Onxy vs St Jude Regent?

[Boo I need a valve]

Hi all.
I just found out I am in need of a valve replacement. Pretty scarry stuff for a first timer, but the forum here has helped me a lot. Thank you all!

I am having my aortic valve replaced at Stanford in roughly two weeks (the week of Aug 15).

I am considering asking my surgeon to use an Onyx valve. I'm 36 and otherwise very healthy and active, so the potential of getting a valve with a reduce need for Coumadin is interesting to me.

Does anyone have additional research information you can send me that can help me make a smart decision. I have already reviewed all the Onyx web material. I found it compelling, but highly selective in how it compared itself to other valves. As such, I am especially interested in info associated with my age group and info that compares Onyx to the Saint Jude Regent (many Onyx comparisons were vs older St Jude models) and I understand the Regent is St Jude's latest and gratest, not to mention the primary competitor to Onyx.

My sergeon feels there is very little difference between the two (Onyx Vs St Jude Regent), has more experience with St Jude, but is willing to go iether way.

Any info or advice would be much appreciated
Adrian

PS - I have already sent an email to Catheran at Onyx (as suggested in another thread... I'll pass on any good info I get.

 

[Ross]

My personal opinion, if you can get an On-X, go with it. It's hemodynamics are better plus you have the added benefit, that if the aspirin only trials workout, the opportunity to be one that doesn't have to take Coumadin. Not that Coumadin is a bad thing, it's not. Many of us, of course, take it, but finding people that really know how to manage Coumadin patients are few and far between. For this reason, that is why so many of us are self doing and self testing.

My surgeon wanted to use the On-X in me, but needed a grafting sleeve attached which On-X did not offer. Therefore, St. Jude it was. St. Jude is still the gold standard, but I honestly look for On-X to one day over take their throwned position.

 

[WayneGM]

I can't help you with your questions, but wanted to welcome you to the VR community. Glad you found us. Good luck with your valve choice.

 

[ALCapshaw2]

Your best bet is to contact Catheran Burnett, Education and Promotion Manager for On-X (NOT Onyx) at 888-339-8000 ext. 265 or [email protected]

She can tell you more about how the On-X Valves compare with the St. Jude Regent and some of the early history of the Regent. Note that the Regent is only available for the Aortic Valve position.

I have discussed this very topic with her but would prefer that you hear it from her. Tell her that 'AL Capshaw' sent you.

'AL Capshaw'

(First Choice for pending MVR is the On-X Valve)
(Second Choice for pending MVR is the Standard St. Jude Valve)

 

[briansmom]

My son just got an On-X. His current ejection fraction is only 30%. I feel more comfortable with the hemodynamics of the On-x with this low of an EF. Originally, they thought that we would be able to keep his INR on the low side of the 2.0-3.0 aortic valve recommendation. We are still comfortable keeping him on the HIGH side of this recommendation since his EF has dropped. I don't think that the docs would have this same comfort level with another valve. I think that the On-x gets good promotion on this site because it is the only mechanical that offers something "different" than the traditional mechanical valves. I don't think that you will be unhappy with either valve.

 

[Marty]

Our surgeons are very slow to go with new valves. Ten years ago they never stocked the silzone valve and this saved me a lot of trouble. They use the tried and true and will wait till ON-X has been out there for years in hundreds of patients before they use it. Dr Lefrak who is a pioneer and wrote the book on prosthetic valve history and development has told me that new valves claiming no need for warfarin have come on the market regularly for the last 30 or 40 years. Frankly, if I was getting a valve today I would opt to be in the control group rather than the On-X group.

 

[Susan BAV]

Hi Adrian -

I saw, from your very first post, that you have already communicated with On-X, so no doubt that was a good thing. I have read very good hopes for it, even on this thread. My other post was deleted but since you had already contacted me by PM, I thought I should put a greeting back up. Again, welcome to the site; glad you found it!

