Tuesday, March 27, 2012

Deaths caused by the failure of St. Jude Riata Implantable Cardioverter-Defibrillator (ICD) leads

I figured it would be useful to post this here since there are currently 79,000 patients in the U.S. with these recalled leads. If you have a Riata or Riata ST, I’d encourage you to stay informed and ask your doctor if he has a plan for the management of your leads.

This manuscript became available yesterday. It’s an assessment of the deaths of patients with Riata and Riata ST leads that have been reported to the FDA in an attempt to determine if these deaths were due to lead malfunction.

The analysis was done by Dr. Robert Hauser of the Minneapolis Heart Institute Foundation. The report claims 22 deaths caused by the St. Jude Riata lead failure. Dr. Hauser concludes that no deaths were caused by externalized wires, the problem most commonly associated with the Riata. Rather, the deaths were caused by short-circuits between high voltage components. This could prove ominous for the Durata lead as well. The Durata lead is currently being implanted worldwide and is not a subject of any recalls or confirmed externalizations. But it’s similar in design to the Riata, apart from its Optim insulation. Watch a St. Jude Medical video about the benefits of Optim insulation.

Adverse events (deaths and injury) are voluntarily reported by hospitals and doctors into a public FDA database called MAUDE. Manufacturers are required to report deaths and injuries, however, there are an unknown number of delays in adverse event reporting by the manufacturer. So, adverse events reported into MAUDE is incomplete. By some accounts, only 5% of all adverse events are ever reported (watch Dr. Rita Redberg, UCSF, in this video at 16:57).

Dr. Hauser believes the information in MAUDE is accurate but incomplete. His study classifies 50 deaths as indeterminate because important information was not reported (see page 22). He says that the number of deaths is likely being underestimated.

We need the reporting of adverse events to be mandatory and for a public registry to be created in the U.S. with data flowing in from all remote monitoring platforms. It’s the only way for us to know for sure what's going on when there's a recall. Patients should have the right to access this information in a way that is timely and easy to understand.

Dr. Hauser’s manuscript:
Deaths Caused By the Failure of Riata and Riata ST Cardioverter-Defibrillator Leads.

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