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There are limited data on trends in nationwide cardiac electrophysiology (EP) procedures in the US before and during the global COVID-19 pandemic.We aimed to understand contemporary EP procedural trends, and how the COVID-19 pandemic impacted them.Trends were obtained from publicly reported Centers for Medicare and Medicaid Services data from 2013 to 2020 (latest available). Rates of catheter-based EP procedures (EP studies and ablations) and cardiac implantable electronic device (CIED) procedures were analyzed. All procedural rates were calculated per 100,000 Medicare beneficiaries (year specific). Procedure physician subspecialty was also reported.From 2013 to 2019, annual rate of all cardiac EP procedures increased from 817.91 to 1089.68 per 100,000 beneficiaries. Catheter-based EP procedures increased from 323.73 to 675.01, while CIED rates decreased from 494.18 to 414.67. While all ablation procedures increased over time, relative proportion of ablation procedures being pulmonary vein isolation (PVI) increased (9.9% of ablations in 2013, to 18.2% in 2019). In 2020, rates of both catheter-based EP procedures and CIED procedures decreased; however, PVI share of ablation continued to increase in 2020 comprising 25.2% of ablation procedures.Rates of EP procedures have increased among Medicare beneficiaries, with catheter-based procedures now eclipsing CIEDs. Additionally, a greater proportion of catheter-based EP procedures are PVI, but they still represent a minority of all ablations. In 2020, rates of EP procedures were attenuated, yet proportion of PVI ablations increased to over one-fourth of ablation procedures. These data have important implications for the EP workforce.

Background: The comparative real-world outcomes of older patients with atrial fibrillation (AF) treated with anticoagulation compared with left atrial appendage occlusion (LAAO) may be different from those in clinical trials because of differences in anticoagulation strategies and patient demographics, including a greater proportion of women. We sought to compare real-world outcomes between older patients with AF treated with anticoagulation and those treated with LAAO by sex. Methods: Using Medicare claims data from 2015 to 2019, we identified LAAO-eligible beneficiaries and divided them into sex subgroups. Patients receiving LAAO were matched 1:1 to those receiving anticoagulation alone through propensity score matching. The risks of mortality, stroke or systemic embolism, and bleeding were compared between matched groups with adjustment for potential confounding characteristics in Cox proportional hazards models. Results: Among women, 4085 LAAO recipients were matched 1:1 to those receiving anticoagulation; among men, 5378 LAAO recipients were similarly matched. LAAO was associated with a significant reduction in the risk of mortality for women and men (hazard ratio [HR], 0.509 [95% CI, 0.447–0.580]; and HR, 0.541 [95% CI, 0.487–0.601], respectively; P P P Conclusions: In a real-world population of older Medicare beneficiaries with AF, compared with anticoagulation, LAAO was associated with a reduction in the risk of death, stroke, and long-term bleeding among women and men. These findings should be incorporated into shared decision-making with patients considering strategies for reduction in AF-related stroke.

Racial and ethnic differences in treatment-cardiovascular and otherwise-have been documented in many aspects of the American health care system and can be seen in implantable cardioverter-defibrillator (ICD) patient selection, counseling, and management. ICDs have been demonstrated to be a powerful tool in the prevention of sudden cardiac death, yet uptake across all eligible patients has been modest. Although patients who do not identify as White are disproportionately eligible for ICDs in the United States, they are less likely to see specialists, be counseled on ICDs, and ultimately have an ICD implanted. This review explores racial and ethnic differences demonstrated in ICD patient selection, outcomes including shock effectiveness, and postimplantation monitoring for both primary and secondary prevention devices. It also highlights barriers for uptake at the health system, physician, and patient levels and suggests areas of further research needed to clarify the differences, illuminate the driving forces of these differences, and investigate strategies to address them.

