It’s made from specially designed polyester, and it fits snugly around the human heart. It’s known as a Cardiac Support Device, and it is stitched into place to prevent diseased heart muscle from further enlargement. And in June, a mother of three became the first person in the United States to try one on, with the help of Dr. Michael A. Acker, associate professor of surgery and surgical director of the heart-transplantation and mechanical-assist program at the Hospital of the University of Pennsylvania. The woman was the first American participant in a multi-site clinical trial sponsored by ACORN Cardiovascular, Inc., the jacket’s manufacturer. And she is reportedly recovering “very nicely.”
The heart jacket had been used in Germany, where a clinical safety trial has reportedly shown encouraging results in patients with chronic heart failures. (A continual balloon-like expansion of heart muscle is a characteristic symptom of cardiomyopathy, which results in a steady deterioration of heart-muscle function.) Acker had participated in one such implantation procedure at a Berlin hospital before performing the operation at HUP.
The U.S. trial is structured to assess the safety and effectiveness of the jacket by observing two randomized patient groups: one treated with the jacket, the other treated without it.
“It is our belief, based on extensive studies, that those patients in whom the jacket is implanted will have improved heart function,” said Acker. “If we can sustain the clinical improvement for an appropriate length of time, the heart jacket may prevent the need for transplantation in some patients.”
