 2). The 21.9% difference was significant at the 0.05 level (Z = 4.6586, P = 0.0001). Medicare patients in the intervention period had nearly half (0.45) the risk (95% confidence interval, 0.314-0.639) of SNF utilization compared with patients in the baseline period. Using Fisher’s exact test and a 2-tailed test, this reduction was found to be significant (P < 0.0001).

Discharge Status of Patients in the Baseline and Performance Periods

Concomitantly, the 90-day all-cause readmission rate among Medicare patients rose from 2.8% (5/177) to 4.7% (9/192), but the difference in proportions was not statistically significant (Z = –0.9356, P = 0.3495). Similarly, the average length of stay for Medicare patients was 2.9 days in both the baseline and performance periods.

 

 

Discussion

The intervention was associated with a statistically significant decrease in the SNF discharge rate following total joint replacement. The readmission rate and average length of stay were statistically unchanged. The lack of a statistically significant change in readmissions is important, as previous research has found that total joint replacement patients discharged to a SNF have higher odds of hospital readmission within 90 days than those discharged home.12 Moreover, the readmission rate in the performance period (4.7%) was still substantially lower than the national estimate of 90-day readmission rates associated with total hip arthroplasty (7.7%) and total knee arthroplasty (9.7%).13 For patients, these quality improvements are associated with improved outcomes and lower costs of care.

These outcomes were achieved after a substantial effort at the facility level to onboard new staff; orient them and their colleagues in each step along the care pathway, from scheduling through post-acute care; and build trust among all team members. The critical difference was changing expectations for post-acute recovery and rehabilitation throughout both the new clinical coordination workflow and processes and the existing processes. Orientation of the clinical coordination role was necessary to establish relationships with inpatient team members who were not as intimately involved with the position and expectations. To accomplish this, competing priorities had to be addressed and resolved through standardization efforts developed and implemented by the multidisciplinary team. The team first reviewed reports of such efforts in the initial review of the BPCI literature.1-5 Subsequent analyses of the most germane study3 and related research14 confirmed that a team-based approach to standardization could be successful. The former study used physician and affiliated care teams to build a care pathway that minimized variation in practices across the episode of care, and the latter used a multidisciplinary team approach to develop rapid recovery protocols. Subsequent research has validated the findings that hospital-based multidisciplinary teams have long been associated with improved patient safety, shorter length of stay, and fewer complications.15

Limitations

This quality improvement project was limited to a single facility. As such, adapting the improvements made to Grant Medical Center’s care pathway for implementation throughout the OhioHealth system will take time due to variation of care provided at each campus; scale-up efforts are ongoing. In the Grant facility, the project uncovered instances of unstandardized provider communication pathways, clinical staff workflows, and expectations for patients. Standardization in all 3 instances improved the patient experience. Additionally, data collection requirements for rigorous research and evaluation efforts that had to be done by hand during the project are now being integrated into the EHR.

The improvements described here, which were implemented in anticipation of adopting the CMS BPCI bundled payment model for joint replacement of the lower extremity, were provided to every patient regardless of payer. Patient outcomes varied across payer, as did preoperative education rates and other variables (Table 1). These differences are being tracked and analyzed following the Center’s entry into the CMS BPCI model on October 1, 2018.

Corresponding author: Gregg M. Gascon, PhD, CHDA, OhioHealth Group, 155 E. Broad Street, Suite 1700, Columbus, Ohio 43215; ggascon@ohiohealthgroup.com.

Financial disclosures: None.

From Grant Medical Center (Dr. Wasielewski, Dr. Polonia, Ms. Barca, Ms. Cebriak, Ms. Lucki), and OhioHealth Group (Mr. Rogers, Ms. St. John, Dr. Gascon), Columbus, OH.

