Pulsed field ablation rivals thermal technique but with faster procedure times: ADVENT
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Key takeaways:
- Pulsed field ablation was noninferior to thermal ablation for the treatment of paroxysmal atrial fibrillation.
- Procedure times significantly improved with pulsed field vs. thermal ablation.
In adults with paroxysmal atrial fibrillation, pulsed field ablation was noninferior to conventional thermal ablation for safety and efficacy, with significantly less pulmonary vein narrowing and faster procedure times, researchers stated.
Thermal ablation, whether via radiofrequency (heat) or cryoballoon methods, is highly effective for treating paroxysmal AF; however, the ablative energy is “tissue indiscriminate” in its destructive capability, 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 the Icahn School of Medicine at Mount Sinai, said during a press conference at the European Society of Cardiology Congress. Pulsed field ablation employs high-energy electrical pulses for microsecond durations and exhibits sufficient ablative specificity, with a limited effect on tissues adjacent to the myocardial tissue, Reddy said.
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“In the hands of 65 new operators, we saw that we had success [with pulsed field ablation] as good as thermal ablation, which is something we have been honing our skills on for decades,” Reddy said during the press conference. “That bodes well [for pulsed field ablation]. There were important safety events, but the overall event rate was quite low and is presumably something that will get better with operator experience.”
Similar efficacy, safety between groups
In the single-blind, noninferiority ADVENT trial, Reddy and colleagues analyzed data from 607 adults with drug-refractory paroxysmal AF who underwent pulsed field ablation (Farapulse pulsed field ablation system, Boston Scientific; n = 305) or conventional radiofrequency or cryoballoon ablation (n = 302). Within the thermal ablation group, 167 patients received radiofrequency ablation and 135 patients received cryoballoon ablation. The primary efficacy endpoint was freedom from a composite of initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardioversion or repeat ablation. The primary safety endpoint included acute and chronic device- and procedure-related serious adverse events.
The findings were simultaneously published in The New England Journal of Medicine.
At 1 year, 204 patients in the pulsed field ablation group remained event-free (estimated probability, 73.3%) and 194 patients in the thermal ablation group remained event-free (estimated probability, 71.3%), for a between-group difference of two percentage points (95% Bayesian credible interval, –5.2 to 9.2; posterior probability of noninferiority > .999). Reddy noted that the trial was not powered for superiority.
Primary safety endpoint events occurred in six patients (estimated incidence, 2.1%) who underwent pulsed field ablation and four patients (estimated incidence, 1.5%) who underwent thermal ablation, for a between-group difference of 0.6 percentage points (95% Bayesian credible interval, –1.5 to 2.8; posterior probability of noninferiority > .999).
Two patients who underwent pulsed field ablation experienced pericardial tamponade, one of whom underwent emergency sternotomy and later died after multiorgan failure, Reddy said.
“This complication occurred as a result of catheter manipulation and was not related to the delivery of pulsed field energy,” the researchers wrote in NEJM. “Such complications may become less frequent with greater operator familiarity with the technology.”
The mean total procedure time was 105.8 minutes for patients who underwent pulsed field ablation and 123.1 minutes for patients who underwent thermal ablation. The mean fluoroscopy time was 21.1 minutes for patients who underwent pulsed field ablation and 13.9 minutes for patients who underwent thermal ablation. The overall success of pulmonary vein isolation during the index procedure was 99.6% with pulsed field ablation and 99.8% with thermal ablation.
Reddy said implantable loop recorders were not used in the ADVENT trial, so undetected silent AF cannot be ruled out.
‘Extremely short’ procedure times with pulsed field ablation
Reddy addressed procedure times, which researchers analyzed as tertiary endpoints, and said there was a marked difference between thermal vs. pulsed field ablation that could potentially benefit patients and operators.
“I can tell you from clinical experience — and now we have tens of thousands of patients treated in Europe — the procedure times are extremely short; routinely less than 1 hour and oftentimes less than half an hour,” Reddy said. “I can say from talking to other physicians and my own experience that the ease of use of the technology of pulsed field in general is qualitatively different than what we are used to. For all of those reasons, things are quite favorable.”
Pulsed field ablation is currently considered an investigational procedure in the U.S. and is not FDA approved; data from this pivotal trial will be submitted to FDA for consideration at a later date, Reddy said.
Reference:
Perspective
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Reddy VY, et al. Hot line 5. Presented at: European Society of Cardiology Congress; Aug. 25-28, 2023; Amsterdam (hybrid meeting).
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