Making the choice: RP, homograft, mechanical, tissue

[LeslieD]

Recovering from Ross

Recovering from Ross

I'm 16 days post op and had a long wait for my surgery and did lots of research on the valve choices, noise factor and coumidin.

It's a personal choice, the Ross is not done very often because the skill the surgeon must possess and sewing that is required. My card is in the top 100 in the country. He suggested this as my best option and then mechanical if not able to do the Ross.

He dislikes future surgeries and felt the Ross had just as many pros/cons as a mechanical. He says anyone can get regulated on coumidin and there is a new drug expected out next year which doesn't react with other drugs like coumidin. There is now a home test for getting and keeping regulated.

I'm 40 and fit the perfect idea for a Ross. I had congenital aortic stenosis. Not as many surgeons will suggest it because they don't want to take the time to learn the procedure. If you want to go with the Ross chose someone that has over 100 operations under the belt.

Good luck in the decision it's a hard one. Also please double check and make a decision about transfusions. This I didn't do and had to have blood and now am worried about it. It wasn't stressed to me at all as a high possibility.

Leslie
[email protected]

 

[Peter Easton]

The other side

The other side

Hi Leslie --

Thanks for the suggestions and good to hear you are motoring ahead a couple of weeks post-op!

As you'll see further up on this interminable thread, I considered the Ross but finally decided on another direction (or other directions, as I am still waffling a bit between two of them -- Cryolife SG homograft and CE Percardial bovine). It's got a lot of promise, though. And interestingly enough, it appears that the same new Synergraft pulmonary valve used for aortic replacement in the operation I am contemplating is the one increasingly used for pulmonary replacement in the RP. Moreover, Dr. Elkins is one of its principal developers and, it seems, a Board member of Cryolife.

I am banking my own blood -- three units, one a week for the remaining time (which must stop a week before surgery) -- at the direction of my surgeon, Dr. Tomas Martin of Shands/University of Florida.

Hope your recovery continues to be smooth sailing. Several of us are just one lap behind!

Peter

 

[Peter Easton]

Semi-replies from the surgeon

Semi-replies from the surgeon

I asked some more of the questions mentioned above of my surgeon in an e-mail to his Program Assistant late last week. She gave him a copy of the message and he pencilled in some responses that she then faxed to me. Pretty telegraphic, but here's the upshot:

(1) I asked whether the hope for recipient cell "repopulation" of the Cryolife SG valve was simply a question of avoiding the dangers of immune reaction/calcification, or whether it was in fact hoped or expected that it would turn the implanted valve (which is presently a pulmonary-origin one) into an aortic one, with the sturdier characteristics of the aortic valve. His answer: "Unknown."

(2) I asked whether relative age of donor and recipient was of any importance in Cryolife SG implantation as it is sometimes held to be in homograft implantation in general. His response: "Have not used this criterion in the past."

(3) I asked if a traditional aortic homograft had any advantages over the pulmonary-origin Cryolife valve. He may not have understood the question, for his response was "hopefully longevity."

In short, this turned out to be something less than the best way of communicating! I think the best bet is going to be for me to schedule one more relatively full-scale consultation with him before D-day to go over all remaining questions and decision points.

Peter

 

[gary]

C-E Valve

C-E Valve

I regret that I did not buy the common stock of Edwards Life Sciences, Inc., the good folk who make and monitor the Baxter C-E pericaridial valve.

It has risen 50% in the last 52 weeks!!

Think this might help in your decision??

 

[Peter Easton]

Taking stock

Taking stock

Certainly in decisions about the family financial portfolio!

I was also interested by an article in the proceedings of this summer's international aortic valve surgery conference in London that showed 77% freedom from reoperation for CE pericardial valve recipients (with an average age of 65 years) 15 years out -- and something like 90% for those 65 and older. Moreover, in a much trumpeted case, Dr. Cohn, cardiologist and professor at Harvard Med, I believe, had AVR himself at Cleveland and opted for the CE valve, though Ken Dell pointed out to me that he has more recently been steering some of his patients toward homografts. Go figure.

Peter

 

[Kevin M]

Peter,
I saw something about the relationship between doner and recipient age, but it was not specific. A study from the Mayo clinic suggests this is a major consideration when dealing with homovital homografts (non-cryco tissue). This does not suggest whether it is or is not a consideration in cryo-preserved homografts also; just that it is a major factor in the success of homovital.

