St.Jude or On-X

[jiniani]

This is my first post in vr.com. I'm living with Bicurpid Aortic Valve for the last 36 years. Though asymptomatic all these years ( I play tennis, badminton, basketball moderately), recent Echo came out at 0.6cm aortic valve opening. Peak pressure gradient is at 130 with mean at 80. I'm looking forward to the surgery in August time frame to get this damn thing fixed and get on with life!!. Hopefully I can play wrestling with my 3 1/2 year old in 6 months!!!:

I made up my mind about mechanical valve. I don't want to go through surgery again in another 10-15 years. I know many young patients in my age group opt for mechanical valve and live happily!!. Taking coumodin should not be a problem for me. I play moderate tennis, cycling and basketball. I don' overdo anything. So I'm not worried about bleeding or other complications.

As I go through this ordeal I will have many questions I know this forum has wonderful people with lotta knowledge. I'm looking forward to get through this phase in my life with the your valuable input.

The big question I have now... St.Jude or On-X? I read about these two valves. I've n't talked to the surgeon yet. However my cardios seem to prefer St.Jude since it is proven. I'm of opinion, if one day On-X is approved for less coumodin it would be of great advantage to me.

For those of you who faced similar choice.. what did u decide? Why? I would like to specifically hear from On-x'ers about the experience. I heard On-X valve is comparitively quiter than St.Jude? Please give me ur feedback.

BTW, I'm from Bay Aea, CA.
cheers
-sk ( call me "sk")

 

[MikeHeim]

The first thing I would like to say (besides "welcome"), is that you really have a great attitude towards surgery. I think we all hope that this is just a bump in the long and dusty road of life, and for the most part, that's all it should be.

Not to get wishy-washy on you, but choosing a valve is really a point of personal preference. Others will come around with experience with both valves, and I'm sure you will get great stories with each. People who are more conservative typically go with the St. Jude. Those who are willing to risk a newer technology may get the reward of reduced anticoagulation with the ON-X. I would choose the latter, but I certainly wouldn't fault anyone for taking the former. Both are great products that should last a lifetime.

 

[Cooker]

I would also like to welcome you. Great place to get the information and the support you will need. Had my AVR on 2-21-06. St Jude mechanical. I can not hear my valve ticking at all. My wife hears it if it is very quiet (I'm not snoring) I was 49 when I had it done and I too did not want the option of having to have a second OHS. My cardio wanted me to choose the St Jude and that is the only one the surgeon will use at this point. I was back at work in five weeks, no coumadin problems and doing very well.

I wish you well; take off your coat and hat you are in the right place.

Tom

 

[Karlynn]

I had my St. Jude installed at the age of 32 over 14 years ago. (And I'm 29 now, so you figure out the math ) So far, so good and life has been very good. One of our members, Randy & Robyn, recently had an On-X installed and really did his homework on the valve. You may want to email or PM him and ask how he arrived at his choice, or have him post it here.

Welcome to our "family".

 

[Ross]

Hello and it's about time you stopped lurking and started posting!

My surgeon wanted to use the On-X in me in 2002, but I required a graft sleeve be attached and On-X doesn't have a model with the sleeve, therefor St. Jude is what I got. Either valve is excellent, though if I could have, On-X it would have been for the same reasons that your thinking of. Doesn't really matter. Either valve will keep you alive! Randy just had his done not to long ago. Hang around for him and I'm sure he'll give you his opinion.

 

[ALCapshaw2]

Welcome 'SK'

I have a St. Jude Mechanical but can certainly understand your interest in the On-X valve. That is a question you need to discuss with your SURGEON. Not all surgeons are familiar with the On-X valve and not all surgeons will use one.

With your numbers (0.6 cm sq opening, 130 psi peak pressure gradient), I don't understand why you have not yet interviewed a surgeon. I'd be wanting to get into surgery in 3 WEEKS (not 3 MONTHS) with those numbers. (My understanding is that surgery is recommended when the valve opening is 0.8 cm sq or less. Again, it's best to let the SURGEON recommend the best time for surgery.

