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MADIT-CHIC: CRT aids patients with chemotherapy-induced cardiomyopathy
SAN FRANCISCO – Patients with cardiomyopathy secondary to cancer chemotherapy who qualified for cardiac resynchronization therapy (CRT) by having a wide QRS interval showed a virtually uniform, positive response to this treatment in a multicenter study with 30 patients.
This is the first time this therapy has been prospectively assessed in this patient population.
The results “show for the first time that patients with chemotherapy-induced cardiomyopathy [CHIC] who meet criteria for CRT show significant improvement in left ventricular function and clinical symptoms in the short term” during follow-up of 6 months, Jagmeet P. Singh, MD, said at the annual scientific sessions of the Heart Rhythm Society.
Dr. Singh acknowledged that, with 30 patients, the study was small, uncontrolled, had a brief follow-up of 6 months, and was highly selective. It took collaborating investigators at 12 U.S. centers more than 3.5 years to find the 30 participating patients, who had to meet very specific criteria designed to identify true CHIC. Nonetheless, Dr. Singh considered the results convincing enough to shift practice.
Based on the results, “I would certainly feel comfortable using CRT in patients with CHIC,” said Dr. Singh, associate chief of cardiology at Massachusetts General Hospital and professor of medicine at Harvard Medical School, both in Boston. “If a patient has CHIC with a wide QRS interval and evidence for a conduction defect on their ECG, they are a great candidate for CRT. The results highlight that there is a cohort of patients who develop cardiomyopathy after chemotherapy, and these patients are often written off” and until now have generally received little follow-up for their potential development of cardiomyopathy. Dr. Singh expressed hope that the recent emergence of cardio-oncology as a subspecialty will focus attention on CHIC patients.
The MADIT-CHIC (Multicenter Automatic Defibrillator Implantation Trial – Chemotherapy-Induced Cardiomyopathy) study enrolled patients with a history of exposure to a cancer chemotherapy regimen known to cause cardiomyopathy who had no history of heart failure prior to the chemotherapy. All patients had developed clinically apparent heart failure (New York Heart Association functional class II, III, or IV) at least 6 months after completing chemotherapy, had no other apparent cause of the cardiomyopathy as ascertained by a cardio-oncologist, and were on guideline-directed medical therapy. Enrolled patients also had to have a class I or II indication for CRT, with a left ventricular ejection fraction of 35% or less, a QRS interval of at least 120 milliseconds, sinus rhythm and left bundle branch block, or no left bundle branch block and a QRS of at least 150 milliseconds.
Just over three-quarters of the patients had received an anthracycline drug, and 73% had a history of breast cancer, 20% a history of leukemia or lymphoma, and 7% had a history of sarcoma. The patients averaged 64 years of age, and 87% were women. CRT placement occurred 18-256 months after the end of chemotherapy, with a median of 188 months.
The study’s primary endpoint was the change in left ventricular ejection fraction after 6 months, which increased from an average of 28% at baseline to 39% at follow-up, a statistically significant change. Ejection fraction increased in 29 of the 30 patients, with one patient showing a flat response to CRT. Cardiac function and geometry significantly improved by seven other measures, including left ventricular mass and left atrial volume, and the improved ejection fraction was consistent across several subgroup analyses. Patients’ NYHA functional class improved by at least one level in 41% of patients, and 83% of the patients stopped showing clinical features of heart failure after 6 months on CRT.
MADIT-CHIC received funding from Boston Scientific. Dr. Singh has been a consultant to Abbott, Back Beat, Biotronik, Boston Scientific, EBR, Impulse Dynamics, Medtronic, Microport, St. Jude, and Toray, and he has received research support from Abbott and Boston Scientific.
SOURCE: Singh JP et al. HRS 2019, Abstract S-LBCT02-04.
No guideline currently addresses using cardiac resynchronization therapy to treat chemotherapy-induced cardiomyopathy. The findings from MADIT-CHIC showed a striking benefit from treatment with cardiac resynchronization therapy of a magnitude we would expect to see in patients with nonischemic cardiomyopathy. Patients showed improvements in all measures of cardiac performance.
It appears that CHIC can take as long as decades to appear in a patient, but we now need to have a high level of suspicion for this complication. We need to come up with better ways to monitor development of CHIC in patients who have received cancer chemotherapy so that we can give eligible patients this beneficial treatment. We can be optimistic about the potential for benefit from CRT in these patients.
Kenneth A. Ellenbogen, MD , is chief of cardiology and a professor of medicine at Virginia Commonwealth University in Richmond, Va. He has been a consultant to Boston Scientific, Medtronic, and St. Jude; he has received honoraria from Biotronik; and he has received research funding from Boston Scientific and Medtronic. He made these comments as the designated discussant for the MADIT-CHIC report.
No guideline currently addresses using cardiac resynchronization therapy to treat chemotherapy-induced cardiomyopathy. The findings from MADIT-CHIC showed a striking benefit from treatment with cardiac resynchronization therapy of a magnitude we would expect to see in patients with nonischemic cardiomyopathy. Patients showed improvements in all measures of cardiac performance.
It appears that CHIC can take as long as decades to appear in a patient, but we now need to have a high level of suspicion for this complication. We need to come up with better ways to monitor development of CHIC in patients who have received cancer chemotherapy so that we can give eligible patients this beneficial treatment. We can be optimistic about the potential for benefit from CRT in these patients.
Kenneth A. Ellenbogen, MD , is chief of cardiology and a professor of medicine at Virginia Commonwealth University in Richmond, Va. He has been a consultant to Boston Scientific, Medtronic, and St. Jude; he has received honoraria from Biotronik; and he has received research funding from Boston Scientific and Medtronic. He made these comments as the designated discussant for the MADIT-CHIC report.
No guideline currently addresses using cardiac resynchronization therapy to treat chemotherapy-induced cardiomyopathy. The findings from MADIT-CHIC showed a striking benefit from treatment with cardiac resynchronization therapy of a magnitude we would expect to see in patients with nonischemic cardiomyopathy. Patients showed improvements in all measures of cardiac performance.
It appears that CHIC can take as long as decades to appear in a patient, but we now need to have a high level of suspicion for this complication. We need to come up with better ways to monitor development of CHIC in patients who have received cancer chemotherapy so that we can give eligible patients this beneficial treatment. We can be optimistic about the potential for benefit from CRT in these patients.
Kenneth A. Ellenbogen, MD , is chief of cardiology and a professor of medicine at Virginia Commonwealth University in Richmond, Va. He has been a consultant to Boston Scientific, Medtronic, and St. Jude; he has received honoraria from Biotronik; and he has received research funding from Boston Scientific and Medtronic. He made these comments as the designated discussant for the MADIT-CHIC report.
SAN FRANCISCO – Patients with cardiomyopathy secondary to cancer chemotherapy who qualified for cardiac resynchronization therapy (CRT) by having a wide QRS interval showed a virtually uniform, positive response to this treatment in a multicenter study with 30 patients.
This is the first time this therapy has been prospectively assessed in this patient population.
The results “show for the first time that patients with chemotherapy-induced cardiomyopathy [CHIC] who meet criteria for CRT show significant improvement in left ventricular function and clinical symptoms in the short term” during follow-up of 6 months, Jagmeet P. Singh, MD, said at the annual scientific sessions of the Heart Rhythm Society.
Dr. Singh acknowledged that, with 30 patients, the study was small, uncontrolled, had a brief follow-up of 6 months, and was highly selective. It took collaborating investigators at 12 U.S. centers more than 3.5 years to find the 30 participating patients, who had to meet very specific criteria designed to identify true CHIC. Nonetheless, Dr. Singh considered the results convincing enough to shift practice.
Based on the results, “I would certainly feel comfortable using CRT in patients with CHIC,” said Dr. Singh, associate chief of cardiology at Massachusetts General Hospital and professor of medicine at Harvard Medical School, both in Boston. “If a patient has CHIC with a wide QRS interval and evidence for a conduction defect on their ECG, they are a great candidate for CRT. The results highlight that there is a cohort of patients who develop cardiomyopathy after chemotherapy, and these patients are often written off” and until now have generally received little follow-up for their potential development of cardiomyopathy. Dr. Singh expressed hope that the recent emergence of cardio-oncology as a subspecialty will focus attention on CHIC patients.
The MADIT-CHIC (Multicenter Automatic Defibrillator Implantation Trial – Chemotherapy-Induced Cardiomyopathy) study enrolled patients with a history of exposure to a cancer chemotherapy regimen known to cause cardiomyopathy who had no history of heart failure prior to the chemotherapy. All patients had developed clinically apparent heart failure (New York Heart Association functional class II, III, or IV) at least 6 months after completing chemotherapy, had no other apparent cause of the cardiomyopathy as ascertained by a cardio-oncologist, and were on guideline-directed medical therapy. Enrolled patients also had to have a class I or II indication for CRT, with a left ventricular ejection fraction of 35% or less, a QRS interval of at least 120 milliseconds, sinus rhythm and left bundle branch block, or no left bundle branch block and a QRS of at least 150 milliseconds.
Just over three-quarters of the patients had received an anthracycline drug, and 73% had a history of breast cancer, 20% a history of leukemia or lymphoma, and 7% had a history of sarcoma. The patients averaged 64 years of age, and 87% were women. CRT placement occurred 18-256 months after the end of chemotherapy, with a median of 188 months.
The study’s primary endpoint was the change in left ventricular ejection fraction after 6 months, which increased from an average of 28% at baseline to 39% at follow-up, a statistically significant change. Ejection fraction increased in 29 of the 30 patients, with one patient showing a flat response to CRT. Cardiac function and geometry significantly improved by seven other measures, including left ventricular mass and left atrial volume, and the improved ejection fraction was consistent across several subgroup analyses. Patients’ NYHA functional class improved by at least one level in 41% of patients, and 83% of the patients stopped showing clinical features of heart failure after 6 months on CRT.
MADIT-CHIC received funding from Boston Scientific. Dr. Singh has been a consultant to Abbott, Back Beat, Biotronik, Boston Scientific, EBR, Impulse Dynamics, Medtronic, Microport, St. Jude, and Toray, and he has received research support from Abbott and Boston Scientific.
SOURCE: Singh JP et al. HRS 2019, Abstract S-LBCT02-04.
SAN FRANCISCO – Patients with cardiomyopathy secondary to cancer chemotherapy who qualified for cardiac resynchronization therapy (CRT) by having a wide QRS interval showed a virtually uniform, positive response to this treatment in a multicenter study with 30 patients.
This is the first time this therapy has been prospectively assessed in this patient population.
The results “show for the first time that patients with chemotherapy-induced cardiomyopathy [CHIC] who meet criteria for CRT show significant improvement in left ventricular function and clinical symptoms in the short term” during follow-up of 6 months, Jagmeet P. Singh, MD, said at the annual scientific sessions of the Heart Rhythm Society.
Dr. Singh acknowledged that, with 30 patients, the study was small, uncontrolled, had a brief follow-up of 6 months, and was highly selective. It took collaborating investigators at 12 U.S. centers more than 3.5 years to find the 30 participating patients, who had to meet very specific criteria designed to identify true CHIC. Nonetheless, Dr. Singh considered the results convincing enough to shift practice.
Based on the results, “I would certainly feel comfortable using CRT in patients with CHIC,” said Dr. Singh, associate chief of cardiology at Massachusetts General Hospital and professor of medicine at Harvard Medical School, both in Boston. “If a patient has CHIC with a wide QRS interval and evidence for a conduction defect on their ECG, they are a great candidate for CRT. The results highlight that there is a cohort of patients who develop cardiomyopathy after chemotherapy, and these patients are often written off” and until now have generally received little follow-up for their potential development of cardiomyopathy. Dr. Singh expressed hope that the recent emergence of cardio-oncology as a subspecialty will focus attention on CHIC patients.
The MADIT-CHIC (Multicenter Automatic Defibrillator Implantation Trial – Chemotherapy-Induced Cardiomyopathy) study enrolled patients with a history of exposure to a cancer chemotherapy regimen known to cause cardiomyopathy who had no history of heart failure prior to the chemotherapy. All patients had developed clinically apparent heart failure (New York Heart Association functional class II, III, or IV) at least 6 months after completing chemotherapy, had no other apparent cause of the cardiomyopathy as ascertained by a cardio-oncologist, and were on guideline-directed medical therapy. Enrolled patients also had to have a class I or II indication for CRT, with a left ventricular ejection fraction of 35% or less, a QRS interval of at least 120 milliseconds, sinus rhythm and left bundle branch block, or no left bundle branch block and a QRS of at least 150 milliseconds.
Just over three-quarters of the patients had received an anthracycline drug, and 73% had a history of breast cancer, 20% a history of leukemia or lymphoma, and 7% had a history of sarcoma. The patients averaged 64 years of age, and 87% were women. CRT placement occurred 18-256 months after the end of chemotherapy, with a median of 188 months.
The study’s primary endpoint was the change in left ventricular ejection fraction after 6 months, which increased from an average of 28% at baseline to 39% at follow-up, a statistically significant change. Ejection fraction increased in 29 of the 30 patients, with one patient showing a flat response to CRT. Cardiac function and geometry significantly improved by seven other measures, including left ventricular mass and left atrial volume, and the improved ejection fraction was consistent across several subgroup analyses. Patients’ NYHA functional class improved by at least one level in 41% of patients, and 83% of the patients stopped showing clinical features of heart failure after 6 months on CRT.
