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Riata 15% Insulation Breach Rate

Discussion in 'St Jude Medical' started by Anonymous, Sep 4, 2011 at 9:02 AM.

  1. Anonymous

    Anonymous Guest

    The abstract from Northern Ireland showed a 15% rate of insulation breach "a nice way of saying the leads are falling apart from the inside."
     
  2. Anonymous

    Anonymous Guest

    Abstract: P1838
    Riata lead failure; A report from Northern Ireland Riata lead screening programme
    Authors:
    V. Kodoth1, N. Cromie1, E. Lau1, D. McEneaney2, C. Wilson1, M.J. Roberts1, 1Royal Victoria Hospital - Belfast - United Kingdom, 2Craigavon Area Hospital, Craigavon Cardiac Centre - Craighavon - United Kingdom,

    Topic(s):
    Automatic implantable cardioverter / defibrillator
    Citation:
    European Heart Journal ( 2011 ) 32 ( Abstract Supplement ), 310
    The st: Jude Medical Riata family of leads (1560,-61,-62,-70,-71,-72,-80,-81,-82,-90,-91,-92,7000,-01,-02,-10,-11,-12,-40,-41,-42,-50,-51,-52,-20,-21,-22,-70,-71,-30,-31) are high voltage implantable cardioverter defibrillator (ICD) leads. Insulation related inappropriate shocks were noted in a patient in Northern Ireland in November 2006. Lead insulation breach was from internal lumen to external surface. The frequency of lead malfunction in Northern Ireland appeared to exceed the manufacturer quoted values. Active surveillance of all patients with a Riata lead in Northern Ireland was commenced in August 2010. On 16/12/2010 the U.K MHRA issued a medical device alert for Riata and Riata-ST leads. The objectives of the Northern Ireland Riata lead screening programme were to identify insulation defects, risk factors, define prevalence, determine management plan for lead defects, and develop a follow up programme and additional lead screening projects.

    Methods: All patients with Riata/Riata-ST and Riata Optim leads in Northern Ireland were invited for screening with high resolution fluoroscopic images at 15fps and ICD lead parameters were checked. Fluoroscopic images were read by two cardiologist blinded to the patient data and insulation breach was identified as negative, positive or borderline.

    Results: Two hundred and twelve patients had a Riata lead implanted in Northern Ireland. Of these, 164 were males and 48 females. Mean age at the time of implantation was 62.7±13.40 years. Lead model 1580 was implanted in 16 patients, 1582 in 69, 1570 in 8, 1572 in 5, 7000 in 60, 7002 in 41, 1571 in 2, 1742 in 2, 7040 in 6 and 7022 in 3 patients. One hundred and sixty five out of 212 patients were screened as 28 were dead, 5 had the lead explanted prior screening, 3 patients were excluded and 11 did not attend the screening programme. Mean screening period after implantation was 3.98±1.43 years. After screening 25 (15%) patients were classified as positive, 3 (1.8%) borderline and 137 (83%) negative for insulation breach. Five (3%) out of the 25 patients presented with spontaneous lead issues and 20 (12%) were identified by fluoroscopy. Seven (25%) patients had the defective lead removed. The rest of the patients are closely monitored with surveillance (fluoroscopy and ICD parameter check) every 3 months.

    Conclusion: A significant proportion (15%) of patients with Riata and Riata-ST leads had an insulation breach on screening. Clinically significant events was noted in 20% of patients. Further surveillance plans for negative and borderline category need to be developed and agreed internationally.
     
  3. Anonymous

    Anonymous Guest

    15% insulation breach at 3.98 years? Lying Irish! They need to read our Important Product Update for the real facts that include:

    "The Riata and Riata ST family of silicone defibrillation leads have exhibited an insulation abrasion rate of 0.47% over 9 years of use." (Note: that is all cause abrasion failures)

    "A more recently reported manifestation of inside-out abrasion involves conductors being visible outside the lead insulation body throughx-ray or fluoroscopy7,8,9,10. This represents a small portion (~10%) of all reported abrasions."

