Abstract 4144974: Pulsed ElectRic FiEld versus Cryoballoon to Treat Paroxysmal Atrial Fibrillation (PERFECT-PAF) Randomized Trial: a Periprocedural Clinical and Cost Analysis

Background: Pulsed ElectRic FiEld versus Cryoballoon to Treat Paroxysmal Atrial Fibrillation (PERFECT-PAF) is an investigator initiated, multicentre, randomized trial on pulmonary vein isolation (PVI) using either a pentaspline pulsed field ablation (PFA) or cryoballoon (CRYO) catheter. Hypothesis: It is of utmost importance to assess both the clinical and economic value of novel ablation technologies to ensure access to therapies that are effective and economically sustainable. Aim: To compare periprocedural safety and costs of PVI via PFA versus CRYO. Methods: Paroxysmal AF patients 18-75 years old were randomly assigned to PFA or CRYO at 6 European Centres. Data regarding clinical management during index hospitalisation, procedural details, and resources used were collected. The primary safety endpoint included procedure- and technology-related adverse events within 7 days post-ablation (e.g., pericardial effusion, persistent (>30 days) or transient (periprocedural) phrenic nerve (PN) injury, vascular complications). Results: A total of 269 paroxysmal AF patients were randomly assigned to undergo PFA (n=134) or CRYO (n=135). Baseline characteristics were similar. Room time (mean ± SD) was 77.1±13.9 min for PFA vs. 97.0±20.4 min for CRYO (+19.9 min, p<0.001). Procedural time was 52.5±11.8 min for PFA and 69.3±18.0 min for CRYO (+16.8 min, p<0.001). Overall periprocedural adverse events were significantly more frequent with CRYO than PFA (+7.4%; p=0.0053). Major adverse events were documented in 1 (0.7%) and 4 (3.0%) patients for PFA and CRYO, respectively (p=0.3703). CRYO-related PN injury, either persistent (n=2; 1.5%) or transient (n=4; 3.0%), was the main determinant of this difference and hindered effective isolation of the right PVs in 3 (2.2%) CRYO cases. The adverse event rate at 7 days was also higher with CRYO than PFA (+5.2%; p=0.036). The total costs per patient within 30 days were 13.7% lower in the PFA group. Conclusion: In paroxysmal AF patients, PFA overcame safety limitations of CRYO with optimal effectiveness, fewer adverse events, and shorter procedural times. Long-term follow-up data will be collected and analysed to further investigate the potential clinical and economic impact of PFA versus CRYO.