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Renal denervation boosts effectiveness of AFib catheter ablation
SAN FRANCISCO – Adding renal denervation when performing catheter ablation of paroxysmal atrial fibrillation in hypertensive patients substantially reduced their arrhythmia recurrence rate during the subsequent year in a multicenter, randomized trial with 302 patients.
The findings established renal denervation (RDN) as a “reasonable” tool to increase the success of atrial fibrillation (AFib) catheter ablation, Jonathan S. Steinberg, MD, said at the annual scientific sessions of the Heart Rhythm Society.
“The RDN procedure seems remarkably safe and seems to be reliably accomplished when an electrophysiologist does it,” said Dr. Steinberg, director of the Arrhythmia Center of the Summit Medical Group in Montclair, N.J. Given the evidence he reported that performing RDN simultaneously with AFib catheter ablation by pulmonary vein isolation significantly improved freedom from arrhythmia recurrence, this approach “is ready for clinical use at institutions that could mount this kind of program,” he declared.
The rate of freedom from arrhythmia recurrence while off antiarrhythmic drugs during the year following treatment was 57% among 138 patients treated with pulmonary vein isolation only, and 72% in 145 who underwent both pulmonary vein isolation and renal denervation. That’s “a pretty big difference in outcome” with no increased risk and with about 20 added minutes of procedure time, Dr. Steinberg said in a video interview. He acknowledged that, currently, no catheter is approved for U.S. marketing that is specifically designed for renal denervation, but the operators in the study he reported all used conventional radiofrequency ablation catheters with an irrigated tip, a design with U.S. availability.
The ERADICATE-AF (Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation) study randomized 302 patients with paroxysmal AFib and hypertension uncontrolled by medication at three centers in Russia, one in Germany, and one in Poland. Enrolled patients averaged about 60 years of age, about 60% were men, and their average blood pressure was roughly 150/90 mm Hg while on treatment with a median of two antihypertensive drugs, including 100% on either an ACE inhibitor or angiotensin receptor blocker. The study operators performed RDN by placing an average of six lesions in a spiral pattern in each of the patient’s two renal arteries.
The investigators screened for arrhythmia recurrence with 7-day Holter monitoring at 3, 6, 9, and 12 months, with full 12-month follow-up available for 283 patients. After 12 months, blood pressures had declined by an average of 16/11 mm Hg among the patients who underwent RDN, with essentially no change in the patients who had pulmonary vein isolation only. Dr. Steinberg attributed the high success of the renal denervation procedures to the familiarity of the participating electrophysiologist operators with catheter-tip ablations.
“We have gone from treating patients with resistant hypertension to now treating patients with less severe hypertension,” Dr. Steinberg noted, and the next study he is planning will take this approach into patients with paroxysmal AFib but without hypertension, using RDN “solely as an anti-arrhythmic intervention,” he explained.
ERADICATE-AF did not receive commercial funding. Dr. Steinberg has been a consultant to Allergan, AtriCure, Biosense Webster, Corfigo, Medtronic, and Omron. He owns stock in AliveCor and receives salary from National Cardiac and G Medical.
ERADICATE-AF was a well-performed, informative, and provocative study that produced exciting results. I was very impressed that, despite the added complexity of performing an extra procedure, there appeared to be virtually no added risk to patients, with essentially identical complication rates in the two arms of the study. The 15.6% absolute difference in the rate of arrhythmia recurrences means that about six patients need to have renal denervation added to their catheter ablation to prevent one arrhythmia recurrence during 12 months, a pretty remarkable number-needed-to-treat.
Despite the successful outcome, adding renal denervation is not a panacea. These patients still had a 28% rate of recurrent atrial fibrillation during follow-up, and on average they also remained above their goal blood pressure despite the pressure reduction that renal denervation produced. The 43% arrhythmia recurrence rate among the patients who underwent only pulmonary vein isolation was consistent with prior reports on the efficacy of this treatment.
The findings raise the question of whether this approach would also work in AFib patients who are not hypertensive, and we must be cautious about the longer-term safety and durability of this treatment.
Cara N. Pellegrini, MD , is director of cardiac electrophysiology at the San Francisco VA Medical Center. She had no disclosures. She made these comments as designated discussant for ERADICATE-AF.
ERADICATE-AF was a well-performed, informative, and provocative study that produced exciting results. I was very impressed that, despite the added complexity of performing an extra procedure, there appeared to be virtually no added risk to patients, with essentially identical complication rates in the two arms of the study. The 15.6% absolute difference in the rate of arrhythmia recurrences means that about six patients need to have renal denervation added to their catheter ablation to prevent one arrhythmia recurrence during 12 months, a pretty remarkable number-needed-to-treat.
Despite the successful outcome, adding renal denervation is not a panacea. These patients still had a 28% rate of recurrent atrial fibrillation during follow-up, and on average they also remained above their goal blood pressure despite the pressure reduction that renal denervation produced. The 43% arrhythmia recurrence rate among the patients who underwent only pulmonary vein isolation was consistent with prior reports on the efficacy of this treatment.
The findings raise the question of whether this approach would also work in AFib patients who are not hypertensive, and we must be cautious about the longer-term safety and durability of this treatment.
Cara N. Pellegrini, MD , is director of cardiac electrophysiology at the San Francisco VA Medical Center. She had no disclosures. She made these comments as designated discussant for ERADICATE-AF.
ERADICATE-AF was a well-performed, informative, and provocative study that produced exciting results. I was very impressed that, despite the added complexity of performing an extra procedure, there appeared to be virtually no added risk to patients, with essentially identical complication rates in the two arms of the study. The 15.6% absolute difference in the rate of arrhythmia recurrences means that about six patients need to have renal denervation added to their catheter ablation to prevent one arrhythmia recurrence during 12 months, a pretty remarkable number-needed-to-treat.
Despite the successful outcome, adding renal denervation is not a panacea. These patients still had a 28% rate of recurrent atrial fibrillation during follow-up, and on average they also remained above their goal blood pressure despite the pressure reduction that renal denervation produced. The 43% arrhythmia recurrence rate among the patients who underwent only pulmonary vein isolation was consistent with prior reports on the efficacy of this treatment.
The findings raise the question of whether this approach would also work in AFib patients who are not hypertensive, and we must be cautious about the longer-term safety and durability of this treatment.
Cara N. Pellegrini, MD , is director of cardiac electrophysiology at the San Francisco VA Medical Center. She had no disclosures. She made these comments as designated discussant for ERADICATE-AF.
SAN FRANCISCO – Adding renal denervation when performing catheter ablation of paroxysmal atrial fibrillation in hypertensive patients substantially reduced their arrhythmia recurrence rate during the subsequent year in a multicenter, randomized trial with 302 patients.
The findings established renal denervation (RDN) as a “reasonable” tool to increase the success of atrial fibrillation (AFib) catheter ablation, Jonathan S. Steinberg, MD, said at the annual scientific sessions of the Heart Rhythm Society.
“The RDN procedure seems remarkably safe and seems to be reliably accomplished when an electrophysiologist does it,” said Dr. Steinberg, director of the Arrhythmia Center of the Summit Medical Group in Montclair, N.J. Given the evidence he reported that performing RDN simultaneously with AFib catheter ablation by pulmonary vein isolation significantly improved freedom from arrhythmia recurrence, this approach “is ready for clinical use at institutions that could mount this kind of program,” he declared.
The rate of freedom from arrhythmia recurrence while off antiarrhythmic drugs during the year following treatment was 57% among 138 patients treated with pulmonary vein isolation only, and 72% in 145 who underwent both pulmonary vein isolation and renal denervation. That’s “a pretty big difference in outcome” with no increased risk and with about 20 added minutes of procedure time, Dr. Steinberg said in a video interview. He acknowledged that, currently, no catheter is approved for U.S. marketing that is specifically designed for renal denervation, but the operators in the study he reported all used conventional radiofrequency ablation catheters with an irrigated tip, a design with U.S. availability.
The ERADICATE-AF (Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation) study randomized 302 patients with paroxysmal AFib and hypertension uncontrolled by medication at three centers in Russia, one in Germany, and one in Poland. Enrolled patients averaged about 60 years of age, about 60% were men, and their average blood pressure was roughly 150/90 mm Hg while on treatment with a median of two antihypertensive drugs, including 100% on either an ACE inhibitor or angiotensin receptor blocker. The study operators performed RDN by placing an average of six lesions in a spiral pattern in each of the patient’s two renal arteries.
The investigators screened for arrhythmia recurrence with 7-day Holter monitoring at 3, 6, 9, and 12 months, with full 12-month follow-up available for 283 patients. After 12 months, blood pressures had declined by an average of 16/11 mm Hg among the patients who underwent RDN, with essentially no change in the patients who had pulmonary vein isolation only. Dr. Steinberg attributed the high success of the renal denervation procedures to the familiarity of the participating electrophysiologist operators with catheter-tip ablations.
“We have gone from treating patients with resistant hypertension to now treating patients with less severe hypertension,” Dr. Steinberg noted, and the next study he is planning will take this approach into patients with paroxysmal AFib but without hypertension, using RDN “solely as an anti-arrhythmic intervention,” he explained.
ERADICATE-AF did not receive commercial funding. Dr. Steinberg has been a consultant to Allergan, AtriCure, Biosense Webster, Corfigo, Medtronic, and Omron. He owns stock in AliveCor and receives salary from National Cardiac and G Medical.
SAN FRANCISCO – Adding renal denervation when performing catheter ablation of paroxysmal atrial fibrillation in hypertensive patients substantially reduced their arrhythmia recurrence rate during the subsequent year in a multicenter, randomized trial with 302 patients.
The findings established renal denervation (RDN) as a “reasonable” tool to increase the success of atrial fibrillation (AFib) catheter ablation, Jonathan S. Steinberg, MD, said at the annual scientific sessions of the Heart Rhythm Society.
“The RDN procedure seems remarkably safe and seems to be reliably accomplished when an electrophysiologist does it,” said Dr. Steinberg, director of the Arrhythmia Center of the Summit Medical Group in Montclair, N.J. Given the evidence he reported that performing RDN simultaneously with AFib catheter ablation by pulmonary vein isolation significantly improved freedom from arrhythmia recurrence, this approach “is ready for clinical use at institutions that could mount this kind of program,” he declared.
The rate of freedom from arrhythmia recurrence while off antiarrhythmic drugs during the year following treatment was 57% among 138 patients treated with pulmonary vein isolation only, and 72% in 145 who underwent both pulmonary vein isolation and renal denervation. That’s “a pretty big difference in outcome” with no increased risk and with about 20 added minutes of procedure time, Dr. Steinberg said in a video interview. He acknowledged that, currently, no catheter is approved for U.S. marketing that is specifically designed for renal denervation, but the operators in the study he reported all used conventional radiofrequency ablation catheters with an irrigated tip, a design with U.S. availability.
The ERADICATE-AF (Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation) study randomized 302 patients with paroxysmal AFib and hypertension uncontrolled by medication at three centers in Russia, one in Germany, and one in Poland. Enrolled patients averaged about 60 years of age, about 60% were men, and their average blood pressure was roughly 150/90 mm Hg while on treatment with a median of two antihypertensive drugs, including 100% on either an ACE inhibitor or angiotensin receptor blocker. The study operators performed RDN by placing an average of six lesions in a spiral pattern in each of the patient’s two renal arteries.
The investigators screened for arrhythmia recurrence with 7-day Holter monitoring at 3, 6, 9, and 12 months, with full 12-month follow-up available for 283 patients. After 12 months, blood pressures had declined by an average of 16/11 mm Hg among the patients who underwent RDN, with essentially no change in the patients who had pulmonary vein isolation only. Dr. Steinberg attributed the high success of the renal denervation procedures to the familiarity of the participating electrophysiologist operators with catheter-tip ablations.
“We have gone from treating patients with resistant hypertension to now treating patients with less severe hypertension,” Dr. Steinberg noted, and the next study he is planning will take this approach into patients with paroxysmal AFib but without hypertension, using RDN “solely as an anti-arrhythmic intervention,” he explained.
ERADICATE-AF did not receive commercial funding. Dr. Steinberg has been a consultant to Allergan, AtriCure, Biosense Webster, Corfigo, Medtronic, and Omron. He owns stock in AliveCor and receives salary from National Cardiac and G Medical.
