Abstract | BACKGROUND: 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.
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Authors | Robert G Hauser, Barry J Maron, Joseph E Marine, Rachel Lampert, Alan H Kadish, Stephen L Winters, David L Scher, Mazda Biria, Amit Kalia |
Journal | Heart rhythm
(Heart Rhythm)
Vol. 5
Issue 11
Pg. 1517-22
(Nov 2008)
ISSN: 1556-3871 [Electronic] United States |
PMID | 18984525
(Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Topics |
- Adult
- Cardiomyopathy, Hypertrophic
(therapy)
- Defibrillators, Implantable
- Equipment Failure
- Equipment Safety
- Female
- Humans
- Male
- Middle Aged
- Retrospective Studies
- Risk Factors
- Survival Rate
- Treatment Outcome
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