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Background: Benefit from cardiac resynchronization therapy (CRT) varies by QRS characteristics; individual randomized trials are underpowered to assess benefit for relatively small subgroups. Methods: The authors analyzed patient-level data from pivotal CRT trials (MIRACLE [Multicenter InSync Randomized Clinical Evaluation], MIRACLE-ICD [Multicenter InSync ICD Randomized Clinical Evaluation], MIRACLE-ICD II [Multicenter InSync ICD Randomized Clinical Evaluation II], REVERSE [Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction], RAFT [Resynchronization-Defibrillation for Ambulatory Heart Failure], BLOCK-HF [Biventricular Versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block], COMPANION [Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure], and MADIT-CRT [Multicenter Automatic Defibrillator Implantation Trial – Cardiac Resynchronization Therapy]) using Bayesian Hierarchical Weibull survival regression models to assess CRT benefit by QRS morphology (left bundle branch block [LBBB], n=4549; right bundle branch block [RBBB], n=691; and intraventricular conduction delay [IVCD], n=1024) and duration (with 150-ms partition). The continuous relationship between QRS duration and CRT benefit was also examined within subgroups defined by QRS morphology. The primary end point was time to heart failure hospitalization (HFH) or death; a secondary end point was time to all-cause death. Results: Of 6264 patients included, 25% were women, the median age was 66 [interquartile range, 58 to 73] years, and 61% received CRT (with or without an implantable cardioverter defibrillator). CRT was associated with an overall lower risk of HFH or death (hazard ratio [HR], 0.73 [credible interval (CrI), 0.65 to 0.84]), and in subgroups of patients with QRS ≥150 ms and either LBBB (HR, 0.56 [CrI, 0.48 to 0.66]) or IVCD (HR, 0.59 [CrI, 0.39 to 0.89]), but not RBBB (HR 0.97 [CrI, 0.68 to 1.34]; P interaction <0.001). No significant association for CRT with HFH or death was observed when QRS was <150 ms (regardless of QRS morphology) or in the presence of RBBB. Similar relationships were observed for all-cause death. Conclusions: CRT is associated with reduced HFH or death in patients with QRS ≥150 ms and LBBB or IVCD, but not for those with RBBB. Aggregating RBBB and IVCD into a single "non-LBBB" category when selecting patients for CRT should be reconsidered. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00271154, NCT00251251, NCT00267098, and NCT00180271. [ABSTRACT FROM AUTHOR]

BACKGROUND: Regulatory approval of the first dual-chamber leadless pacemaker system provides patients an alternative to conventional transvenous pacemakers. The study objective was to quantify the preferences of patients for pacemaker features. METHODS: Patients with a de novo (ie, initial) pacemaker indication were recruited from 7 US sites to complete a Web-based discrete-choice experiment survey between May 11, 2022, and May 24, 2023. Patients chose between pairs of experimentally designed, hypothetical pacemakers that varied according to type (removable leadless, nonremovable leadless, or conventional transvenous); battery life (5, 8, 12, or 15 years); time since regulatory approval (2 or 10 years); discomfort for 6 months (none or discomfort); and complication risk and infection risk (1%, 5%, or 10%/20% for each). Patients' choice data were analyzed using random-parameter logit models and latent-class analysis. RESULTS: Among 117 participants, the mean (SD) age was 67.3 (14.6) years, 94% were white, and 42% were female. On average, patients' survey responses revealed a preference for removable leadless pacemakers (β, 0.340; SE, 0.096) over both nonremovable leadless pacemakers (β, −0.310; SE, 0.131; P =0.001) and conventional transvenous pacemakers (β, −0.030; SE, 0.119; P =0.031). However, latent-class analysis revealed 2 distinct preference classes. One class preferred leadless pacemakers (50.5%), and the other class preferred conventional transvenous pacemakers (49.5%). The conventional pacemaker class prioritized pacemakers with 10 rather than 2 years since regulatory approval (P <0.001), whereas the leadless pacemaker class was insensitive to years since regulatory approval (P =0.83). Complication risks and infection risks were found to be the most influential. All else equal, patients would accept maximum risks of complications or infections ranging about 5% to 18% to receive their preferred pacemaker type. CONCLUSIONS: Latent-class analysis revealed strong patient preferences for the type of pacemaker, with a nearly equal split between recent leadless pacemaker technology and conventional transvenous pacemakers. These findings can inform shared decision-making between health care providers and patients. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05327101. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to reevaluate patients from a previous randomized controlled trial at a long-term follow-up to determine the long-term efficacy of subacromial decompression in patients with full-thickness rotator cuff tears. Methods: This is a secondary study based on a previous, multicenter, randomized controlled trial with patients allocated to arthroscopic rotator cuff repair with or without acromioplasty. The original study was conducted between 2003 and 2011, and the secondary study was conducted between 2015 and 2021. Patients were invited by a blinded assessor to return to complete the Western Ontario Rotator Cuff (WORC) index and a questionnaire about reoperation and to undergo a clinical assessment. If participants were unable to return, they were asked to complete the questionnaires by mail. A chart review on all participants in the original study was conducted. Results: Eighty-six patients were randomized in the original trial, with 31 of 45 from the group without acromioplasty and 25 of 41 from the acromioplasty group returning for long-term follow-up. The mean duration (and standard deviation) of follow-up was 11.2 ± 2.4 years for the group without acromioplasty and 11.5 ± 2.6 years for the acromioplasty group. There was no significant difference in WORC scores between the groups with and without acromioplasty at the time of the long-term follow-up (p = 0.30). Seven (16%) of the 45 patients in the group without acromioplasty underwent reoperation. One (2%) of the initial 41 patients allocated to acromioplasty underwent reoperation. All patients who underwent a reoperation had a Type-2 or 3 acromion. Conclusions: Patients who underwent rotator cuff repair with or without acromioplasty experienced improvement of outcomes from their preoperative level at a long-term follow-up (mean, 11 years), and there were no differences in patient-reported outcomes, specifically WORC scores, between these groups. However, a significantly higher reoperation rate was observed in patients who had rotator cuff repair without acromioplasty, specifically in those with a Type-2 or 3 acromion. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Determinants of the rate of appropriate ICD therapy include patient characteristics, ICD programming, and medical therapy for heart failure with a reduced ejection fraction and ventricular arrhythmias. Limiting the analysis to patients with nonischemic cardiomyopathy, Black patients were observed to have higher rates of first ventricular tachyarrhythmia, fast ventricular tachyarrhythmia, atrial tachyarrhythmia, and appropriate ICD therapy. [Extracted from the article]