MADIT-CHIC received funding from Boston Scientific. Dr. Singh has been a consultant to Abbott, Back Beat, Biotronik, Boston Scientific, EBR, Impulse Dynamics, Medtronic, Microport, St. Jude, and Toray, and he has received research support from Abbott and Boston Scientific.
SOURCE: Singh JP et al. HRS 2019, Abstract S-LBCT02-04.
REPORTING FROM HEART RHYTHM 2019
Energy drinks increase BP and disrupt the heart’s electrical activity
Consuming caffeinated energy drinks leads to a prolonged QT interval and an increase in blood pressure, according to a study of young volunteers who had their hearts tested after drinking either energy drinks or placebo.
“Further investigation is warranted on whether an individual ingredient or a unique combination leads to the observed electrophysiological and hemodynamic changes,” wrote Sachin A. Shah of the University of the Pacific, Stockton, Calif., and coinvestigators. The study was published in the Journal of the American Heart Association.
To analyze electrocardiographic changes in the heart after consumption of 300 mg of caffeine plus other energy drink ingredients, the researchers assigned 34 healthy volunteers with an average age of 22 years to consume two 16-ounce bottles of either Drink A, a commercially available energy drink, Drink B, a different brand of energy drink, or a placebo drink for 3 days, followed by a 6-day washout period. Before and for 4 hours after consuming the beverages, volunteers had their hearts measured via ECG to test for differences in QT interval. Their blood pressures also were recorded.
Compared with placebo, the Drink A group had a 6.1 ms increase in QT interval and the Drink B group had a 7.7 ms rise. The maximum changes from baseline in corrected QT interval for Drink A, Drink B, and placebo were 17.9 ms, 19.6 ms, and 11.9 ms, respectively; both differences were statistically significant. Volunteers in Drink A and Drink B groups also had statistically significant increases of 5 mm Hg in systolic and 4 mm Hg in diastolic blood pressure after energy drink consumption, compared with placebo.
Both energy drinks used in the study contained caffeine (about 300 mg), taurine, glucuronolactone, and B vitamins. The investigators said that caffeine at doses under 400 mg is not expected to induce any electrocardiographic changes.
The coauthors noted their study’s limitations, including not investigating the effects of different doses and the possibility that consuming two 16-ounce bottles is an unrealistic real-world volume. That said, they noted that 16% of respondents to a 2,040-person survey admitted to consuming more than two energy drinks a day. In addition, though not every brand was tested, the researchers stated that, “the class of energy drinks, rather than one particular product, warrants use with caution.”
Dr. Shah reported serving as an expert witness in legal cases related to caffeinated energy drinks. The other authors reported no conflicts of interest.
SOURCE: Shah SA et al. J Am Heart Assoc. 2019 May 29.
Consuming caffeinated energy drinks leads to a prolonged QT interval and an increase in blood pressure, according to a study of young volunteers who had their hearts tested after drinking either energy drinks or placebo.
“Further investigation is warranted on whether an individual ingredient or a unique combination leads to the observed electrophysiological and hemodynamic changes,” wrote Sachin A. Shah of the University of the Pacific, Stockton, Calif., and coinvestigators. The study was published in the Journal of the American Heart Association.
To analyze electrocardiographic changes in the heart after consumption of 300 mg of caffeine plus other energy drink ingredients, the researchers assigned 34 healthy volunteers with an average age of 22 years to consume two 16-ounce bottles of either Drink A, a commercially available energy drink, Drink B, a different brand of energy drink, or a placebo drink for 3 days, followed by a 6-day washout period. Before and for 4 hours after consuming the beverages, volunteers had their hearts measured via ECG to test for differences in QT interval. Their blood pressures also were recorded.
Compared with placebo, the Drink A group had a 6.1 ms increase in QT interval and the Drink B group had a 7.7 ms rise. The maximum changes from baseline in corrected QT interval for Drink A, Drink B, and placebo were 17.9 ms, 19.6 ms, and 11.9 ms, respectively; both differences were statistically significant. Volunteers in Drink A and Drink B groups also had statistically significant increases of 5 mm Hg in systolic and 4 mm Hg in diastolic blood pressure after energy drink consumption, compared with placebo.
Both energy drinks used in the study contained caffeine (about 300 mg), taurine, glucuronolactone, and B vitamins. The investigators said that caffeine at doses under 400 mg is not expected to induce any electrocardiographic changes.
The coauthors noted their study’s limitations, including not investigating the effects of different doses and the possibility that consuming two 16-ounce bottles is an unrealistic real-world volume. That said, they noted that 16% of respondents to a 2,040-person survey admitted to consuming more than two energy drinks a day. In addition, though not every brand was tested, the researchers stated that, “the class of energy drinks, rather than one particular product, warrants use with caution.”
Dr. Shah reported serving as an expert witness in legal cases related to caffeinated energy drinks. The other authors reported no conflicts of interest.
SOURCE: Shah SA et al. J Am Heart Assoc. 2019 May 29.
Consuming caffeinated energy drinks leads to a prolonged QT interval and an increase in blood pressure, according to a study of young volunteers who had their hearts tested after drinking either energy drinks or placebo.
“Further investigation is warranted on whether an individual ingredient or a unique combination leads to the observed electrophysiological and hemodynamic changes,” wrote Sachin A. Shah of the University of the Pacific, Stockton, Calif., and coinvestigators. The study was published in the Journal of the American Heart Association.
To analyze electrocardiographic changes in the heart after consumption of 300 mg of caffeine plus other energy drink ingredients, the researchers assigned 34 healthy volunteers with an average age of 22 years to consume two 16-ounce bottles of either Drink A, a commercially available energy drink, Drink B, a different brand of energy drink, or a placebo drink for 3 days, followed by a 6-day washout period. Before and for 4 hours after consuming the beverages, volunteers had their hearts measured via ECG to test for differences in QT interval. Their blood pressures also were recorded.
Compared with placebo, the Drink A group had a 6.1 ms increase in QT interval and the Drink B group had a 7.7 ms rise. The maximum changes from baseline in corrected QT interval for Drink A, Drink B, and placebo were 17.9 ms, 19.6 ms, and 11.9 ms, respectively; both differences were statistically significant. Volunteers in Drink A and Drink B groups also had statistically significant increases of 5 mm Hg in systolic and 4 mm Hg in diastolic blood pressure after energy drink consumption, compared with placebo.
Both energy drinks used in the study contained caffeine (about 300 mg), taurine, glucuronolactone, and B vitamins. The investigators said that caffeine at doses under 400 mg is not expected to induce any electrocardiographic changes.
The coauthors noted their study’s limitations, including not investigating the effects of different doses and the possibility that consuming two 16-ounce bottles is an unrealistic real-world volume. That said, they noted that 16% of respondents to a 2,040-person survey admitted to consuming more than two energy drinks a day. In addition, though not every brand was tested, the researchers stated that, “the class of energy drinks, rather than one particular product, warrants use with caution.”
Dr. Shah reported serving as an expert witness in legal cases related to caffeinated energy drinks. The other authors reported no conflicts of interest.
SOURCE: Shah SA et al. J Am Heart Assoc. 2019 May 29.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Key clinical point:
Major finding: Compared with placebo, consuming two different energy drinks led to significant QT interval increases of 6.1 ms and 7.7 ms.
Study details: A randomized, double-blind crossover study of 34 healthy volunteers who had their hearts measured via electrocardiogram after consuming energy drink or placebo.
Disclosures: Dr. Shah reported serving as an expert witness in legal cases related to caffeinated energy drinks. The other authors reported no conflicts of interest.
Source: Shah SA et al. J Am Heart Assoc. 2019 May 29.
Warfarin boosts OA risk in Rotterdam Study
TORONTO – The use of warfarin or related vitamin K antagonists was associated with a more than 100% increased risk of incident or progressive knee or hip osteoarthritis in the Rotterdam Study, Cindy G. Boer reported at the OARSI 2019 World Congress.
A biologically plausible mechanism exists for this relationship, added Ms. Boer, a PhD student with a special interest in the molecular genetics of OA at Erasmus University, Rotterdam, the Netherlands.
In a previous genetic study, she and her coinvestigators identified two genetic variants that result in loss of function of matrix Gla protein (MGP), a key inhibitor of cartilage calcification. They showed that the presence of these alleles was associated with a significantly increased risk of hand OA, which makes sense because increased calcification within a vulnerable joint promotes OA.
“The interesting thing here is that, in order for MGP to inhibit calcification, it needs to be gamma-carboxylated by vitamin K. If it’s not gamma-carboxylated it cannot inhibit calcification,” Ms. Boer said at the meeting sponsored by the Osteoarthritis Research Society International.
This observation led her to hypothesize that patients on warfarin or other vitamin K antagonists might have an increased risk of developing new-onset OA or, if they already had OA, of experiencing disease progression, since their medication inhibits MGP. To test this hypothesis, she and her coinvestigators turned to the landmark Rotterdam Study, a prospective, population-based cohort study of 15,000 participants, ongoing since 1990. Two large cohorts within the study had data available on the incidence and progression of radiographic knee and hip OA, one group over the course of 5 years of follow-up, the other with 10 years.
Serial x-rays of 8,845 knee joints were available, including 657 of warfarin users. Their rate of incident or progressive knee OA was 13%, compared with 5.9% in the nonusers in an analysis adjusted for age, sex, BMI, baseline OA status, and time between study visits.
In a similar vein, the rate of incident or progressive hip OA was 12% in the warfarin users, compared with 3.1% in nonusers.
About 80% of the OA endpoints in this analysis involved incident OA, defined radiographically as Kellgren-Lawrence grade 2. Progressive OA was defined as going from grade 2 at baseline to grade 3-4 during follow-up.
There was a signal of a treatment duration-related effect, with OA rates trending highest in individuals on warfarin for longer than 365 days, followed by those on the oral anticoagulant for more than 100 days, who in turn had higher rates than those on warfarin for less time.
Ms. Boer said an important next step in this research is to replicate the warfarin/OA association in an independent cohort. Also, she and her coworkers are now gathering OA incidence and progression data in patients on direct oral anticoagulants rather than warfarin to test the hypothesis that they will not have an increased rate of OA, compared with nonusers, since these newer agents don’t affect vitamin K. Of course, if they do turn out to have an elevated risk, it would point to one or more of the conditions for which oral anticoagulants are commonly prescribed as the explanation.
She reported having no financial conflicts regarding her study, sponsored by Erasmus University and the Dutch government.
TORONTO – The use of warfarin or related vitamin K antagonists was associated with a more than 100% increased risk of incident or progressive knee or hip osteoarthritis in the Rotterdam Study, Cindy G. Boer reported at the OARSI 2019 World Congress.
A biologically plausible mechanism exists for this relationship, added Ms. Boer, a PhD student with a special interest in the molecular genetics of OA at Erasmus University, Rotterdam, the Netherlands.
In a previous genetic study, she and her coinvestigators identified two genetic variants that result in loss of function of matrix Gla protein (MGP), a key inhibitor of cartilage calcification. They showed that the presence of these alleles was associated with a significantly increased risk of hand OA, which makes sense because increased calcification within a vulnerable joint promotes OA.
“The interesting thing here is that, in order for MGP to inhibit calcification, it needs to be gamma-carboxylated by vitamin K. If it’s not gamma-carboxylated it cannot inhibit calcification,” Ms. Boer said at the meeting sponsored by the Osteoarthritis Research Society International.
This observation led her to hypothesize that patients on warfarin or other vitamin K antagonists might have an increased risk of developing new-onset OA or, if they already had OA, of experiencing disease progression, since their medication inhibits MGP. To test this hypothesis, she and her coinvestigators turned to the landmark Rotterdam Study, a prospective, population-based cohort study of 15,000 participants, ongoing since 1990. Two large cohorts within the study had data available on the incidence and progression of radiographic knee and hip OA, one group over the course of 5 years of follow-up, the other with 10 years.
Serial x-rays of 8,845 knee joints were available, including 657 of warfarin users. Their rate of incident or progressive knee OA was 13%, compared with 5.9% in the nonusers in an analysis adjusted for age, sex, BMI, baseline OA status, and time between study visits.
In a similar vein, the rate of incident or progressive hip OA was 12% in the warfarin users, compared with 3.1% in nonusers.
About 80% of the OA endpoints in this analysis involved incident OA, defined radiographically as Kellgren-Lawrence grade 2. Progressive OA was defined as going from grade 2 at baseline to grade 3-4 during follow-up.
There was a signal of a treatment duration-related effect, with OA rates trending highest in individuals on warfarin for longer than 365 days, followed by those on the oral anticoagulant for more than 100 days, who in turn had higher rates than those on warfarin for less time.
Ms. Boer said an important next step in this research is to replicate the warfarin/OA association in an independent cohort. Also, she and her coworkers are now gathering OA incidence and progression data in patients on direct oral anticoagulants rather than warfarin to test the hypothesis that they will not have an increased rate of OA, compared with nonusers, since these newer agents don’t affect vitamin K. Of course, if they do turn out to have an elevated risk, it would point to one or more of the conditions for which oral anticoagulants are commonly prescribed as the explanation.
