COnCOmitaNt pulsed field ablation-based pUlmonary vein isolation and lefT atrial appendage closure: the COCONUT study.
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Heeger Christian-Hendrik, Roten Laurent, Della Rocca Domenico, Velagić Vedran, Gupta Dhiraj, De Potter Tom, Sticherling Christian, Urbanek Lukas, Schmidt Boris, Parwani Abdul Shokor, Garcia-Bolao Ignacio, Arancio Rocco, Nawar Amr, Mathew Shibu, Beney Jennifer, Rolfes Henning, Sievert Kolya, Boveda Serge, Lepillier Antoine, Niro Marjorie, Wakili Reza, Steger Alexander, Awada Ahmad, Pasara Vedran, Massoullié Grégoire, Nekic Andrija, Vanhaverbeke Maarten, Almorad Alexandre, Eschalier Romain, Didenko Maxim, Contarini Marco, Räber Lorenz, Wenzel Jan-Per, Rattka Manuel, Scherr Daniel, Tilz Roland Richard, Bergmann Martin W
Аннотация
METHODS: This is a retrospective, multinational registry study. The primary endpoints were the following: (1) primary safety endpoint: serious adverse events; and (2) primary efficacy endpoint: success of PVI and LAA closure defined as the ability to isolate all pulmonary veins and the successful closure of the LAA. For secondary endpoints, peri-procedural data and follow-up data were collected.
RESULTS: A total of 155 patients from 22 centres of nine European countries were treated by concomitant pentaspline catheter PFA-based PVI and LAAC. The mean CHA2DS2-VA score was 3.1 ± 1.4. The primary efficacy endpoint was achieved at 97.4% with successful PVI at 100% and successful LAAC in 151/155 patients (97.4%). The primary safety endpoint was observed in 3/155 patients (1.9%). Transoesophageal echocardiography and/or CCTA 67 ± 26 days after the procedure showed no device embolization and no device-related thrombus, 24/151 (15.9%) patients showed peri-device gaps of <5 mm while gaps of >5 mm have been observed in 3/151 (2.0%). Among 137/155 patients with available arrhythmia, a follow-up >6 months at 78.1% showed sinus rhythm.
CONCLUSION: In this large multicentre study, concomitant PFA-based AF ablation and LAA closure proved to be feasible, effective, and safe and overall procedure duration was short.