Abstract

  • Background: Organizations participating in the Centers for Medicare and Medicaid Services (CMS) Bundled Payment for Care Improvement (BPCI) initiative enter into payment arrangements that include financial and performance accountability for episodes of care. There is growing evidence that the use of these payment incentives reduces spending for episodes of care while maintaining or improving quality. A recent study of BPCI and quality outcomes in joint replacement episodes found that nearly all the reduction in spending within BPCI hospitals was generated from the reduced use of institutional post-acute care (eg, skilled nursing facilities [SNF], long-term care facilities, and inpatient rehabilitation facilities).
  • Objective: To describe a pilot program designed to reduce the utilization of institutional post-acute care for total joint replacement surgical patients.
  • Methods: A multidisciplinary intervention team optimized scheduling, preadmission testing, patient communication, and patient education along a total joint replacement care pathway.
  • Results: Among Medicare patients, total discharges to a SNF fell from 39.5% (70/177) in the baseline period to 17.7% (34/192) in the performance period. The risk of SNF utilization among patients in the intervention period was nearly half (0.45; 95% confidence interval, 0.314-0.639) that of patients in the baseline period. Using Fisher’s exact test and a 2-tailed test, this reduction was found to be significant (P < 0.0001). The readmission rate was substantially lower than national norms.
  • Conclusion: Optimizing patient care throughout the care pathway using the concerted efforts of a multidisciplinary team is possible given a common vision, shared goals, and clearly communicated expectations.

Keywords: arthroplasty; readmissions; Medicare; post-acute care; Bundled Payment for Care Improvement.

Quality improvement in health care is partially dependent upon processes that standardize episodes of care. This is especially true in the post–acute care setting, where efforts to increase patient engagement and care coordination can improve a patient’s recovery process. One framework for optimizing patient care across an episode of care is the Centers for Medicare and Medicaid Services (CMS) Bundled Payment for Care Improvement (BPCI) initiative, which links payments for the multiple services patients receive during an episode of care. Organizations participating in the BPCI initiative enter into payment arrangements that include financial and performance accountability for episodes of care. The BPCI initiative provides a framework for episodes of care across multiple types of facilities and clinicians over periods of time (30-day, 60-day, and 90-day episodes).1-5 Evidence that the use of these payment incentives reduces spending for episodes of care while maintaining or improving quality is accumulating. A recent study of BPCI and quality outcomes in joint replacement episodes found that nearly all the reduction in spending within BPCI hospitals was generated from the reduced use of institutional post-acute care, such as skilled nursing facilities (SNF), long-term care facilities, and inpatient rehabilitation facilities.1

Our hospital, the Grant Medical Center, which is part of the OhioHealth system, had agreed to participate in the CMS BPCI–Advanced Model for major joint replacement of the lower extremity, with a start date of October 1, 2018. Prior to adopting this bundled payment and service delivery model for major joint replacement through the BPCI program, we implemented strategic interventions to improve the efficiency of care delivery and reduce post-acute utilization. Although the BPCI program applied only to Medicare patients, the interventions that were developed, implemented, and evaluated in this quality improvement project, which we describe in this article, were provided to all patients who underwent lower-extremity joint replacement, regardless of payer.

Gap Analysis

Prior to developing and implementing the intervention, a gap analysis was performed to determine differences between Grant Medical Center’s care pathway/processes and evidence-based best practice. A steering committee comprised of physician champions, rehabilitation services, senior leadership from the Bone and Joint Center, and care management was gathered. The gap analysis examined the care paths in the preoperative phase, index admission phase, and the post-acute phase of care. Findings of the gap analysis included an underutilized joint education class, overutilization of SNF placement, and lack of key resources to assess the needs of patients prior to surgery.

The Grant Bone and Joint Center offered a comprehensive joint education class in person, but also gave patients the option of utilizing an online learning source. While both were successful, staff believed the in-person class had a greater impact than the online version. Patients who attended the class completed a preoperative assessment by hand, which included a social assessment for identifying potential challenges prior to admission. However, because class attendance was low (< 10%), this assessment tool was not utilized until the patient’s admission in most cases. The gap analysis also identified that the educational content of the class lacked key points to encourage a home-going plan.

