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ACIP approves flu vaccine recommendations for 2020-2021
– Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.
The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.
The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.
Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.
Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.
Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.
ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”
The ACIP members had no financial conflicts to disclose.
– Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.
The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.
The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.
Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.
Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.
Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.
ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”
The ACIP members had no financial conflicts to disclose.
– Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.
The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.
The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.
Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.
Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.
Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.
ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”
The ACIP members had no financial conflicts to disclose.
Combined PH subtypes predicts poor survival in kidney disease
based on data from a retrospective study of 12,618 patients.
Pulmonary hypertension (PH) occurs in up to 41% of chronic kidney disease (CKD) patients, but most studies of PH in this population have not examined PH subtypes, wrote Daniel L. Edmonston, MD, of Duke University, Durham, N.C., and colleagues.
“Among patients with CKD with PH, the combined pre- and postcapillary PH subtype (elevated pulmonary capillary wedge pressure with increased pulmonary vascular resistance) may be a substantial contributor to the overall PH burden in CKD” because of factors including chronic volume overload, pulmonary vascular remodeling, inflammation, and comorbid lung disease, they wrote.
In a study published in the American Journal of Kidney Diseases, The researchers investigated subtypes of precapillary, postcapillary, and combination PH, and their associations with all-cause mortality for different levels of CKD severity. The study population included 12,618 adults aged 18 years and older with qualifying right-heart catheterizations. Of these, 4,772 had chronic kidney disease. The average age was 57 years in patients without CKD and 69 years in patients with CKD.
Overall, 73.4% of patients with CKD and 56.9% of patients without CKD had PH. For CKD patients, the most common PH subtypes were isolated postcapillary (39.0%) and combined pre- and postcapillary (38.3%).
Combined pre- and postcapillary PH was associated with higher mortality risk, compared with no PH in CKD patients, with adjusted hazard ratios of 1.89, 1.87, 2.13, and 1.63 for glomerular filtration rate categories G3a, G3b, G4, and G5/G5D, respectively.
For patients without CKD, precapillary PH was the most common subtype (35.9%) and was associated with the highest mortality risk, compared with no PH (HR, 2.27).
Relationships between mortality and specific PH features of mean pulmonary artery pressure, pulmonary capillary wedge pressure, and right atrial pressure were similar for patients with and without CKD.
The study findings were limited by several factors including the observational design, potential lack of generalizability because of the use of data from a single center, and lack of data on vascular access for hemodialysis, and exclusion of patients with heart or lung transplants, the researchers noted.
However, the results suggest that “processes that increase pulmonary vascular resistance and/ or remodeling represent a prominent mechanism and potential therapeutic target for patients with CKD that is complicated by PH,” they said.
Patients with CKD and combined pre- and postcapillary PH are at increased risk for mortality and “recognition of this large combined pre- and postcapillary PH cohort in CKD may present new therapeutic options,” they concluded.
The study was supported by the National Institutes of Health and the American Society of Nephrology. The researchers had no financial conflicts to disclose.
SOURCE: Edmonston DL et al. Am J Kidney Dis. 2019;75:713-24.
.
based on data from a retrospective study of 12,618 patients.
Pulmonary hypertension (PH) occurs in up to 41% of chronic kidney disease (CKD) patients, but most studies of PH in this population have not examined PH subtypes, wrote Daniel L. Edmonston, MD, of Duke University, Durham, N.C., and colleagues.
“Among patients with CKD with PH, the combined pre- and postcapillary PH subtype (elevated pulmonary capillary wedge pressure with increased pulmonary vascular resistance) may be a substantial contributor to the overall PH burden in CKD” because of factors including chronic volume overload, pulmonary vascular remodeling, inflammation, and comorbid lung disease, they wrote.
In a study published in the American Journal of Kidney Diseases, The researchers investigated subtypes of precapillary, postcapillary, and combination PH, and their associations with all-cause mortality for different levels of CKD severity. The study population included 12,618 adults aged 18 years and older with qualifying right-heart catheterizations. Of these, 4,772 had chronic kidney disease. The average age was 57 years in patients without CKD and 69 years in patients with CKD.
Overall, 73.4% of patients with CKD and 56.9% of patients without CKD had PH. For CKD patients, the most common PH subtypes were isolated postcapillary (39.0%) and combined pre- and postcapillary (38.3%).
Combined pre- and postcapillary PH was associated with higher mortality risk, compared with no PH in CKD patients, with adjusted hazard ratios of 1.89, 1.87, 2.13, and 1.63 for glomerular filtration rate categories G3a, G3b, G4, and G5/G5D, respectively.
For patients without CKD, precapillary PH was the most common subtype (35.9%) and was associated with the highest mortality risk, compared with no PH (HR, 2.27).
Relationships between mortality and specific PH features of mean pulmonary artery pressure, pulmonary capillary wedge pressure, and right atrial pressure were similar for patients with and without CKD.
The study findings were limited by several factors including the observational design, potential lack of generalizability because of the use of data from a single center, and lack of data on vascular access for hemodialysis, and exclusion of patients with heart or lung transplants, the researchers noted.
However, the results suggest that “processes that increase pulmonary vascular resistance and/ or remodeling represent a prominent mechanism and potential therapeutic target for patients with CKD that is complicated by PH,” they said.
Patients with CKD and combined pre- and postcapillary PH are at increased risk for mortality and “recognition of this large combined pre- and postcapillary PH cohort in CKD may present new therapeutic options,” they concluded.
The study was supported by the National Institutes of Health and the American Society of Nephrology. The researchers had no financial conflicts to disclose.
SOURCE: Edmonston DL et al. Am J Kidney Dis. 2019;75:713-24.
.
based on data from a retrospective study of 12,618 patients.
Pulmonary hypertension (PH) occurs in up to 41% of chronic kidney disease (CKD) patients, but most studies of PH in this population have not examined PH subtypes, wrote Daniel L. Edmonston, MD, of Duke University, Durham, N.C., and colleagues.
“Among patients with CKD with PH, the combined pre- and postcapillary PH subtype (elevated pulmonary capillary wedge pressure with increased pulmonary vascular resistance) may be a substantial contributor to the overall PH burden in CKD” because of factors including chronic volume overload, pulmonary vascular remodeling, inflammation, and comorbid lung disease, they wrote.
In a study published in the American Journal of Kidney Diseases, The researchers investigated subtypes of precapillary, postcapillary, and combination PH, and their associations with all-cause mortality for different levels of CKD severity. The study population included 12,618 adults aged 18 years and older with qualifying right-heart catheterizations. Of these, 4,772 had chronic kidney disease. The average age was 57 years in patients without CKD and 69 years in patients with CKD.
Overall, 73.4% of patients with CKD and 56.9% of patients without CKD had PH. For CKD patients, the most common PH subtypes were isolated postcapillary (39.0%) and combined pre- and postcapillary (38.3%).
Combined pre- and postcapillary PH was associated with higher mortality risk, compared with no PH in CKD patients, with adjusted hazard ratios of 1.89, 1.87, 2.13, and 1.63 for glomerular filtration rate categories G3a, G3b, G4, and G5/G5D, respectively.
For patients without CKD, precapillary PH was the most common subtype (35.9%) and was associated with the highest mortality risk, compared with no PH (HR, 2.27).
Relationships between mortality and specific PH features of mean pulmonary artery pressure, pulmonary capillary wedge pressure, and right atrial pressure were similar for patients with and without CKD.
The study findings were limited by several factors including the observational design, potential lack of generalizability because of the use of data from a single center, and lack of data on vascular access for hemodialysis, and exclusion of patients with heart or lung transplants, the researchers noted.
However, the results suggest that “processes that increase pulmonary vascular resistance and/ or remodeling represent a prominent mechanism and potential therapeutic target for patients with CKD that is complicated by PH,” they said.
Patients with CKD and combined pre- and postcapillary PH are at increased risk for mortality and “recognition of this large combined pre- and postcapillary PH cohort in CKD may present new therapeutic options,” they concluded.
The study was supported by the National Institutes of Health and the American Society of Nephrology. The researchers had no financial conflicts to disclose.
SOURCE: Edmonston DL et al. Am J Kidney Dis. 2019;75:713-24.
.
FROM THE AMERICAN JOURNAL OF KIDNEY DISEASES
New quadrivalent meningococcal vaccine joins VFC arsenal
No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.
The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.
Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.
Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”
The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.
ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.
Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.
The committee members and Dr. McNamara had no relevant financial conflicts to disclose.
No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.
The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.
Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.
Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”
The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.
ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.
Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.
The committee members and Dr. McNamara had no relevant financial conflicts to disclose.
No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.
The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.
Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.
Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”
The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.
ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.
Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.
The committee members and Dr. McNamara had no relevant financial conflicts to disclose.
LAA Closure noninferior to DOACs to prevent AF-related events
Left atrial appendage closure was noninferior to use of direct oral anticoagulants for the prevention of atrial fibrillation (AFib)–related events in high-risk patients, based on data from 402 adults.
Given the limitations of vitamin K antagonists for preventing stroke in AFib, “a novel site-specific therapeutic alternative, mechanical left atrial appendage occlusion [LAAO], entered clinical practice,” but has not been compared with current safe and effective oral anticoagulants, wrote Pavel Osmancik, MD, of University Hospital Kralovske Vinohrady, Prague, and colleagues.
In a study published in the Journal of the American College of Cardiology, the researchers randomized 201 moderate- or high-risk adults with nonvalvular AFib to LAAO and another 201 to direct oral anticoagulants (DOAC).
Patients in the LAAO group underwent transesophageal echocardiography to exclude left atrial thrombi and underwent implantation with Boston Scientific’s Watchman, Watchman-FLX, or Abbott’s Amulet devices. Patients in the DOAC group received rivaroxaban, apixaban, or dabigatran at the manufacturer-recommended dose.
The primary outcome was a composite of complications related to procedures or devices, thromboembolic events (including stroke), and clinically significant bleeding. After an average of 20 months follow-up, 35 patients in the LAAO group and 41 in the DOAC group met the primary outcome (11% per 100 patient-years vs. 13% per 100 patient-years).
In addition, no differences appeared between the groups for the endpoint components of all-stroke/transient ischemic attack event (subdistribution hazard ratio, 1.00), clinically significantly bleeding (sHR, 0.81), or cardiovascular death (sHR, 0.75).
Nine patients experienced major complications related to LAAO, including clinically significant bleeding (sHR, 0.81; 95% CI, 0.44-1.52) and cardiovascular death (sHR, 0.75; 95% CI, 0.34-1.62). Major LAAO-related complications occurred in nine (4.5%) patients, with a short-term (up to 7 days or hospital discharge) complication rate of 2.1% and a 2.7% late complication rate. The late complications included three pericardial effusions, one of which resulted in death, the researchers wrote.
The study findings were limited by several factors, including the inability to assess the differences among the components of the composite primary endpoint. For example, “Regarding the primary endpoint, stroke reduction may be more important than bleeding reduction,” the investigators wrote.
The results were strengthened, however, by the enrollment of a high-risk AF population and is the first known randomized trial to compare percutaneous LAAO and DOACs for stroke prevention in this group. But the late complication rate of 2.7% is “suboptimal” and safety issues reinforce the need for refinement of operator technique and device technology with LAAO, they concluded.
‘Important step forward,’ with caveats
“How LAAO might stack up against DOAC therapy has remained an open question: Compared with warfarin, DOACs are easier to use and are associated with a reduction in mortality, driven by a substantially lower risk of intracranial hemorrhage and fatal bleeding,” wrote Matthew J. Price, MD, of the Scripps Clinic in La Jolla, Calif., and Jacqueline Saw, MD, of Vancouver General Hospital, in an accompanying editorial.
Previous studies of LAAO have shown a reduced risk of gastrointestinal bleeding, but procedure hazards interfered with long-term benefits, they said. The current study findings of similar rates of stroke and lower bleeding rates with LAAO, compared with DOAC, “are provocative given the clinical consensus that DOACs are safer, well tolerated, and generally better than warfarin, which was an easy target for transcatheter LAAO, given warfarin’s extensive limitations,” the editorialists wrote. Although the findings lend support to the use of LAAO, clinicians should consider several caveats such as the inclusion of patients who were “not optimal candidates for long-term OAC but were selected because they were at high risk for bleeding or because OAC treatment had already failed.”