Atrial fibrillation (AF) is associated with an increased risk of dementia. Emerging evidence suggests AF suppression is associated with reduced risk of dementia, but the optimal strategy to achieve this is unknown. We sought to compare the risk of dementia in patients with AF who underwent catheter ablation (CA) versus anti-arrhythmic drug (AAD) treatment. METHODS AND RESULTS: Using the 2000 to 2021 Optum Clinformatics database, patients with AF who underwent CA versus AAD treatment (≥1 prescription fill for ≥2 different AADs) were identified and propensity score matched overall and within sex subgroups. A cause-specific hazard model was performed to assess dementia overall and in sex-specific subgroups. After matching, there were 19,088 patients per group. CA was associated with a 41% lower risk of dementia compared with AAD alone (1.9% vs 3.3%; hazard ratio [HR] 0.59, 95% confidence interval [CI] 0.52-0.67, log-rank P.0001). When examined by sex, dementia risk reduction associated with CA versus AAD use alone was observed among both males (HR 0.55, 95% CI 0.46-0.66) and females (HR 0.60, 95% CI 0.50-0.72). Though not studied as a primary outcome, patients treated with CA were also observed to have 49% lower associated risk of mortality compared with AAD only (HR 0.51 95% CI 0.46-0.55, P.0001). CONCLUSIONS: Among patients treated for AF, CA was associated with significantly lower risk of dementia and death compared with AADs only. These reductions in risk associated with CA versus AAD were seen in both males and females.

ObjectiveOlder, relatively small studies identified female sex as a risk factor for adverse events after catheter ablation for atrial fibrillation (AF). We aimed to assess contemporary sex-based differences in baseline and procedural characteristics, adverse events, and quality of life among adults undergoing catheter ablation for AF.MethodsIn this observational cohort study, we evaluated those enrolled in the National Cardiovascular Data Registry AFib Ablation Registry between January 2016 and September 2020. Using logistic regression, we analysed the association between patient sex and in-hospital adverse events.ResultsAmong 58 960 adults (34.6% women) from 150 centres undergoing AF ablation by 706 physicians, women were older (68 vs 64 years, p1 day (adjusted OR (aOR) 1.41 (95% CI 1.33 to 1.49)), major adverse event (aOR 1.60 (95% CI 1.33 to 1.92)) and any adverse event (aOR 1.57 (95% CI 1.41 to 1.75)). Women had a higher risk of bradycardia requiring pacemaker, phrenic nerve damage, pericardial effusion, bleeding and vascular injury, but had no differences in death or acute pulmonary vein isolation.ConclusionsAmong almost 60 000 patients in the largest prospective registry of AF ablation procedures, female sex was independently associated with a higher risk of hospitalisation >1 day, adverse events, and reduced quality of life, although there were no differences in death or acute pulmonary vein isolation.

Post-market evaluation is important to ensure the ongoing safety and effectiveness of cardiovascular implantable electronic device (CIED) leads. The Twenty-First Century Cures Act and subsequent Food and Drug Administrative (FDA) Guidance provide an opportunity to leverage real-world data sources for this purpose. The past 4 years have seen the development of EP PASSION: a multi-stakeholder, collaborative effort between the FDA, CIED manufacturers, Heart Rhythm Society, and academics. Using real-world data, EP PASSION enables longitudinal evaluation of the long-term safety of CIED leads, addressing limitations of current approaches to generate evidence that informs regulatory, clinical, and manufacturer decision-making. This state of the art article describes the impetus for and launch of EP PASSION, the lessons learned, its current state, the current analytic approach, and the strengths and limitations of leveraging extant data sources for post-market lead evaluation. We also compare EP PASSION to traditional post-approval studies and describe possible future directions.

