Became a Case Study

[Tracy]

I found out I had aortic stenosis 2 years ago, with no changes in my echos in the past 2 years. My last echo was in Dec. 2002. January, I joined the gym and hired a personal trainer. He has asked for a letter from my cardiologist stating I can be pushed as hard as I wanted. He wanted a TEE done first. That was scheduled for Feb 17th. While I was "under" for that another Dr. came in and said not to do the TEE and ordered a heart cath done. I went in for that on Feb. 20th. He said surgery was needed. I saw the surgeon on Feb. 27th and surgery is now scheduled for March 12th. I was asked to participate in a stufy for a new valve - Medtronic's Advantage Valve. I went in fro pre-op today and signed the papers for the new valve. I am told this valve is on the market in Europe but is still not approved in the US. Has anyone heard of this new vavle? I have also noticed that one of the posters had her surgery at St. Joseph's in Atlanta. That is where I am going. I am very nercous about the surgery but am focusing on the things I have control over. Like how to reduce the scar and recovering as soon as possible. I am finding the posts here very helpful, but I feel I have so much to read in such a short amount of time. And I'm sure this will help with my time at home. All this reading will keep me occupied.

Thank you for all your information.

Tracy

 

[Nancy]

Hi Tracy-

Welcome to this fantastic site. You already have lots of cyber heart buddies. We'll help you along as you head toward surgery.

Reading as many posts as you can will help a lot. There is a ton of information here. It will definitely keep you busy. But your surgery is coming up soon, so ask what you'd like to ask, and we'll try to give you as many answers as possible. Things can happen swiftly like that, sometimes. At least you won't have to be thinking about it for too long.

This surgery is truly life-saving, it's well perfected, the mortality rate is low and the surgeons who do it are experts. You'll be home in about 5-7 days and then it's just a matter of healing.

Wishing you the best, and hope to see you here often.

 

[Granbonny]

Hi Tracy

Hi Tracy

That was me that had my valve replaced at St. Joseph's..1 year ago..March 25th. Doing great. My Doctors were the Peachree Cardiovascular and Thoracic Surgeons.Ten in the group. My surgeon was Dr. W. Morris Brown, III....St. Joseph's is a wonderful hospital and staff so great. Please e-mail me if you need other info. [email protected].. You have found a wealth of info on this forum..From pre-surgery to post-surgery..Bonnie

 

[ShezaGirlie]

Welcome Tracy...

Welcome Tracy...

Here's a site you can access for information on the Medtronic Advantage Valve...

http://www.medtronic.com/servlet/Co...t+Valves&Stage=Treatment&Article=hv_art_trial

http://www.medtronic.com/newsroom/news_19991203132151.html

Now, I need to be clear on your situation before I make any comments so I have a couple of questions for you.

Correct me if I'm wrong.

I understand you went to your Cardiologist and he arranged to perform a TEE on you himself on Feb 17th. After you were anesthetized 'another Doctor' came in and asked your Cardiologist to stop the procedure and he did.

You were then scheduled for a cardiac cath/angiogram on Feb 20th and it was performed. Diagnosis was that you need a new aortic valve. The procedure was performed by the Doctor who stopped your Cardiologist during your TEE.

You have made an appointment with the Surgeon for a valve replacement on March 12 -- next Wednesday. Were you offered options as to what kind of valve would fit your lifestyle? And were you told of the differences in valves -- mechanical vs. tissue?

Is St. Joseph's in Atlanta a teaching hospital?

All this seems so fast to me. Have you considered a second opinion? Or third? That's certainly not unheard of in heart valve replacements.

Now, as to being part of a clinical trial and your acceptance of a valve which has not been approved by the FDA... I think you are seriously concerned about this otherwise you wouldn't have found this website and posed the questions you have. I am not aware of anyone claiming to have this valve even though it has been implanted since 1999 in Europe. Maybe someone can enlighten us on this website if they have it.

I have been under the impression that before a valve can be implanted in a patient in the USA it first has to have FDA approval. Please correct me anyone.... I know there are clinical trials out there... Of course we all know that FDA approval doesn't guarantee there will be no problems with a particular valve. There have been recalls after FDA approval.

Tracy, I don't mean to trivialize your concerns about the scar and your recovery. Please continue to read the threads about both issues. Use the 'search' box on the top of the screen as there have been many, many posts about both. Personally, I never even thought of the scar before surgery and haven't since... You should take your time to recover slowly and fully.....don't rush it. But first of all -- don't rush going into surgery unless your Cardiologist and Surgeon insist all tests warrant replacement surgery and you feel comfortable with your decision and trust their judgment.