She reported having no financial conflicts regarding her study, sponsored by Erasmus University and the Dutch government.
TORONTO – The use of warfarin or related vitamin K antagonists was associated with a more than 100% increased risk of incident or progressive knee or hip osteoarthritis in the Rotterdam Study, Cindy G. Boer reported at the OARSI 2019 World Congress.
A biologically plausible mechanism exists for this relationship, added Ms. Boer, a PhD student with a special interest in the molecular genetics of OA at Erasmus University, Rotterdam, the Netherlands.
In a previous genetic study, she and her coinvestigators identified two genetic variants that result in loss of function of matrix Gla protein (MGP), a key inhibitor of cartilage calcification. They showed that the presence of these alleles was associated with a significantly increased risk of hand OA, which makes sense because increased calcification within a vulnerable joint promotes OA.
“The interesting thing here is that, in order for MGP to inhibit calcification, it needs to be gamma-carboxylated by vitamin K. If it’s not gamma-carboxylated it cannot inhibit calcification,” Ms. Boer said at the meeting sponsored by the Osteoarthritis Research Society International.
This observation led her to hypothesize that patients on warfarin or other vitamin K antagonists might have an increased risk of developing new-onset OA or, if they already had OA, of experiencing disease progression, since their medication inhibits MGP. To test this hypothesis, she and her coinvestigators turned to the landmark Rotterdam Study, a prospective, population-based cohort study of 15,000 participants, ongoing since 1990. Two large cohorts within the study had data available on the incidence and progression of radiographic knee and hip OA, one group over the course of 5 years of follow-up, the other with 10 years.
Serial x-rays of 8,845 knee joints were available, including 657 of warfarin users. Their rate of incident or progressive knee OA was 13%, compared with 5.9% in the nonusers in an analysis adjusted for age, sex, BMI, baseline OA status, and time between study visits.
In a similar vein, the rate of incident or progressive hip OA was 12% in the warfarin users, compared with 3.1% in nonusers.
About 80% of the OA endpoints in this analysis involved incident OA, defined radiographically as Kellgren-Lawrence grade 2. Progressive OA was defined as going from grade 2 at baseline to grade 3-4 during follow-up.
There was a signal of a treatment duration-related effect, with OA rates trending highest in individuals on warfarin for longer than 365 days, followed by those on the oral anticoagulant for more than 100 days, who in turn had higher rates than those on warfarin for less time.
Ms. Boer said an important next step in this research is to replicate the warfarin/OA association in an independent cohort. Also, she and her coworkers are now gathering OA incidence and progression data in patients on direct oral anticoagulants rather than warfarin to test the hypothesis that they will not have an increased rate of OA, compared with nonusers, since these newer agents don’t affect vitamin K. Of course, if they do turn out to have an elevated risk, it would point to one or more of the conditions for which oral anticoagulants are commonly prescribed as the explanation.
She reported having no financial conflicts regarding her study, sponsored by Erasmus University and the Dutch government.
REPORTING FROM OARSI 2019
FDA updates warning about Impella RP System
The Food and Drug Administration has reported that the higher postapproval mortality rates seen with Abiomed’s Impella RP System seem concentrated in a certain subgroup of patients only, according to a letter to health care providers.
The letter updates one from February regarding the observation of higher postapproval mortality rates with the temporary right heart pump.
This subgroup, which did not qualify for premarket clinical studies, was more likely to have been in cardiogenic shock for longer than 48 hours, experienced a cardiac arrest, or suffered a preimplant hypoxic or ischemic neurologic event prior to receiving the device, the FDA suggested in this new letter to health care providers. The 30-day survival rate in this subgroup within a postapproval study (PAS) was 10.7% (3 out of 28), while that among patients who would have qualified for the premarket clinical studies was 64.3% (9 of 14), according to the most recent interim results of that study. The rate among patients who would have qualified for premarket studies is similar to that seen among those premarket studies (73.4%); the overall 30-day survival rate in this PAS was 28.6%.
The FDA said that, based on these analyses, it still believes the benefits outweigh the risks when the Impella RP System is “used for the currently approved indication in appropriately selected patients.”
The FDA advises that health care providers review the device’s revised labeling, which now includes a checklist to help understand which patients could benefit the most. It also advises providers to promptly report any adverse events through MedWatch, which can help the FDA identify and understand the risks associated with the Impella RP System.
More information can be found in the FDA’s letter to health care providers, which is available on the FDA website.
The Food and Drug Administration has reported that the higher postapproval mortality rates seen with Abiomed’s Impella RP System seem concentrated in a certain subgroup of patients only, according to a letter to health care providers.
The letter updates one from February regarding the observation of higher postapproval mortality rates with the temporary right heart pump.
This subgroup, which did not qualify for premarket clinical studies, was more likely to have been in cardiogenic shock for longer than 48 hours, experienced a cardiac arrest, or suffered a preimplant hypoxic or ischemic neurologic event prior to receiving the device, the FDA suggested in this new letter to health care providers. The 30-day survival rate in this subgroup within a postapproval study (PAS) was 10.7% (3 out of 28), while that among patients who would have qualified for the premarket clinical studies was 64.3% (9 of 14), according to the most recent interim results of that study. The rate among patients who would have qualified for premarket studies is similar to that seen among those premarket studies (73.4%); the overall 30-day survival rate in this PAS was 28.6%.
The FDA said that, based on these analyses, it still believes the benefits outweigh the risks when the Impella RP System is “used for the currently approved indication in appropriately selected patients.”
The FDA advises that health care providers review the device’s revised labeling, which now includes a checklist to help understand which patients could benefit the most. It also advises providers to promptly report any adverse events through MedWatch, which can help the FDA identify and understand the risks associated with the Impella RP System.
More information can be found in the FDA’s letter to health care providers, which is available on the FDA website.
The Food and Drug Administration has reported that the higher postapproval mortality rates seen with Abiomed’s Impella RP System seem concentrated in a certain subgroup of patients only, according to a letter to health care providers.
The letter updates one from February regarding the observation of higher postapproval mortality rates with the temporary right heart pump.
This subgroup, which did not qualify for premarket clinical studies, was more likely to have been in cardiogenic shock for longer than 48 hours, experienced a cardiac arrest, or suffered a preimplant hypoxic or ischemic neurologic event prior to receiving the device, the FDA suggested in this new letter to health care providers. The 30-day survival rate in this subgroup within a postapproval study (PAS) was 10.7% (3 out of 28), while that among patients who would have qualified for the premarket clinical studies was 64.3% (9 of 14), according to the most recent interim results of that study. The rate among patients who would have qualified for premarket studies is similar to that seen among those premarket studies (73.4%); the overall 30-day survival rate in this PAS was 28.6%.
The FDA said that, based on these analyses, it still believes the benefits outweigh the risks when the Impella RP System is “used for the currently approved indication in appropriately selected patients.”
The FDA advises that health care providers review the device’s revised labeling, which now includes a checklist to help understand which patients could benefit the most. It also advises providers to promptly report any adverse events through MedWatch, which can help the FDA identify and understand the risks associated with the Impella RP System.
More information can be found in the FDA’s letter to health care providers, which is available on the FDA website.
CABANA: Heart failure patients got biggest bang from AFib ablation
SAN FRANCISCO – Catheter ablation of atrial fibrillation (AFib) in the roughly one-third of patients with heart failure enrolled in the CABANA multicenter, randomized trial produced striking, statistically significant improvements both in the study’s primary, combined endpoint and in all-cause mortality in intention-to-treat analyses.
These findings, from prespecified secondary analyses, contrasted with the study’s overall result, which showed no benefit in the primary endpoint analysis in the total study population of 2,204 patients with AFib (JAMA. 2019 Apr 2;321[13]:1261-74). They are also at odds with the primary endpoint result in the two-thirds of enrolled patients without heart failure, which showed no significant between-group differences in these two outcome measures among the patients assigned to the catheter ablation arm and the study’s control, which was medical management arm.
Among the 778 AFib patients enrolled in CABANA with any form of heart failure (35% of the total study enrollment), the incidence of the study’s primary endpoint – the combined rate of death, disabling stroke, serious bleeding, or cardiac arrest during a median follow-up of slightly more than 4 years – was 36% lower among the catheter-ablated heart failure patients than in the heart failure patients assigned to medical treatment, according to an intention-to-treat analysis, which was a statistically significant difference. The incidence of all-cause mortality during follow-up was 43% lower in the ablated heart failure patients, compared with the controls, Douglas L. Packer, MD, said at the annual scientific sessions of the Heart Rhythm Society.
In contrast, among enrolled patients without heart failure, the intention-to-treat primary endpoint was 6% higher in the ablated patients, and all-cause mortality was a relative 27% higher, although neither difference was statistically significant.
It’s a “little surprising” that the results showed this much benefit in the patients with heart failure, said Dr. Packer, professor of medicine at the Mayo Clinic in Rochester, Minn., and lead investigator of the CABANA (Catheter Ablation vs Anti-Arrhythmic Drug Therapy for Atrial Fibrillation) trial. “I think these data confirm the results of the CASTLE-AF trial, but without some of the glitches some people have cited” about that study, such as concerns about a high level of patient selection in CASTLE-AF and its relatively modest number of enrolled patients, he said in an interview.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) study, run entirely in patients with heart failure with reduced ejection fraction and AFib, showed a statistically significant improvement in patient survival and heart failure hospitalization after catheter ablation compared with medical management (N Engl J Med. 2018 Feb 1;378[5]:417-27). Prior to the CASTLE-AF report, results from several other small studies (J Interv Card Electrophysiol. 2018 Oct;53[1]:19-29), as well as those from the AATAC trial (Circulation. 2016 Apr 26;133[17]:1637-44), also showed consistent evidence for benefit from catheter ablation in patients with heart failure and AFib, noted CABANA coinvestigator Jonathan P. Piccini, MD, during a separate talk at the meeting.
“The improvement of cardiovascular outcomes with ablation in patients with heart failure and AFib is consistent across multiple trials, at least with respect to heart failure with reduced ejection fraction” concluded Dr. Piccini, a cardiac electrophysiologist at Duke University in Durham, N.C.
As a result of the new heart failure analysis, “I think the guidelines will change,” predicted Dr. Packer, with catheter ablation receiving a firmer endorsement for patients with heart failure the next time U.S. guidelines for heart failure and AFib management are updated. The findings say “there is substantial benefit of catheter ablation in heart failure patients, but I don’t think our findings lessen the utility of ablation in patients without heart failure,” he stressed. Even patients without heart failure showed reduction in AFib burden and improvement in quality of life that were similar to what was seen in the heart failure patients.
The new report from CABANA of benefit from AFib catheter ablation in patients with heart failure “absolutely advances the evidence,” commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago. “A number of us were quite circumspect about this based on the CASTLE-AF data, but the new CABANA analyses have addressed our anxiety that the CASTLE-AF results were just by chance.” The new CABANA analyses “may not confirm CASTLE-AF, but it enriches the conversation and makes it possible that we are seeing benefit in some patients with heart failure who get ablated.”
Dr. Yancy, who chaired the most recent update to the U.S. heart failure management guideline (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803) stopped short of saying that the cumulative evidence now supports a guideline change, but he acknowledged in an interview that the evidence could legitimately influence practice. Catheter ablation should now be “strongly considered” in patients with heart failure and AFib, he said, although he also had three qualifications for opting for this approach: Patients must already be on guideline-directed medical therapy for their heart failure, the catheter ablation needs to be performed by an experienced and skilled operator, and follow-up surveillance must focus on both the patient’s AFib and heart failure. “It’s absolutely appropriate to consider catheter ablation” for heart failure patients, but the evidence is not yet there for guideline change, Dr. Yancy concluded.
It remains uncertain why catheter ablation of AFib should be more effective in patients with heart failure than in those without. Dr. Packer speculated that one reason may be the heart rate reduction that AFib ablation produces may especially benefit heart failure patients. An additional helpful effect of ablation in heart failure patients may be reducing heart rate variability. Another notable finding of the new analysis was that 79% of patients with heart failure in CABANA had heart failure with preserved ejection fraction, with a left ventricular ejection fraction of at least 50%. “Getting rid of AFib in patients with heart failure with preserved ejection fraction will be more important than we have thought,” Dr. Packer said.
Other new CABANA analyses presented for the first time in separate talks at the meeting also showed that, while catheter ablation had no meaningful difference in effect on outcomes based on the sex of patients, both age and minority ethnic and racial status appeared to make a substantial difference. For CABANA’s primary endpoint, catheter ablation was especially effective for improving outcomes in patients 64 years old or younger, and the analysis showed a signal of possibly worse outcomes in patients who were at least 75 years old. The “substantially” better outcomes in minority-group patients represented the largest between-group difference among subgroups seen in CABANA and is a “big deal,” said Dr. Packer, who predicted that future catheter ablation use will likely rise in patients with heart failure, in younger patients, and in minority patients.
