EXTRACT Registry and Research Group: Knowledge through Collaboration in Real World Transvenous Lead Extraction Practice and Outcomes — Preliminary Results
/HRS, May 2016
Melanie Maytin, MD, FHRS, Daniel Juergens, BA, Roy M. John, MD, PhD and Laurence M. Epstein, MD. Brigham and Women's Hospital, Boston, MA, Brigham and Women's Hospital - Cardiac Arrhythmia Services, Boston, MA
Expanding cardiovascular electronic implantable device (CIED) indications, improved patient longevity, and an increase in CIED infections and lead related advisories have contributed to a rise in transvenous lead extraction (TLE) procedures, estimated at an annual rate of 24,000 patients worldwide. Data regarding TLE practices and outcomes are largely related to single center observational data and retrospective multicenter analyses at high-volume centers.
A prospective multicenter registry of consecutive patients undergoing TLE in the US was created. Data was collected and managed using a secure, web-based application and randomly audited.
Since June 2014, 573 patients have been enrolled by 3 centers with 5 more centers pending initiation. The cohort was 70% male with EF 40% [28, 55] and >90% with class 2 HF or greater. ICD was predominant CIED type (63%). Infection was the most common indication for TLE (37%) followed by lead malfunction (30%) and prophylactic removal of advisory lead (17%). The majority of the cases were performed in the OR (90%) under GA (97%) with invasive HD monitoring (91%). A total of 938 leads were extracted with 94% complete procedural and 99% clinical success. Median implant duration/lead was 6.9y [3.3, 9.9] and median total lead-years was 9.9y [5.6, 19]. Majority of leads were removed using a laser sheath (64%) with one-quarter of leads removed with simple traction. Additional TLE tools were utilized in 30% of cases (Visi sheath 0.4%, Bulldog 7%, One-Tie 13%). There were 3 major complications (0.5%): 1 tamponade managed percutaneously & 2 SVC tears managed surgically with 1 intraoperative death (0.2%). Minor complication rate was 1.4%. Event rate at 30-days 4.5% (8 hospitalization, 3 surgical reimplant, 2 hematoma, 2 infection, 1 repeat TLE).
EXTRACT is the first large prospective multicenter registry of consecutive patients undergoing TLE in the US. Thus far, major complication and mortality rates with TLE are low in this initial experience. It is hoped that EXTRACT will become a powerful tool that provides real world answers to clinical challenges in both patient management and the technical aspects of TLE.