Study design and protocol for evaluating the long-term prognosis of patients receiving his bundle pacing: A multicenter observational study.

Satoshi Yanagisawa,Rei Shibata,Yosuke Murase,Yosuke Kamikubo,Hiroyuki Kato,Yasunori Kanzaki,Yasuya Inden,Shinji Ishikawa,Masaya Fujita,Hirohiko Suzuki,Toyoaki Murohara

doi:10.1002/joa3.12229

Abstract

BackgroundHis bundle pacing (HBP) is a recently developed pacing technique that can achieve an ideal physiological pattern of ventricular activation via stimulation of the native His‐Purkinje system. Despite the widespread introduction of HBP in clinical practice, its appropriate indications are yet to be determined clearly. Moreover, the efficacy and safety of HBP and long‐term prognosis of patients undergoing such are unknown.MethodsWe conducted a multicenter observational prospective study in patients undergoing HBP in Japan. Patients with atrioventricular block or conduction delay and estimated ventricular pacing of ≥ 40% scheduled for HBP implantation are included. All patients are followed up until 3 years after the implantation. The primary endpoints are all‐cause death, heart failure‐related hospitalization, and upgrade to cardiac resynchronization therapy. The secondary endpoint is changes in cardiac function based on echocardiographic findings and laboratory data after the implantation.ResultsThe results are currently under investigation.ConclusionsThis multicenter observational study evaluates the long‐term prognosis and changes in cardiac function of patients undergoing HBP implantation in a clinical setting. Considering the large number of patients included, the cumulative results would be helpful in establishing evidence on HBP application in this area and consequently allow accurate management and treatment of patients undergoing HBP.

Highlights

His bundle pacing (HBP) is a recently developed pacing technique used in clinical practice
HBP has been reported to improve the New York Heart Association classification, 6‐minute walk test findings, quality of life, and left ventricular ejection fraction (LVEF) when compared to that achieved with right ventricular pacing (RVP) in crossover‐design studies.[4,5]
A recent study demonstrated that HBP was associated with a significant decrease in hospitalizations owing to heart failure, especially in pa‐ tients requiring ventricular pacing at >20%, in comparison with RVP.[6]

Summary

| INTRODUCTION

His bundle pacing (HBP) is a recently developed pacing technique used in clinical practice. Left bundle branch block was successfully corrected with QRS du‐ ration narrowing with the use of HBP in a large number of patients recent study.[8]. This may be based on the hypothesis that the His bun‐ dle may have a longitudinal dissociation separated by the right and left bundle branches at the main His trunk.[12]. The abovementioned results were reported in very re‐ cent studies with a nonrandomized, a crossover, or an observational design These studies were conducted in hospitals with well‐experi‐ enced trained experts who have treated a large number of patients with HBP.[13‒16]. We assess the changes in cardiac function after HBP implantation in these patients

| Objective

| DISCUSSION

Findings

| CONCLUSIONS