Valve Choice - Papers From the Medical Literature

[Arlyss]

It might be helpful to read some of the medical papers that physicians have as resources regarding the choices for prosthetic valves.

http://circ.ahajournals.org/cgi/content/full/117/2/253

These papers are from 2003:

http://content.onlinejacc.org/cgi/content/full/41/6/893

http://content.onlinejacc.org/cgi/content/abstract/42/10/1720

Arlyss










Arlyss

 

[upchurch131]

Thanks for posting these references. I am in the process of figuring out what to do in my age group with the most important factor being the elimination of repeat surgeries.

 

[ALCapshaw2]

Interesting reading and conclusions based on data available at the time.

I found the graphs of Tissue Valve Structural Damage to be interesting, especially noting that Homografts and Procine Valves had similar durability.

To make a more complete "informed" decision, it would be helpful for patients to also know how other factors compare, such as effective area and gradient across the valve (where I 'suspect/believe' that porcine valves have the edge).

In the Mechanical Valve arena, the general conclusion is that the differences in Thrombosis in the Aortic Position are not great (<2.0:1) between different valve suppliers.

The Mitral Position is more prone to "Morbid Events" such as Thromboembolism (clots that break away from their site of origin). This is where differences in Valve Type and Design become more pronounced.

To make a truly "informed" decision, ALL performance parameters need to be considered such as:

Thromboembolism (throwing clots)
Thrombosis (forming clots)
Hemorrhage (function of valve and INR)
Hemolysis (damage to red blood cells)
Hemodynamics (relating to blood flow characteristics)
Gradient (Pressure difference across a valve)
Effective Valve Area
Durability (longevity in patients)
Other?

 

[ALCapshaw2]

The unfortunate part of relying on "just any heart surgeon" for an explanation of ALL of the alternatives is that many (most?) surgeons are NOT totally familiar with ALL of the options, either Tissue or Mechanical.

Not many surgeons perform the ROSS procedure for example, and I would guess that many (most?) who do not perform it would not be likely to recommend it, or even give a good presentation of it's merits.

How many surgeons offer ALL of the Tissue Valve options?
(Bovine Pericardial, Porcine, Stentless Porcine, and the 'improved porcine valves unique to certain suppliers)

How many surgeons offer ALL of the Mechanical Valve options?
(ATS, Carbomedics, On-X, Medtronic-Hall)

Many of our members have been told by surgeons that they are not familiar with the relatively new (1996) On-X valves and they do not use them (or even know anything abut them).

Bottom Line: If a patient is interested in the latest developments in valves (all types) or procedures, or they are High Risk patients, they need to learn what questions to ask and how to find surgeons who offer those alternatives, preferably with experiece with the needed / desired procedure / prosthesis.

Otherwise, you are pretty much limited to the (few) valves that the surgeon you were referred to is familiar with and keeps in stock. Maybe that's 'good enough' for most patients...

'AL Capshaw'

 

[Leah]

True, but, and...

True, but, and...

Bottom Line: If a patient is interested in the latest developments in valves (all types) or procedures, or they are High Risk patients, they need to learn what questions to ask and how to find surgeons who offer those alternatives, preferably with experiece with the needed / desired procedure / prosthesis.
Maybe that's 'good enough' for most patients...

'AL Capshaw'

My concern about this is that, as a well-educated, medically-literate lay person who spent years in college, professional school, and the world of work getting up to speed in my own field, I can't possibly replicate a medical specialist's years of experience, including the context and judgment for making these very fine-tuned decisions. And I certainly can't do this in the amount of time I have to make decisions about my own health. I have asked questions about some of these elements - for example, valve hemodynamics -and I received what appear to be intelligent answers (for example one surgeon's perspective that differences in valve hemodynamics aren't really of great importance absence a small anulus). OK. To independently evaluate each of these elements, I'd have to know the literature (not just a few sample articles), what's really relevant, what appears to be relevant but isn't, and why. The reason I want to go to an expert is for his or her expertise (mostly "his" expertise in this particular field).