 

[ALCapshaw2]

Our surgeons are very slow to go with new valves. Ten years ago they never stocked the silzone valve and this saved me a lot of trouble. They use the tried and true and will wait till ON-X has been out there for years in hundreds of patients before they use it. Dr Lefrak who is a pioneer and wrote the book on prosthetic valve history and development has told me that new valves claiming no need for warfarin have come on the market regularly for the last 30 or 40 years. Frankly, if I was getting a valve today I would opt to be in the control group rather than the On-X group.

Marty,

FYI, On-X HAS "been out there for years in hundreds of patients". Actually, over 55,000 On-X valves have been implanted in patients WorldWide over the last TEN YEARS. The FDA approved On-X Valves for use in the USA 5 years ago.

The FDA later approved the "reduced" anti-coagulation studies for On-X Valves based on encouraging studies in Europe and Africa. The South African study was especially interesting because over 40% of the recipients were non-compliant in taking their anti-coagulation medication to some degree.

The FDA NEVER approved the "older" mechanical valves for "aspirin only" studies because of "their proven record of high complication rates" per Catheran Burnett, RN, Manager of Education and Promotion for On-X. Chatheran has been with On-X for 8 years, preceeded by 2 years at St. Jude, 7 years at CarboMedics, and several years as a Cardiac Surgical Nurse at Baylor in Houston. (She KNOWS VALVES ! - A.C.)

Note that the FDA did NOT require a clinical trial for the St. Jude Silzone Valve before it was released worldwide with unfortunate (sometimes fatal) results.

Supporting documentation for all of the above is available through Catheran at [email protected] or 888-339-8000 ext 265.

'AL Capshaw'

 

[Lynlw]

I've wonderred a couple things after reading about South Africaa few months ago, maybe one of the better minds here than mine can understand it and can explain better to me.
I REALLY am NOT trying to be argumentive,just trying to think things thru
This is from ON-X site
"In South Africa, 438 On-X valve patients have been followed (95 percent) for five years. The patients are documented to have varying amounts of anticoagulation. Approximately 14 percent of On-X patients were categorized as having ?unsatisfactory? or anticoagulation below 1.5 INR. Another 29 percent had ?no? or ?unknown? anticoagulation, which was attributed to poor patient compliance to established protocols. The remarkable aspect of the study is that among aortic, mitral and double valve replacement patients, only one (0.2 percent per patient year) patient experienced thrombosis. "

From how I read this is it really isn't a "study" that I think of w/people put into different groups, with certain instructions and follow and document everything, but more like what was noticed by following the patients since they had their surgery..
it starts w/ 438 patients that got the valve,now I guess the 95% means they were able to follow 95% of the patients but not sure what/where the other 5 % are so don't know what happened to them?
so I'm thinking the 14% who had low INRs and the 29% that had no anticoagulant where that day they checked them,and were the non complient patients given what they should be doing to stay "safe' once they started following them, or did they let them go back to just doing whatever they were in reguards to taken their coumadin? Which I know things are different in other countries, but you would think they wouldn't leave them in danger just to see what happened. So you would think/hope the 14% that had INRs below 1.5 would have had there coum upped so weren't low the whole 5 years.
I also looked and haven't been able to find if there are any reports on what happend to the people from South Africa that had other brands of valves. Does anyone else know of that is available anywhere?
As a side note, since i have trouble sleeping, I also wonderred why they gave mech valves to people that they knew would have trouble getting their coum or whatever caused them to not be complient to start with. Lyn

 

[Marty]

Marty,

FYI, On-X HAS "been out there for years in hundreds of patients". Actually, over 55,000 On-X valves have been implanted in patients WorldWide over the last TEN YEARS. The FDA approved On-X Valves for use in the USA 5 years ago.

The FDA later approved the "reduced" anti-coagulation studies for On-X Valves based on encouraging studies in Europe and Africa. The South African study was especially interesting because over 40% of the recipients were non-compliant in taking their anti-coagulation medication to some degree.

The FDA NEVER approved the "older" mechanical valves for "aspirin only" studies because of "their proven record of high complication rates" per Catheran Burnett, RN, Manager of Education and Promotion for On-X. Chatheran has been with On-X for 8 years, preceeded by 2 years at St. Jude, 7 years at CarboMedics, and several years as a Cardiac Surgical Nurse at Baylor in Houston. (She KNOWS VALVES ! - A.C.)

