Deep dive into the literature: my findings about On-X

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I just got back from my surgical consult and I am having the On-X valve. According to my surgeon one reason that the On-X isnt as widely used is that it sits "taller" in the annulus and is more difficult to install properly without a lot of experience. He also said that if your annulus is small he would recommend a different valve to avoid issues.
 
Robotic Surgery

Robotic Surgery

Hello Friend:

You seem to know quite a bit about this. My question is for my 75 year old Dad, I don't want his chest cracked open for a valve replacement. Have you heard of a company that coordinates non-surgical aortic valve replacement for Americans, this is available in Europe.

Thanks.

Meredith


Meredith,

You may try looking at Scripps Health (http://www.scripps.org/services/hea...nt__cardiovascular-and-thoracic-surgery-group
 
Hello - just caught up on all the new posts. I was off digesting the feedback (and procrastinating the decision). I've been to the ATS/Medtronic site to learn more about the bileaflet valve that NormOfTheMonth pointed me to. There is certainly a lot to like about both the On-X and ATS valves. However, with sincere due respect to the companies that devote their resources to developing better valve options for us, I find it difficult in my search to sort the hype from the help. For example, on the ATS site, I found a section that directly addresses the On-X claims. In this section, I found microscopic imaging (http://www.atsmedical.com/Physicians.aspx?id=2470) of blood adhering to the very substance that On-X purports to have low-adhesion properties, both in the presence of aspirin and aspirin with plavix. At first I was alarmed. But after my emotional response subsided, I realized that it was impossible for me to interpret those photos or the implication that they contradicted the On-X claims. The caption on the site: "Platelets still adhere and aggregate, no magic!" It occurred to me that stagnant blood on any surface in the presence of oxygen might coagulate and simply bind to the surface in different patterns depending on the adhesion characteristics. Whether that's true or not, those photos, unless taken in an environment that is hemodynamically similar to that of the aortic valve, do not seem inherently meaningful - do they? So, perhaps I lack the medical knowledge to see the relevance of those photos - are they indeed more hype than help? On the other hand, it is only reasonable that Carbomedics would report their own findings in only the most favorable light. So, while I believe both companies promulgate facets of the truth, I find it exceedingly difficult to reconcile the apparent differences between them. If anyone can shed light on this, I'd be grateful.

There's also a practical matter. Let's say for argument sake that the ATS valve is even better suited to low ACT or even non-coumadin ACT than the On-X. What would compel someone to opt for the ATS given that the FDA trials for On-X may result in a non-coumadin option, which does not seem to exist on the near horizon for the ATS? With ATS, one would have to go against current FDA-based recommendations for ACT. I suppose one could argue that the value proposition with ATS is that even on standard ACT (INR at 2.5), one could expect very low rates of thromboembolic events relative to other valves, and also fewer such events when ACT had to be temporarily stopped for whatever reason. Someone please check my reasoning here - I'm sure I'm missing something (which is one reason why this forum is so great).

On a more personal note, I continue to be leaning toward mechanical valves because ACT seems better suited to my psychological makeup than the prospect of resurgeries (understanding that each can happen with either valve type). My local surgeon seems to be experienced with ATS valves, but the other surgeon (out-of-state) that I've met with is considered an expert with On-X. I guess the good news is that I have two good options, but it certainly doesn't make the decision any easier. I'm wondering how big of a factor should it be to have the surgery performed close to home - was this a factor in your decision and in retrospect, would you do anything differently?

Another question: My last echo was in November - I don't remember the numbers but I was told my stenosis was moderate and my insufficiency was severe. I was told that surgery was recommended to occur in the next six months (it has now been 5 months). I recently had a follow-up echo that was unchanged since November, no enlargement of the heart, and still no symptoms. How long could I reasonably wait to have surgery? My cardiologist seemed to think that I should be fine as long as I have it by September, which seems to extend the time frame a bit. Just wondering if anyone had an opinion on this, possibly based on personal experience.

Thank you for all your previous insightful replies and for your patience with my posting and my questions.
 