 

[Tracy]

Shezagirlie,

The TEE was to be done by a technician. But they have a cardiologist on staff there. He called my cardiologist and discussed what he saw on the echo they did just before putting me under. My cardiologist agreed to have the cath done. When I went home that day, I did call my cardiologist to find out why this procedure was stopped and to make sure he knew. I was aware that I was heading toward surgery. I was told 2 years ago that it would be about this time that I would have the surgery. I started at the gym to get into shape for that reason. Somehow, it seems to me that the workouts I did in January and early February may have helped to progress this to this point. I can tell that I have been out of breath more lately, but I was on a mission to lose some more weight and get in shape before the surgery. I am ready for the replacement and I really enjoyed the gym and want to get back to it. My cath showed .7 and two years ago it was at 1.

I don't think St. Joseph's is a teaching hospital.

I was born with a bad aortic valve, or so they assume. I have had a murmur since I was two. And a loud one too. Everytime I go to a doctor, they have to have everyone listen to it. I finally got to listen to it when I visited the surgeon. It sounds like a washing machine!

As far as the new valve is concerned. I know very little about it. The surgeon said he would use this one or the St. Jude's, which ever I preferred. I figured, if trials were necessary for it to be approved by the FDA, why not help it along and give it a try. I suggested a tissue valve, since I am only 38 and not sure what I would encounter with coumadin. He said he would prefer to use the mechanical valve so he wouldn't have to do this every 10 years or so. After I thought about it, I'm not sure I want to go through it again. I have found pros and cons for both and I guess I'm just trusting that the surgeon knows what he is doing. I hope this explains a little bit better. I feel guilty typing books, but I do appreciate all the help.

Bonnie,

My surgeon is Doug Murphy, with the same group.

Tracy

 

[LUVMyBirman]

Hi Tracy,

Welcome to VR.com.

I think you will find a weatlh of information here on the site. So far, the others have offered sound information to think about for your forthcoming surgery.

I am almost 4 years post op with one of the few implanted Medtronic single leafltt valves out of the members on this site. Beleive there are one 2 of us. I have been very pleased with my valve thus far. No problems. Though my valve is and was FDA approved at the time of implant. Seriously don't think I would consider a trial for something this crucial.

I do understand someone has to do it. But from experience.... this is nothing to mess around with.

Looked at the site "Girle" posted and the new Medtronic valve looks similar to the St. Jude bi-leaflet mitral valve that has been used with great sucess. You may want to investigate your options futher before making a decision.

This below comment alone extracted from Medtronic's site would make me reconsider

"CAUTION: The ADVANTAGE® Valve is an investigational device and limited by U.S. law to investigational use.

All the best to you. Keep us up to date on your progress.
Take care....

 

[Tracy]

Gina,

I was just reading that when your post came through to me. They have told me that this valve is being used and approved in Europe but I haven't found any of that info on the net yet. They have told me, I can back out of this at any time.

Tracy

 

[Billy]

Tracy

Please consider carefully what valve you go for. Please do not be duped into thinking that if a valve is approved in Europe that it is necessarily a safe device to have.

I have done a lot of research into this subject and I now realise that new devices which are invented in USA are sent to Europe for testing before they are approved by the Food and Drug Administration in the States.

In Europe they are given the 'CE' symbol of approval which isn't worth the paper it's written on. We don't have punitive damages here so this is simply a cheap way for the Manufacturers to test these devices on the unsuspecting European guinea pigs. One major Valve Manufacturer has actually referred to 'The guinea-pig Continent of Europe' in a recent court case.

I thought long and hard before posting to this thread, but I feel it is only right that I should inform you of these facts. My wife had the misfortune to be given a St. Jude 'silzone' valve in 1998. We didn't realise at the time that this valve had also been sent to Europe for testing and indeed it was eventually recalled in January 2000. My wife died ten weeks after surgery, aged 44 and she too had been a very active person who trained in the gym three times weekly.

It is admirable to think of helping medical science by considering having the new valve implanted, but this is your life that's at stake. Please take good advice, don't take any chances.

I am surprised at the lack of response to your questions, especially from those who have been around here long enough to remember the 'silzone' valve and the resulting consequences. Seems like only a very few want to 'touch' this topic.

I hope that all goes well with your surgery and that you get a valve that will give you a long and trouble-free life ahead.

God Bless,

 

[Rain]

I'm just worried about you, Tracy.

I'm just worried about you, Tracy.

Billy,

I?d respond to Tracy, but I have a totally different attitude about the whole thing than he does. I?d have to tell him that I would NEVER be a ?case study? and that I sincerely hope that he listens to you and Ms. Girlie.

He says.... ?I am very nervous about the surgery but am focusing on the things I have control over.? ! ...... you have control over what valve you get!

See, Billy..... now he?s probably mad at me. I

It's scary enough without being a case study... I hope he changes his mind.