Keywords: anticoagulants; apixaban; atrial fibrillation; embolism, paradoxical; hemorrhage; stroke EN anticoagulants apixaban atrial fibrillation embolism, paradoxical hemorrhage stroke 958 960 3 09/19/22 20220920 NES 220920 Factor Xa inhibitors are the predominant type of oral anticoagulant for stroke prevention in atrial fibrillation.[1] Although recommendations exist on holding these medications before procedures with a low, intermediate, or high bleeding risk, whether and for how long to interrupt these medications around the time of a procedure continue to be debated.[2] In a previous analysis of the ARISTOTLE trial (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation), the 30-day postprocedure risk of stroke and major bleeding was similarly low in apixaban- and warfarin-treated patients, regardless of whether or not anticoagulation was interrupted at the time of a procedure.[3] Despite these results, many clinicians remain concerned about the risk of stroke when anticoagulation is held and the risk of bleeding when anticoagulation is not held before an invasive procedure. Atrial fibrillation, hemorrhage, stroke, anticoagulants, apixaban, embolism, paradoxical The rates of stroke/systemic embolism, myocardial infarction, death and major bleeding were <0.5% for patients on study drug 1 or 2 days after the procedure. [Extracted from the article]

[Figure: see text]. [ABSTRACT FROM AUTHOR]

The interrelationships between atrial fibrillation (AF) and heart failure (HF) are complex and poorly understood, yet the number of patients with AF and HF continues to increase worldwide. Thus, there is a need for initiatives that prioritize research on the intersection between AF and HF. This article summarizes the proceedings of a virtual workshop convened by the US National Heart, Lung, and Blood Institute to identify important research opportunities in AF and HF. Key knowledge gaps were reviewed and research priorities were proposed for characterizing the pathophysiological overlap and deleterious interactions between AF and HF; preventing HF in people with AF; preventing AF in individuals with HF; and addressing symptom burden and health status outcomes in AF and HF. These research priorities will hopefully help inform, encourage, and stimulate innovative, cost-efficient, and transformative studies to enhance the outcomes of patients with AF and HF. [ABSTRACT FROM AUTHOR]

