ClinicalDevicesIntermediate-term performance and safety of His-bundle pacing leads: A single-center experience
Graphical abstract
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.