Dr. Piccini noted that, “it’s possible that CABANA identified some patient subgroups that do really well after ablation, but the problem is that, in the United States, we now often don’t treat” minority patients or those with reduced left ventricular ejection fractions with ablation, according to recent registry findings.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Dr. Piccini has ties Boston Scientific, Medtronic, and numerous other drug and device companies, and disclosed an unspecified relationship with GlaxoSmithKline. Dr. Yancy disclosed an unspecified relationship with Abbott Laboratories.
SOURCE: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
SAN FRANCISCO – Catheter ablation of atrial fibrillation (AFib) in the roughly one-third of patients with heart failure enrolled in the CABANA multicenter, randomized trial produced striking, statistically significant improvements both in the study’s primary, combined endpoint and in all-cause mortality in intention-to-treat analyses.
These findings, from prespecified secondary analyses, contrasted with the study’s overall result, which showed no benefit in the primary endpoint analysis in the total study population of 2,204 patients with AFib (JAMA. 2019 Apr 2;321[13]:1261-74). They are also at odds with the primary endpoint result in the two-thirds of enrolled patients without heart failure, which showed no significant between-group differences in these two outcome measures among the patients assigned to the catheter ablation arm and the study’s control, which was medical management arm.
Among the 778 AFib patients enrolled in CABANA with any form of heart failure (35% of the total study enrollment), the incidence of the study’s primary endpoint – the combined rate of death, disabling stroke, serious bleeding, or cardiac arrest during a median follow-up of slightly more than 4 years – was 36% lower among the catheter-ablated heart failure patients than in the heart failure patients assigned to medical treatment, according to an intention-to-treat analysis, which was a statistically significant difference. The incidence of all-cause mortality during follow-up was 43% lower in the ablated heart failure patients, compared with the controls, Douglas L. Packer, MD, said at the annual scientific sessions of the Heart Rhythm Society.
In contrast, among enrolled patients without heart failure, the intention-to-treat primary endpoint was 6% higher in the ablated patients, and all-cause mortality was a relative 27% higher, although neither difference was statistically significant.
It’s a “little surprising” that the results showed this much benefit in the patients with heart failure, said Dr. Packer, professor of medicine at the Mayo Clinic in Rochester, Minn., and lead investigator of the CABANA (Catheter Ablation vs Anti-Arrhythmic Drug Therapy for Atrial Fibrillation) trial. “I think these data confirm the results of the CASTLE-AF trial, but without some of the glitches some people have cited” about that study, such as concerns about a high level of patient selection in CASTLE-AF and its relatively modest number of enrolled patients, he said in an interview.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) study, run entirely in patients with heart failure with reduced ejection fraction and AFib, showed a statistically significant improvement in patient survival and heart failure hospitalization after catheter ablation compared with medical management (N Engl J Med. 2018 Feb 1;378[5]:417-27). Prior to the CASTLE-AF report, results from several other small studies (J Interv Card Electrophysiol. 2018 Oct;53[1]:19-29), as well as those from the AATAC trial (Circulation. 2016 Apr 26;133[17]:1637-44), also showed consistent evidence for benefit from catheter ablation in patients with heart failure and AFib, noted CABANA coinvestigator Jonathan P. Piccini, MD, during a separate talk at the meeting.
“The improvement of cardiovascular outcomes with ablation in patients with heart failure and AFib is consistent across multiple trials, at least with respect to heart failure with reduced ejection fraction” concluded Dr. Piccini, a cardiac electrophysiologist at Duke University in Durham, N.C.
As a result of the new heart failure analysis, “I think the guidelines will change,” predicted Dr. Packer, with catheter ablation receiving a firmer endorsement for patients with heart failure the next time U.S. guidelines for heart failure and AFib management are updated. The findings say “there is substantial benefit of catheter ablation in heart failure patients, but I don’t think our findings lessen the utility of ablation in patients without heart failure,” he stressed. Even patients without heart failure showed reduction in AFib burden and improvement in quality of life that were similar to what was seen in the heart failure patients.
The new report from CABANA of benefit from AFib catheter ablation in patients with heart failure “absolutely advances the evidence,” commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago. “A number of us were quite circumspect about this based on the CASTLE-AF data, but the new CABANA analyses have addressed our anxiety that the CASTLE-AF results were just by chance.” The new CABANA analyses “may not confirm CASTLE-AF, but it enriches the conversation and makes it possible that we are seeing benefit in some patients with heart failure who get ablated.”
Dr. Yancy, who chaired the most recent update to the U.S. heart failure management guideline (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803) stopped short of saying that the cumulative evidence now supports a guideline change, but he acknowledged in an interview that the evidence could legitimately influence practice. Catheter ablation should now be “strongly considered” in patients with heart failure and AFib, he said, although he also had three qualifications for opting for this approach: Patients must already be on guideline-directed medical therapy for their heart failure, the catheter ablation needs to be performed by an experienced and skilled operator, and follow-up surveillance must focus on both the patient’s AFib and heart failure. “It’s absolutely appropriate to consider catheter ablation” for heart failure patients, but the evidence is not yet there for guideline change, Dr. Yancy concluded.
It remains uncertain why catheter ablation of AFib should be more effective in patients with heart failure than in those without. Dr. Packer speculated that one reason may be the heart rate reduction that AFib ablation produces may especially benefit heart failure patients. An additional helpful effect of ablation in heart failure patients may be reducing heart rate variability. Another notable finding of the new analysis was that 79% of patients with heart failure in CABANA had heart failure with preserved ejection fraction, with a left ventricular ejection fraction of at least 50%. “Getting rid of AFib in patients with heart failure with preserved ejection fraction will be more important than we have thought,” Dr. Packer said.
Other new CABANA analyses presented for the first time in separate talks at the meeting also showed that, while catheter ablation had no meaningful difference in effect on outcomes based on the sex of patients, both age and minority ethnic and racial status appeared to make a substantial difference. For CABANA’s primary endpoint, catheter ablation was especially effective for improving outcomes in patients 64 years old or younger, and the analysis showed a signal of possibly worse outcomes in patients who were at least 75 years old. The “substantially” better outcomes in minority-group patients represented the largest between-group difference among subgroups seen in CABANA and is a “big deal,” said Dr. Packer, who predicted that future catheter ablation use will likely rise in patients with heart failure, in younger patients, and in minority patients.
Dr. Piccini noted that, “it’s possible that CABANA identified some patient subgroups that do really well after ablation, but the problem is that, in the United States, we now often don’t treat” minority patients or those with reduced left ventricular ejection fractions with ablation, according to recent registry findings.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Dr. Piccini has ties Boston Scientific, Medtronic, and numerous other drug and device companies, and disclosed an unspecified relationship with GlaxoSmithKline. Dr. Yancy disclosed an unspecified relationship with Abbott Laboratories.
SOURCE: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
SAN FRANCISCO – Catheter ablation of atrial fibrillation (AFib) in the roughly one-third of patients with heart failure enrolled in the CABANA multicenter, randomized trial produced striking, statistically significant improvements both in the study’s primary, combined endpoint and in all-cause mortality in intention-to-treat analyses.
These findings, from prespecified secondary analyses, contrasted with the study’s overall result, which showed no benefit in the primary endpoint analysis in the total study population of 2,204 patients with AFib (JAMA. 2019 Apr 2;321[13]:1261-74). They are also at odds with the primary endpoint result in the two-thirds of enrolled patients without heart failure, which showed no significant between-group differences in these two outcome measures among the patients assigned to the catheter ablation arm and the study’s control, which was medical management arm.
Among the 778 AFib patients enrolled in CABANA with any form of heart failure (35% of the total study enrollment), the incidence of the study’s primary endpoint – the combined rate of death, disabling stroke, serious bleeding, or cardiac arrest during a median follow-up of slightly more than 4 years – was 36% lower among the catheter-ablated heart failure patients than in the heart failure patients assigned to medical treatment, according to an intention-to-treat analysis, which was a statistically significant difference. The incidence of all-cause mortality during follow-up was 43% lower in the ablated heart failure patients, compared with the controls, Douglas L. Packer, MD, said at the annual scientific sessions of the Heart Rhythm Society.
In contrast, among enrolled patients without heart failure, the intention-to-treat primary endpoint was 6% higher in the ablated patients, and all-cause mortality was a relative 27% higher, although neither difference was statistically significant.
It’s a “little surprising” that the results showed this much benefit in the patients with heart failure, said Dr. Packer, professor of medicine at the Mayo Clinic in Rochester, Minn., and lead investigator of the CABANA (Catheter Ablation vs Anti-Arrhythmic Drug Therapy for Atrial Fibrillation) trial. “I think these data confirm the results of the CASTLE-AF trial, but without some of the glitches some people have cited” about that study, such as concerns about a high level of patient selection in CASTLE-AF and its relatively modest number of enrolled patients, he said in an interview.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) study, run entirely in patients with heart failure with reduced ejection fraction and AFib, showed a statistically significant improvement in patient survival and heart failure hospitalization after catheter ablation compared with medical management (N Engl J Med. 2018 Feb 1;378[5]:417-27). Prior to the CASTLE-AF report, results from several other small studies (J Interv Card Electrophysiol. 2018 Oct;53[1]:19-29), as well as those from the AATAC trial (Circulation. 2016 Apr 26;133[17]:1637-44), also showed consistent evidence for benefit from catheter ablation in patients with heart failure and AFib, noted CABANA coinvestigator Jonathan P. Piccini, MD, during a separate talk at the meeting.
“The improvement of cardiovascular outcomes with ablation in patients with heart failure and AFib is consistent across multiple trials, at least with respect to heart failure with reduced ejection fraction” concluded Dr. Piccini, a cardiac electrophysiologist at Duke University in Durham, N.C.
As a result of the new heart failure analysis, “I think the guidelines will change,” predicted Dr. Packer, with catheter ablation receiving a firmer endorsement for patients with heart failure the next time U.S. guidelines for heart failure and AFib management are updated. The findings say “there is substantial benefit of catheter ablation in heart failure patients, but I don’t think our findings lessen the utility of ablation in patients without heart failure,” he stressed. Even patients without heart failure showed reduction in AFib burden and improvement in quality of life that were similar to what was seen in the heart failure patients.
The new report from CABANA of benefit from AFib catheter ablation in patients with heart failure “absolutely advances the evidence,” commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago. “A number of us were quite circumspect about this based on the CASTLE-AF data, but the new CABANA analyses have addressed our anxiety that the CASTLE-AF results were just by chance.” The new CABANA analyses “may not confirm CASTLE-AF, but it enriches the conversation and makes it possible that we are seeing benefit in some patients with heart failure who get ablated.”
Dr. Yancy, who chaired the most recent update to the U.S. heart failure management guideline (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803) stopped short of saying that the cumulative evidence now supports a guideline change, but he acknowledged in an interview that the evidence could legitimately influence practice. Catheter ablation should now be “strongly considered” in patients with heart failure and AFib, he said, although he also had three qualifications for opting for this approach: Patients must already be on guideline-directed medical therapy for their heart failure, the catheter ablation needs to be performed by an experienced and skilled operator, and follow-up surveillance must focus on both the patient’s AFib and heart failure. “It’s absolutely appropriate to consider catheter ablation” for heart failure patients, but the evidence is not yet there for guideline change, Dr. Yancy concluded.
It remains uncertain why catheter ablation of AFib should be more effective in patients with heart failure than in those without. Dr. Packer speculated that one reason may be the heart rate reduction that AFib ablation produces may especially benefit heart failure patients. An additional helpful effect of ablation in heart failure patients may be reducing heart rate variability. Another notable finding of the new analysis was that 79% of patients with heart failure in CABANA had heart failure with preserved ejection fraction, with a left ventricular ejection fraction of at least 50%. “Getting rid of AFib in patients with heart failure with preserved ejection fraction will be more important than we have thought,” Dr. Packer said.
Other new CABANA analyses presented for the first time in separate talks at the meeting also showed that, while catheter ablation had no meaningful difference in effect on outcomes based on the sex of patients, both age and minority ethnic and racial status appeared to make a substantial difference. For CABANA’s primary endpoint, catheter ablation was especially effective for improving outcomes in patients 64 years old or younger, and the analysis showed a signal of possibly worse outcomes in patients who were at least 75 years old. The “substantially” better outcomes in minority-group patients represented the largest between-group difference among subgroups seen in CABANA and is a “big deal,” said Dr. Packer, who predicted that future catheter ablation use will likely rise in patients with heart failure, in younger patients, and in minority patients.
Dr. Piccini noted that, “it’s possible that CABANA identified some patient subgroups that do really well after ablation, but the problem is that, in the United States, we now often don’t treat” minority patients or those with reduced left ventricular ejection fractions with ablation, according to recent registry findings.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Dr. Piccini has ties Boston Scientific, Medtronic, and numerous other drug and device companies, and disclosed an unspecified relationship with GlaxoSmithKline. Dr. Yancy disclosed an unspecified relationship with Abbott Laboratories.
SOURCE: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
REPORTING FROM HEART RHYTHM 2019
Key clinical point: Catheter ablation for atrial fibrillation is especially effective in patients with heart failure.
Major finding: Heart failure patients treated with catheter ablation had a 36% relative cut in the primary endpoint, compared with control patients.
Study details: CABANA, a multicenter, randomized trial with 2,204 patients, including 778 patients with heart failure.
