Pacemaker lead extraction with the laser sheath

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

Bruce L. Wilkoff, Charles L. Byrd, Charles J. Love, David L. Hayes, T. Duncan Sellers, Raymond Schaerf, Victor Parsonnet, Laurence M. Epstein, Robert A Sorrentino, Christopher Reiser

Research output: Contribution to journalArticle

329 Citations (Scopus)

Abstract

OBJECTIVES: The purpose of this study was to evaluate the safety and effectiveness of pacemaker lead extraction with the excimer sheath in comparison to 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 technique of mechanically disrupting the fibrosis. However, ultraviolet excimer laser 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 had the leads removed with identical tools as the nonlaser group with the exception that the inner telescoping sheath was replaced with the 12-F excimer laser sheath. Success for both groups was defined as complete lead removal with the randomized therapy without complications. RESULTS: Complete lead removal rate was 94% in the laser group and 64% in the 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 lead 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 randomized to nonlaser techniques (p < 0.04). Potentially life-threatening complications 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 clinical advantages over extraction without laser tools and is associated with significant risks.

Original languageEnglish (US)
Pages (from-to)1671-1676
Number of pages6
JournalJournal of the American College of Cardiology
Volume33
Issue number6
DOIs
StatePublished - May 1 1999
Externally publishedYes

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Lasers
Telescopes
Excimer Lasers
Lead
Fibrosis
Safety
Light

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Pacemaker lead extraction with the laser sheath : Results of the pacing lead extraction with the excimer sheath (PLEXES) trial. / Wilkoff, Bruce L.; Byrd, Charles L.; Love, Charles J.; Hayes, David L.; Sellers, T. Duncan; Schaerf, Raymond; Parsonnet, Victor; Epstein, Laurence M.; Sorrentino, Robert A; Reiser, Christopher.

In: Journal of the American College of Cardiology, Vol. 33, No. 6, 01.05.1999, p. 1671-1676.

Research output: Contribution to journalArticle

Wilkoff, Bruce L. ; Byrd, Charles L. ; Love, Charles J. ; Hayes, David L. ; Sellers, T. Duncan ; Schaerf, Raymond ; Parsonnet, Victor ; Epstein, Laurence M. ; Sorrentino, Robert A ; Reiser, Christopher. / Pacemaker lead extraction with the laser sheath : Results of the pacing lead extraction with the excimer sheath (PLEXES) trial. In: Journal of the American College of Cardiology. 1999 ; Vol. 33, No. 6. pp. 1671-1676.
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abstract = "OBJECTIVES: The purpose of this study was to evaluate the safety and effectiveness of pacemaker lead extraction with the excimer sheath in comparison to 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 technique of mechanically disrupting the fibrosis. However, ultraviolet excimer laser 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 had the leads removed with identical tools as the nonlaser group with the exception that the inner telescoping sheath was replaced with the 12-F excimer laser sheath. Success for both groups was defined as complete lead removal with the randomized therapy without complications. RESULTS: Complete lead removal rate was 94{\%} in the laser group and 64{\%} in the 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 lead 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 randomized to nonlaser techniques (p < 0.04). Potentially life-threatening complications 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 clinical advantages over extraction without laser tools and is associated with significant risks.",
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AU - Byrd, Charles L.

AU - Love, Charles J.

AU - Hayes, David L.

AU - Sellers, T. Duncan

AU - Schaerf, Raymond

AU - Parsonnet, Victor

AU - Epstein, Laurence M.

AU - Sorrentino, Robert A

AU - Reiser, Christopher

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N2 - OBJECTIVES: The purpose of this study was to evaluate the safety and effectiveness of pacemaker lead extraction with the excimer sheath in comparison to 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 technique of mechanically disrupting the fibrosis. However, ultraviolet excimer laser 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 had the leads removed with identical tools as the nonlaser group with the exception that the inner telescoping sheath was replaced with the 12-F excimer laser sheath. Success for both groups was defined as complete lead removal with the randomized therapy without complications. RESULTS: Complete lead removal rate was 94% in the laser group and 64% in the 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 lead 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 randomized to nonlaser techniques (p < 0.04). Potentially life-threatening complications 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 clinical advantages over extraction without laser tools and is associated with significant risks.

AB - OBJECTIVES: The purpose of this study was to evaluate the safety and effectiveness of pacemaker lead extraction with the excimer sheath in comparison to 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 technique of mechanically disrupting the fibrosis. However, ultraviolet excimer laser 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 had the leads removed with identical tools as the nonlaser group with the exception that the inner telescoping sheath was replaced with the 12-F excimer laser sheath. Success for both groups was defined as complete lead removal with the randomized therapy without complications. RESULTS: Complete lead removal rate was 94% in the laser group and 64% in the 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 lead 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 randomized to nonlaser techniques (p < 0.04). Potentially life-threatening complications 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 clinical advantages over extraction without laser tools and is associated with significant risks.

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