This study sought to assess the comparative effectiveness of cardiac resynchronization therapy with defibrillator (CRT-D) over implantable cardioverter-defibrillator (ICD) alone in older Medicare patients with heart failure with reduced ejection fraction (HFrEF).Despite growing numbers of older patients with HFrEF, the benefits of cardiac resynchronization therapy (CRT) in this group are largely unknown.A cohort of fee-for-service Medicare beneficiaries ≥65 years of age with HFrEF and enrolled in Medicare Part D who underwent CRT-D or ICD implantation from January 2008 to August 2015 was identified. Beneficiaries were divided by age (65-74, 75-84, and 85+ years), and outcomes were compared between the CRT-D and ICD groups after inverse probability weighting.Compared with the ICD group, the CRT-D group was older and more likely to be White, be female, and have left bundle branch block. After weighting, overall complications were high across age and device groups (14%-20%). The 1-year mortality was high across all groups. In the 2 oldest age strata, the hazard of death was lower in the CRT-D group (HR: 0.90; 95% CI: 0.86-0.95 and HR: 0.81; 95% CI: 0.72-0.90, respectively; P 0.001); the hazard of heart failure hospitalization was lower for CRT-D vs ICD in the 85+ years age group (HR: 0.82; 95% CI: 0.74-0.92; P 0.001).In older Medicare beneficiaries undergoing ICD with or without CRT, complications and 1-year mortality were high. Compared with ICD alone, CRT-D was associated with a lower hazard of mortality in patients ≥74 years of age and lower hazard of HF hospitalization in those ≥85 years of age. These findings support the use of CRT in eligible older patients undergoing ICD implantation.

The subcutaneous (S-) implantable cardioverter-defibrillator (ICD) is an alternative to the transvenous (TV-) ICD that is increasingly implanted in younger patients; data on the safety and effectiveness of the S-ICD in older patients are lacking.The purpose of this study was to compare outcomes among older patients who received an S- or TV-ICD.The authors compared S-ICD and single-chamber TV-ICD implants in Fee-For-Service Medicare beneficiaries using the National Cardiovascular Data Registry ICD Registry. Outcomes were ascertained from Medicare claims data. Cox regression or competing-risk models (with TV-ICD as reference) with overlap weights were used to compare death and nonfatal outcomes (device reoperation, device removal for infection, device reoperation without infection, and cardiovascular admission), respectively. Recurrent all-cause readmissions were compared using Anderson-Gill models.A total of 16,063 patients were studied (age 72.6 ± 5.9 years, 28.4% women, ejection fraction 28.3 ± 8.9%). Compared with TV-ICD patients (n = 15,072), S-ICD patients (n = 991, 6.2% overall) were more often Black, younger, and dialysis dependent and less likely to have history of atrial fibrillation or flutter. In adjusted analyses, there were no differences between device type and risk of all-cause mortality (HR: 1.020; 95% CI: 0.819-1.270), device reoperation (subdistribution [s] HR: 0.976; 95% CI: 0.645-1.479), device removal for infection (sHR: 0.614; 95% CI: 0.138-2.736), device reoperation without infection (sHR: 0.975; 95% CI: 0.632-1.506), cardiovascular readmission (sHR: 1.087; 95% CI: 0.912-1.295), or recurrent all-cause readmission (HR: 1.072; 95% CI: 0.990-1.161).In a large representative national cohort of older patients undergoing ICD implantation, risk of death, device reoperation, device removal for infection, device reoperation without infection, and cardiovascular and all-cause readmission were similar among S- and TV-ICD recipients.

Despite the global COVID-19 pandemic, during the past 2 years, there have been numerous advances in our understanding of arrhythmia mechanisms and diagnosis and in new therapies. We increased our understanding of risk factors and mechanisms of atrial arrhythmias, the prediction of atrial arrhythmias, response to treatment, and outcomes using machine learning and artificial intelligence. There have been new technologies and techniques for atrial fibrillation ablation, including pulsed field ablation. There have been new randomized trials in atrial fibrillation ablation, giving insight about rhythm control, and long-term outcomes. There have been advances in our understanding of treatment of inherited disorders such as catecholaminergic polymorphic ventricular tachycardia. We have gained new insights into the recurrence of ventricular arrhythmias in the setting of various conditions such as myocarditis and inherited cardiomyopathic disorders. Novel computational approaches may help predict occurrence of ventricular arrhythmias and localize arrhythmias to guide ablation. There are further advances in our understanding of noninvasive radiotherapy. We have increased our understanding of the role of His bundle pacing and left bundle branch area pacing to maintain synchronous ventricular activation. There have also been significant advances in the defibrillators, cardiac resynchronization therapy, remote monitoring, and infection prevention. There have been advances in our understanding of the pathways and mechanisms involved in atrial and ventricular arrhythmogenesis.

