Trifecta Heart Valve Replacement By St. Jude Medical
During the past week, I have received two emails from Ellen (in New York) and Paul (in California) about the new Trifecta heart valve replacement manufactured by St. Jude Medical.
So you know, I was not aware of the Trifecta heart valve. Nor did I know that a clinical trial was already underway with actual patients. That said, I was interested to learn more about the Trifecta valve replacement made by Minnesota-based, St. Jude Medical.
Here are some quick facts about the Trifecta heart valve and the clinical trial:
- The Trifecta valve replacement is a relatively new investigational stented, pericardial (cow) tissue heart valve.
- The first implant of the Trifecta valve was completed in July, 2007. The first implant was performed by Hartzell V. Schaff, M.D., Cardiovascular Surgery Division, Mayo Clinic. Doctor Schaff is the trial’s principal investigator.
- Approximately 500 adult patients will participate in the study across 22 medical centers in the United Stated and Canada.
- The trial will evaluate the safety and efficacy of the Trifecta as a replacement for the aortic valve. Efficacy will be determined by the valve’s hemodynamic performance (its ability to deliver blood flow to accommodate the body’s needs).
After doing her own primary research, Ellen wrote to me, “This valve sounds almost too good to be true. The Trifecta valve is stented, with Links technology and supposedly easier to implant. Plus, it was suggested the valve has decreased calcification risk and better blood flow.”
Let’s keep tabs on the Trifecta heart valve by St. Jude. If by chance, you are part of the trial, please Leave A Reply below! FYI, we also started hearing from patients in the On-X mitral valve replacement trial.
Keep on tickin!
Adam Pick is a double, heart valve surgery patient and author of The Patient’s Guide To Heart Valve Surgery, a unique book which integrates the clinical facts of heart valve surgery with the personal experiences of an actual heart valve surgery patient. To learn more about Adam and his heart valve surgery book, click here.
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September 21st, 2008 at 5:35 pm
Hi Adam -
just came across your website & book & I’m thinking of getting a copy. My father just received a Trifecta heart valve replacement Friday 09/19/08 so he’s been in the ICU for a day and a half and is doing very well. We only found out last Wednesday that he needed his valve replaced so it’s been a crazy week. Thank you for your website and the information on it. It has been very helpful and comforting in my family’s time of need.
October 16th, 2008 at 11:36 pm
Hello, I am a 51 year old man that is going to have
heart valve surgery very soon. My Dr. is going to speak to me about this new valve. His name is Joseph Casselli in Houston,Tx. I dont know anything about this valve, can you share anything such as the good and bads. I dont like the idea of a mechanical valve working for me. How long does this valve last?
October 29th, 2008 at 6:35 pm
Hello, I am a 48 year old male. I have had a bad aortic valve since birth. I have had it checked all my life. Over the last year I have noticed that I would get a little more out of breath during exercise. My check up last December did show that the valve was getting more leaky with more stenosis (blocking flow). I started looking into what treatment would be right for me. My primary cardeologist suggested an artificial mechanical valve because it would last for a long time. The more I looked into this option the less I liked the option due to the requirments to use blood thinners the rest of my life. I am pretty active and did not like the idea of being concerned about the side effects of blood thinners.
I then looked into the Ross procedure, I was very interested, I researched this option and found a doctor at the Mayo Clinic in Rochester who has performed the procedure before. I made an appointment and continued research. One thing that stuck in my mind was the fact that with Ross you take a one valve problem and potentially turn it into a two valve problem, I am a gambler but did not like those odds, in the long run.
During my consultation at Mayo, I discussed the above with my surgeon, and he agreed with my reasoning, I was pretty sure I wanted to go with a tissue valve. It turned out that I was a good candidate for the Trifecta study, they gave me details about the valve construction, and information about the study, as well as explaining the planned valve benefits/improvements. I decided (after additional internet research and a few phone calls) that I would participate in the study.