REPORTING FROM HEART RHYTHM 2019
Higher AFib ablation volumes linked with better outcomes
SAN FRANCISCO – The number of atrial fibrillation (Afib) catheter ablations a hospital did a year had a substantial, independent effect on patient outcomes in a study of more than 54,000 U.S. catheter ablations performed during 2010-2014.
The results showed that the roughly one-third of studied hospitals with the lowest annual volume of catheter ablations performed, 20 or fewer, had twice the acute complication rate and twice the 30-day in-hospital mortality rate, compared with the hospitals that did 53 or more such procedures annually in patients with atrial fibrillation, Jim W. Cheung, MD, said while presenting a poster at the annual scientific sessions of the Heart Rhythm Society.
The data, taken from 1,738 U.S. hospitals during 2010-2014 and captured in the Nationwide Readmissions Database, also showed that 79% of these hospitals performed 20 or fewer catheter ablations for atrial fibrillation (AFib) annually, with 63% doing 10 or fewer cases per year during the 5 years studied.
The findings raise the question of whether U.S. guidelines for catheter ablation of AFib should specify a minimum case volume for hospital programs, and if so, how high the minimum should be. Volume thresholds are “something to think about,” or a system to designate centers of excellence, Dr. Cheung suggested in a video interview. But interest in setting volume thresholds to better insure competence is often counterbalanced by concerns about patient access, he noted.
The prevailing U.S. guidelines for catheter ablation of AFib are in a 2017 statement from the Heart Rhythm Society and several collaborating groups (J Arrhythm. 2017 Oct;33[5]:369-409). The statement focused on operator volume rather than hospital volume and said that each operator should perform “several” AFib ablation procedures each month, which is generally understood to mean at least 2 per month or at least about 25 annually, commented Hugh Calkins, MD, chair of the panel that wrote the statement and professor of medicine at Johns Hopkins Medicine in Baltimore. The major rationale for setting a suggested minimum of about 25 cases/year came largely from a 2013 report that is cited as the first study to document a volume-outcome relationship for catheter ablation of AFib (Circulation. 2013 Nov 5;128[19]:2104-12), Dr. Calkins noted. “Volume does matter,” he agreed in an interview, but no society or organization monitors hospital or operator volumes, nor takes any steps when volumes are low.
The Nationwide Readmissions Database included 54,599 patients who underwent AFib catheter ablation during 2010-2014. Dr. Cheung and his associates divided these patients into rough tertiles based on the annual procedure volumes of the hospitals that performed these ablations. The 36% of patients treated at hospitals that did 20 or fewer procedures annually were on average older and had more comorbidities than the 31% treated at hospitals in the highest-volume tertile, which performed at least 53 ablations annually. In an analysis that adjusted for these demographic and clinical differences, patients ablated at the lower-volume hospitals had a statistically significant 2.06-fold higher rate of any complication and a 2.24-fold increased rate of in-hospital mortality, either during the index hospitalization or during a 30-day hospital readmission, reported Dr. Cheung, director of clinical electrophysiology research at Weill Cornell Medical College in New York. The increased rate of complications was driven by a fivefold increased rate of cardiac perforations, a greater than doubled periprocedural stroke rate, and a roughly 50% increased rate of vascular complications, compared with the highest-volume hospitals and after adjustment for baseline differences.
Dr. Cheung has been a consultant to Abbott and Biotronik, and has received fellowship support from Biosense Webster, Biotronik, Boston Scientific, Medtronic, and St. Jude. Dr. Calkins disclosed ties to Abbott, Altathera, AtriCure, Boehringer Ingelheim, Boston Scientific, Medtronic, St. Jude, and MRI Interventions.
SOURCE: Cheung JW. HRS 2019, Abstract S-P001-123.
SAN FRANCISCO – The number of atrial fibrillation (Afib) catheter ablations a hospital did a year had a substantial, independent effect on patient outcomes in a study of more than 54,000 U.S. catheter ablations performed during 2010-2014.
The results showed that the roughly one-third of studied hospitals with the lowest annual volume of catheter ablations performed, 20 or fewer, had twice the acute complication rate and twice the 30-day in-hospital mortality rate, compared with the hospitals that did 53 or more such procedures annually in patients with atrial fibrillation, Jim W. Cheung, MD, said while presenting a poster at the annual scientific sessions of the Heart Rhythm Society.
The data, taken from 1,738 U.S. hospitals during 2010-2014 and captured in the Nationwide Readmissions Database, also showed that 79% of these hospitals performed 20 or fewer catheter ablations for atrial fibrillation (AFib) annually, with 63% doing 10 or fewer cases per year during the 5 years studied.
The findings raise the question of whether U.S. guidelines for catheter ablation of AFib should specify a minimum case volume for hospital programs, and if so, how high the minimum should be. Volume thresholds are “something to think about,” or a system to designate centers of excellence, Dr. Cheung suggested in a video interview. But interest in setting volume thresholds to better insure competence is often counterbalanced by concerns about patient access, he noted.
The prevailing U.S. guidelines for catheter ablation of AFib are in a 2017 statement from the Heart Rhythm Society and several collaborating groups (J Arrhythm. 2017 Oct;33[5]:369-409). The statement focused on operator volume rather than hospital volume and said that each operator should perform “several” AFib ablation procedures each month, which is generally understood to mean at least 2 per month or at least about 25 annually, commented Hugh Calkins, MD, chair of the panel that wrote the statement and professor of medicine at Johns Hopkins Medicine in Baltimore. The major rationale for setting a suggested minimum of about 25 cases/year came largely from a 2013 report that is cited as the first study to document a volume-outcome relationship for catheter ablation of AFib (Circulation. 2013 Nov 5;128[19]:2104-12), Dr. Calkins noted. “Volume does matter,” he agreed in an interview, but no society or organization monitors hospital or operator volumes, nor takes any steps when volumes are low.
The Nationwide Readmissions Database included 54,599 patients who underwent AFib catheter ablation during 2010-2014. Dr. Cheung and his associates divided these patients into rough tertiles based on the annual procedure volumes of the hospitals that performed these ablations. The 36% of patients treated at hospitals that did 20 or fewer procedures annually were on average older and had more comorbidities than the 31% treated at hospitals in the highest-volume tertile, which performed at least 53 ablations annually. In an analysis that adjusted for these demographic and clinical differences, patients ablated at the lower-volume hospitals had a statistically significant 2.06-fold higher rate of any complication and a 2.24-fold increased rate of in-hospital mortality, either during the index hospitalization or during a 30-day hospital readmission, reported Dr. Cheung, director of clinical electrophysiology research at Weill Cornell Medical College in New York. The increased rate of complications was driven by a fivefold increased rate of cardiac perforations, a greater than doubled periprocedural stroke rate, and a roughly 50% increased rate of vascular complications, compared with the highest-volume hospitals and after adjustment for baseline differences.
Dr. Cheung has been a consultant to Abbott and Biotronik, and has received fellowship support from Biosense Webster, Biotronik, Boston Scientific, Medtronic, and St. Jude. Dr. Calkins disclosed ties to Abbott, Altathera, AtriCure, Boehringer Ingelheim, Boston Scientific, Medtronic, St. Jude, and MRI Interventions.
SOURCE: Cheung JW. HRS 2019, Abstract S-P001-123.
SAN FRANCISCO – The number of atrial fibrillation (Afib) catheter ablations a hospital did a year had a substantial, independent effect on patient outcomes in a study of more than 54,000 U.S. catheter ablations performed during 2010-2014.
The results showed that the roughly one-third of studied hospitals with the lowest annual volume of catheter ablations performed, 20 or fewer, had twice the acute complication rate and twice the 30-day in-hospital mortality rate, compared with the hospitals that did 53 or more such procedures annually in patients with atrial fibrillation, Jim W. Cheung, MD, said while presenting a poster at the annual scientific sessions of the Heart Rhythm Society.
The data, taken from 1,738 U.S. hospitals during 2010-2014 and captured in the Nationwide Readmissions Database, also showed that 79% of these hospitals performed 20 or fewer catheter ablations for atrial fibrillation (AFib) annually, with 63% doing 10 or fewer cases per year during the 5 years studied.
The findings raise the question of whether U.S. guidelines for catheter ablation of AFib should specify a minimum case volume for hospital programs, and if so, how high the minimum should be. Volume thresholds are “something to think about,” or a system to designate centers of excellence, Dr. Cheung suggested in a video interview. But interest in setting volume thresholds to better insure competence is often counterbalanced by concerns about patient access, he noted.
The prevailing U.S. guidelines for catheter ablation of AFib are in a 2017 statement from the Heart Rhythm Society and several collaborating groups (J Arrhythm. 2017 Oct;33[5]:369-409). The statement focused on operator volume rather than hospital volume and said that each operator should perform “several” AFib ablation procedures each month, which is generally understood to mean at least 2 per month or at least about 25 annually, commented Hugh Calkins, MD, chair of the panel that wrote the statement and professor of medicine at Johns Hopkins Medicine in Baltimore. The major rationale for setting a suggested minimum of about 25 cases/year came largely from a 2013 report that is cited as the first study to document a volume-outcome relationship for catheter ablation of AFib (Circulation. 2013 Nov 5;128[19]:2104-12), Dr. Calkins noted. “Volume does matter,” he agreed in an interview, but no society or organization monitors hospital or operator volumes, nor takes any steps when volumes are low.
The Nationwide Readmissions Database included 54,599 patients who underwent AFib catheter ablation during 2010-2014. Dr. Cheung and his associates divided these patients into rough tertiles based on the annual procedure volumes of the hospitals that performed these ablations. The 36% of patients treated at hospitals that did 20 or fewer procedures annually were on average older and had more comorbidities than the 31% treated at hospitals in the highest-volume tertile, which performed at least 53 ablations annually. In an analysis that adjusted for these demographic and clinical differences, patients ablated at the lower-volume hospitals had a statistically significant 2.06-fold higher rate of any complication and a 2.24-fold increased rate of in-hospital mortality, either during the index hospitalization or during a 30-day hospital readmission, reported Dr. Cheung, director of clinical electrophysiology research at Weill Cornell Medical College in New York. The increased rate of complications was driven by a fivefold increased rate of cardiac perforations, a greater than doubled periprocedural stroke rate, and a roughly 50% increased rate of vascular complications, compared with the highest-volume hospitals and after adjustment for baseline differences.
Dr. Cheung has been a consultant to Abbott and Biotronik, and has received fellowship support from Biosense Webster, Biotronik, Boston Scientific, Medtronic, and St. Jude. Dr. Calkins disclosed ties to Abbott, Altathera, AtriCure, Boehringer Ingelheim, Boston Scientific, Medtronic, St. Jude, and MRI Interventions.
SOURCE: Cheung JW. HRS 2019, Abstract S-P001-123.
REPORTING FROM HEART RHYTHM 2019
Key clinical point: .
Major finding: Hospitals performing 20 or fewer catheter ablations annually had twice as many acute complications as hospitals doing at least 53.
Study details: Analysis of 54,599 atrial fibrillation patients who underwent catheter ablation in the Nationwide Readmissions Database.
Disclosures: Dr. Cheung has been a consultant to Abbott and Biotronik, and has received fellowship support from Biosense Webster, Biotronik, Boston Scientific, Medtronic, and St. Jude.
Source: Cheung JW et al. Heart Rhythm 2019, Abstract S-P001-123.
FDA approves Vyndaqel, Vyndamax for amyloidosis-based heart disease
The disease is caused by the buildup of abnormal deposits of amyloid in the body’s organs and tissues, interfering with normal function, and most often occurs in the heart and nervous system. Symptoms associated with amyloid buildup in the heart include shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms, and death.
FDA approval of both drugs was based on results of a clinical trial in which 441 patients with transthyretin-mediated amyloidosis received either tafamidis meglumine or placebo. After a mean of 30 months, patients who received tafamidis meglumine had a higher survival rate and a lower number of cardiovascular-related hospitalizations than did patients in the placebo group.
No drug-associated side effects have yet been identified; however, tafamidis can cause fetal harm when administered to a pregnant woman.
“Transthyretin-mediated amyloidosis is a rare, debilitating, and often fatal disease. The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
The disease is caused by the buildup of abnormal deposits of amyloid in the body’s organs and tissues, interfering with normal function, and most often occurs in the heart and nervous system. Symptoms associated with amyloid buildup in the heart include shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms, and death.
FDA approval of both drugs was based on results of a clinical trial in which 441 patients with transthyretin-mediated amyloidosis received either tafamidis meglumine or placebo. After a mean of 30 months, patients who received tafamidis meglumine had a higher survival rate and a lower number of cardiovascular-related hospitalizations than did patients in the placebo group.
