January 28th, 2013

Getting a Read on St. Jude Leads: An Interview with Robert G. Hauser


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?


2 Responses to “Getting a Read on St. Jude Leads: An Interview with Robert G. Hauser”

  1. Sandeep Goyal, MD says:

    Vanderbilt EP group published one of the earlier studies about Fluoroscopic evaluation of Riata Leads. Management of these patients is extremely complex and current guidelines are not very helpful (truly, we don’t know enough to have detailed guidelines).

    We usually test all leads electrically and Fluoroscopically and if both are normal, we usually leave the lead alone. Recognizing that abnormalities may develop at anytime, but risk of doing something seems to outweigh any benefits at this time.

    If there are fluoroscopic abnormalities, we tend to extract these leads especially if patients are younger and will have leads in body for long time and also if they are secondary prevention candidates, primary prevention with documented ATP / Shock therapy for ventricular arrhythmias since device implant, or are dependent on pacing support.

    All electrically malfunctioning leads are being at least replaced and also extracted, unless pt is unusually high risk for extraction.

  2. Hi

    After a variable start when the story first developed, we settled on some protocols locally.

    We have screened all of our patients fluoroscopically and electrically. In those with dual coil leads, we have switched the SVC coil off and undertaken DFT testing. In the patients coming up for box change a DFT test has been undertaken. All the recommended electrical changes have been made.

    We have been very well supported by St Jude.

    Those with radiological abnormalities only, but with normal electrical parameters we have left alone. I think this is the correct strategy at the moment, but I recognise we may have to change things in light of new developments.

    We only have a small number of Riata leads in, which has made management easier and do not use St Jude here routinely (largely because of cost pressures and operator/technical experience).

    More details on our protocols are here if anyone is interested.(http://www.markdayer.com/guidance/pacing/riata/).