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Early or delayed AFib ablation after heart failure hospitalization?
TOPLINE:
Among patients with atrial fibrillation (AFib) hospitalized for worsening heart failure (HF), catheter (cath) ablation within 90 days of admission, compared with other times, is associated with reduced risk for all-cause mortality and HF-related mortality.
METHODOLOGY:
Cath ablation has become technically safer for patients with both AFib and HF, but the best timing for the ablation procedure after HF hospitalization has been unclear.
The study included 2,786 patients with HF who underwent cath ablation for AFib at 128 centers in the nationwide Japanese Registry of Acute Decompensated Heart Failure, were hospitalized with worsening HF, and survived at least 90 days after discharge.
The population included 103 individuals who underwent cath ablation within 90 days after admission; the remaining 2,683 participants served as the control group.
The researchers also looked at all-cause mortality 90 days after admission for HF in analysis of 83 early-ablation cases vs. 83 propensity-matched controls.
TAKEAWAY:
The early–cath ablation group was younger, predominantly male, had less history of prior HF hospitalizations, and greater incidence of paroxysmal AF, compared with the control group.
All-cause mortality was significantly lower in the early–cath ablation group than in the control group (hazard ratio, 0.38; 95% confidence interval, 0.24-0.60; P < .001) over a median of 4.1 years.
Risk reductions were similarly significant for secondary endpoints, including cardiovascular (CV) mortality and HF mortality.
In the matched cohort analysis (83 in both groups) all-cause mortality was significantly reduced for those in the early–cath ablation group, compared with the matched controls (HR, 0.47; 95% CI, 0.25-0.88; P = .014), with similarly significant risk reductions for CV mortality and HF mortality.
IN PRACTICE:
the report states. Early catheter ablation, as early as during the hospitalization for HF, “might be a way to stabilize HF and solve the problems associated with long hospitalization periods and polypharmacy.”
SOURCE:
The study was conducted by Kazuo Sakamoto, MD, PhD, Kyushu University, Fukuoka, Japan, and colleagues. It was published online July 19, 2023 in JACC: Clinical Electrophysiology.
LIMITATIONS:
The early-ablation cohort was much smaller than the control group, and the analysis could not adjust for any variation in institutional characteristics, such as location and available equipment. Other unmeasured potential confounders include duration of AFib and patient lifestyle characteristics and success or failure of ablation.
DISCLOSURES:
The study was funded by Johnson & Johnson, the Japan Agency for Medical Research and Development, and Ministry of Health and Labor. Dr. Sakamoto reports no relevant conflicts.
A version of this article first appeared on Medscape.com.
TOPLINE:
Among patients with atrial fibrillation (AFib) hospitalized for worsening heart failure (HF), catheter (cath) ablation within 90 days of admission, compared with other times, is associated with reduced risk for all-cause mortality and HF-related mortality.
METHODOLOGY:
Cath ablation has become technically safer for patients with both AFib and HF, but the best timing for the ablation procedure after HF hospitalization has been unclear.
The study included 2,786 patients with HF who underwent cath ablation for AFib at 128 centers in the nationwide Japanese Registry of Acute Decompensated Heart Failure, were hospitalized with worsening HF, and survived at least 90 days after discharge.
The population included 103 individuals who underwent cath ablation within 90 days after admission; the remaining 2,683 participants served as the control group.
The researchers also looked at all-cause mortality 90 days after admission for HF in analysis of 83 early-ablation cases vs. 83 propensity-matched controls.
TAKEAWAY:
The early–cath ablation group was younger, predominantly male, had less history of prior HF hospitalizations, and greater incidence of paroxysmal AF, compared with the control group.
All-cause mortality was significantly lower in the early–cath ablation group than in the control group (hazard ratio, 0.38; 95% confidence interval, 0.24-0.60; P < .001) over a median of 4.1 years.
Risk reductions were similarly significant for secondary endpoints, including cardiovascular (CV) mortality and HF mortality.
In the matched cohort analysis (83 in both groups) all-cause mortality was significantly reduced for those in the early–cath ablation group, compared with the matched controls (HR, 0.47; 95% CI, 0.25-0.88; P = .014), with similarly significant risk reductions for CV mortality and HF mortality.
IN PRACTICE:
the report states. Early catheter ablation, as early as during the hospitalization for HF, “might be a way to stabilize HF and solve the problems associated with long hospitalization periods and polypharmacy.”
SOURCE:
The study was conducted by Kazuo Sakamoto, MD, PhD, Kyushu University, Fukuoka, Japan, and colleagues. It was published online July 19, 2023 in JACC: Clinical Electrophysiology.
LIMITATIONS:
The early-ablation cohort was much smaller than the control group, and the analysis could not adjust for any variation in institutional characteristics, such as location and available equipment. Other unmeasured potential confounders include duration of AFib and patient lifestyle characteristics and success or failure of ablation.
DISCLOSURES:
The study was funded by Johnson & Johnson, the Japan Agency for Medical Research and Development, and Ministry of Health and Labor. Dr. Sakamoto reports no relevant conflicts.
A version of this article first appeared on Medscape.com.
TOPLINE:
Among patients with atrial fibrillation (AFib) hospitalized for worsening heart failure (HF), catheter (cath) ablation within 90 days of admission, compared with other times, is associated with reduced risk for all-cause mortality and HF-related mortality.
METHODOLOGY:
Cath ablation has become technically safer for patients with both AFib and HF, but the best timing for the ablation procedure after HF hospitalization has been unclear.
The study included 2,786 patients with HF who underwent cath ablation for AFib at 128 centers in the nationwide Japanese Registry of Acute Decompensated Heart Failure, were hospitalized with worsening HF, and survived at least 90 days after discharge.
The population included 103 individuals who underwent cath ablation within 90 days after admission; the remaining 2,683 participants served as the control group.
The researchers also looked at all-cause mortality 90 days after admission for HF in analysis of 83 early-ablation cases vs. 83 propensity-matched controls.
TAKEAWAY:
The early–cath ablation group was younger, predominantly male, had less history of prior HF hospitalizations, and greater incidence of paroxysmal AF, compared with the control group.
All-cause mortality was significantly lower in the early–cath ablation group than in the control group (hazard ratio, 0.38; 95% confidence interval, 0.24-0.60; P < .001) over a median of 4.1 years.
Risk reductions were similarly significant for secondary endpoints, including cardiovascular (CV) mortality and HF mortality.
In the matched cohort analysis (83 in both groups) all-cause mortality was significantly reduced for those in the early–cath ablation group, compared with the matched controls (HR, 0.47; 95% CI, 0.25-0.88; P = .014), with similarly significant risk reductions for CV mortality and HF mortality.
IN PRACTICE:
the report states. Early catheter ablation, as early as during the hospitalization for HF, “might be a way to stabilize HF and solve the problems associated with long hospitalization periods and polypharmacy.”
SOURCE:
The study was conducted by Kazuo Sakamoto, MD, PhD, Kyushu University, Fukuoka, Japan, and colleagues. It was published online July 19, 2023 in JACC: Clinical Electrophysiology.
LIMITATIONS:
The early-ablation cohort was much smaller than the control group, and the analysis could not adjust for any variation in institutional characteristics, such as location and available equipment. Other unmeasured potential confounders include duration of AFib and patient lifestyle characteristics and success or failure of ablation.
DISCLOSURES:
The study was funded by Johnson & Johnson, the Japan Agency for Medical Research and Development, and Ministry of Health and Labor. Dr. Sakamoto reports no relevant conflicts.
A version of this article first appeared on Medscape.com.
FROM JACC: CLINICAL ELECTROPHYSIOLOGY
Omega-3s and AFib: No added risk from eating fish but high-dose supplement questions persist
Regular consumption of fish and other foods rich in omega-3 fatty acids (FA) won’t raise an individual’s risk for developing atrial fibrillation (AFib), suggests a meta-analysis of population-based studies.
The finding may alleviate recent concerns about higher-dose omega-3 FA supplement intake in clinical-trial patients at elevated cardiovascular (CV) risk, researchers say.
Indeed, across the 17 cohort studies in the meta-analysis, risk for incident AFib was unaffected by elevated circulating and adipose tissue levels of eicosapentaenoic acid (EPA) from dietary intake. Moreover, the risk appeared to drop significantly with such levels of docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and EPA plus DHA.
The signals of AFib risk associated with high-dose omega-3 FA in supplements or prescription form in some clinical trials “may not necessarily be generalizable to lower-dose habitual dietary omega-3 intakes,” concludes the study’s report published in the Journal of the American College of Cardiology.
Other recent research suggests that any elevated AFib risk from omega-3 FA intake is dose-related and may be associated with omega-3 FA supplement or medication intake in high doses, such as 4 g/day.
“Coupled with the more consistent benefits of these fatty acids in the prevention of adverse coronary events, our study suggests that current dietary guidelines recommending fish/omega-3 fatty acid consumption should be maintained,” conclude the authors of the report, led by Frank Qian, MD, MPH, Harvard T.H. Chan School of Public Health and Beth Israel Deaconess Medical Center, Boston.
The current study is “important in showing that physiologic levels of omega-3s that would accumulate through diet don’t seem to increase the risk of arrhythmia,” preventive cardiologist Sean Heffron, MD, NYU Langone Health and Grossman School of Medicine, told this news organization.
“It also lends credence to the fact that the increased risk is specific to the high dose supplementation, because that’s the only instance in which we’ve seen increased atrial fibrillation in association with omega-3s,” said Dr. Heffron, who wasn’t involved in the meta-analysis.
An accompanying editorial agrees. “Based on present evidence, moderate dietary intake of fish and seafood is unlikely to achieve sufficiently high levels of omega-3-FAs in blood or tissue that would result in increased AFib risk as observed in clinical trials of fish oil supplements and high-dose prescriptions,” write Christie Ballantyne, MD, and Xiaoming Jia, MD, Baylor College of Medicine, Houston.
Therefore, they conclude, “fish should continue to be an important part of the menu of a heart-healthy diet.”
The meta-analysis comprised 54,799 participants from 21 countries worldwide in 17 prospective cohort studies that yielded data on incident AFib, in which there were 7,720 cases of the arrhythmia over a median follow-up of 13 years. It looked at associations between such cases and levels of omega-3 FA in blood and adipose tissue samples.
In multivariable analysis, EPA levels were not associated with incident AFib, with a hazard ratio of 1.00 (95% confidence interval, 0.95-1.05) per interquintile range, which the report describes as the difference between the 90th and 10th percentiles.
In contrast, levels of DPA, DHA, and EPA plus DHA were all associated with reduced AFib incidence at interquintile-range HRs of 0.89 (95% CI, 0.83-0.95) for DPA, 0.90 (95% CI, 0.85-0.96) for DHA and 0.93 (95% CI, 0.87-0.99) for EPA and DHA combined.
“We found little evidence that the associations significantly varied by age, sex, or global region, or across the various lipid compartments,” the report states. “Moreover, the relationship between omega-3 fatty acids and AFib did not significantly differ among individuals at higher CV risk.”
The authors observe that the prevalence of omega-3 FA supplement use in the cohorts was very low, suggesting that the omega-3 FA biomarker levels largely reflected habitual dietary intake.
Most of the meta-analysis population were free of CV disease or at relatively low CV risk, they write, and “it is conceivable that the effects of omega-3 fatty acids on atrial arrhythmias may differ in those with existing CV disease versus without.”
However, they note, in a prespecified subgroup analysis of participants mirroring the REDUCE-IT cohort of people with established CV disease or at elevated CV risk, no association with incident AFib was observed for EPA and inverse associations emerged for DPA, DHA, and EPA plus DHA.
In their editorial, Dr. Ballantyne and Dr. Jia say the meta-analysis “represents the largest epidemiological study assessing laboratory-measured omega-3 fatty acid concentrations and AFib risk in the general population.”
But significant heterogeneity across the studies and their populations is a major limitation of the analysis, they write, and made for differences in protocols, sample preparation, outcomes ascertainment, follow-up time, and other variables.
“Despite a rigorous approach to harmonize the data across cohorts and adjusting for multiple confounders,” note Dr. Ballantyne and Dr. Jia, “observational studies always have potential for residual confounders.”
The findings support fish consumption as heart-healthy, they write, but “clinicians should be aware of and discuss with patients the risks versus benefits when prescribing high-dose omega-3 FA therapies.”
The Fatty Acid Research Institute retrospectively provided a small honorarium to a subset of the analysts who participated in this study, but it had no role in its design, analysis, manuscript writing, or decision to submit for publication, the report states. Dr. Ballantyne received grant/research support through his institution from Akcea, Amgen, Arrowhead, Esperion, Ionis, Merck, Novartis, and Regeneron, as well as consulting fees from Alnylam Pharmaceuticals, Althera, Amarin, Amgen, Arrowhead, AstraZeneca, Esperion, Genentech, Gilead, Matinas BioPharma, Merck, New Amsterdam, Novartis, Pfizer, and Regeneron. Dr. Heffron and Dr. Jia have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Regular consumption of fish and other foods rich in omega-3 fatty acids (FA) won’t raise an individual’s risk for developing atrial fibrillation (AFib), suggests a meta-analysis of population-based studies.
The finding may alleviate recent concerns about higher-dose omega-3 FA supplement intake in clinical-trial patients at elevated cardiovascular (CV) risk, researchers say.
Indeed, across the 17 cohort studies in the meta-analysis, risk for incident AFib was unaffected by elevated circulating and adipose tissue levels of eicosapentaenoic acid (EPA) from dietary intake. Moreover, the risk appeared to drop significantly with such levels of docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and EPA plus DHA.
The signals of AFib risk associated with high-dose omega-3 FA in supplements or prescription form in some clinical trials “may not necessarily be generalizable to lower-dose habitual dietary omega-3 intakes,” concludes the study’s report published in the Journal of the American College of Cardiology.
Other recent research suggests that any elevated AFib risk from omega-3 FA intake is dose-related and may be associated with omega-3 FA supplement or medication intake in high doses, such as 4 g/day.
“Coupled with the more consistent benefits of these fatty acids in the prevention of adverse coronary events, our study suggests that current dietary guidelines recommending fish/omega-3 fatty acid consumption should be maintained,” conclude the authors of the report, led by Frank Qian, MD, MPH, Harvard T.H. Chan School of Public Health and Beth Israel Deaconess Medical Center, Boston.
The current study is “important in showing that physiologic levels of omega-3s that would accumulate through diet don’t seem to increase the risk of arrhythmia,” preventive cardiologist Sean Heffron, MD, NYU Langone Health and Grossman School of Medicine, told this news organization.
“It also lends credence to the fact that the increased risk is specific to the high dose supplementation, because that’s the only instance in which we’ve seen increased atrial fibrillation in association with omega-3s,” said Dr. Heffron, who wasn’t involved in the meta-analysis.
An accompanying editorial agrees. “Based on present evidence, moderate dietary intake of fish and seafood is unlikely to achieve sufficiently high levels of omega-3-FAs in blood or tissue that would result in increased AFib risk as observed in clinical trials of fish oil supplements and high-dose prescriptions,” write Christie Ballantyne, MD, and Xiaoming Jia, MD, Baylor College of Medicine, Houston.
Therefore, they conclude, “fish should continue to be an important part of the menu of a heart-healthy diet.”
The meta-analysis comprised 54,799 participants from 21 countries worldwide in 17 prospective cohort studies that yielded data on incident AFib, in which there were 7,720 cases of the arrhythmia over a median follow-up of 13 years. It looked at associations between such cases and levels of omega-3 FA in blood and adipose tissue samples.
In multivariable analysis, EPA levels were not associated with incident AFib, with a hazard ratio of 1.00 (95% confidence interval, 0.95-1.05) per interquintile range, which the report describes as the difference between the 90th and 10th percentiles.
In contrast, levels of DPA, DHA, and EPA plus DHA were all associated with reduced AFib incidence at interquintile-range HRs of 0.89 (95% CI, 0.83-0.95) for DPA, 0.90 (95% CI, 0.85-0.96) for DHA and 0.93 (95% CI, 0.87-0.99) for EPA and DHA combined.
“We found little evidence that the associations significantly varied by age, sex, or global region, or across the various lipid compartments,” the report states. “Moreover, the relationship between omega-3 fatty acids and AFib did not significantly differ among individuals at higher CV risk.”
The authors observe that the prevalence of omega-3 FA supplement use in the cohorts was very low, suggesting that the omega-3 FA biomarker levels largely reflected habitual dietary intake.
Most of the meta-analysis population were free of CV disease or at relatively low CV risk, they write, and “it is conceivable that the effects of omega-3 fatty acids on atrial arrhythmias may differ in those with existing CV disease versus without.”
However, they note, in a prespecified subgroup analysis of participants mirroring the REDUCE-IT cohort of people with established CV disease or at elevated CV risk, no association with incident AFib was observed for EPA and inverse associations emerged for DPA, DHA, and EPA plus DHA.
In their editorial, Dr. Ballantyne and Dr. Jia say the meta-analysis “represents the largest epidemiological study assessing laboratory-measured omega-3 fatty acid concentrations and AFib risk in the general population.”
But significant heterogeneity across the studies and their populations is a major limitation of the analysis, they write, and made for differences in protocols, sample preparation, outcomes ascertainment, follow-up time, and other variables.
“Despite a rigorous approach to harmonize the data across cohorts and adjusting for multiple confounders,” note Dr. Ballantyne and Dr. Jia, “observational studies always have potential for residual confounders.”