 

 

The baseline SNF utilization rate (using data from July 1, 2015–June 30, 2016) within the Medicare population was 39.5% (70/177), with an overall (all payers) rate of 22.9% (192/838). This SNF utilization rate was higher than the national benchmark, underscoring the need to focus on a preoperative “plan for home” message. In addition, review of Medicare fee-for-service data from 2014 to 2016 revealed that Grant Medical Center utilized 83 different SNFs over the course of approximately 2 years. In this context, staff saw an opportunity to develop stronger relationships with fewer SNF partners, as well as OhioHealth Home Care, in order to improve care by standardizing functional recovery in post-acute care management.

In sum, the gap analysis found that a lack of standardization, follow through, and engagement in daily multidisciplinary rounds often led to a plan for SNF discharge instead of home. As such, it was determined that the pilot program would target the preoperative and post-acute phases of care and that its primary endpoint would be the reduction of the SNF discharge rate among Medicare fee-for-service patients.

Literature Review

Targeting the SNF discharge rate as the endpoint was also supported by a recent study that showed that most of the reduction in spending for total joint replacement within BPCI hospitals was linked to reduced use of institutional post-acute care.1 Other studies in the joint replacement literature have delineated the specific aspects of care redesign that allow hospitals to provide more efficient and effective care delivery during an episode of care.6-8 A review of these and similar studies of joint replacement quality improvement interventions yielded a number of actionable findings:

  • Engaging and educating patients and families is critical. Families and other caregivers must be identified preoperatively, actively engaged, and committed to helping the patient recover.
  • Providers must build the expectation in patients that they will return home as soon as it is safe to do so. This includes working to restore physiologic function, managing pain with oral medication, and restoring the physical capability of adapting to a home environment.
  • Relationships must be established with post-acute care providers who are able to demonstrate best practices and be willing partners on performance outcomes.
  • Providers need to invest in personnel to coordinate care transitions initiated preoperatively that continue through the post-acute phase of care.
  • Providers must promote processes that allow patients to more fully own their recovery through coaching and improved communication.

A total joint replacement initiative undertaken at another hospital within the OhioHealth system, Riverside Methodist Hospital, that incorporated these aspects of care redesign demonstrated a significant reduction in SNF utilization. That success informed the development of the initiative at Grant Medical Center.

 

 

Methods

Setting

This pilot project was conducted from July 2017 through July 2018 at the Grant Bone and Joint Center in the Grant Medical Center, an urban hospital in Columbus, Ohio. The Bone and Joint Center performs more than 7400 surgeries each year, of which 12% are total joint replacements. Grant Medical Center is a Level I Trauma Center that has received a fourth designation in Magnet Nursing status and has attained The Joint Commission Disease-Specific Care Certification for its total knee and hip arthroplasty, total shoulder, and hip fracture programs.

Intervention

The findings from the gap analysis were incorporated into a standardized preoperative care pathway at the Center. Standardization of the care pathway required developing relationships between office staff, schedulers, inpatient work teams, and preadmission testing, as well as physician group realignment with the larger organization.

During this time, the steering committee identified the need for a designated full-time pre-habilitation case manager to support patients undergoing hip and knee replacements at the Center. With the addition of a new role, prehab case manager, attention was directed to patient social assessment and communication. After the surgery was scheduled but prior to the preoperative education class, each patient received a screening phone call from the prehab case manager that included an initial social assessment. The electronic health record (EHR) was utilized to communicate the results of the assessment, including barriers to a home-going plan. The phone call allowed the case manager to reinforce the importance of class attendance for the patient and primary caregiver, and also allowed any specific concerns identified to be addressed and resolved prior to surgery.