No drug-associated side effects have yet been identified; however, tafamidis can cause fetal harm when administered to a pregnant woman.
“Transthyretin-mediated amyloidosis is a rare, debilitating, and often fatal disease. The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
The disease is caused by the buildup of abnormal deposits of amyloid in the body’s organs and tissues, interfering with normal function, and most often occurs in the heart and nervous system. Symptoms associated with amyloid buildup in the heart include shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms, and death.
FDA approval of both drugs was based on results of a clinical trial in which 441 patients with transthyretin-mediated amyloidosis received either tafamidis meglumine or placebo. After a mean of 30 months, patients who received tafamidis meglumine had a higher survival rate and a lower number of cardiovascular-related hospitalizations than did patients in the placebo group.
No drug-associated side effects have yet been identified; however, tafamidis can cause fetal harm when administered to a pregnant woman.
“Transthyretin-mediated amyloidosis is a rare, debilitating, and often fatal disease. The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
Single-center study outlines stroke risk, DOAC type in nonvalvular AFib patients
PHILADELPHIA – A disproportionate number of breakthrough strokes were observed among patients receiving rivaroxaban for nonvalvular atrial fibrillation in a stroke unit, according to a small, single-center, retrospective study presented at the annual meeting of the American Academy of Neurology.
The researchers reviewed all patients presenting to a tertiary care stroke unit in Australia from January 2015 to June 2018.
A total of 56 patients (median age was 74 years; 61% were male) had received direct oral anticoagulant (DOAC) therapy and then had an ischemic stroke. Of those patients, 37 (66%) had strokes while receiving the treatment; 14 patients (25%) had a stroke after recently stopping a DOAC, often prior to a medical procedure; and 5 patients (9%) were not adherent to their DOAC regimen.
Of the 37 patients who had strokes during DOAC treatment, 48% were on rivaroxaban, 9% were on dabigatran, and 9% were on apixaban, Fiona Chan, MD, of The Princess Alexandra Hospital, Brisbane, Australia, and coinvestigators reported in a poster presentation.
While these findings need to be replicated in a larger study, they do “raise concern for inadequate stroke prevention within this cohort,” they said.
Moreover, the findings illustrate the importance of bridging anticoagulation prior to procedures, when appropriate, to minimize stroke risk, they added, as 25% of the strokes had occurred in patients who recently stopped the DOACs due to procedures.
To determine which DOAC was most often associated with breakthrough ischemic strokes in patients with nonvalvular atrial fibrillation, the investigators compared the proportion of DOACs prescribed in Australia to the proportion of observed strokes in their cohort.
Despite accounting for about 51% of Australian DOAC prescriptions, rivaroxaban represented nearly 73% of breakthrough strokes among the patients who had strokes while receiving the treatment (P = .001), the investigators reported.
Conversely, apixaban accounted for about 35% of prescriptions but 14% of the breakthrough strokes (P = .0007), while dabigatran accounted for 14% of prescriptions and 14% of the strokes (P = 0.99), the investigators said in their poster.
One limitation of this retrospective study is that the patient cohort came from a single specialized center, and may not reflect the true incidence of nonvalvular atrial fibrillation across Australia, the researchers noted.
Dr. Chan and coinvestigators reported that they had no relevant financial disclosures.
SOURCE: Chan F et al. AAN 2019. P1.3-001.
PHILADELPHIA – A disproportionate number of breakthrough strokes were observed among patients receiving rivaroxaban for nonvalvular atrial fibrillation in a stroke unit, according to a small, single-center, retrospective study presented at the annual meeting of the American Academy of Neurology.
The researchers reviewed all patients presenting to a tertiary care stroke unit in Australia from January 2015 to June 2018.
A total of 56 patients (median age was 74 years; 61% were male) had received direct oral anticoagulant (DOAC) therapy and then had an ischemic stroke. Of those patients, 37 (66%) had strokes while receiving the treatment; 14 patients (25%) had a stroke after recently stopping a DOAC, often prior to a medical procedure; and 5 patients (9%) were not adherent to their DOAC regimen.
Of the 37 patients who had strokes during DOAC treatment, 48% were on rivaroxaban, 9% were on dabigatran, and 9% were on apixaban, Fiona Chan, MD, of The Princess Alexandra Hospital, Brisbane, Australia, and coinvestigators reported in a poster presentation.
While these findings need to be replicated in a larger study, they do “raise concern for inadequate stroke prevention within this cohort,” they said.
Moreover, the findings illustrate the importance of bridging anticoagulation prior to procedures, when appropriate, to minimize stroke risk, they added, as 25% of the strokes had occurred in patients who recently stopped the DOACs due to procedures.
To determine which DOAC was most often associated with breakthrough ischemic strokes in patients with nonvalvular atrial fibrillation, the investigators compared the proportion of DOACs prescribed in Australia to the proportion of observed strokes in their cohort.
Despite accounting for about 51% of Australian DOAC prescriptions, rivaroxaban represented nearly 73% of breakthrough strokes among the patients who had strokes while receiving the treatment (P = .001), the investigators reported.
Conversely, apixaban accounted for about 35% of prescriptions but 14% of the breakthrough strokes (P = .0007), while dabigatran accounted for 14% of prescriptions and 14% of the strokes (P = 0.99), the investigators said in their poster.
One limitation of this retrospective study is that the patient cohort came from a single specialized center, and may not reflect the true incidence of nonvalvular atrial fibrillation across Australia, the researchers noted.
Dr. Chan and coinvestigators reported that they had no relevant financial disclosures.
SOURCE: Chan F et al. AAN 2019. P1.3-001.
PHILADELPHIA – A disproportionate number of breakthrough strokes were observed among patients receiving rivaroxaban for nonvalvular atrial fibrillation in a stroke unit, according to a small, single-center, retrospective study presented at the annual meeting of the American Academy of Neurology.
The researchers reviewed all patients presenting to a tertiary care stroke unit in Australia from January 2015 to June 2018.
A total of 56 patients (median age was 74 years; 61% were male) had received direct oral anticoagulant (DOAC) therapy and then had an ischemic stroke. Of those patients, 37 (66%) had strokes while receiving the treatment; 14 patients (25%) had a stroke after recently stopping a DOAC, often prior to a medical procedure; and 5 patients (9%) were not adherent to their DOAC regimen.
Of the 37 patients who had strokes during DOAC treatment, 48% were on rivaroxaban, 9% were on dabigatran, and 9% were on apixaban, Fiona Chan, MD, of The Princess Alexandra Hospital, Brisbane, Australia, and coinvestigators reported in a poster presentation.
While these findings need to be replicated in a larger study, they do “raise concern for inadequate stroke prevention within this cohort,” they said.
Moreover, the findings illustrate the importance of bridging anticoagulation prior to procedures, when appropriate, to minimize stroke risk, they added, as 25% of the strokes had occurred in patients who recently stopped the DOACs due to procedures.
To determine which DOAC was most often associated with breakthrough ischemic strokes in patients with nonvalvular atrial fibrillation, the investigators compared the proportion of DOACs prescribed in Australia to the proportion of observed strokes in their cohort.
Despite accounting for about 51% of Australian DOAC prescriptions, rivaroxaban represented nearly 73% of breakthrough strokes among the patients who had strokes while receiving the treatment (P = .001), the investigators reported.
Conversely, apixaban accounted for about 35% of prescriptions but 14% of the breakthrough strokes (P = .0007), while dabigatran accounted for 14% of prescriptions and 14% of the strokes (P = 0.99), the investigators said in their poster.
One limitation of this retrospective study is that the patient cohort came from a single specialized center, and may not reflect the true incidence of nonvalvular atrial fibrillation across Australia, the researchers noted.
Dr. Chan and coinvestigators reported that they had no relevant financial disclosures.
SOURCE: Chan F et al. AAN 2019. P1.3-001.
REPORTING FROM AAN 2019
Key clinical point: Rivaroxaban was associated with a disproportionate number of breakthrough strokes among patients with nonvalvular atrial fibrillation treated with direct oral anticoagulants at one stroke unit in Australia.
Major finding: Despite accounting for about 51% of Australian DOAC prescriptions, rivaroxaban represented nearly 73% of breakthrough strokes among the patients who had strokes while receiving treatment (P = .001).
Study details: Retrospective study of 56 patients with nonvalvular atrial fibrillation reporting to a tertiary care stroke unit in Australia.
Disclosures: The authors reported no financial disclosures.
Source: Chan F et al. AAN 019. Poster P1.3-001.
Some cardiac devices vulnerable to cybersecurity threats
Implantable cardiac devices made by Medtronic have cybersecurity vulnerabilities, according to a safety communication from the Food and Drug Administration. That said, so far the FDA is unaware of any reports of harm related to these vulnerabilities, and the agency still advises doctors and patients to continue using the devices as intended and in accordance with device labeling.
The Conexus wireless telemetry protocol used with Medtronic’s implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, as well as with certain models of Medtronic’s CareLink Programmer and the MyCareLink Monitor, lacks encryption, authentication, or authorization, which leaves the devices open to exploitation. Such exploitation “could allow unauthorized individuals ... to access and potentially manipulate an implantable device, home monitor, or clinic programmer,” the agency said in its safety communication.
The FDA provides several recommendations in the safety communication, including obtaining these devices “directly from the manufacturer to ensure integrity of the system” and operating “the programmers within well-managed networks.”
Implantable cardiac devices made by Medtronic have cybersecurity vulnerabilities, according to a safety communication from the Food and Drug Administration. That said, so far the FDA is unaware of any reports of harm related to these vulnerabilities, and the agency still advises doctors and patients to continue using the devices as intended and in accordance with device labeling.
The Conexus wireless telemetry protocol used with Medtronic’s implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, as well as with certain models of Medtronic’s CareLink Programmer and the MyCareLink Monitor, lacks encryption, authentication, or authorization, which leaves the devices open to exploitation. Such exploitation “could allow unauthorized individuals ... to access and potentially manipulate an implantable device, home monitor, or clinic programmer,” the agency said in its safety communication.
The FDA provides several recommendations in the safety communication, including obtaining these devices “directly from the manufacturer to ensure integrity of the system” and operating “the programmers within well-managed networks.”
Implantable cardiac devices made by Medtronic have cybersecurity vulnerabilities, according to a safety communication from the Food and Drug Administration. That said, so far the FDA is unaware of any reports of harm related to these vulnerabilities, and the agency still advises doctors and patients to continue using the devices as intended and in accordance with device labeling.
The Conexus wireless telemetry protocol used with Medtronic’s implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, as well as with certain models of Medtronic’s CareLink Programmer and the MyCareLink Monitor, lacks encryption, authentication, or authorization, which leaves the devices open to exploitation. Such exploitation “could allow unauthorized individuals ... to access and potentially manipulate an implantable device, home monitor, or clinic programmer,” the agency said in its safety communication.
The FDA provides several recommendations in the safety communication, including obtaining these devices “directly from the manufacturer to ensure integrity of the system” and operating “the programmers within well-managed networks.”
Increased sudden death risk in HIV linked to cardiac fibrosis
SEATTLE – A marked increase in the risk of sudden cardiac death among people with HIV correlates with a significantly higher burden of myocardial fibrosis, according to an autopsy study presented at the Conference on Retroviruses and Opportunistic Infections.
Fibrosis is a known trigger for fatal arrhythmias, so the take home is that fibrosis should be considered as a criteria for defibrillator implantation in HIV patients, said lead investigator Zian Tseng, MD, a cardiologist, cardiac electrophysiologist, and professor of medicine at the University of California, San Francisco.
The finding also speaks to a larger issue. The main criterion right now for implantation is an ejection fraction below 35%, but “there are a lot of people who die suddenly with normal ejection fractions,” and not just people with HIV, he said.
Many of those deaths might be prevented if fibrosis is added to implantation criteria. All that’s needed for assessment is a cardiac MRI, Dr. Tseng said.
The approach would be particularly fruitful for HIV patients, but cardiac fibrosis “isn’t just an” HIV problem, he said.