You may already know this or have the info, but I was just rereading it, so I thought I'd pass this along:

In the lengthy American Heart Assoc. info on valve choice, there are comments that homografts are often used in patients with small root size or low flow states because it has superior hemodynamics to other tissue valves. At times they are also chosen over tissue valves when there are aortic complications such as aortic aneurysms or aortic dissection. Homografts are often used in patients with active endocarditis.

I found some Mayo Clinic research (not as specific) from 1998 that supports this.

Perhaps the caseload of the doctor you refer to has a higher incidence of such cases or something?

It goes on to state that at around 60 years, the benefits of homografts over other tissue valves are minimal and they typically default to more common, less technical procedures of the other tissue valves.

In summary, it looks like there are subtle pro's and con's that may be of consideration in the choice between homograft vs. bovine pericardial valves.

It's interesting that there is little comparitive information between homografts and other tissue valves.
Kev

 

[Peter Easton]

Countdown

Countdown

Hi again folks,

Had about a week offline getting kids squared away in school. My operation at Shands is just one week away; Joy's is today, I believe; and Steve C is scheduled for September 5th. So it's happening thick and fast.

I still haven't made the final call between CE Pericardial valve and Cryolife SG, but that should happen this week. I have to go down to Gainesville on Thursday for pre-op, because the day before my actual operation coincides with Labor Day. I hope to see the surgeon at that time for some last discussion prior to D-Day.

I'm feeling well but can tell that awareness of the impending moment is creeping up in the background. My struggle right now is to avoid being too preoccupied by all the logistic stuff that must be resolved before the operation -- assigning what portion of me be assignable, as Emily Dickenson put it (more or less)! -- to take time for deep breathing and centering and good ol' Being Here Now.

Peter

 

[darkoosh]

Peter,

I though that was Babba Ram Dass's line!

Deb

 

[srwieland]

Where be now ol' Richard Alpert anyway?!

Peter, my experience with pre-op is that you'll be dealing mostly with residents and the physician assistant, so arrange with Allison ahead of time for time with Dr. Martin if you can.

Good luck and let us know how Thursday goes.

Steve

 

[tnboomer1013]

Hi Peter

Hi Peter

It sounds like not only have you done your homework and you have a wealth of info here. Not to mention actual product comments. I just had a mechancial put in 7-17-01. I suppose the only way I can help you out anymore is explain what happened to me. At the outset we were going for the rp but because of where one of the coronaries were and my aorta and root were enlarged the rp was not feasable. Or so I was told afterwards. I also didn't want to go through this again in the near future we went to plan b which was the mech. one. I have been told that the life of one of the other types ( human-porcine) wear out which means resurgery. I guess what I'm trying to tell you is things can change once they get in there. As I found out reserching this is that you want the rp you have to get a surgeon that has done a number of them. This like anything else means the doc gets better with practice. I don't know where you are from but I can tell you this the surgeon I saw has done almost 200 rp's and actually studied under Dr. Ross. His name is Dr. Davis Drinkwater.and he is the chief of cardio-thoracic surgery at Vanderbilt University. But the most important thing is that you feel very comfortable with whoever you decide on. Remember it is your heart they have in thier hands. Hope I have been of some help. Look forward to the updates.

BOOMER

 

[Peter Easton]

The final toss-up

The final toss-up

Thasnk, Boomer, for your encouragement and thoughts!

This week is decision time on valve replacement choice for me, as the operation rolls around right after Labor Day. I have been going back over my notes and off-prints and the extremely helpful material offered by others on this forum. As anyone with the fortitude to have read large portions of this particular thread (!) might remember, after beginning my investigations with the Ross Procedure, I eventually narrowed the choice to the Carpentier-Edwards Pericardial (bovine) valve and the new genetically-washed Cryolife Synergraft valve -- the pulmonary homograft version now available in the US that Steve Wieland in Florida received, as opposed to the porcine one more common (Steve tells us on the New Advacements Forum) in Europe.

Though it seems to have immense promise, the Cryolife SG pulomnary homograft isn't much mentioned in material available on the web, excepting versions of the article quoted in the first entry on the Synergraft in the New Advancements Forum. A search on Cryolife Synergraft principally brings up descriptions of engineering and early results of the genetically-washed porcine valve, not the pulmonary version.

Steve, do you or does anyone have an idea how many implantations of the pulmonary Synergraft valve to the aortic position have been performed to date (roughly speaking) here or abroad? I believe Steve -- who is doing famously -- was the second for Dr. Tomas Martin at Shands. Any wind of other experiences?

Peter

 

[srwieland]

I've come across some numbers before, but don't remember where. To the best of my memory, though, it's hundreds and not thousands thus far.

