Carolinas HealthCare System

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New Treatment for Heart Valve Replacement Performed at CHS
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In a collaborative effort among interventional cardiologists and cardiothoracic surgeons, a team at Carolinas HealthCare System’sSanger Heart & Vascular Institute performed the healthcare system’s first minimally invasive aortic valve replacement.

The procedure is called a trans-catheter aortic valve replacement and is an alternative treatment option for patients with severe aortic stenosis, or narrowing of the aortic valve, whose medical conditions and age prevent them from receiving traditional surgery. Currently there are no medicines or therapies available to treat the disease, and before now the only treatment option was open heart surgery to replace the valve.

Seventy-one year old Jim Cochran was the first Sanger Heart & Vascular Institute patient to receive the valve replacement. Before the procedure, Jim had very little energy and difficulty breathing. Just hours after the procedure, he was walking around the hospital room and now has much more stamina. Jim is excited to go on walks with his wife and grandchildren, continue community service work and get back on the golf course.

Jim also has multiple myeloma, cancer in the plasma of the bone marrow. Now he can start taking his medications to treat the disease again, and will have more strength to fight off the cancer.

“I am very impressed with the work that the Sanger Heart & Vascular Institute team did, and I am thankful that they were all an advocate in helping me become one of the first patients to receive the procedure,” he said. “Before now I had no treatment options available, and because of this minimally-invasive approach I was able to have the aortic stenosis treated, I can recover in a very short amount of time, and begin treating the cancer again.”

Sanger Heart & Vascular Institute was one of the first centers in the nation selected by Edward’s Lifesciences Corp., who developed the medical device called the Sapien trans-catheter aortic heart valve, to rollout the new technology. The device recently gained FDA approval for treatment of the patient population unable to endure open heart surgery.

Charles R. Bridges, MD, ScD, Chairman of the Department of Thoracic and Cardiovascular Surgery, notes that Sanger Heart and Vascular Institute is uniquely prepared to take a leadership role in the development and application of the new technology, given the well-established precedent for working as an integrated cardiovascular healthcare team and the experience in clinical research.

“The combination of expertise from both a surgery and interventional standpoint required for this procedure ensures the best possible outcomes for every patient,” he said.

“Clinical trials have shown that this procedure provides a life-saving option for these patients,” said William Downey, MD, Medical Director of Interventional Cardiology and Cardiac Catheterization Labs. “However, it is important to remember this remains a major procedure performed in exceptionally ill patients. Substantial risks therefore remain both during and after the procedure.”

Once they develop symptoms, patients with severe aortic stenosis have a 50 percent chance of dying within one or two years unless the valve is replaced. The new treatment, according to the clinical trials, reduces that chance of dying to 30 percent in the sickest group of patients for whom traditional open heart surgery was not an option. Even though the surgery may be successfully performed, 30 percent of the patients who receive the new valve die within one year, mainly from the illnesses that made them ineligible for surgery in the first place. In addition to the benefit of survival, TAVR provided a major improvement in symptoms, quality of life, and freedom from repeat hospitalization.

“While the risks for this procedure remain substantial, transcatheter aortic valve replacement is a huge leap forward for patients who literally had no treatment options for a rapidly fatal illness,” added Dr. Downey. “The development of this procedure is also a huge leap forward for the field of cardiovascular medicine, opening the door to more innovative, minimally invasive options to treat valvular heart disease.”

Traditional open heart surgery requires the patient to be put on a heart-lung machine while the heart beat stops in order to replace the valve. Now, doctors can replace the valve by advancing a catheter through an artery in the patient’s thigh, up through the aorta, and then implant the valve that is sewn into a stent into the area with the diseased valve.

Because of the patients’ current level of illness, it is expected he or she will remain in the hospital a minimum of three days after the procedure, and will be closely monitored by physicians and clinical staff. After discharge, the patient’s progress is continuously monitored and a follow up appointment is scheduled one week after hospital discharge.

In the United States approximately 300,000 patients experience at least moderate aortic stenosis, and 50,000 receive open heart surgery to replace the valve. Five percent of those patients cannot tolerate surgery and until now were unable to receive treatment.

The comprehensive team includes two cardiothoracic surgeons; Dr. Charles Bridges and Dr. Eric Skipper, two interventional cardiologists; Dr. William Downey and Dr. Michael Rinaldi, and two echocardiographers; Dr. Geoffrey Rose and Dr. Markus Scherer.

 

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