However, “despite its imperfections, PRAGUE-17 is an important step forward and reinforces the role of transcatheter LAAO as a stroke-prevention strategy for patients with [AFib] at high risk of bleeding or medical treatment failure, even in the modern era of the DOACs,” they concluded. “Going forward, successful enrollment in ongoing and planned clinical trials while avoiding off-label procedures will be critical to define the appropriate use of transcatheter LAAO in expanded patient populations.”
The study was supported by the Ministry of Health of the Czech Republic. Dr. Osmancik disclosed speaking honoraria from Bayer and Abbot. Dr. Price’s financial disclosures included honoraria, speaker bureau fees, and/or research grants from Abbott Vascular, AstraZeneca, Boston Scientific, Chiesi USA, Daiichi Sankyo, and Medtronic. Dr. Saw disclosed receiving unrestricted research grant support several Canadian research institutes and fees and honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Servier, among other drug companies.
SOURCES: Osmancik P et al. J Am Coll Cardiol. 2020;75:3122-35; Price MJ, Saw J. J Am Coll Cardiol. 2020;75:3136-9.
Left atrial appendage closure was noninferior to use of direct oral anticoagulants for the prevention of atrial fibrillation (AFib)–related events in high-risk patients, based on data from 402 adults.
Given the limitations of vitamin K antagonists for preventing stroke in AFib, “a novel site-specific therapeutic alternative, mechanical left atrial appendage occlusion [LAAO], entered clinical practice,” but has not been compared with current safe and effective oral anticoagulants, wrote Pavel Osmancik, MD, of University Hospital Kralovske Vinohrady, Prague, and colleagues.
In a study published in the Journal of the American College of Cardiology, the researchers randomized 201 moderate- or high-risk adults with nonvalvular AFib to LAAO and another 201 to direct oral anticoagulants (DOAC).
Patients in the LAAO group underwent transesophageal echocardiography to exclude left atrial thrombi and underwent implantation with Boston Scientific’s Watchman, Watchman-FLX, or Abbott’s Amulet devices. Patients in the DOAC group received rivaroxaban, apixaban, or dabigatran at the manufacturer-recommended dose.
The primary outcome was a composite of complications related to procedures or devices, thromboembolic events (including stroke), and clinically significant bleeding. After an average of 20 months follow-up, 35 patients in the LAAO group and 41 in the DOAC group met the primary outcome (11% per 100 patient-years vs. 13% per 100 patient-years).
In addition, no differences appeared between the groups for the endpoint components of all-stroke/transient ischemic attack event (subdistribution hazard ratio, 1.00), clinically significantly bleeding (sHR, 0.81), or cardiovascular death (sHR, 0.75).
Nine patients experienced major complications related to LAAO, including clinically significant bleeding (sHR, 0.81; 95% CI, 0.44-1.52) and cardiovascular death (sHR, 0.75; 95% CI, 0.34-1.62). Major LAAO-related complications occurred in nine (4.5%) patients, with a short-term (up to 7 days or hospital discharge) complication rate of 2.1% and a 2.7% late complication rate. The late complications included three pericardial effusions, one of which resulted in death, the researchers wrote.
The study findings were limited by several factors, including the inability to assess the differences among the components of the composite primary endpoint. For example, “Regarding the primary endpoint, stroke reduction may be more important than bleeding reduction,” the investigators wrote.
The results were strengthened, however, by the enrollment of a high-risk AF population and is the first known randomized trial to compare percutaneous LAAO and DOACs for stroke prevention in this group. But the late complication rate of 2.7% is “suboptimal” and safety issues reinforce the need for refinement of operator technique and device technology with LAAO, they concluded.
‘Important step forward,’ with caveats
“How LAAO might stack up against DOAC therapy has remained an open question: Compared with warfarin, DOACs are easier to use and are associated with a reduction in mortality, driven by a substantially lower risk of intracranial hemorrhage and fatal bleeding,” wrote Matthew J. Price, MD, of the Scripps Clinic in La Jolla, Calif., and Jacqueline Saw, MD, of Vancouver General Hospital, in an accompanying editorial.
Previous studies of LAAO have shown a reduced risk of gastrointestinal bleeding, but procedure hazards interfered with long-term benefits, they said. The current study findings of similar rates of stroke and lower bleeding rates with LAAO, compared with DOAC, “are provocative given the clinical consensus that DOACs are safer, well tolerated, and generally better than warfarin, which was an easy target for transcatheter LAAO, given warfarin’s extensive limitations,” the editorialists wrote. Although the findings lend support to the use of LAAO, clinicians should consider several caveats such as the inclusion of patients who were “not optimal candidates for long-term OAC but were selected because they were at high risk for bleeding or because OAC treatment had already failed.”
However, “despite its imperfections, PRAGUE-17 is an important step forward and reinforces the role of transcatheter LAAO as a stroke-prevention strategy for patients with [AFib] at high risk of bleeding or medical treatment failure, even in the modern era of the DOACs,” they concluded. “Going forward, successful enrollment in ongoing and planned clinical trials while avoiding off-label procedures will be critical to define the appropriate use of transcatheter LAAO in expanded patient populations.”
The study was supported by the Ministry of Health of the Czech Republic. Dr. Osmancik disclosed speaking honoraria from Bayer and Abbot. Dr. Price’s financial disclosures included honoraria, speaker bureau fees, and/or research grants from Abbott Vascular, AstraZeneca, Boston Scientific, Chiesi USA, Daiichi Sankyo, and Medtronic. Dr. Saw disclosed receiving unrestricted research grant support several Canadian research institutes and fees and honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Servier, among other drug companies.
SOURCES: Osmancik P et al. J Am Coll Cardiol. 2020;75:3122-35; Price MJ, Saw J. J Am Coll Cardiol. 2020;75:3136-9.
Left atrial appendage closure was noninferior to use of direct oral anticoagulants for the prevention of atrial fibrillation (AFib)–related events in high-risk patients, based on data from 402 adults.
Given the limitations of vitamin K antagonists for preventing stroke in AFib, “a novel site-specific therapeutic alternative, mechanical left atrial appendage occlusion [LAAO], entered clinical practice,” but has not been compared with current safe and effective oral anticoagulants, wrote Pavel Osmancik, MD, of University Hospital Kralovske Vinohrady, Prague, and colleagues.
In a study published in the Journal of the American College of Cardiology, the researchers randomized 201 moderate- or high-risk adults with nonvalvular AFib to LAAO and another 201 to direct oral anticoagulants (DOAC).
Patients in the LAAO group underwent transesophageal echocardiography to exclude left atrial thrombi and underwent implantation with Boston Scientific’s Watchman, Watchman-FLX, or Abbott’s Amulet devices. Patients in the DOAC group received rivaroxaban, apixaban, or dabigatran at the manufacturer-recommended dose.
The primary outcome was a composite of complications related to procedures or devices, thromboembolic events (including stroke), and clinically significant bleeding. After an average of 20 months follow-up, 35 patients in the LAAO group and 41 in the DOAC group met the primary outcome (11% per 100 patient-years vs. 13% per 100 patient-years).
In addition, no differences appeared between the groups for the endpoint components of all-stroke/transient ischemic attack event (subdistribution hazard ratio, 1.00), clinically significantly bleeding (sHR, 0.81), or cardiovascular death (sHR, 0.75).
Nine patients experienced major complications related to LAAO, including clinically significant bleeding (sHR, 0.81; 95% CI, 0.44-1.52) and cardiovascular death (sHR, 0.75; 95% CI, 0.34-1.62). Major LAAO-related complications occurred in nine (4.5%) patients, with a short-term (up to 7 days or hospital discharge) complication rate of 2.1% and a 2.7% late complication rate. The late complications included three pericardial effusions, one of which resulted in death, the researchers wrote.
The study findings were limited by several factors, including the inability to assess the differences among the components of the composite primary endpoint. For example, “Regarding the primary endpoint, stroke reduction may be more important than bleeding reduction,” the investigators wrote.
The results were strengthened, however, by the enrollment of a high-risk AF population and is the first known randomized trial to compare percutaneous LAAO and DOACs for stroke prevention in this group. But the late complication rate of 2.7% is “suboptimal” and safety issues reinforce the need for refinement of operator technique and device technology with LAAO, they concluded.
‘Important step forward,’ with caveats
“How LAAO might stack up against DOAC therapy has remained an open question: Compared with warfarin, DOACs are easier to use and are associated with a reduction in mortality, driven by a substantially lower risk of intracranial hemorrhage and fatal bleeding,” wrote Matthew J. Price, MD, of the Scripps Clinic in La Jolla, Calif., and Jacqueline Saw, MD, of Vancouver General Hospital, in an accompanying editorial.
Previous studies of LAAO have shown a reduced risk of gastrointestinal bleeding, but procedure hazards interfered with long-term benefits, they said. The current study findings of similar rates of stroke and lower bleeding rates with LAAO, compared with DOAC, “are provocative given the clinical consensus that DOACs are safer, well tolerated, and generally better than warfarin, which was an easy target for transcatheter LAAO, given warfarin’s extensive limitations,” the editorialists wrote. Although the findings lend support to the use of LAAO, clinicians should consider several caveats such as the inclusion of patients who were “not optimal candidates for long-term OAC but were selected because they were at high risk for bleeding or because OAC treatment had already failed.”
However, “despite its imperfections, PRAGUE-17 is an important step forward and reinforces the role of transcatheter LAAO as a stroke-prevention strategy for patients with [AFib] at high risk of bleeding or medical treatment failure, even in the modern era of the DOACs,” they concluded. “Going forward, successful enrollment in ongoing and planned clinical trials while avoiding off-label procedures will be critical to define the appropriate use of transcatheter LAAO in expanded patient populations.”
The study was supported by the Ministry of Health of the Czech Republic. Dr. Osmancik disclosed speaking honoraria from Bayer and Abbot. Dr. Price’s financial disclosures included honoraria, speaker bureau fees, and/or research grants from Abbott Vascular, AstraZeneca, Boston Scientific, Chiesi USA, Daiichi Sankyo, and Medtronic. Dr. Saw disclosed receiving unrestricted research grant support several Canadian research institutes and fees and honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Servier, among other drug companies.
SOURCES: Osmancik P et al. J Am Coll Cardiol. 2020;75:3122-35; Price MJ, Saw J. J Am Coll Cardiol. 2020;75:3136-9.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point:
Major finding: A composite primary outcome including stroke and death was not significantly different in high-risk patients randomized to left atrial appendage occlusion or direct oral anticoagulants at roughly 20 months’ follow-up (11% vs. 13%, respectively).
Study details: The data come from the PRAGUE-17 study, a randomized trial of 402 adults at increased risk for atrial fibrillation.
Disclosures: The study was supported by the Ministry of Health of the Czech Republic. Dr. Osmancik disclosed speaking honoraria from Bayer and Abbot.
Sources: Osmancik P et al. J Am Coll Cardiol. 2020;75:3122-35; Price MJ, Saw J. J Am Coll Cardiol. 2020;75:3136-9.
Preventive services coalition recommends routine anxiety screening for women
according to a new recommendation from the Women’s Preventive Services Initiative.
The lifetime prevalence of anxiety disorders in women in the United States is 40%, approximately twice that of men, and anxiety can be a manifestation of underlying issues including posttraumatic stress, sexual harassment, and assault, wrote Kimberly D. Gregory, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues on behalf of the Women’s Preventive Services Initiative (WPSI), a national coalition of women’s health professional organizations and patient representatives.
“The WPSI based its rationale for anxiety screening on several considerations,” the researchers noted. “Anxiety disorders are the most prevalent mental health disorders in women, and the problems created by untreated anxiety can impair function in all areas of a woman’s life.”
“Effective screening may lead to earlier or timelier treatment (including behavioral and medical interventions) and result in improved clinical outcomes, such as symptoms, function, and quality of life. Screening may also lead to the detection of associated conditions, such as depression and posttraumatic stress disorder, which may also require treatment,” they wrote.