Disclosures: CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Source: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
AFib on the rise in end-stage COPD patients hospitalized for exacerbations
Atrial fibrillation is being seen with increasing frequency in patients admitted to U.S. hospitals for exacerbations of end-stage chronic obstructive pulmonary disease, based on a retrospective analysis of data from the Nationwide Inpatient Sample.
The prevalence of atrial fibrillation (AFib) among patients with end-stage chronic obstructive pulmonary disease (COPD) on home oxygen who were admitted with COPD exacerbations increased from 12.9% in 2003 to 21.3% in 2014, according to Xiaochun Xiao of the department of health statistics at Second Military Medical University in Shanghai and colleagues.
Additionally, “we found that comorbid [AFib] was associated with an increased risk of the need for mechanical ventilation, especially invasive mechanical ventilation. Moreover, comorbid [AFib] was associated with adverse clinical outcomes, including increased in-hospital death, acute respiratory failure, acute kidney injury, sepsis, and stroke,” the researchers wrote in the study published in the journal CHEST.
Patients included in the study were aged at least 18 years, were diagnosed with end-stage COPD and on home oxygen, and were hospitalized because of a COPD-related exacerbation. Based on 1,345,270 weighted hospital admissions of adults with end-stage COPD on home oxygen who met the inclusion criteria for the study, 18.2% (244,488 admissions) of patients had AFib, and the prevalence of AFib in COPD patients increased over time from 2003 (12.9%) to 2014 (21.3%; P less than .0001).
Patients with AFib, compared with patients without AFib, were older (75.5 years vs. 69.6 years; P less than .0001) and more likely to be male (50.7% vs. 59.1%; P less than .0001) and white (80.9% vs. 74.4%; P less than .0001). Patients with AFib also had higher stroke risk reflected in higher CHA2DS2-VASc scores (3.26 vs. 2.45; P less than .0001), and higher likelihood of in-hospital mortality and readmission reflected in Elixhauser scores greater than or equal to 4 (51.2% vs. 35.6%).
In addition, the prevalence of AFib increased with increasing income. Larger hospitals in terms of bed size, urban environment, and Medicare insurance status also were associated with a higher AFib prevalence.
AFib was associated with an increased cost of $1,415 and an increased length of stay of 0.6 days after adjustment for potential confounders. AFib also predicted risk for several adverse events, including stroke (odds ratio, 1.80; in-hospital death, [OR, 1.54]), invasive mechanical ventilation (OR, 1.37), sepsis (OR, 1.23), noninvasive mechanical ventilation (OR, 1.14), acute kidney injury (OR, 1.09), and acute respiratory failure (OR, 1.09).
The researchers noted the database could have potentially overinflated AFib prevalence, as they could not differentiate index admissions and readmissions. The database also does not contain information about secondary diagnoses codes present on admission, which could make it difficult to identify adverse events that occurred during hospitalization.
“Our findings should prompt further efforts to identify the reasons for increased [AFib] prevalence and provide better management strategies for end-stage COPD patients comorbid with [AFib],” the researchers concluded.
This study was funded by a grant from the Fourth Round of the Shanghai 3-year Action Plan on Public Health Discipline and Talent Program. The authors reported no relevant conflict of interest.
SOURCE: Xiao X et al. CHEST. 2019 Jan 23. doi: 10.1016/j.chest.2018.12.021.
Atrial fibrillation is being seen with increasing frequency in patients admitted to U.S. hospitals for exacerbations of end-stage chronic obstructive pulmonary disease, based on a retrospective analysis of data from the Nationwide Inpatient Sample.
The prevalence of atrial fibrillation (AFib) among patients with end-stage chronic obstructive pulmonary disease (COPD) on home oxygen who were admitted with COPD exacerbations increased from 12.9% in 2003 to 21.3% in 2014, according to Xiaochun Xiao of the department of health statistics at Second Military Medical University in Shanghai and colleagues.
Additionally, “we found that comorbid [AFib] was associated with an increased risk of the need for mechanical ventilation, especially invasive mechanical ventilation. Moreover, comorbid [AFib] was associated with adverse clinical outcomes, including increased in-hospital death, acute respiratory failure, acute kidney injury, sepsis, and stroke,” the researchers wrote in the study published in the journal CHEST.
Patients included in the study were aged at least 18 years, were diagnosed with end-stage COPD and on home oxygen, and were hospitalized because of a COPD-related exacerbation. Based on 1,345,270 weighted hospital admissions of adults with end-stage COPD on home oxygen who met the inclusion criteria for the study, 18.2% (244,488 admissions) of patients had AFib, and the prevalence of AFib in COPD patients increased over time from 2003 (12.9%) to 2014 (21.3%; P less than .0001).
Patients with AFib, compared with patients without AFib, were older (75.5 years vs. 69.6 years; P less than .0001) and more likely to be male (50.7% vs. 59.1%; P less than .0001) and white (80.9% vs. 74.4%; P less than .0001). Patients with AFib also had higher stroke risk reflected in higher CHA2DS2-VASc scores (3.26 vs. 2.45; P less than .0001), and higher likelihood of in-hospital mortality and readmission reflected in Elixhauser scores greater than or equal to 4 (51.2% vs. 35.6%).
In addition, the prevalence of AFib increased with increasing income. Larger hospitals in terms of bed size, urban environment, and Medicare insurance status also were associated with a higher AFib prevalence.
AFib was associated with an increased cost of $1,415 and an increased length of stay of 0.6 days after adjustment for potential confounders. AFib also predicted risk for several adverse events, including stroke (odds ratio, 1.80; in-hospital death, [OR, 1.54]), invasive mechanical ventilation (OR, 1.37), sepsis (OR, 1.23), noninvasive mechanical ventilation (OR, 1.14), acute kidney injury (OR, 1.09), and acute respiratory failure (OR, 1.09).
The researchers noted the database could have potentially overinflated AFib prevalence, as they could not differentiate index admissions and readmissions. The database also does not contain information about secondary diagnoses codes present on admission, which could make it difficult to identify adverse events that occurred during hospitalization.
“Our findings should prompt further efforts to identify the reasons for increased [AFib] prevalence and provide better management strategies for end-stage COPD patients comorbid with [AFib],” the researchers concluded.
This study was funded by a grant from the Fourth Round of the Shanghai 3-year Action Plan on Public Health Discipline and Talent Program. The authors reported no relevant conflict of interest.
SOURCE: Xiao X et al. CHEST. 2019 Jan 23. doi: 10.1016/j.chest.2018.12.021.
Atrial fibrillation is being seen with increasing frequency in patients admitted to U.S. hospitals for exacerbations of end-stage chronic obstructive pulmonary disease, based on a retrospective analysis of data from the Nationwide Inpatient Sample.
The prevalence of atrial fibrillation (AFib) among patients with end-stage chronic obstructive pulmonary disease (COPD) on home oxygen who were admitted with COPD exacerbations increased from 12.9% in 2003 to 21.3% in 2014, according to Xiaochun Xiao of the department of health statistics at Second Military Medical University in Shanghai and colleagues.
Additionally, “we found that comorbid [AFib] was associated with an increased risk of the need for mechanical ventilation, especially invasive mechanical ventilation. Moreover, comorbid [AFib] was associated with adverse clinical outcomes, including increased in-hospital death, acute respiratory failure, acute kidney injury, sepsis, and stroke,” the researchers wrote in the study published in the journal CHEST.
Patients included in the study were aged at least 18 years, were diagnosed with end-stage COPD and on home oxygen, and were hospitalized because of a COPD-related exacerbation. Based on 1,345,270 weighted hospital admissions of adults with end-stage COPD on home oxygen who met the inclusion criteria for the study, 18.2% (244,488 admissions) of patients had AFib, and the prevalence of AFib in COPD patients increased over time from 2003 (12.9%) to 2014 (21.3%; P less than .0001).
Patients with AFib, compared with patients without AFib, were older (75.5 years vs. 69.6 years; P less than .0001) and more likely to be male (50.7% vs. 59.1%; P less than .0001) and white (80.9% vs. 74.4%; P less than .0001). Patients with AFib also had higher stroke risk reflected in higher CHA2DS2-VASc scores (3.26 vs. 2.45; P less than .0001), and higher likelihood of in-hospital mortality and readmission reflected in Elixhauser scores greater than or equal to 4 (51.2% vs. 35.6%).
In addition, the prevalence of AFib increased with increasing income. Larger hospitals in terms of bed size, urban environment, and Medicare insurance status also were associated with a higher AFib prevalence.
AFib was associated with an increased cost of $1,415 and an increased length of stay of 0.6 days after adjustment for potential confounders. AFib also predicted risk for several adverse events, including stroke (odds ratio, 1.80; in-hospital death, [OR, 1.54]), invasive mechanical ventilation (OR, 1.37), sepsis (OR, 1.23), noninvasive mechanical ventilation (OR, 1.14), acute kidney injury (OR, 1.09), and acute respiratory failure (OR, 1.09).
The researchers noted the database could have potentially overinflated AFib prevalence, as they could not differentiate index admissions and readmissions. The database also does not contain information about secondary diagnoses codes present on admission, which could make it difficult to identify adverse events that occurred during hospitalization.
“Our findings should prompt further efforts to identify the reasons for increased [AFib] prevalence and provide better management strategies for end-stage COPD patients comorbid with [AFib],” the researchers concluded.
This study was funded by a grant from the Fourth Round of the Shanghai 3-year Action Plan on Public Health Discipline and Talent Program. The authors reported no relevant conflict of interest.
SOURCE: Xiao X et al. CHEST. 2019 Jan 23. doi: 10.1016/j.chest.2018.12.021.
FROM CHEST
Key clinical point: Comorbid atrial fibrillation was associated with an increased risk of the need for mechanical ventilation, especially invasive mechanical ventilation, and of adverse outcomes including in-hospital death, acute respiratory failure, acute kidney injury, sepsis, and stroke.
Major finding: The prevalence of atrial fibrillation with end-stage chronic obstructive pulmonary disease increased over time from 2003 (12.9%) to 2014 (21.3%). Study details: A retrospective analysis based on 1,345,270 weighted hospital admissions of adults with end-stage chronic obstructive pulmonary disease on home oxygen from the Nationwide Impatient Sample during 2003-2014.
Disclosures: The study was funded by a grant from the Fourth Round of the Shanghai 3-Year Action Plan on Public Health Discipline and Talent Program. The authors reported no conflicts of interest.
Source: Xiao X et al. CHEST. 2019 Jan 23. doi: 10.1016/j.chest.2018.12.021.
Ultrasound’s arrhythmia localization surpassed ECG’s accuracy
SAN FRANCISCO – A new type of echocardiography that uses a high frame rate to track tissue motion allowed researchers to noninvasively map the source of cardiac arrhythmias in patients with significantly more precision than did standard 12-lead ECG recordings in a pilot, single-center study with 55 patients.
Electromechanical wave imaging (EWI) correctly identified the arrhythmia source in 53 of 55 (96%) patients scheduled to undergo arrhythmia ablation, whereas only 39 of the same 55 patients (71%) were correctly mapped using recordings from a standard 12-lead ECG read by several trained electrophysiologists. The findings from this pilot study suggested that EWI performed with noninvasive ultrasound can provide useful, added information to 12-lead ECG tracings to localize cardiac arrhythmias of various types prior to invasive procedures, Elaine Y. Wan, MD, said at the annual scientific sessions of the Heart Rhythm Society.
She cautioned, however, that future studies must still establish that adding EWI to standard preprocedural assessment can benefit patients by, for example, reducing their radiation dosages or shortening their procedure times.
Patients at Columbia University Medical Center in New York scheduled to undergo ablation for a cardiac arrhythmia first had noninvasive assessment with EWI and 12-lead ECG. Patients averaged 56 years old; 45% had an atrial flutter, 22% had Wolff-Parkinson-White syndrome accessory pathways, 20% had premature ventricular complexes, and 13% had an atrial tachycardia. The researchers used 3D electroanatomic arrhythmia mapping performed during ablation as the arrhythmia-localization standard against which they compared both the EWI and ECG results.
EWI can map cardiac electromechanical activity in all four heart chambers by tracking, with high temporal and spatial resolution, transient tissue deformations that occur in response to local electrical activation of cardiac myocytes, the depolarizations in cardiac muscle that produce tissue movement. The technique captures 2,000 image frames per second, creating a “video of tissue movement that lets us see where the movement started,” explained Dr. Wan, a cardiac electrophysiologist at Columbia.
Dr. Wan and associates previously reported use of EWI to successfully map accessory pathways in all 14 children with Wolff-Parkinson-White syndrome they tested versus success in 11 of these 14 patients (79%) when using expert interpretation of 12-lead ECG recordings (JACC Clin Electrophysiol. 2019 Apr;5[4]:427-37).
The new study is the first report on using EWI in adults, Dr. Wan noted. Advantages of EWI over 12-lead ECG include its lack of dependence on correct lead placement, and EWI does not share the inherent limitation of 12-lead ECG for localizing arrhythmias on the heart’s posterior wall, she said in a video interview.
SOURCE: Wan EY et al. Heart Rhythm 2019, Abstract S-LCT04-03.
