Transcatheter Aortic Valve Replacement as Good as Open Surgery, According to PARTNER Results

by Columbia Surgery on April 4, 2011

Craig R. Smith, MD, FACS

Craig R. Smith, MD, FACS

Approximately 300,000 patients in the United States have aortic stenosis (narrowing of the aortic heart valve), and about one third of these patients are too sick or too old to undergo surgical replacement. Under the leadership of NewYork-Presbyterian Hospital’s Division of Cardiothoracic Surgery, Transcatheter aortic valve replacement (TAVR) has been under study as a less invasive alternative for these patients.

According to to the most recent results of the landmark PARTNER study, TAVR is as good as open surgery in terms of long-term survival. Craig R. Smith, MD, Principal Investigator of the PARTNER study, presented long-awaited results of cohort A to the American College of Cardiology 2011 Scientific Summit in New Orleans April 3, 2011. This arm of the study compared long-term outcomes of traditional aortic valve replacement with the catheter-based method of replacing the aortic valve.

The study found the two methods equal in terms of long term survival. Patients who underwent transcatheter aortic valve replacement were at higher risk of stroke and vascular complications, while those undergoing open surgery were at greater risk of major bleeding.

Results of the first phase of the PARTNER trial, cohort B, were presented in December 2010. This phase found that compared with medical therapy (including balloon valvuloplasty), patients who were too sick or too old for surgery had a 20% improvement in survival after one year with transcatheter aortic valve replacement. In addition to living longer, patients also felt much better and experienced fewer hospitalizations.

Edwards SAPIEN transcatheter heart valve

Edwards SAPIEN transcatheter heart valve

The pivotal results from both cohorts of the PARTNER trial mean that patients with aortic disease now have a new therapeutic option that works exceedingly well. Craig R. Smith, MD, who presented the newest results at a special showcase session at the ACC summit, said in a statement that transcatheter aortic valve replacement “is the most exciting new treatment for aortic stenosis in the past two to three decades.”

At this time, transcatheter aortic valves are investigational devices in the US. Already approved and on the market in other countries, it is expected that TAVR may gain FDA approval as early as late 2011, at least for patients ineligible for surgery.

Dr. Smith is Chairman, Department of Surgery, Columbia University College of Physicians and Surgeons; Chief, Division of Cardiothoracic Surgery, NewYork-Presbyterian Hospital/Columbia University Medical Center; and Surgeon-in-Chief, NewYork-Presbyterian Hospital/Columbia University Medical Center/ Vivian and Seymour Milstein Family Heart Center. Other PARTNER investigators at NewYork-Presbyterian Hospital include Martin Leon, MD, Jeffrey Moses, MD, Susheel Kodali, MD, and Mathew Williams, MD.

Related Link:
New England Journal of Medicine: Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery

{ 58 comments… read them below or add one }

Columbia Surgery May 8, 2013 at 10:01 am

Thank you, Veronica, for your inquiry. I have forwarded your comment onto Dr. Smith. As soon as I receive a response I will reply.

In the rare occurrence you do not receive a response from him, you can always contact his office directly at: 212-305-8312. More information about Dr. Smith can be found on his Columbia Department of Surgery Profile at: http://asp.cumc.columbia.edu/facdb/profile_list.asp?uni=crs2&DepAffil=Surgery

Columbia Surgery May 13, 2013 at 10:02 am

Veronica,

I have received the following reply from Dr. Smith:

Quality of life can be restored to it’s previous level, prior to the symptoms caused by aortic stenosis. Acceptance can be determined in a few days in some cases. How quickly this can be done, and whether it can be done in one visit, depends on what tests have already been done. Assuming a good outcome and normal recovery, return by car or plane is possible.

I hope this information helps. We wish our best to you and your father.