The findings support fish consumption as heart-healthy, they write, but “clinicians should be aware of and discuss with patients the risks versus benefits when prescribing high-dose omega-3 FA therapies.”
The Fatty Acid Research Institute retrospectively provided a small honorarium to a subset of the analysts who participated in this study, but it had no role in its design, analysis, manuscript writing, or decision to submit for publication, the report states. Dr. Ballantyne received grant/research support through his institution from Akcea, Amgen, Arrowhead, Esperion, Ionis, Merck, Novartis, and Regeneron, as well as consulting fees from Alnylam Pharmaceuticals, Althera, Amarin, Amgen, Arrowhead, AstraZeneca, Esperion, Genentech, Gilead, Matinas BioPharma, Merck, New Amsterdam, Novartis, Pfizer, and Regeneron. Dr. Heffron and Dr. Jia have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Regular consumption of fish and other foods rich in omega-3 fatty acids (FA) won’t raise an individual’s risk for developing atrial fibrillation (AFib), suggests a meta-analysis of population-based studies.
The finding may alleviate recent concerns about higher-dose omega-3 FA supplement intake in clinical-trial patients at elevated cardiovascular (CV) risk, researchers say.
Indeed, across the 17 cohort studies in the meta-analysis, risk for incident AFib was unaffected by elevated circulating and adipose tissue levels of eicosapentaenoic acid (EPA) from dietary intake. Moreover, the risk appeared to drop significantly with such levels of docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and EPA plus DHA.
The signals of AFib risk associated with high-dose omega-3 FA in supplements or prescription form in some clinical trials “may not necessarily be generalizable to lower-dose habitual dietary omega-3 intakes,” concludes the study’s report published in the Journal of the American College of Cardiology.
Other recent research suggests that any elevated AFib risk from omega-3 FA intake is dose-related and may be associated with omega-3 FA supplement or medication intake in high doses, such as 4 g/day.
“Coupled with the more consistent benefits of these fatty acids in the prevention of adverse coronary events, our study suggests that current dietary guidelines recommending fish/omega-3 fatty acid consumption should be maintained,” conclude the authors of the report, led by Frank Qian, MD, MPH, Harvard T.H. Chan School of Public Health and Beth Israel Deaconess Medical Center, Boston.
The current study is “important in showing that physiologic levels of omega-3s that would accumulate through diet don’t seem to increase the risk of arrhythmia,” preventive cardiologist Sean Heffron, MD, NYU Langone Health and Grossman School of Medicine, told this news organization.
“It also lends credence to the fact that the increased risk is specific to the high dose supplementation, because that’s the only instance in which we’ve seen increased atrial fibrillation in association with omega-3s,” said Dr. Heffron, who wasn’t involved in the meta-analysis.
An accompanying editorial agrees. “Based on present evidence, moderate dietary intake of fish and seafood is unlikely to achieve sufficiently high levels of omega-3-FAs in blood or tissue that would result in increased AFib risk as observed in clinical trials of fish oil supplements and high-dose prescriptions,” write Christie Ballantyne, MD, and Xiaoming Jia, MD, Baylor College of Medicine, Houston.
Therefore, they conclude, “fish should continue to be an important part of the menu of a heart-healthy diet.”
The meta-analysis comprised 54,799 participants from 21 countries worldwide in 17 prospective cohort studies that yielded data on incident AFib, in which there were 7,720 cases of the arrhythmia over a median follow-up of 13 years. It looked at associations between such cases and levels of omega-3 FA in blood and adipose tissue samples.
In multivariable analysis, EPA levels were not associated with incident AFib, with a hazard ratio of 1.00 (95% confidence interval, 0.95-1.05) per interquintile range, which the report describes as the difference between the 90th and 10th percentiles.
In contrast, levels of DPA, DHA, and EPA plus DHA were all associated with reduced AFib incidence at interquintile-range HRs of 0.89 (95% CI, 0.83-0.95) for DPA, 0.90 (95% CI, 0.85-0.96) for DHA and 0.93 (95% CI, 0.87-0.99) for EPA and DHA combined.
“We found little evidence that the associations significantly varied by age, sex, or global region, or across the various lipid compartments,” the report states. “Moreover, the relationship between omega-3 fatty acids and AFib did not significantly differ among individuals at higher CV risk.”
The authors observe that the prevalence of omega-3 FA supplement use in the cohorts was very low, suggesting that the omega-3 FA biomarker levels largely reflected habitual dietary intake.
Most of the meta-analysis population were free of CV disease or at relatively low CV risk, they write, and “it is conceivable that the effects of omega-3 fatty acids on atrial arrhythmias may differ in those with existing CV disease versus without.”
However, they note, in a prespecified subgroup analysis of participants mirroring the REDUCE-IT cohort of people with established CV disease or at elevated CV risk, no association with incident AFib was observed for EPA and inverse associations emerged for DPA, DHA, and EPA plus DHA.
In their editorial, Dr. Ballantyne and Dr. Jia say the meta-analysis “represents the largest epidemiological study assessing laboratory-measured omega-3 fatty acid concentrations and AFib risk in the general population.”
But significant heterogeneity across the studies and their populations is a major limitation of the analysis, they write, and made for differences in protocols, sample preparation, outcomes ascertainment, follow-up time, and other variables.
“Despite a rigorous approach to harmonize the data across cohorts and adjusting for multiple confounders,” note Dr. Ballantyne and Dr. Jia, “observational studies always have potential for residual confounders.”
The findings support fish consumption as heart-healthy, they write, but “clinicians should be aware of and discuss with patients the risks versus benefits when prescribing high-dose omega-3 FA therapies.”
The Fatty Acid Research Institute retrospectively provided a small honorarium to a subset of the analysts who participated in this study, but it had no role in its design, analysis, manuscript writing, or decision to submit for publication, the report states. Dr. Ballantyne received grant/research support through his institution from Akcea, Amgen, Arrowhead, Esperion, Ionis, Merck, Novartis, and Regeneron, as well as consulting fees from Alnylam Pharmaceuticals, Althera, Amarin, Amgen, Arrowhead, AstraZeneca, Esperion, Genentech, Gilead, Matinas BioPharma, Merck, New Amsterdam, Novartis, Pfizer, and Regeneron. Dr. Heffron and Dr. Jia have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
High-dose vitamin D may cut risk for new atrial fibrillation
TOPLINE:
a post hoc analysis from a randomized trial conducted in Finland suggests.
METHODOLOGY:
- Observational studies have suggested that vitamin D deficiency is associated with increased risk for AFib, but few randomized trials have looked at the effect of vitamin D supplementation on AFib incidence in healthy people.
- The study, a post hoc analysis from a trial that explored the effects of vitamin D3 supplementation on incidence of cardiovascular diseases and cancer, included 2,495 vitamin D–sufficient healthy older adults, mean age 68.2 years, of whom 43% were women.
- Participants had been randomized to one of three groups in which they received vitamin D3 at either 1,600 IU/day or 3,200 IU/day, or placebo.
- Serum 25(OH)D3 concentrations were measured and data on incident AFib were gathered from national health records.
TAKEAWAY:
- Atrial fibrillation was diagnosed in 190 participants.
- Over a follow-up averaging 4.1 years, risk for incident AFib was reduced by 27% for participants who received the 1,600 IU/day dose, compared with placebo; hazard ratio, 0.73 (95% confidence interval, 0.52-1.02; P = .07), and by 32% for those in the 3,200 IU/day arm; HR, 0.68 (95% CI, 0.48-0.96; P = .03).
- The incident-AFib risk was reduced by 30% in a comparison of the two vitamin D groups combined versus the placebo group; HR, 0.70 (95% CI, 0.53-0.94; P = .02).
- After exclusion of 122 participants who reported being on antiarrhythmic medications at baseline, the 1,600 IU/day group showed a significant 27% reduction in risk for AF (95% CI, 4%-58%; P = .03) and the 3,200 IU/day group a nonsignificant 30% (95% CI, 5%-53%; P = .08) reduction in risk.
IN PRACTICE:
High-dose vitamin D3 supplementation may reduce incidence of AFib in a generally healthy, largely vitamin D–sufficient elderly population, the authors proposed. Additional controlled trials are needed, especially in diverse populations.
STUDY DETAILS:
The study was conducted by Jyrki K. Virtanen, PhD, University of Eastern Finland, Institute of Public Health and Clinical Nutrition, Kuopio, and colleagues. It was published in the American Heart Journal.
LIMITATIONS:
Atrial fibrillation was not prespecified as a primary outcome, and the results differ from those of other randomized controlled trials. Information on type of AFib (whether paroxysmal or nonparoxysmal, for example) wasn’t available nor were participants’ history of AFib. All participants were White and from Finland, limiting generalizability of the results.
DISCLOSURES:
The study was supported by the Academy of Finland, University of Eastern Finland, the Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and the Finnish Cultural Foundation. One coauthor disclosed receiving grants from the National Institutes of Health and Mars Edge. Another coauthor disclosed receipt of a grant from Orion. The other authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
a post hoc analysis from a randomized trial conducted in Finland suggests.
METHODOLOGY:
- Observational studies have suggested that vitamin D deficiency is associated with increased risk for AFib, but few randomized trials have looked at the effect of vitamin D supplementation on AFib incidence in healthy people.
- The study, a post hoc analysis from a trial that explored the effects of vitamin D3 supplementation on incidence of cardiovascular diseases and cancer, included 2,495 vitamin D–sufficient healthy older adults, mean age 68.2 years, of whom 43% were women.
- Participants had been randomized to one of three groups in which they received vitamin D3 at either 1,600 IU/day or 3,200 IU/day, or placebo.
- Serum 25(OH)D3 concentrations were measured and data on incident AFib were gathered from national health records.
TAKEAWAY:
- Atrial fibrillation was diagnosed in 190 participants.
- Over a follow-up averaging 4.1 years, risk for incident AFib was reduced by 27% for participants who received the 1,600 IU/day dose, compared with placebo; hazard ratio, 0.73 (95% confidence interval, 0.52-1.02; P = .07), and by 32% for those in the 3,200 IU/day arm; HR, 0.68 (95% CI, 0.48-0.96; P = .03).
- The incident-AFib risk was reduced by 30% in a comparison of the two vitamin D groups combined versus the placebo group; HR, 0.70 (95% CI, 0.53-0.94; P = .02).
- After exclusion of 122 participants who reported being on antiarrhythmic medications at baseline, the 1,600 IU/day group showed a significant 27% reduction in risk for AF (95% CI, 4%-58%; P = .03) and the 3,200 IU/day group a nonsignificant 30% (95% CI, 5%-53%; P = .08) reduction in risk.
IN PRACTICE:
High-dose vitamin D3 supplementation may reduce incidence of AFib in a generally healthy, largely vitamin D–sufficient elderly population, the authors proposed. Additional controlled trials are needed, especially in diverse populations.
STUDY DETAILS:
The study was conducted by Jyrki K. Virtanen, PhD, University of Eastern Finland, Institute of Public Health and Clinical Nutrition, Kuopio, and colleagues. It was published in the American Heart Journal.
LIMITATIONS:
Atrial fibrillation was not prespecified as a primary outcome, and the results differ from those of other randomized controlled trials. Information on type of AFib (whether paroxysmal or nonparoxysmal, for example) wasn’t available nor were participants’ history of AFib. All participants were White and from Finland, limiting generalizability of the results.
DISCLOSURES:
The study was supported by the Academy of Finland, University of Eastern Finland, the Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and the Finnish Cultural Foundation. One coauthor disclosed receiving grants from the National Institutes of Health and Mars Edge. Another coauthor disclosed receipt of a grant from Orion. The other authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
a post hoc analysis from a randomized trial conducted in Finland suggests.
METHODOLOGY:
- Observational studies have suggested that vitamin D deficiency is associated with increased risk for AFib, but few randomized trials have looked at the effect of vitamin D supplementation on AFib incidence in healthy people.
- The study, a post hoc analysis from a trial that explored the effects of vitamin D3 supplementation on incidence of cardiovascular diseases and cancer, included 2,495 vitamin D–sufficient healthy older adults, mean age 68.2 years, of whom 43% were women.
- Participants had been randomized to one of three groups in which they received vitamin D3 at either 1,600 IU/day or 3,200 IU/day, or placebo.
- Serum 25(OH)D3 concentrations were measured and data on incident AFib were gathered from national health records.
TAKEAWAY:
- Atrial fibrillation was diagnosed in 190 participants.
- Over a follow-up averaging 4.1 years, risk for incident AFib was reduced by 27% for participants who received the 1,600 IU/day dose, compared with placebo; hazard ratio, 0.73 (95% confidence interval, 0.52-1.02; P = .07), and by 32% for those in the 3,200 IU/day arm; HR, 0.68 (95% CI, 0.48-0.96; P = .03).
- The incident-AFib risk was reduced by 30% in a comparison of the two vitamin D groups combined versus the placebo group; HR, 0.70 (95% CI, 0.53-0.94; P = .02).
- After exclusion of 122 participants who reported being on antiarrhythmic medications at baseline, the 1,600 IU/day group showed a significant 27% reduction in risk for AF (95% CI, 4%-58%; P = .03) and the 3,200 IU/day group a nonsignificant 30% (95% CI, 5%-53%; P = .08) reduction in risk.
IN PRACTICE:
High-dose vitamin D3 supplementation may reduce incidence of AFib in a generally healthy, largely vitamin D–sufficient elderly population, the authors proposed. Additional controlled trials are needed, especially in diverse populations.
STUDY DETAILS:
The study was conducted by Jyrki K. Virtanen, PhD, University of Eastern Finland, Institute of Public Health and Clinical Nutrition, Kuopio, and colleagues. It was published in the American Heart Journal.
LIMITATIONS:
Atrial fibrillation was not prespecified as a primary outcome, and the results differ from those of other randomized controlled trials. Information on type of AFib (whether paroxysmal or nonparoxysmal, for example) wasn’t available nor were participants’ history of AFib. All participants were White and from Finland, limiting generalizability of the results.
DISCLOSURES:
The study was supported by the Academy of Finland, University of Eastern Finland, the Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and the Finnish Cultural Foundation. One coauthor disclosed receiving grants from the National Institutes of Health and Mars Edge. Another coauthor disclosed receipt of a grant from Orion. The other authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA approves first leadless dual-chamber pacing system
, one based in part on an already-approved leadless single-chamber device, Abbott has announced.
The company’s AVEIR DR leadless pacing system consists of two percutaneously implanted devices, the single-chamber AVEIR VR leadless pacemaker, implanted within the right ventricle, and the novel AVEIR AR single-chamber pacemaker for implantation in the right atrium.
The AVEIR DR system relies on proprietary wireless technology to provide bidirectional, beat-to-beat communication between its two components to achieve dual-chamber synchronization, the company stated in a press release on the approval.
The system also provides real-time pacing analysis, Abbott said, allowing clinicians to assess proper device placement during the procedure and before implantation. The system is designed to be easily removed if the patient’s pacing needs evolve or its battery needs replacing.
Experienced operators achieved a 98% implantation success rate using the AVIER DR system in a 300-patient study conducted at 55 sites in Canada, Europe, and the United States. In that study, 63% of the patients had sinus-node dysfunction and 33% had AV block as their primary dual-chamber pacing indication.
The system exceeded its predefined safety and performance goals, providing AV-synchronous pacing in 97% of patients for at least 3 months, it was reported in May at the annual scientific sessions of the Heart Rhythm Society and in a simultaneous publication in The New England Journal of Medicine.
“Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual-chamber leadless pacing to that list of achievements,” coauthor Vivek Reddy, MD, director of cardiac arrhythmia services for Mount Sinai Hospital and the Mount Sinai Health System, New York, said in the press release.
A version of this article first appeared on Medscape.com.
, one based in part on an already-approved leadless single-chamber device, Abbott has announced.
The company’s AVEIR DR leadless pacing system consists of two percutaneously implanted devices, the single-chamber AVEIR VR leadless pacemaker, implanted within the right ventricle, and the novel AVEIR AR single-chamber pacemaker for implantation in the right atrium.
The AVEIR DR system relies on proprietary wireless technology to provide bidirectional, beat-to-beat communication between its two components to achieve dual-chamber synchronization, the company stated in a press release on the approval.
The system also provides real-time pacing analysis, Abbott said, allowing clinicians to assess proper device placement during the procedure and before implantation. The system is designed to be easily removed if the patient’s pacing needs evolve or its battery needs replacing.
Experienced operators achieved a 98% implantation success rate using the AVIER DR system in a 300-patient study conducted at 55 sites in Canada, Europe, and the United States. In that study, 63% of the patients had sinus-node dysfunction and 33% had AV block as their primary dual-chamber pacing indication.
The system exceeded its predefined safety and performance goals, providing AV-synchronous pacing in 97% of patients for at least 3 months, it was reported in May at the annual scientific sessions of the Heart Rhythm Society and in a simultaneous publication in The New England Journal of Medicine.
“Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual-chamber leadless pacing to that list of achievements,” coauthor Vivek Reddy, MD, director of cardiac arrhythmia services for Mount Sinai Hospital and the Mount Sinai Health System, New York, said in the press release.
A version of this article first appeared on Medscape.com.
, one based in part on an already-approved leadless single-chamber device, Abbott has announced.
The company’s AVEIR DR leadless pacing system consists of two percutaneously implanted devices, the single-chamber AVEIR VR leadless pacemaker, implanted within the right ventricle, and the novel AVEIR AR single-chamber pacemaker for implantation in the right atrium.
The AVEIR DR system relies on proprietary wireless technology to provide bidirectional, beat-to-beat communication between its two components to achieve dual-chamber synchronization, the company stated in a press release on the approval.
