The original post in this series was number 1340
by someone called coach1357
It is an
Hardly scientific but important
from a humanitarian point of view, and should not be
regarded as a guide for doctors and surgeons
to British MDA or FDA has been given
My reference to an Australian action was not from
the net but from a communication I received by snail
mail. Sorry no url
we anxiously await your response.
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.
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
Definitive cure of recurrent prosthetic
endocarditis using silver-coated St. Jude Medical heart
valves: a preliminary case report.
T; Nguyen T; Kipfer B; Althaus U
Clinic for Thoracic and Cardiovascular Surgery,
University Hospital Berne, Switzerland.
J Heart Valve Dis, 1998 Sep, 7:5,
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.
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
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.
BL, Tweden K, Schroeder RF, Cameron JD
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
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
pseudoaneurysm and that no valve did
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
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
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
I personally have the highest regard for the SJM
valve design, but obfuscations of this
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
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.
papers and then there are papers.