The conclusions have their roots in an investigation to determine the true incidence of sudden cardiac death (SCD) in the general public. SCD is commonly listed on death certificates, but it’s a presumed diagnosis, based on the best guesses of paramedics and clinicians. Autopsy is the only way to know for sure if a death was truly due to a sudden cardiac arrhythmia, or even related to the heart,
To clear the wheat from the chaff, Dr. Tseng and his colleagues performed autopsies on 525 out-of-hospital SCD cases among adults in San Francisco from 2011-2016; to qualify, the cases had to meet World Health Organization SCD criteria, meaning unexpected death within 1 hour of symptom onset, or, in unwitnessed cases, within 24 hours of when the person was last seen alive and well.
Cases were considered sudden arrhythmic death – and, therefore, true SCD – if no extracardiac causes of death or acute heart failure were found on autopsy. Overall, 40% of deaths attributed to SCD “were not sudden or unexpected, and nearly half of presumed SCDs were not arrhythmic.” The findings had “implications for ... mortality data, clinical trials, and cohort studies,” Dr. Tseng and his team concluded (Circulation. 2018 Jun 19;137[25]:2689-2700).
They next turned their attention to HIV. It’s known that the virus increases the risk of strokes, heart attacks, and heart failure; the researchers wanted to see if it did the same for SCD. The HIV results were presented at CROI.
Forty-seven presumed SCD cases with HIV met inclusion criteria during the study period. Based on the earlier findings and epidemiological data, people with HIV had more than an 80% higher risk of SCD and an almost 60% higher risk of confirmed arrhythmic death than did the general public. Similar to the general population, only about half of presumed SCD cases were confirmed on autopsy. About one-third of what turned out to be non-cardiac HIV deaths were due to occult overdose, versus 13.5% in the general population, which points to the increased need for drug screening and treatment in HIV.
Beyond that, though, the team found that the burden of myocardial fibrosis in HIV “was profound,” far surpassing what was found in SCD deaths in the general population. After adjustment for age, gender, and heart disease, “sudden cardiac deaths with HIV had 60% higher interstitial fibrosis by myocardial trichrome staining. Cardiac fibrosis, a known substrate for fatal arrhythmias in the general population, may underlie the mechanism by which HIV increases the risk” of sudden death in HIV, Dr. Tseng said.
It could be that the virus enters heart cells and sets off an inflammatory cardiomyopathy, or perhaps it’s related to chronic inflammation caused by the virus. Whatever the case, infection seems to have an “independent effect” on increasing fibrosis among people with HIV, he said.
Intriguingly, a large epidemiologic study in United States veterans, also presented at CROI, found a higher risk of SCD among HIV patients, but only if their infections were active over an extended period of time, as indicated by sustained high viral loads and low CD4 cell counts. Dr. Tseng was involved in that work, as well, but noted that the number of HIV SCD cases in the San Francisco study was too small to draw meaningful conclusions regarding the relationship between disease control and cardiac fibrosis.
Cardiac defibrillators can prevent arrhythmic death, so, at least for now, he said that the autopsy study findings mean that criteria for implantation should be broadened to include extensive cardiac fibrosis.
The work was funded by the National Institutes of Health. Dr. Tseng didn’t have any disclosures.
SOURCE: Tseng ZH et al. CROI 2019 abstract 32
SEATTLE – A marked increase in the risk of sudden cardiac death among people with HIV correlates with a significantly higher burden of myocardial fibrosis, according to an autopsy study presented at the Conference on Retroviruses and Opportunistic Infections.
Fibrosis is a known trigger for fatal arrhythmias, so the take home is that fibrosis should be considered as a criteria for defibrillator implantation in HIV patients, said lead investigator Zian Tseng, MD, a cardiologist, cardiac electrophysiologist, and professor of medicine at the University of California, San Francisco.
The finding also speaks to a larger issue. The main criterion right now for implantation is an ejection fraction below 35%, but “there are a lot of people who die suddenly with normal ejection fractions,” and not just people with HIV, he said.
Many of those deaths might be prevented if fibrosis is added to implantation criteria. All that’s needed for assessment is a cardiac MRI, Dr. Tseng said.
The approach would be particularly fruitful for HIV patients, but cardiac fibrosis “isn’t just an” HIV problem, he said.
The conclusions have their roots in an investigation to determine the true incidence of sudden cardiac death (SCD) in the general public. SCD is commonly listed on death certificates, but it’s a presumed diagnosis, based on the best guesses of paramedics and clinicians. Autopsy is the only way to know for sure if a death was truly due to a sudden cardiac arrhythmia, or even related to the heart,
To clear the wheat from the chaff, Dr. Tseng and his colleagues performed autopsies on 525 out-of-hospital SCD cases among adults in San Francisco from 2011-2016; to qualify, the cases had to meet World Health Organization SCD criteria, meaning unexpected death within 1 hour of symptom onset, or, in unwitnessed cases, within 24 hours of when the person was last seen alive and well.
Cases were considered sudden arrhythmic death – and, therefore, true SCD – if no extracardiac causes of death or acute heart failure were found on autopsy. Overall, 40% of deaths attributed to SCD “were not sudden or unexpected, and nearly half of presumed SCDs were not arrhythmic.” The findings had “implications for ... mortality data, clinical trials, and cohort studies,” Dr. Tseng and his team concluded (Circulation. 2018 Jun 19;137[25]:2689-2700).
They next turned their attention to HIV. It’s known that the virus increases the risk of strokes, heart attacks, and heart failure; the researchers wanted to see if it did the same for SCD. The HIV results were presented at CROI.
Forty-seven presumed SCD cases with HIV met inclusion criteria during the study period. Based on the earlier findings and epidemiological data, people with HIV had more than an 80% higher risk of SCD and an almost 60% higher risk of confirmed arrhythmic death than did the general public. Similar to the general population, only about half of presumed SCD cases were confirmed on autopsy. About one-third of what turned out to be non-cardiac HIV deaths were due to occult overdose, versus 13.5% in the general population, which points to the increased need for drug screening and treatment in HIV.
Beyond that, though, the team found that the burden of myocardial fibrosis in HIV “was profound,” far surpassing what was found in SCD deaths in the general population. After adjustment for age, gender, and heart disease, “sudden cardiac deaths with HIV had 60% higher interstitial fibrosis by myocardial trichrome staining. Cardiac fibrosis, a known substrate for fatal arrhythmias in the general population, may underlie the mechanism by which HIV increases the risk” of sudden death in HIV, Dr. Tseng said.
It could be that the virus enters heart cells and sets off an inflammatory cardiomyopathy, or perhaps it’s related to chronic inflammation caused by the virus. Whatever the case, infection seems to have an “independent effect” on increasing fibrosis among people with HIV, he said.
Intriguingly, a large epidemiologic study in United States veterans, also presented at CROI, found a higher risk of SCD among HIV patients, but only if their infections were active over an extended period of time, as indicated by sustained high viral loads and low CD4 cell counts. Dr. Tseng was involved in that work, as well, but noted that the number of HIV SCD cases in the San Francisco study was too small to draw meaningful conclusions regarding the relationship between disease control and cardiac fibrosis.
Cardiac defibrillators can prevent arrhythmic death, so, at least for now, he said that the autopsy study findings mean that criteria for implantation should be broadened to include extensive cardiac fibrosis.
The work was funded by the National Institutes of Health. Dr. Tseng didn’t have any disclosures.
SOURCE: Tseng ZH et al. CROI 2019 abstract 32
SEATTLE – A marked increase in the risk of sudden cardiac death among people with HIV correlates with a significantly higher burden of myocardial fibrosis, according to an autopsy study presented at the Conference on Retroviruses and Opportunistic Infections.
Fibrosis is a known trigger for fatal arrhythmias, so the take home is that fibrosis should be considered as a criteria for defibrillator implantation in HIV patients, said lead investigator Zian Tseng, MD, a cardiologist, cardiac electrophysiologist, and professor of medicine at the University of California, San Francisco.
The finding also speaks to a larger issue. The main criterion right now for implantation is an ejection fraction below 35%, but “there are a lot of people who die suddenly with normal ejection fractions,” and not just people with HIV, he said.
Many of those deaths might be prevented if fibrosis is added to implantation criteria. All that’s needed for assessment is a cardiac MRI, Dr. Tseng said.
The approach would be particularly fruitful for HIV patients, but cardiac fibrosis “isn’t just an” HIV problem, he said.
The conclusions have their roots in an investigation to determine the true incidence of sudden cardiac death (SCD) in the general public. SCD is commonly listed on death certificates, but it’s a presumed diagnosis, based on the best guesses of paramedics and clinicians. Autopsy is the only way to know for sure if a death was truly due to a sudden cardiac arrhythmia, or even related to the heart,
To clear the wheat from the chaff, Dr. Tseng and his colleagues performed autopsies on 525 out-of-hospital SCD cases among adults in San Francisco from 2011-2016; to qualify, the cases had to meet World Health Organization SCD criteria, meaning unexpected death within 1 hour of symptom onset, or, in unwitnessed cases, within 24 hours of when the person was last seen alive and well.
Cases were considered sudden arrhythmic death – and, therefore, true SCD – if no extracardiac causes of death or acute heart failure were found on autopsy. Overall, 40% of deaths attributed to SCD “were not sudden or unexpected, and nearly half of presumed SCDs were not arrhythmic.” The findings had “implications for ... mortality data, clinical trials, and cohort studies,” Dr. Tseng and his team concluded (Circulation. 2018 Jun 19;137[25]:2689-2700).
They next turned their attention to HIV. It’s known that the virus increases the risk of strokes, heart attacks, and heart failure; the researchers wanted to see if it did the same for SCD. The HIV results were presented at CROI.
Forty-seven presumed SCD cases with HIV met inclusion criteria during the study period. Based on the earlier findings and epidemiological data, people with HIV had more than an 80% higher risk of SCD and an almost 60% higher risk of confirmed arrhythmic death than did the general public. Similar to the general population, only about half of presumed SCD cases were confirmed on autopsy. About one-third of what turned out to be non-cardiac HIV deaths were due to occult overdose, versus 13.5% in the general population, which points to the increased need for drug screening and treatment in HIV.
Beyond that, though, the team found that the burden of myocardial fibrosis in HIV “was profound,” far surpassing what was found in SCD deaths in the general population. After adjustment for age, gender, and heart disease, “sudden cardiac deaths with HIV had 60% higher interstitial fibrosis by myocardial trichrome staining. Cardiac fibrosis, a known substrate for fatal arrhythmias in the general population, may underlie the mechanism by which HIV increases the risk” of sudden death in HIV, Dr. Tseng said.
It could be that the virus enters heart cells and sets off an inflammatory cardiomyopathy, or perhaps it’s related to chronic inflammation caused by the virus. Whatever the case, infection seems to have an “independent effect” on increasing fibrosis among people with HIV, he said.
Intriguingly, a large epidemiologic study in United States veterans, also presented at CROI, found a higher risk of SCD among HIV patients, but only if their infections were active over an extended period of time, as indicated by sustained high viral loads and low CD4 cell counts. Dr. Tseng was involved in that work, as well, but noted that the number of HIV SCD cases in the San Francisco study was too small to draw meaningful conclusions regarding the relationship between disease control and cardiac fibrosis.
Cardiac defibrillators can prevent arrhythmic death, so, at least for now, he said that the autopsy study findings mean that criteria for implantation should be broadened to include extensive cardiac fibrosis.
The work was funded by the National Institutes of Health. Dr. Tseng didn’t have any disclosures.
SOURCE: Tseng ZH et al. CROI 2019 abstract 32
REPORTING FROM CROI 2019
FDA: Programmable heart failure device approved
. Specifically, these patients are unsuited for other treatments, have marked physical limitations related to their heart failure, and have remained symptomatic despite optimal medical therapy. They also have a regular heart rhythm, are not candidates for resynchronization, and possess a left ventricular ejection fraction of 25%-45%.
The cardiac contractility modulation system is indicated to improve 6-minute hall walk distance, quality of life, and functional status in these patients.
The system is made up of several components, including the implantable pulse generator, a programmer, and software. The pulse generator is connected to three leads that have been implanted in the heart, after which the device is tested and programmed to deliver pulses during normal heartbeats, which improves the heart’s squeezing capability. In randomized, multicenter clinical trials, the system plus optimal medical therapy demonstrated improvements in distance during 6-minute walking tests and standard assessments of heart failure symptoms when compared with optimal medical therapy alone.
The Breakthrough Device designation means this system treats a life-threatening disease and addresses unmet medical needs among some patients. “The FDA recognized the unmet need for these patients and worked with the manufacturer through our Breakthrough Device Program to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness,” Bram Zuckerman, MD, the director of the division of cardiovascular devices in the FDA’s Center for Devices and Radiological Health said in a news release from the agency.
