Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5
|Acute efficacy and safety of Pulsed Field Ablation for atrial fibrillation: Initial German multicenter experience|
|M. A. Gunawardene1, M. Lemoine2, T. Deneke3, R. Wakili4, D. Steven5, B. Schäffer1, A. Rillig2, K. Nentwich6, J. Siebermair4, K. Filipovic5, G. Simu3, L. Riesinger4, A. Sultan5, S. Willems1, A. Metzner2|
|1Kardiologie, Asklepios Klinik St. Georg, Hamburg; 2Klinik für Kardiologie mit Schwerpunkt Elektrophysiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 3Klinik für Kardiologie II / Interventionelle Elektrophysiologie, RHÖN-KLINIKUM AG Campus Bad Neustadt, Bad Neustadt a. d. Saale; 4Klinik für Kardiologie und Angiologie, Universitätsklinikum Essen, Essen; 5Elektrophysiologie, Herzzentrum der Universität zu Köln, Köln; 6RHÖN-KLINIKUM AG Campus Bad Neustadt, Bad Neustadt a. d. Saale;|
Background: Pulsed field ablation (PFA) has recently been introduced as a novel ablation technology for atrial fibrillation (AF). However, multi-center data regarding acute procedural efficacy and safety is sparse.
Objective: To investigate acute procedural success and safety in patients undergoing PFA for the treatment of AF in a multicenter registry.
Methods: Consecutive paroxysmal and persistent AF patients underwent PFA-based catheter ablation using a multispline catheter. PFA-based ablation procedures, including first and repeat ablation procedures, were performed with and without additional 3D electroanatomical mapping. Procedural parameters, acute success and in-hospital safety were assessed.
Results: A total of 154 patients undergoing PFA in 5 German centers were included in the study. Patients suffered from paroxysmal AF (n= 55; 36%), persistent AF (n=93; 60%) and consecutive atrial tachycardias (AT) due to previous catheter ablation (n=6; 4%). Mean age was 68 ± 12 years, median CHA2DS2-VASc Score was 3 (Q1-Q3: 2-4), mean left atrial diameter was 43 ± 6 mm and 111 of 154 (72%) patients had a normal left ventricular ejection fraction.
Of all PFA procedures, 130 (84%) were index ablation procedures with sole isolation of pulmonary veins (PVI) and 24 (16%) were repeat procedures (including re-PVI and ablation of consecutive AT). The median total procedure and left atrial (LA) PFA times were 90 (Q1-Q3: 73-116) and 33 (Q1-Q3: 24-53) minutes, respectively. Mean total fluoroscopy and LA PFA fluoroscopy times were 20.2 ± 8.7 and 12.1 ± 5.5 minutes. Acute pulmonary vein (PV) reconnection following primary PVI and the initial set of PFA-applications was found in 20 of 130 (15%) patients, requiring additional ablation. Finally, successful PVI was achieved in all patients.
Three-dimensional electroanatomical mapping was performed in 151 of 154 (98%) patients. The use of ultra-high-density (UHDx) mapping systems was associated with higher procedure durations (143 ± 39 minutes vs. non-UHDx 85 ± 27 minutes; P <0.0001). Additional PFA lesion sets (including LA posterior wall isolation, anterior ablation, mitral isthmus ablation) were applied in 17 of 154 (11%) patients.
Complications occurred in 6 of 154 (3.8%) patients including 3 groin site complications, 2 pericardial tamponades and 1 transient coronary spasm without sequela. There was no transient ischemic attack and no stroke reported.