Imaging-Based Localization of His Bundle Pacing Electrodes: Results From the Prospective IMAGE-HBP Study

Abstract

Objectives: This study sought to evaluate the correlation between His bundle (HB) pacing (HBP) implantation characteristics, lead-tip location, and association of intraprocedural His recordings with approximated HB anatomic landmarks using computed tomography (CT) imaging.

Background: HBP continues to grow in clinical practice due to offering true physiological pacing. However, a clear understanding of HB anatomy and the lead-tip location's influence on pacing characteristics is lacking.

Methods: The IMAGE-HBP study (Imaging Study of Lead Implant for His Bundle Pacing) was a prospective, multicenter study designed to assess implantation characteristics of the SelectSecure Model 3830 lead placed at the HB, evaluate protocol-specified HBP success (His recording present on electrogram and HBP threshold ≤2.5 V at 1 ms), and correlation between lead-tip location by CT imaging and HBP characteristics as well as lead-related complications through 12 months.

Results: Sixty-nine patients underwent a lead implantation attempt at the HB. Of these, 61 patients (88%) had a lead successfully implanted at the HB, and 52 patients (75%) met the pre-specified definition of successful HBP. In 51 patients with CT imaging, 11 leads (22%) were placed in the atrial aspect of the HB region (36% selective HBP), and 40 leads (78%) were placed in the ventricular aspect (28% selective HBP). Four of the 51 patients had P-wave oversensing, all with leads in the atrium. Freedom from lead-related complication at 12 months was 93%.

Conclusions: Successful HBP could be achieved at lead-tip locations in the atrium or ventricle but is preferable in the ventricle to eliminate risk of oversensing. The IMAGE-HBP study offers better insight into approximated HB anatomic landmarks, lead-tip location, and correlation with pacing characteristics. (Imaging Study of Lead Implant for His Bundle Pacing [IMAGE-HBP]; NCT03294317).

Keywords: CT imaging; His bundle pacing; complications; nonselective HBP; selective HBP.

Conflict of interest statement

Author Disclosures The IMAGE-HBP study (NCT03294317) was funded by Medtronic, Inc. Dr. Vijayaraman had been a consultant and has received honoraria from Abbott, Biotronik, Boston Scientific, Medtronic, Eaglepoint LLC, and Biosense Webster; has received research funding and fellowship support from Medtronic; and has a patent pending for HBP delivery tool. Dr. Dandamudi has received speaking and consulting honoraria and research funding from Medtronic. Dr. Subzposh has received honoraria and funding from Medtronic. Dr. Padala has served as a consultant for Medtronic. Dr. Ellenbogen has served as a consultant and has received honoraria from Abbott, Biotronik, Boston Scientific, Medtronic, and Biosense Webster. Dr. Bergemann is an employee and shareholder of Medtronic, Inc. Ms. Hughes is an employee and shareholder of Medtronic, Inc. Ms. Harris is an employee and shareholder of Medtronic, Inc. Dr. Fagan is an employee and shareholder of Medtronic, Inc. Dr. Yang is an employee and shareholder of Medtronic, Inc. Dr. Koneru has received teaching honoraria from Medtronic, Abbott Medical, and Biotronik; and fellowship support from Biosense Webster, Abbott Medical, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.