To support the recommendation, the researchers evaluated data from 33 studies and 2 systematic reviews for a total of 171 studies. Most studies included screening instruments that involved clinician- or patient-administered questionnaires designed for use in clinical practice. Although none of the studies evaluated the overall effectiveness versus harm of screening for anxiety, the strength of evidence for the effectiveness of anxiety treatment ranged from moderate to high, and the evidence of harms ranged from low for cognitive-behavioral therapy to moderate for anxiety medications.
“Overall, the WPSI determined that the balance of benefits and harms would likely be favorable on the basis of the high prevalence of anxiety in women; its substantial effect on health, function, and quality of life; and evidence on the accuracy of screening instruments in primary care settings and the effectiveness and harms of treatment,” the researchers wrote.
Although anxiety screening is not currently routine in clinical practice in the United States, such screening could be done quickly and efficiently as part of an intake visit in a primary care or obstetric setting, using a brief screening tool similar to those used for depression, the researchers wrote. The goal of anxiety screening, as with depression screening, is to identify those who need further evaluation to diagnose or rule out an anxiety disorder.
“A revised version [of the draft recommendation] was adopted by the Health Resources and Services Administration in December 2019; it will be incorporated into the summary of covered benefits for preventive services without cost sharing as required by the Patient Protection and Affordable Care Act immediately or no later than 1 January 2021, depending on individual coverage,” the researchers noted.
“Covered benefits apply to most group health plans and issuers of group and individual health insurance coverage, as well as to persons who qualify for Medicaid on the basis of Medicaid expansion under the Affordable Care Act,” they wrote.
“Because anxiety disorders can be successfully treated, early detection through the use of a brief questionnaire could prevent years of symptoms and impairment in the lives of women at every stage of life,” they concluded.
Aaron Sutton, LCSW, a behavioral health consultant at Abington (Pa.) Hospital–Jefferson Health, expressed support for the guidelines in an interview.
“With almost half of all women experiencing an anxiety disorder sometime in their life, effective recognition and treatment of anxiety disorders is needed,” he said.
Mr. Sutton described treatment as being “fairly benign” with the initial approach being cognitive-behavioral therapy, a form of psychological talk therapy, and first-line pharmacologic therapies being SSRIs and serotonin norepinephrine reuptake inhibitors.
Mr. Sutton also explained how he expects effective screening and treatment will benefit women with anxiety and the health care system.
“Women will see improvement in areas such as personal relationships, work, school, and social settings. The health care system will see benefits as costs related to anxiety disorders, be it direct or indirect, are in the billions of dollars,” he said.
Although screening for anxiety will increase the workload of primary care physicians, anxiety screening should be included and could perhaps be administered in conjunction with the routine depression screening already recommended as part of primary care visits, Mr. Sutton noted.
“Anxiety disorders can be successfully treated, and early detection can prevent years of symptoms and impairment,” he emphasized.
“Anxiety often occurs among adolescents and adult women and often becomes a chronic problem with impairments,” said Cynthia Pfeffer, MD, professor of psychiatry at Weill Cornell Medicine, New York, in an interview. “Screening for anxiety could identify and enable planning to decrease and prevent this impairing prevalent condition and its associated problems. For example, anxiety can impair adolescents’ academic and social functioning and if this is lasting also impair their success in work and future planning for families. There are successful treatments for anxiety and identification of individuals at an early time may prevent impairments in daily functioning.”
Dr. Pfeffer noted that steps to overcome barriers to prevention and treatment for anxiety include “educating health care professionals about the problems caused from anxiety, learning means to identify and diagnose anxiety, and developing proficiency in offering methods to prevent and intervene for women with symptoms of anxiety.”
The take-home message for clinicians is that anxiety is prevalent among females of all ages and often begins early and becomes chronic.
“There are excellent treatments including psychotherapy and medication that can decrease and prevent anxiety,” she emphasized. “Training practicing clinicians including MDs as well as other professionals in the health care system about anxiety will enhance the wellbeing of women.”
More research is needed to evaluate methods used during health care visits for anxiety screening and treatment in order to determine valid means of preventing the impairments associated with anxiety, Dr. Pfeffer said.
Mr. Sutton noted that no trials “have evaluated overall effectiveness or potential harms including labeling, misdiagnosis, and overdiagnosis.” Other areas in need of research include the changes in incidence and prevalence of anxiety over time, as well as specific risk factors including marriage, divorce, pregnancy, and childbirth, he added.
The research for the recommendation was supported by the Health Resources and Services Administration. The researchers had no financial conflicts to disclose. Mr. Sutton had no financial conflicts to disclose. Dr. Pfeffer has written extensively on depression and anxiety in children, adolescents, and adults. She had no financial conflicts to disclose.
SOURCE: Gregory KD et al. Ann Intern Med. 2020 June 9. doi: 10.7326/M20-0580.
according to a new recommendation from the Women’s Preventive Services Initiative.
The lifetime prevalence of anxiety disorders in women in the United States is 40%, approximately twice that of men, and anxiety can be a manifestation of underlying issues including posttraumatic stress, sexual harassment, and assault, wrote Kimberly D. Gregory, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues on behalf of the Women’s Preventive Services Initiative (WPSI), a national coalition of women’s health professional organizations and patient representatives.
“The WPSI based its rationale for anxiety screening on several considerations,” the researchers noted. “Anxiety disorders are the most prevalent mental health disorders in women, and the problems created by untreated anxiety can impair function in all areas of a woman’s life.”
“Effective screening may lead to earlier or timelier treatment (including behavioral and medical interventions) and result in improved clinical outcomes, such as symptoms, function, and quality of life. Screening may also lead to the detection of associated conditions, such as depression and posttraumatic stress disorder, which may also require treatment,” they wrote.
To support the recommendation, the researchers evaluated data from 33 studies and 2 systematic reviews for a total of 171 studies. Most studies included screening instruments that involved clinician- or patient-administered questionnaires designed for use in clinical practice. Although none of the studies evaluated the overall effectiveness versus harm of screening for anxiety, the strength of evidence for the effectiveness of anxiety treatment ranged from moderate to high, and the evidence of harms ranged from low for cognitive-behavioral therapy to moderate for anxiety medications.
“Overall, the WPSI determined that the balance of benefits and harms would likely be favorable on the basis of the high prevalence of anxiety in women; its substantial effect on health, function, and quality of life; and evidence on the accuracy of screening instruments in primary care settings and the effectiveness and harms of treatment,” the researchers wrote.
Although anxiety screening is not currently routine in clinical practice in the United States, such screening could be done quickly and efficiently as part of an intake visit in a primary care or obstetric setting, using a brief screening tool similar to those used for depression, the researchers wrote. The goal of anxiety screening, as with depression screening, is to identify those who need further evaluation to diagnose or rule out an anxiety disorder.
“A revised version [of the draft recommendation] was adopted by the Health Resources and Services Administration in December 2019; it will be incorporated into the summary of covered benefits for preventive services without cost sharing as required by the Patient Protection and Affordable Care Act immediately or no later than 1 January 2021, depending on individual coverage,” the researchers noted.
“Covered benefits apply to most group health plans and issuers of group and individual health insurance coverage, as well as to persons who qualify for Medicaid on the basis of Medicaid expansion under the Affordable Care Act,” they wrote.
“Because anxiety disorders can be successfully treated, early detection through the use of a brief questionnaire could prevent years of symptoms and impairment in the lives of women at every stage of life,” they concluded.
Aaron Sutton, LCSW, a behavioral health consultant at Abington (Pa.) Hospital–Jefferson Health, expressed support for the guidelines in an interview.
“With almost half of all women experiencing an anxiety disorder sometime in their life, effective recognition and treatment of anxiety disorders is needed,” he said.
Mr. Sutton described treatment as being “fairly benign” with the initial approach being cognitive-behavioral therapy, a form of psychological talk therapy, and first-line pharmacologic therapies being SSRIs and serotonin norepinephrine reuptake inhibitors.
Mr. Sutton also explained how he expects effective screening and treatment will benefit women with anxiety and the health care system.
“Women will see improvement in areas such as personal relationships, work, school, and social settings. The health care system will see benefits as costs related to anxiety disorders, be it direct or indirect, are in the billions of dollars,” he said.
Although screening for anxiety will increase the workload of primary care physicians, anxiety screening should be included and could perhaps be administered in conjunction with the routine depression screening already recommended as part of primary care visits, Mr. Sutton noted.
“Anxiety disorders can be successfully treated, and early detection can prevent years of symptoms and impairment,” he emphasized.
“Anxiety often occurs among adolescents and adult women and often becomes a chronic problem with impairments,” said Cynthia Pfeffer, MD, professor of psychiatry at Weill Cornell Medicine, New York, in an interview. “Screening for anxiety could identify and enable planning to decrease and prevent this impairing prevalent condition and its associated problems. For example, anxiety can impair adolescents’ academic and social functioning and if this is lasting also impair their success in work and future planning for families. There are successful treatments for anxiety and identification of individuals at an early time may prevent impairments in daily functioning.”
Dr. Pfeffer noted that steps to overcome barriers to prevention and treatment for anxiety include “educating health care professionals about the problems caused from anxiety, learning means to identify and diagnose anxiety, and developing proficiency in offering methods to prevent and intervene for women with symptoms of anxiety.”
The take-home message for clinicians is that anxiety is prevalent among females of all ages and often begins early and becomes chronic.
“There are excellent treatments including psychotherapy and medication that can decrease and prevent anxiety,” she emphasized. “Training practicing clinicians including MDs as well as other professionals in the health care system about anxiety will enhance the wellbeing of women.”
More research is needed to evaluate methods used during health care visits for anxiety screening and treatment in order to determine valid means of preventing the impairments associated with anxiety, Dr. Pfeffer said.
Mr. Sutton noted that no trials “have evaluated overall effectiveness or potential harms including labeling, misdiagnosis, and overdiagnosis.” Other areas in need of research include the changes in incidence and prevalence of anxiety over time, as well as specific risk factors including marriage, divorce, pregnancy, and childbirth, he added.
The research for the recommendation was supported by the Health Resources and Services Administration. The researchers had no financial conflicts to disclose. Mr. Sutton had no financial conflicts to disclose. Dr. Pfeffer has written extensively on depression and anxiety in children, adolescents, and adults. She had no financial conflicts to disclose.
SOURCE: Gregory KD et al. Ann Intern Med. 2020 June 9. doi: 10.7326/M20-0580.
according to a new recommendation from the Women’s Preventive Services Initiative.
The lifetime prevalence of anxiety disorders in women in the United States is 40%, approximately twice that of men, and anxiety can be a manifestation of underlying issues including posttraumatic stress, sexual harassment, and assault, wrote Kimberly D. Gregory, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues on behalf of the Women’s Preventive Services Initiative (WPSI), a national coalition of women’s health professional organizations and patient representatives.
“The WPSI based its rationale for anxiety screening on several considerations,” the researchers noted. “Anxiety disorders are the most prevalent mental health disorders in women, and the problems created by untreated anxiety can impair function in all areas of a woman’s life.”
“Effective screening may lead to earlier or timelier treatment (including behavioral and medical interventions) and result in improved clinical outcomes, such as symptoms, function, and quality of life. Screening may also lead to the detection of associated conditions, such as depression and posttraumatic stress disorder, which may also require treatment,” they wrote.
To support the recommendation, the researchers evaluated data from 33 studies and 2 systematic reviews for a total of 171 studies. Most studies included screening instruments that involved clinician- or patient-administered questionnaires designed for use in clinical practice. Although none of the studies evaluated the overall effectiveness versus harm of screening for anxiety, the strength of evidence for the effectiveness of anxiety treatment ranged from moderate to high, and the evidence of harms ranged from low for cognitive-behavioral therapy to moderate for anxiety medications.
“Overall, the WPSI determined that the balance of benefits and harms would likely be favorable on the basis of the high prevalence of anxiety in women; its substantial effect on health, function, and quality of life; and evidence on the accuracy of screening instruments in primary care settings and the effectiveness and harms of treatment,” the researchers wrote.
