Elsevier

Heart Rhythm

Volume 20, Issue 5, May 2023, Pages 699-706
Heart Rhythm

Clinical
Outcomes
Incidence and management of atrioventricular conduction disorders in new-onset left bundle branch block after TAVI: A prospective multicenter study

https://doi.org/10.1016/j.hrthm.2023.01.013Get rights and content

Background

New-onset left bundle branch block (LBBB) is one of the most frequent complications after transcatheter aortic valve implantation (TAVI) and is associated with delayed high degree atrioventricular (AV) block.

Objectives

The objectives of this study were to determine the incidence of AV block in such a population and to assess the performance and safety of a risk stratification algorithm on the basis of electrophysiology study (EPS) followed by implantation of a pacemaker or implantable loop recorder (ILR).

Methods

This was a prospective open-label study with 12-month follow-up. From June 8, 2015, to November 8, 2018, 183 TAVI recipients (mean age 82.3 ± 5.9 years) were included at 10 centers. New-onset LBBB after TAVI persisting for >24 hours was assessed by electrophysiology study during initial hospitalization. High-risk patients (His-ventricle interval ≥70 ms) were implanted with a dual-chamber pacemaker recording AV conduction disturbance episodes. Patients at lower risk were implanted with an ILR with automatic remote monitoring.

Results

A high-grade AV conduction disorder was identified in 56 patients (30.6%) at 12 months. Four subjects were symptomatic, all in the ILR group. No complications were associated with the stratification procedure. Patients with His-ventricle interval ≥70 ms displayed more high-grade AV conduction disorders (53.2% [25 of 47] vs 22.8% [31 of 136]; P < .001). In a multivariate analysis, His-ventricle interval ≥70 ms was independently associated with the occurrence of a high-grade conduction disorder (subdistribution hazard ratio 2.4; 95% confidence interval 1.2–4.8; P = .010).

Conclusion

New-onset LBBB after TAVI was associated with high rates of high-grade AV conduction disturbances. The stratification algorithm provided safe and valuable aid to management decisions and reliable guidance on pacemaker implantation.

Introduction

Transcatheter aortic valve implantation (TAVI) is widely used for the management of patients with severe symptomatic aortic stenosis.1, 2, 3, 4, 5, 6 Currently, new-onset left bundle branch block (LBBB) after TAVI is the most common (13.3%–37%) and potentially most frequent-risk electrical complication for these patients.7, 8, 9, 10 New-onset LBBB is likely associated with an increased risk of complete atrioventricular block (AVB), heart failure, and sudden cardiac arrest.11,12 Sparse data are available on the incidence of AVB in new-onset LBBB, and what has been published has mostly relied on implantable loop recorder (ILR) recordings but with no remote monitoring.10 There have been no studies specifically focusing on the management of new-onset LBBB. Investigations using intracardiac signal recordings have focused on pacemaker-implanted patients after TAVI.13 Alternative methods used in previous studies to identify AVB (ie, right ventricular [RV] pacing rate or 24-hour Holter monitoring) are not effective and relevant (no record of AVB episodes or too short recording) to answer the question of the incidence of AVB in new-onset LBBB and its management.

Management of patients with new-onset LBBB requires a difficult balance between the implantation of a pacemaker, potentially unnecessary or harmful, and the risk of delayed AVB. The latest US expert consensus documents14,15 and European Society of Cardiology guidelines16 have attempted to define algorithms to guide clinicians, but the limited available data impose limitations on what can be generally recommended. The decision remains to a large extent with the treating physician. The European Society of Cardiology guidelines call for further studies, especially to evaluate “the predictive value of a single EPS [electrophysiology study] early after the procedure to predict advanced heart block.” p.20 supplementary data ESC guidelines.16

In the present multicenter study, we used automatic remote monitoring with cardiovascular implantable electronic devices (CIEDs) to determine the incidence of AVB at 12 months and assessed for the first time the potential of a risk stratification strategy in postprocedural LBBB on the basis of EPS followed by remote monitoring with CIEDs.

Section snippets

Methods

LBBB-TAVI (ClinicalTrials.gov identifier NCT02482844) is a French multicenter (10-center), prospective, open-label, nonrandomized study. Rationale and design have been described in detail in a previous publication.17

The study was approved by the local ethics committee (CPP Sud Est VI, AU1181) and the National Agency for the Safety of Medicines and Health Products (ANSM: 2015-AOO271-48). All study subjects provided written informed consent. The research reported in this article adhered to

Study population

From June 8, 2015, to November 8, 2018, 3228 patients underwent TAVI at 10 centers. A total of 411 patients with new-onset LBBB were screened, of whom 200 met inclusion criteria and were included in the study.

After inclusion, 17 patients were excluded because of protocol violations. The final population consisted of 183 consecutive patients with new-onset LBBB after TAVI (Figure 1).

Before TAVI, the mean QRS duration was 94 ± 14 ms and 12% (22 of 183) with QRS duration >110 ms and the mean PR

Discussion

Identifying and managing patients with new-onset LBBB after TAVI represents one of the major challenges in the modern management of symptomatic severe aortic stenosis. In this report, we used EPI-based risk stratification, a combination of EPS and remote monitoring by CIED, and was able to identify high-grade AV conduction disorders 12 months after TAVI in 30.6% of subjects with new-onset LBBB. EPI provided a safe and reliable guide to management of new-onset LBBB after TAVI: only 1 in 10

Conclusion

EPI-based risk stratification was a valuable and safe tool to guide management decisions in new-onset LBBB after TAVI, with low complication rates. The strategy should be implemented for postprocedural stratification in such population. There is a need for greater insight into the impact of new-onset LBBB after TAVI on mortality and morbidity in candidates for permanent pacemaker implantation as well as which pacemaker modality (single-chamber, dual-chamber, or biventricular pacemaker) might

Acknowledgments

We thank Elodie Chazot, MSc and Aurélie Thalamy, MSc for their work during the different steps of the present study (administration, kickoff, monitoring, etc) and all physicians for recruitment, inclusions, and data collection.

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    Funding Sources: This clinical trial was supported by Biotronik and the Sorin Group. However, the authors are solely responsible for the design and conduct of this study as well as all study analyses and the drafting and editing of the article.

    Disclosures: The authors have no conflicts of interest to disclose.

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