on-x valve - scream now if its a dud!

[westie]

hi everyone

on tuesday i intend emailing the surgeon and telling him i have decided, against his advice, on the on-x valve as a standby in case my valve is not repairable. actually, he has never fitted a on-x valve before, but he is an ace, so no worries!

i am sure the on-x valve is the best, but if anyone out there has dirt on it, please, please speak now!

thanks

westie
p.s. surgerery is monday 03-03-2008

 

[Philip B]

On-X

On-X

A number of folks who post regularly here have opted for On-X valves. I haven't seen any negative reports yet. Actually, an On-X would've been my first choice if the valve had been available with a factory installed conduit to repair my aortic anneurysm. It sounds like you have a good backup plan. Good luck with the repair.

-Philip

 

[tobagotwo]

The only question I would have is if there is a specific reason he has why he doesn't want to use it, in terms of its layout and sewing requirements. That's unlikely, although some surgeons prefer not to use it if there is ascending aorta that needs to be replaced as well (only because it doesn't come as one, preassembled unit, valve and replacement aorta sleeve). That doesn't seem to be your case.

As you'd be his first install of one, he may be a bit leery of it taking longer on the pump (he's bound to want to double-and triple-check the install). However, it's not like he's going to go in, open the cellophane pack, and unfold the instructions for it while you're lying there. He'll study it, and discuss it with some surgeons who have used it beforehand, so he can go in confident about how it needs to be done.

If it's just that he doesn't know enough about the valve itself, and he's uncertain about its quality because of that, then no worries. This is the latest material and design from the fellow (Jack Bokros) who developed the materials used in most of the other mechanical valves (St. Jude, Carbomedics, and ATS) in conjunction with Vincent Gott and a small group of developers. He has unparalleled experience with this. It's been on the market long enough to have some confidence in its structure, efficacy, and function.

The material used in the On-X valve is pyrolytic carbon, similar to the others. It differs mainly insofar as it doesn't contain any lingering traces of silicon, which is believed (and so far truly seems) to make it far less susceptible to clot development. The design is also a factor in reducing eddies and slow-flow areas that encourage blood to agglomerate. ATS and Carbomedics have also released new designs that have similar, excellent flow characteristics, but they don't have access to that silicon-free version of the pyrolytic carbon material, as far as I know.

If I were to go for a mechanical valve today, the On-X would be my first choice. The only thing I don't care for about them is some of their marketing practices, which set my teeth on edge. However, that has nothing to do with the product itself.

We're cheering you on. May it all go well for you.

Best wishes,

 

[Cooker]

Westie....I wish you the best....I have the same question Bob has.....Why does your surgeon advise against this valve?....I investigated different valve but ultimately went with the surgeons and cardio recomendation.....I would have felt very uncomfortable going in knowing the surgeon had not used the valve before....I am sure he is great and well qualified.....maybe I am not as adventurous as you.

I am sure all will go well and I hope you are able to have your valve repaired. I think the valve itself is fine but I would ask his reasons for not wanting to use it with you.

 

[Karlynn]

I think there's a difference in the surgeon not wanting to install the valve and recommending a different valve. The question is - which describes your surgeon. It's a little unclear from you saying you were going against his advice, as to which he is. If you said you want the On-X and he, without much begging from you, said he was willing to do it, I don't think I'd be as concerned. If you had to do some heavy convincing, well, then I don't know.

I think you should just point blank ask him "Are you reasonably comfortable with your abilities to successfully install this valve in me?". (You may want to tell him that you aren't asking the question to prepare for a possible law suit. )

If he does a lot of valves, I would think that he shouldn't have an issue. I'm sure he's run up against some tricky installations in people with the valves he's installed many times and has had to trouble shoot them quickly.

If he says he's not very comfortable with installing the On-X, I'd choose another valve, or tell him "Thank you, but I think I'm going to want a surgeon who's installed the On-X."