 

[Peter Easton]

More info on Cryovalve SG

More info on Cryovalve SG

Just came across some additional and apparently more recent information on the CryoValve SG pulmonary valve from Cryolife, and it's encouraging (at th 11th hour before my own decision!) The article can be found at

http://biz.yahoo.com/prnews/010717/attu014.html

and relevant excerpts are reprinted below. Much of the most recent information on the pulmonary valve version (or of what little there is) comes from INVESTMENT sources. Seems that, whatever reticences heart patients may feel, the financial community has identified this as an increasingly good investment.

"SynerGraft® Technology Update

The SynerGraft technology centers around the removal of antigens from human and/or animal tissues leaving a collagen matrix that has the potential to then be repopulated with the recipient's own cells.

CryoLife now has a total of 15 porcine tissue-engineered SynerGraft heart valves implanted throughout the world. There have been six implanted in Australia with two explants that were previously discussed. There have been nine SynerGraft heart valves implanted in Europe, two of which were subsequently explanted for non-valve related reasons. The Company conducted post-operative histologies on the valves and confirmed that both of the explants had been repopulated with the recipient's own cells in vivo and that all of the explants showed minimal, if any, calcification.

Since February 2000, the Company has had over 320 allograft CryoValve® SG implants by 63 surgeons in the U.S. Two of these valves have been removed for non-valve related reasons. Neither valve was removed due to structural failure and both showed that they had remodeled with the recipients' cells. Additionally, the calcification usually observed in allograft valves was greatly reduced in these two valves. To date, only three of the 320 valves have converted to positive PRA (panel reactive antibodies) levels. In conventionally processed allograft valves, it is anticipated that 90% of the pediatric patients' PRA levels would turn positive after implant.

CryoLife was able to confirm that four major medical centers have converted all of their allograft valve business to the SynerGraft treated tissues during the last ninety days. Due to the increased demand for SynerGraft treated tissues, the local tissue bank or organ procurement organization has agreed to send significant portions of their tissues to CryoLife to meet the increased demand.

The importance of SynerGraft technology is underscored by the fact that 33% of all cardiac allograft preservation revenues in June 2001 were from SynerGraft processed tissues.

Since January 2001, the Company had 47 allograft vascular grafts treated with the SynerGraft process implanted in patients with various stages of renal disease. None of the vascular grafts has had to be removed and only one of the vascular grafts has caused an increase in the patient's PRA levels. In conventionally preserved human vascular grafts, over 90% of these graft recipients would have had increased PRA levels. A paper on the human implants of SynerGraft treated allograft vascular grafts was given at the Vascular Access Society Meeting in London in May 2001, by John H. Matsuura, M.D. F.A.C.S., Assistant Professor of Surgery, Medical College of Georgia, Atlanta Medical Center, Atlanta, Georgia. Dr. Matsuura is a consultant to CryoLife, Inc.

Procurement

So far this year, tissue procurement is up 4% over last year, and CryoLife expects that its allograft tissue procurement will be up 10-15% next year. Accordingly, the Company will begin to build out additional clean room space in its present tissue processing laboratory to accommodate growth"

Peter, with scant time left for limbo!

 

[maggie wright]

new valve needs replacment

new valve needs replacment

This is my first time posting and some of the jargin is new to me but I will try to do my best.
My husband had a 4 way bypass and a St Judes aortic valve put in
April of 2000 at age 52. There was not a lot of discusion about the type of valve at this time its just what the doctor said should be used. The controlling of the coumidin hasen't been too difficult
until we went on a trip to Romania this summer and a tooth he had pulled a week before started to bleed and bled for about 7 days but this is off my subject.
He found out in June after an echo cardiogram that this valve that was supposed to last forever is leaking where it is attached and his blood count continues to drop so they want to replace it within a couple months.
Has anyone experienced this and is ther now a choice of valves this time?
Thanks
Maggie

 

[Nancy]

Hi Maggie-Welcome

Hi Maggie-Welcome

Hi Maggie

Welcome to the site. You'll find lots of info. and support. My husband just had a redo on his 2 year old mitral valve. It was also leaking and his blood count dropped through the cellar. He ended up on iron pills three times daily plus folic acid daily and it still wasn't holding, at one point he had to have an emergency transfusion on a Saturday. His mitral was repaired on July 18.

He had an appt. with the hematologist 5 weeks post op. and his blood count is already starting to rise. The leak was repaired and he is feeling quite well. His color is great now.