A work group consisting of the prehab case manager, office staff, and the bone and joint leadership team focused on improving the core preoperative education content, same-day preadmission clearance, and class attendance. To support these efforts, the work group (1) created a scheduling document to align preadmission testing and the preoperative education class so they occurred on the same day, (2) improved prior authorization of the surgery to support the post-surgical care team, (3) clarified expectations and roles among office staff and care management staff to optimize the discharge process, and (4) engaged the physician team to encourage a culture change towards setting patient expectations to be discharged to home or a preferred SNF location. Regarding prior authorization communications, prior to the intervention, communication was insufficient, paper driven, and lacking in continuity. Utilizing the EHR, an EPIC platform, a designated documentation location was created, which increased communication among the office schedulers, preadmission testing, and surgery schedulers. The consistent location for recording prior authorization avoided canceled surgeries and claim denials due to missing pieces of information. In addition to these process changes, the surgical offices were geographically realigned to a new single location, a change that brought the staff together and in turn allowed for role clarification and team building and also allowed the staff to identify opportunities for improvement.

The core content of the education class was redesigned to support patients’ understanding of the procedure and what to expect during the hospital stay and discharge for home. Staff worked first to align all preadmission patient requirements with the content of the class. In pilot studies, patients were asked to provide feedback, and this feedback was incorporated into subsequent revisions. Staff developed multilingual handouts, including a surgery instruction sheet with a preoperative social assessment, in addition to creating opportunities for 1:1 education when it was medically or socially appropriate.

The work group brought the physicians in the care pathway together for a focused conversation and education regarding the need for including class attendance as part of their practice. They worked with the physicians’ support team to coordinate standardized follow-up care in the post-acute setting and encouraged the physicians to create a “home-going” culture and reset expectations for length of stay. Prior to the start of this project, the rehabilitation department began using the 6-Clicks Inpatient Basic Mobility Short Form, a standardized instrument comprised of short forms created from the Activity Measure for Post-Acute Care (AM-PAC) instrument. The AMPAC score is used to help establish the patient’s functional level; patients scoring 18 or higher have a higher probability of a successful return home (rather than an institutional discharge). Physical therapists at the Center adminster the 6-Clicks tool for each therapy patient daily, and document the AM-PAC score in the appropriate flowsheet in the EHR in a manner consistent with best practices.9-11 The group utilized the AMPAC score to determine functional status upon discharge, offering guidance for the correct post-acute discharge plan.

 

 

The workgroup also established a relationship with the lead home health care service to develop a standard notification process to set volume and service expectations. Finally, they worked with the lead SNFs to explain the surgical procedure and set expectations for patient recovery at the facilities. These changes are summarized in the Figure.

Pre-intervention and intervention tactics

Analysis

Descriptive statistics were used to describe patients and metrics in the baseline and performance periods. The difference in the proportion of patients discharged to a SNF in the baseline and performance periods was examined by a Z-test of proportion and change in relative risk. A Z-test of proportion was also used examine differences in the 90-day all-cause readmission rate and in the average length of stay between the 2 periods.

 

Results

Differences between Medicare fee-for-service patients in the baseline and performance periods are reported in Table 1. While age, sex, diagnoses, and surgical types were similar, AM-PAC scores and the proportion of patients married or living with someone were higher in the performance period. The AM-PAC score in Table 1 represents the last documented score prior to discharge.

Demographic Characteristics of Patients in the Baseline and Performance Periods

The proportion of Medicare patients discharged to a SNF fell from 39.5% (70/177) in the baseline period to 17.7% (34/192) in the performance period (Table 2). The 21.9% difference was significant at the 0.05 level (Z = 4.6586, P = 0.0001). Medicare patients in the intervention period had nearly half (0.45) the risk (95% confidence interval, 0.314-0.639) of SNF utilization compared with patients in the baseline period. Using Fisher’s exact test and a 2-tailed test, this reduction was found to be significant (P < 0.0001).

Discharge Status of Patients in the Baseline and Performance Periods

Concomitantly, the 90-day all-cause readmission rate among Medicare patients rose from 2.8% (5/177) to 4.7% (9/192), but the difference in proportions was not statistically significant (Z = –0.9356, P = 0.3495). Similarly, the average length of stay for Medicare patients was 2.9 days in both the baseline and performance periods.

