Pulsed-field ablation device allows simple and safe single-shot pulmonary vein isolation in AF: 5 S Study
Germany: The pulsed-field ablation device allows for simple and safe single-shot pulmonary vein isolation (PVI) by utilizing standard sedation protocols, a recent study in Circulation: Arrhythmia and Electrophysiology has found. However, to further validate and assess the performance characteristics of pulse-field ablation for PVI, large prospective trials are required.
Pulsed-field ablation represents an energy source for the ablation of cardiac arrhythmias including atrial fibrillation. Boris Schmidt, Cardiovascular Center Bethanien, Germany, and colleagues, therefore, aimed to describe the adoption and the process of streamlining procedures with a new ablation technology.
For this purpose, all-comer atrial fibrillation patients (n=191; mean age 69±12 years) underwent catheter ablation with a pulsed-field ablation device through the exclusive use of analog-sedation. In the validation phase (n=25), a comparison was made between device electrogram quality and a circular mapping catheter to assess pulmonary vein isolation, and esophageal temperature monitoring was used. In the streamline phase (n=166), a single-catheter approach was implemented.
In 53 patients, postprocedural cerebral magnetic resonance imaging was performed. Esophageal endoscopy was performed on 52 patients on day 1 after the procedure. Follow-up was performed using 72 hours Holter ECGs.
The study led to the following findings:
- On a pulmonary vein basis, the pulmonary vein isolation rate was 100% including a single shot isolation rate of 99.5%.
- The electrogram information of the pulsed-field ablation catheter and the circular mapping catheter was 100% congruent.
- Neither esophageal temperature rises nor esophageal thermal injury was observed.
- Two minor strokes occurred, presumable due to air embolism during catheter exchanges through the large bore sheath (13.8 F ID).
- In the streamline phase, reduced procedure times (46±14 versus 38±13 minutes), no further strokes, and a low incidence of silent cerebral injury (10/53 patients; 19%) were noted.
- During short-term follow-up, 17/191 patients (9%) had an atrial tachyarrhythmia recurrence.
"The pulsed-field ablation device allows for simple and safe single-shot pulmonary vein isolation using standard sedation protocols," the researchers wrote. "Procedural speed and efficacy are remarkable and streamlining measures have added safety."
Reference:
The study titled, "5 S Study: Safe and Simple Single Shot Pulmonary Vein Isolation With Pulsed Field Ablation Using Sedation," was published in Circulation: Arrhythmia and Electrophysiology.
