Carpentier-Edwards Valve 20 year study

[RobThatsMe]

Hi Everyone,

Just wanted to share some information I resently received from my friend Cardio-Star.

Edwards Lifesciences Corporation

Edwards Announces 20-Year Durability Data for PERIMOUNT Aortic Valve

New Data Reinforce Pericardial Aortic Valve's Long-Term Performance

Irvine, California

May 2, 2003


Edwards Lifesciences Corporation, a global leader in medical technologies to
treat advanced cardiovascular disease, announced today that it has completed
a 20 year follow-up on the effectiveness and durability of its leading
aortic pericardial tissue heart valve.

The data indicate that patients 60 years and older who receive a
Carpentier-Edwards PERIMOUNT aortic valve will have a greater than 90%
chance of not needing a new valve for 20 years.

Edwards' PERIMOUNT valve is the world's FIRST and only biomechanically
engineered valve, and is a leader in the $800 million per year replacement
heart valve market.

Four leading U.S. medical institutions, The Cleveland Clinic Foundation,
Montefiore Medical Center, Albert Einstein College of Medicine, and Good
Samaritan Hospital, contributed to the study, which follows a cohort of
approximately 250 patients ranging in age from 21-86 who had received a
PERIMOUNT aortic valve in the early 1980s.

In addition to excellent durability, the study demonstrated the valve's
safety through a low incidence of complications, including bleeding,
thromboembolism and infection.

As these data indicate, the PERIMOUNT aortic valve demonstrates a level of
durability and performance that may make it an even more attractive therapy
for patients who might otherwise face a mechanical or porcine tissue valve
alternative.

"Our PERIMOUNT aortic heart valve has become the valve of choice", said
Anita B. Bessler, Edward's corporate vice president of global franchise
management.

"These excellent 20-year data, combined with the valve's significant
quality-of-life advantages, further support the trend we have seen as
physicians increasingly prescribe pericardial tissue valves for their
patients."

This news follows on the heels of a paper published in the March 2003
Journal of the American College of Cardiology, which provided a
comprehensive review of available clinical data on aortic valves.

Currently, American College of Cardiology/American Heart Association
Practice Guidelines recommend the use of tissue aortic valves for patients
65 years and older.

This March paper concluded that tissue valves are the valve of choice for
patients as young as 60 years old.

Tissue Valves Offer Quality-of-Life Benefits for Patients

Cardiovascular disease is the No. 1 cause of death in the world and among
the top three diseases in terms of healthcare spending in nearly every
country in the world.

Each year, more than 300,000 people worldwide undergo open-heart surgery to
treat their malfunctioning or diseased heart valves.

In many cases, surgeons choose to replace an affected valve with either a
"bioprosthetic? valve, usually made from bovine pericardium or porcine
tissue, or a "prosthetic"� mechanical valve made of metal and carbon.

Due to their quality-of-life benefits, tissue valves are increasingly chosen
by clinicians and their patients over mechanical valves, and are the
fastest-growing area of heart valve therapy products in the United States.

One of the advantages of tissue valves is that patients are not permanently
dependent on anticoagulant or "so called blood-thinning"� drugs, which are
required after a mechanical valve's implantation.

The Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis will be
featured at the Edwards Lifesciences exhibit at the 83rd annual meeting of
the American Association for Thoracic Surgery (AATS) in Boston next week
(May 4-7, 2003).

About Edwards Lifesciences

Edwards Lifesciences is a leader in advanced cardiovascular disease
treatments and the number-one heart valve company in the world.

Headquartered in Irvine, California, Edwards focuses on four main
cardiovascular disease states: heart valve disease, coronary artery disease,
peripheral vascular disease and congestive heart failure.

The company's global brands, which are sold in approximately 100 countries,
include Carpentier-Edwards, Cosgrove-Edwards, Swan-Ganz and Fogarty.