The system also provides real-time pacing analysis, Abbott said, allowing clinicians to assess proper device placement during the procedure and before implantation. The system is designed to be easily removed if the patient’s pacing needs evolve or its battery needs replacing.
Experienced operators achieved a 98% implantation success rate using the AVIER DR system in a 300-patient study conducted at 55 sites in Canada, Europe, and the United States. In that study, 63% of the patients had sinus-node dysfunction and 33% had AV block as their primary dual-chamber pacing indication.
The system exceeded its predefined safety and performance goals, providing AV-synchronous pacing in 97% of patients for at least 3 months, it was reported in May at the annual scientific sessions of the Heart Rhythm Society and in a simultaneous publication in The New England Journal of Medicine.
“Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual-chamber leadless pacing to that list of achievements,” coauthor Vivek Reddy, MD, director of cardiac arrhythmia services for Mount Sinai Hospital and the Mount Sinai Health System, New York, said in the press release.
A version of this article first appeared on Medscape.com.
Women with atrial fibrillation more likely to develop dementia
New data suggest a significantly stronger link in women compared with men between atrial fibrillation (AF) and mild cognitive impairment (MCI) and dementia.
“Our findings imply that women with AF may be at higher risk for MCI and dementia with potentially more rapid disease progression from normal cognition to MCI or dementia than women without AF or men with and without AF,” wrote authors of a new study led by Kathryn A. Wood, PhD, RN, Neil Hodgson Woodruff School of Nursing at Emory University in Atlanta.
The findings were published online in Alzheimer’s & Dementia.
Researchers used the National Alzheimer’s Coordinating Center data with 43,630 patients and analyzed sex differences between men and women with AF and their performance on neuropsychological tests and cognitive disease progression.
Higher odds of dementia, MCI in women
According to the paper, AF is associated with higher odds of dementia (odds ratio [OR], 3.00; 95% confidence interval [CI], 1.22-7.37) in women and MCI in women (OR, 3.43; 95% CI, 1.55-7.55) compared with men.
Women with AF and normal cognition at baseline had a higher risk of disease progression (hazard ratio [HR], 1.26; 95% CI, 1.06-1.50) from normal to MCI and from MCI to vascular dementia (HR, 3.27; 95% CI, 1.89-5.65) than that of men with AF or men and women without AF.
AF is a major public health problem linked with stroke and heart failure, and is an independent risk factor of increased mortality. It is associated with higher risk of cognitive impairment and dementia independent of stroke history.
Cognitive screening for AF patients
The authors wrote that cognitive screening, especially in women, should be part of yearly cardiology visits for patients with AF to help identify early those at highest risk for cognitive disease.
T. Jared Bunch, MD, professor of medicine in the division of cardiovascular medicine at University of Utah in Salt Lake City, said in an interview, “We have learned that how we treat atrial fibrillation can influence risk.”
First, he said, outcomes, including brain health, are better when rhythm control approaches are used within the first year of diagnosis.
“Restoring a normal heart rhythm improves brain perfusion and cognitive function. Next, aggressive rhythm control – such as catheter ablation – is associated with much lower long-term risks of dementia in the [patients]. Finally, early and effective use of anticoagulation in patients with atrial fibrillation lowers risk of stroke, dementia, and cognitive decline.”
Several factors unknown
Dr. Bunch said there are some unknowns in the study, such as how long patients were in atrial fibrillation.
He said one way to address the inequities is to refer women earlier as women are often referred later in disease to specialty care, which can have consequences.
He said it is not known how many people underwent early and effective rhythm control.
“Women also are less likely to receive catheter ablation, a cardioversion, or be placed on antiarrhythmic drugs,” said Dr. Bunch, who was not part of the study. “These also represent potential opportunities to improve outcomes by treating the rhythm in a similar and aggressive manner in both men and women.”
Also unknown is how many people were on effective oral anticoagulation, Dr. Bunch noted.
The study importantly highlights a significant problem surrounding the care of women with AF, he said, but there are strategies to improve outcomes.
In addition to earlier screening and referral for women, providers should recognize that men and women may present differently with different AF symptoms. He added that physicians should offer catheter ablation, the most effective treatment, equally to men and women who are candidates.
In all people, he said, it’s important “to start anticoagulation very early in the disease to lower the risk of micro- and macrothrombotic events that lead to poor brain health and function.”
The study authors and Dr. Bunch declared no relevant financial relationships.
New data suggest a significantly stronger link in women compared with men between atrial fibrillation (AF) and mild cognitive impairment (MCI) and dementia.
“Our findings imply that women with AF may be at higher risk for MCI and dementia with potentially more rapid disease progression from normal cognition to MCI or dementia than women without AF or men with and without AF,” wrote authors of a new study led by Kathryn A. Wood, PhD, RN, Neil Hodgson Woodruff School of Nursing at Emory University in Atlanta.
The findings were published online in Alzheimer’s & Dementia.
Researchers used the National Alzheimer’s Coordinating Center data with 43,630 patients and analyzed sex differences between men and women with AF and their performance on neuropsychological tests and cognitive disease progression.
Higher odds of dementia, MCI in women
According to the paper, AF is associated with higher odds of dementia (odds ratio [OR], 3.00; 95% confidence interval [CI], 1.22-7.37) in women and MCI in women (OR, 3.43; 95% CI, 1.55-7.55) compared with men.
Women with AF and normal cognition at baseline had a higher risk of disease progression (hazard ratio [HR], 1.26; 95% CI, 1.06-1.50) from normal to MCI and from MCI to vascular dementia (HR, 3.27; 95% CI, 1.89-5.65) than that of men with AF or men and women without AF.
AF is a major public health problem linked with stroke and heart failure, and is an independent risk factor of increased mortality. It is associated with higher risk of cognitive impairment and dementia independent of stroke history.
Cognitive screening for AF patients
The authors wrote that cognitive screening, especially in women, should be part of yearly cardiology visits for patients with AF to help identify early those at highest risk for cognitive disease.
T. Jared Bunch, MD, professor of medicine in the division of cardiovascular medicine at University of Utah in Salt Lake City, said in an interview, “We have learned that how we treat atrial fibrillation can influence risk.”
First, he said, outcomes, including brain health, are better when rhythm control approaches are used within the first year of diagnosis.
“Restoring a normal heart rhythm improves brain perfusion and cognitive function. Next, aggressive rhythm control – such as catheter ablation – is associated with much lower long-term risks of dementia in the [patients]. Finally, early and effective use of anticoagulation in patients with atrial fibrillation lowers risk of stroke, dementia, and cognitive decline.”
Several factors unknown
Dr. Bunch said there are some unknowns in the study, such as how long patients were in atrial fibrillation.
He said one way to address the inequities is to refer women earlier as women are often referred later in disease to specialty care, which can have consequences.
He said it is not known how many people underwent early and effective rhythm control.
“Women also are less likely to receive catheter ablation, a cardioversion, or be placed on antiarrhythmic drugs,” said Dr. Bunch, who was not part of the study. “These also represent potential opportunities to improve outcomes by treating the rhythm in a similar and aggressive manner in both men and women.”
Also unknown is how many people were on effective oral anticoagulation, Dr. Bunch noted.
The study importantly highlights a significant problem surrounding the care of women with AF, he said, but there are strategies to improve outcomes.
In addition to earlier screening and referral for women, providers should recognize that men and women may present differently with different AF symptoms. He added that physicians should offer catheter ablation, the most effective treatment, equally to men and women who are candidates.
In all people, he said, it’s important “to start anticoagulation very early in the disease to lower the risk of micro- and macrothrombotic events that lead to poor brain health and function.”
The study authors and Dr. Bunch declared no relevant financial relationships.
New data suggest a significantly stronger link in women compared with men between atrial fibrillation (AF) and mild cognitive impairment (MCI) and dementia.
“Our findings imply that women with AF may be at higher risk for MCI and dementia with potentially more rapid disease progression from normal cognition to MCI or dementia than women without AF or men with and without AF,” wrote authors of a new study led by Kathryn A. Wood, PhD, RN, Neil Hodgson Woodruff School of Nursing at Emory University in Atlanta.
The findings were published online in Alzheimer’s & Dementia.
Researchers used the National Alzheimer’s Coordinating Center data with 43,630 patients and analyzed sex differences between men and women with AF and their performance on neuropsychological tests and cognitive disease progression.
Higher odds of dementia, MCI in women
According to the paper, AF is associated with higher odds of dementia (odds ratio [OR], 3.00; 95% confidence interval [CI], 1.22-7.37) in women and MCI in women (OR, 3.43; 95% CI, 1.55-7.55) compared with men.
Women with AF and normal cognition at baseline had a higher risk of disease progression (hazard ratio [HR], 1.26; 95% CI, 1.06-1.50) from normal to MCI and from MCI to vascular dementia (HR, 3.27; 95% CI, 1.89-5.65) than that of men with AF or men and women without AF.
AF is a major public health problem linked with stroke and heart failure, and is an independent risk factor of increased mortality. It is associated with higher risk of cognitive impairment and dementia independent of stroke history.
Cognitive screening for AF patients
The authors wrote that cognitive screening, especially in women, should be part of yearly cardiology visits for patients with AF to help identify early those at highest risk for cognitive disease.
T. Jared Bunch, MD, professor of medicine in the division of cardiovascular medicine at University of Utah in Salt Lake City, said in an interview, “We have learned that how we treat atrial fibrillation can influence risk.”
First, he said, outcomes, including brain health, are better when rhythm control approaches are used within the first year of diagnosis.
“Restoring a normal heart rhythm improves brain perfusion and cognitive function. Next, aggressive rhythm control – such as catheter ablation – is associated with much lower long-term risks of dementia in the [patients]. Finally, early and effective use of anticoagulation in patients with atrial fibrillation lowers risk of stroke, dementia, and cognitive decline.”
Several factors unknown
Dr. Bunch said there are some unknowns in the study, such as how long patients were in atrial fibrillation.
He said one way to address the inequities is to refer women earlier as women are often referred later in disease to specialty care, which can have consequences.
He said it is not known how many people underwent early and effective rhythm control.
“Women also are less likely to receive catheter ablation, a cardioversion, or be placed on antiarrhythmic drugs,” said Dr. Bunch, who was not part of the study. “These also represent potential opportunities to improve outcomes by treating the rhythm in a similar and aggressive manner in both men and women.”
Also unknown is how many people were on effective oral anticoagulation, Dr. Bunch noted.
The study importantly highlights a significant problem surrounding the care of women with AF, he said, but there are strategies to improve outcomes.
In addition to earlier screening and referral for women, providers should recognize that men and women may present differently with different AF symptoms. He added that physicians should offer catheter ablation, the most effective treatment, equally to men and women who are candidates.
In all people, he said, it’s important “to start anticoagulation very early in the disease to lower the risk of micro- and macrothrombotic events that lead to poor brain health and function.”
The study authors and Dr. Bunch declared no relevant financial relationships.
FROM ALZHEIMER’S & DEMENTIA
ECG implant tightens AFib management, improves outcomes in MONITOR-AF
Chronic conditions like diabetes or hypertension “often require long-term care through long-term monitoring,” observed a researcher, and “we know that continuous monitoring is superior to intermittent monitoring for long-term outcomes.”
So maybe practice should rely more on continuous ECG monitoring for patients with atrial fibrillation (AFib), also a chronic condition, proposed Dhanunjaya R. Lakkireddy, MD, of the Kansas City Heart Rhythm Institute, Overland Park, Kan., in presenting a new analysis at the annual scientific sessions of the Heart Rhythm Society.
(ILRs), compared with standard care. The latter could include intermittent 12-lead ECG, Holter, or other intermittent monitoring at physicians’ discretion.
Patients with AFib and the ECG implants in the MONITOR-AF study, which was not randomized and therefore only suggestive, were managed “more efficiently” with greater access to electrophysiologists (P < .01) and adherence to oral anticoagulants (P = .020) and other medications.
Followed for a mean of 2 years, patients with ILRs were more likely to undergo catheter ablation, and their time to a catheter ablation “was impressively shorter, 153 days versus 426 days” (P < .001), Dr. Lakkireddy said.
The ILR group also had fewer strokes and bleeding complications and were less likely to be hospitalized for AFib-related reasons, he said, because “a lot of these patients were caught ahead of time through the remote monitoring.”
For example, ILR patients had fewer heart failure (HF) hospitalizations, likely because “you’re not allowing these patients to remain with untreated rapid ventricular rates for a long period of time. You intervene early, thereby mitigating the onset of heart failure.”
Indeed, Dr. Lakkireddy said, their cumulative rate of any cardiovascular complication was “dramatically lower” – 3.4 versus 10.4 events per 100 person-years (P < .001).
Certainly, a routine recommendation to consider AFib patients for continuous monitoring would require randomized-trial evidence, he acknowledged. “This is an observation registry and proof of concept from a very heterogeneous cohort of patients. There were no obvious set criteria for ILR implantation.”
Nonetheless, “continuous and dynamic monitoring enabled quicker decision-making and patient management,” Dr. Lakkireddy said. “Especially in those patients who may have silent atrial fibrillation, an ILR could significantly mitigate the risk of complications from stroke and heart failure exacerbations.”
Several randomized trials have supported “earlier, more aggressive treatment” for AFib, including EAST-AFNET4, EARLY-AF, and CABANA, observed Daniel Morin, MD, MPH, of Ochsner Medical Center, New Orleans, as the invited discussant for Dr. Lakkireddy’s presentation.
So, he continued, if the goal is to “get every single AFib patient to ablation just as soon as possible,” then maybe MONITOR-AF supports the use of ILRs in such cases.
Indeed, it is “certainly possible” that the continuous stream of data from ILRs “allows faster progression of therapy and possibly even better outcomes” as MONITOR-AF suggests, said Dr. Morin, who is director of electrophysiology research at his center.
Moreover, ILR data could potentially “support shared decision-making perhaps by convincing the patient, and maybe their insurers, that we should move forward with ablation.”
But given the study’s observational, registry-based nature, the MONITOR-AF analysis is limited by potential confounders that complicate its interpretation.
For example, Dr. Morin continued, all ILR patients but only 60% of those on standard care˙ had access to an electrophysiologist (P = .001). That means “less access to some antiarrhythmic medications and certainly far less access to ablation therapy.”
Moreover, “during shared decision-making, a patient who sees the results of their ILR monitoring may be more prone to seek out or to accept earlier, more definitive therapy via ablation,” he said. “The presence of an ILR may then be a good way to move the needle toward ablation.”
Of note, an overwhelming majority of ILR patients received ablation, 93.5%, compared with 58.6% of standard-care patients. “It’s unclear how much of that association was caused by the ILR’s presence vs. other factors, such as physician availability, physician aggressiveness, or patient willingness for intervention,” Dr. Morin noted.
MONITOR-AF included 2,458 patients with paroxysmal or persistent AFib who either were implanted with or did not receive an ILR from 2018 to 2021 and were followed for at least 12 months.
The two groups were similar, Dr. Lakkireddy reported, with respect to demographics and baseline history AFib, hypertension, hyperlipidemia, diabetes, coronary disease, neurovascular events, peripheral artery disease, and obstructive sleep apnea.
Dr. Lakkireddy said a subgroup analysis is forthcoming, but that he’d “intuitively” think that the 15%-20% of AFib patients who are asymptomatic would gain the most from the ILR monitoring approach. There is already evidence that such patients tend to have the worst AFib outcomes, often receiving an AFib diagnosis only after presenting with consequences such as stroke or heart failure.
Dr. Lakkireddy disclosed receiving research grants, modest honoraria, or consulting fees from Abbott, Janssen, Boston Scientific, Johnson & Johnson, Biotronik, Bristol-Myers Squibb, Pfizer, Atricure, Northeast Scientific, and Acutus. Dr. Morin disclosed receiving research grants, honoraria, or consulting fees from Abbott and serving on a speakers’ bureau for Boston Scientific, Medtronic, and Zoll Medical.
A version of this article first appeared on Medscape.com.
Chronic conditions like diabetes or hypertension “often require long-term care through long-term monitoring,” observed a researcher, and “we know that continuous monitoring is superior to intermittent monitoring for long-term outcomes.”
So maybe practice should rely more on continuous ECG monitoring for patients with atrial fibrillation (AFib), also a chronic condition, proposed Dhanunjaya R. Lakkireddy, MD, of the Kansas City Heart Rhythm Institute, Overland Park, Kan., in presenting a new analysis at the annual scientific sessions of the Heart Rhythm Society.
(ILRs), compared with standard care. The latter could include intermittent 12-lead ECG, Holter, or other intermittent monitoring at physicians’ discretion.
Patients with AFib and the ECG implants in the MONITOR-AF study, which was not randomized and therefore only suggestive, were managed “more efficiently” with greater access to electrophysiologists (P < .01) and adherence to oral anticoagulants (P = .020) and other medications.
Followed for a mean of 2 years, patients with ILRs were more likely to undergo catheter ablation, and their time to a catheter ablation “was impressively shorter, 153 days versus 426 days” (P < .001), Dr. Lakkireddy said.
The ILR group also had fewer strokes and bleeding complications and were less likely to be hospitalized for AFib-related reasons, he said, because “a lot of these patients were caught ahead of time through the remote monitoring.”
For example, ILR patients had fewer heart failure (HF) hospitalizations, likely because “you’re not allowing these patients to remain with untreated rapid ventricular rates for a long period of time. You intervene early, thereby mitigating the onset of heart failure.”