Aims Age and sex may impact the efficacy of antiarrhythmic drugs on cardiovascular outcomes and arrhythmia recurrences in patients with atrial fibrillation (AF). We report on a post hoc analysis of the ATHENA study (NCT00174785), which examined cardiovascular outcomes in patients with non-permanent AF treated with dronedarone vs. placebo. Methods and results Efficacy and safety of dronedarone were assessed in patients according to age and sex. Baseline characteristics were comparable across subgroups, except for cardiovascular comorbidities, which were more frequent with increasing age. Dronedarone significantly reduced the risk of cardiovascular hospitalization or death due to any cause among patients 65–74 [n = 1830; hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.60–0.83; P < 0.0001] and ≥75 (n = 1925; HR 0.75, 95% CI 0.65–0.88; P = 0.0002) years old and among males (n = 2459; HR 0.74, 95% CI 0.64–0.84; P < 0.00001) and females (n = 2169; HR 0.77, 95% CI 0.67–0.89; P = 0.0002); outcomes were similar for time to AF/AFL recurrence. Among patients aged Conclusions These results support the use of dronedarone for the improvement of clinical outcomes among patients aged ≥65 years and regardless of sex.

CMS' coverage with evidence development (CED) policy allows Medicare beneficiaries to access promising therapies and services while additional data are collected. CED program characteristics are mostly unreported, and qualities associated with retirement of CED data collection requirements are unknown. We aimed to review and systematically describe CED program history and components and report programmatic elements correlated with retirement of CED data collection requirements, while identifying areas for policy improvement.Systematic review.We extracted CED information from the CMS website, ClinicalTrials.gov, PubMed, internet searches, and communication with CMS.There were 27 CED determinations from 2005 to 2022 in 8 therapeutic areas, with the most for cardiovascular diseases (8/27; 30%). Duration of CED programs (range, 1-16 years) and the number of related registries and clinical trials (range, 0-34) were widely variable. Only 4 CEDs have had data collection requirements with continued National Coverage Determination (NCD); 3 relate to cardiovascular therapies, and all have some public availability of findings resulting from CED-related data collection mechanisms. There were 2 instances of NCD revocation and deferral to local coverage decisions.Changes in the CED program through improving program predictability and transparency with regard to outstanding questions, roles of relevant stakeholders, and requirements for reporting and reevaluation would strengthen the program's effectiveness. Ultimately, these improvements would provide incentives for stakeholder participation in data collection to achieve the goal of increasing access to beneficial therapies and improving clinical outcomes.

OptiVol (Medtronic PLC, Minneapolis, MN) is a diagnostic feature of some cardiac implantable electronic devices (CIEDs) based on changes in thoracic impedance (TI) over time. Changes in TI can predict heart failure (HF) hospitalizations and mortality in HF populations. However, the utility of this feature is unknown in patients with a left ventricular assist device (LVAD). To determine if OptiVol and TI correlate with clinical HF events in a population of LVAD patients, hospitalization outcomes were collected retrospectively from the electronic health records at a single academic medical center in 80 LVAD patients with an OptiVol-capable CIED. Demographics, medical history, and available clinical data were reviewed and reported. The primary outcomes of interest were TI and OptiVol trends before and after hospitalization, and association of trends before and after these events was evaluated. Most patients had a HeartMate II LVAD and most CIEDs were defibrillators, and 23 (29%) had at least one HF hospitalization during the study period. HF hospitalizations were preceded by signs of volume overload in Optivol (60%) and TI (78%) with recovery of these measures post hospitalization in 33% and 25% of patients, respectively. Monitoring of TI and OptiVol may be one effective component of HF management in LVAD patients as part of a comprehensive program.

Highlights •Heart failure represents an active area of novel medical device development. •Baroreflex activation therapy, interatrial shunts, and phrenic nerve stimulation are emerging technologies in heart failure. •Along with novel mechanisms of action and design, heart failure devices have demonstrated regulatory innovation. •Lessons learned in development of heart failure devices may apply to other therapeutic areas.