    So the Irish bring all the patients in and fluoro and find a rate of 15% insulation breach, but we do it the right way by sitting back and waiting for returned product to show up, and we come up with a rate of 0.047% insulation breach.

    So, who you going to believe?
     
  4. Anonymous

    Anonymous Guest

    Ummm...the Irish?
     
  5. Anonymous

    Anonymous Guest

    Thanks! Great info!
     
  6. Anonymous

    Anonymous Guest

    THIS COULD BE REALLY BAD!!!!
     
  7. Anonymous

    Anonymous Guest

    My Riata lead failed recently during a planned cardioversion. I was very lucky to have the problem discovered during the procedure. It had worked in February of this year but who knows how long I was at risk--I could have died if my heart needed shocking outside the hospital. They capped off the defective riata lead and left it in because taking it out is risky and replaced it with a new lead so I have a total of 3 leads plus a new ICD. It has not been fun.
     
  8. Anonymous

    Anonymous Guest

    My brother and I both have defibrillators with Riata leads. I actually started out with a Medtronic lead that, after 1 year, broke and had exposed wires which had to be removed with a laser. I would much rather have had some exposed inner wires than wires that were broken that could possibly punch a hole.. Plus... as it was explained to me, the Riata has redundant safety backups. The exposed wires, should an outer insulation breach occur, has more insulation that is a lot more durable. I don't believe that the Medtronic lead had this feature....according to my doctor. That gives me a peace of mind.
     
  9. Anonymous

    Anonymous Guest

    I cant believe St. jude would recomend leaving in a lead that is falling apart
     
  10. Anonymous

    Anonymous Guest

    If you are a real pt I'm very sorry for you. Truth is this is a SERIOUS problem. Simply put the lead is falling apart. You need to seriously seek another opinion. You should NEVER have an active shock lead that is falling apart. please find a real EP
     
  11. Anonymous

    Anonymous Guest

    Find another Dr quickly please. You are terribly misinformed on the failure mechanisms of both these leads. Do it TODAY...Good Luck
     
  12. Anonymous

    Anonymous Guest

    Get a lawyer, now.
     
  13. Anonymous

    Anonymous Guest

    Now that doctors know what to look for, no thanks to St. Jude, they are seeing more of these failures and have a better chance of doing the right thing for their patients.
     
  14. Anonymous

    Anonymous Guest

    Also keep in mind the Durata is the Riata St. So if you have the Durata you are subject to the same failure mechanism.
     
  15. Anonymous

    Anonymous Guest

    Is the Durata the same as the Riata, just a different name???
     
  16. Anonymous

    Anonymous Guest

    The model 7120 lead was approved as "Riata STS Optim." When physicians were only worried about perforation, the name was changed Durata. P950022/S040, P950022/S049.
     
  17. Anonymous

    Anonymous Guest

    Multiple centers in US are doing their own studies and several have stated that their rates are above 20%
     
  18. Anonymous

    Anonymous Guest

    MDT sure as hell did! I was there. They knew there were issues 1 year prior to the recall and trivialized the issue by blaming implanting techniques.
     
  19. Anonymous

    Anonymous Guest

    Medtronic and Boston Scientific paid a heavy price for their product failures and communication delays. St. Jude should have learned. They are about to lose a lot of share. Good luck with a 7 french lead in the bigger is better enviroment!
     
  20. Anonymous

    Anonymous Guest

    I suggest you put down your Blackberry with the your official talking points from your manager and actually read the Medtronic letter. They didn't do it well, but they said one of the root causes under investigation was prolapsing the lead during implant. That letter also promised to keep looking and to provide more information as it became available, which Medtronic did. I'm not a fan of Medtronic, but they tried to provide guidance and responded to physician concerns.

    St. Jude's letter was an advertisement for Optim in light of the silicone issues that plague the entire industry - with no clinical guidance other than "good thing we're not selling those pieces of crap anymore" for the tens of thousands of unfortunate human beings with Riata leads and/or pieces in their chests.
     

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