New Mechanical Valve - Minimizes Thromboses

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J

Jim

This is an interesting artical about the ATS Mechanical Valve. A "Must" read for anyone contemplating getting a Mechanical Valve....




The ATS Bileaflet Mechanical Valve at 6_ Years in 488 Consecutive Patients - Absence of Valve Thrombosis.
Peter J Tesar, Mark F O'Brien, Trevor M Fayers, Michael A Gardner, Lorraine E McLoughlin
The Prince Charles Hospital, Brisbane, Queensland, Australia

--------------------------------------------------------------------------------

OBJECTIVE: The ATS Medical valve represents the second generation of bileaflet medical prosthesis implanted due to its open pivot hinge design, with suggested advantages of reduced valve-related complication (principally thrombotic and thromboembolic). We therefore report the intermediate term outcome analysis of the clinical use of this valve prosthesis at The Prince Charles Hospital. This is timely given the prosthesis is now available globally, having recently received FDA approval.

METHODS: From May 1994 to June 2000, 488 consecutive patients received 536 ATS Medical mechanical valve prostheses. This represents the total institutional experience. Complete follow up was then undertaken by a single research officer. The cumulative follow up was 1203 patient years. 327 implants were in the aortic position. 173 in the mitral position. There were four implants in the tricuspid position and one in the pulmonary position. Thirty-one aortic root replacements were performed with valve conduits. The age range was 0.3 to 85 years (median 59 years; mean 54.8 years). 63.4% were male and 36.6% were female.

RESULTS: The peri-operative mortality (30 day and/or in-hospital) was 1.2%. The actuarial survival at 6 years was 90%. The prosthesis met the Objective Performance Criteria (OPC) established to assess the safety of mechanical valves. Impressively, there were no valve thromboses ? the only absolute OPC without differential diagnosis.

CONCLUSION: The ATS Medical mechanical valve is a safe prosthesis associated with good patient outcomes. At our institution, currently this prosthesis has replaced alternatives to become the first choice mechanical valve implant when this is indicated.
 
ATS Valve

ATS Valve

Jim, You still have to take Coumadin with the ATS valve don't you? Marty
 
ATS Valve

ATS Valve

Marty,

I read somewhere that you are still required to take Coumadin. Thanks for clarifying this. However, in another artical, I remember seeing something mentioning that you can maintain a *lower* INR level.

Jim
 
INR (international normalised ratio) 1.5 to 2.0 for aortic valve patients in sinus rh

INR (international normalised ratio) 1.5 to 2.0 for aortic valve patients in sinus rh

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8875175&dopt=Abstract

Eur J Cardiothorac Surg 1996;10(8):660-5 Related Articles, Books


Valve replacement with the ATS open pivot bileaflet prosthesis.

Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F.

Oxford Heart Centre, John Radeliffe Hospital, UK.

OBJECTIVE: We sought to evaluate the ATS open pivot bileaflet valve with respect to haemodynamics and thromboembolism. METHODS: We prospectively studied 200 consecutive patients aged 13-80 years. One hundred and nineteen aortic, 103 mitral and 11 tricuspid valves were replaced in 172 single, 23 double and 5 triple valve procedures. Thirty-eight were re-operations and 51 underwent coronary bypass. Transvalvular gradients were determined by transoesophageal and transthoracic echocardiography. Patients were followed for 12 months to 3 years. RESULTS: There were four hospital (2%) and three late deaths, each non-valve related. Two patients were reoperated for partial valve dehiscence. One aortic reoperation patient suffered a potential transient thromboembolic event. One tricuspid prosthesis thrombosed after anticoagulation was discontinued but thrombolysis resolved this problem. There were no other thromboembolic events. Valve gradients were equivalent or better than those for other bileaflet valves. CONCLUSIONS: The ATS valve has excellent haemodynamic characteristics and a very low thromboembolic rate, probably related to the convex self-washing hinge mechanism. Consequently, we have reduced anticoagulant levels to INR (international normalised ratio) 1.5 to 2.0 for aortic valve patients in sinus rhythm. Early experience suggests that the ATS valve functions well in the tricuspid position.
 
ATS valve sound comp. with St. Jude (SJM)

ATS valve sound comp. with St. Jude (SJM)

http://www.ncbi.nlm.nih.gov/entrez/...ve&db=PubMed&list_uids=10748357&dopt=Abstract

Ann Thorac Cardiovasc Surg 2000 Feb;6(1):34-8


Mid-term results of ATS open pivot bileaflet mechanical prosthetic heart valve.