Indeed, Dr. Lakkireddy said, their cumulative rate of any cardiovascular complication was “dramatically lower” – 3.4 versus 10.4 events per 100 person-years (P < .001).
Certainly, a routine recommendation to consider AFib patients for continuous monitoring would require randomized-trial evidence, he acknowledged. “This is an observation registry and proof of concept from a very heterogeneous cohort of patients. There were no obvious set criteria for ILR implantation.”
Nonetheless, “continuous and dynamic monitoring enabled quicker decision-making and patient management,” Dr. Lakkireddy said. “Especially in those patients who may have silent atrial fibrillation, an ILR could significantly mitigate the risk of complications from stroke and heart failure exacerbations.”
Several randomized trials have supported “earlier, more aggressive treatment” for AFib, including EAST-AFNET4, EARLY-AF, and CABANA, observed Daniel Morin, MD, MPH, of Ochsner Medical Center, New Orleans, as the invited discussant for Dr. Lakkireddy’s presentation.
So, he continued, if the goal is to “get every single AFib patient to ablation just as soon as possible,” then maybe MONITOR-AF supports the use of ILRs in such cases.
Indeed, it is “certainly possible” that the continuous stream of data from ILRs “allows faster progression of therapy and possibly even better outcomes” as MONITOR-AF suggests, said Dr. Morin, who is director of electrophysiology research at his center.
Moreover, ILR data could potentially “support shared decision-making perhaps by convincing the patient, and maybe their insurers, that we should move forward with ablation.”
But given the study’s observational, registry-based nature, the MONITOR-AF analysis is limited by potential confounders that complicate its interpretation.
For example, Dr. Morin continued, all ILR patients but only 60% of those on standard care˙ had access to an electrophysiologist (P = .001). That means “less access to some antiarrhythmic medications and certainly far less access to ablation therapy.”
Moreover, “during shared decision-making, a patient who sees the results of their ILR monitoring may be more prone to seek out or to accept earlier, more definitive therapy via ablation,” he said. “The presence of an ILR may then be a good way to move the needle toward ablation.”
Of note, an overwhelming majority of ILR patients received ablation, 93.5%, compared with 58.6% of standard-care patients. “It’s unclear how much of that association was caused by the ILR’s presence vs. other factors, such as physician availability, physician aggressiveness, or patient willingness for intervention,” Dr. Morin noted.
MONITOR-AF included 2,458 patients with paroxysmal or persistent AFib who either were implanted with or did not receive an ILR from 2018 to 2021 and were followed for at least 12 months.
The two groups were similar, Dr. Lakkireddy reported, with respect to demographics and baseline history AFib, hypertension, hyperlipidemia, diabetes, coronary disease, neurovascular events, peripheral artery disease, and obstructive sleep apnea.
Dr. Lakkireddy said a subgroup analysis is forthcoming, but that he’d “intuitively” think that the 15%-20% of AFib patients who are asymptomatic would gain the most from the ILR monitoring approach. There is already evidence that such patients tend to have the worst AFib outcomes, often receiving an AFib diagnosis only after presenting with consequences such as stroke or heart failure.
Dr. Lakkireddy disclosed receiving research grants, modest honoraria, or consulting fees from Abbott, Janssen, Boston Scientific, Johnson & Johnson, Biotronik, Bristol-Myers Squibb, Pfizer, Atricure, Northeast Scientific, and Acutus. Dr. Morin disclosed receiving research grants, honoraria, or consulting fees from Abbott and serving on a speakers’ bureau for Boston Scientific, Medtronic, and Zoll Medical.
A version of this article first appeared on Medscape.com.
Chronic conditions like diabetes or hypertension “often require long-term care through long-term monitoring,” observed a researcher, and “we know that continuous monitoring is superior to intermittent monitoring for long-term outcomes.”
So maybe practice should rely more on continuous ECG monitoring for patients with atrial fibrillation (AFib), also a chronic condition, proposed Dhanunjaya R. Lakkireddy, MD, of the Kansas City Heart Rhythm Institute, Overland Park, Kan., in presenting a new analysis at the annual scientific sessions of the Heart Rhythm Society.
(ILRs), compared with standard care. The latter could include intermittent 12-lead ECG, Holter, or other intermittent monitoring at physicians’ discretion.
Patients with AFib and the ECG implants in the MONITOR-AF study, which was not randomized and therefore only suggestive, were managed “more efficiently” with greater access to electrophysiologists (P < .01) and adherence to oral anticoagulants (P = .020) and other medications.
Followed for a mean of 2 years, patients with ILRs were more likely to undergo catheter ablation, and their time to a catheter ablation “was impressively shorter, 153 days versus 426 days” (P < .001), Dr. Lakkireddy said.
The ILR group also had fewer strokes and bleeding complications and were less likely to be hospitalized for AFib-related reasons, he said, because “a lot of these patients were caught ahead of time through the remote monitoring.”
For example, ILR patients had fewer heart failure (HF) hospitalizations, likely because “you’re not allowing these patients to remain with untreated rapid ventricular rates for a long period of time. You intervene early, thereby mitigating the onset of heart failure.”
Indeed, Dr. Lakkireddy said, their cumulative rate of any cardiovascular complication was “dramatically lower” – 3.4 versus 10.4 events per 100 person-years (P < .001).
Certainly, a routine recommendation to consider AFib patients for continuous monitoring would require randomized-trial evidence, he acknowledged. “This is an observation registry and proof of concept from a very heterogeneous cohort of patients. There were no obvious set criteria for ILR implantation.”
Nonetheless, “continuous and dynamic monitoring enabled quicker decision-making and patient management,” Dr. Lakkireddy said. “Especially in those patients who may have silent atrial fibrillation, an ILR could significantly mitigate the risk of complications from stroke and heart failure exacerbations.”
Several randomized trials have supported “earlier, more aggressive treatment” for AFib, including EAST-AFNET4, EARLY-AF, and CABANA, observed Daniel Morin, MD, MPH, of Ochsner Medical Center, New Orleans, as the invited discussant for Dr. Lakkireddy’s presentation.
So, he continued, if the goal is to “get every single AFib patient to ablation just as soon as possible,” then maybe MONITOR-AF supports the use of ILRs in such cases.
Indeed, it is “certainly possible” that the continuous stream of data from ILRs “allows faster progression of therapy and possibly even better outcomes” as MONITOR-AF suggests, said Dr. Morin, who is director of electrophysiology research at his center.
Moreover, ILR data could potentially “support shared decision-making perhaps by convincing the patient, and maybe their insurers, that we should move forward with ablation.”
But given the study’s observational, registry-based nature, the MONITOR-AF analysis is limited by potential confounders that complicate its interpretation.
For example, Dr. Morin continued, all ILR patients but only 60% of those on standard care˙ had access to an electrophysiologist (P = .001). That means “less access to some antiarrhythmic medications and certainly far less access to ablation therapy.”
Moreover, “during shared decision-making, a patient who sees the results of their ILR monitoring may be more prone to seek out or to accept earlier, more definitive therapy via ablation,” he said. “The presence of an ILR may then be a good way to move the needle toward ablation.”
Of note, an overwhelming majority of ILR patients received ablation, 93.5%, compared with 58.6% of standard-care patients. “It’s unclear how much of that association was caused by the ILR’s presence vs. other factors, such as physician availability, physician aggressiveness, or patient willingness for intervention,” Dr. Morin noted.
MONITOR-AF included 2,458 patients with paroxysmal or persistent AFib who either were implanted with or did not receive an ILR from 2018 to 2021 and were followed for at least 12 months.
The two groups were similar, Dr. Lakkireddy reported, with respect to demographics and baseline history AFib, hypertension, hyperlipidemia, diabetes, coronary disease, neurovascular events, peripheral artery disease, and obstructive sleep apnea.
Dr. Lakkireddy said a subgroup analysis is forthcoming, but that he’d “intuitively” think that the 15%-20% of AFib patients who are asymptomatic would gain the most from the ILR monitoring approach. There is already evidence that such patients tend to have the worst AFib outcomes, often receiving an AFib diagnosis only after presenting with consequences such as stroke or heart failure.
Dr. Lakkireddy disclosed receiving research grants, modest honoraria, or consulting fees from Abbott, Janssen, Boston Scientific, Johnson & Johnson, Biotronik, Bristol-Myers Squibb, Pfizer, Atricure, Northeast Scientific, and Acutus. Dr. Morin disclosed receiving research grants, honoraria, or consulting fees from Abbott and serving on a speakers’ bureau for Boston Scientific, Medtronic, and Zoll Medical.
A version of this article first appeared on Medscape.com.
FROM HEART RHYTHM 2023
Leadless dual-chamber pacemaker clears early safety, performance hurdles
Cardiology, well into the age of leadless pacemakers, could be headed for an age of leadless pacemaker systems in which various pacing functions are achieved by multiple implants that “talk” to each other.
Even now, a leadless two-part pacemaker system has shown it can safely achieve atrioventricular (AV) synchrony in patients with standard indications for a dual-chamber device, at least over the short term, suggests a prospective observational study. Currently available leadless pacemakers can stimulate only the right ventricle.
Experienced operators achieved a 98% implantation success rate in 300 patients who received an investigational dual-chamber leadless system, the AVEIR DR i2i (Abbott).
Its two separately implanted miniature pulse generators achieve AV synchrony via “beat-to-beat wireless bidirectional communication,” Daniel J. Cantillon, MD, said when presenting the study at the annual scientific sessions of the Heart Rhythm Societyin New Orleans.
The system seemed to work well regardless of the patient’s body orientation. “Sitting, supine, left lateral, right lateral, standing, normal walk, fast walk – we demonstrated robust AV synchrony in all of those positions and with movement,” said Dr. Cantillon, of the Cleveland Clinic.
Should the device be approved, it could “expand the use case for leadless cardiac pacing” to include atrial-only, ventricular-only, fully functional dual-chamber pacing scenarios.”
Dr. Cantillon is senior author on the study’s online publication in the New England Journal of Medicine, timed to coincide with his HRS presentation, with first author Reinoud E. Knops, MD, PhD, Amsterdam University Medical Center.
“The electrical performance of both the atrial and ventricular leadless pacemakers appears to be similar to that of transvenous dual-chamber pacemakers,” the published report states.
More data needed
The study is important and has “significant implications for our pacing field,” Jonathan P. Piccini, MD, MHS, said in an interview. It suggests that “dual-chamber pacing can be achieved with leadless technology” and “with a very high degree” of AV synchrony.
“Obviously, more data as the technology moves into clinical practice will be critical,” said Dr. Piccini, who directs cardiac electrophysiology at Duke University Medical Center, Durham, N.C. “We will also need to understand which patients are best served by leadless technology and which will be better served with traditional transvenous devices.”
The AVEIR DR i2i system consists of two leadless pulse generators for percutaneous implantation in the right atrium and right ventricle, respectively. They link like components of a wireless network to coordinate their separate sensing and rate-adaptive, AV-synchronous pacing functions.
The right ventricular implant “is physically identical to a commercially available single-chamber leadless pacemaker” from Abbott, the published report states.
Leadless pacemaker systems inherently avoid the two main sources of transvenous devices’ major complication – infection – by not requiring such leads or surgery for creating a pulse-generator subcutaneous pocket.
The first such systems consisted of one implant that could provide single-chamber ventricular pacing but not atrial pacing or AV synchronous pacing. The transcatheter single-chamber leadless Micra (Medtronic) for example, was approved in the United States in April 2016 for ventricular-only pacing.
A successor, the Micra AV, approved in 2020, was designed to simulate AV-synchronous pacing by stimulating the ventricle in sequence with mechanically sensed atrial contractions, as described by Dr. Cantillon and associates. But it could not directly pace the atrium, “rendering it inappropriate for patients with sinus-node dysfunction.”
The AVEIR DR i2i system doesn’t have those limitations. It was, however, associated with 35 device- or procedure-related complications in the study, of which the most common was procedural arrhythmia, “namely atrial fibrillation,” Dr. Cantillon said.
Atrial fibrillation can develop during implantation of pacemakers with transvenous leads but is generally terminated without being considered an important event. Yet the study classified it as a serious complication, inflating the complication rate, because “the patients had to be restored to sinus rhythm so we could assess the AV synchrony and also the atrial electrical performance,” he said.
Some of the devices dislodged from their implantation site within a month of the procedure, but “all of those patients were successfully managed percutaneously,” said Dr. Cantillon.
“The 1.7% dislodgement rate is something that we will need to keep an eye on, as embolization of devices is always a significant concern,” Dr. Piccini said. Still, the observed total complication rate “was certainly in line” with rates associated with conventional pacemaker implantation.
Reliable AV synchrony
Fred M. Kusumoto, MD, Mayo Clinic, Jacksonville, Fla., lauded what seems to be the system’s “incredibly reliable AV synchrony in different conditions, albeit in a very controlled environment.”
Of interest will be whether its performance, including maintenance of AV synchrony, holds up in “a more long-term evaluation in the outpatient setting,” said Dr. Kusumoto, speaking as the invited discussant for Dr. Cantillon’s presentation.
Also missing or in short supply from the study, he observed, are insights about long-term efficacy and complications, battery longevity, effectiveness of its rate-responsive capability, and any effect on clinical outcomes.
Local body network
Of the study’s 300 patients (mean age 69 years; 38% female) at 55 sites in Canada, Europe, and the United States, 63.3% had sinus-node dysfunction and 33.3% had AV block as their primary dual-chamber pacing indication; 298 were successfully implanted with both devices.
About 45% had a history of supraventricular arrhythmia, 4.3% had prior ventricular arrhythmia, and 20% had a history of arrhythmia ablation.
By 3 months, the group reported, the primary safety endpoint (freedom from device- or procedure-related serious adverse events) occurred in 90.3%, compared with the performance goal of 78% (P < .001).
The first of two primary performance endpoints (adequate atrial capture threshold and sensing amplitude by predefined criteria) was met in 90.2%, surpassing the 82.5% performance goal (P < .001).
The second primary performance goal (at least 70% AV synchrony with the patient sitting) was seen in 97.3% against the performance goal of 83% (P < .001).
What shouldn’t be “glossed over” from the study, Dr. Kusumoto offered, is that it’s possible to achieve a wireless connection “between two devices that are actually intracardiac.” That raises the prospect of a “local body network” that could be “expanded even more dramatically with other types of devices. I mean, think of the paradigm shift.”
The AVEIR DR i2i trial was funded by Abbott. Dr. Cantillon discloses receiving honoraria or fees for speaking or consulting from Abbott Laboratories, Boston Scientific, Biosense Webster, and Shockwave Medical, as well as holding royalty rights with AirStrip. Dr. Piccini has disclosed relationships with Abbott, Medtronic, Biotronik, Boston Scientific, and other drug and medical device companies. Dr. Kusumoto reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cardiology, well into the age of leadless pacemakers, could be headed for an age of leadless pacemaker systems in which various pacing functions are achieved by multiple implants that “talk” to each other.
Even now, a leadless two-part pacemaker system has shown it can safely achieve atrioventricular (AV) synchrony in patients with standard indications for a dual-chamber device, at least over the short term, suggests a prospective observational study. Currently available leadless pacemakers can stimulate only the right ventricle.
Experienced operators achieved a 98% implantation success rate in 300 patients who received an investigational dual-chamber leadless system, the AVEIR DR i2i (Abbott).
Its two separately implanted miniature pulse generators achieve AV synchrony via “beat-to-beat wireless bidirectional communication,” Daniel J. Cantillon, MD, said when presenting the study at the annual scientific sessions of the Heart Rhythm Societyin New Orleans.
The system seemed to work well regardless of the patient’s body orientation. “Sitting, supine, left lateral, right lateral, standing, normal walk, fast walk – we demonstrated robust AV synchrony in all of those positions and with movement,” said Dr. Cantillon, of the Cleveland Clinic.
Should the device be approved, it could “expand the use case for leadless cardiac pacing” to include atrial-only, ventricular-only, fully functional dual-chamber pacing scenarios.”
Dr. Cantillon is senior author on the study’s online publication in the New England Journal of Medicine, timed to coincide with his HRS presentation, with first author Reinoud E. Knops, MD, PhD, Amsterdam University Medical Center.
“The electrical performance of both the atrial and ventricular leadless pacemakers appears to be similar to that of transvenous dual-chamber pacemakers,” the published report states.
More data needed
The study is important and has “significant implications for our pacing field,” Jonathan P. Piccini, MD, MHS, said in an interview. It suggests that “dual-chamber pacing can be achieved with leadless technology” and “with a very high degree” of AV synchrony.
“Obviously, more data as the technology moves into clinical practice will be critical,” said Dr. Piccini, who directs cardiac electrophysiology at Duke University Medical Center, Durham, N.C. “We will also need to understand which patients are best served by leadless technology and which will be better served with traditional transvenous devices.”
The AVEIR DR i2i system consists of two leadless pulse generators for percutaneous implantation in the right atrium and right ventricle, respectively. They link like components of a wireless network to coordinate their separate sensing and rate-adaptive, AV-synchronous pacing functions.
The right ventricular implant “is physically identical to a commercially available single-chamber leadless pacemaker” from Abbott, the published report states.
Leadless pacemaker systems inherently avoid the two main sources of transvenous devices’ major complication – infection – by not requiring such leads or surgery for creating a pulse-generator subcutaneous pocket.
The first such systems consisted of one implant that could provide single-chamber ventricular pacing but not atrial pacing or AV synchronous pacing. The transcatheter single-chamber leadless Micra (Medtronic) for example, was approved in the United States in April 2016 for ventricular-only pacing.
