Safety and efficacy of transvenous high-voltage implantable cardioverter-defibrillator leads in high-risk hypertrophic cardiomyopathy patients

Robert G. Hauser, Barry J. Maron, Joseph E. Marine, Rachel Lampert, Alan H. Kadish, Stephen Winters, David L. Scher, Mazda Biria, Amit Kalia

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1517-1522
Number of pages6
JournalHeart Rhythm
Volume5
Issue number11
DOIs
StatePublished - Nov 1 2008
Externally publishedYes

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Implantable Defibrillators
Hypertrophic Cardiomyopathy
Safety
Sudden Cardiac Death
Population
Multicenter Studies
Shock
Survival Rate
Retrospective Studies
Survival
Wounds and Injuries

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Hauser, Robert G. ; Maron, Barry J. ; Marine, Joseph E. ; Lampert, Rachel ; Kadish, Alan H. ; Winters, Stephen ; Scher, David L. ; Biria, Mazda ; Kalia, Amit. / Safety and efficacy of transvenous high-voltage implantable cardioverter-defibrillator leads in high-risk hypertrophic cardiomyopathy patients. In: Heart Rhythm. 2008 ; Vol. 5, No. 11. pp. 1517-1522.
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abstract = "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.",
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Safety and efficacy of transvenous high-voltage implantable cardioverter-defibrillator leads in high-risk hypertrophic cardiomyopathy patients. / Hauser, Robert G.; Maron, Barry J.; Marine, Joseph E.; Lampert, Rachel; Kadish, Alan H.; Winters, Stephen; Scher, David L.; Biria, Mazda; Kalia, Amit.

In: Heart Rhythm, Vol. 5, No. 11, 01.11.2008, p. 1517-1522.

Research output: Contribution to journalArticle

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T1 - Safety and efficacy of transvenous high-voltage implantable cardioverter-defibrillator leads in high-risk hypertrophic cardiomyopathy patients

AU - Hauser, Robert G.

AU - Maron, Barry J.

AU - Marine, Joseph E.

AU - Lampert, Rachel

AU - Kadish, Alan H.

AU - Winters, Stephen

AU - Scher, David L.

AU - Biria, Mazda

AU - Kalia, Amit

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N2 - 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.

AB - 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.

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