Low-value health care services that provide little or no benefit to patients are common, potentially harmful, and costly. Nearly half of the patients in the United States will receive at least 1 low-value test or procedure annually, creating risk of avoidable complications from subsequent cascades of care and excess costs to patients and society. Reducing low-value care is of particular importance to cardiovascular health given the high prevalence and costs of cardiovascular disease in the United States. This scientific statement describes the current scope and impact of low-value cardiovascular care; reviews existing literature on patient-, clinician-, health system–, payer-, and policy-level interventions to reduce low-value care; proposes solutions to achieve meaningful and equitable reductions in low-value care; and suggests areas for future research priorities.

There is a growing appreciation for differences in epidemiology, treatment, and outcomes of cardiovascular conditions by sex. Historically, cardiovascular clinical trials have under-represented females, but findings have nonetheless been applied to clinical care in a sex-agnostic manner. Thus, much of the collective knowledge about sex-specific cardiovascular outcomes result from post hoc and secondary analyses. In some cases, these investigations have revealed important sex-based differences with implications for optimizing care for female patients with arrhythmias. This review explores the available evidence related to cardiac arrhythmia care among females, with emphasis on areas in which important sex differences are known or suggested. Considerations related to improving female enrollment in clinical trials as a way to establish more robust clinical evidence for the treatment of females are discussed. Areas of remaining evidence gaps are provided, and recommendations for areas of future research and specific action items are suggested. The overarching goal is to improve appreciation for sex-based differences in cardiac arrhythmia care as 1 component of a comprehensive plan to optimize arrhythmia care for all patients.

To summarize healthcare resource utilization (HCRU) in patients with newly diagnosed (incident) paroxysmal or persistent atrial fibrillation (AF). This retrospective, observational cohort study assessed HCRU among patients with incident paroxysmal or persistent AF using data from 1 January 2015 to 30 September 2019 in the IBM MarketScan® Research Databases. A total of 50,796 patients were identified in the overall incident AF cohort. Rates of all-cause inpatient hospital stays, all-cause emergency room visits, and all-cause outpatient visits in the overall incident cohort were 46.8, 114.7, and 2,752.7 events per 100 patient-years (PY), respectively. Rates of cardiovascular-related inpatient stays for the overall population were 11.3 events per 100 PY. During follow-up, 50.4% of the overall cohort filled prescriptions for direct-acting oral anticoagulants and 5.0% had catheter ablation. Advances in anticoagulation and ablation have been realized since previously published HCRU analyses of patients with atrial fibrillation. This update suggests that HCRU among patients with incident AF in the US remains high with some subgroups of patients receiving more specialized care.

Cardiac implantable electronic device (CIED) procedures require informed consent and, ideally, shared decision making to guide patients through their experiences as CIED recipients. The information that different patients need or want about cybersecurity risk varies. This article considers device cybersecurity risks in light of federal guidelines and suggests strategies for communicating these risks clearly during informed consent conversations and follow-up.

BACKGROUND The Medtronic Sprint Fidelis® and Abbott Riata®/Riata ST® leads are at risk of failure and are subject to FDA recall. Comparative risks of various lead management strategies during elective generator change in a multi-center population are unknown. We aim to describe patients with functional, recalled ICD leads undergoing elective generator replacement and report outcomes according to lead management strategies. METHODS Using data from the NCDR ICD Registry, patients with a functioning Riata® or Fidelis® lead undergoing generator replacement are described according to lead management: reuse, abandon/replace, and extract/replace. Adjusted rates of death and pre-discharge complications are reported. RESULTS There were 13,144 generator replacement procedures involving a functioning, non-infected Riata® or Fidelis® lead (extraction n = 414, abandonment n = 427). Extraction patients were younger (mean 58 vs. 67 years) with fewer comorbidities than the reuse group. Maximum lead dwell time was similar between groups with average 94, 90, and 99 months in the extraction, abandonment, and reuse groups, respectively. In-hospital complications or mortality were more common in the extraction group (10.14%, 4.35%) compared with abandonment (1.64%, 0.47%) and reuse (0.22%, 0.07%). Compared with reuse, the adjusted odds of death or pre-discharge complication were significantly higher in the extraction group (OR 7.77 95% CI 2.42-24.95, p

