Large registry confirms promising safety performance for PFA

Vivek Reddy

Analysis of outcomes of more than 17,000 patients receiving pulsed field ablation (PFA) using the Farapulse (Boston Scientific) device reinforce the safety profile of the system, investigators say, with no reported permanent phrenic nerve palsy, pulmonary vein stenosis or oesophageal injury and an overall major adverse even rate of less than 1%.

Findings from the MANIFEST 17K registry, a real-world dataset of patients treated commercially using the Farapulse system at more than 106 centres, comprising 17,068 patients, were presented as featured science at the American Heart Association (AHA) 2023 Scientific Sessions (11–13 November, Philadelphia, USA) by Vivek Reddy (Mount Sinai Hospital, New York, USA).

PFA has emerged as an alternative to thermal ablation for the treatment of atrial fibrillation (AF) that allows precise ablation of cardiac tissue, which it is hoped can reduce the risk to surrounding tissues.

After receiving CE mark certification in March 2021, the MANIFEST-PF survey followed outcomes of 1,758 AF patients receiving PFA at 24 European centres and revealed no oesophageal damage or pulmonary stenosis, and phrenic palsy in <0.1%.

However, for cryoablation, oesophageal fistula only occurred after a few thousand patients were treated, and unforeseen PFA-related adverse events (AEs) may only manifest after many cases, investigators have noted. Therefore, the retrospective MANIFEST-10K survey was established to assess the safety of PFA in a large patient cohort  of more than 10,000 patients.

For the latest analysis, data were captured from 102 centres, including 17,068 PFA patients. Investigators report that the study saw no oesophageal adverse events, no pulmonary vein stenosis or persistent phrenic palsy, while major adverse events were reported in 1.01% of patients, pericardial tamponade 0.34% and vascular adverse events in 0.31%.

Stroke was rare, in 0.13% of patients, and death occurred in only 0.03%. Unexpected AEs included coronary spasm in 0.16%, and acute renal failure due to haemolysis in 0.03%.


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