Here are copies of parts of my posts in response to the "St Jude" thread from December 2008 to January 2009. The comparison data is in the second post.
Here is the link to the entire thread:
http://www.valvereplacement.com/forums/showthread.php?t=28571
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The St. Jude Master's Series Valves have been around for 30 years and counting so they are 'Good Valves'. (I have one). I just happen to think that the On-X is a 'Better Valve' in several areas:
Reduced Risk of Clot Formation because of:
1- Reduced Turbulence due to full 90 degree opening
(vs. 75 to 85 degree openings for older valve designs)
2- Harder, Smoother (patented) evolution of the Pyrolytic Carbon material in the leaflets (Designed by Jack Bokros, Ph.D., who also designed the leaflets in St. Jude, ATS, and Carbomedics and holds several Patents)
3- Improved (smoother) Valve Pivots
Less Damage to Red Blood Cells (Hemolysis)
- equivalent to levels in Tissue Valves, about 1/2 the level in older mechanical valves.
ONLY Valve that has a built in Barrier to Pannus Tissue Growth which is the Major Factor in Mechanical Valve Explantation (i.e. Removal and Replacement) - This is a Low (but NOT Zero) Risk condition that has been reported on VR.com for both Mechanical and Tissue Valves.
Anti-Coagulation with Coumadin / Warfarin gets around the Clotting Issue (for the most part) *as long as INR is In-Range*.
The BIG ISSUE and Difference is when it is necessary to go OFF Anti-Coagulation for Invasive Procedures.
OLDER Mechanical Valves are Known to cause Clot Formation after ?? days when going OFF Coumadin.
Experience with the On-X Valves in Africa with a substantial population of Non-Compliant recipients shows greatly reduced risk of Stroke compared with the older Mechanical Valve Designs in patients whose INR is NOT in
Range (ask On-X for a copy of the Study).
FYI, the On-X Valves were introduced to the World Market in 1996 (12 Years ago) and there are over 70,000 On-X Valves in use around the World (64 Countries).
Yes, It's the "New Kid on the Block", but it's no longer in 'childhood' (as many in the Medical Field seem to think).
It comes down to answering the Question:
Do you want the latest improvements in technology with a 12 year track record or,
Do you want a Valve that has been around for 30 years with good results?
BTW, the St. Jude REGENT Valve was introduced in 1999(?), AFTER the On-X valve came onto market. It would be interesting to know how many have been implanted. There was a report on surgical experiences with this valve in a Medical Journal a few years ago. (I'll have to look up the reference).
MY preference would be On-X as First Choice
with the St. Jude Master's Series as Second Choice.
'AL Capshaw'
Disclaimer: I am NOT a Medical Professional, merely an interested Heart Valve Patient. The above is a summary of my 'understanding' and is my non-professional *opinion*.
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Here is the Valve Comparison data:
A few years ago, On-X sent me an 'Information Package' which included a pair of tables entitled "Morbid Event Rates Comparison" for both the Aortic and Mitral positions with footnotes indicating the source of the data for each company which included PMA (something about Safety and Effectiveness) Summaries (ATS and CMI) and FDA submissions.
The combined rates in (% per pt-year) for Thromboembolism, Thrombosis, and Hemorrhage for the
Aortic Position were
On-X = 2.14 % per pt-year
SJM = 3.90 St. Jude Medical
CMI = 2.96 Carbomedics
ATS = 4.04 ATS
MH = 2.50 Medtronic Hall (I believe that is a single leaflet valve)
Mitral Position
On-X = 1.86 % per pt-year
SJM = 3.34
CMI = 4.44
ATS = 5.07
MH = 4.30
I left off the breakdowns by categories because I'm not about to sit here and re-type all that data. Note that other factors such as Hemolysis (blood cell damage) and Pannus Tissue Growth are not included in the above statistics.
The complete charts are available to ANYONE who asks for them. Just call or e-mail On-X and they will send you whatever information you request. Contact information is on their website
www.onxvalves.com or 888-339-8000.
They have recently published another set of Bar Graphs which also include several tissue valves (which I find a little hard to interpret - too much information in too little space... give me the numbers in a spread sheet format please).
'AL Capshaw'