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Credit: Syncardia Systems, Inc.
RICHMOND, Va. (Sept. 9, 2010) – The Virginia Commonwealth University Medical Center is the lead institution in a national clinical trial of technology that will allow artificial heart patients to recuperate, rehabilitate and wait in the comfort of their own homes until a donor heart becomes available for transplant.
The VCU Pauley Heart Center is one of up to 30 centers that will investigate a portable, mechanical driver that can power patients' artificial hearts and enable them to recover outside the hospital environment, including at home and at step-down facilities.
"This is the kind of technology that changes lives," said John Duval, CEO of MCV Hospitals at the VCU Medical Center. "VCU has long been a leader in heart-assist technology, pioneering the implantation of the first Total Artificial Heart on the East Coast in 2006.
"This portable driver, if successful, will allow patients who once had to spend months, and sometimes more than a year in the hospital waiting for a donor heart, to recuperate in the comfort of their own homes," Duval said.
The VCU Medical Center received institutional review board approval in early September to participate in an Investigational Device Exemption (IDE) clinical study of the Freedom driver, the first-ever U.S. portable driver designed to power SynCardia's Total Artificial Heart both inside and outside the hospital. The IDE clinical study is intended to demonstrate that the Freedom driver is a suitable pneumatic driver for stable Total Artificial Heart patients and can be used safely at home.
"Prior to this, everyone who was placed on a Total Artificial Heart had to remain in the hospital until they underwent transplantation," said Michael Hess, M.D., director of the VCU Pauley Heart Center advanced heart failure transplantation program. "The reason for this is that the only FDA-approved driver system for powering the Total Artificial Heart is a 418-pound console.
"Now this driver – thanks to advances in engineering – is 13 and a half pounds and can be worn in a backpack, and we will be able to discharge stable patients away from the hospital to await their transplant," Hess said.
The SynCardia Total Artificial Heart currently used at the VCU Medical Center is approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure.
The portable driver features two onboard lithium-ion batteries and a power adaptor. It is designed to be carried by the patient in a backpack or shoulder bag. Another participating medical center, Mayo Clinic Arizona, discharged a patient with the driver in May.
Vigneshwar Kasirajan, M.D., chair of cardiothoracic surgery and director of the Pauley Heart Center's heart transplantation program, said he anticipates a two-to-three week period from the time of implant to switchover to the driver and then two weeks to discharge.
"We have already talked with some of our patients about potentially being able to go home with a driver and a lot of the patients are excited by it … the possibility they could actually go home while they're waiting for a transplant," Kasirajan said. "Right now the average waiting time for a transplant is about three months for patients with the artificial heart, so I think for patients, it's a great opportunity to be able to go home."
The clinical trial is approved to enroll 60 patients. The VCU Medical Center has one of the best success rates in the country in artificial heart implants, with an approximate 85 percent survival rate among patients since 2006.
SynCardia Systems, Inc., is the manufacturer of the SynCardia temporary Total Artificial Heart.
The SynCardia device is the only device that provides immediate, safe blood flow through both ventricles and is the first and only FDA, Health Canada and European approved total artificial heart in the world. The VCU Medical Center began performing the procedure in 2006.
About the VCU Pauley Heart Center
The VCU Pauley Heart Center is recognized nationally for its heart failure and heart transplantation programs, and was among the first in the United States to implant the CardioWest temporary Total Artificial Heart, or TAH-t – the only total artificial heart approved by the U.S. Food and Drug Administration. The heart center is comprised of the Divisions of Cardiology, Cardiothoracic Surgery and Pediatric Cardiology. There is close collaboration between the divisions to provide advanced, patient-centered care to patients of all ages, with every type of heart disease, with the best possible outcomes. Pauley Heart Center's superior performance resulted in its heart and heart surgery programs being ranked 44th in the country in US News Media Group's 2009 publication of America's Best Hospitals.
About the Virginia Commonwealth University Medical Center
The Virginia Commonwealth University Medical Center is one of the nation's leading academic medical centers and stands alone as the most comprehensive academic medical center in Central Virginia. The medical center includes the 780-bed MCV Hospitals and outpatient clinics, MCV Physicians -- a 600-physician-faculty group practice, and the health sciences schools of Virginia Commonwealth University. The VCU Medical Center, through its VCU Health System, offers state-of-the-art care in more than 200 specialty areas, many of national and international note, including organ transplantation, head and spinal cord trauma, burn healing and cancer treatment. The VCU Medical Center is the site for the region's only Level 1 Trauma Center. As a leader in healthcare research, the VCU Medical Center offers patients the opportunity to choose to participate in programs that advance evolving treatment, such as those sponsored by the National Cancer Institute through VCU's Massey Cancer Center, Virginia's first NCI-designated cancer center. The VCU Medical Center's academic mission is supported by VCU's health sciences schools of medicine, allied health, dentistry, pharmacy and nursing.
Video clips of physicians and animations of device available.