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Experimental Device Gives Damaged Hearts a Hug

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Posted: 5/24/2005

COLUMBUS, Ohio – Ohio State University physicians are among the first in the United States to implant a device that encircles a damaged heart, applying gentle external pressure intended to strengthen the muscle and even shrink an enlarged heart.

The surgery at OSU’s Richard M. Ross Heart Hospital was the first implant of this ventricular support system in Ohio, the 10th in the United States and just the 20th in the world.

The mesh device, made of a metal alloy surrounded by silicone, wraps around the heart and is designed to apply just enough pressure to allow for a reduction of heart wall stress in patients with congestive heart failure, whose hearts are typically enlarged, said Ohio State’s Dr. William Abraham.

“We believe it will make the heart smaller and stronger,” said Abraham, director of the division of cardiovascular medicine at OSU Medical Center and principal investigator of Ohio State’s participation in a study of the investigational device.

The patient, a 68-year-old Columbus man, did well after the surgery, which was performed by Dr. Benjamin Sun, chief of cardiothoracic surgery at OSU Medical Center and Ohio State’s co-investigator for the study. The device was implanted May 19 using minimally invasive techniques involving an incision in the left chest and guided by a fluoroscope, or X-ray camera, that projects images onto a screen in the operating room. The procedure lasted approximately one hour.

Congestive heart failure is the most rapidly growing form of heart disease in the United States and is associated with weakness of the heart. Heart failure is characterized by a reduced ejection fraction – a measurement of how well the heart is squeezing – and often by seepage of fluid into the lungs, feet, legs or abdominal cavity. The heart muscle’s inability to keep up with the body’s demands can cause the heart to enlarge, increasing stress on the heart wall, Abraham said.

The investigational device is composed of nitinol, a nickel titanium shape-memory alloy. Its elastic nature facilitates placement around the heart, Abraham said, and then allows the device to conform to the heart in a controlled and repeatable manner as it is incorporated into the heart’s structure.

“We don’t want to over-constrain the heart,” Abraham said. Because the material can assume the heart’s shape and size, no suturing to the heart is required, and the device is permanent.

“Though more research is needed to ensure its efficacy, we have high hopes that this device will be able to delay, if not prevent, the need for a heart transplant in some patients,” said Abraham, also associate director for clinical/translational research of the Davis Heart and Lung Research Institute at Ohio State.

An additional element of the experimental ventricular support system is the innovative design of the method used to deploy the device, which makes the minimally invasive surgical approach possible, Sun said.

“By using the X-ray camera, we can be sure the device is in place to hold the shape of the heart, provide a gentle squeeze and remove the impetus of the heart to continue to stretch,” he said.

Both physicians said this research demonstrates the importance of academic medicine.

“In many cases, we’re able to partner with industry to work on, develop and try out the newest techniques with the idea of pushing the envelope,” Sun said. “And patients are the ones who benefit most from these collaborative efforts.”

The device was invented and manufactured by Paracor Medical Inc., based in Sunnyvale, Calif.

The Ohio State surgery was the final implantation of the device in an initial round of trials to determine the system’s safety. Following a 30-day assessment of the OSU patient’s heart function, size and strength, and quality of life improvements, Paracor and researchers plan to request permission from the Food and Drug Administration to expand the trial to test the safety and feasibility of the device in a larger number of patients, and eventually, in a larger trial, to test the effectiveness of the support system as part of pursuit of FDA approval of the device.

OSU Medical Center and four other U.S. academic medical centers participated in the safety study.

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Emily Caldwell
Medical Center Communications
614.293.3737
caldwell-6@medctr.osu.edu

Heart Disease; Ross Heart Hospital