| Contributors: |
Ekanem, E; Neuzil, P; Reichlin, T; Kautzner, J; Van Der Voort, P; Jais, P; Chierchia, Gb; Bulava, A; Blaauw, Y; Skala, T; Fiala, M; Duytschaever, M; Szeplaki, G; Schmidt, B; Massoullie, G; Neven, K; Thomas, O; Vijgen, J; Gandjbakhch, E; Scherr, D; Johannessen, A; Keane, D; Boveda, S; Maury, P; García-Bolao, I; Anic, A; Hansen, P; Raczka, F; Lepillier, A; Guyomar, Y; Gupta, D; Van Opstal, J; Defaye, P; Sticherling, C; Sommer, P; Kucera, P; Osca, J; Tabrizi, F; Roux, A; Gramlich, M; Bianchi, S; Adragão, P; Solimene, F; Tondo, C; Dello Russo, A; Schreieck, J; Luik, A; Rana, O; Frommeyer, G; Anselme, F; Kreis, I; Rosso, R; Metzner, A; Geller, L; Baldinger, Sh; Ferrero, A; Willems, S; Goette, A; Mellor, G; Mathew, S; Szumowski, L; Tilz, R; Iacopino, S; Jacobsen, Pk; George, A; Osmancik, P; Spitzer, S; Balasubramaniam, R; Parwani, A; Deneke, T; Glowniak, A; Rossillo, A; Pürerfellner, H; Duncker, D; Reil, P; Arentz, T; Steven, D; Olalla, Jj; De Jong, Jssg; Wakili, R; Abbey, S; Timo, G; Asso, A; Wong, T; Pierre, B; Ewertsen, Nc; Bergau, L; Lozano-Granero, C; Rivero, M; Breitenstein, A; Inkovaara, J; Fareh, S; Latcu, Dg; Linz, D; Müller, P; Ramos-Maqueda, J; Beiert, T; Themistoclakis, S; Meininghaus, Dg; Stix, G |
| Description: |
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. |