Bottom Line: Start Surgeon Shopping next week.

'AL Capshaw'

 

[Joe Cool]

Welcome sk, from this end of the state.

I am choosing, with my surgeon's and cardiologist's blessing, a mechanical valve for the same reason that you are. From what I have read, there isn't enough difference between the two valves to matter. St. Jude has a proven performance, so I am a little more comfortable going that route. As far as the "what if" on less coumadin for the On-X, when the St. Jude originally came out they thought that they could just use asprin as an anticoagulant, and they were wrong. I don't think that you will go wrong with either choice, for what ever that is worth to you. Good luck.

 

[Dustin]

J Heart Valve Dis. 2006 Jan;15(1):73-8; discussion 79.

North American multicenter experience with the On-X prosthetic heart valve.

McNicholas KW, Ivey TD, Metras J, Szentpetery S, Marra SW, Masters RG, Dilling EW, Slaughter MS, Mack MJ.

Christiana Care Health System, Newark, DE, USA.

BACKGROUND AND AIM OF THE STUDY: This ongoing, longitudinal, multi-center, North American study was designed to evaluate the safety and effectiveness of the On-X valve. METHODS: The On-X valve was implanted in isolated aortic (AVR) and mitral (MVR) valve replacement patients at nine North American centers. Follow up was 98.6% complete. Anticoagulation compliance was evaluated by collection of international normalized ratio (INR) results in all patients throughout their postoperative follow up. Adverse events were recorded according to the AATS/STS guidance criteria. Hematologic studies were conducted postoperatively to evaluate hemodynamics and hemolysis. RESULTS: In total, 142 AVR and 142 MVR implants were performed; the mean follow up was 4.5 years; total follow up was 1,273 patient-years (pt-yr). At implant, the mean patient age was 59.2 years (range: 28 to 85 years); 71.8% of patients who underwent AVR and 33.1% who underwent MVR were males. Preoperatively, 89.4% of AVR patients and 56.3% of MVR patients were in sinus rhythm. The cardiac disease etiology was primarily stenotic, calcific degeneration in AVR and rheumatic or degenerative regurgitation in MVR. Hemolysis represented by postoperative elevation of serum lactate dehydrogenase was very low (median 217 IU after AVR and 251 IU after MVR at one year (82% AVR and 98% MVR of upper normal). Late adverse event rates were low, most notably thromboembolism (0.9%/pt-yr after AVR; 1.6%/pt-yr after MVR) and thrombosis. Kaplan-Meier event-free rates at five years were correspondingly high. Anticoagulation compliance analysis showed only about 40% of INR readings to be within target ranges postoperatively; thus, the control range achieved was much greater than the desired target, as might generally be expected for clinic-controlled INR. CONCLUSION: The On-X valve performed well in this study, confirming the original design intent of minimal hemolysis and low adverse event rates.

--

The supranormal hemolisys is something to take on board.

 

[Perry]

Welcome Jiniani,

I am 42 and just had surgery on 3/8/2006 - I was the first ON-X recipient at Johns Hopkins.

I like your outlook too. I will soon be able to let the two boys in picture (8 & 6) beat the crap out of me again - I can't wait. I am now able to do my morning jog with our dog as well as I could do it the day before surgery but....before surgery jogging was getting more labored and now it's getting easier each time. So go get fixed and back where you should be!!!!!

My surgeon went from "I will look into it" to "it's an excellent valve" once I suggested it the ON-X to him. The ON-X is a very comprehensive design in that they seemed to tweak the standard bi-leaflet design in several areas to improve performance and move toward lower INRs (the number coumadin effects). My INR is supposed to be mantained at as low as 2.0 vice 2.5 for other mechanical valves (someone please correct me if I am wrong). If the ON-X study allows further reduction then great. I think it's quieter than my workmates St Jude but I can hear it sometimes (in the echo filled bathroom in the morning is the best). Really - I don't care about noise. But the choice was not that easy.