Although anxiety screening is not currently routine in clinical practice in the United States, such screening could be done quickly and efficiently as part of an intake visit in a primary care or obstetric setting, using a brief screening tool similar to those used for depression, the researchers wrote. The goal of anxiety screening, as with depression screening, is to identify those who need further evaluation to diagnose or rule out an anxiety disorder.
“A revised version [of the draft recommendation] was adopted by the Health Resources and Services Administration in December 2019; it will be incorporated into the summary of covered benefits for preventive services without cost sharing as required by the Patient Protection and Affordable Care Act immediately or no later than 1 January 2021, depending on individual coverage,” the researchers noted.
“Covered benefits apply to most group health plans and issuers of group and individual health insurance coverage, as well as to persons who qualify for Medicaid on the basis of Medicaid expansion under the Affordable Care Act,” they wrote.
“Because anxiety disorders can be successfully treated, early detection through the use of a brief questionnaire could prevent years of symptoms and impairment in the lives of women at every stage of life,” they concluded.
Aaron Sutton, LCSW, a behavioral health consultant at Abington (Pa.) Hospital–Jefferson Health, expressed support for the guidelines in an interview.
“With almost half of all women experiencing an anxiety disorder sometime in their life, effective recognition and treatment of anxiety disorders is needed,” he said.
Mr. Sutton described treatment as being “fairly benign” with the initial approach being cognitive-behavioral therapy, a form of psychological talk therapy, and first-line pharmacologic therapies being SSRIs and serotonin norepinephrine reuptake inhibitors.
Mr. Sutton also explained how he expects effective screening and treatment will benefit women with anxiety and the health care system.
“Women will see improvement in areas such as personal relationships, work, school, and social settings. The health care system will see benefits as costs related to anxiety disorders, be it direct or indirect, are in the billions of dollars,” he said.
Although screening for anxiety will increase the workload of primary care physicians, anxiety screening should be included and could perhaps be administered in conjunction with the routine depression screening already recommended as part of primary care visits, Mr. Sutton noted.
“Anxiety disorders can be successfully treated, and early detection can prevent years of symptoms and impairment,” he emphasized.
“Anxiety often occurs among adolescents and adult women and often becomes a chronic problem with impairments,” said Cynthia Pfeffer, MD, professor of psychiatry at Weill Cornell Medicine, New York, in an interview. “Screening for anxiety could identify and enable planning to decrease and prevent this impairing prevalent condition and its associated problems. For example, anxiety can impair adolescents’ academic and social functioning and if this is lasting also impair their success in work and future planning for families. There are successful treatments for anxiety and identification of individuals at an early time may prevent impairments in daily functioning.”
Dr. Pfeffer noted that steps to overcome barriers to prevention and treatment for anxiety include “educating health care professionals about the problems caused from anxiety, learning means to identify and diagnose anxiety, and developing proficiency in offering methods to prevent and intervene for women with symptoms of anxiety.”
The take-home message for clinicians is that anxiety is prevalent among females of all ages and often begins early and becomes chronic.
“There are excellent treatments including psychotherapy and medication that can decrease and prevent anxiety,” she emphasized. “Training practicing clinicians including MDs as well as other professionals in the health care system about anxiety will enhance the wellbeing of women.”
More research is needed to evaluate methods used during health care visits for anxiety screening and treatment in order to determine valid means of preventing the impairments associated with anxiety, Dr. Pfeffer said.
Mr. Sutton noted that no trials “have evaluated overall effectiveness or potential harms including labeling, misdiagnosis, and overdiagnosis.” Other areas in need of research include the changes in incidence and prevalence of anxiety over time, as well as specific risk factors including marriage, divorce, pregnancy, and childbirth, he added.
The research for the recommendation was supported by the Health Resources and Services Administration. The researchers had no financial conflicts to disclose. Mr. Sutton had no financial conflicts to disclose. Dr. Pfeffer has written extensively on depression and anxiety in children, adolescents, and adults. She had no financial conflicts to disclose.
SOURCE: Gregory KD et al. Ann Intern Med. 2020 June 9. doi: 10.7326/M20-0580.
FROM ANNALS OF INTERNAL MEDICINE
High-fat, high-sugar diet may promote adult acne
A diet higher in fat, sugar, and milk was associated with having acne in a cross-sectional study of approximately 24,000 adults in France.
Acne in adults has been associated with social, emotional, and psychological consequences similar to those found with chronic diseases such as asthma, arthritis, epilepsy, and diabetes, wrote Laetitia Penso, MSc, of the University of Paris in Bobigny, France, and colleagues.
Although acne patients may believe that eating certain foods exacerbates acne, data on the effects of nutrition on acne, including associations between acne and a high-glycemic diet, are limited and have produced conflicting results, they noted.
In their study, published in JAMA Dermatology, the researchers identified 24,452 adults who participated in the NutriNet-Santé study, an ongoing, web-based study in France. Approximately 75% of the participants were women, the average age was 57 years, and 46% reported past or current acne.
Participants responded to an 11-item questionnaire between November 2008 and July 2019. Questions were related to the occurrence and diagnosis of acne, as well as medical history. Based on their acne status, participants were identified as falling into the categories of never acne, past acne, or current acne, and their dietary intake was assessed at baseline and every 6 months using three nonconsecutive 24-hour dietary records for 2 weekdays and 1 weekend day.
In an analysis, after adjustment for confounders, current acne was significantly associated with consumption of fatty and sugary foods (per portion, adjusted odds ratio, 1.54; P = .01), as well as with consumption of sugary drinks (per glass, aOR, 1.18; P = .04) and milk (per glass, aOR, 1.12; P = .04). In addition, carbohydrate intake and saturated fatty acid intake were significantly associated with current acne (aOR, 1.43; P = .02; and aOR, 3.90; P = .048, respectively).
Three dietary patterns accounted for 42% of the total variability, the researchers said. A healthy pattern of higher fruit, vegetable, and fish intake accounted for 18%, a fatty and sugary pattern of higher fat and sugar intake (including chocolate) accounted for 13%, and an animal product and cereal pattern of higher intake of meat, milk, and refined cereals accounted for 11%, they explained.
“The results of our study appear to support the hypothesis that the Western diet (rich in animal products and fatty and sugary foods) is associated with the presence of acne in adulthood,” the researchers concluded. Possible explanations for the findings include the effects of a high glycemic-load diet on circulating IGF-1 and insulin, which ultimately increases both oxidative stress and inflammation that promotes the development of acne, they noted.
The study findings were limited by several factors including the use of relatively homogenous younger and female patient population and the reliance on self-reported acne, as well as the observational design, which did not allow for identification of direct, causal associations between diet and acne, the researchers noted. Larger studies are needed to examine the relationship between diet and adult acne to inform prevention and treatment, they wrote.
“Much of the previous literature on the role of diet in acne has focused on the association of milk consumption and high glycemic-load diet with acne,” John S. Barbieri, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, wrote in an accompanying editorial.
Dr. Barbieri acknowledged the inability to make causal associations given the study design and noted that dietary interventions should be implemented with caution because of the potential for other effects such as reduced calcium or vitamin D.
“Nevertheless, given the potential overall health benefits of a healthy or low glycemic-load diet, and 2 small trials supporting its effectiveness in acne, a low glycemic-load diet is a reasonable recommendation for patients looking for dietary modifications that may improve their acne,” he said.
Dr. Barbieri said that he was encouraged to see that the study findings reflected previous research identifying an association between acne and high-glycemic load foods, as well as milk consumption, but he emphasized that more research is needed before general recommendations about diet and acne can be made.
“Trials are needed to evaluate whether dietary interventions can improve or prevent acne and how the effect size of such interventions compares with other standard treatment modalities,” he emphasized.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Barbieri disclosed support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and from a Pfizer Fellowship grant to the Trustees of the University of Pennsylvania.
SOURCE: Penso L et al. JAMA Dermatol. 2020 June 10. doi: 10.1001/jamadermatol.2020.1602.
A diet higher in fat, sugar, and milk was associated with having acne in a cross-sectional study of approximately 24,000 adults in France.
Acne in adults has been associated with social, emotional, and psychological consequences similar to those found with chronic diseases such as asthma, arthritis, epilepsy, and diabetes, wrote Laetitia Penso, MSc, of the University of Paris in Bobigny, France, and colleagues.
Although acne patients may believe that eating certain foods exacerbates acne, data on the effects of nutrition on acne, including associations between acne and a high-glycemic diet, are limited and have produced conflicting results, they noted.
In their study, published in JAMA Dermatology, the researchers identified 24,452 adults who participated in the NutriNet-Santé study, an ongoing, web-based study in France. Approximately 75% of the participants were women, the average age was 57 years, and 46% reported past or current acne.
Participants responded to an 11-item questionnaire between November 2008 and July 2019. Questions were related to the occurrence and diagnosis of acne, as well as medical history. Based on their acne status, participants were identified as falling into the categories of never acne, past acne, or current acne, and their dietary intake was assessed at baseline and every 6 months using three nonconsecutive 24-hour dietary records for 2 weekdays and 1 weekend day.
In an analysis, after adjustment for confounders, current acne was significantly associated with consumption of fatty and sugary foods (per portion, adjusted odds ratio, 1.54; P = .01), as well as with consumption of sugary drinks (per glass, aOR, 1.18; P = .04) and milk (per glass, aOR, 1.12; P = .04). In addition, carbohydrate intake and saturated fatty acid intake were significantly associated with current acne (aOR, 1.43; P = .02; and aOR, 3.90; P = .048, respectively).
Three dietary patterns accounted for 42% of the total variability, the researchers said. A healthy pattern of higher fruit, vegetable, and fish intake accounted for 18%, a fatty and sugary pattern of higher fat and sugar intake (including chocolate) accounted for 13%, and an animal product and cereal pattern of higher intake of meat, milk, and refined cereals accounted for 11%, they explained.
“The results of our study appear to support the hypothesis that the Western diet (rich in animal products and fatty and sugary foods) is associated with the presence of acne in adulthood,” the researchers concluded. Possible explanations for the findings include the effects of a high glycemic-load diet on circulating IGF-1 and insulin, which ultimately increases both oxidative stress and inflammation that promotes the development of acne, they noted.
The study findings were limited by several factors including the use of relatively homogenous younger and female patient population and the reliance on self-reported acne, as well as the observational design, which did not allow for identification of direct, causal associations between diet and acne, the researchers noted. Larger studies are needed to examine the relationship between diet and adult acne to inform prevention and treatment, they wrote.
“Much of the previous literature on the role of diet in acne has focused on the association of milk consumption and high glycemic-load diet with acne,” John S. Barbieri, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, wrote in an accompanying editorial.
Dr. Barbieri acknowledged the inability to make causal associations given the study design and noted that dietary interventions should be implemented with caution because of the potential for other effects such as reduced calcium or vitamin D.
“Nevertheless, given the potential overall health benefits of a healthy or low glycemic-load diet, and 2 small trials supporting its effectiveness in acne, a low glycemic-load diet is a reasonable recommendation for patients looking for dietary modifications that may improve their acne,” he said.
Dr. Barbieri said that he was encouraged to see that the study findings reflected previous research identifying an association between acne and high-glycemic load foods, as well as milk consumption, but he emphasized that more research is needed before general recommendations about diet and acne can be made.
“Trials are needed to evaluate whether dietary interventions can improve or prevent acne and how the effect size of such interventions compares with other standard treatment modalities,” he emphasized.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Barbieri disclosed support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and from a Pfizer Fellowship grant to the Trustees of the University of Pennsylvania.
SOURCE: Penso L et al. JAMA Dermatol. 2020 June 10. doi: 10.1001/jamadermatol.2020.1602.
A diet higher in fat, sugar, and milk was associated with having acne in a cross-sectional study of approximately 24,000 adults in France.
Acne in adults has been associated with social, emotional, and psychological consequences similar to those found with chronic diseases such as asthma, arthritis, epilepsy, and diabetes, wrote Laetitia Penso, MSc, of the University of Paris in Bobigny, France, and colleagues.
