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St. Jude Medical Inc. Message Board

  • lordonhigh lordonhigh Sep 10, 1999 2:18 AM Flag

    The goods

    Well the new company acquisition looks very interesting. This product - if it works - should be big, big, big.

    Good luck.

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    • The original post in this series was number 1340
      by someone called coach1357

      It is an
      interesting thread

      Hardly scientific but important
      from a humanitarian point of view, and should not be
      regarded as a guide for doctors and surgeons

      Link
      to British MDA or FDA has been given
      before

      My reference to an Australian action was not from
      the net but from a communication I received by snail
      mail. Sorry no url

      Marin

    • we anxiously await your response.
      Folks, like
      it or not silzone is a smoking gun. The stock price
      may be the least of STJ worries if a modification of
      their main product goes south. The AVERT study is
      exposing many more pts. (to the 20-30K? pts already
      implanted) to the potential problem.One more bad mgmt
      decision to not halt this study pending more review of
      current pts.w silzone.

    • I agree that Silzone could very well turn out to
      be a huge mess for this company. The discussion on
      this board has focused on the effectiveness of Silzone
      in preventing endocarditis. One could interpet that
      the experience from Europe and Canada covers another
      issue: based on the data at hand there may be a concern
      that there is a statistically significant higher
      incidence of stroke in patients with the silzone treated
      valve vs. the non-treated valve of the same
      manufacturer. If this proves true, this could turn out to be a
      very, very big problem for STJ shareholders.

    • Hi Guys,

      I am back!

      How about this
      paper, but then we must ignore this one, because it is
      supportive. I hear the Avert results are great
      too.

      Title
      Definitive cure of recurrent prosthetic
      endocarditis using silver-coated St. Jude Medical heart
      valves: a preliminary case report.
      Author
      Carrel
      T; Nguyen T; Kipfer B; Althaus U

      Address
      Clinic for Thoracic and Cardiovascular Surgery,
      University Hospital Berne, Switzerland.
      thierry.carrel@insel.ch
      Source
      J Heart Valve Dis, 1998 Sep, 7:5,
      531-3
      Abstract
      Despite progress in the area of
      antimicrobial treatment and the surgical use of homografts,
      prosthetic valve endocarditis (PVE) remains one of the most
      dangerous complications following heart valve replacement.
      We present the case of a patient treated for acute
      endocarditis which affected the mitral valve and who developed
      recurrent PVE and native aortic valve endocarditis. After
      multiple valve surgery, the infection was controlled
      following aortic and mitral valve replacement using
      silver-coated prostheses. The St. Jude Medical (SJM) mechanical
      heart valve Masters Series with Silzone coating is
      intended to protect heart valve patients against microbial
      infection. The Silzone coating is formed by an ion
      beam-assisted deposition process that incorporates silver into
      the sewing cuff of the SJM heart valve. It has also
      been suggested that silver treatment may improve the
      healing characteristics of the heart valve sewing cuff.
      This technology may be a valuable option to prevent or
      cure PVE, in addition to homografts. Although the
      present patient is an isolated case, it was encouraging
      to find not only a well-healed mitral valve
      silver-coated prosthesis but also no persistent or recurrent
      infection during a nine-month follow up.
      Language of
      Publication
      English

    • If you (or your mother, father, sister or
      brother) needed a mechanical heart valve and your choice
      was the STJ one with the Silzone coating and STJ one
      without, based upon available data (what you have read),
      which would you choose? Take a chance with a heart
      valve??? I don't think so.

      Another mess for a mess
      of a company.

    • abitffy, Your comment on the Denmark paper
      creates a question about your competence in this area.
      See cardiac nurse re: pseudo- aneruysm. he's right it
      was the result of the multiple surgeries/endocarditis
      it was not a preexisting condition. Lordonhigh check
      w docs,if you must, on study but I expect to hear
      back either way. (don't hold your breath fellow
      posters) OK here is the best silzone study I could find on
      medline... It seems to work in Guinea pigs. My kids will be
      glad to hear about that! this product is jeopardizng
      this companies very good reputation not to mention
      (and most impt.) many pts. Share holders should be
      very concerned. I'd love to be wrong
      but....


      J Heart Valve Dis 1998 Sep;7(5):524-30




      In vivo efficacy of silver-coated (Silzone)
      infection-resistant polyester fabric against a biofilm-producing
      bacteria, Staphylococcus epidermidis.