Hi tobagoto and Eva

Thank YOU VERY MUCH for your posts. OMG, I have been shaking at the knees regarding MHV leakage. Your posts supported my personal hypotheses that MHV leakage is not because of the structural/operating design engineering of the MHV. Rather it is associated with the interrelationship between the sewing cuff and the recipients heart muscle.

Joining the class of 2011 on Mar 21.

I sincerely hope it wasn't something I posted that caused the knees to shake. I'm a newbie navigating this space for the first time, and may have been inadvertently reckless in the manner in which I shared my findings.
 
Hi Pem

I'm 55, male and athletic. Like Bryan and the Duff man [and Greg A], I too like beer!

I was diagnosed Oct 14/10 with critical AS. Along with the replacement of the AV, I will be requiring a graft of the ascending aorta. My home city was not implanting the On-X product. They are now! After dealing with me it's going to be a reality on Mar 21. I'm the Guinea pig. Like you, I did my home work and found On-X to be the superior MAV. Then along came brother normofthenorth and his ATS valve. UBETCHA the stats are excellent. I went out of my way to be implanted with the On-X and I'm not deviating from my destination with the surgeon and On-X.

Alrighty kids, just one little itsybinytinyspiceyweiny thing is missing from ALL other MHV that On-X has and this is, pannus or scar tissue protection incorporated into the design. I even called ATS and posed the Pannus question. Nope they said their is not a design feature engineered into the device to hold back pannus. Normofthenorth and I have been over this before and he is correct. ATS has new school technological advancements incorporated into the device and is worthy or attention. Robthatsme had a St. Jude Masters valve replaced because of pannus causing failure of his first MAV. He is now sporting an On-X AV.

It's to late for me to pursue anything different, as HELL week is just over a week away. Bring on On-X, surgery and rehab. I'm working an extended stretch of shifts so I can be off all next week to enjoy a little of life as I know it pre-surgery and to also prepare for the operation.

How did things go? I hope well!
 
Hi Pem, I have an aortic On-X valve that was implanted last November, I'm doing great. One great set of study results have just come out about the On-X valve performance over the past 10 years, and they're pretty damn good. Check out the link below. By the way, I get these through Google news alerts, I find this tool very useful for anything to do with heart valve surgery, valve types etc.

SHVD: On-X Prosthetic Heart Valve: A Long-Term Multicenter Experience
On-X Prosthetic Heart Valve: A Long-Term Multicenter Experience.
www.shvd.org/abstracts/2011/C113.html
 
duncanjo

Yes you must take warfarin with the On-X valve. In the future, Dabigatran with 81 mg aspirn may be approved for mechanical heart valve recipients. My cardiologist is very positive on the future approval.

On-X is accomplishing a proact study, [which a a Canadian study] setting an INR of 1.5-2.0 for MAV implants. [Warfarin is still required].
 
The Randomized On-X Anticoagulation Trial is found at: http://www.clinicaltrials.gov/ct2/show/NCT00291525

To clarify, it states: "This is a longitudinal, randomized (randomization to occur at the 3 month follow-up) study comparing the On-X valve on low dose anticoagulation (test group) to concomitant control groups of On-X valves receiving standard Coumadin/aspirin therapy, and also to FDA objective performance criteria (OPC) for heart valve replacement. It is a multicenter study consisting of 20 centers in the United States enrolling no more than 1200 patients (200 in each of 6 groups). There are three test arms of the study: low risk aortic valve replacement, high risk aortic valve replacement and mitral valve replacement. Each arm has an equivalent control. Test therapies are: low risk aortic valve replacement - aspirin/Plavix, high risk aortic valve replacement - Coumadin at INR of 1.5 to 2.0 plus aspirin, and mitral valve replacement - Coumadin at an INR of 2.0 to 2.5 plus aspirin. Follow-up will run for 5 years in each patient."
 
Dabigatran with 81 mg aspirn may be approved for mechanical heart valve recipients. My cardiologist is very positive on the future approval.

Update: The initial dosing study was halted early on, significantly more stroke and bleeding events in the dabigatran (pradaxa) group. Cardiologists should not be so optimistic about untested medicine / dosages in higher risk patients... :thumbd:
 

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