Although acne patients may believe that eating certain foods exacerbates acne, data on the effects of nutrition on acne, including associations between acne and a high-glycemic diet, are limited and have produced conflicting results, they noted.
In their study, published in JAMA Dermatology, the researchers identified 24,452 adults who participated in the NutriNet-Santé study, an ongoing, web-based study in France. Approximately 75% of the participants were women, the average age was 57 years, and 46% reported past or current acne.
Participants responded to an 11-item questionnaire between November 2008 and July 2019. Questions were related to the occurrence and diagnosis of acne, as well as medical history. Based on their acne status, participants were identified as falling into the categories of never acne, past acne, or current acne, and their dietary intake was assessed at baseline and every 6 months using three nonconsecutive 24-hour dietary records for 2 weekdays and 1 weekend day.
In an analysis, after adjustment for confounders, current acne was significantly associated with consumption of fatty and sugary foods (per portion, adjusted odds ratio, 1.54; P = .01), as well as with consumption of sugary drinks (per glass, aOR, 1.18; P = .04) and milk (per glass, aOR, 1.12; P = .04). In addition, carbohydrate intake and saturated fatty acid intake were significantly associated with current acne (aOR, 1.43; P = .02; and aOR, 3.90; P = .048, respectively).
Three dietary patterns accounted for 42% of the total variability, the researchers said. A healthy pattern of higher fruit, vegetable, and fish intake accounted for 18%, a fatty and sugary pattern of higher fat and sugar intake (including chocolate) accounted for 13%, and an animal product and cereal pattern of higher intake of meat, milk, and refined cereals accounted for 11%, they explained.
“The results of our study appear to support the hypothesis that the Western diet (rich in animal products and fatty and sugary foods) is associated with the presence of acne in adulthood,” the researchers concluded. Possible explanations for the findings include the effects of a high glycemic-load diet on circulating IGF-1 and insulin, which ultimately increases both oxidative stress and inflammation that promotes the development of acne, they noted.
The study findings were limited by several factors including the use of relatively homogenous younger and female patient population and the reliance on self-reported acne, as well as the observational design, which did not allow for identification of direct, causal associations between diet and acne, the researchers noted. Larger studies are needed to examine the relationship between diet and adult acne to inform prevention and treatment, they wrote.
“Much of the previous literature on the role of diet in acne has focused on the association of milk consumption and high glycemic-load diet with acne,” John S. Barbieri, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, wrote in an accompanying editorial.
Dr. Barbieri acknowledged the inability to make causal associations given the study design and noted that dietary interventions should be implemented with caution because of the potential for other effects such as reduced calcium or vitamin D.
“Nevertheless, given the potential overall health benefits of a healthy or low glycemic-load diet, and 2 small trials supporting its effectiveness in acne, a low glycemic-load diet is a reasonable recommendation for patients looking for dietary modifications that may improve their acne,” he said.
Dr. Barbieri said that he was encouraged to see that the study findings reflected previous research identifying an association between acne and high-glycemic load foods, as well as milk consumption, but he emphasized that more research is needed before general recommendations about diet and acne can be made.
“Trials are needed to evaluate whether dietary interventions can improve or prevent acne and how the effect size of such interventions compares with other standard treatment modalities,” he emphasized.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Barbieri disclosed support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and from a Pfizer Fellowship grant to the Trustees of the University of Pennsylvania.
SOURCE: Penso L et al. JAMA Dermatol. 2020 June 10. doi: 10.1001/jamadermatol.2020.1602.
FROM JAMA DERMATOLOGY
Robotics lightens load for bariatric surgeons in super obese
Use of a robotics platform provides a surgeon with more information so they can make better decisions, especially in challenging situations of primary and revisional bariatric surgery, according to Cheguevara Afaneh, MD, of New York–Presbyterian Hospital and Weill Cornell Medical Center, New York.
“The value of modern technology is to be able to do the most difficult cases in a much simpler format,” he said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Dr. Afaneh shared examples of how robotic assistance can help surgeons address challenges in bariatric surgery clinical practice, including managing super- and super-super-obese patients, dealing with gastroesophageal reflux disease (GERD), and negating the impact of surgical assistant experience.
“Super-obese patients pose more of a challenge interoperatively for both the surgeon and the assistant,” Dr. Afaneh noted. He and colleagues conducted a study of perioperative outcomes and found no significant differences between morbidly obese and super-obese patients in perioperative morbidity or operating time when a robotic platform was used.
The benefits to the surgeon when using robotic assistance in super-obese patients include effortless navigation of the abdominal wall, the ability to execute complex maneuvers in a challenging environment, and the security of a stable platform with no assistant fatigue, Dr. Afaneh emphasized. “When you are using the robotic platform, you are negating a lot of the patient factors” and fatigue factors that make bariatric surgery in super-obese and super-super-obese patients especially difficult, he said.
For example, in a patient who weighed nearly 500 pounds, pulling up on the stomach to get behind the actual stomach is easier because assistant fatigue is not a factor, so the surgeon can take more time and prevent a more difficult dissection, he said. In addition, Dr. Afaneh’s research showed no difference in operative time, and that the robot assistance outcomes were reproducible across a range of body mass index categories.
Robotic assistance also allows for comparable outcomes in surgeons with less experience, notably in revisional surgery, said Dr. Afaneh. He reviewed data from his first year of experience in revisional procedures using robotic assistance to his partners’ more than 20 years of laparoscopic experience. He found no significant differences in operative time, complications, or conversions to open procedures.
However, the more important message from the study was that less experienced surgeons were able to safely perform some of the most difficult revisional procedures without increasing morbidity, compared with more experienced surgeons. The data suggest that, with robotic assistance, surgeons early in their career can take on some of the bigger cases and expect outcomes similar to those of more experienced surgeons, Dr. Afaneh said.
Robotics has demonstrated improved outcomes in managing patients with GERD, which has become a common problem after bariatric surgery, noted Dr. Afaneh. When he and his colleagues reviewed data from their center on robotic-assisted approaches to GERD after bariatric surgery, they found that, even in primary magnetic sphincter operations, “robotics maintains comparable outcomes in revisional sleeve gastrectomy fields,” he said.
Another notable benefit of robotics in bariatric surgery is the negation of the “assistant effect,” said Dr. Afaneh. Often, less experienced surgeons are matched with less experienced assistants. “We took a look at the use of the robotic in cases of complex GI surgeries,” he said. They compared laparoscopic and robotic cases and stratified them by third-year assistant or fellow. “If you had a fellow, the operative time dropped by half an hour for laparoscopic cases, but the time was no different in robotics cases,” regardless of the use of fellow or third-year assistant, he said.
“The robotic platform allows you to assist yourself,” and allows for full surgeon autonomy, Dr. Afaneh emphasized. “You are the best person at predicting your next step.” The robotics platform also serves as a teaching tool. “For those who teach, there is no added morbidity based on the assistance of the trainee,” he said. In addition, the improved visualization of robotics “allows for better appreciation of scarred tissue planes and more precise suturing,” he noted.
Overall, “one of the values of the robotic platform is shortening the learning curve,” Dr. Afaneh said. He reviewed data from his fellows and himself, and found no difference in operative times. “My mentee was able to achieve operative times as good as my third year in practice. The robotic platform shaved off several years of learning experience,” he said. Dr. Afaneh’s operative times also decreased with robotics, which shows how experienced surgeons learn from this technology, he said.
Dr. Afaneh disclosed serving as a consultant for Intuitive Surgical.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Use of a robotics platform provides a surgeon with more information so they can make better decisions, especially in challenging situations of primary and revisional bariatric surgery, according to Cheguevara Afaneh, MD, of New York–Presbyterian Hospital and Weill Cornell Medical Center, New York.
“The value of modern technology is to be able to do the most difficult cases in a much simpler format,” he said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Dr. Afaneh shared examples of how robotic assistance can help surgeons address challenges in bariatric surgery clinical practice, including managing super- and super-super-obese patients, dealing with gastroesophageal reflux disease (GERD), and negating the impact of surgical assistant experience.
“Super-obese patients pose more of a challenge interoperatively for both the surgeon and the assistant,” Dr. Afaneh noted. He and colleagues conducted a study of perioperative outcomes and found no significant differences between morbidly obese and super-obese patients in perioperative morbidity or operating time when a robotic platform was used.
The benefits to the surgeon when using robotic assistance in super-obese patients include effortless navigation of the abdominal wall, the ability to execute complex maneuvers in a challenging environment, and the security of a stable platform with no assistant fatigue, Dr. Afaneh emphasized. “When you are using the robotic platform, you are negating a lot of the patient factors” and fatigue factors that make bariatric surgery in super-obese and super-super-obese patients especially difficult, he said.
For example, in a patient who weighed nearly 500 pounds, pulling up on the stomach to get behind the actual stomach is easier because assistant fatigue is not a factor, so the surgeon can take more time and prevent a more difficult dissection, he said. In addition, Dr. Afaneh’s research showed no difference in operative time, and that the robot assistance outcomes were reproducible across a range of body mass index categories.
Robotic assistance also allows for comparable outcomes in surgeons with less experience, notably in revisional surgery, said Dr. Afaneh. He reviewed data from his first year of experience in revisional procedures using robotic assistance to his partners’ more than 20 years of laparoscopic experience. He found no significant differences in operative time, complications, or conversions to open procedures.
However, the more important message from the study was that less experienced surgeons were able to safely perform some of the most difficult revisional procedures without increasing morbidity, compared with more experienced surgeons. The data suggest that, with robotic assistance, surgeons early in their career can take on some of the bigger cases and expect outcomes similar to those of more experienced surgeons, Dr. Afaneh said.
Robotics has demonstrated improved outcomes in managing patients with GERD, which has become a common problem after bariatric surgery, noted Dr. Afaneh. When he and his colleagues reviewed data from their center on robotic-assisted approaches to GERD after bariatric surgery, they found that, even in primary magnetic sphincter operations, “robotics maintains comparable outcomes in revisional sleeve gastrectomy fields,” he said.
Another notable benefit of robotics in bariatric surgery is the negation of the “assistant effect,” said Dr. Afaneh. Often, less experienced surgeons are matched with less experienced assistants. “We took a look at the use of the robotic in cases of complex GI surgeries,” he said. They compared laparoscopic and robotic cases and stratified them by third-year assistant or fellow. “If you had a fellow, the operative time dropped by half an hour for laparoscopic cases, but the time was no different in robotics cases,” regardless of the use of fellow or third-year assistant, he said.
“The robotic platform allows you to assist yourself,” and allows for full surgeon autonomy, Dr. Afaneh emphasized. “You are the best person at predicting your next step.” The robotics platform also serves as a teaching tool. “For those who teach, there is no added morbidity based on the assistance of the trainee,” he said. In addition, the improved visualization of robotics “allows for better appreciation of scarred tissue planes and more precise suturing,” he noted.
Overall, “one of the values of the robotic platform is shortening the learning curve,” Dr. Afaneh said. He reviewed data from his fellows and himself, and found no difference in operative times. “My mentee was able to achieve operative times as good as my third year in practice. The robotic platform shaved off several years of learning experience,” he said. Dr. Afaneh’s operative times also decreased with robotics, which shows how experienced surgeons learn from this technology, he said.
Dr. Afaneh disclosed serving as a consultant for Intuitive Surgical.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Use of a robotics platform provides a surgeon with more information so they can make better decisions, especially in challenging situations of primary and revisional bariatric surgery, according to Cheguevara Afaneh, MD, of New York–Presbyterian Hospital and Weill Cornell Medical Center, New York.
“The value of modern technology is to be able to do the most difficult cases in a much simpler format,” he said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Dr. Afaneh shared examples of how robotic assistance can help surgeons address challenges in bariatric surgery clinical practice, including managing super- and super-super-obese patients, dealing with gastroesophageal reflux disease (GERD), and negating the impact of surgical assistant experience.