Kathleen M. July 18, 2013 at 2:19 pm

Hi. I am an RN and was referred to Dr. Smith by my cardiologist, Dr. Millman. Your hospital is out of network with Qualcare. I have a congenital bicuspid valve and will need surgery to replace it per Dr. Millman. Is there anyway that Colombia Presby. would accept out of network fees from Qualcare as sole payment? I cannot afford to pay thousands of dollars to have this done.
Please advise.

Columbia Surgery July 18, 2013 at 4:35 pm

Hi Kathleen,

Thank you for your inquiry. I am looking into your question at this time and I will respond as soon as I have more information. Thank you for your patience.

Best regards.

Columbia Surgery July 19, 2013 at 9:27 am

Kathleen,

Please call Michelle Castro, who will be able to handle your questions regarding insurance. Her office number is: 212-305-0826.

I wanted to alert you that she will be leaving for vacation shortly, so please try to get in contact with her today.

Thank you. Best regards.

Shana October 28, 2013 at 2:39 am

Dear Dr. Smith
I am 72 years old , 5’3”, weigh 225 lbs and have an A1C of 6.7. My doctor recently did an angiogram on me and said my arteries are ok, and my aortic valve is narrowed to .9 My bp is under control as is my cholesterol. I currently take atenelol, simvastatin, losartan HDCD 100/25, and 81mg of aspirin plus 1000mg of metformin daily. I am suffering from recurrent chest pain and shortness of breath, – cannot stand on my feet or walk without getting breathless and if I’ve eaten within 2 hrs, – chest pain. I swim 2 hrs a week, and recently began to have some discomfort when swimming or walking even if I haven’t eaten for 2 hrs. before. Lately I’m feeling more fatigued as well. I am wondering whether I could be considered for TAVR surgery. I feel very handicapped by my condition, but am afraid of open-heart surgery. I had thrombophlebitis after a c-section and after a miscarriage, and my mother had a stroke followed by a heart attack at age 65. She died after 6 yrs of being unable to speak, read, or write. She still had alot of intuitive understanding and a beautiful smile….but it was tragic that a highly intelligent social worker was so disabled. I am a family therapist, have a husband, 8 married children, 54 grandchildren and 6 great grandchildren – in short – a lot to live for! I would like an easy procedure in terms of recuperation, and a low risk procedure because I’m so afraid of stroke, and disability. I know I’m asking for a lot! I’ve read your reports on line and am very impressed, and interested in the latest info that hasn’t been written on the website yet in terms of outcome and complications. Please advise! Best wishes from Shana

Columbia Surgery October 28, 2013 at 10:31 am

Hi Shana,

Thank you for reaching out to us. It is so wonderful to hear about your great (and very large!) family, though we’re sorry to hear about your struggles. I have forwarded your question onto Dr. Smith, who will be best able to advise. Upon his response, I will reply.

In the meantime, you may learn more information at our website, http://www.columbiaheartvalve.org or call the Heart Valve Center at: 212-342-0444.

You may also learn more about Dr. Smith on his Department of Surgery profile, http://asp.cumc.columbia.edu/facdb/profile_list.asp?uni=crs2&DepAffil=Surgery or contact his office at: 212-305-8312.

Best regards.

Columbia Surgery October 29, 2013 at 9:59 am

Hi Shana,

Thank you again, for reaching out to us. I have heard from Dr. Smith and he has replied with the following:

As you’ve described yourself, you would only be eligible for TAVR in a randomized trial, in which you would have a 50% chance of receiving conventional surgery and a 50% chance of TAVR. Assuming you qualify for treatment at this time based on echo and other variables, that is what I would recommend. If you don’t like the sound of randomization, then surgery is your best option. While we know that TAVR is much better than doing nothing in patients who are too sick for surgery, and we know that TAVR is equal to surgery in producing one-survival in patients at very high risk for surgery, we don’t know how TAVR compares to surgery in people like you. That is why it’s still being done as a trial (an experiment, if you will).

You can be evaluated for TAVR and/or surgery by my valve team, or by the team at doctor’s hospital, and get a more complete discussion of the options that is tailored more accurately to your actual situation than I can do without records.

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