Real-life results of pulmonary vein isolation with the PulseSelect system. Experience of a single tertiary center

Background

Pulmonary vein (PV) isolation (PVI) using pulsed electric fields (PFA) is an emerging form of energy for treating patients with atrial fibrillation (AF).

Purpose

There is little data on the use of PulseSelectTM. We present one of the first experiences of PVI with this technology in routine clinical practice.

Methods

This is an observational and prospective analysis of 210 patients (age 60±8 years; paroxysmal AF=62%; LA enlargement=45%; hypertension=37%; BMI=28) who underwent PVI with PulseSelectTM consecutively at our institution from February 2024 to October 2025. Deep sedation was used without the assistance of an anesthesiologist in all cases. A same-day discharge strategy was established by default.

Results

The mean duration of the procedures (EP laboratory occupancy time) was 80±10 minutes, the average of applications per patient was 34±5, and the fluoroscopy time was 12±8 minutes. Persistent isolation (at least 20 minutes after the last application) of all PVs was achieved in 100% of patients, with 209/210 subjects (99%) discharged on the same day (median time of hospital stay: 8 hours). Only one patient was hospitalized for a mild, uncomplicated inguinal hematoma; he was discharged the next day. There were no complications associated with deep sedation.

The cumulative incidence of patients with complications at 14 days was 3 (1.4%): the patient with mild inguinal hematoma, one patient with transient ST elevation (V1-V2) lasting 1 minute during an antral application in the left superior PV (attributed to coronary spasm), and a transient ischemic attack occurring 72 hours after a PVI procedure for persistent AF. We have follow-up data exceeding 6 months in 124 patients (figure), being the cumulative incidence of symptomatic AF/flutter recurrence: 12/124 (10%): 11 patients with AF and 1 with atrial flutter. A second procedure was performed in 5 of these subjects (4 with AF, 1 with perimitral flutter): all PVs were isolated in all patients except two (recurrence of AF with reconnected left and right PV, and recurrence of AF with reconnected left superior PV).

Conclusions

The PVI with the PulseSelectTM system demonstrates similar efficacy and safety in real life as in the pivotal study. Procedures under deep sedation are feasible, effective, and safe. In our experience, same-day discharge is almost universal.