Background:
Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation energy modality which, in first-in-human clinical trials, has demonstrated preferential myocardial tissue ablation. Recently the MANIFEST-PF Co-operative conducted a center-level survey including all 24 centers that commenced clinical use of the only CE-Mark-approved pentaspline PFA catheter. This analysis confirmed the preferential tissue sparing promise of PFA, as there were no esophageal complications, no pulmonary vein (PV) stenosis, and no phrenic nerve injury persisting beyond hospital discharge. However, this was a center-level survey (not individual patient-level data), and there was no information gathered on either long-term safety or, most importantly, long-term efficacy. Herein, we report the “real-world” one-year efficacy and safety outcomes of AF ablation using the pentaspline PFA catheter using a large retrospective patient-level registry.

Methods:
This retrospective patient-level registry included 23 of the 24 European centers performing clinical PFA procedures, constituting the MANIFEST-PF cooperative. The registry included all consecutive patients who received first-ever ablation for paroxysmal or persistent AF between March 2021 and December 2021 using a pentaspline PFA system. Routine follow-up was per each center’s standard practice. Typically, patients were reviewed in outpatient clinics at 3-, 6- and 12-months post-procedure, with assessments for AF-related symptoms and ECG to document any arrhythmia recurrence, including Holter monitoring as per physician discretion. Primary efficacy endpoint was freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia) recurrence ≥30 seconds after a 3 month-blanking period. Secondary efficacy endpoint was (i) durability of PVI for any patients who underwent a redo-ablation procedure, and (ii) freedom from new class I or III antiarrhythmic agents (AAD), or re-ablation. Safety endpoints included the composite of acute (<7 days post-procedure) and chronic (>7 days post-procedure) major adverse events. 

Results:
The cohort included a total of 1143 AF patients: age 63,5±11,5 years; female 34%; paroxysmal/persistent AF 65%/31,5%; CHA₂DS₂-VASC score 2,1±1,5; mean LVEF 55% and LA diameter 42 mm. Most procedures (71%) were performed under deep sedation without intubation. PVI was performed in 100% of patients, with an acute success rate of 99,2% (1134 of 1143). Additional non-PV ablation was performed in 285 patients (25%): left atrial posterior wall ablation 13,3%; mitral line 2,5%; roof line 0,7% and CTI line 5,5%. Mean fluoroscopy and procedure times were 18,5 min. and 80,8 min. (range 30–375). Class I or III AADs were prescribed on discharge to 27% of patients. Acute major adverse events (2,4%) were pericardial tamponade (1,5%) and stroke/TIA (0,3%); 1 stroke resulted in death (0,05%). One patient had coronary artery spasm. There were no esophageal complications or phrenic nerve injuries within 7 days post-procedure. Minor complications (5%) were primarily vascular (2,7%), but also included transient phrenic nerve paresis (0,4%), small pericardial effusion (0,4%), hemoptysis (0,2%) and air embolism (0,2%). See also Figure.

Conclusions:
In this patient-level registry of a large multicenter “real-world” AF cohort of the first routine clinical use of PFA, catheter ablation using the pentaspline PFA catheter proved to be safe, fast, and efficacious to achieve PVI.

Figure: