Abstract 18350: Preliminary Experience Regarding Re-Use of Explanted, Resterilized Defibrillators

Abstract

Introduction: Large numbers of defibrillators (ICDs) are explanted in the US for upgrades or infections. Such devices often have significant remaining battery life. For the past 15 years, ICDs (including CRT-D) with >70% or at least 3 years of remaining battery life have been sent to India for resterilization and reimplantation in indigent persons who would otherwise be unable to afford ICDs. We report on our experience in consecutive recipients of explanted ICDs since 2003.

Methods: Explanted ICDs were cleaned with saline and shipped to India. The headers were cleaned with pipe cleaners. The devices were immersed in Hibiclens for 12 hrs, H₂O₂ for 24 hrs, betadine for 10 minutes, and then rinsed in distilled H₂O. Finally, gas resterilization with ethylene oxide and sterile repackaging were performed.

Results: Since 2003, a total of 31 consenting patients (pts) with Class I indications for ICD or CRT-D implantation received explanted devices at the Holy Family Hospital in Mumbai, India. Disease categories: CAD, ARVC, sarcoidosis, and dilated CMP. Mean age 52±15 (range 16 – 77) yrs, 6 female. Of these, 17 were CRT-D implants and 14 were ICDs. All implants were performed under conscious sedation and local anesthesia, mean procedure time 104±55 (range 40 – 345) mins. Follow up was available on 29 of 31 (93.6%) pts; 2 pts travelled to remote regions and were lost to follow up. There were no infectious complications, either peri-implant or during follow up. LV lead dislodgement in 1 pt required re-operation. Thirteen of 31 (42%) pts experienced appropriate shocks during a mean follow up duration of 795±579 (range 13 – 2237) days. Five pts (including 3 who survived VT/VF storm) received a second explanted ICD after the first device reached ERI (mean time to second implant 1057±807, range 362 – 2162 days).

Conclusions: Explanted ICDs with >70% or at least 3 years of remaining battery life can be safely reused after careful cleaning and resterilization. Appropriate ICD therapy rates were high, consistent with a sicker pt population. These ICDs continue to function appropriately in delivering life-saving therapies, without an increased risk of complications. These preliminary data deserve further validation, and if confirmed, could have important societal and economic implications.