Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5

The 5 S Study - Safe and Simple Single Shot PV Isolation with Pulsed Field Ablation using Sedation
B. Schmidt1, S. Bordignon2, S. Chen3, S. Tohoku3, F. Bologna2, L. Urbanek4, F. Pansera3, K. R. J. Chun3
1Agaplesion Markus Krankenhaus, Frankfurt am Main; 2Medizinisches Versorgungszentrum, CCB am AGAPLESION BETHANIEN KRANKENHAUS, Frankfurt am Main; 3Medizinische Klinik III - CCB, Agaplesion Markus Krankenhaus, Frankfurt am Main; 4Station 24b Intensivstation, Agaplesion Markus Krankenhaus, Frankfurt am Main;

Aims: Pulsed field ablation (PFA) represents a novel cardiac specific energy source for atrial fibrillation (AF) ablation. The aim of the study was to describe the adoption and the process of streamlining of a new ablation technology in a high volume AF ablation center and to assess its safety, reproducibility and efficacy.

Methods and Results: All-comer AF patients (n=125; mean age 69±12 years),  underwent catheter ablation with a novel PFA ablation device exclusively using analgo-sedation. Overall, pulmonary vein isolation (PVI) rate was 100% including a single shot isolation rate of 99%. In the validation phase (n=25), device electrogram quality was found to provide 100% congruent information for PVI assessment compared to a standard circular mapping catheter In addition, no esophageal temperature rises nor any thermal injury were detected endoscopically. However, two minor strokes occurred, presumable due to air embolism during catheter exchanges through the large bore sheath (13F ID). In the streamline phase (n=100), a single catheter approach was implemented leading to reduced procedure times (46±14 mins versus 38±12 mins, p=0.008), no further strokes and a low incidence of silent cerebral injury (1/22 patients; 4.5%) detected by post-procedural magnetic resonance imaging. During short-term follow-up, 13/100 patients (13%) had a atrial tachyarrhythmia recurrence.

Conclusions: The novel pulsed field ablation device allows for simple and safe simple single shot pulmonary vein isolation using standard sedation protocols  in a non-selected all comer AF population. Procedural speed and efficacy are remarkable and streamlining measures have added safety. 


https://dgk.org/kongress_programme/jt2022/aP1159.html