First TAVR with FDA Nod

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