Author + information
- Received April 10, 2009
- Revision received July 13, 2009
- Accepted August 3, 2009
- Published online February 9, 2010.
- 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*
- ↵*Reprint requests and correspondence:
Dr. Oussama M. Wazni, Cleveland Clinic, Department of Cardiovascular Medicine/J2-2, 9500 Euclid Avenue, Cleveland, Ohio 44195
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/m2and 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.
This study was sponsored by Spectranetics Inc. Dr. Epstein has received honorarium for speaking, research, and consulting from Spectranetics, St. Jude, Medtronic, and Boston Scientific. Dr. Carrillo is a consultant for Spectranetics and Medtronic. Dr. Love is an advisor for Spectranetics. Dr. Adler is a consultant for Medtronic Inc., and has industry-sponsored research from Medtronic Inc. and Boston Scientific. Dr. Riggio is a physician-trainer for Spectranetics. Dr. Karim is a consultant and proctor for Spectranetics. Dr. DiMarco has received research support from and is a consultant for Medtronic, St. Jude Medical, and Boston Scientific. Dr. Onufer is a consultant for St. Jude. Dr. Ellenbogen is a consultant for and has received honoraria and research support from Medtronic, Boston Science, and St. Jude Medical, and has received honoraria from Biotronik. Dr. Kutalek is a consultant for Spectranetics. Ms. Dentry-Mabry is an employee of Spectranetics. Dr. Ervin is the senior biostatistician with Spectranetics. Dr. Wilkoff is on the advisory board of Spectranetics.
- Received April 10, 2009.
- Revision received July 13, 2009.
- Accepted August 3, 2009.
- American College of Cardiology Foundation