Performance of the Durata implantable cardioverter defibrillator lead: results of an independent multicenter study

Roberto Rordorf, Erika Taravelli, Giovanni B. Forleo, Gabriele Giannola, Vittorio Calzolari, Giorgio Tadeo, Stefano Rossi, Alfredo Vicentini, Antonio Curnis, Paolo Serra, Matteo Santamaria, Leonardo Calò

Research output: Contribution to journalArticle

Abstract

AIMS: The high rate of implantable cardioverter defibrillator (ICD) lead failures related to the Sprint Fidelis' and Riata's design have raised serious concerns about the reliability of ICD leads. The St. Jude Medical Durata family of leads replaced the preceding Riata line following increased rates of lead failure (1.17% per year). The aim of our study was to evaluate the long-term performance of the Durata lead. METHODS: Eight hundred and eighteen Durata ICD leads were implanted in 11 Italian centers. The incidence of lead failure, defined as a sudden rise in long-term pacing or defibrillation impedance and/or a sudden change in R-wave amplitude and capture thresholds, was assessed. The incidences of lead dislodgment and lead perforation were also evaluated. RESULTS: During a median follow-up of 1353 days (3.7 years; 25-75th interquartile range 806-1887 days) lead failure occurred in 16/818 leads (0.54%/year). The overall survival, free of lead failure, was 98.9% at 3 years, 98.2% at 4 years and 97.5% at 5 years. Lead dislodgment occurred in 12/818 leads with an incidence of 0.4%/year. No cases of cardiac perforation were reported. No major adverse events were reported except for two cases of inappropriate shocks as a consequence of failure or dislodgment. CONCLUSION: Our study suggests that the Durata lead does not engender a higher risk of failure. Overall survival, free from lead failure, was found to be higher than previously reported for the Riata lead.

Original languageEnglish
Pages (from-to)676-681
Number of pages6
JournalJournal of cardiovascular medicine (Hagerstown, Md.)
Volume20
Issue number10
DOIs
Publication statusPublished - Oct 1 2019

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Implantable Defibrillators
Multicenter Studies
Incidence
Lead
Electric Impedance
Shock

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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Performance of the Durata implantable cardioverter defibrillator lead : results of an independent multicenter study. / Rordorf, Roberto; Taravelli, Erika; Forleo, Giovanni B.; Giannola, Gabriele; Calzolari, Vittorio; Tadeo, Giorgio; Rossi, Stefano; Vicentini, Alfredo; Curnis, Antonio; Serra, Paolo; Santamaria, Matteo; Calò, Leonardo.

In: Journal of cardiovascular medicine (Hagerstown, Md.), Vol. 20, No. 10, 01.10.2019, p. 676-681.

Research output: Contribution to journalArticle

Rordorf, R, Taravelli, E, Forleo, GB, Giannola, G, Calzolari, V, Tadeo, G, Rossi, S, Vicentini, A, Curnis, A, Serra, P, Santamaria, M & Calò, L 2019, 'Performance of the Durata implantable cardioverter defibrillator lead: results of an independent multicenter study', Journal of cardiovascular medicine (Hagerstown, Md.), vol. 20, no. 10, pp. 676-681. https://doi.org/10.2459/JCM.0000000000000843
Rordorf, Roberto ; Taravelli, Erika ; Forleo, Giovanni B. ; Giannola, Gabriele ; Calzolari, Vittorio ; Tadeo, Giorgio ; Rossi, Stefano ; Vicentini, Alfredo ; Curnis, Antonio ; Serra, Paolo ; Santamaria, Matteo ; Calò, Leonardo. / Performance of the Durata implantable cardioverter defibrillator lead : results of an independent multicenter study. In: Journal of cardiovascular medicine (Hagerstown, Md.). 2019 ; Vol. 20, No. 10. pp. 676-681.
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T1 - Performance of the Durata implantable cardioverter defibrillator lead

T2 - results of an independent multicenter study

AU - Rordorf, Roberto

AU - Taravelli, Erika

AU - Forleo, Giovanni B.

AU - Giannola, Gabriele

AU - Calzolari, Vittorio

AU - Tadeo, Giorgio

AU - Rossi, Stefano

AU - Vicentini, Alfredo

AU - Curnis, Antonio

AU - Serra, Paolo

AU - Santamaria, Matteo

AU - Calò, Leonardo

PY - 2019/10/1

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N2 - AIMS: The high rate of implantable cardioverter defibrillator (ICD) lead failures related to the Sprint Fidelis' and Riata's design have raised serious concerns about the reliability of ICD leads. The St. Jude Medical Durata family of leads replaced the preceding Riata line following increased rates of lead failure (1.17% per year). The aim of our study was to evaluate the long-term performance of the Durata lead. METHODS: Eight hundred and eighteen Durata ICD leads were implanted in 11 Italian centers. The incidence of lead failure, defined as a sudden rise in long-term pacing or defibrillation impedance and/or a sudden change in R-wave amplitude and capture thresholds, was assessed. The incidences of lead dislodgment and lead perforation were also evaluated. RESULTS: During a median follow-up of 1353 days (3.7 years; 25-75th interquartile range 806-1887 days) lead failure occurred in 16/818 leads (0.54%/year). The overall survival, free of lead failure, was 98.9% at 3 years, 98.2% at 4 years and 97.5% at 5 years. Lead dislodgment occurred in 12/818 leads with an incidence of 0.4%/year. No cases of cardiac perforation were reported. No major adverse events were reported except for two cases of inappropriate shocks as a consequence of failure or dislodgment. CONCLUSION: Our study suggests that the Durata lead does not engender a higher risk of failure. Overall survival, free from lead failure, was found to be higher than previously reported for the Riata lead.

AB - AIMS: The high rate of implantable cardioverter defibrillator (ICD) lead failures related to the Sprint Fidelis' and Riata's design have raised serious concerns about the reliability of ICD leads. The St. Jude Medical Durata family of leads replaced the preceding Riata line following increased rates of lead failure (1.17% per year). The aim of our study was to evaluate the long-term performance of the Durata lead. METHODS: Eight hundred and eighteen Durata ICD leads were implanted in 11 Italian centers. The incidence of lead failure, defined as a sudden rise in long-term pacing or defibrillation impedance and/or a sudden change in R-wave amplitude and capture thresholds, was assessed. The incidences of lead dislodgment and lead perforation were also evaluated. RESULTS: During a median follow-up of 1353 days (3.7 years; 25-75th interquartile range 806-1887 days) lead failure occurred in 16/818 leads (0.54%/year). The overall survival, free of lead failure, was 98.9% at 3 years, 98.2% at 4 years and 97.5% at 5 years. Lead dislodgment occurred in 12/818 leads with an incidence of 0.4%/year. No cases of cardiac perforation were reported. No major adverse events were reported except for two cases of inappropriate shocks as a consequence of failure or dislodgment. CONCLUSION: Our study suggests that the Durata lead does not engender a higher risk of failure. Overall survival, free from lead failure, was found to be higher than previously reported for the Riata lead.

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