      Illingworth
      BL, Tweden K, Schroeder RF, Cameron JD
      St Jude
      Medical, Inc., St. Paul, Minnesota 55117, USA.


      BACKGROUND AND AIMS OF THE STUDY: Prosthetic valve
      endocarditis (PVE) is an infrequent but serious complication
      of cardiac valve replacement. PVE is a foreign body
      infection predominantly based in the sewing cuff of a
      prosthetic heart valve leading to thromboembolism, ring
      abscess, paravalvular leakage, and eventual invasion of
      the myocardium. Mortality rates as high as 75% have
      been reported. A silver-coated sewing cuff is now
      available (St. Jude Medical mechanical heart valve SJMR
      Masters Series with Silzone coating) intended to inhibit
      the colonization and attachment to the sewing cuff of
      those microorganisms commonly associated with PVE.
      Silzone is a dense layer of metallic silver deposited on
      individual fiber surfaces of the valve cuff. Previously,
      Silzone coating was shown in vitro to decrease attachment
      and colonization of microorganisms with no adverse
      affect on biocompatibility. The present study was
      designed to assess the efficacy of Silzone-coated
      polyester fabric in vivo in a direct-contamination model.
      The organism chosen was a pathogenic strain of
      Staphylococcus epidermidis capable of producing biofilm.
      METHODS: Infection resistance of uncoated polyester and
      Silzone-coated polyester fabric was assessed by the acute
      inflammatory response in a guinea pig subdermal model. Fabric
      samples were implanted sterile or inoculated with S.
      epidermidis. The ability of the strain to produce biofilm was
      verified in vitro. Samples were explanted at one and two
      days postoperatively. Verification of the infecting
      bacteria was by colony morphology and Gram-staining
      properties of bacteria from the explanted samples.
      Inflammation was assessed histopathologically. Percent
      necrotic tissue within the fabric was determined by
      computer-assisted image analysis. RESULTS: Histopathology and image
      analysis of necrotic tissue showed significantly less
      inflammation within the Silzone-coated fabric than within
      uncoated polyester fabric. CONCLUSIONS: The Silzone
      coating reduced inflammation in this direct-contamination
      model using a strain of S. epidermidis that is capable
      of producing biofilm. This indicates a concentration
      of silver ions sufficient for bacteriostatic or
      bactericidal activity within the fabric in vivo.

    • I am going to write to the authors of the article
      in question and ask a few questions of my own.

      Hopefully I will post the answers.

      In the meantme
      lets progress the topics for
      discussion.

      lordy...lordy.

    • After all it was more likely a complication of
      the third surgery, the one with the homograft....is a
      guess. The extract I read off the Internet didn't
      speculate as to the age of the pseudoaneurysm. It says when
      it was observed and treated which isn't necessarily
      the same thing.

    • <<The important point about this patient is
      the
      pseudoaneurysm and that no valve did
      well.>>

      Sorry I dont understand why the pseudoaneurysm is
      important in respect of the silzone question. After all it
      was more likely a complication of the third surgery,
      the one with the homograft. This was several months
      after the second silzone valve needed to be
      replaced.

      You say the abstract did not address one of your
      questions about this Pseudoaneurysm but you also state that
      you did read the paper itself. Why didnt you read in
      the paper the answer about the
      pseudoaneurysm?

      Or perhaps you have seen the paper but not read,
      because after all there are papers and there are papers
      ;-).

      For the record a pseudoaneurysm is a healed partial
      rupture of the heart, occasioned by an abscess in this
      case.

      I personally have the highest regard for the SJM
      valve design, but obfuscations of this
      sort

      Cardiac

    • I have seen this paper. Go to medline and search
      under Silzone and discuss all the papers you find not
      just a selected one. The important point about this
      patient is the pseudoaneurysm and that no valve did well.
      I would have thought the homograft would have been
      the best but even that failed. Once this condition
      was treated I understand the patient then did
      well.
      The authors conclude the bacteriostatic ( not
      bacteriocidal)advantages of a silver coated prosthesis but that in the
      presence of this condition needs to be assessed in a
      clinical trial.I have a question about the pseudoaneurysm
      which the abstract was not able to answer.
      There are
      papers and then there are papers.

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