“Super-obese patients pose more of a challenge interoperatively for both the surgeon and the assistant,” Dr. Afaneh noted. He and colleagues conducted a study of perioperative outcomes and found no significant differences between morbidly obese and super-obese patients in perioperative morbidity or operating time when a robotic platform was used.
The benefits to the surgeon when using robotic assistance in super-obese patients include effortless navigation of the abdominal wall, the ability to execute complex maneuvers in a challenging environment, and the security of a stable platform with no assistant fatigue, Dr. Afaneh emphasized. “When you are using the robotic platform, you are negating a lot of the patient factors” and fatigue factors that make bariatric surgery in super-obese and super-super-obese patients especially difficult, he said.
For example, in a patient who weighed nearly 500 pounds, pulling up on the stomach to get behind the actual stomach is easier because assistant fatigue is not a factor, so the surgeon can take more time and prevent a more difficult dissection, he said. In addition, Dr. Afaneh’s research showed no difference in operative time, and that the robot assistance outcomes were reproducible across a range of body mass index categories.
Robotic assistance also allows for comparable outcomes in surgeons with less experience, notably in revisional surgery, said Dr. Afaneh. He reviewed data from his first year of experience in revisional procedures using robotic assistance to his partners’ more than 20 years of laparoscopic experience. He found no significant differences in operative time, complications, or conversions to open procedures.
However, the more important message from the study was that less experienced surgeons were able to safely perform some of the most difficult revisional procedures without increasing morbidity, compared with more experienced surgeons. The data suggest that, with robotic assistance, surgeons early in their career can take on some of the bigger cases and expect outcomes similar to those of more experienced surgeons, Dr. Afaneh said.
Robotics has demonstrated improved outcomes in managing patients with GERD, which has become a common problem after bariatric surgery, noted Dr. Afaneh. When he and his colleagues reviewed data from their center on robotic-assisted approaches to GERD after bariatric surgery, they found that, even in primary magnetic sphincter operations, “robotics maintains comparable outcomes in revisional sleeve gastrectomy fields,” he said.
Another notable benefit of robotics in bariatric surgery is the negation of the “assistant effect,” said Dr. Afaneh. Often, less experienced surgeons are matched with less experienced assistants. “We took a look at the use of the robotic in cases of complex GI surgeries,” he said. They compared laparoscopic and robotic cases and stratified them by third-year assistant or fellow. “If you had a fellow, the operative time dropped by half an hour for laparoscopic cases, but the time was no different in robotics cases,” regardless of the use of fellow or third-year assistant, he said.
“The robotic platform allows you to assist yourself,” and allows for full surgeon autonomy, Dr. Afaneh emphasized. “You are the best person at predicting your next step.” The robotics platform also serves as a teaching tool. “For those who teach, there is no added morbidity based on the assistance of the trainee,” he said. In addition, the improved visualization of robotics “allows for better appreciation of scarred tissue planes and more precise suturing,” he noted.
Overall, “one of the values of the robotic platform is shortening the learning curve,” Dr. Afaneh said. He reviewed data from his fellows and himself, and found no difference in operative times. “My mentee was able to achieve operative times as good as my third year in practice. The robotic platform shaved off several years of learning experience,” he said. Dr. Afaneh’s operative times also decreased with robotics, which shows how experienced surgeons learn from this technology, he said.
Dr. Afaneh disclosed serving as a consultant for Intuitive Surgical.
Global Academy for Medical Education and this news organization are owned by the same parent company.
FROM MISS
Weight loss stays consistent in one- and two-step in gastric band conversion
with either a one- or two-step procedure, a study of 78 patients showed.
“Laparoscopic adjustable gastric banding (LAGB) has largely fallen out of favor, likely related to variable efficacy in weight reduction coupled with poor effectiveness in reducing obesity related comorbidities like type 2 diabetes and hypercholesterolemia,” Vasu Chirumamilla, MD, of Westchester Medical Center, Valhalla, N.Y., and colleagues wrote in a poster presented at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.
LAGB also can cause complications including, slippage, erosion, and gastric pouch dilation; subsequently many patients undergo conversion to laparoscopic sleeve gastrectomy (LSG). However, the impact of a one-step vs. two-step conversion procedure on patient weight loss remains unclear, the researchers said.
To compare weight loss after the two types of procedures, the researchers reviewed data from 78 patients (71 women) aged 15-74 years treated between 2013 and 2018 at a multi-surgeon, private practice bariatric surgery center. All patients had a history of LAGB; 31 underwent conversion to LSG in one stage, and 47 underwent conversion in two stages. Weight loss, defined as the percentage excess weight loss, was the primary endpoint.
The average excess weight loss was 44% for patients in both the one-stage and two-stage groups, and body mass index decreased by 8.9 points and 8.8 points, respectively, in the two groups, the researchers wrote.
Patients in the two-stage group experienced a significant increase in body mass index (P = .008) during the time between band removal to sleeve gastrectomy, which was an average of 207 days, they said.
The findings were limited in part by the small sample size and retrospective design, and more data are needed to compare complication rates in one-stage and two-stage procedures, the researchers noted. However, the results showed “no difference in excess weight loss in patients converted from laparoscopic adjustable gastric band to sleeve gastrectomy in one-stage versus a two-stage procedure,” they concluded.
“LAGB used to be a very popular weight loss procedure – bands were placed in a great deal of patients,” Dr. Chirumamilla said in an interview. “Now those patients are presenting with increasing frequency to bariatric surgeons with band complications or weight regain. The volume for LSG is increasing and results in percentage excess weight loss of approximately 65% versus approximately 42% for LAGB,” he said. A goal of the study was to provide patients and the surgeons with a more informed approach to performing and consenting to the particular operation, he added.
“The results have not surprised us, because as long as done by experienced surgeons on compliant patients the weight loss outcomes from the day of surgery onward should be equivalent,” Dr. Chirumamilla explained. “We were also not surprised to find that patients undergoing a two-stage conversion gained weight before their second-stage sleeve gastrectomy.”
The bottom line for clinicians is that “patients getting a conversion from band to sleeve in one-stage versus two-stages experience the same percentage excess body weight loss from time of surgery,” although two-stage patients do gain weight while awaiting their second-stage sleeve gastrectomy, Dr. Chirumamilla said.
“More research is needed to compare short- and long-term complications rates between one-stage and two-stage conversions. The ideal research situation would be a randomized, multicenter, large volume study to reduce bias,” he noted.
Dr. Chirumamilla’s collaborators included Akia Caine MD, Zachary Ballinger, Rebecca Castro, Thomas Cerabona MD, and Ashutosh Kaul MD, of the surgical group Advanced Surgeons at nygetfit.com.
Global Academy for Medical Education and this news organization are owned by the same parent company. The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Chirumamilla V et al. MISS 2020. Poster PA-14.
with either a one- or two-step procedure, a study of 78 patients showed.
“Laparoscopic adjustable gastric banding (LAGB) has largely fallen out of favor, likely related to variable efficacy in weight reduction coupled with poor effectiveness in reducing obesity related comorbidities like type 2 diabetes and hypercholesterolemia,” Vasu Chirumamilla, MD, of Westchester Medical Center, Valhalla, N.Y., and colleagues wrote in a poster presented at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.
LAGB also can cause complications including, slippage, erosion, and gastric pouch dilation; subsequently many patients undergo conversion to laparoscopic sleeve gastrectomy (LSG). However, the impact of a one-step vs. two-step conversion procedure on patient weight loss remains unclear, the researchers said.
To compare weight loss after the two types of procedures, the researchers reviewed data from 78 patients (71 women) aged 15-74 years treated between 2013 and 2018 at a multi-surgeon, private practice bariatric surgery center. All patients had a history of LAGB; 31 underwent conversion to LSG in one stage, and 47 underwent conversion in two stages. Weight loss, defined as the percentage excess weight loss, was the primary endpoint.
The average excess weight loss was 44% for patients in both the one-stage and two-stage groups, and body mass index decreased by 8.9 points and 8.8 points, respectively, in the two groups, the researchers wrote.
Patients in the two-stage group experienced a significant increase in body mass index (P = .008) during the time between band removal to sleeve gastrectomy, which was an average of 207 days, they said.
The findings were limited in part by the small sample size and retrospective design, and more data are needed to compare complication rates in one-stage and two-stage procedures, the researchers noted. However, the results showed “no difference in excess weight loss in patients converted from laparoscopic adjustable gastric band to sleeve gastrectomy in one-stage versus a two-stage procedure,” they concluded.
“LAGB used to be a very popular weight loss procedure – bands were placed in a great deal of patients,” Dr. Chirumamilla said in an interview. “Now those patients are presenting with increasing frequency to bariatric surgeons with band complications or weight regain. The volume for LSG is increasing and results in percentage excess weight loss of approximately 65% versus approximately 42% for LAGB,” he said. A goal of the study was to provide patients and the surgeons with a more informed approach to performing and consenting to the particular operation, he added.
“The results have not surprised us, because as long as done by experienced surgeons on compliant patients the weight loss outcomes from the day of surgery onward should be equivalent,” Dr. Chirumamilla explained. “We were also not surprised to find that patients undergoing a two-stage conversion gained weight before their second-stage sleeve gastrectomy.”
The bottom line for clinicians is that “patients getting a conversion from band to sleeve in one-stage versus two-stages experience the same percentage excess body weight loss from time of surgery,” although two-stage patients do gain weight while awaiting their second-stage sleeve gastrectomy, Dr. Chirumamilla said.
“More research is needed to compare short- and long-term complications rates between one-stage and two-stage conversions. The ideal research situation would be a randomized, multicenter, large volume study to reduce bias,” he noted.
Dr. Chirumamilla’s collaborators included Akia Caine MD, Zachary Ballinger, Rebecca Castro, Thomas Cerabona MD, and Ashutosh Kaul MD, of the surgical group Advanced Surgeons at nygetfit.com.
Global Academy for Medical Education and this news organization are owned by the same parent company. The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Chirumamilla V et al. MISS 2020. Poster PA-14.
with either a one- or two-step procedure, a study of 78 patients showed.
“Laparoscopic adjustable gastric banding (LAGB) has largely fallen out of favor, likely related to variable efficacy in weight reduction coupled with poor effectiveness in reducing obesity related comorbidities like type 2 diabetes and hypercholesterolemia,” Vasu Chirumamilla, MD, of Westchester Medical Center, Valhalla, N.Y., and colleagues wrote in a poster presented at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.
LAGB also can cause complications including, slippage, erosion, and gastric pouch dilation; subsequently many patients undergo conversion to laparoscopic sleeve gastrectomy (LSG). However, the impact of a one-step vs. two-step conversion procedure on patient weight loss remains unclear, the researchers said.
To compare weight loss after the two types of procedures, the researchers reviewed data from 78 patients (71 women) aged 15-74 years treated between 2013 and 2018 at a multi-surgeon, private practice bariatric surgery center. All patients had a history of LAGB; 31 underwent conversion to LSG in one stage, and 47 underwent conversion in two stages. Weight loss, defined as the percentage excess weight loss, was the primary endpoint.
The average excess weight loss was 44% for patients in both the one-stage and two-stage groups, and body mass index decreased by 8.9 points and 8.8 points, respectively, in the two groups, the researchers wrote.
Patients in the two-stage group experienced a significant increase in body mass index (P = .008) during the time between band removal to sleeve gastrectomy, which was an average of 207 days, they said.
The findings were limited in part by the small sample size and retrospective design, and more data are needed to compare complication rates in one-stage and two-stage procedures, the researchers noted. However, the results showed “no difference in excess weight loss in patients converted from laparoscopic adjustable gastric band to sleeve gastrectomy in one-stage versus a two-stage procedure,” they concluded.
“LAGB used to be a very popular weight loss procedure – bands were placed in a great deal of patients,” Dr. Chirumamilla said in an interview. “Now those patients are presenting with increasing frequency to bariatric surgeons with band complications or weight regain. The volume for LSG is increasing and results in percentage excess weight loss of approximately 65% versus approximately 42% for LAGB,” he said. A goal of the study was to provide patients and the surgeons with a more informed approach to performing and consenting to the particular operation, he added.
