Making the choice: RP, homograft, mechanical, tissue

[Kevin M]

Re: Dick and Peter's discussion about coagulation & mortality

Re: Dick and Peter's discussion about coagulation & mortality

The 2% per year figure sounds similar to what my surgeon told me also. I think he said 1.5-2% per year.

I wonder if we aren't a little biased on this forum because we have so many younger people here.

I would suspect that the mortality stats would include many elderly patients in their 80's and 90's. That can skew the numbers dramatically.

When reading research studies, I noticed they are careful to describe the health/age of the groups in question in their methodologies because these factors skew results dramatically.

Just food for thought.
Kev

 

[Simon Gee]

Re: Re: Warfarin no problem for me

Re: Re: Warfarin no problem for me

Peter,
the short answer to your question is no, I don't have an explantion for the difference. I take the view that my INR is sufficiently stable to be able to 'go the distance' between blood tests. I was tested daily immediately after surgery, then weekly, then at two, then four and now eight week intervals. My target range is between 2.5 and 3.5 - my actual range appears to be 2.8 to 3.3 so far.
An alternative, cynical, view is that my treatment is part of our wonderful National Health Service here in the UK. Whilst a splendid idea that has worked well for me and millions of other patients over the years, the system is currently chronically short of funds and maybe, just maybe, there is an element of cost saving in less frequent blood tests.
Either way, I'm happy with the situation and that's the most important thing to me!
Best regards, Simon

Thank you, Simon. Having the operation done in London and then recuperating in the British countryside actually sounds pretty therapeutic ... though out of the present realm of the possible. (I did have one "procedure" done in London in my salad days, actually: a week for a thorough check-up at the London Institute of Tropical Medecine after returning from years in Africa, quite a probing experience.)

You mention 8-weekly INR blood checkups in your local clinic. I gather the regime is weekly here. Any explanation for the difference?

Best,

Peter

 

[Peter Easton]

Data on bioprosthetic and mechanical valve outcomes

Data on bioprosthetic and mechanical valve outcomes

Interesting results of a Veterans' Administration study of comparative results and failure rates of bioprosthetic and mechanical valves 15 years out can be found at

http://www.acc.org/education/online/trials/acc2000/15year.htm

Peter

 

[Kevin M]

Peter, the study in question is interesting because it is based on 15 years, which isn't all that easy to come by. I think the Hancock bioprothesis they refer to is a stented valve, since the stentless have only emerged over the past decade or so.

The data is consistent with other info I've read that suggests these stented pig valved as appropriate for use in 65+ years patients.

My surgeon said the same thing. I believe he mentioned something about the rate of deterioration for tissue valves slows as patient age increases. He said a stented pig valve can last 15+ years in someone 65+ years, but only 5 years in a younger person.

The results of the mechanical valve instill some confidence. I guess it's true that they will outlast most patients. If anti-coagulation wasn't a factor, they would probably be the perfect machine!
Kev

 

[Herb M]

The results of the VA survey is similar to the general intuitive feeling my surgeon had 13 years ago when he described the options I had for an aortic valve replacement. I was 57 at the time and I chose the St. Jude mechanical. I was a bit concerned about the requirement to have my blood tested every few weeks, whether at home or on travel, for the rest of my life. As it turned out, I found the coumadin and the blood tests no big deal. My personal recommendation is that the requirement for a lifetime of anticoagulation medication should only be a very minor factor in the selection of the type of Aortic valve or surgical procedure. Although there there are new options and replacement valves now being reported, it will take another 15 years before we know if they provide better results .

 

[Peter Easton]

Leveling the playing field?

Leveling the playing field?

The options do seem to be getting nearer each other. I, too, have gathered that bioprosthetic valves are recommended in older and even relatively older folks (and I presume I belong to the latter category) not only because of their excellent hemodynamics and because the elderly are less likely to outlive the valve itself, but because calcification (if I've got that right), which is the main cause of failure in bioprostheses, goes on much more slowly in oldsters than it does in younger patients. Now if you combine that fact with the recent improvements and increased longevity of bioprosthetic alternatives (like C-E Percardium and Cryovalve Synograft options, if I haven't misspelled all that), the set of alternatives on the bovine and porcine and perhaps homograft side commences, it would seem, to look better as a way to stay off Coumadin.

On the other hand, hand-held and home administered INR checkers -- purportedly appearing over the technological horizon in another year or so and already available, I gather, in a rather pricey version with ProTime (sp?) -- plus maybe a less virulent replacement for warfarin make things look better on that end as well. What's more, to judge by Simon's remarks in message above, Britain has found a way to reduce frequency of INR checks to once every eight weeks -- though the method may be called "budgetary austerity." In any case, it seems to have had no ill effects on him to date.

