TY - JOUR
T1 - Lead Extraction in the Contemporary Setting
T2 - The LExICon Study. An Observational Retrospective Study of Consecutive Laser Lead Extractions
AU - Wazni, Oussama
AU - Epstein, Laurence M.
AU - Carrillo, Roger G.
AU - Love, Charles
AU - Adler, Stuart W.
AU - Riggio, David W.
AU - Karim, Shahzad S.
AU - Bashir, Jamil
AU - Greenspon, Arnold J.
AU - DiMarco, John P.
AU - Cooper, Joshua M.
AU - Onufer, John R.
AU - Ellenbogen, Kenneth A.
AU - Kutalek, Stephen P.
AU - Dentry-Mabry, Sherri
AU - Ervin, Carolyn M.
AU - Wilkoff, Bruce L.
N1 - Funding Information:
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.
PY - 2010/2/9
Y1 - 2010/2/9
N2 - 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.
AB - 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.
KW - cardiac implantable electronic devices
KW - extraction
KW - laser
KW - leads
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U2 - 10.1016/j.jacc.2009.08.070
DO - 10.1016/j.jacc.2009.08.070
M3 - Article
C2 - 20152562
AN - SCOPUS:75249088559
SN - 0735-1097
VL - 55
SP - 579
EP - 586
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 6
ER -