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PROHLÍŽENÍ ABSTRAKTA

PULSED FIELD ABLATION VERSUS SHAM ABLATION TO TREAT ATRIAL FIBRILLATION (THE PFA-SHAM TRIAL)
Tématický okruh: Poruchy rytmu, kardiostimulace
Typ: Ústní sdělení - lékařské , Číslo v programu: 252
Etický kodex:
Podpora výzkumu / granty: Research grant, Biotronik, Germany
Osmančík P. 1, Neužil P. 2, Hozmanová J. 1, Petrů J. 1, Heřman D. 3, Královec Š. 1, Hozman M. 1, Tichý M. 1, Waldauf P. 4, Karel T. 1, Šedivá L. 1, Fischer J. 1, Štěpánek L. 1, Lekešová V. 2, Hála P. 2, Funasako M. 1, Veselá J. 1, Filipcová V. 1, Karch J. 1, Reddy V. 2

1 Kardiocentrum, 3. LF UK a FNKV, Praha, Praha, 2 Nemocnice na Homolce, 3 Kardiocentrum, 3. LF UK a FNKV, Praha, 4 Klinika anesteziologie


Background: Catheter ablation for atrial fibrillation (AF) reduces arrhythmia recurrences more effectively than antiarrhythmic drugs. However, prior ablation studies were largely unblinded, raising concerns about placebo effects. We compared pulsed field ablation (PFA) to a sham procedure to treat symptomatic AF.
Methods: This single-blind, randomized trial enrolled patients with AF that was highly symptomatic (AFEQT [Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire] score < 50). Patients were assigned 1:1 to PFA or Sham. All participants received implantable cardiac monitors for continuous rhythm monitoring. The 6-month co-primary outcomes were: (1) time to first recurrence of atrial tachyarrhythmia, and (2) changes from baseline in AFEQT scores, compared between groups. Secondary outcomes were AF burden and psychological distress (assessed by the Hospital Anxiety and Depression Scale [HADS]).
Results: Patients (n=60) each were randomized to PFA or Sham. At 6 months, the first co-primary endpoint of AF recurrence was met in 2 (6.7%) patients who underwent PFA and 25 (83.3%) patients who underwent Sham (posterior HR 24.3, 95% Bayesian credible intervals, 5.7- 104.2; posterior probability of superiority, 1.0). For the second co-primary endpoint, AFEQT scores showed greater improvement from baseline with PFA than Sham (improved 47.1 vs 0.45 points; posterior median difference, 32.6; 95% Bayesian credible interval, 20.2 – 44.9; posterior probability of superiority, 1.0). AF burden and HADS scores were significantly lower with PFA, vs Sham.
Conclusions: In patients with AF, PFA was superior to Sham in reducing arrhythmia recurrences and burden, and improving the quality-of-life and the psychological distress associated with AF.