. Specifically, these patients are unsuited for other treatments, have marked physical limitations related to their heart failure, and have remained symptomatic despite optimal medical therapy. They also have a regular heart rhythm, are not candidates for resynchronization, and possess a left ventricular ejection fraction of 25%-45%.
The cardiac contractility modulation system is indicated to improve 6-minute hall walk distance, quality of life, and functional status in these patients.
The system is made up of several components, including the implantable pulse generator, a programmer, and software. The pulse generator is connected to three leads that have been implanted in the heart, after which the device is tested and programmed to deliver pulses during normal heartbeats, which improves the heart’s squeezing capability. In randomized, multicenter clinical trials, the system plus optimal medical therapy demonstrated improvements in distance during 6-minute walking tests and standard assessments of heart failure symptoms when compared with optimal medical therapy alone.
The Breakthrough Device designation means this system treats a life-threatening disease and addresses unmet medical needs among some patients. “The FDA recognized the unmet need for these patients and worked with the manufacturer through our Breakthrough Device Program to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness,” Bram Zuckerman, MD, the director of the division of cardiovascular devices in the FDA’s Center for Devices and Radiological Health said in a news release from the agency.
. Specifically, these patients are unsuited for other treatments, have marked physical limitations related to their heart failure, and have remained symptomatic despite optimal medical therapy. They also have a regular heart rhythm, are not candidates for resynchronization, and possess a left ventricular ejection fraction of 25%-45%.
The cardiac contractility modulation system is indicated to improve 6-minute hall walk distance, quality of life, and functional status in these patients.
The system is made up of several components, including the implantable pulse generator, a programmer, and software. The pulse generator is connected to three leads that have been implanted in the heart, after which the device is tested and programmed to deliver pulses during normal heartbeats, which improves the heart’s squeezing capability. In randomized, multicenter clinical trials, the system plus optimal medical therapy demonstrated improvements in distance during 6-minute walking tests and standard assessments of heart failure symptoms when compared with optimal medical therapy alone.
The Breakthrough Device designation means this system treats a life-threatening disease and addresses unmet medical needs among some patients. “The FDA recognized the unmet need for these patients and worked with the manufacturer through our Breakthrough Device Program to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness,” Bram Zuckerman, MD, the director of the division of cardiovascular devices in the FDA’s Center for Devices and Radiological Health said in a news release from the agency.
Abstinence by moderate drinkers improves their AFib
NEW ORLEANS – Abstinence from alcohol on the part of moderate drinkers with atrial fibrillation resulted in clinically meaningful improvement in their arrhythmia in the randomized controlled Alcohol-AF trial, Aleksandr Voskoboinik, MBBS, reported at the annual meeting of the American College of Cardiology.
The benefits of abstinence included significant reductions in the AFib recurrence rate, total AFib burden, and symptom severity. And the payoff extended beyond the arrhythmia: The abstinent group also averaged a 12–mm Hg drop in systolic blood pressure and dropped 3 kg of body weight over the course of the 6-month trial, added Dr. Voskoboinik, a cardiologist at the Baker Heart & Diabetes Institute at the University of Melbourne.
“We would conclude that significant reduction in alcohol intake should be considered as part of the lifestyle intervention in moderate drinkers with AFib,” he said.
Some physicians already advise alcohol abstinence for moderate drinkers with AFib, but until now such recommendations were not evidence based. Instead, the guidance was based on extrapolation from the well-established harmful effects of heavy drinking and binge drinking on AFib as well as epidemiologic studies.
“We wanted to provide some evidence base for physicians to say, ‘If I have motivated patients, here’s what’s potentially achievable,’” he explained.
The key word here is “motivated.” Conducting the Alcohol-AF trial made clear that many moderate drinkers with AFib enjoy their beverages more than they hate having their arrhythmia. Indeed, out of 697 moderate-drinking patients with paroxysmal or persistent AFib who were deemed good candidates and were approached about study participation, more than 500 were excluded because they were flat out unwilling to consider abstinence. After Dr. Voskoboinik and his coinvestigators shortened the planned trial duration from 12 months to 6 because so many recruits were unwilling to abstain for a full year, 140 of the initial 697 patients were randomized to abstinence or continuation of their usual consumption. Thirty percent of them had previously undergone AFib ablation.
The Alcohol-AF study was a multicenter, prospective, open-label study conducted at six Australian hospitals. All subjects underwent comprehensive rhythm monitoring via an implantable loop recorder or an existing pacemaker. Twice daily they triggered the AliveCor mobile phone app together with Holter monitoring. Patients assigned to abstinence were counseled to abstain completely, got written and verbal advice to help with compliance, and had contact with the investigators on a monthly basis. They also underwent urine testing to monitor compliance. All study participants kept a weekly alcohol intake diary, reviewed monthly by investigators.
Participants averaged 17 standard drinks per week at enrollment. Two-thirds were primarily wine drinkers. At the 6-month mark, patients in the abstinence arm averaged two drinks per week, for an 88% reduction from baseline, and 43 of the 70, or 61%, had remained completely abstinent. The control arm averaged a 20% reduction in weekly consumption.
One of the two co-primary endpoints was recurrent AFib episodes lasting for at least 30 seconds. The rate was 53% in the abstinence group and 73% in controls. The time to first recurrence averaged 118 days in the abstinence group, compared to 86 days in controls, for a 37% prolongation through abstinence.
The other primary endpoint was total AFib burden. During the 6-month study, the abstinence group spent a mean of 5.6% of their time in AFib, compared to 8.2% in controls. The median times were 0.5% and 1.2%.
In a multivariate analysis, neither AFib type, duration, history of AFib ablation, age, nor gender predicted AFib recurrence. In fact, the only significant predictor was alcohol abstinence, which conferred a 48% reduction in risk.
Symptom severity, a secondary endpoint, showed an impressive between-group difference at follow-up. Ten percent of patients in the abstinence group had moderate or severe symptoms at follow-up as assessed via the European Heart Rhythm Association score of atrial fibrillation, compared to 32% of controls, for an absolute 22% difference. And 90% of the abstinence group had no or mild symptoms, as did 68% of controls. Nine percent of the abstinence group had an AFib-related hospitalization, as did 20% of controls.
Cardiac MRI, performed in all subjects, showed that the abstinence group experienced a significant reduction in left atrial area, from 29.5 cm2 at baseline to 27.1 cm2 at follow-up. They also experienced significant improvement in left atrial mechanical function, with their left atrial emptying fraction climbing from 42% to 50%.
The 3-kg weight loss from a baseline of 90 kg in the abstinent group represented a 0.7 kg/m2 reduction in body mass index.
In terms of the likely mechanism of benefit of alcohol abstinence in moderate drinkers, Dr. Voskoboinik noted that he and his colleagues recently demonstrated that regular moderate alcohol consumption, but not mild intake, is associated with potentially explanatory atrial electrical and structural changes, including conduction slowing, lower global bipolar atrial voltage, and an increase in complex atrial potentials (Heart Rhythm. 2019 Feb;16[2]:251-9).
Alcohol has been shown to be linked with AFib through multiple mechanisms. Alcohol has adverse effects on the atrial substrate, including promotion of left atrial remodeling, dilation, and fibrosis via oxidative stress, and alcohol has a contributory role in hypertension and obstructive sleep apnea. Alcohol can act as an acute trigger of AFib through binge drinking – the holiday heart syndrome – which causes autonomic changes, electrolyte abnormalities, and electrophysiologic effects, he continued.
Epidemiologic evidence in support of the notion that moderate drinking increases the risk of AFib includes a Swedish meta-analysis of seven prospective studies comprising 12,554 patients with AFib. The researchers concluded that the relative risk of AFib rose by about 8% with each drink per day, compared with the risk of a reference group composed of current drinkers at a rate of less than one drink per week (J Am Coll Cardiol. 2014 Jul 22;64[3]:281-9).
Although discussants were wowed by the 61% complete abstinence rate in the trial, Dr. Voskoboinik cautioned that the study participants were a highly motivated subset of the universe of moderate drinkers with AFib. And even so, “It was an incredibly challenging study to run,” he said.
“I think lifestyle change is a challenge, and with alcohol particularly so, because alcohol is so ubiquitous in our society. I think the important key message for us as physicians is to take an alcohol history and have a discussion with the patient. And we now have some data to show them. But at the end of the day, it’s up to the patient in conjunction with the physician,” he observed.
Discussant Annabelle S. Volgman, MD, noted that 85% of study participants were men, and because of important differences in AFib between men and women, she doesn’t consider the findings applicable to women.
“You need to redo the study in women,” advised Dr. Volgman, professor of medicine at Rush University, Chicago, and director of the Rush Heart Center for Women.
She suggested that an interventional trial such as this one is a great opportunity to utilize wearable device technology, such as the Apple Watch, which can detect irregular pulse rhythms as demonstrated in the Apple Heart Study. This technology is especially popular with younger individuals.
“A lot of young men and women drink a lot of alcohol,” Dr. Volgman noted.
“That’s a great idea. It gets around a problem with AliveCor, which can miss episodes while you’re sleeping,” Dr. Voskoboinik replied.
He reported having no financial conflicts regarding the investigator-initiated and -funded Alcohol-AF trial.
SOURCE: Voskoboinik A. ACC 19, Session 413-08.
NEW ORLEANS – Abstinence from alcohol on the part of moderate drinkers with atrial fibrillation resulted in clinically meaningful improvement in their arrhythmia in the randomized controlled Alcohol-AF trial, Aleksandr Voskoboinik, MBBS, reported at the annual meeting of the American College of Cardiology.
The benefits of abstinence included significant reductions in the AFib recurrence rate, total AFib burden, and symptom severity. And the payoff extended beyond the arrhythmia: The abstinent group also averaged a 12–mm Hg drop in systolic blood pressure and dropped 3 kg of body weight over the course of the 6-month trial, added Dr. Voskoboinik, a cardiologist at the Baker Heart & Diabetes Institute at the University of Melbourne.
“We would conclude that significant reduction in alcohol intake should be considered as part of the lifestyle intervention in moderate drinkers with AFib,” he said.
Some physicians already advise alcohol abstinence for moderate drinkers with AFib, but until now such recommendations were not evidence based. Instead, the guidance was based on extrapolation from the well-established harmful effects of heavy drinking and binge drinking on AFib as well as epidemiologic studies.
“We wanted to provide some evidence base for physicians to say, ‘If I have motivated patients, here’s what’s potentially achievable,’” he explained.
The key word here is “motivated.” Conducting the Alcohol-AF trial made clear that many moderate drinkers with AFib enjoy their beverages more than they hate having their arrhythmia. Indeed, out of 697 moderate-drinking patients with paroxysmal or persistent AFib who were deemed good candidates and were approached about study participation, more than 500 were excluded because they were flat out unwilling to consider abstinence. After Dr. Voskoboinik and his coinvestigators shortened the planned trial duration from 12 months to 6 because so many recruits were unwilling to abstain for a full year, 140 of the initial 697 patients were randomized to abstinence or continuation of their usual consumption. Thirty percent of them had previously undergone AFib ablation.
The Alcohol-AF study was a multicenter, prospective, open-label study conducted at six Australian hospitals. All subjects underwent comprehensive rhythm monitoring via an implantable loop recorder or an existing pacemaker. Twice daily they triggered the AliveCor mobile phone app together with Holter monitoring. Patients assigned to abstinence were counseled to abstain completely, got written and verbal advice to help with compliance, and had contact with the investigators on a monthly basis. They also underwent urine testing to monitor compliance. All study participants kept a weekly alcohol intake diary, reviewed monthly by investigators.
Participants averaged 17 standard drinks per week at enrollment. Two-thirds were primarily wine drinkers. At the 6-month mark, patients in the abstinence arm averaged two drinks per week, for an 88% reduction from baseline, and 43 of the 70, or 61%, had remained completely abstinent. The control arm averaged a 20% reduction in weekly consumption.
One of the two co-primary endpoints was recurrent AFib episodes lasting for at least 30 seconds. The rate was 53% in the abstinence group and 73% in controls. The time to first recurrence averaged 118 days in the abstinence group, compared to 86 days in controls, for a 37% prolongation through abstinence.
The other primary endpoint was total AFib burden. During the 6-month study, the abstinence group spent a mean of 5.6% of their time in AFib, compared to 8.2% in controls. The median times were 0.5% and 1.2%.
