Outcomes of external repair of HeartMate IITM LVAD percutaneous leads

Background The HeartMate II Left Ventricular Assist Device (LVAD) receives power via a percutaneous lead connected to an external controller and batteries. At times, this lead can be damaged during normal wear, as well as by traumatic fracture, which may jeopardize the functionality of the LVAD. If there is significant internal damage, surgical replacement of the LVAD is required. However it is possible to repair externally damaged leads by replacing the distal portion of the lead to avoid pump replacement. We report the overall experience and outcomes in patients with external lead repairs. Methods A procedure for full external lead replacement has been developed and is approved for implementation by the FDA. Pre-procedural steps include examination of high resolution x-rays of the driveline and analysis of pump log files. Efficacy and outcomes of all attempted external lead repairs were evaluated between initiation of repairs in 2008 through 2014. Results A total of 321 repairs were attempted in 297 patients with suspected isolated external lead damage after a median of 2.0 yr [range: 7d to 8.7 yr] of support. Of 297 patients, 37 (12.5%) had attempts at external repair that were unsuccessful  due to concomitant internal lead damage. 31 patients (10.4%) had additional serious malfunctions after lead repair resulting in 17 with repeat repairs and 14 who continued on ungrounded cables, and ultimately 14 of these 31 patients required pump exchanges. 27 of the 297 patients (9.1%) with lead repairs had only minor additional problems, including cuts or abrasion in the insulation which was fixed with tape or external reinforcement. There was one catastrophic failure during attempted lead repair requiring emergent pump exchange, and there were three deaths within 14 days of attempted repair related to continued percutaneous lead damage. One of these patients refused pump exchange, and two were not candidates for other clinical reasons. 202 of the 297 patients (68%) have had no recurrence of lead problems after a median follow-up of 189 days [n=11 over 2 years, longest 5.8 yr]. Conclusions HeartMate II dysfunction due to percutaneous lead damage is uncommon but is of serious concern due to potential abrupt pump stoppage. Lead repair by replacement of the external distal percutaneous lead can be performed by trained personnel in a standardized fashion and may provide a durable solution in select patients with isolated external lead damage, thus avoiding the need for surgical pump exchange. We provide an algorithm for evaluating potential lead damage.