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Greenville, NC 27834

Clinical trial proves successful for high-risk heart patients

Written By Carissa Etters on February 09, 2012

 

New device used for the first time in the Carolinas at the East Carolina Heart Institute at Vidant Medical Center


GREENVILLE – A new tool to remedy stiff or narrowed aortic valves in high-risk patients and a less invasive way to implant it could soon be a standard of care after a successful clinical trial by East Carolina University physicians.


The procedure, known as transcatheter aortic valve replacement, or TAVR, allows doctors to replace a worn valve without opening the chest. TAVR is considered to be less invasive than a traditional valve-replacement operation, which involves open-heart surgery. Candidates for a TAVR are either not good candidates for the traditional surgery or might be considered too weak or too old to undergo the surgery.


In the TAVR procedure, the valve is inserted with a catheter through either an artery in the leg (transfemoral) or by making a small chest incision and inserting the valve through the tip of the left ventricle of the heart (transapical). The TAVR can be performed by implanting the new valve and pushing back the old one. 
Replacing a valve in this way is fairly new, and ECU physicians are using the technique to implant the latest version of the artificial valve, which is smaller and more flexible and hence gentler to arteries than older styles.


“Many years ago, doctors could never fathom a valve replacement without opening the chest,” said Dr. Walter A. Tan, an interventional cardiologist and associate professor of cardiovascular sciences at ECU and principal investigator on the TAVR trial. “It is a game-changing technology.”


Patients will benefit from less invasive aortic valve replacements with faster recovery, less pain and fewer complications than are associated with traditional aortic valve replacement, said Dr. W. Randolph Chitwood Jr., director of the Heart Institute and professor of cardiovascular surgery at ECU.


Chitwood said patients are looking for less-invasive surgery and catheter-based technology. These methods have been reserved for unfavorable surgical candidates. Now more patients who have poor health but who need a new valve can be treated effectively.


A team of ECU physicians performed the first TAVR procedure at the East Carolina Heart Institute at Vidant Medical Center on Jan. 23. The team was led by Drs. Chitwood ; Tan, who is also associate director of the Heart Institute cardiac catheterization labs ; Curtis Anderson, a cardiothoracic surgeon and associate professor of cardiovascular sciences at ECU; Alan Kypson, a cardiothoracic surgeon and associate professor of cardiovascular sciences at ECU; and Ramesh Daggubati, a cardiologist and clinical associate professor at ECU. 
Tan said this procedure was the first TAVR in the Carolinas using the latest generation of the valve, called the Edwards SAPIEN XT™ Transcatheter Heart Valve. ECU is participating in the PARTNER II trial (Placement of Aortic Transcatheter Valves), which is evaluating these new valves.


“The Heart Institute has the unique distinction of being the only center in the world in a city with a population less than a half a million people involved in this selective clinical trial because of our superb track record for innovation in cardiac care,” Tan said.


The patient in the first trial case was an 85-year-old retired Navy veteran from Elizabeth City who was very high-risk for a traditional valve replacement because he had lung disease, heart failure and had previously undergone valve repair and coronary artery bypass surgery. The patient was excited to be a part of history in an effort to help other patients in the future.
This patient received the valve implantation transfemorally, which proceeded without complications. Typically this procedure takes about 90 minutes to perform; because this case included multiple safety checks, it took nearly three hours to complete. Subsequent TAVR implantations will take less time.


Tan said the patient recovered remarkably. He immediately experienced easier breathing and just hours after the procedure was able to walk more briskly than he has been able to in years. The patient was discharged from the Heart Institute four days after getting his new valve. The patient said the first thing he wants to do when he is fully recovered is to go fishing with his son. 
Tan attributes much of the success to the patient’s will to live, his supportive family, and the mission-driven teamwork of doctors, nurses, and hospital and medical school administrators. Within the next five years, Tan estimated, a TAVR procedure using the new valve will be the option for about 30 percent of patients with aortic stenosis. 
The team has performed a total of three successful TAVR procedures.


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Vidant Health, a mission-driven, not-for-profit corporation, owns, leases or has a majority membership interest in nine eastern North Carolina hospitals and has a management agreement with one other. The health system includes Albemarle Health, Vidant Beaufort Hospital, Vidant Bertie Hospital, Vidant Chowan Hospital, Vidant Duplin Hospital, Vidant Edgecombe Hospital, The Outer Banks Hospital, Vidant Medical Center, Vidant Pungo Hospital, Vidant Roanoke-Chowan Hospital, Vidant Home Health and Hospice; Vidant Wellness Centers and physician practices, and is affiliated with the Brody School of Medicine at East Carolina University.