In a multivariate analysis, neither AFib type, duration, history of AFib ablation, age, nor gender predicted AFib recurrence. In fact, the only significant predictor was alcohol abstinence, which conferred a 48% reduction in risk.
Symptom severity, a secondary endpoint, showed an impressive between-group difference at follow-up. Ten percent of patients in the abstinence group had moderate or severe symptoms at follow-up as assessed via the European Heart Rhythm Association score of atrial fibrillation, compared to 32% of controls, for an absolute 22% difference. And 90% of the abstinence group had no or mild symptoms, as did 68% of controls. Nine percent of the abstinence group had an AFib-related hospitalization, as did 20% of controls.
Cardiac MRI, performed in all subjects, showed that the abstinence group experienced a significant reduction in left atrial area, from 29.5 cm2 at baseline to 27.1 cm2 at follow-up. They also experienced significant improvement in left atrial mechanical function, with their left atrial emptying fraction climbing from 42% to 50%.
The 3-kg weight loss from a baseline of 90 kg in the abstinent group represented a 0.7 kg/m2 reduction in body mass index.
In terms of the likely mechanism of benefit of alcohol abstinence in moderate drinkers, Dr. Voskoboinik noted that he and his colleagues recently demonstrated that regular moderate alcohol consumption, but not mild intake, is associated with potentially explanatory atrial electrical and structural changes, including conduction slowing, lower global bipolar atrial voltage, and an increase in complex atrial potentials (Heart Rhythm. 2019 Feb;16[2]:251-9).
Alcohol has been shown to be linked with AFib through multiple mechanisms. Alcohol has adverse effects on the atrial substrate, including promotion of left atrial remodeling, dilation, and fibrosis via oxidative stress, and alcohol has a contributory role in hypertension and obstructive sleep apnea. Alcohol can act as an acute trigger of AFib through binge drinking – the holiday heart syndrome – which causes autonomic changes, electrolyte abnormalities, and electrophysiologic effects, he continued.
Epidemiologic evidence in support of the notion that moderate drinking increases the risk of AFib includes a Swedish meta-analysis of seven prospective studies comprising 12,554 patients with AFib. The researchers concluded that the relative risk of AFib rose by about 8% with each drink per day, compared with the risk of a reference group composed of current drinkers at a rate of less than one drink per week (J Am Coll Cardiol. 2014 Jul 22;64[3]:281-9).
Although discussants were wowed by the 61% complete abstinence rate in the trial, Dr. Voskoboinik cautioned that the study participants were a highly motivated subset of the universe of moderate drinkers with AFib. And even so, “It was an incredibly challenging study to run,” he said.
“I think lifestyle change is a challenge, and with alcohol particularly so, because alcohol is so ubiquitous in our society. I think the important key message for us as physicians is to take an alcohol history and have a discussion with the patient. And we now have some data to show them. But at the end of the day, it’s up to the patient in conjunction with the physician,” he observed.
Discussant Annabelle S. Volgman, MD, noted that 85% of study participants were men, and because of important differences in AFib between men and women, she doesn’t consider the findings applicable to women.
“You need to redo the study in women,” advised Dr. Volgman, professor of medicine at Rush University, Chicago, and director of the Rush Heart Center for Women.
She suggested that an interventional trial such as this one is a great opportunity to utilize wearable device technology, such as the Apple Watch, which can detect irregular pulse rhythms as demonstrated in the Apple Heart Study. This technology is especially popular with younger individuals.
“A lot of young men and women drink a lot of alcohol,” Dr. Volgman noted.
“That’s a great idea. It gets around a problem with AliveCor, which can miss episodes while you’re sleeping,” Dr. Voskoboinik replied.
He reported having no financial conflicts regarding the investigator-initiated and -funded Alcohol-AF trial.
SOURCE: Voskoboinik A. ACC 19, Session 413-08.
NEW ORLEANS – Abstinence from alcohol on the part of moderate drinkers with atrial fibrillation resulted in clinically meaningful improvement in their arrhythmia in the randomized controlled Alcohol-AF trial, Aleksandr Voskoboinik, MBBS, reported at the annual meeting of the American College of Cardiology.
The benefits of abstinence included significant reductions in the AFib recurrence rate, total AFib burden, and symptom severity. And the payoff extended beyond the arrhythmia: The abstinent group also averaged a 12–mm Hg drop in systolic blood pressure and dropped 3 kg of body weight over the course of the 6-month trial, added Dr. Voskoboinik, a cardiologist at the Baker Heart & Diabetes Institute at the University of Melbourne.
“We would conclude that significant reduction in alcohol intake should be considered as part of the lifestyle intervention in moderate drinkers with AFib,” he said.
Some physicians already advise alcohol abstinence for moderate drinkers with AFib, but until now such recommendations were not evidence based. Instead, the guidance was based on extrapolation from the well-established harmful effects of heavy drinking and binge drinking on AFib as well as epidemiologic studies.
“We wanted to provide some evidence base for physicians to say, ‘If I have motivated patients, here’s what’s potentially achievable,’” he explained.
The key word here is “motivated.” Conducting the Alcohol-AF trial made clear that many moderate drinkers with AFib enjoy their beverages more than they hate having their arrhythmia. Indeed, out of 697 moderate-drinking patients with paroxysmal or persistent AFib who were deemed good candidates and were approached about study participation, more than 500 were excluded because they were flat out unwilling to consider abstinence. After Dr. Voskoboinik and his coinvestigators shortened the planned trial duration from 12 months to 6 because so many recruits were unwilling to abstain for a full year, 140 of the initial 697 patients were randomized to abstinence or continuation of their usual consumption. Thirty percent of them had previously undergone AFib ablation.
The Alcohol-AF study was a multicenter, prospective, open-label study conducted at six Australian hospitals. All subjects underwent comprehensive rhythm monitoring via an implantable loop recorder or an existing pacemaker. Twice daily they triggered the AliveCor mobile phone app together with Holter monitoring. Patients assigned to abstinence were counseled to abstain completely, got written and verbal advice to help with compliance, and had contact with the investigators on a monthly basis. They also underwent urine testing to monitor compliance. All study participants kept a weekly alcohol intake diary, reviewed monthly by investigators.
Participants averaged 17 standard drinks per week at enrollment. Two-thirds were primarily wine drinkers. At the 6-month mark, patients in the abstinence arm averaged two drinks per week, for an 88% reduction from baseline, and 43 of the 70, or 61%, had remained completely abstinent. The control arm averaged a 20% reduction in weekly consumption.
One of the two co-primary endpoints was recurrent AFib episodes lasting for at least 30 seconds. The rate was 53% in the abstinence group and 73% in controls. The time to first recurrence averaged 118 days in the abstinence group, compared to 86 days in controls, for a 37% prolongation through abstinence.
The other primary endpoint was total AFib burden. During the 6-month study, the abstinence group spent a mean of 5.6% of their time in AFib, compared to 8.2% in controls. The median times were 0.5% and 1.2%.
In a multivariate analysis, neither AFib type, duration, history of AFib ablation, age, nor gender predicted AFib recurrence. In fact, the only significant predictor was alcohol abstinence, which conferred a 48% reduction in risk.
Symptom severity, a secondary endpoint, showed an impressive between-group difference at follow-up. Ten percent of patients in the abstinence group had moderate or severe symptoms at follow-up as assessed via the European Heart Rhythm Association score of atrial fibrillation, compared to 32% of controls, for an absolute 22% difference. And 90% of the abstinence group had no or mild symptoms, as did 68% of controls. Nine percent of the abstinence group had an AFib-related hospitalization, as did 20% of controls.
Cardiac MRI, performed in all subjects, showed that the abstinence group experienced a significant reduction in left atrial area, from 29.5 cm2 at baseline to 27.1 cm2 at follow-up. They also experienced significant improvement in left atrial mechanical function, with their left atrial emptying fraction climbing from 42% to 50%.
The 3-kg weight loss from a baseline of 90 kg in the abstinent group represented a 0.7 kg/m2 reduction in body mass index.
In terms of the likely mechanism of benefit of alcohol abstinence in moderate drinkers, Dr. Voskoboinik noted that he and his colleagues recently demonstrated that regular moderate alcohol consumption, but not mild intake, is associated with potentially explanatory atrial electrical and structural changes, including conduction slowing, lower global bipolar atrial voltage, and an increase in complex atrial potentials (Heart Rhythm. 2019 Feb;16[2]:251-9).
Alcohol has been shown to be linked with AFib through multiple mechanisms. Alcohol has adverse effects on the atrial substrate, including promotion of left atrial remodeling, dilation, and fibrosis via oxidative stress, and alcohol has a contributory role in hypertension and obstructive sleep apnea. Alcohol can act as an acute trigger of AFib through binge drinking – the holiday heart syndrome – which causes autonomic changes, electrolyte abnormalities, and electrophysiologic effects, he continued.
Epidemiologic evidence in support of the notion that moderate drinking increases the risk of AFib includes a Swedish meta-analysis of seven prospective studies comprising 12,554 patients with AFib. The researchers concluded that the relative risk of AFib rose by about 8% with each drink per day, compared with the risk of a reference group composed of current drinkers at a rate of less than one drink per week (J Am Coll Cardiol. 2014 Jul 22;64[3]:281-9).
Although discussants were wowed by the 61% complete abstinence rate in the trial, Dr. Voskoboinik cautioned that the study participants were a highly motivated subset of the universe of moderate drinkers with AFib. And even so, “It was an incredibly challenging study to run,” he said.
“I think lifestyle change is a challenge, and with alcohol particularly so, because alcohol is so ubiquitous in our society. I think the important key message for us as physicians is to take an alcohol history and have a discussion with the patient. And we now have some data to show them. But at the end of the day, it’s up to the patient in conjunction with the physician,” he observed.
Discussant Annabelle S. Volgman, MD, noted that 85% of study participants were men, and because of important differences in AFib between men and women, she doesn’t consider the findings applicable to women.
“You need to redo the study in women,” advised Dr. Volgman, professor of medicine at Rush University, Chicago, and director of the Rush Heart Center for Women.
She suggested that an interventional trial such as this one is a great opportunity to utilize wearable device technology, such as the Apple Watch, which can detect irregular pulse rhythms as demonstrated in the Apple Heart Study. This technology is especially popular with younger individuals.
“A lot of young men and women drink a lot of alcohol,” Dr. Volgman noted.
“That’s a great idea. It gets around a problem with AliveCor, which can miss episodes while you’re sleeping,” Dr. Voskoboinik replied.
He reported having no financial conflicts regarding the investigator-initiated and -funded Alcohol-AF trial.
SOURCE: Voskoboinik A. ACC 19, Session 413-08.
REPORTING FROM ACC 19
AUGUSTUS: Dual surpasses triple therapy when AFib patients have PCI or ACS
NEW ORLEANS – For patients with atrial fibrillation and either a recent acute coronary syndrome or percutaneous coronary intervention, combined treatment for 6 months with the anticoagulant apixaban and a P2Y12 inhibitor antiplatelet drug, but without aspirin, was safer than and as effective as a regimen that either also included aspirin or that substituted a vitamin K antagonist, such as warfarin, for the direct-acting oral anticoagulant, based on results from a multicenter, randomized trial with more than 4,600 patients.
The apixaban plus P2Y12 inhibitor (typically, clopidogrel) combination “resulted in less bleeding and fewer hospitalizations without significant differences in ischemic events than regimens that included a vitamin K antagonist, aspirin, or both,” Renato D. Lopes, MD, said at the annual meeting of the American College of Cardiology. Concurrently, his report of the results also appeared in an online article.
This finding in the AUGUSTUS trial gives clinicians more guidance for the long-standing dilemma of how to best prevent arterial thrombus formation in patients with atrial fibrillation (AFib). To prevent a stroke, these patients routinely receive treatment with an anticoagulant when they have an acute coronary syndrome (ACS) event or undergo percutaneous coronary intervention (PCI). Typically, they receive several months of dual antiplatelet therapy with aspirin plus a P2Y12 inhibitor to prevent a clot from forming in the stented or unstable region of a coronary artery.
These patients are not uncommon; this circumstance occurs for about 20% of all AFib patients, and poses the question of what is the safest and most effective way to treat them. Should they get triple therapy with an anticoagulant, aspirin, and a P2Y12 inhibitor, an option that could cause excess bleeding; or should one of the three drugs drop out with the potential for an increased rate of ischemic events? The AUGUSTUS findings suggest that one solution is treatment with a combination of the direct-acting oral anticoagulant apixaban (Eliquis) and the P2Y12 inhibitor clopidogrel (Plavix) but without aspirin.
