ICD Leads and Postmarketing Surveillance

Abstract

Jude Medical (SJM). To ensure accuracy and address misperceptions, we are providing responses to assertions in the Perspective article by Hauser in this issue of the Journal. 1 Assertion: Recommendations for following patients with Riata silicone-only leads for implant-able cardioverter-defibrillators (ICDs) are not based on meaningful data, and SJM has not instituted clinical studies. Facts: We have conducted extensive bench and short-term studies, and on the basis of the scientific data and clinical experience, in which 85% of externalized conductors in returned leads functioned normally, we have worked with our independent medical advisory board to develop guidelines regarding care management. These guidelines have received support from both an expert panel of the Heart Rhythm Society and the Food and Drug Administration. No reports of a failure to pace or deliver a shock have been attributed to the presence of an externalized conductor. We recognize that externalized conductors still present complex care-management issues for physicians. To help inform future care-management recommendations, SJM initiated a 500-patient, multicenter study to evaluate the long-term performance of Riata silicone-only leads. SJM communicated all available information to physicians and regulatory bodies around the world, beginning in 2010. We updated physicians again in November 2011 and participated in a recent public physician forum on the topic, hosted by the Minneapolis Heart Institute Foundation. Assertion: There is no surveillance system in place to detect adverse events involving SJM's next-generation Durata leads. Facts: SJM created prospective, actively monitored registries to assess the performance of its Optim/Durata leads more than 5 years ago. 2,3 We feel that SJM has effective postmarketing surveillance to protect patient safety. We maintain three postmarketing-surveillance registries that include data on 10,836 leads that were implanted at 292 medical centers with more than 24,000 patient-years of experience representing the true clinical performance of Optim/Durata leads. To date, there have been no reports of externalization of conductors and a very low (0.09%) incidence of mechanical failure from any cause. Assertion: The Durata lead is similar in design to the Riata silicone-only lead. Facts: The Durata lead incorporates substantial design changes that considerably reduce the risk of externalization of conductors and improve overall reliability. These changes include increasing the insulation thickness by 50% with Optim (a material 50 times more abrasion-resistant than silicone) and repositioning the conductors in the lead to reduce cable tension. Furthermore, there have been no reports of externalization of conductors during the more than 5 years that the Durata lead has been on the market, with approximately 250,000 leads implanted worldwide.