Log in to MyACC
Pulsed Field Ablation to Treat Paroxysmal AF
Quick Takes
- Acute pulmonary vein isolation was successful in 100% of cases, first-pass isolation was achieved in 97.5% of targeted veins, and primary effectiveness success was 74.6%.
- Procedure, fluoroscopy, and pulsed field ablation (PFA) application times were short, and the primary adverse event rate was low (<3%).
- Overall, this study met the long-term safety and effectiveness endpoints using the variable-loop PFA catheter, and demonstrated short procedure and PFA application times, as well as low fluoroscopy exposure, and appears to be a viable strategy for AF ablation.
Study Questions:
What is the long-term safety and effectiveness of an integrated pulsed field ablation (PFA) system in a large United States–based drug-refractory symptomatic paroxysmal atrial fibrillation (AF) patient population?
Methods:
The investigators report the primary outcomes of AdmIRE, including the safety and effectiveness of this fully integrated PFA system. Using the PFA catheter with a compatible electroanatomic mapping system, patients with drug-refractory symptomatic paroxysmal AF underwent pulmonary vein isolation (PVI). The primary safety endpoint was primary adverse event within 7 days of ablation. The primary effectiveness endpoint was a composite endpoint that included 12-month freedom from documented atrial tachyarrhythmia (i.e., AF, atrial tachycardia, atrial flutter) episodes, failure to achieve PVI, use of a nonstudy catheter for PVI, repeat procedure (except for one redo during blanking), taking a new or previously failed class I or III antiarrhythmic drug at higher dose after blanking, or direct current cardioversion after blanking.
Results:
At 30 centers, 277 patients with paroxysmal AF (61.5 ± 10.3 years of age; 64.3% male) in the pivotal cohort underwent PFA. More than 25% of the procedures were performed without fluoroscopy. Median (Q1, Q3) PVI procedure, fluoroscopy, and transpired PFA application times were 81.0 (61.0, 112.0), 7.1 (0.00, 14.3), and 31.0 (24.8, 40.9) minutes, respectively. The primary adverse event rate was 2.9% (8 of 272), with the most common complication being pericardial tamponade. The 12-month primary effectiveness endpoint was 74.6%. The 1-year freedom from AF, atrial tachycardia, or atrial flutter recurrence rate after blanking was 75.4%. Substantial improvements in quality of life were observed as early as 3 months after the procedure, concurrent with a reduction in multiple health care use measures.
Conclusions:
The authors report that the AdmIRE trial confirmed the safety and effectiveness of the variable-loop PFA catheter, with short procedure and PFA application times and low fluoroscopy exposure.
Perspective:
This multicenter Food and Drug Administration investigational device exemption pivotal study of the biphasic PFA catheter fully integrated with three-dimensional mapping reports an overall favorable safety profile. Furthermore, acute PVI was successful in 100% of cases, first-pass isolation was achieved in 97.5% of targeted veins, and primary effectiveness success was 74.6%. Procedure, fluoroscopy, and PFA application times were short, and the primary adverse event rate was low (<3%). Overall, this study met the long-term safety and effectiveness endpoints using the variable-loop PFA catheter, and demonstrated short procedure and PFA application times, as well as low fluoroscopy exposure, and appears to be a viable strategy for AF ablation.
Clinical Topics: Arrhythmias and Clinical EP, Atrial Fibrillation/Supraventricular Arrhythmias
Keywords: Ablation, Atrial Fibrillation
< Back to Listings