A successor, the Micra AV, approved in 2020, was designed to simulate AV-synchronous pacing by stimulating the ventricle in sequence with mechanically sensed atrial contractions, as described by Dr. Cantillon and associates. But it could not directly pace the atrium, “rendering it inappropriate for patients with sinus-node dysfunction.”
The AVEIR DR i2i system doesn’t have those limitations. It was, however, associated with 35 device- or procedure-related complications in the study, of which the most common was procedural arrhythmia, “namely atrial fibrillation,” Dr. Cantillon said.
Atrial fibrillation can develop during implantation of pacemakers with transvenous leads but is generally terminated without being considered an important event. Yet the study classified it as a serious complication, inflating the complication rate, because “the patients had to be restored to sinus rhythm so we could assess the AV synchrony and also the atrial electrical performance,” he said.
Some of the devices dislodged from their implantation site within a month of the procedure, but “all of those patients were successfully managed percutaneously,” said Dr. Cantillon.
“The 1.7% dislodgement rate is something that we will need to keep an eye on, as embolization of devices is always a significant concern,” Dr. Piccini said. Still, the observed total complication rate “was certainly in line” with rates associated with conventional pacemaker implantation.
Reliable AV synchrony
Fred M. Kusumoto, MD, Mayo Clinic, Jacksonville, Fla., lauded what seems to be the system’s “incredibly reliable AV synchrony in different conditions, albeit in a very controlled environment.”
Of interest will be whether its performance, including maintenance of AV synchrony, holds up in “a more long-term evaluation in the outpatient setting,” said Dr. Kusumoto, speaking as the invited discussant for Dr. Cantillon’s presentation.
Also missing or in short supply from the study, he observed, are insights about long-term efficacy and complications, battery longevity, effectiveness of its rate-responsive capability, and any effect on clinical outcomes.
Local body network
Of the study’s 300 patients (mean age 69 years; 38% female) at 55 sites in Canada, Europe, and the United States, 63.3% had sinus-node dysfunction and 33.3% had AV block as their primary dual-chamber pacing indication; 298 were successfully implanted with both devices.
About 45% had a history of supraventricular arrhythmia, 4.3% had prior ventricular arrhythmia, and 20% had a history of arrhythmia ablation.
By 3 months, the group reported, the primary safety endpoint (freedom from device- or procedure-related serious adverse events) occurred in 90.3%, compared with the performance goal of 78% (P < .001).
The first of two primary performance endpoints (adequate atrial capture threshold and sensing amplitude by predefined criteria) was met in 90.2%, surpassing the 82.5% performance goal (P < .001).
The second primary performance goal (at least 70% AV synchrony with the patient sitting) was seen in 97.3% against the performance goal of 83% (P < .001).
What shouldn’t be “glossed over” from the study, Dr. Kusumoto offered, is that it’s possible to achieve a wireless connection “between two devices that are actually intracardiac.” That raises the prospect of a “local body network” that could be “expanded even more dramatically with other types of devices. I mean, think of the paradigm shift.”
The AVEIR DR i2i trial was funded by Abbott. Dr. Cantillon discloses receiving honoraria or fees for speaking or consulting from Abbott Laboratories, Boston Scientific, Biosense Webster, and Shockwave Medical, as well as holding royalty rights with AirStrip. Dr. Piccini has disclosed relationships with Abbott, Medtronic, Biotronik, Boston Scientific, and other drug and medical device companies. Dr. Kusumoto reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cardiology, well into the age of leadless pacemakers, could be headed for an age of leadless pacemaker systems in which various pacing functions are achieved by multiple implants that “talk” to each other.
Even now, a leadless two-part pacemaker system has shown it can safely achieve atrioventricular (AV) synchrony in patients with standard indications for a dual-chamber device, at least over the short term, suggests a prospective observational study. Currently available leadless pacemakers can stimulate only the right ventricle.
Experienced operators achieved a 98% implantation success rate in 300 patients who received an investigational dual-chamber leadless system, the AVEIR DR i2i (Abbott).
Its two separately implanted miniature pulse generators achieve AV synchrony via “beat-to-beat wireless bidirectional communication,” Daniel J. Cantillon, MD, said when presenting the study at the annual scientific sessions of the Heart Rhythm Societyin New Orleans.
The system seemed to work well regardless of the patient’s body orientation. “Sitting, supine, left lateral, right lateral, standing, normal walk, fast walk – we demonstrated robust AV synchrony in all of those positions and with movement,” said Dr. Cantillon, of the Cleveland Clinic.
Should the device be approved, it could “expand the use case for leadless cardiac pacing” to include atrial-only, ventricular-only, fully functional dual-chamber pacing scenarios.”
Dr. Cantillon is senior author on the study’s online publication in the New England Journal of Medicine, timed to coincide with his HRS presentation, with first author Reinoud E. Knops, MD, PhD, Amsterdam University Medical Center.
“The electrical performance of both the atrial and ventricular leadless pacemakers appears to be similar to that of transvenous dual-chamber pacemakers,” the published report states.
More data needed
The study is important and has “significant implications for our pacing field,” Jonathan P. Piccini, MD, MHS, said in an interview. It suggests that “dual-chamber pacing can be achieved with leadless technology” and “with a very high degree” of AV synchrony.
“Obviously, more data as the technology moves into clinical practice will be critical,” said Dr. Piccini, who directs cardiac electrophysiology at Duke University Medical Center, Durham, N.C. “We will also need to understand which patients are best served by leadless technology and which will be better served with traditional transvenous devices.”
The AVEIR DR i2i system consists of two leadless pulse generators for percutaneous implantation in the right atrium and right ventricle, respectively. They link like components of a wireless network to coordinate their separate sensing and rate-adaptive, AV-synchronous pacing functions.
The right ventricular implant “is physically identical to a commercially available single-chamber leadless pacemaker” from Abbott, the published report states.
Leadless pacemaker systems inherently avoid the two main sources of transvenous devices’ major complication – infection – by not requiring such leads or surgery for creating a pulse-generator subcutaneous pocket.
The first such systems consisted of one implant that could provide single-chamber ventricular pacing but not atrial pacing or AV synchronous pacing. The transcatheter single-chamber leadless Micra (Medtronic) for example, was approved in the United States in April 2016 for ventricular-only pacing.
A successor, the Micra AV, approved in 2020, was designed to simulate AV-synchronous pacing by stimulating the ventricle in sequence with mechanically sensed atrial contractions, as described by Dr. Cantillon and associates. But it could not directly pace the atrium, “rendering it inappropriate for patients with sinus-node dysfunction.”
The AVEIR DR i2i system doesn’t have those limitations. It was, however, associated with 35 device- or procedure-related complications in the study, of which the most common was procedural arrhythmia, “namely atrial fibrillation,” Dr. Cantillon said.
Atrial fibrillation can develop during implantation of pacemakers with transvenous leads but is generally terminated without being considered an important event. Yet the study classified it as a serious complication, inflating the complication rate, because “the patients had to be restored to sinus rhythm so we could assess the AV synchrony and also the atrial electrical performance,” he said.
Some of the devices dislodged from their implantation site within a month of the procedure, but “all of those patients were successfully managed percutaneously,” said Dr. Cantillon.
“The 1.7% dislodgement rate is something that we will need to keep an eye on, as embolization of devices is always a significant concern,” Dr. Piccini said. Still, the observed total complication rate “was certainly in line” with rates associated with conventional pacemaker implantation.
Reliable AV synchrony
Fred M. Kusumoto, MD, Mayo Clinic, Jacksonville, Fla., lauded what seems to be the system’s “incredibly reliable AV synchrony in different conditions, albeit in a very controlled environment.”
Of interest will be whether its performance, including maintenance of AV synchrony, holds up in “a more long-term evaluation in the outpatient setting,” said Dr. Kusumoto, speaking as the invited discussant for Dr. Cantillon’s presentation.
Also missing or in short supply from the study, he observed, are insights about long-term efficacy and complications, battery longevity, effectiveness of its rate-responsive capability, and any effect on clinical outcomes.
Local body network
Of the study’s 300 patients (mean age 69 years; 38% female) at 55 sites in Canada, Europe, and the United States, 63.3% had sinus-node dysfunction and 33.3% had AV block as their primary dual-chamber pacing indication; 298 were successfully implanted with both devices.
About 45% had a history of supraventricular arrhythmia, 4.3% had prior ventricular arrhythmia, and 20% had a history of arrhythmia ablation.
By 3 months, the group reported, the primary safety endpoint (freedom from device- or procedure-related serious adverse events) occurred in 90.3%, compared with the performance goal of 78% (P < .001).
The first of two primary performance endpoints (adequate atrial capture threshold and sensing amplitude by predefined criteria) was met in 90.2%, surpassing the 82.5% performance goal (P < .001).
The second primary performance goal (at least 70% AV synchrony with the patient sitting) was seen in 97.3% against the performance goal of 83% (P < .001).
What shouldn’t be “glossed over” from the study, Dr. Kusumoto offered, is that it’s possible to achieve a wireless connection “between two devices that are actually intracardiac.” That raises the prospect of a “local body network” that could be “expanded even more dramatically with other types of devices. I mean, think of the paradigm shift.”
The AVEIR DR i2i trial was funded by Abbott. Dr. Cantillon discloses receiving honoraria or fees for speaking or consulting from Abbott Laboratories, Boston Scientific, Biosense Webster, and Shockwave Medical, as well as holding royalty rights with AirStrip. Dr. Piccini has disclosed relationships with Abbott, Medtronic, Biotronik, Boston Scientific, and other drug and medical device companies. Dr. Kusumoto reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM HRS 2023
Cut in AFib burden gains traction as gauge of ablation success: PULSED-AF
suggests a new analysis.
It’s the first study tying those outcomes to residual AFib burden after ablation achieved using the emerging pulsed-field ablation (PFA) technology, say researchers. These associations are already established for cath ablation using traditional radiofrequency energy or cryoablation.
The new findings come from a secondary analysis of the recently published PULSED-AF study, which highlighted the ablation efficacy of Medtronic’s investigational PulseSelect PFA system in patients with either paroxysmal AFib (PAF) or persistent AFib.
The trial had entered 300 adult candidates for catheter ablation of recurrent, symptomatic PAF or persistent AFib at 41 centers in Australia, Canada, Europe, Japan, and the United States.
After ablation, 69% of PAF patients and 62% of those who had persistent AFib showed no sign of atrial arrhythmia (AA) over 12 months, based on the trial’s method for estimating AA burden.
Residual AA burden less than 10% was seen in 87% and 82% of those initially with PAF and persistent AFib, respectively. Burdens in that lowest range, compared with greater AA burden, predicted a “clinically meaningful” improvement in QoL scores in PAF patients.
Those who entered the study with persistent AFib showed such improvement – defined as a more than 19-point gain on the Atrial Fibrillation Effect on Quality-of-Life Questionnaire – regardless of postablation AA burden.
Moreover, patients initially with either type of AFib and residual burdens in the lowest range went on to have fewer cardioversions and repeat ablations (P < .01), Atul Verma, MD, McGill University Health Centre, Montreal, reported at the annual scientific sessions of the Heart Rhythm Society.
Dr. Verma, the trial’s principal investigator, is also lead author on the same-day publication of the secondary analysis in Heart Rhythm.
Binary endpoint lacks relevance
The PULSED-AF primary analysis defined ablation efficacy partly as freedom from AA recurrence lasting at least 30 seconds, with or without symptoms, a traditional AFib-ablation trial endpoint that is nonetheless considered clinically unhelpful.
The secondary analysis recasts that binary endpoint as degree of reduction in AFib burden, a continuous variable. That potentially allows AFib ablation efficacy to be assessed in a more nuanced way likely to be more meaningful to patients and the health care system, observed Dr. Verma and colleagues.
The “30-second endpoint” is limited in clinical usefulness and “doesn’t mean much to the patient,” he said at a press conference on the analysis before formally presenting it at the HRS sessions.
Recent AFib ablation trials have explored AA burden as possibly a superior way to assess the procedure’s success “but also to see if it’s better correlated with quality of life and health care outcomes,” Dr. Verma said. “So that’s exactly what we’ve tried to do here using the PULSED-AF data.”
In the secondary analysis, he said, patients’ rate of freedom from the 30-second endpoint was about 70%, but “more than 85% of them had an AFib burden of less than 10%.”
“This efficacy endpoint of 30 seconds of atrial arrhythmia has been challenged and has been seen clinically as insignificant,” agreed Rajeev Pathak, MBBS, PhD, of Australian National University and director of cardiac electrophysiology at Canberra (Australia) Hospital.
In AFib radiofrequency ablation and cryoablation studies “there is clear disconnect between these 30-second episodes of atrial arrhythmias we see and the clinical relevance of health care utilization and quality of life,” said Dr. Pathak, invited discussant for Dr. Verma’s presentation at the sessions.
Now an AFib ablation trial using PFA catheters has yielded similar results, finding AA burden to be “a more objective and relevant measure of success,” he said. “A 30-second endpoint is arbitrary, lacks significance, and is highly dependent on the monitoring strategy.”
The more you look, the more you see
The new secondary analysis included a demonstration that success rates based on the 30-second endpoint indeed vary depending on how subsequent arrhythmias are monitored.
As described by Dr. Verma, PULSED-AF data were assessed for the 30-second endpoint captured using three separate intermittent monitoring strategies that it and other recent ablation trials have used:
- Strategy A: Transtelephonic monitoring weekly and in the event of symptoms, plus 24-hour Holter monitoring at 6 and 12 months and 12-lead ECG at 3, 6, and 12 months
- Strategy B: Transtelephonic monitoring weekly and at symptoms for 3-6 months followed by monthly and at symptoms from 6 to 12 months, plus 24-hour Holter monitoring at 6 and 12 months, plus 12-lead ECG at 3, 6, and 12 months
- Strategy C: The median of two 24-hour Holter monitoring sessions per patient over 12 months
As Dr. Verma reported, rates of freedom from the 30-second endpoint climbed with successive monitoring strategies. The rates for PAF and persistent AFib patients, respectively, were: Strategy A – 70% and 62%, Strategy B – 71% and 68%, Strategy C – 91% and 86%.
“If you’re using the ‘freedom-from-30-seconds’ endpoint, the results that you are going to get are highly dependent on the monitoring strategy,” Dr. Verma said. “The more you look, the more you see.”
Valid estimation of burden
For the main PULSED-AF secondary analysis, the investigators defined AA burden according to findings on either Holter monitoring or the 12-lead ECG. “So as not to bias these results,” Dr. Verma said, “for every patient, we picked the method that gave us the highest atrial arrhythmia burden.”
Ideally, Dr. Verma said in an interview, arrhythmia burden would be determined using devices such as implantable loop recorders. “The problem is, this is expensive and not practical” in both clinical practice and many trials, so PULSED-AF investigators went with the intermittent monitoring strategy to estimate burdens.
Their method appears valid, he said, given that the study identified a statistically relevant 10% AA burden cut off for predicting quality of life improvement or less health care resource use.
“If their residual atrial arrhythmia burden was greater than 10%, they did not have a statistically significant improvement in quality of life,” Dr. Verma observed. And “very few” of them had cardioversions or repeat ablation.
“I couldn’t agree more” that residual AA burden is preferable to the 30-second endpoint for gauging AFib ablation success, Kenneth Ellenbogen, MD, Virginia Commonwealth University Medical Center, Richmond, said in an interview. Dr. Ellenbogen is also director of clinical cardiac electrophysiology and pacing at VCU Health Pauley Heart Center and not associated with PULSED-AF.
That AA burden was linked to health care resource use in the study “is absolutely brilliant,” he said, “because that’s what the bean counters really want at the end of the day. And as doctors we care about patients feeling better – improving quality of life.”
PULSED-AF was funded by Medtronic. Dr. Verma disclosed financial relationships with Bayer, Biosense Webster, Medtronic, Thermedical, Kardium, and Galaxy Medical, as well as and research grants from Adagio Medical. Dr. Ellenbogen disclosed financial relationships with Boston Scientific, Medtronic, Kestra, Hylomorph, Biotronik, MediLynx, Impulse Dynamics USA, Abbott, Biosense Webster, Milestone Pharmaceuticals, Sanofi, Medpace, and Elsevier. Dr. Pathak disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
suggests a new analysis.
It’s the first study tying those outcomes to residual AFib burden after ablation achieved using the emerging pulsed-field ablation (PFA) technology, say researchers. These associations are already established for cath ablation using traditional radiofrequency energy or cryoablation.
The new findings come from a secondary analysis of the recently published PULSED-AF study, which highlighted the ablation efficacy of Medtronic’s investigational PulseSelect PFA system in patients with either paroxysmal AFib (PAF) or persistent AFib.
The trial had entered 300 adult candidates for catheter ablation of recurrent, symptomatic PAF or persistent AFib at 41 centers in Australia, Canada, Europe, Japan, and the United States.
After ablation, 69% of PAF patients and 62% of those who had persistent AFib showed no sign of atrial arrhythmia (AA) over 12 months, based on the trial’s method for estimating AA burden.
Residual AA burden less than 10% was seen in 87% and 82% of those initially with PAF and persistent AFib, respectively. Burdens in that lowest range, compared with greater AA burden, predicted a “clinically meaningful” improvement in QoL scores in PAF patients.
Those who entered the study with persistent AFib showed such improvement – defined as a more than 19-point gain on the Atrial Fibrillation Effect on Quality-of-Life Questionnaire – regardless of postablation AA burden.
