The following trials illustrate the story of clinical evidence for the Durata™ defibrillation lead:
Durata™ Lead Performance: Results from a prospective, multicenter study.
Hayes D, Freedman R, Porterfield J, Porterfield L, Dinerman J, Styperek R, Machell C, Kim G, Curtis A. Heart Rhythm Society. Accessed November 7, 2018.
Conclusion: In 880 Durata leads systematically imaged at enrollment, none have exhibited externalized cables. One Durata lead after 1 year of follow-up was adjudicated to have externalized cables, likely due to clavicular crush. Eight leads (0.9%) monitored through 21.7± 5.1 months post-enrollment have exhibited electrical dysfunction, none of which exhibited externalized cables.
Clinical performance of different DF-4 implantable cardioverter defibrillator leads.
Sarrazin JF, Philippon F, Sellier R, et al. Pacing Clin Electrophysiol. 2018;41:953-958. doi:10.1111/pace.13400.
Conclusion: All ICD DF‐4 leads had excellent acute and mid‐term electrical performances. Longer follow‐up will be necessary to confirm their sustained performance.
Comparative study of the failure rates among 3 implantable defibrillator leads.
Van Malderen SC, Szili-Torok T, Yap SC, Bhagwandien R, Wijchers S, Theuns DA. Heart Rhythm. 2016;13:2299-2305.
Conclusion: This study demonstrates a higher failure rate of Linox S/SD high-voltage leads compared to contemporary leads. Although the mechanism of lead failure is unclear, the majority presents with abnormal electrical parameters. Comprehensive monitoring of Linox S/SD high-voltage leads includes remote monitoring to facilitate early detection of lead failure.
Cosgriff-Hernandez E, Tkatchouk E, Touchet T, et al. Journal of Biomedical Materials Research. 2016;104(7):1805-16. doi:10.1002/jbm.a.35709.
Conclusion: This study demonstrated a significantly improved lead performance in the Boston Scientific and St. Jude Medical leads as compared with Medtronic leads. Some lead construction variables (insulation and number of coils) also had a significant impact on lead failure, which was independent of the manufacturer. Recalled St. Jude Medical leads performed better than recalled Medtronic leads in our study. Recalled St. Jude Medical leads had no significant difference in lead failure when compared with the other manufacturer's non-recalled leads. Defibrillator recalled lead status was associated with an increased mortality as compared with non-recalled leads. This correlation was independent of the lead manufacturer and clinically significant even when considering known mortality risk factors. These results must be tempered by the largely unknown mechanism of death in these patients.
The biostability of cardiac lead insulation materials as assessed from long-term human implants.
Wilkoff BL, Rickard J, Tkatchouk E, Padsalgikar AD, Gallagher G, Runt J. Journal of Biomedical Materials Research Part B: Applied Biomaterials. 2016;104(2):411-421. doi:10.1002/jbm.b.33405.
Conclusion: The results of this study clearly establish that Optim™, P55D, and silicone insulation demonstrate excellent and comparable biostability when used as cardiac lead insulation implanted in human patients for up to five years. The inherent strength noted in the Optim samples after 4–5 years of clinical use without any negative data trends demonstrates that Optim is resistant to hydrolysis and oxidation and maintains tensile strength superior to silicone at 4–5 years.
Forleo GB, Di Biase L, Panattoni G, et al. EP Europace. 2014;16(2):265-270. doi.10.1093/europace/eut236.
Conclusion: This study represents the first systematic screening of Optim-coated leads in a large unselected cohort of ICD patients. Over a 5-year period few lead failures were observed and normal fluoroscopic appearance was present in all patients.
Longitudinal follow-up of implantable cardioverter defibrillator leads.
Liu J, Brumberg G, Rattan R, et al The American Journal of Cardiology. 2014;113(1):103-106. doi:10.1016/J.AMJCARD.2013.08.046.
Conclusion: The overall survival rate of ICD leads is nearly 90% at 5 years. Survival curves of recalled leads diverge from nonrecalled leads after 2 years of implantation. These data have important implications on postmarket release monitoring of ICD leads and physicians’ choice of leads.
Failure-free survival of the Durata defibrillator lead.
Liu J, Patel D, Rattan R, et al. Europace. 2013;15(7):1002-1006. doi:10.1093/europace/eut010.
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.
MAT-2011144 v1.0
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