Elsevier

Heart Rhythm

Volume 18, Issue 5, May 2021, Pages 743-749
Heart Rhythm

Clinical
Devices
Intermediate-term performance and safety of His-bundle pacing leads: A single-center experience

https://doi.org/10.1016/j.hrthm.2020.12.031Get rights and content

Background

The short-term safety, feasibility, and performance of His-bundle pacing (HBP) leads have been reported; however, their longer-term performance beyond 1 year remains unclear.

Objective

The purpose of this study was to examine the intermediate-term performance and safety of HBP.

Methods

All HBP lead implants at Virginia Commonwealth University between January 2014 and January 2019 were analyzed. HBP was performed using a Medtronic SelectSecure 3830-69 cm pacing lead.

Results

Of 295 attempts, successful HBP implantation (selective or nonselective) was seen in 274 cases (93%). Mean follow-up duration was 22.8 ± 19.5 months (median 19.5; interquartile range 11–33). Mean age was 69 ± 15 years; 58% were males; and ejection fraction <50% was noted in 30%. Indications for pacemaker included sick sinus syndrome in 41%, atrioventricular block in 36%, cardiac resynchronization therapy in 7%, and refractory atrial fibrillation in 15%. Selective HBP was achieved in 33%. Mean HBP capture threshold at implant was 1.1 ± 0.9 V at 0.8 ± 0.2 ms, which significantly increased at chronic follow-up to 1.7 ± 1.1 V at 0.8 ± 0.3 ms (P <.001). Threshold was ≥2.5 V in 24% of patients, and 28% had an increase in HBP threshold ≥1 V. Loss of His-bundle capture at follow-up (septal right ventricular pacing) was seen in 17%. There was a total of 31 (11%) lead revisions, primarily for unacceptably high thresholds.

Conclusion

Although HBP can prevent or improve pacing-induced cardiomyopathy, the elevated capture thresholds, loss of His-bundle capture, and lead revision rates at intermediate follow-up are of concern. Longer-term follow-up data from multiple centers are needed.

Introduction

Conduction system pacing by implanting leads in the His-bundle region has gained global popularity in the past decade for patients with symptomatic bradycardia.1, 2, 3, 4, 5, 6, 7 His-bundle pacing (HBP) is now an accepted alternative to traditional pacing in the right ventricular (RV) apex in select populations with anticipated high RV pacing burden.8 The superiority of HBP over RV pacing in preventing cardiomyopathy has been reported.4,7 Although the His bundle theoretically is the ideal physiological pacing site, high capture thresholds at implant and unpredictable, delayed rise in HBP capture thresholds are major concerns, resulting in premature battery depletion and high lead revision rates.6,9 The safety, feasibility, and short-term performance of HBP leads have been reported by several groups1,3, 4, 5,7; however, data on the intermediate- and long-term performance of HBP leads are limited.2,6 In this study, we sought to analyze the intermediate-term outcomes and safety of HBP from a single, large, academic medical center in the United States.

Section snippets

Study design

Patients with a successful permanent HBP lead implantation for standard indications in accordance with the American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines8 at Virginia Commonwealth University between January 2014 and January 2019 were included in this retrospective, observational study. Patients <18 years of age were excluded. After approval from the university institutional review board, data were collected retrospectively and followed prospectively in

Results

Between January 2014 and 2019, 274 patients had successful HBP lead implantation out of 295 attempts, yielding a success rate of 93%. Baseline characteristics of the patients are summarized in Table 1. Mean patient age was 69 ± 15 years, and males accounted for 58% of the cohort. Indications for pacemaker included sick sinus syndrome in 41%, AV block in 36%, cardiac resynchronization therapy in 7%, and refractory atrial fibrillation before atrioventricular junction ablation in 15%. There was a

Discussion

The primary findings of this large, single-center study describing intermediate-term performance and safety of HBP leads during mean follow-up of 23 months (median 19) are as follows (1) Mean HBP capture threshold increased significantly during the follow-up period. (2) About one-fourth of patients had chronic HBP thresholds ≥2.5 V. (3) Loss of conduction system pacing (septal RV pacing) was seen in 17%. (4) Lead revision was required in 11% of patients.

HBP is the ideal, physiological form of

Conclusion

We report a significant rise in the capture thresholds of HBP leads, loss of His-bundle capture, and need for lead revisions at intermediate-term follow-up. The clinical benefit of HBP must be weighed against these intermediate-term lead performance issues. Long-term follow-up data on HBP lead performance from multiple centers are needed.

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Funding sources: Dr Huizar has received research support from Abbott. Dr Kaszala has received research support from Boston Scientific and Abbott. Disclosures: Dr Koneru has received teaching honoraria from Medtronic and Biotronik; and fellowship support from Boston Scientific, Biosense Webster, Medtronic, and Abbott Medical. Dr Ellenbogen has served as consultant to, receive honoraria from, served as DSMB Chair, and received research support from Medtronic. Dr Padala has served as consultant to Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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