Home address:

http://www.edwards.com

For a summary of the 20-year clinical experience of the Carpentier-Edwards
PERIMOUNT aortic valve, visit -

http://www.edwards.com/perimount


- End

 

[Marty]

Thanks Rob,

Thanks Rob,

Rob, those kind of numbers make it hard to recommend mechanical valves for anybody in the aortic position. I think I mentioned in a previous post that one of our 50 year old heart surgeons told me he would have a bio valve if he need one now and take his chances with a second operation in 15 -20 or more years. You are so good at finding this data that I will ask a favor.
I have a mitral- do you know of any similar data for mitrals?

 

[RobThatsMe]

Hi Marty,

I don't know of any reports or information for your request. But, I wonder if you checked the links to the site from my post and requested the same info from them. Perhaps they can help.

Hope things are well with you!

Rob

 

[mamsram]

THANKS


Being 66 yrs. old, that sure looks like the way to go for me. You made my day (many days) with that good report.

I'll bring a copy of that with me when I discuss my choices with the surgeon.

 

[Don]

Thanks for a great relevant report!

Thanks for a great relevant report!

Hi Rob,
I greatly appreciate your posting that report since I am a receipant of that particular valve.
Or am I ???
The ID card I carry states:
"Edwards Lifesciences, Bovine Pericardial Heart Valve, Model 2700, 25 mm, Aortic"
At any rate I received the implant at age 69 and at the 13-month mark it is working well.
Don
AVR; MI; CCF; 4/02; Cosgrove

 

[RCB]

Maybe I'm reading this wrong but............

Maybe I'm reading this wrong but............

There have been at least 6 studies in the mitral position on CE perimount mitral valves. That data has shown these valves regularly last at least 16 years.
http://www.edwards.com/Products/HeartValves/ClinicalCommuniquePDF.htm

If you look at fig. 16, it show that pt. <60 had 56.9 % freedom from explant. To me that means 43.1 % had their valves replaced. To say that "these valves regularly last at least 16 years.' is certainly not factual if you are in the under 60 group. The data that I have seen from CC, show the freedom from explant is considerable less the younger a pt. is.

 

[Randy & Robyn]

If you look at fig. 16, it show that pt. <60 had 56.9 % freedom from explant. To me that means 43.1 % had their valves replaced. To say that "these valves regularly last at least 16 years.' is certainly not factual if you are in the under 60 group. The data that I have seen from CC, show the freedom from explant is considerable less the younger a pt. is.

I was told by my surgeon at Mayo that a good run for this valve at my age of 36 would be 8 years. I got the impression this was an average. A few years more would have been possible but then so would a few years less...

The newest anticalcification treatment might improve that but it hasn't been used long enough to make any determinations.

 

[epstns]

Re: Exhibit 16 -- I would also surmise that a lot depends upon how young the patient is. If I read the intro correctly the study incouded patients as young as 21 years old. I interpret the implication of the data to be that if the patient is a lot younger than 60, the explant stats are high. As the patient's age approaches 60 at time of implantation, the life expectancy of the valve approaches that of the 60 and older group. Thus for a 58 year old like me, the implication is that my results would be closer to the 60 and older group than to the under 60 group.

Ah, the joy of statistics.

 

[RCB]

The Joys of...........

The Joys of...........

Re: Exhibit 16 -- I would also surmise that a lot depends upon how young the patient is. If I read the intro correctly the study incouded patients as young as 21 years old. I interpret the implication of the data to be that if the patient is a lot younger than 60, the explant stats are high. As the patient's age approaches 60 at time of implantation, the life expectancy of the valve approaches that of the 60 and older group. Thus for a 58 year old like me, the implication is that my results would be closer to the 60 and older group than to the under 60 group.

Ah, the joy of statistics.

Steve, in my opinion, you have a very practical grasp of statistical inference.
No one could argue with you about such a measured statement about what fig. 16 meant. I wish everyone was as thoughtful and perceptive as you before they make a statement! I look forward to your book on "The Joys of Statistics".

 

[Andyrdj]

Mitral valve

Mitral valve

Hi, to add some information to the guy interested in using one in the Mitral position - I understand that the risk of taking Coudamin in the Mitral position due to Atrial Fibrillation is higher, becuase the Mitral area seems to be "nerve central".

Still not certain, mind, and not necessarily life long (AF can spontaneously correct itself)