SAN FRANCISCO – A new type of echocardiography that uses a high frame rate to track tissue motion allowed researchers to noninvasively map the source of cardiac arrhythmias in patients with significantly more precision than did standard 12-lead ECG recordings in a pilot, single-center study with 55 patients.
Electromechanical wave imaging (EWI) correctly identified the arrhythmia source in 53 of 55 (96%) patients scheduled to undergo arrhythmia ablation, whereas only 39 of the same 55 patients (71%) were correctly mapped using recordings from a standard 12-lead ECG read by several trained electrophysiologists. The findings from this pilot study suggested that EWI performed with noninvasive ultrasound can provide useful, added information to 12-lead ECG tracings to localize cardiac arrhythmias of various types prior to invasive procedures, Elaine Y. Wan, MD, said at the annual scientific sessions of the Heart Rhythm Society.
She cautioned, however, that future studies must still establish that adding EWI to standard preprocedural assessment can benefit patients by, for example, reducing their radiation dosages or shortening their procedure times.
Patients at Columbia University Medical Center in New York scheduled to undergo ablation for a cardiac arrhythmia first had noninvasive assessment with EWI and 12-lead ECG. Patients averaged 56 years old; 45% had an atrial flutter, 22% had Wolff-Parkinson-White syndrome accessory pathways, 20% had premature ventricular complexes, and 13% had an atrial tachycardia. The researchers used 3D electroanatomic arrhythmia mapping performed during ablation as the arrhythmia-localization standard against which they compared both the EWI and ECG results.
EWI can map cardiac electromechanical activity in all four heart chambers by tracking, with high temporal and spatial resolution, transient tissue deformations that occur in response to local electrical activation of cardiac myocytes, the depolarizations in cardiac muscle that produce tissue movement. The technique captures 2,000 image frames per second, creating a “video of tissue movement that lets us see where the movement started,” explained Dr. Wan, a cardiac electrophysiologist at Columbia.
Dr. Wan and associates previously reported use of EWI to successfully map accessory pathways in all 14 children with Wolff-Parkinson-White syndrome they tested versus success in 11 of these 14 patients (79%) when using expert interpretation of 12-lead ECG recordings (JACC Clin Electrophysiol. 2019 Apr;5[4]:427-37).
The new study is the first report on using EWI in adults, Dr. Wan noted. Advantages of EWI over 12-lead ECG include its lack of dependence on correct lead placement, and EWI does not share the inherent limitation of 12-lead ECG for localizing arrhythmias on the heart’s posterior wall, she said in a video interview.
SOURCE: Wan EY et al. Heart Rhythm 2019, Abstract S-LCT04-03.
SAN FRANCISCO – A new type of echocardiography that uses a high frame rate to track tissue motion allowed researchers to noninvasively map the source of cardiac arrhythmias in patients with significantly more precision than did standard 12-lead ECG recordings in a pilot, single-center study with 55 patients.
Electromechanical wave imaging (EWI) correctly identified the arrhythmia source in 53 of 55 (96%) patients scheduled to undergo arrhythmia ablation, whereas only 39 of the same 55 patients (71%) were correctly mapped using recordings from a standard 12-lead ECG read by several trained electrophysiologists. The findings from this pilot study suggested that EWI performed with noninvasive ultrasound can provide useful, added information to 12-lead ECG tracings to localize cardiac arrhythmias of various types prior to invasive procedures, Elaine Y. Wan, MD, said at the annual scientific sessions of the Heart Rhythm Society.
She cautioned, however, that future studies must still establish that adding EWI to standard preprocedural assessment can benefit patients by, for example, reducing their radiation dosages or shortening their procedure times.
Patients at Columbia University Medical Center in New York scheduled to undergo ablation for a cardiac arrhythmia first had noninvasive assessment with EWI and 12-lead ECG. Patients averaged 56 years old; 45% had an atrial flutter, 22% had Wolff-Parkinson-White syndrome accessory pathways, 20% had premature ventricular complexes, and 13% had an atrial tachycardia. The researchers used 3D electroanatomic arrhythmia mapping performed during ablation as the arrhythmia-localization standard against which they compared both the EWI and ECG results.
EWI can map cardiac electromechanical activity in all four heart chambers by tracking, with high temporal and spatial resolution, transient tissue deformations that occur in response to local electrical activation of cardiac myocytes, the depolarizations in cardiac muscle that produce tissue movement. The technique captures 2,000 image frames per second, creating a “video of tissue movement that lets us see where the movement started,” explained Dr. Wan, a cardiac electrophysiologist at Columbia.
Dr. Wan and associates previously reported use of EWI to successfully map accessory pathways in all 14 children with Wolff-Parkinson-White syndrome they tested versus success in 11 of these 14 patients (79%) when using expert interpretation of 12-lead ECG recordings (JACC Clin Electrophysiol. 2019 Apr;5[4]:427-37).
The new study is the first report on using EWI in adults, Dr. Wan noted. Advantages of EWI over 12-lead ECG include its lack of dependence on correct lead placement, and EWI does not share the inherent limitation of 12-lead ECG for localizing arrhythmias on the heart’s posterior wall, she said in a video interview.
SOURCE: Wan EY et al. Heart Rhythm 2019, Abstract S-LCT04-03.
REPORTING FROM HEART RHYTHM 2019
No raised risk of cardiovascular events for COPD patients on aclidinium
, compared with placebo, in a randomized trial of more than 3,000 patients.
Aclidinium, a long-acting muscarinic antagonist (LAMA), has been shown to reduce COPD exacerbation in the short term, but long-term effectiveness has not been examined, wrote Robert A. Wise, MD, of Johns Hopkins University, Baltimore, and colleagues.
ASCENT-COPD is a multicenter, double-blind, randomized, placebo-controlled, parallel-group noninferiority study conducted at 522 sites in the United States and Canada. A paper on recent data from ASCENT-COPD, published in JAMA, supports early findings reported last year at the American Thoracic Society meeting.
The researchers randomized adults with COPD to a 400-mg dose of aclidinium bromide twice daily, or placebo. The average age of the patients was 67 years; 59% were men. The median exposure time to aclidinium or placebo was 365 days during the first year of treatment, and the median exposure overall was 495 days for aclidinium patients and 478 days for placebo patients.
Of the 2,537 patients who completed the study, 69 (3.9%) in the aclidinium group and 76 (4.2%) in the placebo group experienced a major adverse cardiovascular event (MACE, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).
In addition, annual rates of moderate to severe COPD exacerbations were significantly lower in the aclidinium patients compared with placebo patients (0.44 vs. 0.57, P less than .001).
In a secondary analysis with a definition of MACE expanded to include heart failure, arrhythmias, or cerebrovascular disease, results remained similar between the groups; events occurred in 168 aclidinium patients (9.4%) and 160 placebo patients (8.9%). The rate of COPD exacerbations requiring hospitalization was significantly lower in aclidinium patients, compared with placebo patients (0.07 vs. 0.10, P = .006).
Overall, the most common treatment-emergent adverse events were similar in the aclidinium and placebo groups, respectively; pneumonia (6.1% vs. 5.8%), urinary tract infections (5.2% vs. 5.0%), and upper respiratory tract infections (4.8% vs. 5.6%). The most common serious adverse events (in at least 1% of patients) were pneumonia, atrial fibrillation, heart failure, and coronary artery disease. Dry mouth and urinary retention were rare, and occurred in less than 1% of patients in each group.
“No patient subgroup demonstrated a difference in efficacy except when analyzed by baseline COPD severity, in which the treatment benefit was observed only in patients with FEV1 [forced expiratory volume in 1 second] of 50% predicted or less,” the researchers noted. “This may be explained by the lower exacerbation rate seen in the placebo group in patients with moderate airway obstruction vs. severe or very severe obstruction,” they said.
“Outcomes of this trial add data to the long-standing controversy over the safety of LAMAs in COPD” and support the need for additional research, they said.
The study findings were limited by several factors including insufficient power to detect cause-specific mortality and the use of a LAMA with low risk of systemic effects, the researchers noted.
SOURCE: Wise R et al. JAMA. 2019. 321:1693-1701.
, compared with placebo, in a randomized trial of more than 3,000 patients.
Aclidinium, a long-acting muscarinic antagonist (LAMA), has been shown to reduce COPD exacerbation in the short term, but long-term effectiveness has not been examined, wrote Robert A. Wise, MD, of Johns Hopkins University, Baltimore, and colleagues.
ASCENT-COPD is a multicenter, double-blind, randomized, placebo-controlled, parallel-group noninferiority study conducted at 522 sites in the United States and Canada. A paper on recent data from ASCENT-COPD, published in JAMA, supports early findings reported last year at the American Thoracic Society meeting.
The researchers randomized adults with COPD to a 400-mg dose of aclidinium bromide twice daily, or placebo. The average age of the patients was 67 years; 59% were men. The median exposure time to aclidinium or placebo was 365 days during the first year of treatment, and the median exposure overall was 495 days for aclidinium patients and 478 days for placebo patients.
Of the 2,537 patients who completed the study, 69 (3.9%) in the aclidinium group and 76 (4.2%) in the placebo group experienced a major adverse cardiovascular event (MACE, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).
In addition, annual rates of moderate to severe COPD exacerbations were significantly lower in the aclidinium patients compared with placebo patients (0.44 vs. 0.57, P less than .001).
In a secondary analysis with a definition of MACE expanded to include heart failure, arrhythmias, or cerebrovascular disease, results remained similar between the groups; events occurred in 168 aclidinium patients (9.4%) and 160 placebo patients (8.9%). The rate of COPD exacerbations requiring hospitalization was significantly lower in aclidinium patients, compared with placebo patients (0.07 vs. 0.10, P = .006).
Overall, the most common treatment-emergent adverse events were similar in the aclidinium and placebo groups, respectively; pneumonia (6.1% vs. 5.8%), urinary tract infections (5.2% vs. 5.0%), and upper respiratory tract infections (4.8% vs. 5.6%). The most common serious adverse events (in at least 1% of patients) were pneumonia, atrial fibrillation, heart failure, and coronary artery disease. Dry mouth and urinary retention were rare, and occurred in less than 1% of patients in each group.
“No patient subgroup demonstrated a difference in efficacy except when analyzed by baseline COPD severity, in which the treatment benefit was observed only in patients with FEV1 [forced expiratory volume in 1 second] of 50% predicted or less,” the researchers noted. “This may be explained by the lower exacerbation rate seen in the placebo group in patients with moderate airway obstruction vs. severe or very severe obstruction,” they said.
“Outcomes of this trial add data to the long-standing controversy over the safety of LAMAs in COPD” and support the need for additional research, they said.
The study findings were limited by several factors including insufficient power to detect cause-specific mortality and the use of a LAMA with low risk of systemic effects, the researchers noted.
SOURCE: Wise R et al. JAMA. 2019. 321:1693-1701.
, compared with placebo, in a randomized trial of more than 3,000 patients.
Aclidinium, a long-acting muscarinic antagonist (LAMA), has been shown to reduce COPD exacerbation in the short term, but long-term effectiveness has not been examined, wrote Robert A. Wise, MD, of Johns Hopkins University, Baltimore, and colleagues.
ASCENT-COPD is a multicenter, double-blind, randomized, placebo-controlled, parallel-group noninferiority study conducted at 522 sites in the United States and Canada. A paper on recent data from ASCENT-COPD, published in JAMA, supports early findings reported last year at the American Thoracic Society meeting.
The researchers randomized adults with COPD to a 400-mg dose of aclidinium bromide twice daily, or placebo. The average age of the patients was 67 years; 59% were men. The median exposure time to aclidinium or placebo was 365 days during the first year of treatment, and the median exposure overall was 495 days for aclidinium patients and 478 days for placebo patients.
Of the 2,537 patients who completed the study, 69 (3.9%) in the aclidinium group and 76 (4.2%) in the placebo group experienced a major adverse cardiovascular event (MACE, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).
In addition, annual rates of moderate to severe COPD exacerbations were significantly lower in the aclidinium patients compared with placebo patients (0.44 vs. 0.57, P less than .001).
In a secondary analysis with a definition of MACE expanded to include heart failure, arrhythmias, or cerebrovascular disease, results remained similar between the groups; events occurred in 168 aclidinium patients (9.4%) and 160 placebo patients (8.9%). The rate of COPD exacerbations requiring hospitalization was significantly lower in aclidinium patients, compared with placebo patients (0.07 vs. 0.10, P = .006).
Overall, the most common treatment-emergent adverse events were similar in the aclidinium and placebo groups, respectively; pneumonia (6.1% vs. 5.8%), urinary tract infections (5.2% vs. 5.0%), and upper respiratory tract infections (4.8% vs. 5.6%). The most common serious adverse events (in at least 1% of patients) were pneumonia, atrial fibrillation, heart failure, and coronary artery disease. Dry mouth and urinary retention were rare, and occurred in less than 1% of patients in each group.
“No patient subgroup demonstrated a difference in efficacy except when analyzed by baseline COPD severity, in which the treatment benefit was observed only in patients with FEV1 [forced expiratory volume in 1 second] of 50% predicted or less,” the researchers noted. “This may be explained by the lower exacerbation rate seen in the placebo group in patients with moderate airway obstruction vs. severe or very severe obstruction,” they said.
