In August 2012, Dr. Robert G. Hauser and colleagues from the Minneapolis Heart Institute published a paper analyzing failures of St. Jude Durata and Riata ST Optim ICD leads. Last week the FDA released a warning letter previously sent to St. Jude indicating serious violations found in a California plant manufacturing these leads and that the company’s response has not been adequate. CardioExchange’s Dr. John Ryan asked Dr. Hauser about the problems with these products.
Dr. Ryan: Do you feel vindicated having being among the first to highlight the issues with the Riata leads?
Dr. Hauser: Disturbed more than vindicated. Why does it take a major device recall for the FDA to uncover manufacturing deficiencies in a Class 3 product?
Dr. Ryan: What do you think is the path forward for oversight of ICD leads and similar devices?
Dr. Hauser: Creation of a transparent active post-market surveillance system for all implantables but certainly for lifesaving/life supporting devices.
Dr. Ryan: What are your recommendations to your patients that have Riata and Durata leads?
Dr. Hauser: We are evaluating every patient who received a Riata lead and deciding if prophylactice replacement is appropriate. Of particular concern is short-circuiting, which can be fatal if it occurs during shock delivery for Ventricular Fibrillation and Ventricular Tachycardia; this is usually due to a short between a high voltage cable and a shocking coil, and it has been seen in Riata leads that appeared to be functioning normally based on standard testing. In regard to Durata, we no longer implant this lead. I believe Durata has the same design flaw as Riata but we need long-term data to prove this hypothesis one way or the other.
What are you doing for patients with these leads? Are there steps that you think need to be taken to make these devices safer?