AVR coming soon. Getting OX-X with Asending aorta grat

[new_onx_34]

Sine the day I found out that I need Aortic Valve replaced due to severe aortic insufficiency, I've been browsing through these forums and found tons of useful information. But as the surgery data is coming closer, I'm beginning to get cold feet and forgetting lots of stuff I've already read. So pardon me if I ask the question which have been addresses before.

Little bit of history:
I'm 34 year old male without any other health issues or symptoms. In fact I don't have any symptoms related to aortic insufficiency. I came to know about my bicuspid valve in 2001 but at that time everything else seemed fine so my cardiologist asked me follow-up in few years. Since I never had any health issues I forgot to follow-up and when I got my latest echo, I was told that I need the surgery as my left ventricle is staring to dilate.

LV: Chamber size - End systolic dimension 44 mm
End diastolic dimension 63 mm

I met with the surgeon and he suggested that I should get aortic valve replaced as soon as possible and recommended ON-X valve. My ascending aorta is 40 mm so he would see during the surgery if he needs to do the graft.

Given my case is low risk, he asked if I would like to participate in On-X Valve Reduced Anticoagulation Clinical Trial.
Here is what I found on the internet.
http://www.onxvalves.com/Med_AnticoagulationStudy.asp
http://clinicaltrials.gov/ct/show/NCT00291525

I'm seriously considering participating in the trial.

I'll post more info later but now I want to get to the burning questions I've.

1. I know ON-X valve has been around for a while and lots of people here have got one but I still see lots of big hospitals don't use it. Is it only because surgeon don't want to learn new techniques as ON-X valve is slightly different than other valve? What are the reason you have been given by the surgeons for not using ON-X valve.

2. How about the clinical trial? Anybody of this trail or following the trial very closely. Any incidents reported coming out of this trial?

3. I'm in Boston area and going to have surgery at Beth Israel. I heard Dr. Torre is one of the best person for Aortic Valve replacement. Any feedback.

4. I read about some people getting Aortic Repaired. My cardiologist and surgeon ruled out the option of repair. From what I read so far, repair has a low success rate but I was wondering if I need to take second opinion.

Most probably I would have lot more questions but I want to close this post so that I start getting some feedback.

Thanks in advance. I know we have a great community here.
Kudos to all the people who take time to post such a valuable information here.

-Day

 

[new_onx_34]

Forgot to ash about asending aorta graft

Forgot to ash about asending aorta graft

I remember some post about how ON-X valve is not very well suited for people needing graft as it does not come with the conduit. Any feedback on ON-X with graft?

 

[Karlynn]

Welcome, I'm glad you found us. Good luck with your On-x choice. It is a very promising valve.

I don't know that I'd be willing to participate in the study. I'd be more than happy to benefit from the findings, once they establish that lowered ACT is safe. But for me, it would be too much of a risk to voluteer to be one of the guinea pigs. Particularly since warfarin managed within current protocol is a safe drug to take.

Alcapshaw2 has a contact with On-X that may be able to answer the graft question for you.

 

[briansmom]

My son has an On-x with dacron graft. His surgeon said that sewing on the graft adds about 5 minutes to the surgery. I'm sure that some surgeons would be uncomfortable with the procedure, but our doc does a lot of valves so he had no problem with it.

As to the number of docs using the On-x, I think that most docs are resistant to change something that is working (St. Judes, etc valves). It appears that the docs that endorse the On-X are passionate about it's benefits.

As for the trial, I am not sure that I would want my son to participate, though before the surgery I was all for it. We have found that the coumadin is really not all that big a deal. My son has many heart problems and needs the coumadin regardless of the valve. What I like, is that I feel more comfortable with the On-X, regardless of whether his INR drops down to the lower end of the range.

Good luck and feel free to ask any questions

 

[Phyllis]

Welcome, Fast Eddie had his surgery at Beth Israel with Dr. Torre- click on his name in the members list and read all posts by him and you may also try to private message him. I too, would be loathe to enter the clinical trial, but I wish you the best. Please come back with all questions and be sure to let us know your surgery date.

 

[ALCapshaw2]

The story I hear about the difficulty penetrating the Big Hospital Market is that many of them treat valves as commodities and put the business up for Bid. The Lowest Two Bidders get the business.

Don't you just love the technical merit of that system?
Aren't you glad they don't have imports from China yet?

'AL Capshaw'

 

[new_onx_34]

On-X Valve Reduced Anticoagulation Clinical Trial

On-X Valve Reduced Anticoagulation Clinical Trial

I see the point of view of avoiding any additional risk given everything I'm going through.

Here is are some pros and cons I've thought about. Please add your thought to the list.

Pros:

1. People in the trial will be monitored very closely. Lots of people will be looking at every report and comparing it with all the other people in the trial so any abnormality will be detected quickly. One will benefit from the collective wisdom just like this forum.

2. People in the trial will have home testing machine to monitor their INR more regerously.

3. I'll be making small contribution to the over all well being of humanity.

Cons:

1. As 34 year old father of 2 small kids why should I add even slightest risk in the mix.

2. Once I get the ON-X valve, I'll benefit from the study even if I don't participate then why bother participating in the risk.

3. ON-X is relatively new valve so any claims about its benefit may not hold true in the long run. So I'll be in worst situation than people going with more convetional valve.

<Updated based on the further reading on this topic)
4. Plavix is an antiplatelet drug. Unlike coumadin which has the INR, there is currently no blood test to monitor or determine whether one is in a therapeutic range.