 

 

Discussion

The intervention was associated with a statistically significant decrease in the SNF discharge rate following total joint replacement. The readmission rate and average length of stay were statistically unchanged. The lack of a statistically significant change in readmissions is important, as previous research has found that total joint replacement patients discharged to a SNF have higher odds of hospital readmission within 90 days than those discharged home.12 Moreover, the readmission rate in the performance period (4.7%) was still substantially lower than the national estimate of 90-day readmission rates associated with total hip arthroplasty (7.7%) and total knee arthroplasty (9.7%).13 For patients, these quality improvements are associated with improved outcomes and lower costs of care.

These outcomes were achieved after a substantial effort at the facility level to onboard new staff; orient them and their colleagues in each step along the care pathway, from scheduling through post-acute care; and build trust among all team members. The critical difference was changing expectations for post-acute recovery and rehabilitation throughout both the new clinical coordination workflow and processes and the existing processes. Orientation of the clinical coordination role was necessary to establish relationships with inpatient team members who were not as intimately involved with the position and expectations. To accomplish this, competing priorities had to be addressed and resolved through standardization efforts developed and implemented by the multidisciplinary team. The team first reviewed reports of such efforts in the initial review of the BPCI literature.1-5 Subsequent analyses of the most germane study3 and related research14 confirmed that a team-based approach to standardization could be successful. The former study used physician and affiliated care teams to build a care pathway that minimized variation in practices across the episode of care, and the latter used a multidisciplinary team approach to develop rapid recovery protocols. Subsequent research has validated the findings that hospital-based multidisciplinary teams have long been associated with improved patient safety, shorter length of stay, and fewer complications.15

Limitations

This quality improvement project was limited to a single facility. As such, adapting the improvements made to Grant Medical Center’s care pathway for implementation throughout the OhioHealth system will take time due to variation of care provided at each campus; scale-up efforts are ongoing. In the Grant facility, the project uncovered instances of unstandardized provider communication pathways, clinical staff workflows, and expectations for patients. Standardization in all 3 instances improved the patient experience. Additionally, data collection requirements for rigorous research and evaluation efforts that had to be done by hand during the project are now being integrated into the EHR.

The improvements described here, which were implemented in anticipation of adopting the CMS BPCI bundled payment model for joint replacement of the lower extremity, were provided to every patient regardless of payer. Patient outcomes varied across payer, as did preoperative education rates and other variables (Table 1). These differences are being tracked and analyzed following the Center’s entry into the CMS BPCI model on October 1, 2018.

Corresponding author: Gregg M. Gascon, PhD, CHDA, OhioHealth Group, 155 E. Broad Street, Suite 1700, Columbus, Ohio 43215; ggascon@ohiohealthgroup.com.

Financial disclosures: None.

References

1. Dummit LA, Kahvecioglu D, Marrufo G, et al. Association between hospital participation in a Medicare bundled payment initiative and payments and quality outcomes for lower extremity joint replacement episodes. JAMA. 2016;316:1267-1278.

2. Urdapilleta O, Weinberg D, Pedersen S, et al. Evaluation of the Medicare Acute Care Episodes (ACE) demonstration: final evaluation report. Centers for Medicare & Medicaid Services. May 31, 2013. http://downloads.cms.gov/files/cmmi/ACE-EvaluationReport-Final-5-2-14.pdf.

3. Froemke C, Wang L, DeHart ML, et al. Standardizing care and improving quality under a bundled payment initiative for total joint arthroplasty. J Arthroplasty. 2015;30:1676-1682.

4. US Department of Health and Human Services. (2015 Better, smarter, healthier: In historic announcement, HHS sets clear goals and timeline for shifting Medicare reimbursements from volume to value. New Release. January 26, 2015.

5. Tsai TC, Joynt KE, Wild RC, et al. Medicare’s Bundled Payment Initiatives: most hospitals are focused on a few high-volume conditions. Health Aff (Millwood). 2015;34;371-380.

6. Mechanic RE. Opportunities and challenges for episode-based payment. N Engl J Med. 2011,365:777-779.

7. Mallinson TR, Bateman J, Tseng HY, et al. A comparison of discharge functional status after rehabilitation in skilled nursing, home health, and medical rehabilitation settings for patients after lower-extremity joint replacement surgery. Arch Phys Med Rehabil. 2011:92:712-720.