Please do a search on all my posts by going to the members area and looking for: Nancy, wife of Joe, then you will see that you can look at all my posts.

I hope they help you, and please feel free to email me either through the site or at [email protected] mention the website Valve Replacement.com in the subject line so I don't think it's spam. I'd be happy to chat with you.

 

[srwieland]

Hi Nancy, glad to hear the nice update on Joe.

Hi Maggie, welcome to a great bunch of heart buddies. Read this entire thread and you'll hear a lot about valve choices. Also, surf the rest of this website and you'll find even more, plus a lot of other related stuff. There's a lot of experience and info here to help you.

Fortunately, there are more good valve choices now than ever, but, unfortunately, you have to choose and the best choice is not always so clearcut.

But the choice is a very personal one and depends most on your own disposition and circumstances. So, get informed and then make the best informed choice you can.

The initiator of this thread, Peter, is in the final days of having to make his choice. We're all eagerly awaiting to hear what he chooses for himself, since he has probably informed himself more than anyone else I know.

Also, your choice includes which surgeon, because either you must choose a valve your surgeon is confident to implant, or you must find a surgeon who's confident in and experienced with the valve you choose. It's not good to expect your surgeon to artificially adjust to your choice, and I doubt if anyone of them would anyway.

Good Luck and Godspeed. Keep in touch.

 

[maggie wright]

new valve

new valve

Thanks for the replies so quickly.
It sounds like after reading some old posts that once a person has had a mechanical valve thats what he or she has to stick with. Am I right?
Maggie

 

[Peter Easton]

Last minute

Last minute

My surgeon called today to inquire about my decision and we had a good talk. His giving me until operation time to make the final choice -- good for an eternal waffler. I am leaning toward the CE Pericardium, or perhaps (his late suggestion) the new Medtronic Hancock porcine valve, which -- it now appears -- has also been treated to reduce calcification. The Cryovalve Synergraft is a fascinating and hope-inspiring alternative, but I guess in my somewhat later years I am getting a bit more conservative and would rather have a relatively sure 15 years, than a sure 10 with a live possibility of 20 or 25. The next 15 years are key with us, having teen and pre-teen kids, and the difference between 10 and 15 is appreciable. Add to this the shorter duration and cross-clamp time of the CE pericardium operation (or the new Mosaic Hancock) and you get a sense of my emerging preferences. Emerging none too soon, I'd say! We leave tomorrow morning at 3:30 AM for Shands. The idea was to get to bed early, but that didn't take account of the need to comfort the kids, calm their worries and spend a bunch of time with them.

See you in the morning!

Peter

 

[darkoosh]

Peter,

Wishing you the very possible best for the upcoming week. You are taking lots of prayers and well wishes with you on this journey.

Let us hear from you soon!

Deb Arkoosh

 

[Peter Easton]

Grande finale?

Grande finale?

Dear friends,

It seemed appropriate to post one more entry on this kilometric thread before archiving it -- in order to explain the choice that I did in fact make, the more so as there were some eleventh hour changes. I got back from the hospital on Sunday following an operation the preceding Tuesday (September 4th) and, as related elsewhere, have been doing quite well with initial steps in convalescence.

Before going into the nitty gritty of the final decision, here are the main things that I see myself as having learned from the process.

1. The experience of taking initiative and investigating options was itself very therapeutic for me and gave me a lot more confidence about what I was getting into. Reactions of medical staff (surgeons, cardiologists, physicians? assistants) to my investigations varied, running the gamut from bemused and skeptical to supportive and encouraging, though definitely shaded, I?m happy to report, toward the helpful end of the spectrum. I found that I felt good about making physicians? openness to ? better yet, preparedness for ? my inquiries and efforts a criterion for further involvement, given some baseline level of reputation and previous experience. I imagine that had my own case been more complex (e.g. fraught with collateral conditions) or more of an emergency, I would have done less of my own research and been more earnest about finding The Best.

2. To some degree, ALL the options look progressively better as I went forward. I got the distinct feeling that a rising tide of biomedical technology and artistry is raising all boats. There are improved mechanical valves out there, plus home-testing for INR levels and less virulent versions of Coumadin somewhere on the horizon. Tissue valves have improved noticeably. Homografts have gotten more available and the SynerGraft technology holds out real hope for overcoming the calcification barrier. And there are increasing numbers of very competent practitioners of the Ross Procedure with real mileage behind them and the ability to bring operating times down to ranges similar to other approaches. The limitation on cinching the latest improvements, of course, is the need for longitudinal evaluations and studies. Since one the biggest questions the consumer is asking is ?How long is this valve likely to function well in a person of my description?? ? and since the critical frontier for durability in tissue valves and homografts is upwards of 15 years ? it obviously takes a while to get answers.