I had the operation on a Friday afternoon, I was in ICU for less than 24 hours, I was up and walking around the next day, and went home on Tuesday morning, 5 hour car ride, and did fine.
That was 6 months ago, I just had my 6 month echo/checkup, and am doing great. I feel excellent, I have no limitations, and so far I am very happy with the Trifecta Valve.
November 9th, 2008 at 5:42 pm
Just read this blog and I am wondering if anyone knows anything about a similar
type of valve for mitral valve replacement as this new Trifecta? I am looking for
a valve that does not require life long Coumadin. It seems that there is not
as much work being done on mitral as there is on aortic.
February 11th, 2009 at 12:02 pm
Hello. I am a 57 year old male. I had my aortic valve replaced with the trifecta valve on 9/26/2007. I chose a tissue valve because I did not want to be on coumadin the rest of my life. The trifecta valve was offered to me with absolutely no pressure. After considering the pros and cons I decided to go with this valve. The surgery went well and my recovery also went well. Because this was a research valve I am being followed by the surgeon and hospital where I had the surgery performed. Every six months I have an echo cardiogram and an examination by the surgeon. My last check up was in November and the echo cardiogram was not the greatest. The gradient (pressure difference) across the valve was higher then it should have been. This could have been a bad reading on the echo but the surgeon seemed a little concerned. I am schedule for another echo and checkup in April so I will get back to this site then and let all know of the reults of that checkup. Good luck to all.
February 15th, 2009 at 10:05 pm
My Father-in-Law had this surgery done on February 10, 2009 at the Vanderbilt Medical Center in Nashville. My husband and I didn’t exactly understand what the Trifecta Valve was or what it did. We have never heard of this before. My father-in-law was having all kinds of problems and the surgeons told him after several different tests that if he didnt have this test, he would not survive too long. He had heard of all the advantages this valve would do for him and after giving it lots of thought, he and his wife decided this was the best decision for him. They knew that he would be under the clinical trials for this and was even told that this Trifecta valve was not even approved by the FDA yet.
He went through the surgery fine and recovered very fast. We all were very shocked over how fast he recovered. By the next day he went to the step down unit and by the end of the week he was able to go home.
I am very impressed with this. He should live a much longer life. He is in his 70’s and I have high hopes for my father-in-law.
Good luck to all and am anxious for the approval from the FDA.
March 7th, 2009 at 9:05 pm
Hi, My mother (Loyce Gleason) was given a tirfecta valve on 2/11 by Dr Starnes. She passed away on 3/4/09. She was part of the study.
Victoria Bjork
March 9th, 2009 at 3:28 pm
I am 64 years old and am considering the trifecta valve but am unsure of the advantage for me compared to a pig tissue valve. Would I notice any difference? We know of the durability of the pig but not the bovine trifecta. Is it worth the risk and additional checkups req’d?
March 9th, 2009 at 3:35 pm
I am scheduled for heart valve replacement in April and wanted to know alittle more about the trifecta valve. I have been asked to participate and it seems like it might be what I need. I am a 48 yr old man who doesn’t smoke.
I am trying to find out if any one has had to use blood thinners and if so have they told you how long?
I am also curious about recovery time and getting back to your everyday life after surgery?
March 20th, 2009 at 3:56 pm
Hi Scott. I will try to answer some of your questions. I am 57 and I had the my aortic valve replaced with the Trifecta valve when I was 55. Prior to my surgery I did a ton of research and I decided that I definitely wanted a tissue valve because I did not want to take coumadin. The concern was that the tissue valve may need to be replaced in around 15 years but with my surgeons OK I decided to go with the tissue valve and I made the decision on my own (with my family) to go with the Trifecta valve.
It appeared to me that the hope with the Trifecta valve (by St. Jude Medical) was that it would have an improved blood flow over other tissue valves. That was important to me because I liked to run and I wanted to be able to run after I recoverd from my surgery.
