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Europace. 2013 Jul;15(7):1002-6. doi: 10.1093/europace/eut010. Epub 2013 Feb 1.

Failure-free survival of the Durata defibrillator lead.

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1
Heart and Vascular Institute, University of Pittsburgh Medical Center, 200 Lothrop Street, UPMC Presbyterian, Pittsburgh, PA 15213-2582, USA.

Abstract

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.

KEYWORDS:

Defibrillator lead; Durata; Failure; Riata

PMID:
23376976
DOI:
10.1093/europace/eut010
[Indexed for MEDLINE]
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