Charleston Regional Development Alliance

Berkeley, Charleston & Dorchester Counties

Printed from www.crda.org

MUSC taking part in feasibility trials for new device that supports heartbeat

Aug. 1, 2003
Charleston Post and Courier
Columbia resident Pamela Goodwin was breathing easier, her weak heart pumping almost effortlessly Friday evening thanks to a new device, the first one used in this country.

Goodwin, a patient in her 50s with severe congestive heart failure, was rushed to the Medical University of South Carolina for treatment with special intravenous drugs, which in themselves can be toxic. The likely next step would be emergency heart transplant surgery, if her heart could survive until a donor heart became available.

Instead she spent about two hours Friday in an MUSC heart catheterization lab, where Dr. Adrian Van Bakel inserted catheters into her groin, much as he would for a routine balloon angioplasty. Blood flows out of a femoral artery through one catheter and into the new pump, which sends blood back to the aorta of her heart. The pump, about the size of two fists, rests in the bed near Goodwin's knees.

She will remain on the temporary assist for five days at most and then will go home with her husband, Van Bakel said.

"We expect patients to benefit," he said, adding that the device is still investigational. "It has a lot of promise."

Designed to decrease resistance, the assist allows the heart to work more easily and efficiently and so to supply more blood to organs, especially the kidneys, which may stop working during acute heart failure.

After that rest, it's hoped, a patient's heart will work better and may not need intravenous medicines, which can only be given in hospitals, Van Bakel said.

"This allows the heart to recover from acute congestive heart failure or when traditional medicine is not enough," said Van Bakel.

More familiar left ventricular assist devices, implanted during invasive open heart surgery, take over by making the heart beat. They're designed to last for months but carry some risks, including blood clots and mechanical problems.
A temporary device, the new Orqis Medical Cancion CRS, partially supports the beating heart, Van Bakel said. The new concept could be used to get a patient off heavy medication and home, whether or not the patient ultimately needs a transplant.He will watch Goodwin closely and remove the catheters when her condition improves. She can then go home and, being healthier, plan for a future, non-emergency transplant.

Goodwin is the first of 12 anticipated patients in this country to receive the new device with MUSC as one of four centers approved to take part in the safety and feasibility trial. It could lead to a larger trial and ultimately approval from the federal Food and Drug Administration.

So far, seven people in Europe have a Cancion CRS, Van Bakel said. While formal reports haven't been published, he said, the hearts of some patients worked better after five days or less of treatment, and the patients needed less or no intravenous medicine.

Van Bakel anticipates having more South Carolina patients in the trial, learning more and improving the device.

"MUSC is on the cutting edge of innovative therapy for heart failure," he said. "Our mission is to be on the forefront of research."
related information