Pulsed field ablation did not demonstrate superior efficacy over radiofrequency ablation for paroxysmal AF (77% vs 77% success; P=0.84), but had fewer procedure-related serious adverse events.
RCT (n=292)
Open-label
1:1
Yes
Does pulsed field ablation improve single-procedure success compared to radiofrequency ablation in patients with symptomatic, drug-resistant paroxysmal atrial fibrillation?
In patients with paroxysmal AF, pulsed field ablation did not demonstrate superior efficacy compared to radiofrequency ablation for single-procedure success at 12 months, but was associated with fewer safety events.
Absolute Event Rate: 77% vs 77%
p-value: p=.84
Atrial fibrillation: an underappreciated complication of diabetes', by Lingli Cai from Shanghai JiaoTong University School of Medicine in China, and colleagues. 1 The authors outline the intricate and close relationship between diabetes and atrial fibrillation (AF), addressing the epidemiology, pathogenesis, and management strategies built on the CARE-based approach in diabetic patients.Such consideration may facilitate timely prevention, early detection, and effective intervention, ultimately improving the health outcomes of patients with AF and diabetes.AF should be recognized as a complication of diabetes, with a prevalence of up to 25%.AF can develop in individuals with diabetes independent of hypertension, atherosclerotic cardiovascular disease, or heart failure.The pathogenesis linking diabetes to AF is multifactorial, involving atrial structural, electrical, electromechanical, and autonomic remodelling, as well as diabetes-related metabolic comorbidities.Given that the prevalence of diabetes (mainly type 2) is expected to increase further, the co-existent burden of AF on individuals, society, and healthcare systems will continue to increase.Thus, an integrated CARE-based management approach should be adopted to optimize care for diabetic patients across all stages of those at risk for AF and those with subclinical or clinical AF.This comprises 'Comorbidity and risk factor management', 'Avoidance of stroke and thromboembolism', 'Reduction of symptoms by rate and rhythm control', and 'Evaluation and dynamic reassessment'.AF is characterized by a complex pathogenesis, is the most common sustained cardiac arrhythmia in humans, represents a substantial burden for patients, clinicians, and healthcare systems worldwide, and requires a careful management. 23]456789101112 In a Fast Track Clinical Research article entitled 'Pulsed field vs radiofrequency ablation for paroxysmal atrial fibrillation: the BEAT PAROX-AF trial', Pierre Jais from the University of Bordeaux in France, and colleagues compare single-procedure efficacy and safety of pulsed field ablation (PFA) vs radiofrequency ablation (RFA) in patients with drug-resistant paroxysmal AF. 13 BEAT PAROX-AF is a European, multicentre, open-label, randomized, controlled, superiority trial conducted across nine European sites.Eligible patients (aged 18-80 years) with symptomatic, drug-resistant paroxysmal AF were randomized (1:1) to either PFA (pentaspline) or RFA following the CLOSE protocol (contact force sensing catheter and electroanatomical mapping system).The primary endpoint was the single-procedure success rate after 12 months defined as the absence of recurrence 30 s atrial arrhythmia, cardioversion, class I/III antiarrhythmic drug resumption after a 2-month blanking period, or any repeat ablation.From December 2021 to January 2024, a total of 292 patients were randomized and 289 (median age 63 years, 58% male) were analysed.Single-procedure success at 12 months was 77% in the PFA group and 77% in the RFA group (P = .84).Procedure-related serious adverse events occurred in 3.4% of PFA vs 7.6% of RFA patients.No deaths, persistent phrenic palsy, or stroke occurred.In the RFA group, two patients had pulmonary vein stenosis >70% and 12 had stenosis >50%; there were also two tamponades, and one oesophageal bleed (Figure 1).The authors conclude that this randomized trial performed in patients with paroxysmal AF does not demonstrate superior efficacy of single-shot PFA vs point-by-point RFA using the CLOSE protocol regarding single-procedure freedom from atrial arrhythmias, but fewer safety events being observed in this study with PFA.The manuscript is accompanied by an
“This important study sets the bar for ongoing prospective trials and argues strongly for changes in practice and changes in guidelines. Given that the mean ejection fraction in this study was 60%, it argues that at least for patients with a normal ejection fraction, spending an extra 5 min placing a conduction system lead in the interventricular septum is worth the time and effort, with better clinical outcomes.”
F Crea (Wed,) conducted a rct in Symptomatic, drug-resistant paroxysmal atrial fibrillation (n=292). Pulsed field ablation (PFA) vs. Radiofrequency ablation (RFA) was evaluated on Single-procedure success rate after 12 months defined as the absence of recurrence 30 s atrial arrhythmia, cardioversion, class I/III antiarrhythmic drug resumption, or any repeat ablation (p=.84). Pulsed field ablation did not demonstrate superior efficacy over radiofrequency ablation for paroxysmal AF (77% vs 77% success; P=0.84), but had fewer procedure-related serious adverse events.