8. Froimson M, Deadwiller M, Schill M, Cousineau K. Early results of a total joint bundled payment program: the BPCI initiative. Poster No. 2026. Poster presented at Orthopaedic Research Society Annual Meeting; March 15-18, 2014; New Orleans, LA.

9. Haley SM, Coster WJ, Andres PL, et al. Activity outcome measurement for postacute care. Med Care. 2004;42(1 Suppl):S49-S61.

10. Jette DU, Stilphen M, Ranganathan VK, et al. Validity of the AM-PAC “6-Clicks” inpatient daily activity and basic mobility short forms. Phys Ther. 2014;94;379-391.

11. Jette DU, Stilphen M, Ranganathan VK, et al. AM-PAC “6-Clicks” functional assessment scores predict acute care hospital discharge destination. Phys Ther. 2014;94:1252-1261.

12. Bini SA, Fithian DC, Paxton LW, et al. Does discharge disposition after primary total joint arthroplasty affect readmission rates? J Arthroplasty. 2010;25:114-117.

13. Ramkumar PN, Chu CT, Harris JD, et al. Causes and rates of unplanned readmissions after elective primary total joint arthroplasty: a systematic review and meta-analysis. Am J Orthop. 2015;44:397-405.

14. Klingenstein GG, Schoifet SD, Jain RK, et al. Rapid discharge to home after total knee arthroplasty is safe in eligible Medicare patients. J Arthroplasty. 2017;32:3308-3313.

15. Epstein NE. Multidisciplinary in-hospital teams improve patient outcomes: A review. Surg Neurol Int. 2014;5(Suppl 7):S295-S303.

References

1. Dummit LA, Kahvecioglu D, Marrufo G, et al. Association between hospital participation in a Medicare bundled payment initiative and payments and quality outcomes for lower extremity joint replacement episodes. JAMA. 2016;316:1267-1278.

2. Urdapilleta O, Weinberg D, Pedersen S, et al. Evaluation of the Medicare Acute Care Episodes (ACE) demonstration: final evaluation report. Centers for Medicare & Medicaid Services. May 31, 2013. http://downloads.cms.gov/files/cmmi/ACE-EvaluationReport-Final-5-2-14.pdf.

3. Froemke C, Wang L, DeHart ML, et al. Standardizing care and improving quality under a bundled payment initiative for total joint arthroplasty. J Arthroplasty. 2015;30:1676-1682.

4. US Department of Health and Human Services. (2015 Better, smarter, healthier: In historic announcement, HHS sets clear goals and timeline for shifting Medicare reimbursements from volume to value. New Release. January 26, 2015.

5. Tsai TC, Joynt KE, Wild RC, et al. Medicare’s Bundled Payment Initiatives: most hospitals are focused on a few high-volume conditions. Health Aff (Millwood). 2015;34;371-380.

6. Mechanic RE. Opportunities and challenges for episode-based payment. N Engl J Med. 2011,365:777-779.

7. Mallinson TR, Bateman J, Tseng HY, et al. A comparison of discharge functional status after rehabilitation in skilled nursing, home health, and medical rehabilitation settings for patients after lower-extremity joint replacement surgery. Arch Phys Med Rehabil. 2011:92:712-720.

8. Froimson M, Deadwiller M, Schill M, Cousineau K. Early results of a total joint bundled payment program: the BPCI initiative. Poster No. 2026. Poster presented at Orthopaedic Research Society Annual Meeting; March 15-18, 2014; New Orleans, LA.

9. Haley SM, Coster WJ, Andres PL, et al. Activity outcome measurement for postacute care. Med Care. 2004;42(1 Suppl):S49-S61.

10. Jette DU, Stilphen M, Ranganathan VK, et al. Validity of the AM-PAC “6-Clicks” inpatient daily activity and basic mobility short forms. Phys Ther. 2014;94;379-391.