That isn't to say that I don't - or that others shouldn't - spend lots and lots of time reading about the condition, treatment options, trade-offs, etc. That's a given. But at some point you get into a level of detail that's not productive. If I think someone is a great doctor, at some point I have to assume that some expertise has gone into his or her narrowing of the options. I might ask, "what valves do you use and why - and why don't you use x, y, or z" - but that may be the least important of my choices (other than the obvious tissue versus mechanical issue).

That said, I salute anyone who can do this productively, but I wouldn't want anyone to think this is a prerequisite to getting a good result.

With respect,
Leah

 

[mrwjd]

This is a rather tedious, for the reader, recounting of the path I followed in, first, identifying the decisions that were mine to make, and second, making them. I am not, in these paragraphs, actually reporting my conclusions. It isn't worth reading unless you are in the process of sorting through the same variables, and collecting all the information you can to that end.


I had some time--well, I TOOK some time--to (a) understand the disease, and (b) explore my options. I decided not to waste time reading about post-surgery or recovery, questions that could be answered another day if I was lucky. My cardiologist and cardiothoracic surgeon gave me the time I needed to feel comfortable about my decisions. I now know I waited a little too long, they were both a little uneasy, but I never felt pushed ahead of my readiness.

When I understood the medical problem, I also understood that the decision of the moment--the one that, made now, would have lifelong consequences--was valve choice, and focused my reading on outcome research comparing results as related to valve type. Most influential, in the end, were some 2007 and early 2008 meta-analyses of outcome data. In my reading, I formed a strong opinion, but as Leah says, I had no illusion that I could competently make a final decision by myself.

Early on, I let go of the brand-name question. Most data regarding specific brands appeared in single-brand studies, many of them funded by the manufacturer, and might not be totally reliable. For that reason, I ultimately passed on even reading about manufacturers and brands, as a matter best handled by experts. Not everyone would go this way, of course, and there's nothing obligatory about it; I just considered that, for me in the weeks available, taking the extra time to sift through proprietary information and marketing hype would be a bad investment. (I felt vindicated when my surgeon told me at the end that valve manufacturers are highly competitive--he didn't quite say "cut-throat"; he may have thought the phrase a little insensitive under the circumstances.)

In the end, I kept for myself a single choice, the one that nobody could make for me--the informed choice of what risks to incur and what trade-offs to make. My initial goal in studying had been to identify reasonable options, and I had already concluded that either mechanical valve or xenograft was a responsible choice. Now I assessed the relevant factors--the greatest being medication vs. re-operation--in light of my personal comfort with them and their effect on my health and lifestyle. I knew my preference, subject to vetting by my doctors, but another could reasonably weigh the same factors and make a different choice.

It meant a lot to me that I was going into surgery knowing that I had made the best choice I could in the situation, and that my doctors understood and were on board with my choice. Of course, the final returns are not in. We all know that there is great variability in individual outcomes. But I am comfortable that I made the best choice I could, for me, with the knowledge available at the time. And that matters to me.

 

[mrwjd]

Al says: "Otherwise, you are pretty much limited to the (few) valves that the surgeon you were referred to is familiar with and keeps in stock. Maybe that's 'good enough' for most patients..."
_________________

Certainly, the decision process will be different if you feel your cardiothoracic surgeon is doing operations based on old information, under indifferent conditions, with bargain-table valves. For instance, you might decide to get another surgeon.

It is not lost on me that I would not have had my cardiologist, and might not have had the renowned surgeon I had if my daughter-in-law were not their junior colleague. And then I would not have had the incredible team of surgeons and nurses, the constant updating of information by residents (especially as my decision was supported most heavily by very recent research data), and the history of several thousand open heart surgeries to give me confidence. [Remind me to tell you sometime about the cardiothoracic residents and the bullet in the heart.]

