Abstract Body (Do not enter title and authors here): 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.