 

[hensylee]

It's only March 10th - you can still change your mind. Many of us know the tragedy of Billy's family - and they have no recourse at all. If this is a 'case study' then that's probably the only way it can be used in USA since it's not FDA tested and approved? Prayers are with you as you go with your surgery - whichever way you finally decide. GODSPEED

 

[Tracy]

I hear you

I hear you

Ok, I am listening. I have been thinking about it all weekend. And yesterday, one of my family members said that I can still change my mind if I want to. So, I guess I was really wanting to hear someone tell me that I was taking a risk that I shouldn't. I was reading posts yesterday. And I can't remember who said it or why. But she said she had to have another surgery because her new valve was leaking. I never thought about this before but it hit me hard. I understand there is a chance that I may have to have surgery again someday. But I started questioning if I was increasing the chances for this to happen. I have one more day to call the surgeon and I think I may just give him a call.

Rain, you are correct about having control over this, or over which valve to choose. The surgeon had mentioned a St. Jude's vavle but I didn't catch the name. Oh, and Rain... I'm a woman, hehehehe. A single mom with 2 teenage daughters, one still living at home. Both, I think are worried about this experimental valve, but don't know enough about it to question me or my decision.

Thank you all for your advice.

Tracy

 

[sylviayasgur]

hi tracy!
i was so glad to see shezagirlie post that!
also, i was waiting for billy to chime in and he did_ just in time.
please remember that this is surgery that will save your life. please don't risk taking a chance on something new. i would recommend staying with the "tried and true" for more peace of mind.
wishing you all the best, sylvia

 

[hensylee]

Congratulations, Tracy - I was recently invited to be part of a case study in a neurological study done by a very reputable university in USA (Medicare apparently gave my name out) and it is locally conducted by a doctor (among others countrywide) that I know (he is my brother's Parkinson's doctor). I pondered it a bit, especially since I know the doctor - but then, I decided I don't want to be anyone's guinea pig. They will have to find out all about the study of Alzheimers' without me! And if they get some good information, perhaps I may someday benefit from that study, but not by being a participant. I wish you well, my dear. God bless - Ann

 

[Billy]

Hi Tracy

I hope that I didn't alarm you. I felt I had to tell you of our experiences. The new valve might turn out to be the greatest valve ever, but if I was in your position I would honestly prefer that it was properly tested before I took it on board.

Maybe your Cardio knows something that we don't, so listen to what he has to say before YOU make the final decision. Your daughters need their Mother, just like my three sons needed theirs.

I will add an Irish prayer to the many others that VR members will be offering for you on Wednesday.

God Bless,

 

[Rain]

It's all scary stuff.... and a decision only you can make.

It's all scary stuff.... and a decision only you can make.

Tracy,

I?m sorry! I don?t know why I assumed you were a male.

I?m really happy to hear that you are considering changing your mind about your valve. It seemed like you had pretty much made up your mind about it and I didn?t wanna rock your boat. It may be a better valve than the St. Jude I have inside me..... but its just not a chance I?d wanna take. I have a nine year old daughter.... I just can?t stand the thought of anyone but me raising her. I?m not even done raising the two boys I have in college.... whether they know it or not!! I?m sure you feel the same way about your children.

You have all my best wishes for a long and happy life with them.

 

[hensylee]

Rain - didn't they tell you? You never get through raising them - my mother was still at it when she was 91.

 

[Rain]

You're right, Hensylee.....

You're right, Hensylee.....

My Mom died a year and a half ago... Absolutely the most traumatic thing that?s ever happened to me... even though I was 40 and she was 80 at the time. I didn?t realize until she was gone how much I still need her.

As for my boys.... now 21 & 19... I think the heart surgery helped them realize how much their Mom means to them. It had quite an impact on my kids, even though we all tried to act like it was not big deal.

 

[Tracy]

I did it, I think.

I did it, I think.

I called the surgeon this morning. I was to leave a message with the person who does the scheduling, and I did. I was also given a name of another person to call and tell her. I did. Now tomorrow morning, bright and early (have to be there at 6:30am) I will tell anyone who will listen that I want them to use the St. Jude's valve. Thank you all. I do feel much better. Still scared as can be about the surgery but feel much better knowing that I have a valve that is used and approved

Billy, I am sorry to hear about your wife. And I thank you for sharing it with me.

the waiting is almost over,
Tracy

 

[Ross]

Tracy try to relax as much as possible and remember that we are all there with you. It'll soon be over and you'll be on the road to recovery and feeling better. I hope someone can post on your behalf to let us know how your doing. Talk to you when your up to it. Good luck!

 

[Granbonny]

Tracy

Tracy

I just e-mailed you..but wanted to tell you..You will be fine. Bonnie