Importance Left atrial appendage occlusion (LAAO) has emerged as an alternative to anticoagulation for select patients with atrial fibrillation; however, women have been underrepresented in clinical trials of LAAO, and sex-specific subanalyses are limited. Objective To evaluate the sex differences in the baseline characteristics of patients undergoing LAAO implant and in the in-hospital outcomes after LAAO implant. Design, Setting, and Participants A total of 49 357 patients in the National Cardiovascular Data Registry LAAO Registry undergoing LAAO with the Watchman device between January 1, 2016, and June 30, 2019, were included in this study. Exposure Female or male sex. Main Outcomes and Measures The primary outcomes were aborted or canceled procedure, major adverse event, any adverse event, prolonged hospital stay longer than 1 day, and death. Unadjusted and multivariable adjusted logistic regression analyses were performed to assess sex differences in in-hospital adverse events. Results In this cohort study of 49 357 patients (mean [SD] age, 76.1 [8.0] years), 20 388 women (41.3%) and 28 969 (58.7%) men underwent LAAO. Compared with men, women were older and had a higher prevalence of paroxysmal atrial fibrillation, prior stroke, and uncontrolled hypertension but a lower prevalence of congestive heart failure, diabetes, and coronary artery disease. After multivariable adjustment, there were no differences in aborted or canceled procedures between women and men (613 [3.0%] vs 851 [2.9%]; odds ratio [OR] 1.01, 95% CI, 0.90-1.13). Women were more likely than men to experience any adverse event (1284 [6.3%] vs 1144 [3.9%]; P

Although 50% of U.S. medical students are women, this percentage fails to translate to cardiology. Gender disparities are striking in interventional cardiology (IC) and electrophysiology (EP) and in leadership. Left atrial appendage closure with the WATCHMAN device, as a novel procedure, is a lens into inequities.The purpose of this study was to identify the characteristics and prevalence of women (1) as early WATCHMAN implanters and (2) in related leadership.Data were collected on WATCHMAN implanters and hospitals from January 2017 to December 2018. The gender of physicians in leadership positions was identified via survey as Director of IC, Director of EP, and Chief of Cardiology. The Firth logistic model controlling for covariates modeled the rare event of a woman implanter.Data were obtained for 100% of the cohort. Men comprised 97% of implanters (860/886). No differences in subspecialty or implants by gender were observed. There were 414 hospitals performing WATCHMAN: 24% academic, 97% urban, and most medium/large size (94%). EP made up 61% of implanters. Only 4.8% of hospitals had women in selected leadership roles. Women represented1% of Directors of IC and only 2.6% of both Directors of EP and Chiefs of Cardiology. Hospitals with a woman in leadership had a 4 times greater odds of a woman implanter (odds ratio 4.24; 95% confidence interval 1.16-15.41; P = .028).Women are underrepresented in cardiology procedural subspecialties in the use of novel technology and in key leadership roles. There was a greater odds of women early implanters of WATCHMAN if a woman led locally. Increasing women in leadership may improve gender diversity through visibility of role models.

Background Centers for Medicare and Medicaid Services has mandated the use of shared decision-making (SDM) for implantable cardioverter-defibrillator (ICD) implantation. SDM tools help facilitate quality SDM by presenting patients with balanced evidence-based facts related to risk and benefits. Perceptions of ICD implantation may differ based on patients' sex and race. Objective To determine if and how physicians are incorporating SDM in counseling patients about ICD and if they are aware of sex- and race-based differences in patients' perception of ICDs. Methods This was a pilot study involving an online survey targeting attending physicians who implant ICDs. Physicians were randomly selected by a computer-based program; 350 surveys were sent. Results Of the 124 (35%) respondents to the survey, 102 (84%) met the inclusion criteria, and of those, 99 (97%) were adult electrophysiologists. Most physicians (90, 88%) stated they engaged in SDM during the general consent process. Sixty-three (62%) physicians discuss end of life issues while obtaining general consent. Forty-four (43%) physicians said they use an existing SDM tool with the Colorado SDM tool being the most common (39, 89%). The majority of physicians were unaware of sex- and race-based differences in perceptions related to ICD implantation (sex 64, 63% and race 63, 62%). Conclusion A vast majority of physicians are engaging in SDM; however less than half are using a formal SDM tool, and a minority of physicians were aware of sex- and race-based differences in patients' perception of ICD implantation. Sex- and race-based tools might help address this gap.