“The results have not surprised us, because as long as done by experienced surgeons on compliant patients the weight loss outcomes from the day of surgery onward should be equivalent,” Dr. Chirumamilla explained. “We were also not surprised to find that patients undergoing a two-stage conversion gained weight before their second-stage sleeve gastrectomy.”
The bottom line for clinicians is that “patients getting a conversion from band to sleeve in one-stage versus two-stages experience the same percentage excess body weight loss from time of surgery,” although two-stage patients do gain weight while awaiting their second-stage sleeve gastrectomy, Dr. Chirumamilla said.
“More research is needed to compare short- and long-term complications rates between one-stage and two-stage conversions. The ideal research situation would be a randomized, multicenter, large volume study to reduce bias,” he noted.
Dr. Chirumamilla’s collaborators included Akia Caine MD, Zachary Ballinger, Rebecca Castro, Thomas Cerabona MD, and Ashutosh Kaul MD, of the surgical group Advanced Surgeons at nygetfit.com.
Global Academy for Medical Education and this news organization are owned by the same parent company. The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Chirumamilla V et al. MISS 2020. Poster PA-14.
FROM MISS
Key clinical point: Weight loss was the same for patients after conversions from LAGB to LSG in both one-step and two-step procedures.
Major finding: The average excess weight loss was 44% for patients in both one-step and two-step conversion groups, and body mass index decreased by approximately 9 points in both groups.
Study details: The data come from a retrospective study of 78 adults who underwent conversion from LABG to LSG.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Chirumamilla V et al. MISS 2020. Poster PA-14.
Elevated inflammation common in children’s severe COVID-19 disease
according to data from 50 patients at a single tertiary care center.
“Risk factors for severe disease in pediatric populations have not been clearly identified and the high prevalence of SARS-CoV-2 in NYC offers an opportunity to describe severe pediatric disease in more detail,” wrote Philip Zachariah, MD, of New York–Presbyterian Hospital, New York, and colleagues.
In a retrospective case series published in JAMA Pediatrics, the researchers reviewed data from 50 patients: 41 classified as severe and 9 classified as nonsevere. Among the patients, 27 were male and 25 were Hispanic. The patient population had a median of 2 days from symptom onset to hospital admission. The most common symptoms were fever (80%) and respiratory symptoms (64%). Seventy-six percent of patients had a median length of stay of 3 days (range 1-30 days).
At hospital admission, children with severe disease had significantly higher levels of several inflammatory markers compared with those without severe disease, notably C-reactive protein (median 8.978 mg/dL vs. 0.64 mg/dL) and procalcitonin (median 0.31 ng/mL vs. 0.17 ng/mL, (P < .001 for both). High mean peak levels of C-reactive protein, procalcitonin, interleukin 6, ferritin, and D-dimer were seen among the nine children (16%) who required mechanical ventilation, Dr. Zachariah and associates said.
None of the 14 infants and 1 of the 8 immunocompromised children in the study had severe disease, the researchers wrote.
Bacterial coinfections detected while patients were hospitalized were bacteremia in 6%, suspected bacterial pneumonia in 18%, urinary tract infections in 10%, skin and soft tissue infections in 6%, and streptococcus pharyngitis in 2%, Dr. Zachariah and associates reported.
Overall, 61% of the children had comorbidities identified in previous COVID-19 studies, of which obesity was the most common (22%); other comorbidities included asthma, sickle cell disease, cardiac disease, and diabetes. Obesity also was significantly associated with the need for mechanical ventilation in children aged 2 years and older (67%). A total of 16 patients required respiratory support, 9 of these were placed on mechanical ventilation; 6 of these 9 children were obese.
Fifteen patients (30%) who met criteria for increased oxygen requirements and respiratory distress received hydroxychloroquine, but the small sample size did not allow for assessment of treatment efficacy, the researchers said.
“Expanding our knowledge of COVID-19 [disease] in children will potentially permit early recognition of SARS-CoV-2 infection, understanding of the natural history of disease, and potential complications, said Stephen I. Pelton, MD, professor of pediatrics and epidemiology at Boston University and senior attending physician at Boston Medical Center. This review of 50 SARS-CoV-2 infected children (less than 21 years of age) “provides insight into the short period of symptoms prior to hospitalization, challenges the concept that infants less than 1 year are at greatest risk of severe disease (as from the experience in China), and suggests rapid recovery in many children, as median length of stay was 3 days.
“The review revealed two findings that were surprising to me. First, the median length of stay of 3 days. As nearly 20% of the children required mechanical ventilation, it suggests many of the children were discharged quickly after evaluation, suggesting that we need to identify markers of severity to predict those children likely to have progressive disease and require respiratory support,” Dr. Pelton noted.
“The second observation suggests high rates of bacterial infection (bacteremia, pneumonia, UTI, and skin and soft tissue infection). I do not think this has been widely reported in adults, and may represent a difference between child and adult disease. More studies such as this will be required to identify how common coinfection with bacteria is,” he said.
“The take-home message is that although most children with COVID-19 have a mild or even asymptomatic course, some become severely ill requiring ventilator support and potentially ECMO [extracorporeal membrane oxygenation]. Potential predictors of severity include high C-reactive protein, obesity, and older age [adolescence], said Dr. Pelton, who was not involved in the study.
What additional research is needed? Dr. Pelton said that better markers of severe disease are needed, as well as an understanding of why obesity is a risk factor for severe disease in both children and adults. Are these prediabetic patients? he asked.
The study findings were limited by the small sample size and high proportion of Hispanic patients, which may limit generalizability, and some symptoms and comorbidities may have been missed because of the retrospective nature of the study, the researchers noted. However, the results support the need for hospitals to remain vigilant to the variable presentations of COVID-19 infections in children.
“Therapeutic considerations need to [include] the risk of toxicity, control of antiviral replication, and early recognition and management of immune dysregulation,” they concluded.
The study received no outside funding. Dr. Zachariah had no financial conflicts to disclose. Two coauthors reported ties with various pharmaceutical companies and organizations. Dr. Pelton said he had no relevant financial disclosures.
SOURCE: Zachariah P et al. JAMA Pediatr. 2020 June 3. doi:10.1001/jamapediatrics.2020.2430.
according to data from 50 patients at a single tertiary care center.
“Risk factors for severe disease in pediatric populations have not been clearly identified and the high prevalence of SARS-CoV-2 in NYC offers an opportunity to describe severe pediatric disease in more detail,” wrote Philip Zachariah, MD, of New York–Presbyterian Hospital, New York, and colleagues.
In a retrospective case series published in JAMA Pediatrics, the researchers reviewed data from 50 patients: 41 classified as severe and 9 classified as nonsevere. Among the patients, 27 were male and 25 were Hispanic. The patient population had a median of 2 days from symptom onset to hospital admission. The most common symptoms were fever (80%) and respiratory symptoms (64%). Seventy-six percent of patients had a median length of stay of 3 days (range 1-30 days).
At hospital admission, children with severe disease had significantly higher levels of several inflammatory markers compared with those without severe disease, notably C-reactive protein (median 8.978 mg/dL vs. 0.64 mg/dL) and procalcitonin (median 0.31 ng/mL vs. 0.17 ng/mL, (P < .001 for both). High mean peak levels of C-reactive protein, procalcitonin, interleukin 6, ferritin, and D-dimer were seen among the nine children (16%) who required mechanical ventilation, Dr. Zachariah and associates said.
None of the 14 infants and 1 of the 8 immunocompromised children in the study had severe disease, the researchers wrote.
Bacterial coinfections detected while patients were hospitalized were bacteremia in 6%, suspected bacterial pneumonia in 18%, urinary tract infections in 10%, skin and soft tissue infections in 6%, and streptococcus pharyngitis in 2%, Dr. Zachariah and associates reported.
Overall, 61% of the children had comorbidities identified in previous COVID-19 studies, of which obesity was the most common (22%); other comorbidities included asthma, sickle cell disease, cardiac disease, and diabetes. Obesity also was significantly associated with the need for mechanical ventilation in children aged 2 years and older (67%). A total of 16 patients required respiratory support, 9 of these were placed on mechanical ventilation; 6 of these 9 children were obese.
Fifteen patients (30%) who met criteria for increased oxygen requirements and respiratory distress received hydroxychloroquine, but the small sample size did not allow for assessment of treatment efficacy, the researchers said.
“Expanding our knowledge of COVID-19 [disease] in children will potentially permit early recognition of SARS-CoV-2 infection, understanding of the natural history of disease, and potential complications, said Stephen I. Pelton, MD, professor of pediatrics and epidemiology at Boston University and senior attending physician at Boston Medical Center. This review of 50 SARS-CoV-2 infected children (less than 21 years of age) “provides insight into the short period of symptoms prior to hospitalization, challenges the concept that infants less than 1 year are at greatest risk of severe disease (as from the experience in China), and suggests rapid recovery in many children, as median length of stay was 3 days.
“The review revealed two findings that were surprising to me. First, the median length of stay of 3 days. As nearly 20% of the children required mechanical ventilation, it suggests many of the children were discharged quickly after evaluation, suggesting that we need to identify markers of severity to predict those children likely to have progressive disease and require respiratory support,” Dr. Pelton noted.
“The second observation suggests high rates of bacterial infection (bacteremia, pneumonia, UTI, and skin and soft tissue infection). I do not think this has been widely reported in adults, and may represent a difference between child and adult disease. More studies such as this will be required to identify how common coinfection with bacteria is,” he said.
“The take-home message is that although most children with COVID-19 have a mild or even asymptomatic course, some become severely ill requiring ventilator support and potentially ECMO [extracorporeal membrane oxygenation]. Potential predictors of severity include high C-reactive protein, obesity, and older age [adolescence], said Dr. Pelton, who was not involved in the study.
What additional research is needed? Dr. Pelton said that better markers of severe disease are needed, as well as an understanding of why obesity is a risk factor for severe disease in both children and adults. Are these prediabetic patients? he asked.
The study findings were limited by the small sample size and high proportion of Hispanic patients, which may limit generalizability, and some symptoms and comorbidities may have been missed because of the retrospective nature of the study, the researchers noted. However, the results support the need for hospitals to remain vigilant to the variable presentations of COVID-19 infections in children.
“Therapeutic considerations need to [include] the risk of toxicity, control of antiviral replication, and early recognition and management of immune dysregulation,” they concluded.
The study received no outside funding. Dr. Zachariah had no financial conflicts to disclose. Two coauthors reported ties with various pharmaceutical companies and organizations. Dr. Pelton said he had no relevant financial disclosures.
SOURCE: Zachariah P et al. JAMA Pediatr. 2020 June 3. doi:10.1001/jamapediatrics.2020.2430.
according to data from 50 patients at a single tertiary care center.
“Risk factors for severe disease in pediatric populations have not been clearly identified and the high prevalence of SARS-CoV-2 in NYC offers an opportunity to describe severe pediatric disease in more detail,” wrote Philip Zachariah, MD, of New York–Presbyterian Hospital, New York, and colleagues.
In a retrospective case series published in JAMA Pediatrics, the researchers reviewed data from 50 patients: 41 classified as severe and 9 classified as nonsevere. Among the patients, 27 were male and 25 were Hispanic. The patient population had a median of 2 days from symptom onset to hospital admission. The most common symptoms were fever (80%) and respiratory symptoms (64%). Seventy-six percent of patients had a median length of stay of 3 days (range 1-30 days).
At hospital admission, children with severe disease had significantly higher levels of several inflammatory markers compared with those without severe disease, notably C-reactive protein (median 8.978 mg/dL vs. 0.64 mg/dL) and procalcitonin (median 0.31 ng/mL vs. 0.17 ng/mL, (P < .001 for both). High mean peak levels of C-reactive protein, procalcitonin, interleukin 6, ferritin, and D-dimer were seen among the nine children (16%) who required mechanical ventilation, Dr. Zachariah and associates said.
None of the 14 infants and 1 of the 8 immunocompromised children in the study had severe disease, the researchers wrote.