And then the Ross Procedure advocates and veterans report that operation times and complications -- the principal bugaboo in that otherwise superior sounding approach -- are lessening noticeably, particulary in the hands of those who do a ton of such stuff, like Elkins, Oury, Stelzer...

Ain't that the way it goes? The more you look, the more the options even out!

Still mulling things over nonetheless. Meet with one surgeon and talk with another by phone tomorrow. Vamos a ver.

Peter
And advocates of the Ross Procedure

 

[Tammy]

Peter and All -

The 1.5 - 2% risk factor with Coagulation (Coumadin Users) is also what my Doctor quoted BUT it is NOT cummalative (sp) over the years. The risk factor would not be 40% for 20 years it would still be 2%. That is how my Doctor explained it, if that makes sense. Its all so confusing.

Take Care -
Tammy

Peter-I also noted you are waiting to get to .5 cm. My Doctor told me and I also found on the computer that .7 - .8 cm is the recommended surgery time. Just wondering.

 

[Peter Easton]

Hi Tammy --

Not waiting, plotting. We are on course for early or mid-August surgery. The measurement turned up incidental to that process and -- at least as far as I can see -- hasn't impelled the cardiologist to say the operation should happen tomorrow, as opposed to the planned timeframe.

On the 2% mystery, have found another few references and analyses. The focus seems to be the likelihood of bleeding and clots ("thrombolism" in the technical jargon?) consequent to Coumadin use with mechanical valve, not to malfunction of the valve itself, which is quite rare (though pretty sudden and discombobulating if it does happen, I gather). All references I have found do treat it as cumulative -- i.e. there is a signficant difference between (e.g.) 2% per patient-year, which is the way the rate is generally phrased, and 2% likelihood of incidence over, say, 15 or 20 years.

Peter

Peter and All -

The 1.5 - 2% risk factor with Coagulation (Coumadin Users) is also what my Doctor quoted BUT it is NOT cummalative (sp) over the years. The risk factor would not be 40% for 20 years it would still be 2%. That is how my Doctor explained it, if that makes sense. Its all so confusing.

Take Care -
Tammy

Peter-I also noted you are waiting to get to .5 cm. My Doctor told me and I also found on the computer that .7 - .8 cm is the recommended surgery time. Just wondering.

 

[Howellmc]

On the 2% mystery, have found another few references and analyses. The focus seems to be the likelihood of bleeding and clots ("thrombolism" in the technical jargon?) consequent to Coumadin use with mechanical valve, not to malfunction of the valve itself, which is quite rare (though pretty sudden and discombobulating if it does happen, I gather). All references I have found do treat it as cumulative -- i.e. there is a signficant difference between (e.g.) 2% per patient-year, which is the way the rate is generally phrased, and 2% likelihood of incidence over, say, 15 or 20 years.

Peter

Peter - The "patient-year" confuses me too. I have no clue as to what that means, but if it is cumulative, survival after 15 years would be almost impossible. From what I remember of stastical analysis, at 2% a year after 5 years less then 75% would still be alive, after 10 only about 30% would survive and after 15 only 6% would still be standing upright. Considering we know that there are plenty of folks still around, "patient year" must mean something else. I certainly hope this is mis-interperted as I just had a mechanical valve put in about 3 months ago. I also doubt surgeons would do mechanical surgeries if that was the survival rate.

Howell

 

[Peter Easton]

Cumulation, accumulation, confusion

Cumulation, accumulation, confusion

Just talked with a local cardiac surgeon about the rate of thrombosis for Coumadin-taking mechanical valve recipients and the issue of "cumulativeness." As I get it (from this source), several things have to be taken into consideration:

(1) The same people without surgery or Coumadin would have had some rate of thrombosis -- call it 1% a year -- so the increased likelihood due to the procedures is the hard-to-determine difference.

(2) Reported rates vary a bit, depending on whether the author is pro- or anti- in the mechanical valve/Coumadin debate.

(3) The rate is cumulative, but it is a rate of what they call "thrombosis-related events" (don't hold me to that) -- not of e.g. mortality.

(4) The long and the short of the matter seems to be that mechanical valve and Coumadin are characterized by a small though cumulatively increasing "marginal" likelihood (i.e. above what they would have been in the same people without these procedures) of thrombosis and related events. The longer they last, the greater the likelihood, but many would mantain that this situation still stacks up favorably or at least more or less equally against the reoperative risks associated with bioprosthesis.

Peter

 

[RobThatsMe]

Hi,

Just thought I would add some more thought to this topic. The sample groups used also has much to do with the results of the study.

