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Trifecta Valve Gets Approval From European Union And… Joe

By Adam Pick on March 10, 2010

As many of you know, this is a very exciting time for the heart valve surgery community given the rapid advance of medical technologies used to treat diseases including aortic stenosis and mitral regurgitation.

Last week, St. Jude Medical, one of the leading heart valve manufacturers, cleared a significant hurdle for the commercial release of its new Trifecta heart valve replacement. In case you missed it, St. Jude announced that its Trifecta valve received CE mark approval for the device within the European Union. (The device is still in clinical trials here in the United States.)

St. Jude Trifecta Heart Valve Replacement Devicement

Trifecta Heart Valve (Source: Medgadget)

As we have discussed before, the Trifecta heart valve is a pericardial, stented tissue valve used to replace a patient’s diseased, damaged or malfunctioning aortic heart valve. According to the St. Jude, this next-generation tissue valve has a tri-leaflet stented pericardial design which offers excellent hemodynamic performance, or nearly unobstructed blood flow, which closely mimics the blood flow of a natural, healthy heart. The valve also features the Linx AC Technology, an anti-calcification treatment designed to reduce tissue mineralization (hardening).

Specific to the patient perspective on the Trifecta valve, I recently opened an email from Joe Worden about his aortic valve replacement. As you can read below, Joe received a Trifecta heart valve replacement, nearly a year ago. Here is what Joe wrote to me:

Hi Adam –

I recently celebrated my one year anniversary of aortic valve replacement surgery at the Cleveland Clinic. Just before my surgery, my wife found your website and ordered your book, The Patient’s Guide To Heart Valve Surgery. I continue to stay on your mailing list to monitor and comment occasionally on your blog. Thanks so much for making the commitment to continue helping people by constantly making more information available.

In reading the post about Jack LaLanne valve surgery, I noticed your comment wondering that if LaLanne had a valve replacement — might it be a pig valve, a cow valve, or a mechanical valve. As you probably know, there is another option for Jack LaLanne known as the Trifecta valve. I personally know about the Trifecta valve because I received this valve as part of its clinical trials here in the United States.

Trifecta Heart Valve Replacement By ST. Jude Medical

To say the Trifecta is a completely new valve device is… not necessarily accurate.

In fact, the Trifecta valve is really just a new twist on a tried-and-true valve replacement device from St. Jude. The valve leaflets are tissue (bovine). The valve frame is metal (titanium). The new twist is that the metal frame on the Trifecta valve is covered in porcine tissue. Thus, I have both cow and pig tissue in one valve with a metal frame… I guess that is why it’s called the “Trifecta”.

The valve is also coated with a long-lasting substance to enhance its anti-clotting ability. The hope is that the design will add longer life to the valve.

I did quite a bit of soul-searching before deciding to use the experimental valve. But since it’s just a small change on a very successful valve, I decided to go ahead with it. After all, if no one had used experimental valves before me, I may not be here to tell my tale!

I’m healthy now and I made it through my surgery just fine. Still, I’m 56 so the possibility exists that I may need to have the Trifecta replaced. If that is required, I’m hoping a less invasive procedure will be available. Personally, I just couldn’t bear the thought of dealing with Coumadin for the rest of my life, as well as hearing a mechanical click in my chest all the time.

Again Adam, thanks for your commitment to helping others!

Joe Worden

Written by Adam Pick
- Patient & Website Founder

Written by Adam Pick - Patient & Website Founder

Adam Pick is a heart valve patient and author of The Patient's Guide To Heart Valve Surgery. In 2006, Adam founded HeartValveSurgery.com to educate and empower patients. This award-winning website has helped over 10 million people fight heart valve disease. Adam has been featured by the American Heart Association and Medical News Today.

Dolores Wisecarver says on March 13th, 2010 at 2:17 pm

Hi Adam,
I loved your book. I’ve read it cover to cover, twice. My husband, now 56, has a bicuspid aortic valve and an aortic aneurysm. Our surgeon said that the mechanical valve has shown to last a whole lot longer than the porcine valves or a human cadaver valve. Did your doctors give you any indication as to how long this human valve will last in the pulmonary position? Also, you mentioned you had lung problems after the surgery which was alleviated with regular use of the spirometer. Do you think that was also aggravated by the fact that the pulmonary valve had been replaced?

I am amazed at this new possibility of the Trifecta valve.

Judy says on March 13th, 2010 at 4:29 pm

Dear Adam,

The St Jude trifecta valve sounds promising for someone like me, 66 years old with a small aorta. Where can we find out more about its approval in the EU, the trials going on in the US and technical information about the valve. My cardiologist and surgeon do not know anything about it? Thank you for all you are doing.

Judy

Ludmila Khalid says on March 13th, 2010 at 8:26 pm

Dear Adam,
I am 55y.o. NICU RN for the past 10 years who stopped working do to severe
MVP. Planning to see Dr.Gaudiani who already agreed to a repair surgery.However,in the course of operation Dr.Gaudiani will know for sure whether my valve is repairable. And I hope it is. Meanwhile,my concern remains
that I might need to assume the possibility of replacement vs.
repair. My question to you,Adam is do you know if Trifecta valve can be used
for MV replacement?

Sincerely,Ludmila.

Ann says on April 7th, 2010 at 10:45 pm

Message to Judy – I have a trifecta valve. My surgery was 9/09 by Dr. Donald Glower at Duke Medical Center in Durham, NC. Wonderful surgeon and hospital!

Ray Bachmann says on November 4th, 2013 at 2:38 pm

Just celebrated my 5th anniversary of having a trifecta valve replacement procedure. Annual follow-up with my surgeon, Dr. Oliver Binns and with Mission Hospital in Asheville, N.C. have been most positive. Annual Echo has looked good—–Very pleased with all parties involved——Mission Hospital System, my surgeon—Dr. Oliver Binns and my cardiologist, Dr. Ben Trichon. Exceptional support and care.

Ray Bachmann

Rahul says on October 21st, 2015 at 3:39 am

I was fitted with a Trifecta Arotic valve in June 2013 at Max Hospital, Saket, in India by Dr Rajneesh Malhotra Chief – CTVS and I am doing fine till now.