When I left the hospital the only blood thinner that I was taking was 325mg aspirin. About 3 days after I left the hospital I started to have floaters in my vision. I went to my eye doctor and he said my eyes were fine and to call my heart surgeon. My heart surgeon then put me on Plavix and I stayed on Plavix until my 6 month checkup. The floaters were almost totally gone at my six month checkup. The theory with the floaters (according to my heart surgeon) was that the sewing ring on the new valve sometimes has microscopic particles that break off and get into your blood and this causes the floaters. In time your body builds its natural tissue around the valves sewing ring and this is why the floaters stop. This can happen in all types of tissue valves. Not just the Trifecta valve.
I left the hospital on day seven. I returned to work 3 months after my surgery. I probably could have returned to work sooner but my job is a litle physical and I did not want to take a chance. I started doing some light running around 6 months after surgey. The recovery was not too bad. The main concern is that your sternum is healing well and you do not do something to injure your sternum.
I hope this information helps you and I wish you the best of luck and good health.
April 20th, 2009 at 9:24 am
On April 16th I had another echo and checkup with my surgeon. This was my 18 month post surgery checkup. The echo showed the trifecta valve was working fine with very little gradient. This was a much better report then the one I had 6 months ago. It apears that the results of the echo six months ago were inaccuarate. I have been given the ok to do whatever I want and I plan to start running vigorously.
April 25th, 2009 at 11:58 am
Thanks for this info, Bill! Glad to hear the echo was good. My husband had the surgery on April 14 and also has the trifecta. We will follow with interest the results of this study.
May 15th, 2009 at 8:18 pm
Just signed on to the Trifecta wagon today.Surgery due on Monday at the Cleveland Clinic.(what a nice place). New valve and a dacron graft on my aorta on the menu. Will report back when I know more.
July 9th, 2009 at 6:09 am
My husband is now about three months past surgery and doing fine. He went back to work after six weeks. He is still being careful with lifting, but otherwise he has resumed his normal activities and has also lost some weight. He did go to cardiac rehab and we recommend that. He feels great. So far he has not had an echo. I guess that comes at six months.
July 9th, 2009 at 9:03 am
I am happy to hear your husband is doing well (M. Hult). I have heard only good things from people about the Trifecta valve. I have started running again and I fell great. Good luck to you and your husband.
July 16th, 2009 at 5:02 pm
5/18 @ the Cleveland Clinic had an aortic valve replacement and part of my aorta replaced. Chose to go with the Trifecta Valve. Now 8 weeks post surgery and I feel great-all systems are normal. Cardiologists have given my a big thumbs up and no need for any rehab. I’m hoping that the Trifecta is what they think-better design and longer lasting. Will go for my clinical trail check up in October.
July 24th, 2009 at 3:38 pm
i am getting a trifecta valve on monday at cleveland clinic. will let you know what i think of it as time goes on
August 4th, 2009 at 6:18 am
Thanks Bill and congratulations Mark!! Continued great results for you both. And hope your surgery went well also Allen. My husband is doing great too. I’ll report on his six month check in a couple of months.
August 14th, 2009 at 6:18 am
well, all was goinng well for a while. i developed a pleural effusion and a pericardial effusion and had to be flown back to cleveland clinic. underwent another surgery august 5th and doing well again. problem was NOT due to new valve in any way. my progress is slow, but i think at times i expect too much. still smoke free for 19 days
September 18th, 2009 at 6:34 pm
Oh Allen, hope you are still smoke free!! It’s very hard to quit. Both my husband and I smoked for years but quit on July 15, 1984. (which almost caused a divorce; we were so mean!) Anyway, I was addicted to Nicorette gum for over a year, but finally got away from it all. Good luck to you and hope you are doing well. My husband is going in for his 6 month trifecta check on Oct. 21 and I will post then.
December 23rd, 2009 at 5:17 am
Sorry for the delay in posting about Mike’s 6 month check. Everything looked good. He is feeling well and doing great. He has lost some weight and that also has helped. So far so good!