Note that the FDA did NOT require a clinical trial for the St. Jude Silzone Valve before it was released worldwide with unfortunate (sometimes fatal) results.

Supporting documentation for all of the above is available through Catheran at [email protected] or 888-339-8000 ext 265.

'AL Capshaw'

Al, No doubt about it, On-X is taking a good share of the market and apparently their patients are doing well. Dr. Lefrak recommends that all On-X patients take warfarin and keep their INR 2.0-3.0.

 

[ALCapshaw2]

Al, No doubt about it, On-X is taking a good share of the market and apparently their patients are doing well. Dr. Lefrak recommends that all On-X patients take warfarin and keep their INR 2.0-3.0.

Thank you for clarifying Dr. Lefrak's recommendation Marty.

I have NO problem with that recommendation for patients who prefer to take a SAFE and CONSERVATIVE approach.

Since I already have a Standard St. Jude Valve in the Aortic Position, I will be anti-coagulated for Life, therefore I have little interest in the Low / No anticoagulation study result.

What appeals to me is that the On-X Valve reports the Lowest Incidence of Morbid Events (Thromboembolism, Thrombosis, Hemorrhage) versus their 4 major competitors, especially in the Mitral Position where Clot formation is more likely. This is especially important for those times when one must go OFF their anti-coagulation for invasive procedures or surgery such as MVR at some future date.

'AL Capshaw'

Apologies for the use of CAPS.

The Bold, Italics, Underline, and Icon Features of VR.com do NOT function on my computer with AOL connection.

 

[Phyllis]

Just wanted to welcome you, Boo. Please let us know when you have the definite surgery date so we can cheer you over the mountain and on to a complete recovery.

 

[ALCapshaw2]

Lyn,

You posed some VERY GOOD questions.

I will try to get some good answers for you.

'AL Capshaw'

 

[Susan BAV]

Well, at the risk of getting my post deleted again, I am wondering if it is really necessary, not to mention appropriate, to repeatedly put the very same sales/promotional contact information on the very same thread to a person who clearly states they have already contacted that very same person in their very first post. To clarify, I don't mean this as an attack against anyone or any valve.

 

[ALCapshaw2]

Susan,

I must have missed, i.e. Not Read, the Post Script following Boo's signature line which contained the information that he had already contacted Catheran.

Sorry for the confusion.

'AL Capshaw'

 

[aussie girl]

Many of the patients in the South Africa are socioeconnomically disadvantaged and live in remote areas in primitive conditions they are also often nomadic so contacting them for follow ups has been extremely difficult. Even when finally located getting them to take anticoagulation was difficult. Here in Australia they have been implanting the on-x valve in aborigines for the same reason. These people have a habit of going "walkabouts" as we call it here and can disappear for months at a time going into the australian bush and are virtually impossible to find. Linearized rate of thrombosis % per patient-year for different valves implanted in noncompliant South Africans are as follows On-x 0.2 Medtronic Hall 2.0 St. Jude 2.0 Carbomedics 6.5 . This information was published in the Journal of Heart Valve Disease 2006 ....Mary

 

[Lynlw]

Many of the patients in the South Africa are socioeconnomically disadvantaged and live in remote areas in primitive conditions they are also often nomadic so contacting them for follow ups has been extremely difficult. Even when finally located getting them to take anticoagulation was difficult. Here in Australia they have been implanting the on-x valve in aborigines for the same reason. These people have a habit of going "walkabouts" as we call it here and can disappear for months at a time going into the australian bush and are virtually impossible to find. Linearized rate of thrombosis % per patient-year for different valves implanted in noncompliant South Africans are as follows On-x 0.2 Medtronic Hall 2.0 St. Jude 2.0 Carbomedics 6.5 . This information was published in the Journal of Heart Valve Disease 2006 ....Mary

Thanks, I guess my question at the end about whythey would give mech valves knowing all of this,is why they wouldn't use tissue valves that wouldn't need the meds. My thoughts were since they had sugery, they would want to do whatever it would be to make it easiest for them after it to stay as healthy as possible, the easiestway.
those numbers are a huge difference.