My cardiologist has told me that in many cases the problems with Coumadin occur with the elderly. They either forget to take their pills, take to many, or fail to get moniored as regularly as they should. All of these possibilities can cause thrombosis and other Coumadin related problems which could be a part of the 2% patient factor you mentioned.

Rob

 

[Mara]

procedure type

procedure type

Peter-
my pick is the Ross. Just had one on 7/12. But I am 33, so consider that. I feel pretty good.
You should make the pick that is best for you.

i understand you wariness of coumadin. too scary for me. but, folks on here have a good handle on it. Which proves it's not too scary!
-Mara

 

[Gerry]

Hi jan

You asked about the ATS mechanical valve.

It was finally approved for use in the USA by the FDA last October, after having been used extensively in Europe for many years and undergoing extensive clinical trials in the US.

It looks very similar to a St Jude valve, with the main difference being the hinge mechanisms of the 2 leaves. In the St Jude valve, the leaves have littled nipples which sit in little recesses in the body to create the hinges. With the ATS, it is the reverse.

The manufactureres claim that this puts the little "pockets" of the hinges closer into the blood flow with less chance of clots being formed in little side recesses off to the sides. The principle advantage being claimed by this technology is that there is the potential for the patient to be on a lower INR level with lower doses of Warfarin.

By the way, ATS stands for "Advancing The Standard". You should be able to find their web page through a search engine.

Hope this helps

Regards

 

[Gerry]

Jan

The URL for ATS mechanical valves is http://www.atsmedical.com/

Regards

 

[Peter Easton]

Questions for a surgeon

Questions for a surgeon

Folks might be interested in the questions that I sent in an e-mail to Dr. Gosta Pettersson at the Cleveland Heart Clinic about possible surgery and possible RP up there. I have been following up on Cleveland for three reasons: (1) Ben's good experience there; (2) the fact that an old schoolmate happens to be a cardiologist there; and (3) my perception that they do a pretty good job on both sides of the coin -- RP and other varieties of valve replacement. My letter to Dr. Pettersson is copied below. I haven't managed to talk with him by phone yet, but am hoping to get hooked up sometime this week.

Peter

Dear Dr. Pettersson,

I thought I might offer you another means of contact, since it's tough getting into "synchronic" communication these days, especially with the case load and other occupations you must have. I gather from your office staff that they received the rundown on results of my echocardiogram and catheterization sent by my cardiologist and that you have had a little time to look them over.

Here are basically the questions that I was hoping to discuss with you. If it's convenient for you, I'd be happy to get an e-mail response or to carry on some electronic communication. On the other hand, if it seems possible to hook-up on the phone before too long -- or if you prefer to do things that way -- then the following may help us to organize the conversation and save you some time.

(1) From brief examination of the results of my exams, do I seem to you to be a feasible candidate for the Ross Procedure? I gather than the procedure is not often carried out with people over 55, due to the longer duration and rigors of the operation, but that it is really more a question of physical health and heart condition than one of chronological age. (In fact, I even note a recent article in the Journal of the American College of Cardiology by C. Schmidtke and others on "Up to seven years of experience with the Ross procedure in patients over 60 years of age" [2000 Oct; 36(4): 1173-7] concluding that RP "may be performed in selected patients >60 years of age without increased risk for mortality or complications in experienced centers." The operative terms there seem to be "selected" and "experienced," however!)

(2) More generally, from what you see in the record (plus any other information that I can give you in return e-mails or over the phone), what would be your recommendation regarding type and strategy of valve replacement in my case? I guess that the question really concerns the "preference" or priority order of procedures, since I gather that one seldom knows with absolute certainty just what technique should be used before actually "getting into" the chest cavity during the operation itself.

(3) Like most valve replacement patients, I imagine, my twin concerns are the (heretofore?) mostly incompatible ones of reducing exposure to Coumadin and minimizing likelihood of re-operation in the short (and, if possible) medium term. Of the two, if in informed opinion re-operation seemed feasible for a patient like myself after the expectable life of a bioprosthetic valve -- whether because I would have a reasonable expectation of supporting the new procedure well at age 69, 74 or 79, because in another ten to twenty years technique may be so much improved it will make little difference, or some combination of the above -- then I guess I would prefer the tissue valve. But you know better than I in this area, and so my third question has to do with your assessment of these options.

(4) In the bioprosthetic arena, what is your evaluation of the relative worth and appropriateness for someone like me of the alternatives, which I take to be (with a layman's likely misspelling or mis-citation!) the CE Pericardial valve, the Toronto SPV, the recently approved Cryovalve SG, the Medtronic Mosaic -- or a homograft solution?

(5) If you felt that a mechanical valve was at least the best "Plan B," do you perceive there to be any advantage of the recently-approved ATS (http://www.atsmedical.com/) over the older but more tested St. Jude's valve?