All the while the ON-X seemed the way to go I couldn't help but think that I ought to be sticking with the 'ole faithful St Jude. The St Jude is a proven valve and no amount of testing and research can substitute for that. A mechanical valve ought to be a one time fix - it appears to me that this longevity is based more on the St Jude's track record that any other valve. But the ON-X (and other bi-leaflet designs) are similar in design, FDA approved so it should last three full lifetimes etc etc. Mechanically, most any current mechanical should be your aortic valve for life.

You are asking the right people by coming to this site - so read and post and become as informed as you can handle.

Perry

 

[Dustin]

Hemolysis parameters of St. Jude Medical: Hemodynamic Plus and Regent valves in aortic position.

Suedkamp M, Lercher AJ, Mueller-Riemenschneider F, LaRosee K, Tossios P, Mehlhorn U.

Department of Cardiothoracic Surgery, University of Cologne, Joseph-Stelzmann-Str. 9, 50924 Cologne, Germany. [email protected]

BACKGROUND: Elevated plasma lactate dehydrogenase (LDH) concentration may reflect hemolysis due to mechanical heart valve dysfunction. Thus, knowledge of LDH levels in patients with properly working prostheses is required. Because hemolysis parameters for the SJM Hemodynamic Plus (HP) and Regent series are currently not available, the purpose of our study was to determine these data. METHODS: At 12-19 months follow-up after isolated aortic valve replacement with SJM HP(R) or Regent prostheses, we examined 102 patients by transthoracic echocardiography and determined plasma LDH, haptoglobin, bilirubin and hemoglobin. RESULTS: Five patients with properly working prostheses were excluded because of increased LDH due to non-cardiac reasons. In four patients with paravalvular leakage, LDH was 244, 307, 446 and 628 U/l, respectively. In patients with properly working prostheses, LDH was 287+/-52 (range: 163-374) U/l for HP(R) (n=33) and 274+/-48 (151-386) U/l for Regent valves (n=60, p=0.2). Haptoglobin was <1g/l in all patients; in 91% of HP and 75% of Regent valves, haptoglobin was below detection limit. Bilirubin and hemoglobin as well as red blood cell count (RBC) were normal in all patients except for five patients with renal anemia, two patients with paravalvular leakage and four patients with macrocytosis due to alcohol abuse. There was no correlation between LDH and transvalvular gradient (r=-0.02) or valve size (r=0.25). CONCLUSIONS: In patients with SJM HP(R) or Regent valves in aortic position, LDH values > 400 U/l indicate valvular dysfunction or leakage if non-cardiac causes for hemolysis are excluded. However, paravalvular leakage can be present without substantially increased LDH. Haptoglobin has no diagnostic value as it is almost always markedly reduced. Hemolysis does not correlate with transvalvular gradient or prosthesis size.

--

The On-X appears to be less hemolitic than the St. Jude. Time will tell whether this actually improves resistance against thrombus.

 

[Dustin]

I should stop my copy-n-paste session... Anyway, choosing a valve has 1001 variables, where emotion is likely to be de dominant one.

 

[Emma]

On-X website -

www.mcritx.com

 

[jiniani]

Yes, I'm going to see the surgeon in couple of weeks. Initially I was thinking to wait till October, not any more. I will get it done by July/August.

I have Kaiser through my employer. My wife is going to start a job shortly with a small company. They provide PPO. So I have two choices Kaiser or Stanford through PPO. Hopefully PPO will pay for the surgery in Stanford. I have already talked to Dr.Liang in Stanford. And will be talking to Dr.Craig Miller at Stanford shortly. At Kaiser i'm thinking of going to Dr.Hon Lee at Alta bates medical center, Oakland. Any feedback about these surgeons???

