FDA approved trail of ON-X Mechanical w/o Coumadin

[Ross]

It it works out, that'd be great! Only problem then will be the time it takes for our FDA to approve it. You folks might get a faster approval then us.

 

[escargome]

When I was on Plavix, I coughed up blood, had bloody noses constantly and explosive uncontrollable diarrhea. I've heard others having problems with it as well, but don't recall who they were.

While not an expert on Coumadin/Warfarin, I can only agree with Ross on the effects my husband suffered when put on Plavix after triple by-pass surgery. He also suffered with diarrhea issues and as a long distance truck driver that certainly was not conducive to his work environment. Additionally any slight bump to his skin resulted in bruising/bleeding under the skin. After discussing with his cardologist, he was placed back on aspirin at 325mg dose daily. No more problems.
However, I do applaud those who will be pioneers in this clinical trial, but I'm still glad I chose a biological valve for my replacement.
It's that old saying "different strokes for different folks" oops I'm dating myself

 

[vprnet]

ON-X Life Tech info on surgeons

ON-X Life Tech info on surgeons

For those interested in the ON-X this was a reply from the valve makers to me when I inquired and about those experiences with an aorta cuff.

Below are the surgeons in NJ and New York City that have used On-X in 2008. There are more than this but these are our best customers in your area right now.

Joseph DeRose MD, Albert Einstein, The Bronx
David Johnson MD, Jersey Shore UMC, Neptune NJ
Richar Neibart MD, Jersey Shore UMC, Neptune NJ
Yoshifumi Naka MD, Presbyterian, NYC
Mehmet Oz MD, Presbyterian, NYC
Daniel Swistel MD, St. Luke's, NYC
Mark Connolly MD, St. Michaels, Newark NJ
Margarita Camacho MD, Beth Israel, Newark NJ
Joann Starr MD, Beth Israel, Newark NJ

We are working on a valve conduit--the product used to replace the aortic root when there is a dilation. It is not complete yet. But we have had great success all over the USA with surgeons assembling the conduit during surgery. It only takes about 5 extra minutes and most surgeons are very familiar with conduit assembly. There have been no extra complications reported by our surgeons for doing this.

The most frequent user by far of any of the surgeon listed above is Dr. Naka at Presby in NYC. He more than likely has made a conduit with the On-X valve. In New Jersey it is Dr. David Johnson. If you want contact information for any of these surgeons, please let us know.

As to the study, we have completed our enrollment of centers, I believe. But I can ask for you and let you know. The qualifying centers have to have enough volume of mechanical valves each year in order to participate. The closest participating center to you would be in Philadelphia at the University.

We hope this information helps. Please let me know if you have further questions.

Best regards,

Catheran Burnett RN BSN
Manager, Clinical Projects and Education

On-X Life Technologies, Inc.™
Office: 888 339 8000 x 265
Cell: 512 413 9469
Fax: 512 339 3636
E mail: [email protected]
www.onxvalves.com
www.heartvalvechoice.com


PS. I am not a medical professional or a doctor. My comments in this forum are my own opinion and are not intended to be given as medical or professional advise or a recommendation of any valve choice. Decisions that affect your health and wellbeing are ultimately yours and your doctors. vprnet

 

[marciemarine]

In November 2006 I had both my aortic and mitral valves replaced with ONX mechanical valves and have been on warfarin. I have consistently been on a very low dosage. (1 mg on Sun and Wed, and 1/2 mg every other day of the week. I get regular blood tests and it has been this dosage for over a year. I think I've been fortunate and I'm very happy with my OnX valves!

Marcie

 

[vprnet]

Thanks Marcie,

Are you in the ON-X study or did you doc offer the low dos regimine to you anyway?

Vince

 

[ALCapshaw2]

In November 2006 I had both my aortic and mitral valves replaced with ONX mechanical valves and have been on warfarin. I have consistently been on a very low dosage. (1 mg on Sun and Wed, and 1/2 mg every other day of the week. I get regular blood tests and it has been this dosage for over a year. I think I've been fortunate and I'm very happy with my OnX valves!

