Novel ultrarapid AF ablation technology safe in first-in-human trial

Vivek Y. Reddy

BOSTON — Pulsed electrical field ablation, a new technology that enables ablation for atrial fibrillation to be performed rapidly, appears to be safe, according to short-term data from a first-in-human study presented at the Heart Rhythm Society Annual Scientific Sessions.

The technology can be used in surgical ablation or in catheter-based ablation, Vivek Y. Reddy, MD, director of cardiac arrhythmia services for The Mount Sinai Hospital and the Mount Sinai Health System and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn School of Medicine at Mount Sinai, said during a press conference.

“Unlike every other kind of ablation energy source, this is nonthermal,” he said. “The mechanism of damage is delivered electrical pulses to punch nanoscale holes in some membranes. There are a couple of advantages to that. No. 1 is time. Instead of ablating over hours, minutes or seconds, this happens over milliseconds. The other one is that there are data from tumor literature, liver ablation literature and preclinical experience with cardiac ablation suggesting that there may be some degree of selectivity with ablations using pulsed electrical fields. There seems to be a particular sensitivity of myocardial tissue and a relatively low instance of pulmonary stenosis.”

The researchers performed ablation with two pulsed electrical field devices (Farapulse, Iowa Approach). One was a custom over-the-wire endocardial catheter for percutaneous transseptal pulmonary vein isolation, and the other was a linear catheter for encircling the pulmonary vein and posterior left atrium during concomitant cardiac surgery. The findings were simultaneously published in JACC: Clinical Electrophysiology. The devices are not yet approved for commercial use in the United States.

There were 22 patients who underwent ablation for AF with general anesthesia: 15 had the percutaneous approach (mean age, 64 years; 47% men) and seven had the surgical approach (mean age, 69 years; 71% men).

Among those who had the percutaneous approach, pulmonary vein isolation was successful in all 57 pulmonary veins of all 15 patients, using 3.26 lesions per pulmonary vein.

According to the researchers, in the percutaneous group, mean procedure time was 67 minutes, mean catheter time was 19 minutes, mean total pulsed electrical field energy delivery time was less than 60 seconds and mean fluoroscopy time was 12 minutes.

Among those who had the surgical approach, procedural success occurred in 86% of patients, using two lesions per patient, and catheter time was 50.7 minutes.

“In the one surgical case where it was not successful, it was a technical issue in terms of positioning of the catheter,” Reddy said.

There were no complications in any patient, Reddy said at the press conference.

“Acutely, there was no evidence of pulmonary vein stenosis, there were no reconnections and there was no evidence of phrenic nerve damage,” he said. “This is all very early data, but we think it’s pretty exciting.” – by Erik Swain

References:

Reddy VY, et al. LBCT03-05. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 9-12, 2018; Boston.

Reddy VY, et al. JACC Clin Electrophysiol. 2018;doi:10.1016/j.jacep.2018.04.005.

Disclosure: The study was funded by Iowa Approach. Reddy reports he has served as a consultant for Biosense Webster, Boston Scientific and Iowa Approach; has received grant support from Biosense Webster and Boston Scientific; and holds stock options in Iowa Approach.