Three-year extraction experience of a novel substernal extravascular defibrillation lead in sheep

Abstract

Background: The extravascular implantable cardioverter-defibrillator (EV ICD) with lead implantation in the substernal space may provide an alternative to transvenous and subcutaneous systems. This is the first-reported chronic extraction experience for EV ICD leads. The aim of the study is to evaluate the chronic encapsulation and extractability of EV ICD leads. Methods: Two EV ICD leads and one transvenous lead were implanted in each of 24 mature sheep. A subset of animals was evaluated yearly for histology and lead extractability. Extractions were performed using simple traction or extraction tools. Histology evaluated the encapsulating tissue. Results: At 1 year, extraction was performed successfully for two of five EV ICD leads with traction alone using ≤3.1 kg-force (kgf) and the remainder extracted successfully with extraction tools; no transvenous leads were removed with traction alone. At 2 years, no EV ICD or transvenous leads were extracted with traction alone, while at 3 years, one of eight EV ICD leads and two of four transvenous leads were extracted with traction (0.8 and ≤2.3 kgf, respectively). There was one observation of hemopericardium resulting in tamponade with EV ICD extraction but without injury to cardiovascular structures and related to the unique implant tract. Among transvenous leads, inversion of the ventricle with loss of cardiac output resulted in abandonment of traction for two animals. Conclusions: Chronic extraction of EV ICD leads from the substernal space was successfully performed using traction and simple tools through 3 years in sheep with one observation of hemopericardium that did not originate from cardiovascular injury.