Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial.

BACKGROUND: Continuous automatic optimisation of cardiac resynchronisation therapy (CRT), stimulating only the left ventricle to fuse with intrinsic right bundle conduction (synchronised left ventricular stimulation), might offer better outcomes than conventional CRT in patients with heart failure, left bundle branch block, and normal atrioventricular conduction. This study aimed to compare clinical outcomes of adaptive CRT versus conventional CRT in patients with heart failure with intact atrioventricular conduction and left bundle branch block. METHODS: This global, prospective, randomised controlled trial was done in 227 hospitals in 27 countries across Asia, Australia, Europe, and North America. Eligible patients were aged 18 years or older with class 2-4 heart failure, an ejection fraction of 35% or less, left bundle branch block with QRS duration of 140 ms or more (male patients) or 130 ms or more (female patients), and a baseline PR interval 200 ms or less. Patients were randomly assigned (1:1) via block permutation to adaptive CRT (an algorithm providing synchronised left ventricular stimulation) or conventional biventricular CRT using a device programmer. All patients received device programming but were masked until procedures were completed. Site staff were not masked to group assignment. The primary outcome was a composite of all-cause death or intervention for heart failure decompensation and was assessed in the intention-to-treat population. Safety events were collected and reported in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02205359, and is closed to accrual. FINDINGS: Between Aug 5, 2014, and Jan 31, 2019, of 3797 patients enrolled, 3617 (95·3%) were randomly assigned (1810 to adaptive CRT and 1807 to conventional CRT). The futility boundary was crossed at the third interim analysis on June 23, 2022, when the decision was made to stop the trial early. 1568 (43·4%) of 3617 patients were female and 2049 (56·6%) were male. Median follow-up was 59·0 months (IQR 45-72). A primary outcome event occurred in 430 of 1810 patients (Kaplan-Meier occurrence rate 23·5% [95% CI 21·3-25·5] at 60 months) in the adaptive CRT group and in 470 of 1807 patients (25·7% [23·5-27·8] at 60 months) in the conventional CRT group (hazard ratio 0·89, 95% CI 0·78-1·01; p=0·077). System-related adverse events were reported in 452 (25·0%) of 1810 patients in the adaptive CRT group and 440 (24·3%) of 1807 patients in the conventional CRT group. INTERPRETATION: Compared with conventional CRT, adaptive CRT did not significantly reduce the incidence of all-cause death or intervention for heart failure decompensation in the included population of patients with heart failure, left bundle branch block, and intact AV conduction. Death and heart failure decompensation rates were low with both CRT therapies, suggesting a greater response to CRT occurred in this population than in patients in previous trials. FUNDING: Medtronic.

Guidance for Cardiac Electrophysiology During the COVID-19 Pandemic from the Heart Rhythm Society COVID-19 Task Force; Electrophysiology Section of the American College of Cardiology; and the Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology, American Heart Association.

Coronavirus disease 2019 (COVID-19) is a global pandemic that is wreaking havoc on the health and economy of much of human civilization. Electrophysiologists have been impacted personally and professionally by this global catastrophe. In this joint article from representatives of the Heart Rhythm Society, the American College of Cardiology, and the American Heart Association, we identify the potential risks of exposure to patients, allied healthcare staff, industry representatives, and hospital administrators. We also describe the impact of COVID-19 on cardiac arrhythmias and methods of triage based on acuity and patient comorbidities. We provide guidance for managing invasive and noninvasive electrophysiology procedures, clinic visits, and cardiac device interrogations. In addition, we discuss resource conservation and the role of telemedicine in remote patient care along with management strategies for affected patients.

Implantable cardioverter-defibrillators for primary prevention of sudden cardiac death in patients with left ventricular systolic dysfunction: 14 years after MADIT.

Sudden cardiac death (SCD) is the most common cause of death among patients with heart failure and left ventricular systolic dysfunction. Implantable cardioverter-defibrillators (ICDs) have been shown to be the single most effective therapy for primary prevention of SCD in patients with heart failure. The superiority of this therapy was clearly established for patients with ischemic cardiomyopathy by large clinical trials, such as the Multicenter Automatic Defibrillator Implantation Trial (MADIT), Multicenter Unsustained Tachycardia Trial (MUSTT), and MADIT-II studies. On the other hand, there was much debate on whether these results could be extrapolated for patients with non-ischemic cardiomyopathy until the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) demonstrated a significant benefit of this therapy. Given the high costs of this therapy and the limited resources allocated to health care multiple studies have attempted to identify patients at higher risk of suffering SCD, who in theory will benefit the most out of this therapy. However, these studies have not established a reliable way to predict which patients will receive a direct survival benefit from ICD therapy. Until we are capable of further defining which patients will derive the absolute highest benefit from an ICD, we must rely on the information available from published trials and adhere to current clinical practice guidelines regarding this pressing issue.

