MANIFEST-17k registry shows promising safety performance for PFA

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Vivek Reddy

Pulsed field ablation (PFA) is safe for treating patients with common types of atrial fibrillation (AF), findings of the largest real-world registry of the technology to date have shown. 

MANIFEST-17K is an international study that is the first to show safety outcomes in a large patient population among patients undergoing PFA with the Farapulse (Boston Scientific) device, with the results published today in Nature Medicine. The findings indicate that there is no significant risk of oesophageal damage with PFA, investigators have claimed.

“MANIFEST-17K provides confidence that, unlike conventional thermal ablation, PFA with the pentaspline catheter does not cause the most feared complication of AF ablation—oesophageal damage—nor does it cause pulmonary vein stenosis or persistent injury to the diaphragm,” says senior author Vivek Reddy (Icahn Mount Sinai, New York, USA). “This study found that other general complications were also rare, including pericardial tamponade occurring in approximately one in 200 patients, stroke in one in 1,000, and death in even less than one in 1,000 patients. Given the relative novelty of pulsed field ablation, these are important safety outcomes.”

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

PFA does not use temperature, but instead short high-energy electrical pulses. This catheter procedure is more precise than radiofrequency and cryoablation and does not cause damage to the oesophagus, pulmonary veins, or phrenic nerve.

This retrospective, observational study analysed 17,642 patients with paroxysmal and persistent AF after undergoing PFA procedures at 106 centres in 2021. Procedures were performed with pentaspline PFA catheter, the most commonly used PFA catheter worldwide.

Researchers found no energy-specific complications among patients, including no oesophageal damage, pulmonary vein stenosis, or persistent phrenic nerve injury. There was a 1% overall major complication rate, and more specifically, rates of 0.36% for pericardial tamponade, 0.3% for vascular complications, 0.12% for stroke, and 0.03% for death. Unexpected complications of PFA were coronary arterial spasm (0.14%) and haemolysis-related acute renal failure necessitating haemodialysis (0.03%).

“While we should continue to remain vigilant to identify any other rare complications of PFA that may be identified in the future, these favourable safety outcomes in over 17,000 patients increase our confidence in the use of this PFA catheter technology,” says Reddy.


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