Pulsed field ablation system for AF demonstrates safety, efficacy in pivotal trial
Click Here to Manage Email Alerts
Key takeaways:
- An integrated pulsed field ablation and mapping system to treat atrial fibrillation was linked to low rates of adverse events at 12 months.
- The system met its efficacy performance goal and improved symptoms.
A pulsed field ablation system was associated with low rates of safety events and high rates of efficacy for patients with paroxysmal atrial fibrillation at 12 months, according to the results of the admIRE pivotal trial.
The 12-month data of the admIRE trial of the pulsed field ablation system (Varipulse, Biosense Webster) were presented at Heart Rhythm 2024.
“Pulsed field ablation is a novel, largely nonthermal ablation technology for treating cardiac arrhythmia that offers improved tissue selectivity vs. thermal ablation,” Vivek Y. Reddy, MD, director of cardiac arrhythmia services at 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 presentation. “No currently approved pulsed field ablation devices are fully integrated with a 3D mapping system; the lack of a fully integrated mapping system posed limitations in lesion creation and workflow options. A novel biphasic bipolar pulsed field ablation catheter system has been developed that includes a multielectrode, regional variable-loop circular catheter and dedicated, fully integrated electroanatomical mapping system. [The admIRE trial] assessed the long-term safety and efficacy of the integrated pulsed field ablation system for treating paroxysmal AF in a large patient population across a broad group of centers and operators in the United States.”
The trial included 277 patients (mean age, 62 years; 37% women) with drug-refractory symptomatic paroxysmal AF.
All patients achieved acute procedural success and 97.5% of pulmonary veins were isolated on the first pass, Reddy said during the presentation, noting that 43% of patients were discharged on the day of the procedure and 25% were able to have the procedure without fluoroscopy.
Reddy said 2.9% of patients (95% CI, 1.3-5.7) had primary adverse events at 12 months, including three patients with cardiac tamponade perforation (one of who also had pericarditis), two patients with stroke, one patient with transient ischemic attack and two with major vascular access complication/bleeding. He said there were no cases of device- or procedure-related death, atrioesophageal fistula, coronary spasm or hemolysis-related renal failure requiring hemodialysis.
The rate of success of the primary effectiveness endpoint, defined as freedom from recurrence of AF/atrial tachycardia/atrial flutter and from new or higher-dose antiarrhythmic drugs at 12 months, was 74.1% (95% CI, 69.1-80.1), and the lower confidence bound exceeded the performance goal, Reddy said during the presentation.
At 12 months, 91% of patients were free from repeat ablation (95% CI, 87.3-94.6) and 70.6% were free from recurrence of AF/atrial tachycardia/atrial flutter without class I or III antiarrhythmic drugs (95% CI, 64.9-76.3), he said.
Age 65 years or older (OR = 2.5; 95% CI, 1.3-4.6) and diabetes (OR = 3.1; 95% CI, 1.4-7.1) were associated with higher risk for failure of the primary effectiveness endpoint, whereas number of pulsed field ablations between 73 and 96 was associated with lower risk for failure (OR = 0.4; 95% CI, 0.2-0.8), Reddy said during the presentation, noting the latter group had an 85% success rate.
The mean improvement between baseline and 12 months in the Atrial Fibrillation Effect on Quality of Life score was 32.03 points (P < .001) and 90% of patients reported being asymptomatic at 12 months, he said.
Use of class I or III antiarrhythmic drugs declined from 79.1% at baseline to 6.6% at 12 months, whereas no patients had CV hospitalization and only 0.4% had direct current cardioversion between baseline and 12 months, he said.
“The admIRE study demonstrated the safety and effectiveness of the fully integrated Varipulse pulsed field ablation system in a large U.S. population,” Reddy said during the presentation. “There was substantial improvement in clinical benefits and health care utilization.”
Collapse
Reddy VY, et al. Late-breaking clinical trials and science – ablation. Presented at: Heart Rhythm 2024; May 16-18, 2024; Boston.
Click Here to Manage Email Alerts