Key result
Durata ICD lead linked to ~82% lower annual electrical failure vs Riata.
Why the study?
Suspicions regarding the Durata defibrillator lead's failure rates arose due to design similarities and a common manufacturer with the recalled Riata lead.
Does the Durata defibrillator lead have better failure-free survival compared to Riata and Sprint Quattro leads in patients requiring ICDs?
Cohort (n=2,475)
No
Does the Durata defibrillator lead have better failure-free survival compared to Riata and Sprint Quattro leads in patients requiring ICDs?
The Durata defibrillator lead demonstrates excellent failure-free survival, comparable to the Sprint Quattro and significantly better than the recalled 8 Fr Riata lead.
Answers are grounded in this paper and cite their sources.
Durata may be preferable to recalled Riata leads in ICD patients; leaves open need for randomized durability confirmation.
AIMS: Given design similarities and a common manufacturer, there have been suspicions regarding the Durata™ defibrillator (ICD) lead, in the aftermath of the Riata™ class I recall. We therefore examined the failure-free survival rates of the Durata™ compared with the Riata™ and Sprint Quattro™ ICD leads. METHODS AND RESULTS: All patients (n = 2475) implanted with a Durata (n = 828), Riata [n = 627; 8 Fr. (n = 472) and 7 Fr. (n = 155)], or Sprint Quattro (n = 1020) leads at our institution were included and Kaplan-Meier failure-free survival curves were constructed for all leads. Lead failure was defined as electrical malfunction resulting in lead replacement, excluding dislodgements or perforations. Annual electrical failure rates were 0.3%, 1.7, and 0.3% for the Durata, Riata, and Sprint Quattro leads, respectively (P < 0.0001 for the comparison of Durata to Riata and P = 0.1.0 for the comparison of Durata to Sprint Quattro). The failure-free survival of the Durata lead was significantly better than that of the Riata lead (P < 0.0001) and similar to that of the Sprint Quattro (P = 0.94). The 7 Fr. Riata ST lead had better survival compared with the 8 Fr. Riata lead (P = 0.050) and comparable survival with the Durata lead (P = 0.12). CONCLUSION: The Durata lead failure-free survival is significantly better than the 8 Fr. Riata, albeit at a shorter follow-up time. Riata and comparable with that of the 7 Fr. Riata ST and the Sprint Quattro ICD leads. These data provide an insight into the mechanism of electrical failure of Riata leads and have implications for patient management.
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Liu et al. (2013) conducted a cohort in Patients requiring an implantable cardioverter-defibrillator (ICD) (n=2,475). Durata ICD lead vs. Riata and Sprint Quattro ICD leads was evaluated on Annual electrical failure rate (electrical malfunction resulting in lead replacement, excluding dislodgements or perforations) (p=<0.0001). The Durata ICD lead demonstrated an annual electrical failure rate of 0.3%, which was significantly lower than the Riata lead (1.7%, P<0.0001) and similar to the Sprint Quattro lead.
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