The Lead Podcast - Episode 93: A Discussion of Safety of pulsed field ablation in more than 17,000 patients with AFib...

William Sauer, MD, FHRS, CCDS, Brigham and Women's Hospital is joined by Tobias Reichlin, MD, University Hospital Basel, Switzerland, and Nikolas Nozica, MD, Brigham and Women's Hospital, to discuss the Nature Medicine article Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. The following is a brief summary of the study covered in the article.

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 profle 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. 

https://www.hrsonline.org/education/TheLead
https://doi.org/10.1038/s41591-024-03114-3

Host Disclosure(s):
W. Sauer: Honoraria/Speaking/Consulting: Biotronik, Biosense Webster, Inc., Abbott, Boston Scientific, Research: Medtronic

 

Contributor Disclosure(s):
N. Nozica: Nothing to disclose.
T. Reichlin: Nothing to disclose.

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