 

[queenie]

I am not smashing the on-x merely reporting what happened when I asked a surgeon about it. He said it isn't any better than the others, his practice has put them in but, he feels it will not be in use much longer, he says the company is struggling with it. Don't know how accurate his info but, I too was excited about it until then. The valve I have now is also designed to reduce pannus growth. As for the anti-coag-I have been let down before with hopes of getting off coumadin. Didn't work out then either. Don't mean to be a downer just a realist. I want a valve my Dr. is expert at installing and is the perfect size and shape for my body, whatever that is. This is just one of the many weighty decisions weighing on folks like us. I wish you success!!

 

[ALCapshaw2]

On-X offers considerable support to First Time Surgeons in the form of information, sizing recommendations, and even to the point of having a representative at the hospital (and sometimes in the O.R.) to answer questions on the spot. Contact the company for details.

'AL Capshaw'

 

[cp172]

Westie,

I went into surgery with Plan A being a repair and Plan B being the On-X. My surgeon does nothing but valves and a lot of them. While the choice was mine he said he recommended the On-X. I have not heard any negative news on the valve. Best of luck to you. You are in our prayers.

 

[queenie]

cp172

cp172

cp172--you say your surgeon only does valves, would you share the name and location? Do you know if he does redo's? Thanks

 

[cp172]

Queenie,

I would be surprised if he does not do redos.I have sent you a lengthy PM with the information you requested.

You could call and ask for his PA and she can answer the question about redos. I plan to see the surgeon Wed. and I will be happy to ask him if you like.

I hope this info helps.

 

[queenie]

If you wouldn't mind asking him if he does them that would be great. Could you also ask him if he needed a complicated redo where would he go? Thanks a bunch!

 

[tobagotwo]

I'm not sure where a surgeon would get the idea that the ON-X would not be in use much longer, or that the company is "struggling" with it. From the looks of recent posts, MCRI could support itself from those in this forum alone.

Sounds like that surgeon just came off a visit from one of the competitor's salespeople, or has an emotional investment in another brand. It must be frustrating to sell against a company that's in reduced-ACT and ACT-free trials. Be wary of using out-of-reference remarks as a basis of comparison. They're certainly worth investigating, but need to be substantiated before becoming part of your decision.

I've not seen anything negative about the On-X anywhere, other than cautions about whether it will work as safely as hoped without ACT. If there are issues associated strictly with this valve, someone will no doubt bring them to light in this forum shortly.

You can look up Dr. Bokros, who founded MCRI to build his new valve made with his improved pyrolytic carbon material, by Googling "Jack Bokros carbon" as a filter.

This is not to put a damper on the other brands, the St. Jude, Carbomedics, Sorin, ATS, or others. They all seem to give excellent performance. It's simply that the On-X has what some of us perceive as a technical edge in the current market. Not everyone will see it that way.

Best wishes,

 

[westie]

mitral valve

mitral valve

the surgery is hoped to repair my mitral valve; the surgeons contention is that the on-x valve does not have the long track record of the st judes and says there is a lack independant study with peer review on the on-x valve; but he says he will install the on-x valve for me, just it would not be his first choice for himself

karlyn
- this is auckland new zealand, the medical world is diferent to the usa. doctors do not live in fear of law suits from patients; perhaps the set up of our law system does not encourage it. it does not happen often. if we are unhappy about a medical matter, we tend to complain to the ""health and disability commissioner" who can sanction doctors etc and sometimes gives a patient a small cash settlement.

tobagoto
- which of the on-x marketing practices do you not care for? actually, the surgeon alluded to this i think, he said all the good news in the market place comes from on-x themselves. "why are they self promoting so hard he asked"

queenie
the surgeon concerned is a valve repair and replacement specialist with great experience and professional standing, possibly a little bit old school.
of course he does redo's and hazardous proceedures; as mentioned above, he is not in fear of lawsuits. he is in auckland, new zealand; i do not think it fair to mention his name here but do not hesitate to message me if you still want it. new zealand offers leading first world medical care at very good prices

 

[Susan BAV]

Early Clinical Experience with the On-X Valve...