Bacterial coinfections detected while patients were hospitalized were bacteremia in 6%, suspected bacterial pneumonia in 18%, urinary tract infections in 10%, skin and soft tissue infections in 6%, and streptococcus pharyngitis in 2%, Dr. Zachariah and associates reported.
Overall, 61% of the children had comorbidities identified in previous COVID-19 studies, of which obesity was the most common (22%); other comorbidities included asthma, sickle cell disease, cardiac disease, and diabetes. Obesity also was significantly associated with the need for mechanical ventilation in children aged 2 years and older (67%). A total of 16 patients required respiratory support, 9 of these were placed on mechanical ventilation; 6 of these 9 children were obese.
Fifteen patients (30%) who met criteria for increased oxygen requirements and respiratory distress received hydroxychloroquine, but the small sample size did not allow for assessment of treatment efficacy, the researchers said.
“Expanding our knowledge of COVID-19 [disease] in children will potentially permit early recognition of SARS-CoV-2 infection, understanding of the natural history of disease, and potential complications, said Stephen I. Pelton, MD, professor of pediatrics and epidemiology at Boston University and senior attending physician at Boston Medical Center. This review of 50 SARS-CoV-2 infected children (less than 21 years of age) “provides insight into the short period of symptoms prior to hospitalization, challenges the concept that infants less than 1 year are at greatest risk of severe disease (as from the experience in China), and suggests rapid recovery in many children, as median length of stay was 3 days.
“The review revealed two findings that were surprising to me. First, the median length of stay of 3 days. As nearly 20% of the children required mechanical ventilation, it suggests many of the children were discharged quickly after evaluation, suggesting that we need to identify markers of severity to predict those children likely to have progressive disease and require respiratory support,” Dr. Pelton noted.
“The second observation suggests high rates of bacterial infection (bacteremia, pneumonia, UTI, and skin and soft tissue infection). I do not think this has been widely reported in adults, and may represent a difference between child and adult disease. More studies such as this will be required to identify how common coinfection with bacteria is,” he said.
“The take-home message is that although most children with COVID-19 have a mild or even asymptomatic course, some become severely ill requiring ventilator support and potentially ECMO [extracorporeal membrane oxygenation]. Potential predictors of severity include high C-reactive protein, obesity, and older age [adolescence], said Dr. Pelton, who was not involved in the study.
What additional research is needed? Dr. Pelton said that better markers of severe disease are needed, as well as an understanding of why obesity is a risk factor for severe disease in both children and adults. Are these prediabetic patients? he asked.
The study findings were limited by the small sample size and high proportion of Hispanic patients, which may limit generalizability, and some symptoms and comorbidities may have been missed because of the retrospective nature of the study, the researchers noted. However, the results support the need for hospitals to remain vigilant to the variable presentations of COVID-19 infections in children.
“Therapeutic considerations need to [include] the risk of toxicity, control of antiviral replication, and early recognition and management of immune dysregulation,” they concluded.
The study received no outside funding. Dr. Zachariah had no financial conflicts to disclose. Two coauthors reported ties with various pharmaceutical companies and organizations. Dr. Pelton said he had no relevant financial disclosures.
SOURCE: Zachariah P et al. JAMA Pediatr. 2020 June 3. doi:10.1001/jamapediatrics.2020.2430.
FROM JAMA PEDIATRICS
Pandemic conditions can complicate care of patients with PAH
in these patients, according to a research article published in Pulmonary Circulation.
“The impetus for this manuscript was a recent discussion within the Pulmonary Hypertension Association (PHA) and [its] Scientific Leadership Council who expressed a need for guidelines from experts in the field,” wrote John J. Ryan, MD, of the University of Utah, Salt Lake City, and colleagues.
The authors highlight some of the unique challenges in caring for patients with pulmonary hypertension (PH), particularly pulmonary arterial hypertension (PAH), in the context of the COVID-19 pandemic.
Telemedicine and temporary visit schedules for new and returning PAH patients can help reduce risk of virus transmission, if patient accessibility to telemedicine is feasible. Protocols to reduce the risk of virus exposure or transmission in the office setting included less frequent echocardiography and 6-Minute Walk Tests (6MWTs) for patients in stable condition. In stable patients, “avoid pulmonary function of V/Q tests when possible,” the authors wrote.
New patients who have been referred for PAH present a challenge in conducting a thorough evaluation that would normally include measurement of invasive hemodynamics in keeping with current diagnostic guidelines. Clinicians will need to balance the potential risks of COVID-19 exposure during elective procedures against the benefits of full evaluations to plan PAH treatment, the authors noted.
For established patients who are clinically stable, remote visits may be an option, with a risk/benefit assessment of the need for in-person diagnostic tests at the current time, they said. However, telemedicine’s limitations include not only patient accessibility and understanding of audio and video technology, but also inability to accurately measure vital signs, they said.
As for routine testing such as echocardiograms, 6MWTs, and other laboratory testing, “it is important to consider the additive value of these sometimes comprehensive tests in the context of the risks associated with visiting the hospital or clinic to obtain them,” the authors said.
Patients who are unstable and experience worsening right heart failure (RHF) at home may have contracted a COVID-19 infection, but the differential diagnosis includes sepsis, ischemia, and PAH disease progression. “During the current pandemic, fever at home in a PAH patient should be assumed to represent a COVID-19 infection,” and patients with worsening respiratory symptoms that require hospitalization should be tested for COVID-19, the authors emphasized.
Use of ECMO or other intensive interventions should be considered in the context of risk assessment, the authors said. “As a general recommendation, practitioners should consider utilizing an established PAH-specific risk assessment tool to help identify patients who are more likely to survive heroic interventions during the COVID-19 outbreak,” they wrote.
Training and education of PH providers will continue to be limited by the pandemic, and many clinical trials and research programs have been suspended and will need to be restructured to minimize risk of transmission of the COVID-19 virus, the authors said. However, health care providers must continue to provide PAH patients and families with advice and updates in best practices, while “acknowledging that the situation changes rapidly,” they concluded.
Dr. Ryan disclosed participating on the speakers bureau, and provides consulting services for, Actelion and Bayer, as well as research support from the Reagan Corporation, the Gordon Family, and the Cushman Family.
SOURCE: Ryan JJ et al. Pulm Circ. 2020 Apr 29. doi: 10.1177/2045894020920153.
in these patients, according to a research article published in Pulmonary Circulation.
“The impetus for this manuscript was a recent discussion within the Pulmonary Hypertension Association (PHA) and [its] Scientific Leadership Council who expressed a need for guidelines from experts in the field,” wrote John J. Ryan, MD, of the University of Utah, Salt Lake City, and colleagues.
The authors highlight some of the unique challenges in caring for patients with pulmonary hypertension (PH), particularly pulmonary arterial hypertension (PAH), in the context of the COVID-19 pandemic.
Telemedicine and temporary visit schedules for new and returning PAH patients can help reduce risk of virus transmission, if patient accessibility to telemedicine is feasible. Protocols to reduce the risk of virus exposure or transmission in the office setting included less frequent echocardiography and 6-Minute Walk Tests (6MWTs) for patients in stable condition. In stable patients, “avoid pulmonary function of V/Q tests when possible,” the authors wrote.
New patients who have been referred for PAH present a challenge in conducting a thorough evaluation that would normally include measurement of invasive hemodynamics in keeping with current diagnostic guidelines. Clinicians will need to balance the potential risks of COVID-19 exposure during elective procedures against the benefits of full evaluations to plan PAH treatment, the authors noted.
For established patients who are clinically stable, remote visits may be an option, with a risk/benefit assessment of the need for in-person diagnostic tests at the current time, they said. However, telemedicine’s limitations include not only patient accessibility and understanding of audio and video technology, but also inability to accurately measure vital signs, they said.
As for routine testing such as echocardiograms, 6MWTs, and other laboratory testing, “it is important to consider the additive value of these sometimes comprehensive tests in the context of the risks associated with visiting the hospital or clinic to obtain them,” the authors said.
Patients who are unstable and experience worsening right heart failure (RHF) at home may have contracted a COVID-19 infection, but the differential diagnosis includes sepsis, ischemia, and PAH disease progression. “During the current pandemic, fever at home in a PAH patient should be assumed to represent a COVID-19 infection,” and patients with worsening respiratory symptoms that require hospitalization should be tested for COVID-19, the authors emphasized.
Use of ECMO or other intensive interventions should be considered in the context of risk assessment, the authors said. “As a general recommendation, practitioners should consider utilizing an established PAH-specific risk assessment tool to help identify patients who are more likely to survive heroic interventions during the COVID-19 outbreak,” they wrote.
Training and education of PH providers will continue to be limited by the pandemic, and many clinical trials and research programs have been suspended and will need to be restructured to minimize risk of transmission of the COVID-19 virus, the authors said. However, health care providers must continue to provide PAH patients and families with advice and updates in best practices, while “acknowledging that the situation changes rapidly,” they concluded.
Dr. Ryan disclosed participating on the speakers bureau, and provides consulting services for, Actelion and Bayer, as well as research support from the Reagan Corporation, the Gordon Family, and the Cushman Family.
SOURCE: Ryan JJ et al. Pulm Circ. 2020 Apr 29. doi: 10.1177/2045894020920153.
in these patients, according to a research article published in Pulmonary Circulation.
“The impetus for this manuscript was a recent discussion within the Pulmonary Hypertension Association (PHA) and [its] Scientific Leadership Council who expressed a need for guidelines from experts in the field,” wrote John J. Ryan, MD, of the University of Utah, Salt Lake City, and colleagues.
The authors highlight some of the unique challenges in caring for patients with pulmonary hypertension (PH), particularly pulmonary arterial hypertension (PAH), in the context of the COVID-19 pandemic.
Telemedicine and temporary visit schedules for new and returning PAH patients can help reduce risk of virus transmission, if patient accessibility to telemedicine is feasible. Protocols to reduce the risk of virus exposure or transmission in the office setting included less frequent echocardiography and 6-Minute Walk Tests (6MWTs) for patients in stable condition. In stable patients, “avoid pulmonary function of V/Q tests when possible,” the authors wrote.
New patients who have been referred for PAH present a challenge in conducting a thorough evaluation that would normally include measurement of invasive hemodynamics in keeping with current diagnostic guidelines. Clinicians will need to balance the potential risks of COVID-19 exposure during elective procedures against the benefits of full evaluations to plan PAH treatment, the authors noted.
For established patients who are clinically stable, remote visits may be an option, with a risk/benefit assessment of the need for in-person diagnostic tests at the current time, they said. However, telemedicine’s limitations include not only patient accessibility and understanding of audio and video technology, but also inability to accurately measure vital signs, they said.
As for routine testing such as echocardiograms, 6MWTs, and other laboratory testing, “it is important to consider the additive value of these sometimes comprehensive tests in the context of the risks associated with visiting the hospital or clinic to obtain them,” the authors said.
Patients who are unstable and experience worsening right heart failure (RHF) at home may have contracted a COVID-19 infection, but the differential diagnosis includes sepsis, ischemia, and PAH disease progression. “During the current pandemic, fever at home in a PAH patient should be assumed to represent a COVID-19 infection,” and patients with worsening respiratory symptoms that require hospitalization should be tested for COVID-19, the authors emphasized.
Use of ECMO or other intensive interventions should be considered in the context of risk assessment, the authors said. “As a general recommendation, practitioners should consider utilizing an established PAH-specific risk assessment tool to help identify patients who are more likely to survive heroic interventions during the COVID-19 outbreak,” they wrote.
Training and education of PH providers will continue to be limited by the pandemic, and many clinical trials and research programs have been suspended and will need to be restructured to minimize risk of transmission of the COVID-19 virus, the authors said. However, health care providers must continue to provide PAH patients and families with advice and updates in best practices, while “acknowledging that the situation changes rapidly,” they concluded.
Dr. Ryan disclosed participating on the speakers bureau, and provides consulting services for, Actelion and Bayer, as well as research support from the Reagan Corporation, the Gordon Family, and the Cushman Family.
SOURCE: Ryan JJ et al. Pulm Circ. 2020 Apr 29. doi: 10.1177/2045894020920153.
FROM PULMONARY CIRCULATION