“Outcomes of this trial add data to the long-standing controversy over the safety of LAMAs in COPD” and support the need for additional research, they said.
The study findings were limited by several factors including insufficient power to detect cause-specific mortality and the use of a LAMA with low risk of systemic effects, the researchers noted.
SOURCE: Wise R et al. JAMA. 2019. 321:1693-1701.
FROM JAMA
New risk score predicts cardiac-device infection
SAN FRANCISCO – Researchers have devised a five-item scoring formula to quantify the risk for infection in patients undergoing placement, revision, or removal of a cardiac-rhythm device based on data from nearly 20,000 patients enrolled in a recent infection-prophylaxis trial.
The risk score can help identify patients who might benefit from intensified antibiotic prophylaxis, and it can also help during shared decision making with patients to better understand the risk a patient faces from infection, compared with their predicted device benefit, David H. Birnie, MD, said at the annual scientific sessions of the Heart Rhythm Society.
The new risk score produced a concordance statistic, the area under the receiver-operator characteristic curve, of 0.704. It showed that, although it could use further validation, the score as it currently stands has substantial predictive value, said Dr. Birnie, professor of medicine at the University of Ottawa and deputy chief of cardiology at the University of Ottawa Heart Institute. “It’s certainly better than anything we have now,” he said in a video interview.
Dr. Birnie and his associates used data they collected on baseline characteristics and infection outcomes of the 19,603 patients enrolled in PADIT (Prevention of Arrhythmia Device Infection Trial) who underwent a rhythm-device procedure at 1 of 28 participating Canadian centers. The primary aim of PADIT was to assess the safety and efficacy of an intensified antibiotic-prophylaxis regimen, compared with a standard regimen of a cefazolin infusion just before the procedure. The study’s primary endpoint was the incidence of hospitalization for device infection during 1-year follow-up, and while the intensified prophylactic regimen linked with a 23% relative reduction in the hospitalization rate, compared with standard treatment, the difference was not statistically significant (J Am Coll Cardiol. 2018 Dec 18;72[24]:3098-109).
The researchers analyzed the baseline patient data and the blindly adjudicated infection outcomes and identified five factors that were independently associated with an increased infection rate. They organized the five factors and produced a formula they call the PADIT score (see chart). Those five factors are: prior procedures (the greater the number the greater the risk), age (which unexpectedly had an inverse relationship with infection incidence), depressed renal function, immuno-compromised status, and type of procedure. A patient can potentially score 0-15 points.
Among the PADIT patients a score of 0 correlated with about a 0.3% rate of hospitalization for a device-related infection during 1 year of follow-up, a score of 5 with about a 1.1% rate, a score of 6 with about a 1.8% rate, and a score of seven or more with a 3.4% infection rate over the following year. About 5% of patients had a score of 7 or more, and roughly another 5% had a score of 5 or 6, Dr. Birnie said. At his center, clinicians have begun routinely calculating scores for patients scheduled for an arrhythmia-device procedure, and they are considering routinely administering added antibiotic prophylaxis to patients with a preprocedural score of 6 or higher. They may also use the score to determine whether to use the antibacterial envelope recently reported to prevent cardiac-device infections (N Engl J Med. 2019 May 16;380[20]:1895-905).
“It’s very easy for patients to get to a PADIT score of 7 or higher,” Dr. Birnie noted. As an example, he cited a common patient, an 85-year-old with renal dysfunction who is under consideration for a second replacement of an implantable cardioverter defibrillator. The patient would score 1 point for renal insufficiency, 2 points for the type of device, and 4 points for having a prior history of two devices, and the consequent 3.4% risk for infection might counterbalance the potential benefit this elderly patient could expect from the new device. The score will be very important for targeting treatment, shared decision making, and selection of patients for future intervention trials, he concluded.
“I think this risk score will change practice by giving clinicians a better idea of a patient’s risk for infection,” commented Fred M. Kusumoto, MD, professor of medicine at the Mayo Medical School, Rochester, Minn., and director of heart rhythm services at the Mayo Clinic in Jacksonville, Fla. The PADIT score will help identify patients for whom leaving a device in place is a better option than taking it out because of their infection risk. The risk score could also help improve the cost effectiveness of preventive treatments, such as antibiotic-eluting envelopes, by targeting treatment to higher-risk patients, Dr. Kusumoto said during a press briefing.
SOURCE: Birnie DH. Heart Rhythm 2019, Absract S-LCT02-01.
I like this new infection risk score. It addresses a very clinically relevant issue. It’s important for the electrophysiology community to better understand how to best manage infections related to cardiac rhythm devices and ideally prevent them from happening.
I’m not a big fan of risk scores in general because they can sometimes detract from independent thinking about how to manage a patient. However, it is also helpful to have this type of risk-assessment information when discussing management options with a patient.
The PADIT risk score may also help identify which patients could potentially benefit the most from an antibiotic-eluting envelope when receiving an implanted cardiac-rhythm device. Recently reported results from WRAP-IT showed that routinely using envelopes cut the incidence of major infections by a relative 40%, but in absolute terms, the number needed to treat with the envelop to prevent one major infection was about 200 patients, a big number given the high cost of the envelope (N Engl J Med. 2019 May 16;380[20]:1895-905). It is therefore very interesting to think about using the PADIT risk score to better target an effective but expensive preventive measure like an antibiotic-eluting envelop to patients at the highest risk for infection.
Ulrika Birgersdotter-Green, MD , professor of medicine and director of pacemaker and ICD services at the University of California, San Diego, made these comments as a designated discussant for the report. She has been a consultant to and received honoraria from Abbott, Boston Scientific, and Medtronic.
I like this new infection risk score. It addresses a very clinically relevant issue. It’s important for the electrophysiology community to better understand how to best manage infections related to cardiac rhythm devices and ideally prevent them from happening.
I’m not a big fan of risk scores in general because they can sometimes detract from independent thinking about how to manage a patient. However, it is also helpful to have this type of risk-assessment information when discussing management options with a patient.
The PADIT risk score may also help identify which patients could potentially benefit the most from an antibiotic-eluting envelope when receiving an implanted cardiac-rhythm device. Recently reported results from WRAP-IT showed that routinely using envelopes cut the incidence of major infections by a relative 40%, but in absolute terms, the number needed to treat with the envelop to prevent one major infection was about 200 patients, a big number given the high cost of the envelope (N Engl J Med. 2019 May 16;380[20]:1895-905). It is therefore very interesting to think about using the PADIT risk score to better target an effective but expensive preventive measure like an antibiotic-eluting envelop to patients at the highest risk for infection.
Ulrika Birgersdotter-Green, MD , professor of medicine and director of pacemaker and ICD services at the University of California, San Diego, made these comments as a designated discussant for the report. She has been a consultant to and received honoraria from Abbott, Boston Scientific, and Medtronic.
I like this new infection risk score. It addresses a very clinically relevant issue. It’s important for the electrophysiology community to better understand how to best manage infections related to cardiac rhythm devices and ideally prevent them from happening.
I’m not a big fan of risk scores in general because they can sometimes detract from independent thinking about how to manage a patient. However, it is also helpful to have this type of risk-assessment information when discussing management options with a patient.
The PADIT risk score may also help identify which patients could potentially benefit the most from an antibiotic-eluting envelope when receiving an implanted cardiac-rhythm device. Recently reported results from WRAP-IT showed that routinely using envelopes cut the incidence of major infections by a relative 40%, but in absolute terms, the number needed to treat with the envelop to prevent one major infection was about 200 patients, a big number given the high cost of the envelope (N Engl J Med. 2019 May 16;380[20]:1895-905). It is therefore very interesting to think about using the PADIT risk score to better target an effective but expensive preventive measure like an antibiotic-eluting envelop to patients at the highest risk for infection.
Ulrika Birgersdotter-Green, MD , professor of medicine and director of pacemaker and ICD services at the University of California, San Diego, made these comments as a designated discussant for the report. She has been a consultant to and received honoraria from Abbott, Boston Scientific, and Medtronic.
SAN FRANCISCO – Researchers have devised a five-item scoring formula to quantify the risk for infection in patients undergoing placement, revision, or removal of a cardiac-rhythm device based on data from nearly 20,000 patients enrolled in a recent infection-prophylaxis trial.
The risk score can help identify patients who might benefit from intensified antibiotic prophylaxis, and it can also help during shared decision making with patients to better understand the risk a patient faces from infection, compared with their predicted device benefit, David H. Birnie, MD, said at the annual scientific sessions of the Heart Rhythm Society.
The new risk score produced a concordance statistic, the area under the receiver-operator characteristic curve, of 0.704. It showed that, although it could use further validation, the score as it currently stands has substantial predictive value, said Dr. Birnie, professor of medicine at the University of Ottawa and deputy chief of cardiology at the University of Ottawa Heart Institute. “It’s certainly better than anything we have now,” he said in a video interview.
Dr. Birnie and his associates used data they collected on baseline characteristics and infection outcomes of the 19,603 patients enrolled in PADIT (Prevention of Arrhythmia Device Infection Trial) who underwent a rhythm-device procedure at 1 of 28 participating Canadian centers. The primary aim of PADIT was to assess the safety and efficacy of an intensified antibiotic-prophylaxis regimen, compared with a standard regimen of a cefazolin infusion just before the procedure. The study’s primary endpoint was the incidence of hospitalization for device infection during 1-year follow-up, and while the intensified prophylactic regimen linked with a 23% relative reduction in the hospitalization rate, compared with standard treatment, the difference was not statistically significant (J Am Coll Cardiol. 2018 Dec 18;72[24]:3098-109).
The researchers analyzed the baseline patient data and the blindly adjudicated infection outcomes and identified five factors that were independently associated with an increased infection rate. They organized the five factors and produced a formula they call the PADIT score (see chart). Those five factors are: prior procedures (the greater the number the greater the risk), age (which unexpectedly had an inverse relationship with infection incidence), depressed renal function, immuno-compromised status, and type of procedure. A patient can potentially score 0-15 points.
Among the PADIT patients a score of 0 correlated with about a 0.3% rate of hospitalization for a device-related infection during 1 year of follow-up, a score of 5 with about a 1.1% rate, a score of 6 with about a 1.8% rate, and a score of seven or more with a 3.4% infection rate over the following year. About 5% of patients had a score of 7 or more, and roughly another 5% had a score of 5 or 6, Dr. Birnie said. At his center, clinicians have begun routinely calculating scores for patients scheduled for an arrhythmia-device procedure, and they are considering routinely administering added antibiotic prophylaxis to patients with a preprocedural score of 6 or higher. They may also use the score to determine whether to use the antibacterial envelope recently reported to prevent cardiac-device infections (N Engl J Med. 2019 May 16;380[20]:1895-905).
“It’s very easy for patients to get to a PADIT score of 7 or higher,” Dr. Birnie noted. As an example, he cited a common patient, an 85-year-old with renal dysfunction who is under consideration for a second replacement of an implantable cardioverter defibrillator. The patient would score 1 point for renal insufficiency, 2 points for the type of device, and 4 points for having a prior history of two devices, and the consequent 3.4% risk for infection might counterbalance the potential benefit this elderly patient could expect from the new device. The score will be very important for targeting treatment, shared decision making, and selection of patients for future intervention trials, he concluded.
“I think this risk score will change practice by giving clinicians a better idea of a patient’s risk for infection,” commented Fred M. Kusumoto, MD, professor of medicine at the Mayo Medical School, Rochester, Minn., and director of heart rhythm services at the Mayo Clinic in Jacksonville, Fla. The PADIT score will help identify patients for whom leaving a device in place is a better option than taking it out because of their infection risk. The risk score could also help improve the cost effectiveness of preventive treatments, such as antibiotic-eluting envelopes, by targeting treatment to higher-risk patients, Dr. Kusumoto said during a press briefing.
SOURCE: Birnie DH. Heart Rhythm 2019, Absract S-LCT02-01.
SAN FRANCISCO – Researchers have devised a five-item scoring formula to quantify the risk for infection in patients undergoing placement, revision, or removal of a cardiac-rhythm device based on data from nearly 20,000 patients enrolled in a recent infection-prophylaxis trial.
The risk score can help identify patients who might benefit from intensified antibiotic prophylaxis, and it can also help during shared decision making with patients to better understand the risk a patient faces from infection, compared with their predicted device benefit, David H. Birnie, MD, said at the annual scientific sessions of the Heart Rhythm Society.
The new risk score produced a concordance statistic, the area under the receiver-operator characteristic curve, of 0.704. It showed that, although it could use further validation, the score as it currently stands has substantial predictive value, said Dr. Birnie, professor of medicine at the University of Ottawa and deputy chief of cardiology at the University of Ottawa Heart Institute. “It’s certainly better than anything we have now,” he said in a video interview.
Dr. Birnie and his associates used data they collected on baseline characteristics and infection outcomes of the 19,603 patients enrolled in PADIT (Prevention of Arrhythmia Device Infection Trial) who underwent a rhythm-device procedure at 1 of 28 participating Canadian centers. The primary aim of PADIT was to assess the safety and efficacy of an intensified antibiotic-prophylaxis regimen, compared with a standard regimen of a cefazolin infusion just before the procedure. The study’s primary endpoint was the incidence of hospitalization for device infection during 1-year follow-up, and while the intensified prophylactic regimen linked with a 23% relative reduction in the hospitalization rate, compared with standard treatment, the difference was not statistically significant (J Am Coll Cardiol. 2018 Dec 18;72[24]:3098-109).
