Heart News | Valve Disorders

First TAVR with FDA Nod

Surgeons Dr. Roselli and Dr. Svensson; cardiologists Dr. Tuzcu and Dr. Kapadia

The four doctors – two interventional cardiologists and two heart surgeons — were exhilarated as they emerged from the operating room. They’d just completed a transcatheter aortic valve replacement (TAVR) operation at Cleveland Clinic – and heard of the news of pending FDA approval.

As he removed his mask, prominent aortic surgeon Eric Roselli, MD, told TBE correspondent Betsy Stovsky RN, MSN, “There are so many patients out there who have been told over and over that they have no options. We now have a wonderful opportunity to give them a real, lasting therapy.”

TAVR is new minimally invasive technique for replacing a diseased aortic heart valve. TAVR delivers a collapsible artificial valve into the heart using a catheter, inserted through a small incision in the chest. The artificial valve is expanded inside the native valve by inflating a balloon, and almost immediately goes to work.

“This has been the culmination of seven years work for me,” said Lars Svensson, MD, director of the Aorta Center at Cleveland Clinic, who helped develop the new transapical technique beginning in 2004. He was co-principle investigator of the clinical trial that tested the efficacy of TAVR. “The results were equivalent to open surgical valve replacement for very high risk patients and much better than we expected for inoperable patients. We’ve done 220 patients with excellent outcomes.” Dr. Svensson is a member of the Exectuive Committee of the PARTNER trial and the co-principle investigator for the trial at Cleveland Clinic.

The FDA has so far approved TAVR only for a condition known as senile aortic stenosis, an age-related hardening of the valve, in inoperable patients. Candidates for the procedure are those who have been turned down for conventional surgical replacement of the aortic valve. “Almost one third of aortic stenosis patients are very old,” said cardiologist Samir Kapadia, MD. “They have so many medical problems that they are not fit for surgery. TAVR can not only improve their longevity, but it improves their quality of life considerably.” Dr. Kapadia is the Director of Cardiac Catheterization Laboratories at Cleveland Clinic and is a member of the steering committee of the PARTNER trial.

Interventional cardiologist and Vice Chairman of the Department of Cardiovascular Medicine E. Murat Tuzcu, MD, told Ms. Stovsky, “This effort has been an unprecedented collaboration between cardiologists and surgeons. It also involved critical contributions from imagers, anesthesiologists, critical care experts, nurse technicians, OR technicians and others – coming together as a single team to save lives.” Dr. Tuzcu is a member of the Exectuive Committee of the PARTNER trial and the co-principle investigator for the trial at Cleveland Clinic.

Cleveland Clinic was one of three early pioneering centers in the USA and one of more than 20 centers involved in the randomized PARTNER trails of TAVR. All patients are carefully evaluated to see if they are candidates for minimally invasive keyhole open surgical aortic valve replacement. TAVR is only considered if they are very high risk or ineligible for open surgical replacement.

Questions and answers about percutaneous transcatheter aortic valve replacement can be found at our previous web chat transcripts.

“Why Are The New Transcatheter Therapies Only For Inoperable Patients?” with Dr. Svensson – posted on Adam Pick’s Valve Surgery Blog

Tags: heart, heart and vascular institute, heart surgery, innovation, news, TAVI, TAVR, Valve Disease, valve surgery
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  • Jack

    I am very much interested in the new Sapien heart valve implant, as I
    am 84 years old and have had many operations including 5 by pass operation about 20 years ago . sincerely, Jack

    • CC Heart

      Jack – we will be replying to you offline. betsyRN

  • Crystal Anderson

    I am an Echocardiography student interested in learning more about this procedure. Thank you for any information you can pass along.

  • CHARLES GLOVER

    Hello

    I work for a Cardiology group here in Arizona, I recently moved by grandmother down here to be evaluated. She is a patient a Scottsdale Health Care. 88 year of age, good mental capacity, controlled diabetes , afib ( Medtronic pacemaker) LVEF 55%. Cath is negative for coronary artery disease

  • Denise

    I had aortic valve repair in 2005 at age 35 due to ascending aortic aneurysm, valve was always a little leaky but tolerable. Now im symptomatic and need valve replaced. When will younger patients like myself be able to have the minimally invasive procedure? I have children and don’t want to endure open heart surgery again to replace the valve but it’s getting more difficult to manage symptoms. I’m located in northern California

    • CC Heart

      Dear Denise, I invite you to register for our web chat next Thursday on this topic. Please go to http://www.clevelandclinic.org/health/ChatReg/ . Dr. Tuzcu and Dr. Svensson will be answering questions. You can log in 24 hours prior to the chat to begin asking questions. They will be answered on 3/15 at 12 noon EST. betsyRN

  • Beatitudes

    Could my 88 yr old father do well with a TAVR? Significant AS, anemia / associated kidney demise (non-dialysis), never a smoker, but environmental COPD? What can recovery be like for him…. Mom is UNABLE to care for herself or him and she does not drive. Does Medicare pay for this?

    • The_Beating_Edge_Team

      It is difficult to know if TAVR can help your father. Please contact our heart nurses – http://www.clevelandclinic.org/heartnurse. They will answer your questions and tell you how to send in records for surgical review. betsyRN