Clin Res Cardiol (2022).

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. 

Conclusion: In this first real-world multicenter registry, PFA applied in patients with atrial fibrillation demonstrates high acute procedural success rates and a favorable safety profile.