The researchers analyzed the baseline patient data and the blindly adjudicated infection outcomes and identified five factors that were independently associated with an increased infection rate. They organized the five factors and produced a formula they call the PADIT score (see chart). Those five factors are: prior procedures (the greater the number the greater the risk), age (which unexpectedly had an inverse relationship with infection incidence), depressed renal function, immuno-compromised status, and type of procedure. A patient can potentially score 0-15 points.
Among the PADIT patients a score of 0 correlated with about a 0.3% rate of hospitalization for a device-related infection during 1 year of follow-up, a score of 5 with about a 1.1% rate, a score of 6 with about a 1.8% rate, and a score of seven or more with a 3.4% infection rate over the following year. About 5% of patients had a score of 7 or more, and roughly another 5% had a score of 5 or 6, Dr. Birnie said. At his center, clinicians have begun routinely calculating scores for patients scheduled for an arrhythmia-device procedure, and they are considering routinely administering added antibiotic prophylaxis to patients with a preprocedural score of 6 or higher. They may also use the score to determine whether to use the antibacterial envelope recently reported to prevent cardiac-device infections (N Engl J Med. 2019 May 16;380[20]:1895-905).
“It’s very easy for patients to get to a PADIT score of 7 or higher,” Dr. Birnie noted. As an example, he cited a common patient, an 85-year-old with renal dysfunction who is under consideration for a second replacement of an implantable cardioverter defibrillator. The patient would score 1 point for renal insufficiency, 2 points for the type of device, and 4 points for having a prior history of two devices, and the consequent 3.4% risk for infection might counterbalance the potential benefit this elderly patient could expect from the new device. The score will be very important for targeting treatment, shared decision making, and selection of patients for future intervention trials, he concluded.
“I think this risk score will change practice by giving clinicians a better idea of a patient’s risk for infection,” commented Fred M. Kusumoto, MD, professor of medicine at the Mayo Medical School, Rochester, Minn., and director of heart rhythm services at the Mayo Clinic in Jacksonville, Fla. The PADIT score will help identify patients for whom leaving a device in place is a better option than taking it out because of their infection risk. The risk score could also help improve the cost effectiveness of preventive treatments, such as antibiotic-eluting envelopes, by targeting treatment to higher-risk patients, Dr. Kusumoto said during a press briefing.
SOURCE: Birnie DH. Heart Rhythm 2019, Absract S-LCT02-01.
REPORTING FROM HEART RHYTHM 2019
Key clinical point: Researchers have devised a five-item scoring formula to predict a patient’s risk for infection from an cardiac rhythm–device procedure.
Major finding: The risk score had an optimism-corrected concordance statistic of 0.704.
Study details: Investigators developed the risk score using data from PADIT, a multicenter, randomized trial with 19,603 patients.
Disclosures: PADIT received no commercial funding. Dr. Birnie had no relevant disclosures.
Source: Birnie DH. Heart Rhythm 2019, Absract S-LCT02-01.
AFib screening cuts hospitalizations and ED visits
NEW ORLEANS – People diagnosed with atrial fibrillation by screening with a wearable ECG patch had significantly fewer emergency department visits or hospital admissions, compared with similar people diagnosed with atrial fibrillation by usual-care surveillance in an observational study with 5,109 total participants.
People diagnosed with atrial fibrillation (AFib) through screening had a statistically significant 80% relative cut in hospitalizations and a 65% cut in emergency department visits during 12 months of follow-up, compared with controls in the study who had their AFib identified and diagnosed as part of routine practice, Steven R. Steinhubl, MD, said at the annual meeting of the American College of Cardiology.
The data also showed no difference between the screened and control patients identified with AFib in the average number of cardiologist consultations during a year of follow-up, and a trend that missed statistical significance for 16% fewer primary care physician visits in Afib patients diagnosed by screening rather than by routine surveillance.
These findings provided some insight into the potential clinical impact of AFib screening in at-risk people. Dr. Steinhubl and his associates plan to report on the incidence of strokes and MIs in the two study subgroups after 3 years of follow-up, but he noted that preliminary findings for these two outcomes after 1 year indicated that active screening for AFib also had reduced these rates, compared with waiting for the arrhythmia to become apparent by emergence of symptoms.
The data came from the mSToPS (mHealth Screening to Prevent Strokes) study, which randomized 2,659 U.S. residents enrolled in a large health plan who had risk factors for AFib to either immediate or delayed arrhythmia assessment by ECG patches. Half the participants used a patch for about 14 days immediately and then a second time 3 months later, while the other half waited 4 months and then wore an ECG patch for 2 weeks and again 3 months later. The primary endpoint, first reported at the ACC annual meeting a year before and subsequently published, was the incidence of newly diagnosed AFib during the first 4 months in the actively monitored cohort, compared with a cohort followed by usual care. The results showed that screening identified AFib in 3.9% of people, while no screening and usual-practice follow-up identified a 0.9% incidence of AFib, showing that screening worked better for AFib case identification (JAMA. 2018 Jul 10;320[2]:146-55).
To examine the clinical impact of screening and an increased incidence of diagnosed AFib cases, Dr. Steinhubl and his associates focused on 1,725 of the original 2,659 patients who underwent ECG patch assessment, either immediate or delayed, and continued through 12 months of follow-up, and compared them with 3,384 matched controls who never underwent ECG patch screening but were also followed for 12 months for incident AFib identified during routine care and surveillance. This resulted in a cumulative incidence of newly diagnosed AFib of 6.3% in those who had worn two ECG patches and 2.3% among the matched controls.
During follow-up, use of various interventions was more common among the screened people than the controls. Initiation of anticoagulation treatment started in 4.0% of the entire screened group, compared with 1.9% of the controls, The screened people also had a 0.9% rate of receiving a pacemaker or defibrillator, a 0.8% rate of starting on treatment with an antiarrhythmic drug, and a 0.3% rate of undergoing catheter ablation, compared with none, 0.3%, and one of the controls, respectively, said Dr. Steinhubl, director of digital medicine at the Scripps Research Translational Institute in La Jolla, Calif.
The mSToPS study was funded by Janssen. Dr. Steinhubl has received research funding from DynoSense, EasyG, Janssen, the Qualcomm Foundation, and Striv.
SOURCE: Steinhubl SR et al. J Am Coll Cardiol. 2019 Mar 12;73(9)suppl 1:296.
NEW ORLEANS – People diagnosed with atrial fibrillation by screening with a wearable ECG patch had significantly fewer emergency department visits or hospital admissions, compared with similar people diagnosed with atrial fibrillation by usual-care surveillance in an observational study with 5,109 total participants.
People diagnosed with atrial fibrillation (AFib) through screening had a statistically significant 80% relative cut in hospitalizations and a 65% cut in emergency department visits during 12 months of follow-up, compared with controls in the study who had their AFib identified and diagnosed as part of routine practice, Steven R. Steinhubl, MD, said at the annual meeting of the American College of Cardiology.
The data also showed no difference between the screened and control patients identified with AFib in the average number of cardiologist consultations during a year of follow-up, and a trend that missed statistical significance for 16% fewer primary care physician visits in Afib patients diagnosed by screening rather than by routine surveillance.
These findings provided some insight into the potential clinical impact of AFib screening in at-risk people. Dr. Steinhubl and his associates plan to report on the incidence of strokes and MIs in the two study subgroups after 3 years of follow-up, but he noted that preliminary findings for these two outcomes after 1 year indicated that active screening for AFib also had reduced these rates, compared with waiting for the arrhythmia to become apparent by emergence of symptoms.
The data came from the mSToPS (mHealth Screening to Prevent Strokes) study, which randomized 2,659 U.S. residents enrolled in a large health plan who had risk factors for AFib to either immediate or delayed arrhythmia assessment by ECG patches. Half the participants used a patch for about 14 days immediately and then a second time 3 months later, while the other half waited 4 months and then wore an ECG patch for 2 weeks and again 3 months later. The primary endpoint, first reported at the ACC annual meeting a year before and subsequently published, was the incidence of newly diagnosed AFib during the first 4 months in the actively monitored cohort, compared with a cohort followed by usual care. The results showed that screening identified AFib in 3.9% of people, while no screening and usual-practice follow-up identified a 0.9% incidence of AFib, showing that screening worked better for AFib case identification (JAMA. 2018 Jul 10;320[2]:146-55).
To examine the clinical impact of screening and an increased incidence of diagnosed AFib cases, Dr. Steinhubl and his associates focused on 1,725 of the original 2,659 patients who underwent ECG patch assessment, either immediate or delayed, and continued through 12 months of follow-up, and compared them with 3,384 matched controls who never underwent ECG patch screening but were also followed for 12 months for incident AFib identified during routine care and surveillance. This resulted in a cumulative incidence of newly diagnosed AFib of 6.3% in those who had worn two ECG patches and 2.3% among the matched controls.
During follow-up, use of various interventions was more common among the screened people than the controls. Initiation of anticoagulation treatment started in 4.0% of the entire screened group, compared with 1.9% of the controls, The screened people also had a 0.9% rate of receiving a pacemaker or defibrillator, a 0.8% rate of starting on treatment with an antiarrhythmic drug, and a 0.3% rate of undergoing catheter ablation, compared with none, 0.3%, and one of the controls, respectively, said Dr. Steinhubl, director of digital medicine at the Scripps Research Translational Institute in La Jolla, Calif.
The mSToPS study was funded by Janssen. Dr. Steinhubl has received research funding from DynoSense, EasyG, Janssen, the Qualcomm Foundation, and Striv.
SOURCE: Steinhubl SR et al. J Am Coll Cardiol. 2019 Mar 12;73(9)suppl 1:296.
NEW ORLEANS – People diagnosed with atrial fibrillation by screening with a wearable ECG patch had significantly fewer emergency department visits or hospital admissions, compared with similar people diagnosed with atrial fibrillation by usual-care surveillance in an observational study with 5,109 total participants.
People diagnosed with atrial fibrillation (AFib) through screening had a statistically significant 80% relative cut in hospitalizations and a 65% cut in emergency department visits during 12 months of follow-up, compared with controls in the study who had their AFib identified and diagnosed as part of routine practice, Steven R. Steinhubl, MD, said at the annual meeting of the American College of Cardiology.
The data also showed no difference between the screened and control patients identified with AFib in the average number of cardiologist consultations during a year of follow-up, and a trend that missed statistical significance for 16% fewer primary care physician visits in Afib patients diagnosed by screening rather than by routine surveillance.
These findings provided some insight into the potential clinical impact of AFib screening in at-risk people. Dr. Steinhubl and his associates plan to report on the incidence of strokes and MIs in the two study subgroups after 3 years of follow-up, but he noted that preliminary findings for these two outcomes after 1 year indicated that active screening for AFib also had reduced these rates, compared with waiting for the arrhythmia to become apparent by emergence of symptoms.
The data came from the mSToPS (mHealth Screening to Prevent Strokes) study, which randomized 2,659 U.S. residents enrolled in a large health plan who had risk factors for AFib to either immediate or delayed arrhythmia assessment by ECG patches. Half the participants used a patch for about 14 days immediately and then a second time 3 months later, while the other half waited 4 months and then wore an ECG patch for 2 weeks and again 3 months later. The primary endpoint, first reported at the ACC annual meeting a year before and subsequently published, was the incidence of newly diagnosed AFib during the first 4 months in the actively monitored cohort, compared with a cohort followed by usual care. The results showed that screening identified AFib in 3.9% of people, while no screening and usual-practice follow-up identified a 0.9% incidence of AFib, showing that screening worked better for AFib case identification (JAMA. 2018 Jul 10;320[2]:146-55).
To examine the clinical impact of screening and an increased incidence of diagnosed AFib cases, Dr. Steinhubl and his associates focused on 1,725 of the original 2,659 patients who underwent ECG patch assessment, either immediate or delayed, and continued through 12 months of follow-up, and compared them with 3,384 matched controls who never underwent ECG patch screening but were also followed for 12 months for incident AFib identified during routine care and surveillance. This resulted in a cumulative incidence of newly diagnosed AFib of 6.3% in those who had worn two ECG patches and 2.3% among the matched controls.
During follow-up, use of various interventions was more common among the screened people than the controls. Initiation of anticoagulation treatment started in 4.0% of the entire screened group, compared with 1.9% of the controls, The screened people also had a 0.9% rate of receiving a pacemaker or defibrillator, a 0.8% rate of starting on treatment with an antiarrhythmic drug, and a 0.3% rate of undergoing catheter ablation, compared with none, 0.3%, and one of the controls, respectively, said Dr. Steinhubl, director of digital medicine at the Scripps Research Translational Institute in La Jolla, Calif.
The mSToPS study was funded by Janssen. Dr. Steinhubl has received research funding from DynoSense, EasyG, Janssen, the Qualcomm Foundation, and Striv.
SOURCE: Steinhubl SR et al. J Am Coll Cardiol. 2019 Mar 12;73(9)suppl 1:296.
REPORTING FROM ACC 2019