His-bundle pacing vs biventricular pacing following atrioventricular nodal ablation in patients with atrial fibrillation and reduced ejection fraction: A multicenter, randomized, crossover study-The ALTERNATIVE-AF trial

Heart Rhythm. 2022 Dec;19(12):1948-1955. doi: 10.1016/j.hrthm.2022.07.009. Epub 2022 Jul 14.

Abstract

Background: Atrioventricular nodal ablation (AVNA) combined with biventricular pacing (BVP) improves outcomes in patients with persistent atrial fibrillation (AF), adequate rate control, and reduced left ventricular ejection fraction (LVEF). His-bundle pacing (HBP) delivers physiological ventricular activation and is a promising alternative to BVP.

Objective: The purpose of this trial was to compare HBP with BVP following AVNA.

Methods: In this multicenter, prospective, randomized crossover trial, we recruited patients with persistent AF and reduced LVEF (≤40%). All patients underwent AVNA and received both HBP and BVP. Patients were randomized to either HBP or BVP for 9 months (phase 1), then were switched to the alternative pacing modality for the next 9 months (phase 2). The primary endpoint was change in LVEF.

Results: Fifty patients (age 64.3 ± 10.3 years; ventricular rate 93.1 ± 19.9 bpm; 72% male) were enrolled. Thirty-eight patients completed the 2 phases and were included in the crossover analysis. A significant improvement in LVEF was observed with HBP compared to BVP (phase 1: ΔLVEFHBP 21.3% and ΔLVEFBVP 16.7%; phase 2: ΔLVEFHBP 3.5% and ΔLVEFBVP -2.4%; Pgeneralizedadditivemodel = 0.015). Significant improvements in left ventricular end-diastolic diameter, New York Heart Association functional class, and B-type natriuretic peptide level were observed with both pacing modalities compared with baseline, whereas no significant differences were observed between HBP and BVP.

Conclusion: HBP delivers a modest but significant improvement in LVEF in patients with persistent AF, impaired ventricular function, and narrow QRS duration post-AVNA compared with BVP. Larger long-term trials are required to confirm the additional improvements in function with HBP.

Trial registration: ClinicalTrials.gov NCT02805465.

Keywords: Atrial fibrillation; Atrioventricular nodal ablation; Cardiac resynchronization therapy; Heart failure; His-bundle pacing.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Atrial Fibrillation* / surgery
  • Bundle of His
  • Cardiac Pacing, Artificial
  • Cardiac Resynchronization Therapy*
  • Cross-Over Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Stroke Volume
  • Treatment Outcome
  • Ventricular Function, Left / physiology

Associated data

  • ClinicalTrials.gov/NCT02805465