Under other circumstances, I might not have felt I could delegate to my doctors whole areas of decision, and let go (little trust issues, maybe?). Surely my peace of mind, perhaps even the surgical outcome, might have been less salubrious.

Now, of course, I can't imagine having done this any other way, just as I can't imagine doing it without the insurance I serendipitously accumulated, with no particular intent, somewhere along life's path. Two not-bad starts at good luck, don't you think, for someone who's never even won a door prize?

 

[Ana]

My husband's story:

Carl was diagnosed 4-5 years ago with a moderate heart murmur. Due to some vague memory of his mother's, we thought this might have been the result of rheumatic fever as a young child. Due to the moderate nature of the regurgitation, the cardiologist thought my husband would not have to have his mitral valve repaired "for decades". Because of this, we put the condition out of our minds with the idea that he would go for nuclear stress tests every few years. I had done a Google search at the time and knew the differences and issues with both types of valve, but not really any in-depth info.

However, it turned out that his heart valve was damaged by chemo and radiation treatments he had 15 years ago and the valve failed very quickly, roping in another valve in the process (When Valves Go Bad! - next on Geraldo). This led to a pretty urgent surgery situation. His cath/angio was on a Wed. morning, the surgeon was so booked the rest of that week, they couldn't get Carl in until Monday. The consult with the surgeon over which type of valve took approximately 10 minutes in the CCU. My husband was 57 at the time and the issue was that longer-lived bovine tissue valve would "most likely" require one replacement in his lifetime, but he wasn't keeon on a mechanical valve and coumadin therapy for life. Carl asked what the surgeon would do personally, and he replied, "tissue valve, definitely". His reasoning was that replacement (specific to my husband's situation) would be at the very least 12 years down the road and that at that time, he was confident that most if not all valve replacement surgeries would be done as minimally invasive procedures. Obviously, no guarantees.

I had already done some research on the surgeon, and he had some amazing credentials - worked under Debakey in Texas, for one - and all the nursing staff really liked and respected him. More than one called him very conservative in his approach to treatments and so we felt that going on the fly with his recommendation was the best route to take.

I have to say, though, that every situation is so different - it's not just a question of what is being fixed, but treatment history and its efficacy, overall patient health and comorbidity, age and prognosis, yada yada yada. So many factors make this such a difficult decision (when a patient has the time to decide on their own) that the best thing is to have a cardiologist and surgeon you absolutely trust. And the more I read these boards, it seems THAT is the truly hard part about going through such serious health problems.

Thankfully this board is here for people.

 

[upchurch131]

My husband was 57 at the time and the issue was that longer-lived bovine tissue valve would "most likely" require one replacement in his lifetime, but he wasn't keeon on a mechanical valve and coumadin therapy for life. Carl asked what the surgeon would do personally, and he replied, "tissue valve, definitely". His reasoning was that replacement (specific to my husband's situation) would be at the very least 12 years down the road and that at that time, he was confident that most if not all valve replacement surgeries would be done as minimally invasive procedures. Obviously, no guarantees.

This is where I get concerned. I am 53- having surgery for BAV soon and faced with the same obvious choices. My surgeon and hospital are very "pro" tissue. They told me the same thing about minimally invasive surgeries of the future....... maybe. He also said if faced with a choice, his personal direction would be the tissue valve. Being conservative in my mind, I am looking at what is available today rather than what I am hoping for in the future. Because some of these new procedures take years to develop, years for FDA approvals and seem to crawl at a snails pace. I'm afraid that I will be looking for a replacement well before any such "simple" procedures are available to me. So far, I am of the belief that the rest of my life on controlled anti coags is far better than the risks involved with a repeat surgery when I am 65 or 70.

Agree or disagree?

