Focus Issue: DevicesClinicalHis-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
Graphical abstract
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.
References (27)
- et al.
Pacing treatment of atrial fibrillation patients with heart failure: His bundle pacing combined with atrioventricular node ablation
Card Electrophysiol Clin
(2018) - et al.
Right ventricular pacing can induce ventricular dyssynchrony in patients with atrial fibrillation after atrioventricular node ablation
J Am Coll Cardiol
(2006) - et al.
Biventricular pacing improves cardiac function and prevents further left atrial remodeling in patients with symptomatic atrial fibrillation after atrioventricular node ablation
Am Heart J
(2010) - et al.
Electrical dyssynchrony induced by biventricular pacing: Implications for patient selection and therapy improvement
Heart Rhythm
(2015) - et al.
Safety of distal His bundle pacing via the right ventricle backed up by adjacent ventricular capture
JACC Clin Electrophysiol
(2021) - et al.
A randomized trial of His pacing versus biventricular pacing in symptomatic HF patients with left bundle branch block (His-alternative)
JACC Clin Electrophysiol
(2021) - et al.
Temporal relations of atrial fibrillation and congestive heart failure and their joint influence on mortality: the Framingham Heart Study
Circulation
(2003) - et al.
Advancing research on the complex interrelations between atrial fibrillation and heart failure: a report from a US National Heart, Lung, and Blood Institute Virtual Workshop
Circulation
(2020) - et al.
Atrial fibrillation in heart failure: epidemiology, pathophysiology, and rationale for therapy
Am J Cardiol
(2003) - et al.
Clinical outcomes after ablation and pacing therapy for atrial fibrillation: a meta-analysis
Circulation
(2000)
2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy
Eur Heart J
Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial
JAMA
Left ventricular-based cardiac stimulation post AV nodal ablation evaluation (the PAVE study)
J Cardiovasc Electrophysiol
Cited by (0)
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.