Marcie

What is your recommended Range for INR?

I don't know how to interpret your dosing schedule.
Does "1/2 mg every other day of the week"
along with 1 mg on Sunday and Wed mean that there are some days you take ZERO mg of Coumadin/Warfarin.
This description is as clear as mud to me.

'AL Capshaw'

 

[ALCapshaw2]

Some people here are confused about the difference between Coumadin and Plavix or Aspirin. You can not alternate Coumadin and Plavix because they do not do the same things. They have different mechanisms of working.

Coumadin = venous clots like deep vein thrombosis

Plavix and Aspirin = arterial clots like stroke and heart attack

The reason why Coumadin is used to prevent clots originating from ventricles that goes to the arteries instead of Plavix or Aspirin is because the structure of those clots is most similar to those of DVT.

A more complete explanation would include a statement to the effect that Coumadin / Warfarin are Anti-Coagulants and Plavix / Aspirin are Anti-Platelets.

My understanding of the NO (additional) Risk Clinical Trials with the On-X Valve place the NO Risk Patients on Plavix and/or Aspirin with NO Coumadin/ Warfarin.

My understanding of the LOW (additional) Risk Clinical Trials with the On-X Valve place the LOW Risk Patients on a Lower than usual dose of Coumadin / Warfarin (actually a Lower than normal INR range which results in a lower than 'their' normal Dose of Coumadin/Warfarin).

The details of those studies can be found on the On-X website.

UIHCCHI - It would be useful to me (and probably others as well) to know more about your background in your stated occupation of "pediatric cardiology". Are you an MD, PA, CRNP, RN, or something else in the field?

'AL Capshaw'

 

[Fran]

I was on Coumadin due to a clot in my arm immediately following my aVR wiht an ONx valve. Due to a bad combo with Zpack in January, and that I was supposed to be on Plavix and aspirin combo (81mg), I switched over then. I was in the study. At Thanksgiving I was in ICU with a horrible stomach ulcer attributed to the ASPIRIN and I guess the Plavix just sped up that whole thing. I was in dire straits there, sicker than I was the day after the AVR.

I'm doing Lovenox now and the ulcer's healed and I'm going back on the Coumadin as soon as my cardiologist's office opens again.

Plavix and aspirin - I bruised if someone looked at me funny.

I chose the ONX valve because of my age and the fact it'd take LESS Coumadin if I had to be on it, not to avoid Coumadin altogether. Dr A said the tissue valve would wear out due to my metabolism, being younger.

My home healthcare nurse, Martha, smartest woman I've ever met, said the Plavix is like Teflon on your platelets so that they can slide past each other. I thought that was a cool analogy.

 

[vprnet]

Hello fellow HVF friends,

Just an update,

I came home on Christmas day with my new ON-X AV. Today is the frist day I can honestly say the aches and pains are not dominating my day and it feels wonderful to be home this way.

I cannot thank all of you and this forum enough for all the compassionate support that helped me through this... no doubt the most challenging period of my life. And I learned so much along the way!

It will be my committment to return to the forum to share my experience and bring encouragement to my fellow AVF friends.

I wish you all the blessings of happiness and health as we enter the new year.

Vincent
AVR ON-X December 19, 2008

 

[Teresa]

Welcome Home!

 

[Woodbutcher]

Welcome home Vincent ! Here's wishing you a speedy recovery and happy 2009.

 

[skeptic49]

Great to read your post, Vincent! Congratulations and welcome to the other side of the mountian. Hey, I envy you that shiny new ON-X valve. I hope to have one someday soon. Please be sure to post of your experiences with the PROACT trial.

Jim

 

[Fran]

Woohoo, fellow Onx recipient! Take each day nice and slow and breathe all that wonderful O2 deep into your (much happier) system.

Congrats - job well done!

 

[ctyguy]

Great job Vincent !

Im 10 months post-op also with an On-X. Other than having to take a few pills each day I have no complaints at all.

Keep up the good work your gonna be bouncing around like your old self in no time.