Journal of the American College of Cardiology最新文献

Non-communicable diseases (NCDs) account for 70% of global mortality and are responsible for over 38 million deaths annually, with cardiovascular disease (CVD) constituting most of these fatalities. While traditional risk factors for CVD have long been recognized, there is growing evidence that a rising prevalence of ubiquitous environmental risk factors (ERFs) may play an increasingly significant role in the genesis and rising prevalence of NCDs. ERFs include many interconnected anthropogenic exposures with cumulative compound health impacts, including air pollution, noise exposure, artificial light at night, plastic pollution, chemical pollution and the various effects of climate change, such as heat extremes, desert storms, floods and wildfires. Urbanization has intensified the impact of many ERFs and created intense exposure environments, highlighting the urgency and the opportunity to address these for maximum public health benefit. Impactful intervention often requires regulatory and policy-driven efforts addressing the genesis of exposures and minimizes their health impact, particularly in vulnerable populations who may contribute the least but may be impacted the most. Solutions must involve the development of resiliency and adaptation measures to a changing world, where the probability of sudden catastrophic and cascading events is much more likely. Political will and international cooperation are essential in establishing and enforcing regulations that promote cleaner air and water, quieter and natural biodiverse environments, and sustainable infrastructure in urban, and rural medical facilities. Integration of planetary and environmental health into cardiovascular care will be vital in reducing the burden of NCDs globally. By addressing the root causes of environmental stressors, it is possible to reduce the incidence of CVDs and promote healthier, just and sustainable societies.

Background: Polygenic risk scores (PRS) hold promise in risk stratification and screening for cardiovascular diseases, including atrial fibrillation (AF).

Objectives: This study investigated the efficacy of AF screening for stroke prevention based on a PRS for AF.

Methods: This prespecified post hoc analysis of the randomized LOOP (Atrial Fibrillation Detected by Continuous ECG Monitoring Using Implantable Loop Recorder to Prevent Stroke in High-Risk Individuals) study included 5,656 AF-naive individuals aged ≥70 years with stroke risk factors and available genetic data. The participants were randomized 1:3 for screening with an implantable loop recorder (ILR) vs usual care. Genetic risk of AF was assessed using a PRS for AF (PRS_AF). The primary outcome was a composite of stroke and systemic embolism (SE). Interaction between the randomization arm and PRS_AF was assessed in cause-specific Cox regressions for the full cohort and across the observed range of polygenic risk using a continuous prediction grid. Secondary analyses included models stratified by PRS level, gene-screening interactions for major bleeding events, and associations between PRS_AF and AF burden (≥1 episode lasting ≥24 hours among participants with ILR-detected AF).

Results: Over a median follow-up period of 5.4 years, 969 participants (17.1%) received a diagnosis of AF, 296 (5.2%) had stroke/SE, and 206 (3.6%) had major bleeding. PRS_AF was associated with higher rates of AF (HR per SD increase: 1.20; 95% CI: 1.13-1.28; P < 0.001). A significant interaction was observed between ILR screening and PRS_AF for stroke/SE (P_interaction = 0.006). ILR screening was associated with lower rates of stroke/SE in individuals with PRS_AF ≥median (HR: 0.65; 95% CI: 0.43-0.97; P = 0.036) but not in those with PRS_AF AF (P_interaction = 0.036), corresponding to a HR of 1.71 (95% CI: 1.12-2.64; P = 0.011) in those with PRS_AF AF was associated with an OR of 1.35 (95% CI: 1.02-1.78; P = 0.037) for having ≥1 AF episode lasting ≥24 hours.

Conclusions: ILR screening for AF was associated with a significant reduction in stroke/SE in individuals with higher genetic risk of AF but not in those with lower genetic risk. These hypothesis-generating findings indicate that genetic predisposition may aid in selecting individuals who benefit from AF screening.

Background: Cardiac resynchronization therapy (CRT) improves heart failure outcomes and reduces morbidity and mortality but carries the highest infection risk among cardiac implantable electronic devices. Studies on surgical-site infections show conflicting results regarding the use of alcohol-based povidone-iodine vs chlorhexidine for skin antisepsis, especially as CRT implantation remains insufficiently studied.

