Pacemaker lead extraction with the laser sheath: Results of the pacing lead extraction with the excimer sheath (PLEXES) trial

OBJECTIVES The purpose of this study was to evaluate the safety and effecti veness of pacemaker lead extraction with the excimer sheath in comparison t o nonlaser lead extraction. BACKGROUND Fibrotic attachments that develop between chronically implanted pacemaker leads and to the venous, valvular and cardiac structures are the major obstacles to safe and consistent lead extraction. Locking stylets and telescoping sheaths produce a technically demanding but effective techniqu e of mechanically disrupting the fibrosis. However, ultraviolet excimer las er light dissolves instead of tearing the tissue attachments. METHODS A randomized trial of lead extraction was conducted in 301 patients with 465 chronically implanted pacemaker leads. The laser group patients h ad the leads removed with identical tools as the nonlaser group with the ex ception that the inner telescoping sheath was replaced with the 12-F excime r laser sheath. Success for both groups was defined as complete lead remova l with the randomized therapy without complications. RESULTS Complete lead removal rate was 94% in the laser group and 64% in th e nonlaser group (p = 0.001). Failed nonlaser extraction was completed with the laser tools 88% of the time. The mean time to achieve a successful lea d extraction was significantly reduced for patients randomized to the laser tools, 10.1 +/- 11.5 min compared with 12.9 +/- 19.2 min for patients rand omized to nonlaser techniques (p < 0.04). Potentially life-threatening comp lications occurred in none of the nonlaser and three of the laser patients, including one death (p = NS). CONCLUSIONS Laser-assisted pacemaker lead extraction has significant clinic al advantages over extraction without laser tools and is associated with si gnificant risks. (C) 1999 by the American College of Cardiology.