Special Technology Update: FDA Approves First Transcatheter Aortic Valve Replacement Therapy For “Inoperable” Patients

Big, big, big, biggggggg news everybody!

I just learned that the Edwards SAPIEN Aortic Valve has received FDA approval for “inoperable” patients. On the heels of this exciting announcement, there are several implications for patients and caregivers that should be considered.

SAPIEN Valve With FDA Seal
Edwards SAPIEN Heart Valve Replacement

First… This is the first time that a transcatheter therapy has been approved by the FDA for aortic valve treatment. Using SAPIEN, physicians deploy a catheter-based delivery system to replace a diseased aortic valve without any incision to the patient’s sternum or ribs.

Here is a fascinating video animation that illustrates how this amazing technology works to replace a narrowed aortic valve.

Second… It must be emphasized that the Edwards SAPIEN valve is only intended for patients that are “inoperable”.  Said differently, the FDA approved the SAPIEN for patients who are NOT eligible for open-heart surgery. The “inoperable” category includes patients with aortic valve stenosis and other ailments who are turned away from surgical treatment because it is unlikely they will survive the operation. To learn more about stenotic valves, click here.

Reflecting on the SAPIEN announcement, Dr. David Homes, a cardiologist at The Mayo Clinic, noted that the SAPIEN valve is a “game changer” for inoperable patients, many of whom are in their 80’s with medical conditions like diabetes, emphysema and liver disease.

Third… The SAPIEN valve, which is made of cow tissue, polyester and a stainless steel mesh, is intended for patients with aortic stenosis only. The device is not indicated for patients with aortic regurgitation or a bicuspid aortic valve.

SAPIEN Aortic Heart Valve Replacement Implant Procedure

Fourth… Like most surgical procedures, the Edwards SAPIEN valve implant is not without risk. We must remind ourselves that this is a new technology that can and will be improved over time. During my recent conversation with Dr. Lars Svensson, Director of the Aorta Program and Quality at The Cleveland Clinic, he noted that transcatheter aortic valve implantations (TAVI) during the PARTNER trial did result in higher incidences of stroke. Doctor Svensson also noted that the clinicians and Edwards Lifesciences, the manufacturer of the SAPIEN, were working to decrease the stroke rate with strategies including filtering systems.

Fifth… I believe we need to offer Edwards Lifesciences a mighty “Congratulations!” on this important day. From what I understand, Edwards has spent an extraordinary amount of time and money to develop this technology. I am hopeful the Edwards’ team, which is led by Mike Mussallem, is taking the time to celebrate this transformational event for heart valve therapy in the United States.

Mike Mussallem – Edwards Lifesciences CEO

“This day marks an important milestone for inoperable American patients who have long been awaiting a therapeutic option for the often debilitating symptoms associated with severe aortic stenosis,” said Michael Mussallem, Edwards CEO.

If you did not know, aortic stenosis is an often-overlooked and under-diagnosed disease that is deadly. According to reports, aortic stenosis kills 50% of patients within two years after the onset of symptoms. Today, thanks to Edwards’ commitment and pursuit of healthy heart valves, physicians may begin to treat a select, patient population that deserves the attention, the care and the right to live.

Sixth… Edwards is not alone in this accomplishment. Throughout the development of the SAPIEN valve, Edwards has relied upon and benefited from the clinicians – both surgeons and cardiologists – who have supported this effort. Personally, I would like to thank Dr. Smith, Dr. Stewart, Dr. Svensson, Dr. Roselli, Dr. McCarthy and so many others who have shared their clinical updates about the SAPIEN valve with our community over the years.

The medical technology that impacts heart valve therapy continues to amaze me. That said, I will continue to monitor such revolutionary advances, including the SAPIEN, in the future. To instantly receive my latest updates, you can subscribe to my complimentary newsletter by clicking here.

Keep on tickin!

P.S. If you are curious, reports estimate that about 300,000 people suffer from the degeneration of the aortic valve in the United States. According to reports, about 20,000 new patients will be eligible to receive a SAPIEN heart valve here in the United States on an annual basis.

Adam Pick
Written by Adam Pick

Adam Pick is a patient, author of The Patient's Guide To Heart Valve Surgery and the founder of HeartValveSurgery.com.

To learn how Adam has helped millions of people with heart valve disease, watch Adam's video, subscribe to his free newsletter, or visit his Facebook, or Twitter pages.

  • Cheryl

    Adam I am confused by your assertion that the Sapien valve is the first transcatheter valve approved by the FDA. I thought the Melody pulmonary valve was approved by the FDA back in 2010, long before the Sapien. My 13 year old son just recently received a Melody valve and it was a miraculous thing! I believe transcatheter valves are definitely a game changer as Dr. Homes said.

    Eventually, a percutaneous delivery will be the first choice for all valve replacements. As you know, all tissue valves wear out and must be replaced. My son’s next valve will have to be surgically placed because of the larger size he will need by the time the current one wears out. Maybe the one after that can be another Melody valve (we can hope). Or with a little luck medical science will have developed something even better!

    As the parent of a child born with a CHD, I would really like to see more of that part of the valve replacement community represented on your blog. There are many parents out there who have children receiving prosthetic heart valves who have no idea what to expect.

    Congratulations to Edwards Life Sciences on their accomplishment!

  • Hi Cheryl,

    Thanks soooooo much for the catch. I goofed by not clarifying the statement relative to the aortic valve. I just edited it appropriately.

    So glad to hear all is going well with your son!

    Keep on tickin!

  • Norma

    My 79 y/o mom needs to have this (if she qualifies). I say it is a no-brainer (though it is not me having to decide). She has severe lung disease and this is her only option.

  • Toni

    I appreciate this information Adam. Question: Are you aware of any work in the field that includes the transcatheter procedure to replace a biosynthetic aortic valve, or is it solely for native valve replacement?


  • sandra chaplin

    my Mom who is 87 had an angioplasty last week. she has been in icu since then . now that her blood pressure has stabilized, and her oxygen is regulated (has copd) we will go forward with rehab and if she meets criteria, then a TAVR is suggested by the hospital (JFK in florida) i am a bit apprehensive as they have done 45 of these procedures and the high risk of stoke associated with these procedures. what is the per centage of stroke results and are there any other risks involved? please send more info also.

Have A Question? Call Us at (888) 725-4311

P.O. Box 4049
Redondo Beach, CA 90277
Phone: (888) 725-4311