Riata implantable cardioverter-defibrillator lead failure: Analysis of explanted leads with a unique insulation defect

Fluoroscopic investigation of Riata® transvenous defibrillator leads

“…We have reported a case of failed defibrillation in a patient who came to our attention when his device recorded low (< 10 Ω) HV impedance during therapy delivery for a supraventricular tachycardia detected as ventricular tachycardia [19]. Hauser et al [20] found 13 out of 22 cases of deaths related to Riata ® and Riata ST ® where HV impedance issues were detected. In their analysis of explanted leads from the Manufacturer and User Facility Device Defined Experience (MAUDE) database of 105 patients, almost a quarter (26.7%) leads had evidence of inside-out insulation defect under one or more of the HV shocking coils [20].…”

“…Hauser et al [20] found 13 out of 22 cases of deaths related to Riata ® and Riata ST ® where HV impedance issues were detected. In their analysis of explanted leads from the Manufacturer and User Facility Device Defined Experience (MAUDE) database of 105 patients, almost a quarter (26.7%) leads had evidence of inside-out insulation defect under one or more of the HV shocking coils [20]. These observations are worrisome as the integrity and functionality of the HV system may not come into attention until delivery of therapy as no significant deviations are noted on routine surveillance.…”

Implantable Cardioverter-Defibrillator Leads

“…All of these leads have large-diameter lumens that permit the cables to move more freely than narrower lumens. Internal motion of cables is the root cause of a unique failure mode in which the cables abrade against and through the silicone elastomer insulation that constitutes the walls of their lumens, 14,15 which results in inside-out insulation breaches ( Figure 2B). …”

“…14 In leads without external copolymer tubing, abrasions between the coils present most commonly as exteriorized cables 14 that are identified radiographically. At diagnosis, routine follow-up identifies >70% of leads as having normal electrical function 16 because of the biocompatibility and high dielectric strength of intact ethylene-tetrafluoroethylene (ETFE) insulation (Figure 1; Appendix in the online-only Data Supplement).…”

Mechanism and Management of Pacing Lead Related Cardiac Perforation

“…The reasons for higher perforation rate are largely unknown but may include lead design and breeches in structural integrity [26]. Another important property in assessing the propensity of a lead to perforate is "thickness".…”