Moreover, patients initially with either type of AFib and residual burdens in the lowest range went on to have fewer cardioversions and repeat ablations (P < .01), Atul Verma, MD, McGill University Health Centre, Montreal, reported at the annual scientific sessions of the Heart Rhythm Society.
Dr. Verma, the trial’s principal investigator, is also lead author on the same-day publication of the secondary analysis in Heart Rhythm.
Binary endpoint lacks relevance
The PULSED-AF primary analysis defined ablation efficacy partly as freedom from AA recurrence lasting at least 30 seconds, with or without symptoms, a traditional AFib-ablation trial endpoint that is nonetheless considered clinically unhelpful.
The secondary analysis recasts that binary endpoint as degree of reduction in AFib burden, a continuous variable. That potentially allows AFib ablation efficacy to be assessed in a more nuanced way likely to be more meaningful to patients and the health care system, observed Dr. Verma and colleagues.
The “30-second endpoint” is limited in clinical usefulness and “doesn’t mean much to the patient,” he said at a press conference on the analysis before formally presenting it at the HRS sessions.
Recent AFib ablation trials have explored AA burden as possibly a superior way to assess the procedure’s success “but also to see if it’s better correlated with quality of life and health care outcomes,” Dr. Verma said. “So that’s exactly what we’ve tried to do here using the PULSED-AF data.”
In the secondary analysis, he said, patients’ rate of freedom from the 30-second endpoint was about 70%, but “more than 85% of them had an AFib burden of less than 10%.”
“This efficacy endpoint of 30 seconds of atrial arrhythmia has been challenged and has been seen clinically as insignificant,” agreed Rajeev Pathak, MBBS, PhD, of Australian National University and director of cardiac electrophysiology at Canberra (Australia) Hospital.
In AFib radiofrequency ablation and cryoablation studies “there is clear disconnect between these 30-second episodes of atrial arrhythmias we see and the clinical relevance of health care utilization and quality of life,” said Dr. Pathak, invited discussant for Dr. Verma’s presentation at the sessions.
Now an AFib ablation trial using PFA catheters has yielded similar results, finding AA burden to be “a more objective and relevant measure of success,” he said. “A 30-second endpoint is arbitrary, lacks significance, and is highly dependent on the monitoring strategy.”
The more you look, the more you see
The new secondary analysis included a demonstration that success rates based on the 30-second endpoint indeed vary depending on how subsequent arrhythmias are monitored.
As described by Dr. Verma, PULSED-AF data were assessed for the 30-second endpoint captured using three separate intermittent monitoring strategies that it and other recent ablation trials have used:
- Strategy A: Transtelephonic monitoring weekly and in the event of symptoms, plus 24-hour Holter monitoring at 6 and 12 months and 12-lead ECG at 3, 6, and 12 months
- Strategy B: Transtelephonic monitoring weekly and at symptoms for 3-6 months followed by monthly and at symptoms from 6 to 12 months, plus 24-hour Holter monitoring at 6 and 12 months, plus 12-lead ECG at 3, 6, and 12 months
- Strategy C: The median of two 24-hour Holter monitoring sessions per patient over 12 months
As Dr. Verma reported, rates of freedom from the 30-second endpoint climbed with successive monitoring strategies. The rates for PAF and persistent AFib patients, respectively, were: Strategy A – 70% and 62%, Strategy B – 71% and 68%, Strategy C – 91% and 86%.
“If you’re using the ‘freedom-from-30-seconds’ endpoint, the results that you are going to get are highly dependent on the monitoring strategy,” Dr. Verma said. “The more you look, the more you see.”
Valid estimation of burden
For the main PULSED-AF secondary analysis, the investigators defined AA burden according to findings on either Holter monitoring or the 12-lead ECG. “So as not to bias these results,” Dr. Verma said, “for every patient, we picked the method that gave us the highest atrial arrhythmia burden.”
Ideally, Dr. Verma said in an interview, arrhythmia burden would be determined using devices such as implantable loop recorders. “The problem is, this is expensive and not practical” in both clinical practice and many trials, so PULSED-AF investigators went with the intermittent monitoring strategy to estimate burdens.
Their method appears valid, he said, given that the study identified a statistically relevant 10% AA burden cut off for predicting quality of life improvement or less health care resource use.
“If their residual atrial arrhythmia burden was greater than 10%, they did not have a statistically significant improvement in quality of life,” Dr. Verma observed. And “very few” of them had cardioversions or repeat ablation.
“I couldn’t agree more” that residual AA burden is preferable to the 30-second endpoint for gauging AFib ablation success, Kenneth Ellenbogen, MD, Virginia Commonwealth University Medical Center, Richmond, said in an interview. Dr. Ellenbogen is also director of clinical cardiac electrophysiology and pacing at VCU Health Pauley Heart Center and not associated with PULSED-AF.
That AA burden was linked to health care resource use in the study “is absolutely brilliant,” he said, “because that’s what the bean counters really want at the end of the day. And as doctors we care about patients feeling better – improving quality of life.”
PULSED-AF was funded by Medtronic. Dr. Verma disclosed financial relationships with Bayer, Biosense Webster, Medtronic, Thermedical, Kardium, and Galaxy Medical, as well as and research grants from Adagio Medical. Dr. Ellenbogen disclosed financial relationships with Boston Scientific, Medtronic, Kestra, Hylomorph, Biotronik, MediLynx, Impulse Dynamics USA, Abbott, Biosense Webster, Milestone Pharmaceuticals, Sanofi, Medpace, and Elsevier. Dr. Pathak disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
suggests a new analysis.
It’s the first study tying those outcomes to residual AFib burden after ablation achieved using the emerging pulsed-field ablation (PFA) technology, say researchers. These associations are already established for cath ablation using traditional radiofrequency energy or cryoablation.
The new findings come from a secondary analysis of the recently published PULSED-AF study, which highlighted the ablation efficacy of Medtronic’s investigational PulseSelect PFA system in patients with either paroxysmal AFib (PAF) or persistent AFib.
The trial had entered 300 adult candidates for catheter ablation of recurrent, symptomatic PAF or persistent AFib at 41 centers in Australia, Canada, Europe, Japan, and the United States.
After ablation, 69% of PAF patients and 62% of those who had persistent AFib showed no sign of atrial arrhythmia (AA) over 12 months, based on the trial’s method for estimating AA burden.
Residual AA burden less than 10% was seen in 87% and 82% of those initially with PAF and persistent AFib, respectively. Burdens in that lowest range, compared with greater AA burden, predicted a “clinically meaningful” improvement in QoL scores in PAF patients.
Those who entered the study with persistent AFib showed such improvement – defined as a more than 19-point gain on the Atrial Fibrillation Effect on Quality-of-Life Questionnaire – regardless of postablation AA burden.
Moreover, patients initially with either type of AFib and residual burdens in the lowest range went on to have fewer cardioversions and repeat ablations (P < .01), Atul Verma, MD, McGill University Health Centre, Montreal, reported at the annual scientific sessions of the Heart Rhythm Society.
Dr. Verma, the trial’s principal investigator, is also lead author on the same-day publication of the secondary analysis in Heart Rhythm.
Binary endpoint lacks relevance
The PULSED-AF primary analysis defined ablation efficacy partly as freedom from AA recurrence lasting at least 30 seconds, with or without symptoms, a traditional AFib-ablation trial endpoint that is nonetheless considered clinically unhelpful.
The secondary analysis recasts that binary endpoint as degree of reduction in AFib burden, a continuous variable. That potentially allows AFib ablation efficacy to be assessed in a more nuanced way likely to be more meaningful to patients and the health care system, observed Dr. Verma and colleagues.
The “30-second endpoint” is limited in clinical usefulness and “doesn’t mean much to the patient,” he said at a press conference on the analysis before formally presenting it at the HRS sessions.
Recent AFib ablation trials have explored AA burden as possibly a superior way to assess the procedure’s success “but also to see if it’s better correlated with quality of life and health care outcomes,” Dr. Verma said. “So that’s exactly what we’ve tried to do here using the PULSED-AF data.”
In the secondary analysis, he said, patients’ rate of freedom from the 30-second endpoint was about 70%, but “more than 85% of them had an AFib burden of less than 10%.”
“This efficacy endpoint of 30 seconds of atrial arrhythmia has been challenged and has been seen clinically as insignificant,” agreed Rajeev Pathak, MBBS, PhD, of Australian National University and director of cardiac electrophysiology at Canberra (Australia) Hospital.
In AFib radiofrequency ablation and cryoablation studies “there is clear disconnect between these 30-second episodes of atrial arrhythmias we see and the clinical relevance of health care utilization and quality of life,” said Dr. Pathak, invited discussant for Dr. Verma’s presentation at the sessions.
Now an AFib ablation trial using PFA catheters has yielded similar results, finding AA burden to be “a more objective and relevant measure of success,” he said. “A 30-second endpoint is arbitrary, lacks significance, and is highly dependent on the monitoring strategy.”
The more you look, the more you see
The new secondary analysis included a demonstration that success rates based on the 30-second endpoint indeed vary depending on how subsequent arrhythmias are monitored.
As described by Dr. Verma, PULSED-AF data were assessed for the 30-second endpoint captured using three separate intermittent monitoring strategies that it and other recent ablation trials have used:
- Strategy A: Transtelephonic monitoring weekly and in the event of symptoms, plus 24-hour Holter monitoring at 6 and 12 months and 12-lead ECG at 3, 6, and 12 months
- Strategy B: Transtelephonic monitoring weekly and at symptoms for 3-6 months followed by monthly and at symptoms from 6 to 12 months, plus 24-hour Holter monitoring at 6 and 12 months, plus 12-lead ECG at 3, 6, and 12 months
- Strategy C: The median of two 24-hour Holter monitoring sessions per patient over 12 months
As Dr. Verma reported, rates of freedom from the 30-second endpoint climbed with successive monitoring strategies. The rates for PAF and persistent AFib patients, respectively, were: Strategy A – 70% and 62%, Strategy B – 71% and 68%, Strategy C – 91% and 86%.
“If you’re using the ‘freedom-from-30-seconds’ endpoint, the results that you are going to get are highly dependent on the monitoring strategy,” Dr. Verma said. “The more you look, the more you see.”
Valid estimation of burden
For the main PULSED-AF secondary analysis, the investigators defined AA burden according to findings on either Holter monitoring or the 12-lead ECG. “So as not to bias these results,” Dr. Verma said, “for every patient, we picked the method that gave us the highest atrial arrhythmia burden.”
Ideally, Dr. Verma said in an interview, arrhythmia burden would be determined using devices such as implantable loop recorders. “The problem is, this is expensive and not practical” in both clinical practice and many trials, so PULSED-AF investigators went with the intermittent monitoring strategy to estimate burdens.
Their method appears valid, he said, given that the study identified a statistically relevant 10% AA burden cut off for predicting quality of life improvement or less health care resource use.
“If their residual atrial arrhythmia burden was greater than 10%, they did not have a statistically significant improvement in quality of life,” Dr. Verma observed. And “very few” of them had cardioversions or repeat ablation.
“I couldn’t agree more” that residual AA burden is preferable to the 30-second endpoint for gauging AFib ablation success, Kenneth Ellenbogen, MD, Virginia Commonwealth University Medical Center, Richmond, said in an interview. Dr. Ellenbogen is also director of clinical cardiac electrophysiology and pacing at VCU Health Pauley Heart Center and not associated with PULSED-AF.
That AA burden was linked to health care resource use in the study “is absolutely brilliant,” he said, “because that’s what the bean counters really want at the end of the day. And as doctors we care about patients feeling better – improving quality of life.”
PULSED-AF was funded by Medtronic. Dr. Verma disclosed financial relationships with Bayer, Biosense Webster, Medtronic, Thermedical, Kardium, and Galaxy Medical, as well as and research grants from Adagio Medical. Dr. Ellenbogen disclosed financial relationships with Boston Scientific, Medtronic, Kestra, Hylomorph, Biotronik, MediLynx, Impulse Dynamics USA, Abbott, Biosense Webster, Milestone Pharmaceuticals, Sanofi, Medpace, and Elsevier. Dr. Pathak disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM HRS 2023
Earlier anticoagulation safe in stroke with AFib: ELAN
, a new study suggests.
The ELAN trial found that starting DOAC treatment earlier was not associated with an increased risk for intracranial hemorrhage (ICH) but rather was linked to a lower rate of ischemic events.
“We conclude that there is no reason to delay DOAC treatment in these patients. Our results suggest that early DOAC treatment is reasonable; it is unlikely to cause harm, and it is probably better at reducing ischemic events,” lead investigator of the study, Urs Fischer, MD, professor of neurology at University Hospital Basel (Switzerland), commented in an interview.
“This trial will change clinical practice in that we can feel much more reassured that starting DOAC treatment early in these patients will not cause harm,” he said.
Senior investigator Jesse Dawson, MD, professor of stroke medicine at Queen Elizabeth University Hospital, Glasgow, added: “This issue of timing of DOAC treatment causes a lot of anxiety in our daily workload. Clinicians are scared of causing an ICH, so they tend to wait. These results will ease a lot of that anxiety.”
Dr. Fischer presented the results of the ELAN trial at the European Stroke Organisation Conference (ESOC) in Munich. The trial was also simultaneously published online in The New England Journal of Medicine.
He explained that patients presenting with acute ischemic stroke who are found to have atrial fibrillation need to be started on anticoagulation to reduce the risk for a recurrent stroke. But there are no clear guidelines on when to start anticoagulation in these patients at present, with concerns that starting very early may increase the risk for hemorrhagic transformation and ICH.
Based on observations that patients with larger strokes have a higher risk for ICH in the early post-stroke period, some guidelines advise different times for starting anticoagulation for different stroke severities: 1 day for a transient ischemic attack, 3 days for a minor stroke, 6 days for a moderate stroke, and 12 days for a severe stroke – known as the 1-, 3-, 6-, 12-day rule.
“But this is not based on evidence – just on expert opinion,” Dr. Fischer noted. “The ELAN trial was conducted to obtain more solid information on optimal timing for starting anticoagulation and whether we can safely start a DOAC earlier than these guidelines currently advise.”
For the trial, which was conducted in 15 countries, 2,013 patients with an acute ischemic stroke and found to have AFib were randomly selected to start DOAC treatment earlier or later.
The later-treatment strategy followed the current approach of starting treatment at day 3 or 4 after a minor stroke, day 6 or 7 after a moderate stroke, or day 12, 13, or 14 after a major stroke, whereas the earlier-treatment group started DOAC treatment within 48 hours after a minor or moderate stroke or on day 6 or 7 after a major stroke.
In terms of stroke severity, which was defined on imaging-based criteria, 37% of patients had a minor stroke, 40% had a moderate stroke, and 23% had a major stroke.
The primary outcome was a composite of recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial hemorrhage, or vascular death within 30 days after randomization.
Results showed that this occurred in 2.9% in the early-treatment group and 4.1% in the later-treatment group (risk difference, –1.18 percentage points; 95% confidence interval, –2.84-0.47) by 30 days.
Recurrent ischemic stroke occurred in 1.4% in the early-treatment group and 2.5% in the later-treatment group (odds ratio, 0.57; 95% CI, 0.29-1.07). Symptomatic intracranial hemorrhage occurred in two participants (0.2%) in both groups by 30 days.
The rates of the outcomes increased only slightly more at 90 days than at 30 days, “findings that suggest there was not an excessive risk associated with early anticoagulation through that period,” the researchers report in the NEJM paper.
“Early treatment initiation can therefore be supported if indicated or if desired,” they conclude.
“The most important finding was that among 2,000 patients randomized, there was a very low rate of bleeding complications and no increase in any bleeding complication in the early DOAC group. This has been a major worry about starting anticoagulation early,” Dr. Fischer commented.
“These are very practical findings in that we can keep things simple,” Dr. Dawson added. “If the patient has a big stroke, anticoagulation with a DOAC can now be started at 6 days. For everyone else, we can start DOAC treatment as soon as possible without fear of causing harm. So, we can now confidently give patients with a minor or moderate stroke, as defined by imaging, a beneficial treatment as soon as we establish they are having an ischemic stroke and have AFib.”
Dr. Dawson pointed out that about 25% of patients with ischemic stroke are found to have AFib on admission ECG, and in another 4%-5%, AFib is found in the first 48 hours. “These are the patients we are targeting in this study.”
The researchers note that the trial did not have a statistical superiority or noninferiority design but rather aimed to estimate the treatment effects of early initiation versus later initiation of DOACs.
“This trial was slightly different in that we weren’t testing a strict statistical hypothesis because we didn’t have any data with which to formulate what sort of effect size to aim for, so we performed a qualitative trial to look at what the event rates were with the two approaches,” Dr. Fischer explained. “Our main findings are that ICH rates were not increased with early DOAC treatment and that ischemic event rates were numerically reduced, but because we didn’t have strict statistical limits, we can only say this is a high probability but not a certainty.”
Dr. Dawson added: “We can say from these results that there is a high level of probability that early DOAC treatment does not cause harm and a reasonable probability that it reduces risks of a recurrent stroke or other ischemic event.”
The researchers give an estimate of the effect size for the primary composite endpoint, which combines the major ischemic and bleeding events, ranging from a 2.8% lower risk to a 0.5% higher risk with early DOAC treatment.
“So, it is very likely that the composite endpoint would be lower,” Dr. Dawson said.
Dr. Fischer noted that a previous study (TIMING) tried to address the issue of earlier versus later anticoagulation in these patients but was stopped early after 880 patients had been enrolled because of slow recruitment.
