FDA viewpoint: St. Jude Medical's Riata ST leads.
Center for Devices and Radiological Health, US Food and Drug Administration, USA.Pacing and Clinical Electrophysiology (Impact Factor: 1.75). 02/2008; 31(1):16. DOI:10.1111/j.1540-8159.2007.00944.x
- Pacing and Clinical Electrophysiology 07/2008; 31(6):784-5. · 1.75 Impact Factor
- Netherlands heart journal: monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation 03/2013; 21(3):125-6. · 1.41 Impact Factor
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ABSTRACT: Recent attention has been focused on the performance of high-voltage implantable cardioverter-defibrillator (ICD) leads. Lead-related adverse events can be caused by several factors, including patient characteristics, concomitant therapies, implantation technique, access site, and lead design. Few studies have included the number of patients and the follow-up duration necessary to characterize accurately the lead performance and the incidence of lead-related adverse events. This study sought to define the incidence of lead-related adverse events including conductor fracture, insulation damage, perforation, and dislodgement of St. Jude Medical Riata ICD leads. Data from the Advancements in ICD Therapy, OPTIM Lead InsUlation Material (OPTIMUM), Resynchronization HemodYnamic Treatment for Heart Failure Management (RHYTHM), and Post Approval Study (PAS) registries provided data from 7,497 patients with Riata leads. Patients were followed up for a median of 22 months. Adverse events, defined as those that required lead revision, extraction, or replacement, were recorded. Conductor fracture occurred in 0.09%, insulation damage in 0.13%, dislodgement in 0.88%, and perforation in 0.31% of patients, respectively. During more than 22 months of follow-up of over 7,000 Riata leads in 4 prospective registries and clinical trials, the incidence of lead-related adverse events including conductor fracture, insulation damage, dislodgement, and perforation necessitating lead revision, extraction, or replacement is rare.Heart rhythm: the official journal of the Heart Rhythm Society 11/2008; 6(2):204-9. · 4.56 Impact Factor
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