 

[Boo I need a valve]

Thank You All

Thank You All

Thanks to everyone for all the feedback. Dates are coming up fast. I am now scheduled for August 15.

Al, I appreciate the contact point. Please keep posting her name. I sent her an email the same night I posted this info request. She was back to me the next day. She has been incredibly helpful and supportive. She has worked to answer my questions and even sent me internal info. I feel lucky to have contacted her.

In all this, I am very sensitive to what is ?marketing? vs. ?real?. Ie ? X plans to do an Iron man? vs. ?X did run a successful iron man? are very different statements, but in a scan they feel the same. So I look for these inconsistencies.

One example: On one slide I saw, On-x advertised a lower Thromboembolism rate 1.0% vs. 2.2% and a lower hemorrhage rate compared to the St Jude valve (0.6% vs. 2.5%). I was confused as I understand that hemorrhage is associated more with INR vs. valve design.

Catheran provided me with the background to the report. Turns out, INR values were different in the studies. But in my reaction to the inconsistency, I missed the key point.
I think the key point for me to walk away with was that although the On-X test was done at a lower INR mean (2.2), the Thromboembolism was not higher, which one would expect. Instead it was lower. Why a lower INR you ask? Turns out the On-X data is from their European study from 1996 ? 2001, and apparently the docs in Europe are a little less aggressive in their Coumadin dosing.

Per another ten year study on the old St Jude valve (not the regent), an INR of 2.2 would likely have resulted in a TE rate of 2 to 3% and a bleeding risk of 0.5 to 1%. This bleeding risk is in line with On-x on the hemorrhage side, so that made me feel pretty good about the On-X data.

Maybe too much detail, but if anyone wants the actual reports, shoot me a message. Or of course contact Al?s contact Catheran.

So? so far, I have been sold on On-x. Does anyone have a contact at St Jude that could give me their best data?

Adrian (Boo is my dog - a true unphased companion in this - although he seems to have left me and gone to bed)

 

[ALCapshaw2]

Thank you for your testimonial Adrian.

You provided a perfect example of WHY I refer people to Catheran Burnett of On-X. She KNOWS her stuff, has access to LOTS of DATA, and educating patients is her JOB.

Good Luck finding a similar resource at St. Jude! My experience and that posted by Gina (aka geebee) was that extracting detailed information from St. Jude "was like pulling teeth". I encourage you to TRY however. MAYBE they have improved / changed their philosophy about dealing with PATIENTS. If so, that would be good information to share. See www.sjm.com

'AL Capshaw'

 

[noverholtz]

To Boo I need a valve

I got an OnX aortic valve last July. Surgeons in my area were not interested in using a 'new' valve. I worked with Catheran Burnett and she helped me find a great doctor here in Florida who prefers the OnX when mechanical valves are used. Plus he fixed several other problems in my heart, that the two surgeons I interviewed in my hometown did not even address.
He replaced my ascending aorta which was well within the guidelines for replacement (people with bicuspid aortic valves usually have a problem with the tissue in the ascending aorta and mine was quite swollen). Plus he repaired my mitral valve which had moderate leaking. He told me if these things were not repaired, I would most likely be having surgery again in 5 years. If the purpose of getting a mechanical valve is to avoid future surgery, then it made sense to me to get everything fixed at once. I beleive if you find a good doctor he will most likely be informed about the OnX valve as an option.
Before my surgery last year there was a forum member who identified his surgeon in his post. The surgeon was in Los Angeles and I found his website which listed his email address. I sent an inquiry to him regarding the OnX valve and he very kindly replied and told me that in his practice group the OnX valve is the valve of choice when mechanical valves are used.
I like the OnX valve. It is very quiet. I rarely hear it. My recommended INR is 2.2 to 2.8 which I think is good for this valve. I do home testing of my INR.

Best wishes,
Nina