“Results from this study failed to show superiority of early versus late DOAC treatment but they did suggest noninferiority, and they also found no increase in major bleeding complications, which is an added reassurance,” he commented.
Another trial looking at early versus late anticoagulation in these patients, OPTIMAS, is ongoing in the United Kingdom and is aiming to randomize 3,500 patients.
Imaging-based assessment of stroke severity
In the ELAN trial, the definition of stroke severity was based on imaging rather than on the National Institutes of Health Stroke Scale (NIHSS).
“We took a cautious approach by using imaging to define stroke severity. So, when using these results in clinical practice, it is important that patients are selected for the timing of DOAC treatment based on the imaging results,” Dr. Dawson explained. “This is very straightforward, as the size of the stroke can be seen clearly on the routine CT imaging that all patients receive up front. This is a very pragmatic and simple protocol. And advanced imaging is not required.”
He noted that though clinicians tend to use the NIHSS clinical symptom score to define mild, moderate, and severe stroke, the imaging approach is actually more accurate when determining the risk for bleeding and ICH. And though imaging results often correlate with NIHSS scores, there can be some exceptions.
Commenting on the ELAN trial results at the ESOC meeting, Georgios Tsivgoulis, MD, professor of neurology, University of Athens, said that the trial showed that early administration of DOACs in these patients was safe and did not increase the rate of ICH.
“There was a very low ICH rate with only two events in each group. And then there was above a 1% reduction in the composite outcome including ischemic vascular events and bleeding,” he noted.
“This is important because there are many thousands of patients with acute ischemic stroke and AFib, and now we have a large study showing we can treat them with a DOAC early, and this appears to be safe and it appears also be more effective in terms of outcome events,” Dr. Tsivgoulis said.
But he highlighted one important caveat: The majority of patients had mild or moderate stroke.
A version of this article first appeared on Medscape.com.
, a new study suggests.
The ELAN trial found that starting DOAC treatment earlier was not associated with an increased risk for intracranial hemorrhage (ICH) but rather was linked to a lower rate of ischemic events.
“We conclude that there is no reason to delay DOAC treatment in these patients. Our results suggest that early DOAC treatment is reasonable; it is unlikely to cause harm, and it is probably better at reducing ischemic events,” lead investigator of the study, Urs Fischer, MD, professor of neurology at University Hospital Basel (Switzerland), commented in an interview.
“This trial will change clinical practice in that we can feel much more reassured that starting DOAC treatment early in these patients will not cause harm,” he said.
Senior investigator Jesse Dawson, MD, professor of stroke medicine at Queen Elizabeth University Hospital, Glasgow, added: “This issue of timing of DOAC treatment causes a lot of anxiety in our daily workload. Clinicians are scared of causing an ICH, so they tend to wait. These results will ease a lot of that anxiety.”
Dr. Fischer presented the results of the ELAN trial at the European Stroke Organisation Conference (ESOC) in Munich. The trial was also simultaneously published online in The New England Journal of Medicine.
He explained that patients presenting with acute ischemic stroke who are found to have atrial fibrillation need to be started on anticoagulation to reduce the risk for a recurrent stroke. But there are no clear guidelines on when to start anticoagulation in these patients at present, with concerns that starting very early may increase the risk for hemorrhagic transformation and ICH.
Based on observations that patients with larger strokes have a higher risk for ICH in the early post-stroke period, some guidelines advise different times for starting anticoagulation for different stroke severities: 1 day for a transient ischemic attack, 3 days for a minor stroke, 6 days for a moderate stroke, and 12 days for a severe stroke – known as the 1-, 3-, 6-, 12-day rule.
“But this is not based on evidence – just on expert opinion,” Dr. Fischer noted. “The ELAN trial was conducted to obtain more solid information on optimal timing for starting anticoagulation and whether we can safely start a DOAC earlier than these guidelines currently advise.”
For the trial, which was conducted in 15 countries, 2,013 patients with an acute ischemic stroke and found to have AFib were randomly selected to start DOAC treatment earlier or later.
The later-treatment strategy followed the current approach of starting treatment at day 3 or 4 after a minor stroke, day 6 or 7 after a moderate stroke, or day 12, 13, or 14 after a major stroke, whereas the earlier-treatment group started DOAC treatment within 48 hours after a minor or moderate stroke or on day 6 or 7 after a major stroke.
In terms of stroke severity, which was defined on imaging-based criteria, 37% of patients had a minor stroke, 40% had a moderate stroke, and 23% had a major stroke.
The primary outcome was a composite of recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial hemorrhage, or vascular death within 30 days after randomization.
Results showed that this occurred in 2.9% in the early-treatment group and 4.1% in the later-treatment group (risk difference, –1.18 percentage points; 95% confidence interval, –2.84-0.47) by 30 days.
Recurrent ischemic stroke occurred in 1.4% in the early-treatment group and 2.5% in the later-treatment group (odds ratio, 0.57; 95% CI, 0.29-1.07). Symptomatic intracranial hemorrhage occurred in two participants (0.2%) in both groups by 30 days.
The rates of the outcomes increased only slightly more at 90 days than at 30 days, “findings that suggest there was not an excessive risk associated with early anticoagulation through that period,” the researchers report in the NEJM paper.
“Early treatment initiation can therefore be supported if indicated or if desired,” they conclude.
“The most important finding was that among 2,000 patients randomized, there was a very low rate of bleeding complications and no increase in any bleeding complication in the early DOAC group. This has been a major worry about starting anticoagulation early,” Dr. Fischer commented.
“These are very practical findings in that we can keep things simple,” Dr. Dawson added. “If the patient has a big stroke, anticoagulation with a DOAC can now be started at 6 days. For everyone else, we can start DOAC treatment as soon as possible without fear of causing harm. So, we can now confidently give patients with a minor or moderate stroke, as defined by imaging, a beneficial treatment as soon as we establish they are having an ischemic stroke and have AFib.”
Dr. Dawson pointed out that about 25% of patients with ischemic stroke are found to have AFib on admission ECG, and in another 4%-5%, AFib is found in the first 48 hours. “These are the patients we are targeting in this study.”
The researchers note that the trial did not have a statistical superiority or noninferiority design but rather aimed to estimate the treatment effects of early initiation versus later initiation of DOACs.
“This trial was slightly different in that we weren’t testing a strict statistical hypothesis because we didn’t have any data with which to formulate what sort of effect size to aim for, so we performed a qualitative trial to look at what the event rates were with the two approaches,” Dr. Fischer explained. “Our main findings are that ICH rates were not increased with early DOAC treatment and that ischemic event rates were numerically reduced, but because we didn’t have strict statistical limits, we can only say this is a high probability but not a certainty.”
Dr. Dawson added: “We can say from these results that there is a high level of probability that early DOAC treatment does not cause harm and a reasonable probability that it reduces risks of a recurrent stroke or other ischemic event.”
The researchers give an estimate of the effect size for the primary composite endpoint, which combines the major ischemic and bleeding events, ranging from a 2.8% lower risk to a 0.5% higher risk with early DOAC treatment.
“So, it is very likely that the composite endpoint would be lower,” Dr. Dawson said.
Dr. Fischer noted that a previous study (TIMING) tried to address the issue of earlier versus later anticoagulation in these patients but was stopped early after 880 patients had been enrolled because of slow recruitment.
“Results from this study failed to show superiority of early versus late DOAC treatment but they did suggest noninferiority, and they also found no increase in major bleeding complications, which is an added reassurance,” he commented.
Another trial looking at early versus late anticoagulation in these patients, OPTIMAS, is ongoing in the United Kingdom and is aiming to randomize 3,500 patients.
Imaging-based assessment of stroke severity
In the ELAN trial, the definition of stroke severity was based on imaging rather than on the National Institutes of Health Stroke Scale (NIHSS).
“We took a cautious approach by using imaging to define stroke severity. So, when using these results in clinical practice, it is important that patients are selected for the timing of DOAC treatment based on the imaging results,” Dr. Dawson explained. “This is very straightforward, as the size of the stroke can be seen clearly on the routine CT imaging that all patients receive up front. This is a very pragmatic and simple protocol. And advanced imaging is not required.”
He noted that though clinicians tend to use the NIHSS clinical symptom score to define mild, moderate, and severe stroke, the imaging approach is actually more accurate when determining the risk for bleeding and ICH. And though imaging results often correlate with NIHSS scores, there can be some exceptions.
Commenting on the ELAN trial results at the ESOC meeting, Georgios Tsivgoulis, MD, professor of neurology, University of Athens, said that the trial showed that early administration of DOACs in these patients was safe and did not increase the rate of ICH.
“There was a very low ICH rate with only two events in each group. And then there was above a 1% reduction in the composite outcome including ischemic vascular events and bleeding,” he noted.
“This is important because there are many thousands of patients with acute ischemic stroke and AFib, and now we have a large study showing we can treat them with a DOAC early, and this appears to be safe and it appears also be more effective in terms of outcome events,” Dr. Tsivgoulis said.
But he highlighted one important caveat: The majority of patients had mild or moderate stroke.
A version of this article first appeared on Medscape.com.
, a new study suggests.
The ELAN trial found that starting DOAC treatment earlier was not associated with an increased risk for intracranial hemorrhage (ICH) but rather was linked to a lower rate of ischemic events.
“We conclude that there is no reason to delay DOAC treatment in these patients. Our results suggest that early DOAC treatment is reasonable; it is unlikely to cause harm, and it is probably better at reducing ischemic events,” lead investigator of the study, Urs Fischer, MD, professor of neurology at University Hospital Basel (Switzerland), commented in an interview.
“This trial will change clinical practice in that we can feel much more reassured that starting DOAC treatment early in these patients will not cause harm,” he said.
Senior investigator Jesse Dawson, MD, professor of stroke medicine at Queen Elizabeth University Hospital, Glasgow, added: “This issue of timing of DOAC treatment causes a lot of anxiety in our daily workload. Clinicians are scared of causing an ICH, so they tend to wait. These results will ease a lot of that anxiety.”
Dr. Fischer presented the results of the ELAN trial at the European Stroke Organisation Conference (ESOC) in Munich. The trial was also simultaneously published online in The New England Journal of Medicine.
He explained that patients presenting with acute ischemic stroke who are found to have atrial fibrillation need to be started on anticoagulation to reduce the risk for a recurrent stroke. But there are no clear guidelines on when to start anticoagulation in these patients at present, with concerns that starting very early may increase the risk for hemorrhagic transformation and ICH.
Based on observations that patients with larger strokes have a higher risk for ICH in the early post-stroke period, some guidelines advise different times for starting anticoagulation for different stroke severities: 1 day for a transient ischemic attack, 3 days for a minor stroke, 6 days for a moderate stroke, and 12 days for a severe stroke – known as the 1-, 3-, 6-, 12-day rule.
“But this is not based on evidence – just on expert opinion,” Dr. Fischer noted. “The ELAN trial was conducted to obtain more solid information on optimal timing for starting anticoagulation and whether we can safely start a DOAC earlier than these guidelines currently advise.”
For the trial, which was conducted in 15 countries, 2,013 patients with an acute ischemic stroke and found to have AFib were randomly selected to start DOAC treatment earlier or later.
The later-treatment strategy followed the current approach of starting treatment at day 3 or 4 after a minor stroke, day 6 or 7 after a moderate stroke, or day 12, 13, or 14 after a major stroke, whereas the earlier-treatment group started DOAC treatment within 48 hours after a minor or moderate stroke or on day 6 or 7 after a major stroke.
In terms of stroke severity, which was defined on imaging-based criteria, 37% of patients had a minor stroke, 40% had a moderate stroke, and 23% had a major stroke.
The primary outcome was a composite of recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial hemorrhage, or vascular death within 30 days after randomization.
Results showed that this occurred in 2.9% in the early-treatment group and 4.1% in the later-treatment group (risk difference, –1.18 percentage points; 95% confidence interval, –2.84-0.47) by 30 days.
Recurrent ischemic stroke occurred in 1.4% in the early-treatment group and 2.5% in the later-treatment group (odds ratio, 0.57; 95% CI, 0.29-1.07). Symptomatic intracranial hemorrhage occurred in two participants (0.2%) in both groups by 30 days.
The rates of the outcomes increased only slightly more at 90 days than at 30 days, “findings that suggest there was not an excessive risk associated with early anticoagulation through that period,” the researchers report in the NEJM paper.
“Early treatment initiation can therefore be supported if indicated or if desired,” they conclude.
“The most important finding was that among 2,000 patients randomized, there was a very low rate of bleeding complications and no increase in any bleeding complication in the early DOAC group. This has been a major worry about starting anticoagulation early,” Dr. Fischer commented.
“These are very practical findings in that we can keep things simple,” Dr. Dawson added. “If the patient has a big stroke, anticoagulation with a DOAC can now be started at 6 days. For everyone else, we can start DOAC treatment as soon as possible without fear of causing harm. So, we can now confidently give patients with a minor or moderate stroke, as defined by imaging, a beneficial treatment as soon as we establish they are having an ischemic stroke and have AFib.”
Dr. Dawson pointed out that about 25% of patients with ischemic stroke are found to have AFib on admission ECG, and in another 4%-5%, AFib is found in the first 48 hours. “These are the patients we are targeting in this study.”
The researchers note that the trial did not have a statistical superiority or noninferiority design but rather aimed to estimate the treatment effects of early initiation versus later initiation of DOACs.
“This trial was slightly different in that we weren’t testing a strict statistical hypothesis because we didn’t have any data with which to formulate what sort of effect size to aim for, so we performed a qualitative trial to look at what the event rates were with the two approaches,” Dr. Fischer explained. “Our main findings are that ICH rates were not increased with early DOAC treatment and that ischemic event rates were numerically reduced, but because we didn’t have strict statistical limits, we can only say this is a high probability but not a certainty.”
Dr. Dawson added: “We can say from these results that there is a high level of probability that early DOAC treatment does not cause harm and a reasonable probability that it reduces risks of a recurrent stroke or other ischemic event.”
The researchers give an estimate of the effect size for the primary composite endpoint, which combines the major ischemic and bleeding events, ranging from a 2.8% lower risk to a 0.5% higher risk with early DOAC treatment.
“So, it is very likely that the composite endpoint would be lower,” Dr. Dawson said.
Dr. Fischer noted that a previous study (TIMING) tried to address the issue of earlier versus later anticoagulation in these patients but was stopped early after 880 patients had been enrolled because of slow recruitment.
“Results from this study failed to show superiority of early versus late DOAC treatment but they did suggest noninferiority, and they also found no increase in major bleeding complications, which is an added reassurance,” he commented.
Another trial looking at early versus late anticoagulation in these patients, OPTIMAS, is ongoing in the United Kingdom and is aiming to randomize 3,500 patients.
Imaging-based assessment of stroke severity
In the ELAN trial, the definition of stroke severity was based on imaging rather than on the National Institutes of Health Stroke Scale (NIHSS).
“We took a cautious approach by using imaging to define stroke severity. So, when using these results in clinical practice, it is important that patients are selected for the timing of DOAC treatment based on the imaging results,” Dr. Dawson explained. “This is very straightforward, as the size of the stroke can be seen clearly on the routine CT imaging that all patients receive up front. This is a very pragmatic and simple protocol. And advanced imaging is not required.”
He noted that though clinicians tend to use the NIHSS clinical symptom score to define mild, moderate, and severe stroke, the imaging approach is actually more accurate when determining the risk for bleeding and ICH. And though imaging results often correlate with NIHSS scores, there can be some exceptions.
Commenting on the ELAN trial results at the ESOC meeting, Georgios Tsivgoulis, MD, professor of neurology, University of Athens, said that the trial showed that early administration of DOACs in these patients was safe and did not increase the rate of ICH.
“There was a very low ICH rate with only two events in each group. And then there was above a 1% reduction in the composite outcome including ischemic vascular events and bleeding,” he noted.
“This is important because there are many thousands of patients with acute ischemic stroke and AFib, and now we have a large study showing we can treat them with a DOAC early, and this appears to be safe and it appears also be more effective in terms of outcome events,” Dr. Tsivgoulis said.
But he highlighted one important caveat: The majority of patients had mild or moderate stroke.
A version of this article first appeared on Medscape.com.
FROM ESOC 2023
Losing weight may bolster AFib ablation’s chances for success: LEAF interim results
, a new analysis suggests.
The finding comes from a small study that entered such patients with paroxysmal and especially persistent AFib who were candidates for ablation. Those shedding at least 3% of body weight in the months before the procedure while engaged in a structured risk-factor modification (RFM) program were “dramatically” more likely to be AFib-free 6 months later.
The improved ablation efficacy, compared with results in similar patients who didn’t lose as much weight, was most pronounced among those whose AFib had been the persistent form, reported investigators at the annual scientific sessions of the Heart Rhythm Society, held in New Orleans.
Of note, ablations in the study were consistently limited, as much as possible, to standard pulmonary-vein isolation (PVI).
Associations between AFib and obesity and other behavioral and lifestyle-related risk factors are well recognized, but the limited studies of their effect on AFib ablation success have been inconsistent. The current analysis, the group says, points specifically to preablation weight loss as means to improving AFib-ablation outcomes.
“Adjunctive therapy focused on weight loss should be incorporated in the treatment plan for obese patients undergoing ablation for atrial fibrillation,” Jeffrey J. Goldberger, MD, MBA, of the University of Miami, said when presenting the new results at the HRS sessions.
Such a plan is entirely consistent with recent guidelines and especially a 2020 American Heart Association (AHA) consensus statement, but is inconsistently and perhaps even seldom realized in clinical practice.
