B-PO01-029 CHRONIC RETRIEVABILITY OF A LEADLESS PACEMAKER: WORLDWIDE EXPERIENCE OUT TO 7 YEARS

Abstract

Nanostim leadless pacemaker (LP; Abbott Inc) clinical trials were halted after 1,423 implants in 10/2016 due to premature battery depletion and a docking button detachment vulnerability. To describe the long-term worldwide experience with LP retrieval. Patients enrolled in multicenter LP clinical trials in the US, Canada, Europe, Japan, and Australia, and who underwent an LP retrieval attempt were included. Data were collected for each retrieval attempt and any adverse events were adjudicated by a clinical events committee. The overall success of chronic LP retrieval was 87.6% (176 of 201 LPs). The mean time from implant to retrieval attempt was 2.6 ± 1.5 years (range 0 to 7.2); the mean times from implant to retrieval for the 176 successful and 25 unsuccessful attempts were 2.6 ± 1.5 years (range 0 to 7.2) and 2.5 ± 1.4 years (range 0.3 to 5.1), respectively. The retrieval success rate was above 80% over time, regardless of implant duration (Figure). Most unsuccessful retrieval attempts (21 of 25; 84%) were attributed to an inability to access the docking button, an inability to deliver the retrieval catheter, or detachment of the docking button. The device and/or procedure complication rate associated with attempted retrievals was 5.0% (10 of 201 attempts). The most common of these were tricuspid valve injury (n=3) or an inability to release the snare from the docking button (n=2). There were no deaths related to attempted retrieval. There is a high chronic LP retrieval success rate out to 7 years post-implant, accompanied by a low complication rate. Retrieval success rates remained above 80%, regardless of the LP implant duration.