For the majority of patients like the ones enrolled, “less is more.” By dropping aspirin from the treatment mix, patients did better, said Dr. Lopes, a professor of medicine at Duke University in Durham, N.C.
Dr. Lopes and his associates designed AUGUSTUS (A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis [Blood Clots] Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart) as a two-by-two factorial study to address two different questions: During 6 months of treatment, how did apixaban compare with a vitamin K antagonist (usually warfarin) in these patients for safety and efficacy, and how did aspirin compare with placebo in this setting for the same endpoints?
The trial enrolled 4,614 patients at 492 sites in 33 countries. All patients in the study received a P2Y12 inhibitor, with 93% treated with clopidogrel. The study had roughly as many patients as the combined total of patients enrolled in two smaller, prior studies that had looked at roughly the same questions in similar patients.
“The aspirin part is the more interesting, and probably more unique and important finding,” John H. Alexander, MD, a coinvestigator on the study, said in a video interview. Regardless of the anticoagulant used, patients who received aspirin had a 16% rate of major bleeds or clinically relevant non-major bleeds, compared with a 9% rate among those on placebo, a statistically significant result that underscored the bleeding risk posed by adding aspirin to an anticoagulant and a P2Y12 inhibitor.
The results also showed no statistically significant difference in any efficacy measure with or without aspirin, including the rate of death or hospitalization, or of any individual ischemic endpoint. However the results showed a signal of a small increase in the rates of each of three types of ischemic events – stent thrombosis, MI, and need for urgent revascularization, each of which showed a numerical increase when aspirin was dropped. But the increase was small.
Dr. Lopes calculated that, for example, to prevent one episode of stent thrombosis by treating with aspirin also would cause 15 major or clinically relevant non-major bleeds, which makes inclusion of aspirin something of a judgment call for each patient, said Dr. Alexander, a professor of medicine at Duke. An AFib patient with a high risk for thrombosis but a low risk for bleeding following PCI or an ACS event might be a reasonable patient to treat with aspirin along with apixaban and a P2Y12 inhibitor, he explained.
The rate of major or clinically relevant bleeds was 11% with apixaban and 15% with a vitamin K antagonist, a statistically significant difference. Patients treated with apixaban also had a significantly reduced rate of death or hospitalization, 24%, compared with 27% among those on the vitamin K antagonist, as well as a significantly lower rate of stroke.
Overall the lowest bleeding rate was in patients on apixaban but no aspirin, a 7% rate, while the highest rate was in patients on a vitamin K antagonist plus aspirin, a 19% rate.
Dr. Alexander said that it would be an overreach to extrapolate these findings to other direct-acting oral anticoagulants, compared with a vitamin K antagonist, but he believed that the findings the study generated about aspirin were probably relevant regardless of the anticoagulant used.
[email protected]
On Twitter @mitchelzoler
It’s very reassuring to see that you can use a direct-acting oral anticoagulant like apixaban along with a P2Y12 inhibitor, but with no aspirin, and have no statistically significant increase in ischemic events. This is a fantastic finding. The finding shows once again that warfarin is a problematic drug. As the cost for direct-acting oral anticoagulants has decreased, their use has increased.
These results were not unexpected and also are probably the final nail in the coffin for using a combination of warfarin and aspirin. Prior findings from the PIONEER AF-PCI study that used rivaroxaban (N Engl J Med. 2016 Dec 22;375[25]:2423-34) and from the RE-DUAL PCI study that used dabigatran (N Engl J Med. 2017 Oct 19;377[16]:1513-24) also showed the advantages of using a direct-acting oral anticoagulant when compared with a vitamin K antagonist in this setting, The AUGUSTUS trial, with just over 4,600 patients, had nearly as many patients as the roughly 4,850 enrolled in these two prior studies put together.
Dhanunjaya Lakkireddy, MD , is medical director of the Kansas City Heart Rhythm Institute in Overland Park. He had no disclosures. He made these comments as the designated discussant during a press briefing.
It’s very reassuring to see that you can use a direct-acting oral anticoagulant like apixaban along with a P2Y12 inhibitor, but with no aspirin, and have no statistically significant increase in ischemic events. This is a fantastic finding. The finding shows once again that warfarin is a problematic drug. As the cost for direct-acting oral anticoagulants has decreased, their use has increased.
These results were not unexpected and also are probably the final nail in the coffin for using a combination of warfarin and aspirin. Prior findings from the PIONEER AF-PCI study that used rivaroxaban (N Engl J Med. 2016 Dec 22;375[25]:2423-34) and from the RE-DUAL PCI study that used dabigatran (N Engl J Med. 2017 Oct 19;377[16]:1513-24) also showed the advantages of using a direct-acting oral anticoagulant when compared with a vitamin K antagonist in this setting, The AUGUSTUS trial, with just over 4,600 patients, had nearly as many patients as the roughly 4,850 enrolled in these two prior studies put together.
Dhanunjaya Lakkireddy, MD , is medical director of the Kansas City Heart Rhythm Institute in Overland Park. He had no disclosures. He made these comments as the designated discussant during a press briefing.
It’s very reassuring to see that you can use a direct-acting oral anticoagulant like apixaban along with a P2Y12 inhibitor, but with no aspirin, and have no statistically significant increase in ischemic events. This is a fantastic finding. The finding shows once again that warfarin is a problematic drug. As the cost for direct-acting oral anticoagulants has decreased, their use has increased.
These results were not unexpected and also are probably the final nail in the coffin for using a combination of warfarin and aspirin. Prior findings from the PIONEER AF-PCI study that used rivaroxaban (N Engl J Med. 2016 Dec 22;375[25]:2423-34) and from the RE-DUAL PCI study that used dabigatran (N Engl J Med. 2017 Oct 19;377[16]:1513-24) also showed the advantages of using a direct-acting oral anticoagulant when compared with a vitamin K antagonist in this setting, The AUGUSTUS trial, with just over 4,600 patients, had nearly as many patients as the roughly 4,850 enrolled in these two prior studies put together.
Dhanunjaya Lakkireddy, MD , is medical director of the Kansas City Heart Rhythm Institute in Overland Park. He had no disclosures. He made these comments as the designated discussant during a press briefing.
NEW ORLEANS – For patients with atrial fibrillation and either a recent acute coronary syndrome or percutaneous coronary intervention, combined treatment for 6 months with the anticoagulant apixaban and a P2Y12 inhibitor antiplatelet drug, but without aspirin, was safer than and as effective as a regimen that either also included aspirin or that substituted a vitamin K antagonist, such as warfarin, for the direct-acting oral anticoagulant, based on results from a multicenter, randomized trial with more than 4,600 patients.
The apixaban plus P2Y12 inhibitor (typically, clopidogrel) combination “resulted in less bleeding and fewer hospitalizations without significant differences in ischemic events than regimens that included a vitamin K antagonist, aspirin, or both,” Renato D. Lopes, MD, said at the annual meeting of the American College of Cardiology. Concurrently, his report of the results also appeared in an online article.
This finding in the AUGUSTUS trial gives clinicians more guidance for the long-standing dilemma of how to best prevent arterial thrombus formation in patients with atrial fibrillation (AFib). To prevent a stroke, these patients routinely receive treatment with an anticoagulant when they have an acute coronary syndrome (ACS) event or undergo percutaneous coronary intervention (PCI). Typically, they receive several months of dual antiplatelet therapy with aspirin plus a P2Y12 inhibitor to prevent a clot from forming in the stented or unstable region of a coronary artery.
These patients are not uncommon; this circumstance occurs for about 20% of all AFib patients, and poses the question of what is the safest and most effective way to treat them. Should they get triple therapy with an anticoagulant, aspirin, and a P2Y12 inhibitor, an option that could cause excess bleeding; or should one of the three drugs drop out with the potential for an increased rate of ischemic events? The AUGUSTUS findings suggest that one solution is treatment with a combination of the direct-acting oral anticoagulant apixaban (Eliquis) and the P2Y12 inhibitor clopidogrel (Plavix) but without aspirin.
For the majority of patients like the ones enrolled, “less is more.” By dropping aspirin from the treatment mix, patients did better, said Dr. Lopes, a professor of medicine at Duke University in Durham, N.C.
Dr. Lopes and his associates designed AUGUSTUS (A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis [Blood Clots] Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart) as a two-by-two factorial study to address two different questions: During 6 months of treatment, how did apixaban compare with a vitamin K antagonist (usually warfarin) in these patients for safety and efficacy, and how did aspirin compare with placebo in this setting for the same endpoints?
The trial enrolled 4,614 patients at 492 sites in 33 countries. All patients in the study received a P2Y12 inhibitor, with 93% treated with clopidogrel. The study had roughly as many patients as the combined total of patients enrolled in two smaller, prior studies that had looked at roughly the same questions in similar patients.
“The aspirin part is the more interesting, and probably more unique and important finding,” John H. Alexander, MD, a coinvestigator on the study, said in a video interview. Regardless of the anticoagulant used, patients who received aspirin had a 16% rate of major bleeds or clinically relevant non-major bleeds, compared with a 9% rate among those on placebo, a statistically significant result that underscored the bleeding risk posed by adding aspirin to an anticoagulant and a P2Y12 inhibitor.
The results also showed no statistically significant difference in any efficacy measure with or without aspirin, including the rate of death or hospitalization, or of any individual ischemic endpoint. However the results showed a signal of a small increase in the rates of each of three types of ischemic events – stent thrombosis, MI, and need for urgent revascularization, each of which showed a numerical increase when aspirin was dropped. But the increase was small.
Dr. Lopes calculated that, for example, to prevent one episode of stent thrombosis by treating with aspirin also would cause 15 major or clinically relevant non-major bleeds, which makes inclusion of aspirin something of a judgment call for each patient, said Dr. Alexander, a professor of medicine at Duke. An AFib patient with a high risk for thrombosis but a low risk for bleeding following PCI or an ACS event might be a reasonable patient to treat with aspirin along with apixaban and a P2Y12 inhibitor, he explained.
The rate of major or clinically relevant bleeds was 11% with apixaban and 15% with a vitamin K antagonist, a statistically significant difference. Patients treated with apixaban also had a significantly reduced rate of death or hospitalization, 24%, compared with 27% among those on the vitamin K antagonist, as well as a significantly lower rate of stroke.
Overall the lowest bleeding rate was in patients on apixaban but no aspirin, a 7% rate, while the highest rate was in patients on a vitamin K antagonist plus aspirin, a 19% rate.
Dr. Alexander said that it would be an overreach to extrapolate these findings to other direct-acting oral anticoagulants, compared with a vitamin K antagonist, but he believed that the findings the study generated about aspirin were probably relevant regardless of the anticoagulant used.
[email protected]
On Twitter @mitchelzoler
NEW ORLEANS – For patients with atrial fibrillation and either a recent acute coronary syndrome or percutaneous coronary intervention, combined treatment for 6 months with the anticoagulant apixaban and a P2Y12 inhibitor antiplatelet drug, but without aspirin, was safer than and as effective as a regimen that either also included aspirin or that substituted a vitamin K antagonist, such as warfarin, for the direct-acting oral anticoagulant, based on results from a multicenter, randomized trial with more than 4,600 patients.
The apixaban plus P2Y12 inhibitor (typically, clopidogrel) combination “resulted in less bleeding and fewer hospitalizations without significant differences in ischemic events than regimens that included a vitamin K antagonist, aspirin, or both,” Renato D. Lopes, MD, said at the annual meeting of the American College of Cardiology. Concurrently, his report of the results also appeared in an online article.
This finding in the AUGUSTUS trial gives clinicians more guidance for the long-standing dilemma of how to best prevent arterial thrombus formation in patients with atrial fibrillation (AFib). To prevent a stroke, these patients routinely receive treatment with an anticoagulant when they have an acute coronary syndrome (ACS) event or undergo percutaneous coronary intervention (PCI). Typically, they receive several months of dual antiplatelet therapy with aspirin plus a P2Y12 inhibitor to prevent a clot from forming in the stented or unstable region of a coronary artery.
These patients are not uncommon; this circumstance occurs for about 20% of all AFib patients, and poses the question of what is the safest and most effective way to treat them. Should they get triple therapy with an anticoagulant, aspirin, and a P2Y12 inhibitor, an option that could cause excess bleeding; or should one of the three drugs drop out with the potential for an increased rate of ischemic events? The AUGUSTUS findings suggest that one solution is treatment with a combination of the direct-acting oral anticoagulant apixaban (Eliquis) and the P2Y12 inhibitor clopidogrel (Plavix) but without aspirin.