11. Jette DU, Stilphen M, Ranganathan VK, et al. AM-PAC “6-Clicks” functional assessment scores predict acute care hospital discharge destination. Phys Ther. 2014;94:1252-1261.

12. Bini SA, Fithian DC, Paxton LW, et al. Does discharge disposition after primary total joint arthroplasty affect readmission rates? J Arthroplasty. 2010;25:114-117.

13. Ramkumar PN, Chu CT, Harris JD, et al. Causes and rates of unplanned readmissions after elective primary total joint arthroplasty: a systematic review and meta-analysis. Am J Orthop. 2015;44:397-405.

14. Klingenstein GG, Schoifet SD, Jain RK, et al. Rapid discharge to home after total knee arthroplasty is safe in eligible Medicare patients. J Arthroplasty. 2017;32:3308-3313.

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Hospitalist comanagement reduced odds of MI, shortened vascular surgery stays

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– A care model that uses hospitalists to comanage vascular surgery patients cut myocardial infarction rates by more than half and reduced hospital stays by about 12%, according to results of a study of the hospitalist comanagement model from Loyola University Chicago, Maywood, Ill., presented at the annual meeting of the Midwestern Vascular Surgery Society.

Adam Kaavya

“Hospitalist comanagement was associated with decreased length of stay without affecting readmission for patients undergoing amputation, embolectomy, and infected graft,” said Kaavya Adam, a third-year medical student at Loyola University Chicago. “In the overall population, there was a reduction in cases of MI, 30-day readmissions, and overall length of stay.”

In 2014, Loyola implemented a program that used 11 hospitalists to rotate through the vascular surgery service. The hospitalists call on any patient who stays more than 24 hours on the non-ICU floors. Adam said hospitalist duties include evaluating patient comorbidities, adjusting medication, talking with family about medical management, seeing patients on the day of surgery, ordering preoperative labs, and meeting with the anesthesiology and vascular surgery teams.

The study compared outcomes in 866 patients admitted during 2007-2013, before the comanagement model was put into place, and 572 admitted during 2014-2017.

Rates of diabetes, hypertension, chronic kidney disease, coronary artery disease, hyperlipidemia, and malnutrition were similar between the groups. However, the pre-comanagement group had significantly higher rates of ischemic pain (27.8% vs. 10.7%), gangrene (21.3% vs. 13.6%) and ulceration (30.6% vs. 21.9%), while the comanaged group had significantly higher rates of claudication (34.3% vs. 13.2%). The statistical analysis accounted for these variations, Adam said.

“We did find significant results for the reduction in the odds of MI at 30 days; there was a 61% reduction,” he said.

The reduction in hospital stay was even more pronounced for patients with complex cases, Adam said. In amputation, the length of stay was reduced by 3.77 days (P = .01); in embolectomy, by 7.35 (P = .004); and in infected graft, by 8.35 (P = .007).

Continuing research will evaluate the cost effectiveness of the hospitalist model and define a comanagement model that is most beneficial, Mr. Adam said. He had no relevant financial disclosures.

SOURCE: Adam K et al. Midwestern Vascular 2019, Abstract 14.

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– A care model that uses hospitalists to comanage vascular surgery patients cut myocardial infarction rates by more than half and reduced hospital stays by about 12%, according to results of a study of the hospitalist comanagement model from Loyola University Chicago, Maywood, Ill., presented at the annual meeting of the Midwestern Vascular Surgery Society.

Adam Kaavya

“Hospitalist comanagement was associated with decreased length of stay without affecting readmission for patients undergoing amputation, embolectomy, and infected graft,” said Kaavya Adam, a third-year medical student at Loyola University Chicago. “In the overall population, there was a reduction in cases of MI, 30-day readmissions, and overall length of stay.”

In 2014, Loyola implemented a program that used 11 hospitalists to rotate through the vascular surgery service. The hospitalists call on any patient who stays more than 24 hours on the non-ICU floors. Adam said hospitalist duties include evaluating patient comorbidities, adjusting medication, talking with family about medical management, seeing patients on the day of surgery, ordering preoperative labs, and meeting with the anesthesiology and vascular surgery teams.