Early Clinical Experience with the On-X Valve...

I found this paper, Westie... http://icvts.ctsnetjournals.org/cgi/content/full/4/6/588

And, "after almost one decade of clinical experience in a single center," this information:
http://www.icr-heart.com/journal/content/2007/sept/abstracts/article.php?id=14

"Single-Center Experience with the On-X Prosthetic Heart Valve between 1996 and 2005

Paschalis Tossios MD, Delawer Reber MD, Maria Oustria, Tim Holland-Letz PhD, Alfried Germing MD, Dirk Buchwald, Axel Laczkovics MD
Departments of Cardiothoracic Surgery, Medical Informatics, Biometry and Epidemiology and Cardiology, BG Universitätsklinikum Bergmannsheil, University of Bochum, Bochum, Germany


Background and aim of the study: Herein are presented long-term results for the On-X mechanical heart valve. All On-X heart valve recipients since the first implantation worldwide at the University of Bochum in September 1996 were followed retrospectively; the present authors’ single-center experience over a period of almost 10 years is reported.
Methods: A total of 428 patients (255 males, 173 females; mean age 62.7 years) underwent either aortic valve replacement (AVR; n = 264) or mitral valve replacement (MVR; n = 164) using the On-X prosthesis. Preoperatively, 329 patients (76.8%) were in NYHA class III or IV. Approximately 5% of AVR and 23% of MVR patients had undergone previous cardiac surgery. Concomitant surgery was performed in 189 patients (44.2%). The mean follow up was 3.9 years, and cumulative follow up 1,625 patient-years (pt-yr); the overall follow up rate was 98.7%.
Results: Early mortality (≤30 days) was 3.7% after
AVR and 14.0% after MVR, with valve-related mortality rates of 0.4% and 1.2%, respectively. At autopsy (n = 12) all implants were intact. Freedom from valve-related death at nine years was 85.0 ± 3.9% after AVR and 87.6 ± 3.2% after MVR. The overall survival rate was 67.9 ± 4.3% after AVR and 52.7 ± 8.1% after MVR. The linearized rate of thromboembolism for AVR and MVR was 1.49%/pt-yr and 1.61%/pt-yr; of thrombosis 0%/pt-yr and 0.35%/pt-yr; of hemorrhage 0.93%/pt-yr and 1.43%/pt-yr; of endocarditis 0.37%/pt-yr and 0.17%/pt-yr; of non-structural failure 0.18%/pt-yr and 1.43%/pt-yr; and of reoperation 0.28%/pt-yr and 0.53%/pt-yr. There were no cases of structural valve failure.
Conclusion: After almost one decade of clinical experience in a single center, the On-X heart valve continues to be reliable and effective.

The Journal of Heart Valve Disease 2007;16:551-557"

 

[Susan BAV]

One more thing, Westie. I don't have an opinion about the On-X valve. I just did a quick search and found a couple of hopefully independent articles about the valve that were available without a subscription and that didn't appear to me to be personally sponsored by the company. (See previous post.)

Best wishes to you and take care.

 

[ALCapshaw2]

the surgery is hoped to repair my mitral valve; the surgeons contention is that the on-x valve does not have the long track record of the st judes and says there is a lack independant study with peer review on the on-x valve; but he says he will install the on-x valve for me, just it would not be his first choice for himself

SNIP

tobagoto
- which of the on-x marketing practices do you not care for? actually, the surgeon alluded to this i think, he said all the good news in the market place comes from on-x themselves. "why are they self promoting so hard he asked" SNIP

St. Jude does indeed hold the record for Longevity at 30 years.
Does this surgeon's reply also suggest that he would not use Carbomedics or ATS because they have "only" been around for 20 years? Note that the On-X valves have been in the World Marketplace for almost 12 years.

His answer would suggest that he is 'set' on using St. Jude Valves for the remainder of his career, unless he will still be doing Valve Replacement Surgery in another 18 years when the 30 year results will begin to come in for On-X.

