Journal Article

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

Müller, Patrick, Gupta, Dhiraj, Pierre, Bertrand, Bohnen, Jan, Sticherling, Christian, Duncker, David, Ramos-Maqueda, Javier, Funasako, Moritoshi, Solimene, Francesco, Rollin, Anne, Geller, Laszlo, Mathew, Shibu, Van Opstal, Jurren, Kautzner, Joseph, Inkovaara, Jaakko, Luik, Armin, Goette, Andreas, Baldinger, Samuel H., Moravec, Ondrej, Osca, Joaquin, Rana, Obaida, Skala, Tomas, Hansen, Jim, Tzeis, Stylianos, Schreieck, Jürgen, Glowniak, Andrzej, Fink, Thomas, Szeplaki, Gabor, Gunawerdene, Melanie, Wong, Tom, Roux, Antoine, Parwani, Abdul Shokor, Duytschaever, Mattias, Fiala, Martin, Sultan, Arian, Fareh, Samir, Maury, Philippe, Adragão, Pedro, Johannessen, Arne, Vijgen, Johan, Peichl, Petr, Ekanem, Emmanuel, Nentwich, Karin, Rosso, Raphael, Chun, Julian, Neuzil, Petr, Thomas, Olivier, Asso, Antonio, Petru, Jan, Baran, Jakub, Jurisic, Zrinka, Frommeyer, Gerrit, Almroth, Henrik, George, Andrikopoulos, Kucera, Pavel, Steven, Daniel, Tilz, Roland, Munoz, Daniel Rodriguez, Della Rocca, Domenico G., Timo, Gottschling, de Sousa, João, Tabrizi, Fariborz, Bulava, Alan, Metzner, Andreas, Wakili, Reza, Sommer, Philipp, Balsa

2024

Overview

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. In a post-approval study including more than 17,000 patients on the safety of pulsed field ablation, a new method for treatment of atrial fibrillation, the procedure was found to have a low rate of adverse events but was associated with some unexpected rare complications that will need further study.

• Publisher: Nature Publishing Group US,Nature Publishing Group
• Subject: 692/308/409 / 692/699/75/29/1309 / Ablation / Aged / Atrial Fibrillation - surgery / Atrial Fibrillation - therapy / Biomedical and Life Sciences / Biomedicine / Cancer Research / Cardiac arrhythmia / Catheter Ablation - adverse effects / Catheter Ablation - methods / Damage assessment / Female / Fibrillation / Hemodialysis / Humans / Infectious Diseases / Male / Medical instruments / Metabolic Diseases / Middle Aged / Molecular Medicine / Neurosciences / Paralysis / Patients / Postoperative Complications - epidemiology / Postoperative Complications - etiology / Renal failure / Safety / Safety management / Stenosis / Tamponade / Treatment Outcome