Hata M, Shiono M, Orime Y, Yagi S, Yamamoto T, Okumura H, Kimura S, Sezai A, Kashiwazaki S, Choh S, Hasegawa M, Negishi N, Sezai Y.

Second Department of Surgery, Nihon University School of Medicine, 30-1 Oyaguchi-kamimachi, Itabashi-ku, Tokyo 173-8610, USA.

We investigated mid-term results of the patients with an ATS bileaflet valve in our institution. In the past 6 years, 69 patients received valve replacement with an ATS valve. We assessed the changes of serum lactate dehydrogenase (LDH) level in the hospital, and the valve's closing sound. The serum LDH level had almost normalized one week postoperatively and they have maintained normal levels since then. According to the questionnaire about the valvular sound at a random period after surgery, it was unnoticeable in 61 (88.4%) of the patients with ATS valve. In the 8 patients (12.6%) who recognized the valve sound, 7 of them were reoperation cases. As to the frequency analysis for the valve's closing sound, the sound peak was indicated at around 1.2 kHz in the patients with ATS valves. In patients with St. Jude Medical (SJM) valves, it appeared not only around 1.2 kHz but also around 2 to 7 kHz. Postoperative cerebral infarction was complicated in one patient. Mortality occurred in 4 (5.7%) of the patients with ATS valves. The follow up periods were from one to 66 months. Thromboembolic event free and actuarial survival rate in the patients with ATS valves were 98.6% and 94.2%, respectively. These results indicated that the ATS valve is considered to be a safe valve and mid-term follow-up shows excellent results in terms of the patients quality of life.
 
ATS Valve

ATS Valve

Great stuff Ken! Thanks for adding your research to this.

I guess my next questions are:

1) Is there anyone in our community who has had the ATS implanted or know of someone who has?

2) What surgeons / hospitals have experience in implanting the ATS valve?

Just curious....

Jim
 
The valve does not require any unusual techniques to install.

According to their website, www.atsmedical.com, They have implanted 25,000 of these in 40 countries since 1992. The product is still listed as "investigational" in the U.S. I do not know if that means it can be implanted in the U.S. or not.

ATS claims lower risk of thromboembolism due to better hemodynamic performance. If this is true, it means the valve will tolerate a lower INR range, thus reducing some of the risk inherent in coumadin use.

The research is based on mid-term results (5-10 years) and reports promising numbers for being thromboembolic event free, however, as many members here can attest, blood related events do not happen on a regular basis, so it would be interesting to see some long term data or some in-vitro testing to see how it holds up over a longer period.

It would be interesting to see a comparison of its lower pressure gradients compared to other mechanicals and tissue valves too.

I'm curious as to why it's been implanted since 1992 and holds all this promise, yet it's approved only for investigational use in the States and the lower performance of the St. Jude and others remain the mech of choice? Who knows, it could be that they are smaller and have trouble competing with the big guys.

Regardless of the answer, this is still great news. If ATS pans out, this could be a great thing. Even if it eventually shows some flaw, it pushes the limit one step closer to our dream of a coumadin and reop free world while enjoying the excellent hemodynamic performance of some new breakthrough technology.
Kev
 
Sorry Janie, I do not know the answer.
I'll contact them at their website and see if I can't get a reply. If I do, I'll post onto this thread.

As the market leader, St. Jude's probably doesn't have to fight for credibility as much as some of these niche players. Plus, with their resources, they likely can expedite research, marketing efforts, etc.
Kev
 
Thanks!

Thanks!

You guys are awesome the way you search the literature! Thanks for the answer to my question. It would be good to go with the lower INR - less chance of hemorrhaging and bruising.
 
Hi Marty,

Was wondering... Just how low is low? My recommended INR range is 2.0 to 2.5 because I am taking my Coumadin with Aspirin.

So far so good, It's been about 1 1/2 yrs and I have been fairly stable. The good news is that I don't worry so much if it gets a little high, it the low that I really watch for.

I think the lowest I ever read my INR was 1.7 and the highest was 3.4 but mostly I am staying around 2.3 to 2.5

My surgeon provided me with info regarding the lower INR range if taken with aspirin. I take a 325 mg coated aspiring daily. I take that in the morning and the Coumadin in the evening.

I check my INR weekly.

Rob
 
How low is low?

How low is low?

Rob, You ask a good question? The recommendation for mechanical valves is INR 2.5-3.5. I asked my own cardiologist and Dr. Ansell, the Boston authority, if it would be prudent to add aspirin. both said it would do no good and Dr. Ansell particularly
warned that it might be harmful i.e. lead to hemorrhage. Having said this I have seen articles in the literature and heard other cardiologists recommend the aspirin supplement as your cardiologist did. What is a patient to do? What they have always done-find a doctor you can trust and follow his advice. I chose not to take aspirin and go with the higher INR. Marty
 
Hi Marty,

Actually my surgeon at Vanderbilt Medical Center was the one that put me on that regiment of Coumadin and Aspirin. My cardiologist also concurred.