5. There is no quick way to reverse this drug.

6. Some members have reposted higher incidents of bruising.

Here are the other points to consider:

1. If people like me who are otherwise very healthy and free from any complication will not participate in the trail then who will?

2. This study is new in US but similar trials have been done outside US so I'm not the first one on the block. I don't know how many people are in the trial in US till date.

3. With all risk considered, additional risk added by being in the trail might be very low.

It would be nice to hear from someone in the forum who had the option to participate in the trial and accepted or declined.

I asked number of people I know and opinion is mixed.

 

[new_onx_34]

Thanks

Thanks

I'm very thankful to all the people who responded so promptly.
My surgery is on September 10th.
I'm sure this forum will be tremendous help in keeping my anxiety low and moral high.

I'm new to this forum and I'm not sure If I should cross post in Pre-Surgery forum. Any advice?

Thanks again.

 

[Lynlw]

There was someone a little while ago , that had the option of going in the trial, I've been looking for the thread since he had a few good replies from what i remember, but haven't been able to find it,maybe someone else can find it.
Since you asked, I'm not a heart patient, my son is, but personally I wouldn't go on the trial,my big fear in life has always been a stroke, and even with monotoring, strokes don't give warnings.That would be my concern especially with a young family to provide for. Also plavix can be even trickier than Coumadin since you can't monitor it and i know some people have problems w/alot of bruising, bleeding ect on it.
I'll see if I can find that thread again, I wish I could remeber who the member was, it would make it easier to find. Lyn
found it http://valvereplacement.com/forums/showthread.php?t=21708&highlight=clinical+trial

 

[ALCapshaw2]

I believe in the technology and am comforted by the fact that nearly 60,000 On-X valves have been implanted around the world since it's introduction in 1996. I think it is the best mechanical valve on the market.

Your reasons 1 and 2 in the Con List are pretty compelling for NOT participating in the study.

Cons:

1. As 34 year old father of 2 small kids why should I add even slightest risk in the mix.

2. Once I get the ON-X valve, I'll benefit from the study even if I don't participate then why bother participating in the risk.

 

[brd]

Day, I believe "Isis" is scheduled to have an OnX implanted on Sept 11 (see today's posts).

I personally would not participate in the trial due to the risk of stroke.

Barbara

 

[Phyllis]

I think the biggest con is that you are the father of two small children and I would not take the risk for that reason alone! Wishing you the best and I will put you on the calendar for September 10.

 

[uchong]

Heart Hugger

Heart Hugger

before you are put out for the op. you need to tell them when you wake up you want a HEART HUGGER STERNUM SUPPORT HARNESS. IF you want to know what it is go to www.hearthugger.com it`s for your own good. i wish you all the best in the world.

Bill

 

[fencemeister]

My Thoughts/partial Story

My Thoughts/partial Story

First Let Me Say I Am Quite Shocked At The Number Of Young People With Heart Problems. I'm 62 An Just Found Out 2 Weeks Ago That I Had A Problem That My Dr. Says Started On My Birthday 3/17/45!

My A/v Was Barley Working! Lot's Of Quick Decisions Were Made And To My Extreme Delight Were All The Right Ones.

I Was Cast Into A Group Of Younger Dr's In Ft. Wayne Indiana Where We Raised Our Kids & Now Spend Our Summers(winter Naples, Fl) And Ended Up With A Saint Of A Surgeon And A Great Card. Guy.

I Came Home From The " Kick In The Head" Announcement That I Needed Surgery. And Found This Site And Thru It The On-x Valve.

My Dr. Had Not Used One And Was Very Open To Putting It In For The Same Reasons That I Chose It.

I Had My Surg. 9/6/07 And All Is Well. I Really Lucked Out In The Accommodations Area. Every Time They Wanted To Get Me Out Of The ICU There Were No Rooms Available And My Entire 8 Days Were In The ICU! Just Got Home Yesterday With What I Think Are The Normal Aches, Pains,pooped Feeling, Swelling
Etc.

My Dr. Was "giddy" Over The On-x Valve. He Said I Had The Ugliest, Most Deformed, Stone Like Looking Thing He Had Ever Seen. I Told Him That I Wanted To See It And He Had The Lab Wash It Up And Sent It To My Room In A Small Bottle. It Was In 2 Pieces And They Rattled Around In The Bottle Like Rocks! Looked Just Like Barnacles! Then He Had The Lab Make Up An 8x1o Glossy For Me To Take Home!

He Said Because Of The On-x Design That He Was Able To Put One In 2 Sizes Larger Than He Could Have With The One He Had Been Using.
And Quiet! He Could Hardly Get Over It. You Need A Steth. To Hear It. He Liked Every Aspect Of It. On-x Sent In Two Guys To Coach Him And Were By His Side All The Time.

I Have No Idea Whatsoever That It Is In My Chest, Even In Bed At 2 Am Lying Dead Still. The Only Reason I Give It Any Thought Is That It Is New And Everyone Is Talking About It.

I Will Try To Get Into The Study If I Can Get The One Using Plavix And Aspirin. If Not I'll Wait & See What I Settle Out At With The Comedian And If It's Close To The Study Doses Probable Won't Do It.
It's All Or Nothing With Me!

You Sound Like A Bright Young Man Who Has Done His Homework. The Best To You And Your Family....

Mike
On-x A/v-- 9/6/07 And Lov'in It!