Dramatic increase in success
Even modest weight loss before ablation may help, proposed Dr. Goldberger, who directs his institution’s Center for Atrial Fibrillation. Decreases for the greater-weight-loss group actually averaged less than 6% of baseline body weight.
Yet it was apparently enough to improve ablation outcomes significantly: Eighty-eight percent were free of AFib 6 months after the procedure, compared with 61% for patients who lost less than 3% of their preablation weight.
For improving ablation success, he said, “We’re talking about a moderate amount of weight loss. These patients are not going from being obese to being thin. They’re still quite overweight.”
In an analysis limited to the four-fifths of patients with persistent AFib, “we saw the same pattern,” Dr. Goldberger said at a media presentation prior to his formal report at the HRS sessions.
Moreover, that subgroup’s benefit persisted out to 12 months, at which time 42% and 81% of patients with less and greater weight loss, respectively, were free of AFib. That represents, he said, “a really tremendous – dramatic, actually – increase in success of pulmonary vein isolation in those who lost weight.”
“We’ve known for a long time that weight loss is important for preventing atrial fibrillation or increasing the success rates of the different treatments we use,” Cynthia M. Tracy, MD, said in an interview. “Probably in some studies, weight loss has been as effective as antiarrhythmics.”
A loss of 3% body weight “is not a lot,” she said. In the current analysis, “It’s notable that it made that much difference with even a fairly modest amount of weight loss.”
Now when asked, “ ‘How much do I have to lose before you’ll consider doing my ablation?’ we have a bit more concrete data to give patients and doctors as to what amount might be beneficial,” said Dr. Tracy of George Washington University Hospital, Washington, who is not associated with the study.
Evolving view of AFib
The findings are emblematic of the profession’s evolving view of AFib and its management, Dr. Goldberger observed at the press conference. Should clinicians think of AFib as similar to “a disease like Wolff-Parkinson-White syndrome,” in which the patient usually has a successful ablation, and then “we expect that to last in perpetuity with no further interventions?”
Or, he said, “is atrial fibrillation more a disease like coronary artery disease, where even if they have an intervention, the disease process is still ongoing and requires long-term disease management? I think it’s pretty clear that we’re dealing with the latter case.”
Dr. Goldberger’s report was an interim analysis of an ongoing randomized trial called LEAF (Liraglutide Effect on Atrial Fibrillation), which is comparing patients with AFib assigned to “take” vs. “not take” the GLP-1 receptor agonist liraglutide, an antidiabetic (Victoza) and weight-loss (Saxenda) drug. The trial aims to assess the drug’s apparent ability to shrink atrial epicardial adipose tissue which, Dr. Goldberger said, is thought to contribute to AFib development and influence AFib-ablation outcomes.
It’s unknown and a limitation of the current analysis, he said, whether the observed link between improved preablation–weight ablation success “is specifically related to weight loss, liraglutide treatment, or both.”
As the invited discussant for Dr. Goldberger’s presentation, David Frankel, MD, observed that studies have been inconsistent on whether substantial weight loss may improve the results of AFib rhythm-control therapy.
Those finding such an association, including LEAF and the influential LEGACY study, differed from others showing a null effect by including “a comprehensive risk factor management” program, observed Dr. Frankel, of the Hospital of the University of Pennsylvania and Penn Heart and Vascular Center, Philadelphia.
Rather than focusing solely on weight loss or sleep apnea as AFib risk factors, he said, the studies linking weight loss to AFib rhythm control also included “hypertension, diabetes, hyperlipidemia, smoking cessation, and alcohol reduction,” Dr. Frankel said. “So it seems clear that to significantly impact AF recurrence, we need to focus on all these contributors to metabolic syndrome.”
Comprehensive risk-factor management
LEAF entered patients with AFib, 79% of whom had persistent AF and the rest paroxysmal AF, who followed the RFM program and were randomly assigned also to take liraglutide or placebo. The “nurse-practitioner-led” RFM program, conducted both in-clinic and online, featured “established goals for each patient” using AHA diet and lifestyle recommendations, an exercise prescription, dietary counseling, evaluation and treatment of sleep apnea, and measures to control any diabetes, hyperlipidemia, or hypertension, Dr. Goldberger said. And patients “were counseled on alcohol reduction and smoking cessation as necessary.”
After 3 months, 29 and 30 patients – regardless of randomization assignment – had lost < 3% and at least 3% of baseline body weight, respectively.
Catheter ablation achieved PVI in all patients. A 3-month blanking period followed, after which they went off antiarrhythmic meds.
It’s very difficult for patients to lose 10% or more of body weight, “and it would not happen overnight,” Dr. Tracy observed. “These are symptomatic patients, for the most part, if they get referred to an electrophysiologist. So you don’t want to defer them indefinitely.”
The current findings, she said, point to “a more realistic target,” suggesting that weight loss of at least 3% should improve AFib ablation’s chances for success.
Dr. Goldberger disclosed ties to Medtronic. Dr. Frankel disclosed ties to Medtronic, Stryker, Biosense Webster, and Boston Scientific. Dr. Tracy reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a new analysis suggests.
The finding comes from a small study that entered such patients with paroxysmal and especially persistent AFib who were candidates for ablation. Those shedding at least 3% of body weight in the months before the procedure while engaged in a structured risk-factor modification (RFM) program were “dramatically” more likely to be AFib-free 6 months later.
The improved ablation efficacy, compared with results in similar patients who didn’t lose as much weight, was most pronounced among those whose AFib had been the persistent form, reported investigators at the annual scientific sessions of the Heart Rhythm Society, held in New Orleans.
Of note, ablations in the study were consistently limited, as much as possible, to standard pulmonary-vein isolation (PVI).
Associations between AFib and obesity and other behavioral and lifestyle-related risk factors are well recognized, but the limited studies of their effect on AFib ablation success have been inconsistent. The current analysis, the group says, points specifically to preablation weight loss as means to improving AFib-ablation outcomes.
“Adjunctive therapy focused on weight loss should be incorporated in the treatment plan for obese patients undergoing ablation for atrial fibrillation,” Jeffrey J. Goldberger, MD, MBA, of the University of Miami, said when presenting the new results at the HRS sessions.
Such a plan is entirely consistent with recent guidelines and especially a 2020 American Heart Association (AHA) consensus statement, but is inconsistently and perhaps even seldom realized in clinical practice.
Dramatic increase in success
Even modest weight loss before ablation may help, proposed Dr. Goldberger, who directs his institution’s Center for Atrial Fibrillation. Decreases for the greater-weight-loss group actually averaged less than 6% of baseline body weight.
Yet it was apparently enough to improve ablation outcomes significantly: Eighty-eight percent were free of AFib 6 months after the procedure, compared with 61% for patients who lost less than 3% of their preablation weight.
For improving ablation success, he said, “We’re talking about a moderate amount of weight loss. These patients are not going from being obese to being thin. They’re still quite overweight.”
In an analysis limited to the four-fifths of patients with persistent AFib, “we saw the same pattern,” Dr. Goldberger said at a media presentation prior to his formal report at the HRS sessions.
Moreover, that subgroup’s benefit persisted out to 12 months, at which time 42% and 81% of patients with less and greater weight loss, respectively, were free of AFib. That represents, he said, “a really tremendous – dramatic, actually – increase in success of pulmonary vein isolation in those who lost weight.”
“We’ve known for a long time that weight loss is important for preventing atrial fibrillation or increasing the success rates of the different treatments we use,” Cynthia M. Tracy, MD, said in an interview. “Probably in some studies, weight loss has been as effective as antiarrhythmics.”
A loss of 3% body weight “is not a lot,” she said. In the current analysis, “It’s notable that it made that much difference with even a fairly modest amount of weight loss.”
Now when asked, “ ‘How much do I have to lose before you’ll consider doing my ablation?’ we have a bit more concrete data to give patients and doctors as to what amount might be beneficial,” said Dr. Tracy of George Washington University Hospital, Washington, who is not associated with the study.
Evolving view of AFib
The findings are emblematic of the profession’s evolving view of AFib and its management, Dr. Goldberger observed at the press conference. Should clinicians think of AFib as similar to “a disease like Wolff-Parkinson-White syndrome,” in which the patient usually has a successful ablation, and then “we expect that to last in perpetuity with no further interventions?”
Or, he said, “is atrial fibrillation more a disease like coronary artery disease, where even if they have an intervention, the disease process is still ongoing and requires long-term disease management? I think it’s pretty clear that we’re dealing with the latter case.”
Dr. Goldberger’s report was an interim analysis of an ongoing randomized trial called LEAF (Liraglutide Effect on Atrial Fibrillation), which is comparing patients with AFib assigned to “take” vs. “not take” the GLP-1 receptor agonist liraglutide, an antidiabetic (Victoza) and weight-loss (Saxenda) drug. The trial aims to assess the drug’s apparent ability to shrink atrial epicardial adipose tissue which, Dr. Goldberger said, is thought to contribute to AFib development and influence AFib-ablation outcomes.
It’s unknown and a limitation of the current analysis, he said, whether the observed link between improved preablation–weight ablation success “is specifically related to weight loss, liraglutide treatment, or both.”
As the invited discussant for Dr. Goldberger’s presentation, David Frankel, MD, observed that studies have been inconsistent on whether substantial weight loss may improve the results of AFib rhythm-control therapy.
Those finding such an association, including LEAF and the influential LEGACY study, differed from others showing a null effect by including “a comprehensive risk factor management” program, observed Dr. Frankel, of the Hospital of the University of Pennsylvania and Penn Heart and Vascular Center, Philadelphia.
Rather than focusing solely on weight loss or sleep apnea as AFib risk factors, he said, the studies linking weight loss to AFib rhythm control also included “hypertension, diabetes, hyperlipidemia, smoking cessation, and alcohol reduction,” Dr. Frankel said. “So it seems clear that to significantly impact AF recurrence, we need to focus on all these contributors to metabolic syndrome.”
Comprehensive risk-factor management
LEAF entered patients with AFib, 79% of whom had persistent AF and the rest paroxysmal AF, who followed the RFM program and were randomly assigned also to take liraglutide or placebo. The “nurse-practitioner-led” RFM program, conducted both in-clinic and online, featured “established goals for each patient” using AHA diet and lifestyle recommendations, an exercise prescription, dietary counseling, evaluation and treatment of sleep apnea, and measures to control any diabetes, hyperlipidemia, or hypertension, Dr. Goldberger said. And patients “were counseled on alcohol reduction and smoking cessation as necessary.”
After 3 months, 29 and 30 patients – regardless of randomization assignment – had lost < 3% and at least 3% of baseline body weight, respectively.
Catheter ablation achieved PVI in all patients. A 3-month blanking period followed, after which they went off antiarrhythmic meds.
It’s very difficult for patients to lose 10% or more of body weight, “and it would not happen overnight,” Dr. Tracy observed. “These are symptomatic patients, for the most part, if they get referred to an electrophysiologist. So you don’t want to defer them indefinitely.”
The current findings, she said, point to “a more realistic target,” suggesting that weight loss of at least 3% should improve AFib ablation’s chances for success.
Dr. Goldberger disclosed ties to Medtronic. Dr. Frankel disclosed ties to Medtronic, Stryker, Biosense Webster, and Boston Scientific. Dr. Tracy reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a new analysis suggests.
The finding comes from a small study that entered such patients with paroxysmal and especially persistent AFib who were candidates for ablation. Those shedding at least 3% of body weight in the months before the procedure while engaged in a structured risk-factor modification (RFM) program were “dramatically” more likely to be AFib-free 6 months later.
The improved ablation efficacy, compared with results in similar patients who didn’t lose as much weight, was most pronounced among those whose AFib had been the persistent form, reported investigators at the annual scientific sessions of the Heart Rhythm Society, held in New Orleans.
Of note, ablations in the study were consistently limited, as much as possible, to standard pulmonary-vein isolation (PVI).
Associations between AFib and obesity and other behavioral and lifestyle-related risk factors are well recognized, but the limited studies of their effect on AFib ablation success have been inconsistent. The current analysis, the group says, points specifically to preablation weight loss as means to improving AFib-ablation outcomes.
“Adjunctive therapy focused on weight loss should be incorporated in the treatment plan for obese patients undergoing ablation for atrial fibrillation,” Jeffrey J. Goldberger, MD, MBA, of the University of Miami, said when presenting the new results at the HRS sessions.
Such a plan is entirely consistent with recent guidelines and especially a 2020 American Heart Association (AHA) consensus statement, but is inconsistently and perhaps even seldom realized in clinical practice.
Dramatic increase in success
Even modest weight loss before ablation may help, proposed Dr. Goldberger, who directs his institution’s Center for Atrial Fibrillation. Decreases for the greater-weight-loss group actually averaged less than 6% of baseline body weight.
Yet it was apparently enough to improve ablation outcomes significantly: Eighty-eight percent were free of AFib 6 months after the procedure, compared with 61% for patients who lost less than 3% of their preablation weight.
For improving ablation success, he said, “We’re talking about a moderate amount of weight loss. These patients are not going from being obese to being thin. They’re still quite overweight.”
In an analysis limited to the four-fifths of patients with persistent AFib, “we saw the same pattern,” Dr. Goldberger said at a media presentation prior to his formal report at the HRS sessions.
Moreover, that subgroup’s benefit persisted out to 12 months, at which time 42% and 81% of patients with less and greater weight loss, respectively, were free of AFib. That represents, he said, “a really tremendous – dramatic, actually – increase in success of pulmonary vein isolation in those who lost weight.”
“We’ve known for a long time that weight loss is important for preventing atrial fibrillation or increasing the success rates of the different treatments we use,” Cynthia M. Tracy, MD, said in an interview. “Probably in some studies, weight loss has been as effective as antiarrhythmics.”
A loss of 3% body weight “is not a lot,” she said. In the current analysis, “It’s notable that it made that much difference with even a fairly modest amount of weight loss.”
Now when asked, “ ‘How much do I have to lose before you’ll consider doing my ablation?’ we have a bit more concrete data to give patients and doctors as to what amount might be beneficial,” said Dr. Tracy of George Washington University Hospital, Washington, who is not associated with the study.
Evolving view of AFib
The findings are emblematic of the profession’s evolving view of AFib and its management, Dr. Goldberger observed at the press conference. Should clinicians think of AFib as similar to “a disease like Wolff-Parkinson-White syndrome,” in which the patient usually has a successful ablation, and then “we expect that to last in perpetuity with no further interventions?”
Or, he said, “is atrial fibrillation more a disease like coronary artery disease, where even if they have an intervention, the disease process is still ongoing and requires long-term disease management? I think it’s pretty clear that we’re dealing with the latter case.”
Dr. Goldberger’s report was an interim analysis of an ongoing randomized trial called LEAF (Liraglutide Effect on Atrial Fibrillation), which is comparing patients with AFib assigned to “take” vs. “not take” the GLP-1 receptor agonist liraglutide, an antidiabetic (Victoza) and weight-loss (Saxenda) drug. The trial aims to assess the drug’s apparent ability to shrink atrial epicardial adipose tissue which, Dr. Goldberger said, is thought to contribute to AFib development and influence AFib-ablation outcomes.
It’s unknown and a limitation of the current analysis, he said, whether the observed link between improved preablation–weight ablation success “is specifically related to weight loss, liraglutide treatment, or both.”
As the invited discussant for Dr. Goldberger’s presentation, David Frankel, MD, observed that studies have been inconsistent on whether substantial weight loss may improve the results of AFib rhythm-control therapy.
Those finding such an association, including LEAF and the influential LEGACY study, differed from others showing a null effect by including “a comprehensive risk factor management” program, observed Dr. Frankel, of the Hospital of the University of Pennsylvania and Penn Heart and Vascular Center, Philadelphia.
Rather than focusing solely on weight loss or sleep apnea as AFib risk factors, he said, the studies linking weight loss to AFib rhythm control also included “hypertension, diabetes, hyperlipidemia, smoking cessation, and alcohol reduction,” Dr. Frankel said. “So it seems clear that to significantly impact AF recurrence, we need to focus on all these contributors to metabolic syndrome.”
Comprehensive risk-factor management
LEAF entered patients with AFib, 79% of whom had persistent AF and the rest paroxysmal AF, who followed the RFM program and were randomly assigned also to take liraglutide or placebo. The “nurse-practitioner-led” RFM program, conducted both in-clinic and online, featured “established goals for each patient” using AHA diet and lifestyle recommendations, an exercise prescription, dietary counseling, evaluation and treatment of sleep apnea, and measures to control any diabetes, hyperlipidemia, or hypertension, Dr. Goldberger said. And patients “were counseled on alcohol reduction and smoking cessation as necessary.”
After 3 months, 29 and 30 patients – regardless of randomization assignment – had lost < 3% and at least 3% of baseline body weight, respectively.
Catheter ablation achieved PVI in all patients. A 3-month blanking period followed, after which they went off antiarrhythmic meds.
It’s very difficult for patients to lose 10% or more of body weight, “and it would not happen overnight,” Dr. Tracy observed. “These are symptomatic patients, for the most part, if they get referred to an electrophysiologist. So you don’t want to defer them indefinitely.”
The current findings, she said, point to “a more realistic target,” suggesting that weight loss of at least 3% should improve AFib ablation’s chances for success.
Dr. Goldberger disclosed ties to Medtronic. Dr. Frankel disclosed ties to Medtronic, Stryker, Biosense Webster, and Boston Scientific. Dr. Tracy reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM HEART RHYTHM 2023