Elastic Mesh Device That Cradles Heart May Impede Cardiomyopathy
URMC only Upstate NY center offering clinical trial to heart failure patient volunteers
July 31, 2008
Cardiac specialists at the University of Rochester Medical Center
are studying an investigational device that wraps around the enlarged hearts of heart failure patients in an effort to possibly prevent them from enlarging further. The first case was performed July 16. [View surgery video here.]
URMC has been chosen as a site for the PEERLESS-HF
(Prospective Evaluation of Elastic Restraint to LESSen the effects of Heart Failure) clinical research trial. It is being led by cardiologist Leway Chen, M.D., M.P.H.
, director of the Program in Heart Failure and Transplantation
, and transplant surgeon H. Todd Massey, M.D.
, surgical director of the Program in Heart Failure and Transplantation and director of the Artificial Heart Program.
Paracor Medical Inc. is sponsoring the study that will evaluate its HeartNet therapy
. The HeartNet Ventricular Support System implant is delivered in a less-invasive surgical procedure that can typically be completed in less than 90 minutes. This elastic device provides continuous support to the walls of the heart’s pumping chambers, the ventricles. It is the intent of HeartNet to stop or control further enlargement of the heart and alleviate the symptoms of advanced heart failure, which can include extreme fatigue, swelling in the extremities and shortness of breath.
“We are studying this therapy to see if it is possible that treatment with the HeartNet Ventricular Support System will improve signs and symptoms of heart failure,” Chen said. “For patients living with heart failure and its debilitating effects, the potential for improved quality of life offers hope.”
Patient volunteers are randomly assigned into a treatment or control group. For those in the treatment group, the HeartNet Ventricular Support System is placed during a surgical procedure. An incision is made on the volunteer’s left side, usually under the ribs or breastbone, between the ribs, or through the breastbone. An X-ray and a delivery device designed to place the implant around the lower chambers of the heart are used to guide the proper placement of the implant.
The American Heart Association and the Heart Failure Society of America estimate that 5 million Americans have been diagnosed with heart failure and that as many as 500,000 new heart failure diagnoses are made annually. Heart failure is reported to be the cause or a leading contributor to more than 300,000 deaths in the United States each year.
Those interested in participating in the study for the HeartNet investigational device must be between 18 and 74, have moderate heart failure, be on heart failure medications, have had heart failure for more than six months, have not had nor are considering a heart bypass procedure, and must not have severe kidney disease. Additional criteria exist. Only a clinical research study staff member can make the determination for eligibility to participate in this study.
For more information or to determine eligibility for participation, please call (585) 273-4460. For details about the Program in Heart Failure and Transplantation, log on to www.urmc.rochester.edu.