Anyway, it looks like On-X would be a good choice. I won't mind doctor sticking St.Jude in me as well. Given choice I'm thinking of going with On-X. I've been reading a lot about On-X. I like what I read so far.

 

[tobagotwo]

I suggest you click on search, advanced search, and search for On-X. There are many threads and posts available that compare or discuss the two.

One earlier post of mine on this subject is a response to a post I disagreed with. A surgeon had told a patient that the St. Jude is very similar to the On-X, and would likely qualify for lower anticoagulation:

Actually, there is a difference in materials between the On-X and the St. Jude, as well as in hemodynamics. I'm surprised the surgeon brushed those issues off so readily.

Yes, both - in fact all of the best-known mechanical valves - are now pyrolytic carbon (thus the term "carbon valve"). However, the processes for creating that material are different. The pyrolytic carbon used in the manufacture of On-X valves is the only one at this time that is free of silicon, which is a part of the manufacturing process for other carbons. This makes its surface more slick than standard carbon materials and less permeable than the carbons used for other valves. It's even less brittle, although the value of that is moot, because all carbons used in valves are capable of outlasting their human hosts several times over.

The hemodynamic differences include shaping that creates flow points where momentary stagnations were previously possible, particularly around pivots, which reduce the blood's ability to clot. Along with the slicker surface and reduced permeability, it also interferes with the spontaneous growth of tissue on the valve.

The valve leaflets are also desiged to fall closed more gently, which causes less hemolysis (damage to blood cells - mostly red cells), reducing the chance and amount of anemia from that cause. This also means that fewer byproducts of broken blood cells are floating through the body. The body is set up to react to a significant presence of damaged blood cell components, and they can raise inflammation chemical levels and even cause enlargement of the spleen. Their very presence can form the base for blood clots or add to arterial plaque.

It may also mean less noise from the valve, but that's not important to function. I believe the amount of noise is dependent on body mass, body density, volume of the area inside the rib cage and above the diaphragm, conductive ("bone") hearing of the patient, volume of lungs, size of the heart, position of the heart, heart rate, and how hard the heart beats (pump stroke impact), and probably a few other things as well...

The current warfarin INR recommendations are really based mostly on years of experience with the St. Jude valve. It is by far the most common mechanical valve and has thus been the dominant valve in all carbon valve studies done over the last decade and a half. If the St. Jude could tolerate a lower INR profile, it would likely have surfaced in that time.

The St. Jude is a fine valve that has probably saved more lives than any other single valve of any type from any manufacturer. But the St. Jude and the On-X are not the same valve, and in no way would I agree that the results of the study under discussion would be interchangeable between them.

There are many posts from others on this topic as well, though, and even some more of mine. As you might guess from this, although the St. Jude valve is an excellent valve, I would personally opt for an On-X valve, were I to go carbon.

Best wishes,

 

[Randy & Robyn]

I became an On-Xer in February and couldn't be happier with my decision.

As you are aware, reduced levels of anticoagulation are possible in the future with the On-X, dependent on the outcome of current studies. That factored heavily into my decision, especially since I had great fear of how difficult coumadin might make my life. Now that I realize it isn't as much of a monster as I thought it might be, I don't worry as much about the outcome of those studies. I decided that, should Plavix be deemed safe in the future, I would probably not even bother switching over to it.

I concur with Perry on the ticking. When I'm in a small, quiet room I can hear the ticking softly but clearly. The vast majority of the time I don't hear it at all. This might be more due to the varying internal acoustics of each person's body more than the inherent quietness of the valve itself. Many people with St. Jude's do no hear their valves either.

I do believe the On-X provides an extra safety buffer if and when your inr drops to suboptimal levels as it does with many people occasionally.

There are other design features of the On-X that could prove beneficial after more time has passed. It was designed to prevent tissue impingement of the leaflets that sometimes can happen many years after implant as your own tissue encroaches on the valve. Only time will tell if it accomplishes that goal.

