MANIFEST-PF: Good results for the pentaspline PFA catheter 

The 1-year results of the MANIFEST-PF registry showed that patients with atrial fibrillation (AF) undergoing a first ablation using the pentaspline pulsed-field ablation (PFA) catheter had 1-year freedom from an AF recurrence rate of 78%.

Dr Vivek Reddy (Mount Sinai Hospital, NY, USA) presented the results of a retrospective study, including 1,568 patients who underwent first-time PFA for AF [1]. The primary effectiveness outcome was freedom from AF/atrial flutter (AFL)/atrial tachycardia (AT) recurrence of 30 seconds or more. The median follow-up time was 367 days.

The primary outcome showed a success rate of 78.1% after 12 months of follow-up. In addition, the success rate was higher in patients with paroxysmal AF than in patients with persistent AF (81.6% vs 71.5%; P_log-rank=0.001). Furthermore, Dr Reddy mentioned that a left atrial diameter of >45 mm, a left ventricular ejection fraction of ≤50%, a procedure time of >60 minutes, age >65 years, and persistent AF were independent risk factors for primary efficacy failure (P<0.001 for all). For the secondary endpoint of freedom from AF/AFL/AT or antiarrhythmic drugs or redo ablation, the success rate was 70.8% after 12 months.

Finally, Dr Reddy said that the safety profile of the PFA catheter was good, with no cases of oesophageal damage or pulmonary vein stenosis, and major adverse events occurred in 1.9% of the patients. “However, 1 patient sustained a phrenic nerve injury beyond hospitalisation,” according to Dr Reddy.

Dr Reddy concluded that the 1-year effectiveness and safety data of the pentaspline PFA catheter were good in the population of patients with AF who underwent a first ablation.

1. 1. Reddy VY, et al. 1-year outcomes from the MANIFEST-PF Registry. Late-Breaking Science Day 1, EHRA 2023, 16–18 April, Barcelona, Spain.

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Posted on 3 May, 20233 May, 2023