The study compared outcomes in 866 patients admitted during 2007-2013, before the comanagement model was put into place, and 572 admitted during 2014-2017.

Rates of diabetes, hypertension, chronic kidney disease, coronary artery disease, hyperlipidemia, and malnutrition were similar between the groups. However, the pre-comanagement group had significantly higher rates of ischemic pain (27.8% vs. 10.7%), gangrene (21.3% vs. 13.6%) and ulceration (30.6% vs. 21.9%), while the comanaged group had significantly higher rates of claudication (34.3% vs. 13.2%). The statistical analysis accounted for these variations, Adam said.

“We did find significant results for the reduction in the odds of MI at 30 days; there was a 61% reduction,” he said.

The reduction in hospital stay was even more pronounced for patients with complex cases, Adam said. In amputation, the length of stay was reduced by 3.77 days (P = .01); in embolectomy, by 7.35 (P = .004); and in infected graft, by 8.35 (P = .007).

Continuing research will evaluate the cost effectiveness of the hospitalist model and define a comanagement model that is most beneficial, Mr. Adam said. He had no relevant financial disclosures.

SOURCE: Adam K et al. Midwestern Vascular 2019, Abstract 14.

 

– A care model that uses hospitalists to comanage vascular surgery patients cut myocardial infarction rates by more than half and reduced hospital stays by about 12%, according to results of a study of the hospitalist comanagement model from Loyola University Chicago, Maywood, Ill., presented at the annual meeting of the Midwestern Vascular Surgery Society.

Adam Kaavya

“Hospitalist comanagement was associated with decreased length of stay without affecting readmission for patients undergoing amputation, embolectomy, and infected graft,” said Kaavya Adam, a third-year medical student at Loyola University Chicago. “In the overall population, there was a reduction in cases of MI, 30-day readmissions, and overall length of stay.”

In 2014, Loyola implemented a program that used 11 hospitalists to rotate through the vascular surgery service. The hospitalists call on any patient who stays more than 24 hours on the non-ICU floors. Adam said hospitalist duties include evaluating patient comorbidities, adjusting medication, talking with family about medical management, seeing patients on the day of surgery, ordering preoperative labs, and meeting with the anesthesiology and vascular surgery teams.

The study compared outcomes in 866 patients admitted during 2007-2013, before the comanagement model was put into place, and 572 admitted during 2014-2017.

Rates of diabetes, hypertension, chronic kidney disease, coronary artery disease, hyperlipidemia, and malnutrition were similar between the groups. However, the pre-comanagement group had significantly higher rates of ischemic pain (27.8% vs. 10.7%), gangrene (21.3% vs. 13.6%) and ulceration (30.6% vs. 21.9%), while the comanaged group had significantly higher rates of claudication (34.3% vs. 13.2%). The statistical analysis accounted for these variations, Adam said.

“We did find significant results for the reduction in the odds of MI at 30 days; there was a 61% reduction,” he said.

The reduction in hospital stay was even more pronounced for patients with complex cases, Adam said. In amputation, the length of stay was reduced by 3.77 days (P = .01); in embolectomy, by 7.35 (P = .004); and in infected graft, by 8.35 (P = .007).

Continuing research will evaluate the cost effectiveness of the hospitalist model and define a comanagement model that is most beneficial, Mr. Adam said. He had no relevant financial disclosures.

SOURCE: Adam K et al. Midwestern Vascular 2019, Abstract 14.

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REPORTING FROM MIDWESTERN VASCULAR 2019

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Key clinical point: Hospitalist comanagement of vascular surgery patients reduced hospital stays.

Major finding: Hospitalist comanagement significantly reduced the odds of MI at 30 days; a 61% reduction.

Study details: Database query of 1,438 vascular surgery admissions during 2007-2017.

Disclosures: Mr. Adam had no relevant financial disclosures.

Source: Adam K et al. Midwestern Vascular 2019, Abstract 14.

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