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 language | English |
|---|---|
| Pages (from-to) | 676-681 |
| Number of pages | 6 |
| Journal | Journal of cardiovascular medicine (Hagerstown, Md.) |
| Volume | 20 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - Oct 1 2019 |
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ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
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 journal › Article
}
TY - JOUR
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
Y1 - 2019/10/1
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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U2 - 10.2459/JCM.0000000000000843
DO - 10.2459/JCM.0000000000000843
M3 - Article
C2 - 31343450
AN - SCOPUS:85071784673
VL - 20
SP - 676
EP - 681
JO - Journal of Cardiovascular Medicine
JF - Journal of Cardiovascular Medicine
SN - 1558-2027
IS - 10
ER -