 

[geebee]

This is where I get concerned. I am 53- having surgery for BAV soon and faced with the same obvious choices. My surgeon and hospital are very "pro" tissue. They told me the same thing about minimally invasive surgeries of the future....... maybe. He also said if faced with a choice, his personal direction would be the tissue valve. Being conservative in my mind, I am looking at what is available today rather than what I am hoping for in the future. Because some of these new procedures take years to develop, years for FDA approvals and seem to crawl at a snails pace. I'm afraid that I will be looking for a replacement well before any such "simple" procedures are available to me. So far, I am of the belief that the rest of my life on controlled anti coags is far better than the risks involved with a repeat surgery when I am 65 or 70.

Agree or disagree?

Stu,

This is indeed one of those questions that has come up over and over. I am one of those people who make decisions based on what is before me at the time and not on what might be down the road. In the vast majority of cases, it has worked very well. Although I am one of those folks who did not get a lifetime from my mechanical valve, it was not because the valve failed but because of the way my body produces scar tissue and the effect it had on the workings of my valve. The same would have happened if I had chosen tissue.

Coumadin has been a true non-issue for me and I have been on it for almost 28 years (half my life) now. I lead a perfectly normal life and scuba dive, have raced sailboats, horseback ride, travel, etc. I have had severe head bangs, cuts and bruises and survived them all. I have had 3 major surgeries (and a couple minor ones) after starting coumadin and did just fine. I would choose mechanical again if I had to have another surgery because I want to minimize surgeries. Having been through 3 OHS, I can assure you that each one is more difficult and there are issues that might not be thought of.

As we are quick to point out, there are no guarantees. One can only make the best decision given the information at hand. Whether to factor in future advances really depends on how much of a gambler you are.

 

[Ana]

This is where I get concerned. I am 53- having surgery for BAV soon and faced with the same obvious choices. My surgeon and hospital are very "pro" tissue. They told me the same thing about minimally invasive surgeries of the future....... maybe. He also said if faced with a choice, his personal direction would be the tissue valve. Being conservative in my mind, I am looking at what is available today rather than what I am hoping for in the future. Because some of these new procedures take years to develop, years for FDA approvals and seem to crawl at a snails pace. I'm afraid that I will be looking for a replacement well before any such "simple" procedures are available to me. So far, I am of the belief that the rest of my life on controlled anti coags is far better than the risks involved with a repeat surgery when I am 65 or 70.

Agree or disagree?

It seems as if an age in the fifties pose a difficulty when making this choice. If Carl was just 4 years older, it would be highly probable that a tissue valve needing explant in 15 years might last him the rest of his life (God willing). But he was 57 and had to make the decision on the fly, based on gut instinct on how he felt about the surgeon's advice. Since then, we have discussed the issue of another OHS and though he would rather not, for his personality, it's better than managing warfarin use for the rest of his life. I must add that, post-surgery, Carl had absolutely no problem regulating his PTINR on 2mgs of warfarin. He had more problems with the Lisinopril.

Anyway, in another thread on this board (I am sorry, I do not know which one) someone recommended going through a trial run of coumadin treatment to see how well your body responds to it. If you do well, your choice of a mechanical valve is a good one and should have little impact on your lifestyle. However, we can never tell how our bodies will react to medications until we actually take them and there are some who have real problems on coumadin, not only in how they respond to it, but in having it properly managed. If I were you, I would request a trial run and see how well you respond, while at the same time, doing research on how to best monitor your PTINR - whether through a reliable clinic in your area or on your own.

It's a sticky wicket - good luck!

 

[Karlynn]

Trial runs for Coumadin may be advised if someone has allergy sensitivities. It's fairly rare for someone to be allergic to it. But I suppose it wouldn't be a bad idea to test and see. However, using a trial run to see if it's something you can manage in your life style would take months and in my opinion, cause you to put much more thought into it than most of us who've been on the drug for years would tell you you need to. Living with Coumadin is just something we do and a few weeks trial period is not going to give someone a good idea of how it fits into their lives. I think it would be better to learn the truth about Coumadin and then question your doctor or possible Coumadin manager to see if they know what they're managing. In the US - finding people that truly know how to manage Coumadin can be the toughest part of being on the drug. If people want to know what questions to ask and what answers to look for, we'd be happy to provide that.