(6) What would be next steps in potentially scheduling surgery in Cleveland for someone coming from the jungles of North Florida like myself?

Thanks for your time and assistance!

Peter Easton

 

[Turkey Hunter]

Peter

Peter

Please keep me posted on the reply that you recieve from Dr. Pettersen.

I do have his direct e-mail address and those of his Nurse Clinicians.

 

[Peter Easton]

Response from Cleveland

Response from Cleveland

Here are the replies to the letter of inquiry that I sent to Pettersson (with copy for the Cardiologist, Dr. Roger Mills) and posted earlier on the listserve. Interesting.

FIRST FROM THE SURGEON, DR. GOSTA PETTERSSON

Dear Mr Easton,

Thanks for your mail. I have also talked to Dr Mills an d we do agree that the two first chooice options for you are either a human cadaver valve/homograft or a bioprosthesis. We believe the Carpentier- Edwards pericardial valve has proven its durability and excellent performance in the circulation and we consider it to be the best choice for bioprosthesis.

There are no important differences between the modern mechanical valves but they have some differences which are technically important in individual cases, mainly with regard to design of the sewing cuff.

No operation is perfect, not even the Ross operation. The results after homograft valve replacement are so good and the homograft so durable that it is not possible to argue i favour of the Ross operation for a patient of your age.

My personal preference would be a homograft.

If you want to come here for surgery, call my office 1-216-444-2035.

Sincerely

Gosta Pettersson

SECOND FROM THE CARDIOLOGIST, DR. ROGER MILLS, a classmate of years long flown (to whom I had sent the initial inquiry and who had at that time recommended the C-E Pericardial valve and counseled against RP)

Peter:

I have talked to Gosta Pettersson, and to our pediatric cardiology staff about you. This is simple. We will NOT do a Ross procedure on an adult in the 55-60 year age range!

My recommendations to you are as follows:

1. stop trying to push the limits on this, and accept the consistant recommendations of people who have been in the business now for a LONG time!

2. go with a bioprosthesis if you want to remain active, accepting an outside chance that you may need a re-do long after Social Security goes broke, or

3. go with a mechanical valve if you are willing to take coumadin daily, have an INR done every 3 weeks, and can accept a 3% per year risk of serious bleeding despite all precautions.

I urge you not to make this more complicated than outlined above. If I were in your shoes, I would go with a bio-prosthesis.

Best.

Roger

 

[Kevin M]

It's not often we get to read something from the actual doc's on this forum.

Their comments were interesting. The choice is difficult for us analytical types, isn't it? Sometimes I wish I could just leave well enough alone and do what I'm told, but then there's much to be said about steering your own ship.

Please let us know what you decide to do, Peter. Everytime someone makes a choice here, it feels like a little victory because some of us are fortunate enough to have that choice.
Kev

 

[Turkey Hunter]

Steering own ship

Steering own ship

Kevin makes a good point.
When my surgery came up and I was doing the research to attempt to make an educated choice.... It just was all moving so fast, with the aneurysm and extreme 4+ regurgitation.
There were many days when part of me wished that someone would just make the decision for me so I wouldn't have to worry about the technical stuff.
Although, now that it is over, I am very glad to have continued on and made the decision myself (with guidance from docs of course).
And yes, we all are very interested to hear who and which procedure and valve you choose.

God Bless,

Ben

 

[Peter Easton]

The medical response

The medical response

As concerns correspondence with Cleveland Clinic posted earlier, the following reflections sent to some folks on the RP listserve might be of interest to friends here:

"Interestingly, despite the cardiologist's firm advice to stop all these extra-curricular investigations and go with what the experts say, he and the surgeon say two slightly different things.

* The cardiologist says to go with the bioprosthetic valve (and
specifically the C-E Pericardial valve, doubtless a good choice, but also their stock-in-trade); and he offers no commentary on the other bioprosthetic options which I asked about: Cryograft SG, Medtronic Mosaic...

* The surgeon recommends going with a homograft.

I imagine the choice would be made face-to-face, with more data in hand, were I to opt for the Cleveland Clinic.

In fact, though, I think you have put your finger on one of the paradoxes and interesting quandaries in this whole situation. On the one hand, the medical people know a lot, have a lot of important experience and understandably like to have their credentials respected. After all, they paid a pretty penny for them(and are getting paid pretty handsomely for them as well) -- even if too much of that hubris probably isn't good for anyone. On the other, they don't seem often to agree among themselves, so what exactly does it mean to respect medical expertise?

And does expertise necessarily mean belittling patient participation in the decision? Seems to me the greatest professional is the one who handles him/herself like a good teacher.


Peter"