Human Use Conditions in Fatigue of Intravenous Leads Used in Cardiac Implanted Electronic Devices

Published

July 3, 2025

Author(s)

Timothy Quinn, Charles Swerdlow, Lucas Koepke, James Dawson, Nicki Mara, Jason Santelli, Diane Muff, Jordan Savela, Alex Felber, Michael Friedrich, Jens Rump, Torsten Luther, Jake Benzing, Michael Peterson, Mohit Chawla, Stanislav Weiner, Byron Colley III, Jonathan Piccini

Abstract

Background: Transvenous lead conductors are subject to fatigue fracture from repetitive bending stresses, which are proportional to alternating curvature. Knowledge of the stresses on implanted leads (fatigue environment) is a prerequisite for developing a valid preclinical lead-testing standard. Yet, little is known about this fatigue environment. Objective: The Human Use Condition Study (HUCS) quantified this fatigue environment, including the relationship between lead stiffness and alternating curvature. Methods: HUCS was a prospective, observational, multicenter clinical study. Leads from four manufacturers were chosen to span the range of stiffness in clinical use. They were imaged with biplane cinefluoroscopy during cardiac motion and in the shoulder region during arm motion. In each image, the lead was traced, and its curvature was calculated as a function of time. Results: Images were analyzed for 109 subjects. In each region of the lead analyzed, maximum alternating curvature was determined primarily by between-patient differences, not differences in lead stiffness. Across regions, maximum alternating curvature was greatest in the extravenous region (p=0.001). In this region, the length of the highly-stressed portion of the lead correlated inversely with lead stiffness (p<0.001). Conclusions: HUCS is the first study to measure alternating in vivo stresses applied to leads from multiple manufacturers and thereby enable development of an evidence-based lead testing standard. The greatest alternating stress occurs in the extravenous region. There, lead stiffness predicts how much of the lead is highly stressed but not maximum alternating curvature.

Citation

Heart Rhythm

Pub Type

Journals

Download Paper

https://doi.org/10.1016/j.hrthm.2025.06.050

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Keywords

Cardiac device leads, in vivo fatigue use conditions, fatigue failure, alternating curvature, arm motion, AAMI standards

Citation

Quinn, T. , Swerdlow, C. , Koepke, L. , Dawson, J. , Mara, N. , Santelli, J. , Muff, D. , Savela, J. , Felber, A. , Friedrich, M. , Rump, J. , Luther, T. , Benzing, J. , Peterson, M. , Chawla, M. , Weiner, S. , Colley III, B. and Piccini, J. (2025), Human Use Conditions in Fatigue of Intravenous Leads Used in Cardiac Implanted Electronic Devices, Heart Rhythm, [online], https://doi.org/10.1016/j.hrthm.2025.06.050, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=959887 (Accessed January 23, 2026)