3. One size certainly doesn?t fit all in this area. The needs of pediatric patients are quite different from those of young adults, middle-agers and senior citizens; men and women have different issues; and differing medical histories make the scene even more varied.

4. The criteria that I ended up applying to the decision, at roughly comparable levels of apparent surgeon experience and competence, were (a) freedom from anticoagulant therapy (a personal idiosyncrasy, since many do quite well on Coumadin); (b) average duration of valve for patients of my age group -- or ?freedom from explantation,? as I believe the jargon goes; (c) evidence of hemodynamic performance and post-operative well-being of patients; and (d) complexity and duration of the operation itself, particularly ?cross-clamp? time (required time on heart-lung machine).

5. Fifth principle or lesson: whatever the decision made, it becomes ?ex post? the best one and I get behind it to make it work!

That might sound highly organized, but was really much more intuitive in practice. In any case, in this wise I gradually narrowed choices to the Carpentier-Edwards Pericardium valve (a bovine valve) or the new Cryovalve SynerGraft homograft, a re-engineered human pulmonary valve just recently introduced but which Steve Wieland received this summer at Shands Hospital. (Steve looks great, by the way, and says tests have just confirmed that his heart ? enlarged in recent months by atrial fibrillation ? has returned to normal size and function much more rapidly than anyone expected!)

I stopped by Shands the Thursday before my operation for tests and had a good discussion with the Physician?s Assistant but was unable to see the surgeon, Dr. Tomas Martin. The PA said that I could probably hold my choice till I came back the next Monday for the operation on Tuesday the 4th. By that time I was leaning toward the CE Pericardium for the following reason. The literature suggests a very good likelihood of 15+ years in the majority of cases my age, and the valve requires no more operative time than a mechanical one. By contrast, the Cryovalve SG can guarantee only 8-10 years, since it is a pulmonary valve by origin, though it holds out the substantial possibility of lasting much longer (25 years, for example) if its collagen matrix is repopulated with recipient stem cells in most human implant cases as has happened in animal tests and the few human beneficiaries who died for other causes in the limited time since its use began to spread. In addition, Dr. Tomas said that operative and cross-clamp time for the Cryovalve SG were about twice what they would be for the Pericardium, comparable to other homograft procedures, though still somewhat less than for the Ross Procedure.

I was basically beginning to feel that for someone like myself on the cusp of 60 with children in their very early teens, the next fifteen years were most important and operative time was a consideration ? so, one thing in the other, I would opt for a procedure giving a strong llkelihood of 15 years free of explantation, along with short operative time, in preference to one ensuring 8-10 years with real hope of as much as 25, and with longer operative time.

During the weekend, Dr. Martin called, catching me at the office where I was closing up affairs. I didn?t know who it was at first, because he just said, ?Hello. This is Tom Martin.? But I got resituated in the right universe fairly shortly and ran down my remaining questions with him. He expanded on some points that we had discussed before, offered some new information, said I could basically decide as late as the moments before I was rolled into the operating room (!) and then said he was also increasingly impressed with the Hancock Medtronics Mosaic porcine valve, because it had many of the virtures of the CE Pericardium and was in addition treated in some ways that promised to ****** calcification. I thanked him, took that nugget under advisement and did a quick search for articles on the Hancock valve. I found several (references that I?ve misplaced but will add to the thread here as soon as I can locate them), including an article reporting on a comparative study of freedom from explantation in recipients of CE Pericardium and Hancock Mosaic valves aged 55-75 ? right down my alley. In fact, results for recipients of both valves were good ? the bulk lying in the 15-20 year range, if (post-operative!) memory serves me well. But in fact outcomes for the Hancock Mosaic valve were marginally better. Since the outlook in that direction looked potentially a little better with no perceptible downsides (operative time for the two, for example, was the same, Dr. Martin assured me), I decided late one of those nights to take the plunge and go porcine.

And so I ended up at the final decision, relayed to the PA and anesthesiologist staff on Tuesday morning early prior to my operation. And, as far as I know, that?s what I?ve got! I go back for a two-week post-operative check up at Shands next Monday and we?ll see what Dr. Martin has to say then.

So one story ends, another begins!

Let me end, barring PS's, with that wonderful couplet from Robert Frost I used as signature tag line early on and that seems written for heart patients --

I see for Nature no defeat


Peter