Friday, December 17, 2010

St. Jude Withdraws Riata Defibrillator Leads

St. Jude Medical announced they are withdrawing a portion of their thinner 7Fr Riata defibrillator lead line despite earlier glowing company reports because of a higher degree of insulation failures in the earlier design of the leads made with silicone insulation material:
The Riata and Riata ST family of silicone defibrillation leads have exhibited an insulation abrasion rate of 0.47% over 9 years of use. Silicone rubber, while representing the industry’s most commonly used defibrillation lead insulation material over the past 20 years, has been observed to be vulnerable to abrasion. Abrasion of silicone defibrillation leads is acknowledged within the clinical community as a well known clinical risk and is well documented in the literature as the number one cause of lead failure across the industry with reported failure rates ranging from 3 to 10 %. Lead insulation damage and its possible effects are also described as a potential adverse event in all silicone defibrillation lead user’s manuals, including Riata User’s manuals.
Later St. Jude lead designs with their newer "Optim" polymer insulation appear to not be affected by this action. St. Jude had hoped their Riata line of defibrillator leads could replace the niche left by Medtronic's earlier withdrawl of their downsized Sprint Fidelis defibrillator leads after Medtronic's line of 7Fr defibrillator leads experienced higher-than-expected fracture rates.

Just as with the Medtronic Sprint Fidelis defibrillator lead withdrawl, St. Jude does not recommend the affected leads be extracted. I would suspect that doctors will weigh the risks vs. benefits of placing a new defibrillator lead at the time of device battery changes.

In November 2007, the Riata line of defibrillator leads were plagued by concerns of a higher-than-average rate cardiac perforation, but these were quickly disputed by the company.

-Wes

7 comments:

Hugo Campos said...

That's too bad. There are 227,000 Riatas sold worldwide? Do you think there will be a software patch to help identify insulation breach (akin to Medtronic's Lead Integrity Alert)?

DrWes said...

Hugo-

St. Jude has been fairly creative at developing software patches with other issues like this, but I have no idea if such a patch is possible or forthcoming.

Anonymous said...

Isn't the optium just a polymer coating over the same silicone? And the internal construction of the newer lead durata the as the riata ..so are the both prone to the internal abrasion?

Anonymous said...

I saw an AP xray of a Riata lead back in April 2010 that showed this breakdown. Between the two coils you could see four separate wires that looked as if the outer insulation/layer had completely allowed the inner wires to float still attached to the coils above and below....Tough situation...The Lead Integrity Alert software is very efficient. It will be interesting to see how this all pans out long term.

jagaxstaff said...

My son had a total of two St. Jude ICDs implanted. The first one in 2004, the lead fractured in 2007 and he was given a new device with new leads. The leads on the second ICD failed in the same place as the first one and my 23 year old son died as a result. How many other people died as a result of the same problem. There were at least 13 deaths associated with the Medtronic's Leads.

TakeItTo11 said...

These Riata failures are inside to out insulation breeches. A poly overlay is like fixing a hernia with a band aid. Dr. Wes, do you think Durata will ultimately show the same problem?

Shan said...

Saw one this week and also have a colleague who saw a Durata with the same problem.