I've had much more trouble with statin drugs and anti-arrhythmics than I've ever had with Coumadin.

 

[mrwjd]

Think about this: A very short time ago, surgeons were routinely recommending mechanical valves for patients under 65, really insisting it was the only way to go. All of a sudden, as a group, they have flipped to tissue valves, even for people quite a bit younger.

What does that say? Your guess is as good as mine.

 

[geebee]

Think about this: A very short time ago, surgeons were routinely recommending mechanical valves for patients under 65, really insisting it was the only way to go. All of a sudden, as a group, they have flipped to tissue valves, even for people quite a bit younger.

What does that say? Your guess is as good as mine.

This sure seems to be a pretty broad statement. Where does this information come from? Sorry but I haven't read anything that indicates surgeons "as a group" have switched to tissue valves.

 

[mrwjd]

Just a rumor, I'm sure. Out in the hinterlands, probably nothing has changed.

However, there are at least three meta-analyses of outcome data comparing mechanical and tissue, two in 2007 and one in 2008, that show more comparable outcome for the types of valves.

Each has its benefits and drawbacks, right? Totally a personal choice. Just that there was a time they'd tell you, oh, that's not for you (medical opinion) and I'm not hearing that now--now it's kind of picking your own poison, so to speak, the problems and risks you think you can live best with.

It looks like one major variable these studies identified was that reoperation, when the statistics are adjusted for other risk factors, is not as prohibitively dangerous as it was, or was thought to be. Also, some studies now are factoring in morbidity where it used to be that only mortality was considered in quite a lot of studies.

Of course, the "right" decision for the individual is still not knowable, is it? We're always playing the odds.

 

[tobagotwo]

Coumadin is not a non-issue to everyone, for a certainty. Unfortunately, neither is reoperation. There are health issues you can develop that make anticoagulation or warfarin interactions more dangerous in later life. There are also health issues that you can develop that make reoperations more dangerous.

Having a mechanical valve doesn't guarantee that you will never have to have valve surgery again. Having a tissue valve doesn't guarantee that you won't ever have to take Coumadin for something else.

Some cardiologists and more than some cardiac surgeons are fairly knowledgeable about valves. However, it's to be recognized that particularly for most cardiologists, it's only a narrow, sideline part of their field, and not where they concentrate their efforts at all.

The many times we've seen posts where cardiologists tell their 60+ year-old patients that a tissue valve only lasts ten to twelve years attests to that. So do the many reports that people's cardiologists can't manage their patients' Coumadin properly, or warn patients they might bleed to death from minor cuts on warfarin.

In short, if you're disappointed with your doctor's or surgeon's explanations or what they offer you as choices (or lack of choices), dump them. Immediately and ruthlessly. Get other doctors who make sense to you, who answer your questions, and who are open to your needs. This is your heart. Don't go with half-baked physicians. Don't settle for less than you need to feel confident.

You're on your own here, unless you've lucked into a wonderful and very unusual doctor-surgeon situation. Even then, it's a matter of trust that the doctors are considering you personally, and not just following a formula that has worked pretty well for them generically.

The most important thing seems to be your own feelings about the situation. Fish swim, birds fly. People are nearly as polar-divided on the valve type issue. Some of my interpretations of long-time observations: In general, people who like to be more in control of their surroundings or people who are petrified of the surgery tend to favor mechanical valves and warfarin. In general, people who are antithetic to authority figues, who don't want to be bothered, or who are fearful of outside dependencies will drift toward the tissue valves. Look to yourself to see what your own reasons would be with each type of valve, and which would make you feel the most emotionally comfortable.

