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CLINICAL RESEARCH: HEART RHYTHM DISORDER

Lead Extraction in the Contemporary Setting: The LExICon Study

An Observational Retrospective Study of Consecutive Laser Lead Extractions

Oussama Wazni, MD^_*,_*, Laurence M. Epstein, MD, Roger G. Carrillo, MD, Charles Love, MD, Stuart W. Adler, MD^||, David W. Riggio, MD^¶, Shahzad S. Karim, MD^#, Jamil Bashir, MD^#, Arnold J. Greenspon, MD^_**, John P. DiMarco, MD, PhD, Joshua M. Cooper, MD, John R. Onufer, MD^||||, Kenneth A. Ellenbogen, MD^¶¶, Stephen P. Kutalek, MD, Sherri Dentry-Mabry, MSN^##, Carolyn M. Ervin, PhD^## and Bruce L. Wilkoff, MD^_*

^_* Department of Cardiovascular Disease, Cleveland Clinic, Cleveland, Ohio
Ohio State University, Columbus, Ohio
Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
Mt. Sinai Medical Center, New York, New York
^|| St. Paul Heart Clinic, St. Paul, Minnesota
^¶ Arizona Heart Hospital, Phoenix, Arizona
^# University of British Columbia, Vancouver, British Columbia, Canada
^_** Thomas Jefferson University, Philadelphia, Pennsylvania
University of Pennsylvania, Philadelphia, Pennsylvania
Drexel College of Medicine, Philadelphia, Pennsylvania
University of Virginia, Charlottesville, Virginia
^|||| Sentara Cardiovascular Research, Norfolk, Virginia
^¶¶ Virginia Commonwealth University, Richmond, Virginia
^## Spectranetics Corporation, Colorado Springs, Colorado

Manuscript received April 10, 2009; revised manuscript received July 13, 2009, accepted August 3, 2009.

^_* Reprint requests and correspondence: Dr. Oussama M. Wazni, Cleveland Clinic, Department of Cardiovascular Medicine/J2-2, 9500 Euclid Avenue, Cleveland, Ohio 44195 (Email: waznio{at}ccf.org).

Objectives: This study sought to examine the safety and efficacy of laser-assisted lead extraction and the indications, outcomes, and risk factors in a large series of consecutive patients.

Background: The need for lead extraction has been increasing in direct relationship to the increased numbers of cardiovascular implantable electronic devices.

Methods: Consecutive patients undergoing transvenous laser-assisted lead extraction at 13 centers were included.

Results: Between January 2004 and December 2007, 1,449 consecutive patients underwent laser-assisted lead extraction of 2,405 leads (20 to 270 procedures/site). Median implantation duration was 82.1 months (0.4 to 356.8 months). Leads were completely removed 96.5% of the time, with a 97.7% clinical success rate whereby clinical goals associated with the indication for lead removal were achieved. Failure to achieve clinical success was associated with body mass index <25 kg/m² and low extraction volume centers. Procedural failure was higher in leads implanted for >10 years and when performed in low volume centers. Major adverse events in 20 patients were directly related to the procedure (1.4%) including 4 deaths (0.28%). Major adverse effects were associated with patients with a body mass index <25 kg/m². Overall all-cause in-hospital mortality was 1.86%; 4.3% when associated with endocarditis, 7.9% when associated with endocarditis and diabetes, and 12.4% when associated with endocarditis and creatinine 2.0. Indicators of all-cause in-hospital mortality were pocket infections, device-related endocarditis, diabetes, and creatinine 2.0.

Conclusions: Lead extraction employing laser sheaths is highly successful with a low procedural complication rate. Total mortality is substantially increased with pocket infections or device-related endocarditis, particularly in the setting of diabetes, renal insufficiency, or body mass index <25 kg/m². Centers with smaller case volumes tended to have a lower rate of successful extraction.

Key Words: leads • cardiac implantable electronic devices • extraction • laser

Abbreviations and Acronyms   BMI = body mass index   CIED = cardiovascular implantable electronic device   DRE = device-related endocarditis   LALE = laser-assisted lead extraction   MAE = major adverse event   NASPE = North American Society of Pacing and Electrophysiology

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