My GUESS about the marketing is that it comes down to gaining business, especially in the USA. From my contact 'in the business', the Major Heart Hospitals put the Valve Business up for Competitive Bid, typically selecting 2 Mechanical and 2 Tissue Valves for general use in their hospitals. I expect that it is extremely difficult for a small young company to compete on price with large long established companies. FWIW, On-X has just recently been added to the offerings at the Cleveland Clinic. I expect that patient requests were a factor in this decision.

As far as 'self promotion', who else is going to do it? Certainly their competitors are not going to promote a newcomer. Welcome to the world of Capitalism. We will see what direction the Medical System in the USA goes after the next general election.

'AL Capshaw'

 

[Hank]

The Most Important Things

The Most Important Things

Just seeing a discussion like this taking place reinforces to me what the real important things are.

Education on our parts as patients, families of patients and physicians.

This forum serves it's purpose when it becomes a place where decisions such as these can be openly discussed.

Every Dr. has their personal preferences and every valve company thinks their valves are the best.

As we continue to educate ourselves, we enable everyone to make the best decisions.

Thanks to everyon for your inputs and feedback..

 

[Marty]

Just seeing a discussion like this taking place reinforces to me what the real important things are.

Education on our parts as patients, families of patients and physicians.

This forum serves it's purpose when it becomes a place where decisions such as these can be openly discussed.

Every Dr. has their personal preferences and every valve company thinks their valves are the best.

As we continue to educate ourselves, we enable everyone to make the best decisions.

Thanks to everyon for your inputs and feedback..

I never thought to question my surgeon as to his choice of valve. I guess this is the new way of doing things. Lay people, telling the surgeon what to do. I can see, if a patient has his/her heart set on an On-X valve that they consult enough surgeons till they find one that uses On-X without being prompted by the patient.

 

[tobagotwo]

Actually, I think the Starr-Edwards has the record, Al. This, from Dick's signature: Starr-Edwards mechanical aortic valve implanted 1967 at age 31. Univ. of KY Med. Ctr., Lexington KY... No surgery (heart or otherwise) since. Over 40 years...

As far as the marketing question, I am offended by the slant that MCRI takes on tissue valves. You can see it on their website. Old data and scare tactics. Again, that's just marketing. And they're not the only ones to use it.

On the other hand, as far as the only good news about their product coming from them, that's simply not so. Whether or not it winds up being able to use reduced ACT, it's holding below the average stroke rate so far, and is being used successfully in areas of the world where coumadin is either unavailable or too expensive for the patient.

It's not that patients tell their surgeons what to do. It's that, within medical reason, patients do and should have a say in their treatment. If a doctor directs you to only one treatment that you believe affects your future health or quality of life, you've a right to know why he thinks it's best. Maybe he has a great reason. Or maybe he's just stuck in his ways, figures what he's always used is good enough, and hasn't taken the time to really research the field since. It's easy to understand. Surgeons are busy people.

But it's not good enough to just listen to the salespeople detailing. They're all pushing their own products, after all. The doctor's opinion about products shouldn't be biased by his perception of the companies' representatives or their marketing tactics. It's a rut. Understandable, but an unfortunate rut, more common than we'd like to think.

Best wishes,

 

[Faye]

"Remarkable Piece of Equipment"

"Remarkable Piece of Equipment"

Westie,
I had on On-X valve "installed" last September in the aoritc position. I also had an aortic root and ascending aorta replacement.

During my initial consultation with my surgeon, he was less than enthused about my request for an On-X valve. He hadn't used one before and said that he would rather stick to the St Jude but he did offer to investigate further for me. He spoke with the On-X people and had some valves sent to him - he called me almost as soon as he opened the package to tell me that he was pleasantly surprised and the valve was a "remarkable piece of equipment" with significant structural improvements.

After my surgery, the surgeon told me that there wasn't too much difference in the surgical technique and he was pleased with the outcome. Now, 6 months post surgery my valve looks great! I'm very happy I went with the On-X valve.