Objective : To perform meta-analyses comparing safety and effectiveness of cardiac resynchronization therapy (CRT) in older versus younger patients with heart failure with reduced ejection fraction (HFrEF). Background : Pivotal CRT trials enrolled patients with HFrEF significantly younger than the typical contemporary patient with HFrEF. Thus, risks and benefits in this older population with HFrEF are largely unknown. Methods : PubMed, The Cochrane Library, Scopus, and Web of Science were queried for comparative effectiveness studies of CRT in older HFrEF patients. Title, abstract, and full text screening was performed to identify studies comparing at least one pre-specified endpoint between older and younger adult patients with at least 50 participants. Random effects meta-analysis in LVEF mean difference (older minus younger) and relative risk (RR) of death, improvement in New York Heart Association (NYHA) class, and complications are reported along with estimates of heterogeneity. Results : In 7 studies, there was similar LVEF improvement between groups [mean difference 1.14; 95% CI -0.04 – 2.32, p=0.06, I 2 =53%]. Older patients were equally likely as younger patients to see an improvement in NYHA class of at least 1 in 6 studies [RR 0.99; 95% CI, 0.93 – 1.06; p=0.76; I 2 =25%]. No significant differences in the incidence of hematoma, pneumothorax, lead dislodgment, cardiac perforation, or infection requiring explant was observed. RR of mortality in 11 studies demonstrated higher risk of all-cause mortality in older patients [RR 1.05; 95% CI, 1.03 – 1.08, p Conclusions : Compared with younger patients, older patients receiving CRT were equally likely to experience improvement in LVEF, LVEDD, and NYHA class. There was no difference in procedural complications. The higher rate of all-cause mortality in older patients likely reflects a greater underlying risk of death from competing causes.

Background: Among patients with atrial fibrillation (AF), women are less likely to receive catheter ablation and may have more complications and less durable results. Most information about sex-specific differences after ablation comes from observational data. We prespecified an examination of outcomes by sex in the 2204-patient CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation). Methods: CABANA randomized patients with AF age ≥65 years or Results: CABANA randomized 819 (37%) women (ablation 413, drug 406) and 1385 men (ablation 695, drug 690). Compared with men, women were older (median age, 69 years versus 67 years for men), were more symptomatic (48% Canadian Cardiovascular Society AF Severity Class 3 or 4 versus 39% for men), had more symptomatic heart failure (42% with New York Heart Association Class ≥II versus 32% for men), and more often had a paroxysmal AF pattern at enrollment (50% versus 39% for men) ( P P =0.043), and complications from treatment were infrequent in both sexes. For the primary outcome, the hazard ratio for those who underwent ablation versus drug therapy was 1.01 (95% CI, 0.62–1.65) in women and 0.73 (95% CI, 0.51–1.05) in men (interaction P value=0.299). The risk of recurrent AF was significantly reduced in patients undergoing ablation compared with those receiving drug therapy regardless of sex, but the effect was greater in men (hazard ratio, 0.64 [95% CI, 0.51–0.82] for women versus hazard ratio, 0.48 [95% CI, 0.40–0.58] for men; interaction P value=0.060). Conclusions: Clinically relevant treatment-related strategy differences in the primary and secondary clinical outcomes of CABANA were not seen between men and women, and there were no sex differences in adverse events. The CABANA trial results support catheter ablation as an effective treatment strategy for both women and men. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00911508.