For the majority of patients like the ones enrolled, “less is more.” By dropping aspirin from the treatment mix, patients did better, said Dr. Lopes, a professor of medicine at Duke University in Durham, N.C.
Dr. Lopes and his associates designed AUGUSTUS (A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis [Blood Clots] Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart) as a two-by-two factorial study to address two different questions: During 6 months of treatment, how did apixaban compare with a vitamin K antagonist (usually warfarin) in these patients for safety and efficacy, and how did aspirin compare with placebo in this setting for the same endpoints?
The trial enrolled 4,614 patients at 492 sites in 33 countries. All patients in the study received a P2Y12 inhibitor, with 93% treated with clopidogrel. The study had roughly as many patients as the combined total of patients enrolled in two smaller, prior studies that had looked at roughly the same questions in similar patients.
“The aspirin part is the more interesting, and probably more unique and important finding,” John H. Alexander, MD, a coinvestigator on the study, said in a video interview. Regardless of the anticoagulant used, patients who received aspirin had a 16% rate of major bleeds or clinically relevant non-major bleeds, compared with a 9% rate among those on placebo, a statistically significant result that underscored the bleeding risk posed by adding aspirin to an anticoagulant and a P2Y12 inhibitor.
The results also showed no statistically significant difference in any efficacy measure with or without aspirin, including the rate of death or hospitalization, or of any individual ischemic endpoint. However the results showed a signal of a small increase in the rates of each of three types of ischemic events – stent thrombosis, MI, and need for urgent revascularization, each of which showed a numerical increase when aspirin was dropped. But the increase was small.
Dr. Lopes calculated that, for example, to prevent one episode of stent thrombosis by treating with aspirin also would cause 15 major or clinically relevant non-major bleeds, which makes inclusion of aspirin something of a judgment call for each patient, said Dr. Alexander, a professor of medicine at Duke. An AFib patient with a high risk for thrombosis but a low risk for bleeding following PCI or an ACS event might be a reasonable patient to treat with aspirin along with apixaban and a P2Y12 inhibitor, he explained.
The rate of major or clinically relevant bleeds was 11% with apixaban and 15% with a vitamin K antagonist, a statistically significant difference. Patients treated with apixaban also had a significantly reduced rate of death or hospitalization, 24%, compared with 27% among those on the vitamin K antagonist, as well as a significantly lower rate of stroke.
Overall the lowest bleeding rate was in patients on apixaban but no aspirin, a 7% rate, while the highest rate was in patients on a vitamin K antagonist plus aspirin, a 19% rate.
Dr. Alexander said that it would be an overreach to extrapolate these findings to other direct-acting oral anticoagulants, compared with a vitamin K antagonist, but he believed that the findings the study generated about aspirin were probably relevant regardless of the anticoagulant used.
[email protected]
On Twitter @mitchelzoler
REPORTING FROM ACC 19
Antibiotic-eluting envelope reduces CIED infections
An absorbable, antibiotic-eluting envelope around cardiac implantable electronic devices could significantly reduce the incidence of infection, according to a presentation at the annual meeting of the American College of Cardiology.
The WRAP-IT trial, which was simultaneously published online March 17 in the New England Journal of Medicine, involved 6,983 patients undergoing cardiac implantable electronic device (CIED) implantation, replacement, revision, or upgrade. Patients were randomized either to receive the TYRX Absorbable Antibacterial Envelope or not.
After a mean follow-up of 20.7 months, there was a significant 40% lower rate of major infections in the envelope group compared to the control group, which met the efficacy objective of the study. Researchers saw 30 major infections in 25 patients in the envelope group; in the control group, there were 45 major infections in 42 patients (P = 0.04). The trial excluded patients at high risk of systemic infection due to other sources and patients with existing infection.
“CIED infection is a rare but serious event, and its management requires prolonged hospitalization, which involves device and lead extraction with adjunctive antibiotic therapy,” wrote Dr. Khaldoun G. Tarakji, from The Cleveland Clinic, and co-authors. “Despite proper management of CIED infection, both short- and long-term mortality remains high.”
One previous randomized study had shown that intravenous administration of antibiotics during CIED procedures can reduce the risk of infection, while a different study failed to find a benefit. The vast majority of patients in this study (98.7%) received periprocedural antibiotics, 74.5% received pocket wash and 29.6% received post-procedural antibiotics. These strategies were not controlled, but there is no clear evidence that any particular strategy influenced the infection rate, the authors wrote.
Patients in the envelope group experienced numerically fewer pocket infections but more endocarditis or bacteremia compared to those in the control group, a finding that the authors could not explain.
The most common pathogen responsible was staphylococcus, but data on antibiotic susceptibility was not collected. The authors stressed that this limited their ability to assess the risk of antibiotic resistance developing.
In this study, the researchers noted that the reduction in the risk of infection was greater among individuals who were implanted with higher-power devices, compared to those implanted with low-power devices or an initial cardiac resynchronization therapy device.
However, they said, the rate of infections was generally lower among those receiving low-power devices.
There was no increase in complications related to use of the envelope. The rate of complications occurring within 12 months of the procedure and relating to the CIED procedure or envelope was 6% in the envelope group and 6.9% in the control group.
When major infections were excluded, the rate of complications in each group was 5.7% and 5/9% respectively. There was also no significant difference in mortality rates between the two groups (17.4% and 17.8% respectively).
The authors wrote that while use of the envelope can require a slightly larger CIED dissection pocket, this was not associated with increased procedural time or complications. The envelope was successfully implanted in 99.7% of procedure attempts.
“There were fewer system revisions in the envelope group than in the control group and no complications due to allergy to the envelope mesh, polymer, or antibiotics,” they wrote.
The study was supported by Medtronic, the maker of the TYRX Absorbable Antibacterial Envelope. Twenty-four authors declared institutional funding or research grants from Medtronic, thirteen declared fees, consultancies and other support from private industry outside the submitted work. Three authors were employees of Medtronic.
SOURCE: Tarakji K et al. NEJM, 2019, March 17. DOI: 10.1056/NEJMoa1901111
An absorbable, antibiotic-eluting envelope around cardiac implantable electronic devices could significantly reduce the incidence of infection, according to a presentation at the annual meeting of the American College of Cardiology.
The WRAP-IT trial, which was simultaneously published online March 17 in the New England Journal of Medicine, involved 6,983 patients undergoing cardiac implantable electronic device (CIED) implantation, replacement, revision, or upgrade. Patients were randomized either to receive the TYRX Absorbable Antibacterial Envelope or not.
After a mean follow-up of 20.7 months, there was a significant 40% lower rate of major infections in the envelope group compared to the control group, which met the efficacy objective of the study. Researchers saw 30 major infections in 25 patients in the envelope group; in the control group, there were 45 major infections in 42 patients (P = 0.04). The trial excluded patients at high risk of systemic infection due to other sources and patients with existing infection.
“CIED infection is a rare but serious event, and its management requires prolonged hospitalization, which involves device and lead extraction with adjunctive antibiotic therapy,” wrote Dr. Khaldoun G. Tarakji, from The Cleveland Clinic, and co-authors. “Despite proper management of CIED infection, both short- and long-term mortality remains high.”
One previous randomized study had shown that intravenous administration of antibiotics during CIED procedures can reduce the risk of infection, while a different study failed to find a benefit. The vast majority of patients in this study (98.7%) received periprocedural antibiotics, 74.5% received pocket wash and 29.6% received post-procedural antibiotics. These strategies were not controlled, but there is no clear evidence that any particular strategy influenced the infection rate, the authors wrote.
Patients in the envelope group experienced numerically fewer pocket infections but more endocarditis or bacteremia compared to those in the control group, a finding that the authors could not explain.
The most common pathogen responsible was staphylococcus, but data on antibiotic susceptibility was not collected. The authors stressed that this limited their ability to assess the risk of antibiotic resistance developing.
In this study, the researchers noted that the reduction in the risk of infection was greater among individuals who were implanted with higher-power devices, compared to those implanted with low-power devices or an initial cardiac resynchronization therapy device.
However, they said, the rate of infections was generally lower among those receiving low-power devices.
There was no increase in complications related to use of the envelope. The rate of complications occurring within 12 months of the procedure and relating to the CIED procedure or envelope was 6% in the envelope group and 6.9% in the control group.
When major infections were excluded, the rate of complications in each group was 5.7% and 5/9% respectively. There was also no significant difference in mortality rates between the two groups (17.4% and 17.8% respectively).
The authors wrote that while use of the envelope can require a slightly larger CIED dissection pocket, this was not associated with increased procedural time or complications. The envelope was successfully implanted in 99.7% of procedure attempts.
“There were fewer system revisions in the envelope group than in the control group and no complications due to allergy to the envelope mesh, polymer, or antibiotics,” they wrote.
The study was supported by Medtronic, the maker of the TYRX Absorbable Antibacterial Envelope. Twenty-four authors declared institutional funding or research grants from Medtronic, thirteen declared fees, consultancies and other support from private industry outside the submitted work. Three authors were employees of Medtronic.
SOURCE: Tarakji K et al. NEJM, 2019, March 17. DOI: 10.1056/NEJMoa1901111
An absorbable, antibiotic-eluting envelope around cardiac implantable electronic devices could significantly reduce the incidence of infection, according to a presentation at the annual meeting of the American College of Cardiology.
The WRAP-IT trial, which was simultaneously published online March 17 in the New England Journal of Medicine, involved 6,983 patients undergoing cardiac implantable electronic device (CIED) implantation, replacement, revision, or upgrade. Patients were randomized either to receive the TYRX Absorbable Antibacterial Envelope or not.
After a mean follow-up of 20.7 months, there was a significant 40% lower rate of major infections in the envelope group compared to the control group, which met the efficacy objective of the study. Researchers saw 30 major infections in 25 patients in the envelope group; in the control group, there were 45 major infections in 42 patients (P = 0.04). The trial excluded patients at high risk of systemic infection due to other sources and patients with existing infection.
“CIED infection is a rare but serious event, and its management requires prolonged hospitalization, which involves device and lead extraction with adjunctive antibiotic therapy,” wrote Dr. Khaldoun G. Tarakji, from The Cleveland Clinic, and co-authors. “Despite proper management of CIED infection, both short- and long-term mortality remains high.”
One previous randomized study had shown that intravenous administration of antibiotics during CIED procedures can reduce the risk of infection, while a different study failed to find a benefit. The vast majority of patients in this study (98.7%) received periprocedural antibiotics, 74.5% received pocket wash and 29.6% received post-procedural antibiotics. These strategies were not controlled, but there is no clear evidence that any particular strategy influenced the infection rate, the authors wrote.
Patients in the envelope group experienced numerically fewer pocket infections but more endocarditis or bacteremia compared to those in the control group, a finding that the authors could not explain.
The most common pathogen responsible was staphylococcus, but data on antibiotic susceptibility was not collected. The authors stressed that this limited their ability to assess the risk of antibiotic resistance developing.
In this study, the researchers noted that the reduction in the risk of infection was greater among individuals who were implanted with higher-power devices, compared to those implanted with low-power devices or an initial cardiac resynchronization therapy device.
However, they said, the rate of infections was generally lower among those receiving low-power devices.
There was no increase in complications related to use of the envelope. The rate of complications occurring within 12 months of the procedure and relating to the CIED procedure or envelope was 6% in the envelope group and 6.9% in the control group.
When major infections were excluded, the rate of complications in each group was 5.7% and 5/9% respectively. There was also no significant difference in mortality rates between the two groups (17.4% and 17.8% respectively).
The authors wrote that while use of the envelope can require a slightly larger CIED dissection pocket, this was not associated with increased procedural time or complications. The envelope was successfully implanted in 99.7% of procedure attempts.
“There were fewer system revisions in the envelope group than in the control group and no complications due to allergy to the envelope mesh, polymer, or antibiotics,” they wrote.
The study was supported by Medtronic, the maker of the TYRX Absorbable Antibacterial Envelope. Twenty-four authors declared institutional funding or research grants from Medtronic, thirteen declared fees, consultancies and other support from private industry outside the submitted work. Three authors were employees of Medtronic.
SOURCE: Tarakji K et al. NEJM, 2019, March 17. DOI: 10.1056/NEJMoa1901111
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