Safety and efficacy of transvenous high-voltage implantable cardioverter-defibrillator leads in high-risk hypertrophic cardiomyopathy patients.
BACKGROUND
The implantable cardioverter-defibrillator (ICD) prevents sudden cardiac death in high-risk patients with hypertrophic cardiomyopathy (HCM). However, recently concerns have been raised regarding the performance of transvenous high-voltage ICD leads (HVL) in this population.


OBJECTIVE
The purpose of this retrospective, multicenter study was to assess the safety and efficacy of HVL in high-risk HCM patients.


METHODS
The study population consisted of HCM patients who received HVL ICDs and were subsequently followed at seven centers in the United States. Kaplan-Meier survival rates were calculated for HVL and patients. HVL failure was a malfunction caused by a noniatrogenic defect.


RESULTS
Between 1992 and 2007, 324 HCM patients (mean age 47 +/- 16 years) received 343 HVL from three major manufacturers. The average HVL implant duration was 3.3 +/- 2.8 years. Overall, the HVL failure rate was 1.4%/year. However, two models (Sprint Fidelis and Transvene, Medtronic, Inc.) accounted for 60% of HVL failures. Survival probabilities for HVL and patients at 10 years were 93% and 91%, respectively. No deaths or serious injuries were reported, although inappropriate shocks occurred in 12% of cases.


CONCLUSIONS
This multicenter experience shows that HVLs are safe and effective in high-risk HCM patients. However, differences in failure rates were found between lead models.
Hauser
Robert G
RG
Minneapolis Heart Institute Foundation, Minneapolis, Minnesota 55407, USA. Rhauser747@aol.com
Maron
Barry J
BJ
Marine
Joseph E
JE
Lampert
Rachel
R
Kadish
Alan H
AH
Winters
Stephen L
SL
Scher
David L
DL
Biria
Mazda
M
Kalia
Amit
A
D000328:Adult; D002312:Cardiomyopathy, Hypertrophic / Q000628:therapy*; D017147:Defibrillators, Implantable; D004868:Equipment Failure; D004869:Equipment Safety; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome