In vitro modeling accurately predicts cardiac lead fracture at 10 years

Abstract

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Rationale and design of the Lead Evaluation for Defibrillation and Reliability study: Safety and efficacy of a novel ICD lead design

“…Since then, physicians and industry engineers have recognized the interaction between lead design, implant technique, and patient factors, resulting in new methods for evaluating lead fracture. These methods incorporate both bench test results and in‐vivo flexural use conditions to predict performance 17,21,23 . The design of the LEADR ICD lead is based upon a pacemaker lead (Medtronic SelectSecure Model 3830) that was commercially released in 2003 and has demonstrated 97% survival at 110 months for RV implant locations, showing that a small diameter, lumenless lead can be designed for reliability 13 .…”

“…17 The model was validated using field data for market-released Quattro and Fidelis leads. The LEADR ICD lead has shown very high fatigue strength in established methods 15,[18][19][20][21] that are designed to mimic the cyclic bending experienced in the shoulder and the heart in bench tests. Fatigue strength data along with in-vivo lead bending data (imaging clinical data cohort) will be combined 19 to model fracture survival in the LEADR study.…”

Time course of oversensing and impedance changes in developing implantable cardioverter-defibrillator lead fracture

“…Most fractures occur in the shoulder region near the anchor sleeve or under the clavicle. 16 If the fracture faces appose in the shoulder’s resting position, periodic impedance measurements will be normal unless recorded during shoulder motion. In contrast, oversensing is monitored continuously and will detect fracture-induced signals triggered by motion.…”

Predictive Modeling of Lead Durability, An Important Step Forward

“…The authors used techniques that were developed during the analysis of the Fidelis® lead failure to study the specific use conditions for a given lead with given implantation techniques 7 . Prior to that analysis, the stressors that were induced by skeletal motor activity on the lead in the pocket had largely been ignored and the impact of prolapsing the lead across the valve had not been appreciated.…”