If you don't take Coumadin already, getting a mechanical valve in your seventies is slightly detrimental, as your risk of a brain bleed rises, and a tissue valve would be a lifetime valve by that point. Anticoagulation can be problematic if you have a blood disease or are prone to stomach ulcers or intestinal or colon issues, like colitis, Crohn's Disease, or polyps. Consider carefully if you have aneurysms, as surgeries that cause doctors to have to turn anticoagulation on and off ("bridge") can raise your immediate risk for strokes higher than other patients. As well, aortic aneurysms may sometimes be genetically linked with intercranial aneurysms, which do not play well with anticoagulation.

Youth is hard on tissue valves. If you're in your twenties, a tissue valve means you will definitely have several more heart surgeries (likely at least four more). If you have any tendency to lung or kidney issues, that can make the required heart surgeries later on much more risky or even impossible. And at the end of the valve's lifecycle, there may be a year or more of diminishing function before it's replaced that will feel much the same way you feel now.

The mechanical valve is reassuring, nearly indestructible, ticking its message of lifetime stability. The associated anticoagulation can be under your own supervision and control. The tissue valve is relatively carefree, needs no tending or required prescriptions, and allows women to have babies with no special considerations.

Search yourself to determine which of those circumstances you can best live with. Listen to the information and stories of those who offer them, but be wary of trying to change your own base nature to suit an opinion that sounds logical for the moment. Once the surgery is done, you won't be able to go back and change your mind (excepting that with a tissue valve, you could change over to mechanical the next time you're operated on).

Best wishes,

 

[ALCapshaw2]

Well Said Bob !

I especially liked the association of personality types with valve choices.

'AL Capshaw'

 

[Karlynn]

Well said Bob. The only wrong decision is not to have the surgery. We have no crystal balls (except Mary - and she's afraid of malpractice lawsuits so she doesn't pull it out often).

I think it's important to highlight the mean ages of any valve study. With some spunky, much-younger-than-their-years exceptions, people who use the internet to research valve choice are going to be younger than the mean age of most of the valve studies. But the mean age is there because more people are luckier than many of us, and don't have to face valve replacement until their senior years. The younger you are, the more quickly you wear out a tissue valve. Even with the improvement of valve longevity, a 30 year-old will still wear out a tissue valve much sooner than a 65 year-old. In the same thought process - I don't really understand someone 70 getting a mechanical given the vascular issues that can occur with Coumadin and the advanced senior years.

It seems like here at VR we see trends. For a while we seemed to be getting a lot of new members who were younger and getting a tissue valve. Of late (few months) the pendulum seems to have swung to the mechanical (particularly the On-X). I've also casually observed here that if you go to Cleveland for your replacement, you have a greater chance of coming away with a tissue valve. If you go to Mayo, it seems to be reversed and they do more mechanicals. (I could be wrong, I'm just saying what I have observed here.)

I think my biggest advice to someone speaking with a doctor or surgeon about this is to be very wary of those who are 4-square against one of the 2 main choices for you - be it tissue or mechanical. That would just say to me that they haven't done their research and may not be up to speed on current science. With the exception of some specific medical issues I think you need to look out for the use of the word "never", even when asking a physician what their own personal choice would be. That signifies close-mindedness and people who are close minded don't really bother to explore or look past their own preconceived notions.

 

[Duff Man]

Hey I have a quick side question: I have minor peptic ulcers with some esophogeal erosion from reflux. Obviously there's some incrased risk of bleeding there... but does this make warfarin out of the question?

 

[geebee]

Well stated - except the the part about personality & choice. You state it like it is fact when it is clearly conjecture on your part. You're trying to associate a personality type to valve selection that has no supporting evidence for this opinion, other than personal experience.

I sometimes think you just like to take a stand to get responses.

We have all stated, many, many times that our posts are our opinions unless we are quoting or referring to specific articles or studies. Bob wrote a wonderful post full of great ideas and thoughts. Is there some reason we have to have a disclaimer in every post so that people don't jump on us?