Catheter ablation has brought major advances in the management of patients with atrial fibrillation (AF). As evidenced by multiple randomized trials, AF catheter ablation can reduce the risk of recurrent AF and improve quality of life. In some studies, AF ablation significantly reduced cardiovascular hospitalizations. Despite the existing data on AF catheter ablation, numerous knowledge gaps remain concerning this intervention. This report is based on a recent virtual workshop convened by the National Heart, Lung, and Blood Institute to identify key research opportunities in AF ablation. We outline knowledge gaps related to emerging technologies, the relationship between cardiac structure and function and the success of AF ablation in patient subgroups in whom clinical benefit from ablation varies, and potential platforms to advance clinical research in this area. This report also considers the potential value and challenges of a sham ablation randomized trial. Prioritized research opportunities are identified and highlighted to empower relevant stakeholders to collaborate in designing and conducting effective, cost-efficient, and transformative research to optimize the use and outcomes of AF ablation. [ABSTRACT FROM AUTHOR]

Only 4 patients needed their S-ICD replaced with a transvenous ICD because of the need for antitachycardia or cardiac resynchronization therapy pacing, but none needed device replacement for bradycardia pacing. 1 Published in August 2020, the PRAETORIAN trial (Prospective, Randomized Comparison of Subcutaneoous and Transvenous Implantable Cardioverter Defibrillator Therapy) was the first trial to compare the S-ICD with the transvenous ICD in patients with ICD indications and no pacing requirements. Only 12 patients (1.1%) had their S-ICD explanted because of an infection, and no patient had bacteremia. This trial was a prospective, multinational investigation of patients with an indication for a primary prevention ICD on the basis of a reduced ejection fraction that aimed to evaluate the rate of inappropriate ICD shocks in a real-world contemporary ICD patient population receiving generation 2 or 3 S-ICD with optimal device programming and improved discrimination algorithms. [Extracted from the article]

Background: The risk of sudden cardiac death (SCD) in patients with heart failure after coronary artery bypass graft surgery (CABG) has not been examined in a contemporary clinical trial of surgical revascularization. This analysis describes the incidence, timing, and clinical predictors of SCD after CABG. Methods: Patients enrolled in the STICH trial (Surgical Treatment of Ischemic Heart Failure) who underwent CABG with or without surgical ventricular reconstruction were included. We excluded patients with prior implantable cardioverter-defibrillator and those randomized only to medical therapy. The primary outcome was SCD as adjudicated by a blinded committee. A Cox model was used to examine and identify predictors of SCD. The Fine and Gray method was used to estimate the incidence of SCD accounting for the competing risk of other deaths. Results: Over a median follow-up of 46 months, 113 of 1411 patients who received CABG without (n = 934) or with (n = 477) surgical ventricular reconstruction had SCD; 311 died of other causes. The mean left ventricular ejection fraction at enrollment was 28±9%. The 5-year cumulative incidence of SCD was 8.5%. Patients who had SCD and those who did not die were younger and had fewer comorbid conditions than did those who died of causes other than SCD. In the first 30 days after CABG, SCD (n=5) accounted for 7% of all deaths. The numerically greatest monthly rate of SCD was in the 31- to 90-day time period. In a multivariable analysis including baseline demographics, risk factors, coronary anatomy, and left ventricular function, end-systolic volume index and B-type natriuretic peptide were most strongly associated with SCD. Conclusions: The monthly risk of SCD shortly after CABG among patients with a low left ventricular ejection fraction is highest between the first and third months, suggesting that risk stratification for SCD should occur early in the postoperative period, particularly in patients with increased preoperative end-systolic volume index or B-type natriuretic peptide. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT0002359. [ABSTRACT FROM AUTHOR]

Given the limitations of observational studies and the small number of patients older than 75 years of age enrolled in the pivotal randomized clinical trials of ICDs, the question of whether the ICD is beneficial in older patients is of great importance. Even if one accounts for patients who may have received an ICD during follow-up and the fact that the Swedish Heart Failure Registry includes only 54% of patients countrywide, this utilization rate is disappointingly low. Indeed, the negative control analysis is consistent with best practices for observational comparative effectiveness research and provides reassurance that worse outcomes in the no ICD group are not explained by avoidance of ICD implantation in sicker patients. Multicenter Automatic Defibrillator Implantation Trial II Investigators Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. [Extracted from the article]

