Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study.

Ekanem, Emmanuel; Neuzil, Petr; Reichlin, Tobias; Kautzner, Joseph; van der Voort, Pepijn; Jais, Pierre; Chierchia, Gian-Battista; Bulava, Alan; Blaauw, Yuri; Skala, Tomas; Fiala, Martin; Duytschaever, Mattias; Szeplaki, Gabor; Schmidt, Boris; Massoullie, Grégoire; Neven, Kars; Thomas, Olivier; Vijgen, Johan; Gandjbakhch, Estelle; Scherr, Daniel; ... (2024). Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. (In Press). Nature medicine Nature Publishing Group 10.1038/s41591-024-03114-3

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Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.

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