Update in atrial fibrillation.

Atrial fibrillation (AF) is a common cardiac arrhythmia associated with major morbidity and mortality. Atrial enlargement, remodeling, and fibrosis are key to initiation and perpetuation of AF. Therapy for AF is directed at symptom control via rate or rhythm control, as well as prevention of thromboembolic events. In the recent past multiple alternatives, including pharmacological and non-pharmacological, have emerged as possible therapies for AF. In this review, we intend to summarize the most important advances in AF therapy in recent years.

Ventricular tachycardia as a presentation of congenital left ventricular aneurysm.

Left ventricular aneurysm (LVA) describes a region of ventricular wall that is thinner than the adjacent myocardial segments, balloons outward and exhibits either akinesis or dyskinesis. Congenital LVA is diagnosed by exclusion with a very low incidence, especially in adult patients with very few cases reported. Clinically, most congenital LVA are asymptomatic. The most common complaints are typical angina or atypical chest pain followed by syncope and heart rhythm disturbances. We describe the case of a 26-year-old-woman that presented with monomorphic sustained ventricular tachycardia as a first manifestation of congenital LVA. Successful endoventricular circular patch placement, or Dor procedure was performed. Successful substrate modification for arrhythmia development was performed and confirmed by an electrophysiological study. This would constitute the first case of this nature reported in Puerto Rico.

Guidance for cardiac electrophysiology during the COVID-19 pandemic from the Heart Rhythm Society COVID-19 Task Force; Electrophysiology Section of the American College of Cardiology; and the Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology, American Heart Association.

Coronavirus disease 2019 (COVID-19) is a global pandemic that is wreaking havoc on the health and economy of much of human civilization. Electrophysiologists have been impacted personally and professionally by this global catastrophe. In this joint article from representatives of the Heart Rhythm Society, the American College of Cardiology, and the American Heart Association, we identify the potential risks of exposure to patients, allied healthcare staff, industry representatives, and hospital administrators. We also describe the impact of COVID-19 on cardiac arrhythmias and methods of triage based on acuity and patient comorbidities. We provide guidance for managing invasive and noninvasive electrophysiology procedures, clinic visits, and cardiac device interrogations. In addition, we discuss resource conservation and the role of telemedicine in remote patient care along with management strategies for affected patients.

Survey of cardiac rhythm management and device implant patterns in Puerto Rico: analysis of 13,854 cardiac implants.

BACKGROUND: Surveys of cardiac pacing and implantable cardiovertor defibrillators (ICD) have been reported since 1969 and 1993 respectively. Increasing costs of medical technology, budget constraints and emergent new clinical indications prompted our committee to conduct the first survey of cardiac rhythm management and device implant patterns in Puerto Rico. METHOD: Clinical and demographic data were obtained for all cardiac devices sold and implanted from 2000 to 2006, through a joint agreement with official representatives of the 2 largest manufacturers and distributors of cardiac pacemakers and ICD in Puerto Rico. RESULTS: 13,854 cardiac devices were implanted from 2000 to 2006. The number of permanent pacemakers (PP) implanted per million population has varied from 430 in the year 2000 to 482 in the year 2006. A significant greater number of males received PP than females (P < .05). Yearly increases in implant rates for cardiac resynchronization therapy (CRT) and ICD were observed, mainly due to new emergent clinical indications, appropriate insurance coverage and availability of implanting electrophysiologists. CONCLUSIONS: Sales figures from PP and ICD manufacturers are a reliable system to calculate and analyze changes in cardiac device implant patterns. The rate of 482 PP per million population positions Puerto Rico as the third largest implant market in North and South America. This finding should be useful to insurance health providers since 76% of the implants are performed in patients over 65 years old. In the year 2006, Puerto Rico was the 10th largest implant market in the world with 67 CRT implanted per million population. A significant greater number of CRT and ICD were implanted in males than females. This gender difference has increased in spite of strict requirements to include more females in clinical trials and intensive, educational and awareness efforts conducted among physicians and patients. A summary of the current guidelines and clinical indications is provided to assist the physician in the selection of patients referred for cardiac rhythm management and implant procedures.