ClinicalOutcomesIncidence and management of atrioventricular conduction disorders in new-onset left bundle branch block after TAVI: A prospective multicenter study
Graphical abstract
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.