Elsevier

Heart Rhythm

Volume 19, Issue 12, December 2022, Pages 1948-1955
Heart Rhythm

Focus Issue: Devices
Clinical
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

https://doi.org/10.1016/j.hrthm.2022.07.009Get rights and content

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%; Pgeneralized additive model = 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.

Introduction

Atrial fibrillation (AF) may adversely affect cardiac function and can be the trigger for the development of heart failure (HF) in susceptible individuals.1,2 Loss of atrial contraction, as well as elevation and irregularity of the ventricular rate, may adversely affect cardiac function.3 In patients with persistent AF, optimal heart rate control and rate regularization can be achieved with atrioventricular nodal ablation (AVNA) combined with ventricular pacing.4, 5, 6 The method for delivering ventricular pacing may impact ventricular function and patient outcomes. Right ventricular (RV) pacing causes nonphysiological ventricular activation, which is known to be harmful when delivered to patients with impaired ventricular function,7 and thus may offset the beneficial effects of heart rate regularization and control.8

Biventricular pacing (BVP) overcomes some of the disadvantages of RV pacing by delivering more rapid less dyssynchronous ventricular activation.9, 10, 11 BVP combined with AVNA has been demonstrated to improve cardiac function, symptoms, morbidity, and mortality when delivered to patients who have persistent AF with adequate ventricular rate control, narrow QRS duration, and reduced left ventricular ejection fraction (LVEF).12,13 However, BVP also delivers nonphysiological ventricular activation because it does not utilize the proximal conduction system. When delivered to patients with narrow QRS duration, it prolongs ventricular activation.14 His-bundle pacing (HBP) can be delivered with a single lead and utilizes the heart’s intrinsic conduction system and therefore may preserve normal physiological ventricular activation even after AVNA.15

Nonrandomized observational studies have reported that HBP combined with AVNA is technically feasible,16, 17, 18 but data from prospective randomized studies confirming feasibility are lacking, and no comparisons of HBP with BVP in this group of patients have been made.

In the comparison of His bundle pacing and bi-ventricular pacing in heart failure patients with atrial fibrillation who need atrioventricular node ablation (ALTERNATIVE-AF) trial, we prospectively assessed the feasibility of HBP combined with AVNA in patients with persistent AF, adequate ventricular rate control, reduced LVEF, and intrinsic QRS duration <120 ms. We compared outcomes with HBP to those obtained with BVP, and the primary endpoint was change in LVEF.

Section snippets

Methods

The data supporting the findings of this trial are available from the corresponding author on request.

Patient flow

One hundred thirty-three patients with AF and LV impairment were identified during the recruitment period. Sixty patients did not meet the inclusion criteria (QRS duration >120 ms or LVEF >40%). Eighteen patients met ≥1 of the exclusion criteria, and 3 patients chose not to participate in the trial. One patient failed to achieve AVNA, and 1 patient was referred for HBP and left bundle branch pacing (LBBP). The remaining fifty patients were recruited into the trial (Supplemental Figure 1). All

Discussion

The ALTERNATIVE-AF trial is the first prospective multicenter trial to assess the feasibility of HBP combined with AVNA in patients with persistent AF, adequate rate control, narrow QRS duration, and reduced LVEF.

We observed high HBP implant success rates and stable capture thresholds throughout the trial period, suggesting that this is a feasible method for pacing delivery in this group of patients. Improvements in LVEF and clinical endpoints were observed during follow-up after AVNA with both

Conclusion

The findings of this prospective multicenter trial suggest that HBP is a promising alternative to BVP in patients with persistent AF, adequate rate control, narrow QRS duration, and reduced LVEF undergoing AVNA. Similar improvements in echocardiographic parameters, NYHA functional class, and BNP were obtained with both pacing modalities. HBP produced modest additional improvements in ventricular function compared to BVP and has the advantage that it can be delivered with a single lead and

Acknowledgments

We thank Dr Xi Li (National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases) for his help in the statistical analysis of this manuscript.

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    Funding Sources: This work was supported by Key Research and Development Program of Zhejiang, China (2019C03012).

    Disclosures: Dr Whinnett reports consultant and speaker fees from Medtronic; serving as a consultant for Boston Scientific; and serving on the advisory board of Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. ClinicalTrials.gov Identifier: NCT02805465.

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