Objectives: This study sought to compare the effectiveness of 2% alcohol-based chlorhexidine with that of 4-phase povidone-iodine-alcohol skin preparation in preventing local or systemic infections after cardiac resynchronization therapy device implantation, and to assess the impact on other major cardiovascular events and treatment-related adverse effects over 24 months.

Methods: In this randomized, multicenter, open-label trial with blinded outcome adjudication, patients undergoing CRT (implantation, upgrade, or replacement) pacemaker, or defibrillator implantation were assigned 1:1 to receive skin antisepsis with either 2% alcoholic chlorhexidine or alcoholic povidone-iodine. Randomization was conducted centrally using an interactive web-response system, with stratification according to trial center. The primary outcome was local or systemic infection related to the device over a 24-month follow-up period. The secondary outcomes were major cardiovascular events and noninfectious side effects.

Results: From April 2013 to December 2018, 2,272 patients were randomized to the chlorhexidine (n = 1,143) or the povidone-iodine group (n = 1,129). Median age was 72 years; 75.1% were men. Device-related infections occurred in 2.9% of the chlorhexidine group and 3.9% of the povidone-iodine group (adjusted subhazard ratio: 0.75; 95% CI: 0.48-1.20; P = 0.23). Major cardiovascular events occurred in 31.5% and 31.3% of patients, respectively (subhazard ratio: 1.01; 95% CI: 0.87-1.17). Noninfectious local side effects occurred in 12.9% vs 13.3%.

Conclusions: The study did not demonstrate a significant reduction in infection rates with alcoholic chlorhexidine compared with alcoholic povidone-iodine in patients undergoing cardiac resynchronization device implantation. Both antiseptics showed similar rates of major infectious and noninfectious events. Further research is needed to optimize infection prevention strategies in this population. (Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation [CHLOVIS]; NCT01841242).

Background: In first-in-human studies of the treatment of paroxysmal atrial fibrillation (PAF), a multielectrode globular spherical array pulsed field ablation (PFA) catheter and system able to map, pace, sense contact, and ablate exhibited a high rate, 94%, of durable pulmonary vein isolation (PVI).

Objectives: In this study, the authors sought to assess the 1-year outcomes of a multicenter single-arm pivotal trial of the spherical array system to treat PAF.

Methods: In the multicenter PULSAR pivotal investigational device exemption trial, patients with symptomatic drug-resistant or intolerant PAF underwent PVI with the use of the spherical array system. The array catheter was used to render left atrial anatomy and voltage and perform PVI. The primary effectiveness endpoint was a composite of 12-month freedom from atrial arrhythmias (as assessed by weekly and symptomatic transtelephonic monitoring and 24-hour Holter monitoring) and freedom from other failure modes: failure to achieve PVI, repeated ablation or cardioversion, and the use of new or increased doses of class I or III antiarrhythmic drugs. The primary safety endpoint included primary adverse events within 7 days of the index ablation procedure.

Results: The study cohort of 183 patients included 19 roll-in and 164 pivotal patients: aged 65 ± 9.1 years, 40% female, CHA₂DS₂-VASc 2.1 ± 1.4, left atrial diameter 3.8 ± 0.6 cm. Mapping time (9.0 ± 5.5 min), transpired ablation time (25.6 ± 9.8 min), left atrial catheter dwell time (59.9 ± 11.6 min), and procedure time (95.8 ± 20.7 min) revealed an efficient procedure. Most pulmonary veins (PVs) (94%, 607/647 veins) were electrically isolated by the first pulsed field application. The primary safety event rate was 0.6% (1/164): a hemorrhagic stroke identified immediately after the procedure in a patient with severe hypertension and polycystic kidney disease. The PV stenosis substudy revealed no patients with moderate or severe vein narrowing. Primary effectiveness at 12 months was 77.8% (95% CI: 70.6%-83.9%). During redo ablation in 11 patients, 39 of 41 (95.1%) pulmonary veins remained durably isolated.

Conclusions: The favorable clinical success observed in this multicenter Food and Drug Administration trial of this novel PFA catheter appears to reflect the clinical success achievable with durable PVI in PAF patients. (Safety and Effectiveness of the Globe Pulsed Field System for Treating Patients with Symptomatic Paroxysmal or Persistent Atrial Fibrillation [PULSAR]; NCT05462145).