Background: Prior studies have demonstrated low use of implantable cardioverter defibrillators (ICDs) as primary prevention, particularly among women and blacks. The degree to which the overall use of ICD therapy and disparities in use have changed is unclear.Methods and Results: We examined 11 880 unique patients with a history of heart failure and left ventricular ejection fraction ≤35% who were ≥65 years old and enrolled in the Get With the Guidelines-Heart Failure (GWTG-HF) program from January 2005 through December 2009. We determined the rate of ICD use by year for the overall population and for sex and race groups. From 2005 to 2007, overall ICD use increased from 30.2% to 42.4% and then remained unchanged in 2008 to 2009. After adjustment for potential confounders, ICD use increased significantly in the overall study population during 2005 to 2007 (odds ratio, 1.28; 95% confidence interval, 1.11-1.48 per year; P=0.0008) and in black women (odds ratio, 1.82; 95% confidence interval, 1.28-2.58 per year; P=0.0008), white women (odds ratio, 1.30; 95% confidence interval, 1.06-1.59 per year; P=0.010), black men (odds ratio, 1.54; 95% confidence interval, 1.19-1.99 per year; P=0.0009), and white men (odds ratio, 1.25; 95% confidence interval, 1.06-1.48 per year; P=0.0072). The increase in ICD use was greatest among blacks.Conclusions: In the GWTG-HF quality improvement program, a significant increase in ICD therapy use was observed over time in all sex and race groups. The previously described racial disparities in ICD use were no longer present by the end of the study period; however, sex differences persisted. [ABSTRACT FROM AUTHOR]

Advances in the field of defibrillation have brought to practice different types of devices that include the transvenous implantable cardioverter-defibrillator (ICD) with or without cardiac resynchronization therapy, the subcutaneous ICD (S-ICD), and the wearable cardioverter-defibrillator. To ensure optimal use of these devices and to achieve best patient outcomes, clinicians need to understand how these devices work, learn the characteristics of patients who qualify them for one type of device versus another, and recognize the remaining gaps in knowledge surrounding these devices. The transvenous ICD has been shown in several randomized clinical trials to improve the survival of patients resuscitated from near-fatal ventricular fibrillation and those with sustained ventricular tachycardia with syncope or systolic heart failure as a result of ischemic or nonischemic cardiomyopathy despite receiving guideline-directed medical therapy. Important gaps in knowledge regarding the transvenous ICD involve the role of the ICD in patient subgroups not included, or not well represented, in clinical trials and the need to refine the selection criteria for the ICD in patients who are indicated for it. S-ICDs were recently introduced into the clinical arena as another option for many patients who have an approved indication for a transvenous ICD. The main advantage of the S-ICD is a lower risk of infection and lead-related complications; however, the S-ICD does not offer bradycardia or antitachycardia pacing. The S-ICD may be ideal for patients with limited vascular access, high infection risk, or some congenital heart diseases. However, more data are needed regarding the efficacy and effectiveness of the S-ICD in comparison to transvenous ICDs, the extent of defibrillation testing required, and the use of the S-ICD with other novel technologies, including leadless pacemakers. Cardiac resynchronization therapy-defibrillators are indicated in patients with a left ventricular ejection fraction ≤35%, QRS width ≥130 ms, and New York Heart Association class II, III, or ambulatory IV symptoms despite treatment with guideline-directed medical therapy. Multiple randomized controlled trials have shown that the cardiac resynchronization therapy-defibrillator improves survival, quality of life, and several echocardiographic measures. One main challenge related to cardiac resynchronization therapy-defibrillators is the 30% nonresponse rate. Many initiatives are underway to address this challenge including improved cardiac resynchronization therapy and imaging technologies and enhanced selection of patients and device programming. [ABSTRACT FROM AUTHOR]

Background-Patients with an unused or malfunctioning implantable cardioverter-defibrillator (ICD) lead may have the lead either abandoned or explanted; yet there are limited data on the comparative acute and longer-term safety of these 2 approaches. Methods and Results-We examined in-hospital events among 24 908 subject encounters using propensity score 1:1 matching for ICD lead abandonment or explantation in the National Cardiovascular Data Registry (NCDR) ICD Registry (April 2010 to June 2014). Relative to patients undergoing lead abandonment, patients undergoing lead explantation had more in-hospital procedure-related complications: 2.19% (n=273) versus 3.77% (n=469; P<0.001), respectively. Similarly, patients undergoing lead explantation had slightly higher rates of in-hospital death: 0.21% (n=26) versus 0.64% (n=80; P<0.001), respectively. At 1 year in a Medicare subset for survival, there was a trend of increased mortality in the explantation group (11% versus 8%; P=0.06). In the Medicare subset analyzed for postprocedure complications, there was no difference with respect to 6-month bleeding (4.80% in both the groups), tamponade (0.38% versus 0.58%), infection (1.34% versus 3.07%), upper extremity thrombosis (0.77% versus 0.96%), pulmonary embolism (0.38% versus 0.96%), or urgent surgery (1.15% for both the groups; P>0.05 for all). Conclusions-After matching, patients undergoing removal of an unused or malfunctioning ICD lead had slightly higher in-hospital complications and deaths than those with a lead abandonment strategy. Although the 1-year mortality risk was slightly higher in the lead explantation group, this difference was not statistically significant and may be explained by chance. [ABSTRACT FROM AUTHOR]