The year 2024 witnessed significant advancements in the treatment of atrial fibrillation (AF), with pulsed field ablation (PFA) taking center stage. Several key developments, from regulatory approvals to innovative clinical trials, are reshaping the landscape of heart rhythm disorder management.
Pulsed Field Ablation (PFA) Revolution
Pulsed field ablation (PFA) emerged as a transformative technology in 2024, highlighted by multiple regulatory approvals. Boston Scientific received FDA approval for the Farapulse PFA system in late January, following positive 12-month data from the ADVENT clinical trial, which demonstrated comparable safety and efficacy to conventional thermal ablation but with statistically shorter ablation times. This was preceded by Medtronic's PulseSelect system approval at the end of 2023 and followed by Johnson & Johnson MedTech's Varipulse platform approval. The Affera mapping and ablation system with Sphere-9 catheter (Medtronic) also received approval, capable of delivering both pulsed-field and radiofrequency energy.
Kalyanam Shivkumar, MD, PhD, editor-in-chief of JACC: Clinical Electrophysiology, noted that PFA "has taken the world by storm," significantly impacting clinical workflows. While electrophysiologists are enthusiastic about PFA's potential for shorter and safer procedures, ongoing research is addressing questions about long-term durability and rare complications such as coronary spasm and hemolysis leading to acute renal failure.
Landmark Clinical Trials
The SHAM-PVI trial, presented at the European Society of Cardiology (ESC) Congress and published in JAMA, addressed the feasibility of sham-controlled trials for catheter ablation in AF. The study demonstrated that pulmonary vein isolation (PVI) using cryoablation significantly reduced AF burden and improved arrhythmia-related symptoms and quality of life compared to a sham procedure.
The OPTION trial, presented at the American Heart Association (AHA) Scientific Sessions and published in the New England Journal of Medicine, investigated the role of left atrial appendage occlusion (LAAO) with the Watchman FLX device (Boston Scientific) in conjunction with catheter ablation. Results indicated that LAAO, when added to catheter ablation, lessened bleeding and provided noninferior efficacy compared with direct oral anticoagulants. However, some experts have raised questions regarding the trial's endpoints.
Edoxaban Monotherapy in AF and Coronary Artery Disease
The EPIC-CAD trial, presented at ESC 2024 and published in NEJM, evaluated the efficacy and safety of edoxaban (Savaysa; Daiichi Sankyo) monotherapy versus edoxaban plus antiplatelet therapy in patients with high-risk AF and stable coronary artery disease. The study found that edoxaban alone significantly reduced the rate of net adverse clinical events at 1 year, primarily due to a lower risk of bleeding.
Updated Guidelines and Emerging Technologies
Updated European AF guidelines introduced the AF-CARE pathway, emphasizing a comprehensive approach to AF management. This pathway incorporates comorbidity and risk factor management (C), avoidance of stroke and thromboembolism (A), reduction of symptoms by rate and rhythm control (R), and evaluation and dynamic assessment (E).
Beyond AF ablation, there is growing interest in conduction-system pacing, including left bundle branch area pacing. Additionally, artificial intelligence-aided diagnosis is gaining traction as an active area of research. A study published in JACC: EP highlighted that quitting smoking is associated with a lower risk of developing AF, underscoring the importance of preventative measures.