I agree with the majority opinion that either valve has the potential to keep you alive and healthy for a long, long time.

Good luck with your decision and your upcoming surgery.

Randy

 

[Troy]

I really like the ON-X valve and after lots of research and a lot of feedback from ON-X I decided on ON-X. You can email them and they can answer any questions. They are VERY supportive. I had to get a Carbomedics valve because of a aortic anurysm and needed an extention for the aorta the ON-X doesn't have yet. I am REALLY dissappointed, but realistic. I do hear and feel the valve and hard to sleep at night. The ON-X is quieter, you can compare different valves sounds if you do a web search.

 

[Richnlil2]

st jude

st jude

I AM HOPING THAT I AM REPLYING THE CORRECT WAY. I DO NOT KNOW WHAT QA ON-X IS I HAVE A ST JUDE AND HAVE NEVER HEARD IT TICKING, OTHERS HAVE IF ITS QUIET.. BUT MY THOUGHT IS THAT I WOULD LOVE TO HEAR IT TICK AS THEN I KNOW ITS WORKING. IM ON COUMIDAN AND HAVE JUST STARTED THERPY ON MY OWN... (QAS) ITS A GRET THING MY INR HAS BEEN PERFECT FOR A MONTH 3.1 CANT GET NO PERFECT THNA THAT. GOOD LUCK TO YOU IN WHATEVERR U CHOOSE. GOD BLESS.

Yes, I'm going to see the surgeon in couple of weeks. Initially I was thinking to wait till October, not any more. I will get it done by July/August.

I have Kaiser through my employer. My wife is going to start a job shortly with a small company. They provide PPO. So I have two choices Kaiser or Stanford through PPO. Hopefully PPO will pay for the surgery in Stanford. I have already talked to Dr.Liang in Stanford. And will be talking to Dr.Craig Miller at Stanford shortly. At Kaiser i'm thinking of going to Dr.Hon Lee at Alta bates medical center, Oakland. Any feedback about these surgeons???

Anyway, it looks like On-X would be a good choice. I won't mind doctor sticking St.Jude in me as well. Given choice I'm thinking of going with On-X. I've been reading a lot about On-X. I like what I read so far.

 

[afraidofsurgery]

Caveats

Caveats

As you are aware, reduced levels of anticoagulation are possible in the future with the On-X, dependent on the outcome of current studies.

But one really cannot predict what the outcome of a clinical study will be... Will be interesting to see if the promise plays out.

I chose to go with proven technology, although I was very impressed with the On-X valve design.

My surgeon recommended the ATS valve - designed by the same guy who introduced the St. Jude valve, but with a few subtle improvements resulting (maybe by accident?) the valve being quieter. I am extremely pleased with it, and with being alive and having the whole surgery thing behind me, etc. No problems whatsoever so far with coumadin and I'm not concerned about that aspect.

Good luck on your surgery!!!
Patty

 

[RunMartin]

Will the On-X be available with a Dacron graft in the future?

 

[DiscoG4]

On-X

On-X

Hi Jiniani,

Looks of chaps on here have differing opinions on valve election, ranging from the mechanical versus biological debate to what model of either valve to choose, all have good reasons for their choice and there seem to be lots of compelling arguments on either side.

I chose a mechanical valve for 1 reason only, there is no way I wanted to go through the experience of surgery again, and having undergone the surgery on 03/04 this year, I'm very glad I made that decision!

As for the On-X, the decision was made on the grounds of the remote possibility of reduced anti-coagulation at some point in the future. As a former pilot, I felt there may be some chance of a full private licence being granted here in the UK if I was no longer on warfarin. The On-X appears to be the only valve currently offering a glimmer of hope in that direction.

If you're at all interested in the very remote chance that the On-X has to offer, I guess it's the way to go. No problems with the valve since surgery, except it's much louder than I thought it would but according to my GP this is as much down to a patients physiology as anything else.

All the very best for your surgery.

Regards

Steve