A recent study has demonstrated 100% pulmonary vein isolation (PVI) using only pulsed field ablation (PFA), resulting in no PFA-related serious adverse events. This was the concluding finding of the PULSED AF (Pulsed-field ablation to irreversibly electroporate tissue and treat atrial fibrillation) pilot trial, which was recently published in Circulation: Arrhythmia and Electrophysiology.
According to the author, Atul Verma (University of Toronto, Southlake Regional Health Centre, Ontario, Canada), the study is the first-in-human clinical trial that focuses on PFA. As PFA is a novel form of ablation which uses electrical fields to ablate cardiac tissue, the authors note that there is currently limited data on assessing the safety of this ablation method in humans. As a result, the research team set out to evaluate the feasibility and efficacy of PVI using a novel PFA system delivering bipolar, biphasic electrical fields through a circular multielectrode array catheter (PulseSelect; Medtronic).
“I believe that PFA represents a sea change in how we deliver ablation energy. It will likely take over from thermal energies for AF ablation, making these procedures safer and faster for patients”, Verma told Cardiac Rhythm News.
In this non-randomised, prospective, multicentre, premarket clinical study, the research team recruited 38 patients (aged 18–80) who were diagnosed with paroxysmal or persistent atrial fibrillation (AF). These patients, the author notes, were treated in six centres across Australia (n=5), Canada (n=7), USA (n=22), and The Netherlands (n=4), with the primary outcome to achieve acute PVI intraprocedurally and safety at 30 days. The author also noted that before the procedure, a full baseline evaluation was carried out on all patients. This included medical history, a physical examination, arrhythmia symptom review, medication review, transthoracic echocardiogram, and transesophageal echocar-diogram. which was performed to ensure a left ventricular ejection fraction of ≥35% and no gross enlargement of the left atrium >5cm.
The author illustrates that the research team achieved acute electrical isolation in 100% of the pulmonary veins (n=152) across the 38 patients. The average time period for the skin-to-skin procedure was 160±91 minutes, left atrial dwell time was 82±35 minutes, and fluoroscopy time was 28±9 minutes. The researchers also reported no serious adverse events (phrenic nerve injury, esophageal injury, stroke, or death) in relation to the PFA system during the 30-day follow-up period.