I even brought in the articles that expressed the concerns of the drug combination. My surgeon said that according to the most recent data Coumadin and Aspirin were OK to take. and the INR range is lower if on the combination. He even showed me the report summary showing the ranges recommend with and without taking the aspirin.

I still wonder though. Seems there are 2 camps on this issue. I have been OK so far. If I ever have any problems from it I will surely post it on here to inform everyone.

Hope your weekend is going well. I am stuck out in Los Angeles working through this weekend until next Thurday, then back to Nashville for 2 days,(congical visit hehehe), then fly back here for another couple of weeks. Sure glad I have access to this board from work. It sure helps when I need a break.

Rob
 
Coumadin and aspirin

Coumadin and aspirin

Rob, my gut feeling is that you are OK taking both Coumadin and aspirin. Both work in different areas of the clotting cascade-coumadin on Vitamin K and aspirin on platelets. I think my cardiologists idea was that this complicates the situation and makes diagnosis more difficult if there is trouble.However you are careful, self test frequently and shoot for a lower INR. It works for you and this is OK. Glad you are getting home for a conjugal visit.
I am home already and was going to play golf this weekend but we have had torrential rains, floods, lightning, falling trees,etc. Hopefully nest weekend will be better.
 
More ATS info; from the horses mouth

More ATS info; from the horses mouth

ATS was quick to reply I might add.

I asked them to explain more about the "investigational device" label put on them by the FDA.

Since their website wasn't patient friendly; they were very clear that if you were a patient, you should ask your doctor. Good marketing strategy, I suppose. I told a white lie and went under the guise as a potential investor, which I suppose isn't all that far-fetched since I'm sure many of us are always on the look out for the next hot thing.

Here is their response:


"The ATS Open Pivot heart valve was approved by the FDA for commercial distribution on 13 October, 2000. The FDA approved most of the ATS sizes in the aortic and mitral position, however, there are some very small Mitral valves that have not yet been FDA approved. These valves are available to other countries, but not yet in the USA. That is why there may be some asterisks and the warning label (required by the FDA) that some sizes are not yet approved in the US and not yet FDA approved.

There have been approximately 45,000 ATS valves implanted worldwide since the first ATS valve was implanted in May of 1992, in Switzerland. The delay in FDA approval was very typical of the regulatory system and approval process requirements in the USA.

We have recently completed hiring and training of our US sales force, now are beginning to see results/increases in the US."

It's not much, but it does tell us that the ATS is being implanted for typical cases in the U.S.
Kev
 
Great stuff!

Great stuff!

Kevin,

We are going to have to give you the Magnum PI award! Way to think on your toes. Next thing you know, you will be going undercover for Dateline NBC.

Thanks for clearing this up for the group. I'm glad to hear the delay has nothing to do with questions related to the overall function of the valve. Did they give you any indication on which hospitals are currently requesting the ATS valves? I'm curious as to how quickly the surgeons will start to trust the new technology over the St. Judes and other tried and true valves with a long track record.

Thanks again for completing an excellent research assignment!

Jim
 
No mention of what hospitals.
They like to push patients to ask their doctor's about it. After all, generating a buzz is good for business.

I gotta go. I have a mustache to grow and I have to earn enough money to buy a Ferrari.
 
More ATS information

More ATS information

One of the surgeons in the first quoted article was my surgeon. He told me that the original owners of the St Jude company sold out a few years ago and are now the owners of ATS.

They claim that the ATS is the "next generation" of bileaflet valve. It looks very similar to the St Jude and operates in exactly the same way and is made from the same material; the main difference being the hinge mechanism. The St Jude has recesses in the body and little dimples on the leaves that fit into the recesses to form the hinge. The ATS is mirror image - ie dimples in the body and recesses in the leaves. This puts the little recesses closer to the actual blood flow, providing less chance of a "dead" pocket in which a clot can form. That's why there's the potential for lower INR levels with the ATS.

My surgeon said that while they (in Brisbane) now use the ATS valve exclusivly as the valve of choice for mechanical valves, they still maintain the same INR levels until a longer track record of experience is obtained. Van Nooten in the Netherlands does, however, use lower levels.

In Australia and USA, the authorities (TGA in Australia and FDA in the USA) are more cautious because of our litigious societies. They don't want another silzone situation. That's why it has taken so long for the ATS to get approved.

Gerry
 
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