Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions.
BACKGROUND
It is difficult to predict adverse patient outcomes associated with transvenous lead extraction (TLE) procedures.


OBJECTIVE
The purpose of this study was to examine the safety and efficacy of chronic endovascular pacemaker and implantable cardioverter-defibrillator (ICD) lead extraction and risk factors associated with adverse patient outcomes.


METHODS
Consecutive patients undergoing TLE at the Cleveland Clinic between August 1996 and August 2011 were included in the analysis. Univariate and multivariable logistic regression analyses were performed to evaluate for associations with outcomes. Continuous data are given as median (25th, 75th percentile). Categorical data are given as number (percentage).


RESULTS
In total, 5521 leads (4137 [74.9%] pacemaker, 1384 [25.1%] ICD) were extracted during 2999 TLE procedures (patient age 67.2 [55.2, 76.2] years, 30.2% female). Lead implant duration was 4.7 (2.4, 8.3) years, and 2.0 (1.0, 2.0) leads were extracted per procedure. Powered sheaths were used in 74.9% of procedures. Overall, there was 95.1% complete procedural success, 98.9% clinical success, and 1.1% failure, with 3.6% minor complications and 1.8% major complications. All-cause mortality within 30 days of TLE was 2.2%. Multivariable predictors of major complications included cerebrovascular disease, ejection fraction ≤15%, lower platelet count, international normalized ratio ≥1.2, mechanical sheaths, and powered sheaths. Multivariable predictors of all-cause mortality within 30 days of TLE included body mass index <25 kg/m(2), end-stage renal disease, higher New York Heart Association functional class, lower hemoglobin, higher international normalized ratio, lead extraction for infection, and extraction of a dual-coil ICD lead.


CONCLUSIONS
TLE in this single-center experience was highly successful. Risk factors associated with adverse patient outcomes were identified.
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
Michael P
MP
Brunner
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
Edmond M
EM
Cronin
Department of Internal Medicine, Cleveland Clinic, Cleveland, Ohio.
Valeria E
VE
Duarte
Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.
Changhong
C
Yu
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
Khaldoun G
KG
Tarakji
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
David O
DO
Martin
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
Thomas
T
Callahan
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
Daniel J
DJ
Cantillon
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
Mark J
MJ
Niebauer
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
Walid I
WI
Saliba
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
Mohamed
M
Kanj
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
Oussama
O
Wazni
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
Bryan
B
Baranowski
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio. Electronic address: wilkofb@ccf.org.
Bruce L
BL
Wilkoff
D000368:Aged; D017147:Defibrillators, Implantable; D020878:Device Removal / Q000009:adverse effects* / Q000379:methods; D057510:Endovascular Procedures / Q000009:adverse effects*; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D006331:Heart Diseases / Q000628:therapy; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009820:Ohio / Q000453:epidemiology; D010138:Pacemaker, Artificial; D011183:Postoperative Complications / Q000453:epidemiology*; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome
Complications; Extraction; Implantable cardioverter defibrillator; Lead; Pacemaker