It was in April 2004 when surgeons from the University of Pittsburgh Medical Center (UPMC) led by McGowan Institute for Regenerative Medicine
faculty member Robert Kormos, MD (pictured left), Director Artificial Heart Program, Co-Director Heart Transplantation at UPMC, and Medical Director of Vital Engineering, implanted the HeartMate II--at that time a new left ventricular assist system (LVAS)--in a 22-year-old woman. The implant was the third in the United States as part of a pilot trial sponsored by Thoratec Corporation to test the safety and potential effectiveness of the HeartMate II.
The device is a miniature rotary pump with axial flow bearings and is intended for patients with end-stage heart failure. A key feature of the design is a sophisticated control system developed by researchers at the McGowan Institute for Regenerative Medicine that senses when to increase or decrease the rate of blood flow. Other approved and experimental devices require manual adjustments. The control system developed by the researchers involves a patented algorithm that permits the LVAS to respond to the needs of the patient based on the level of activity, generating up to10 liters of blood flow per minute, a rate that would be required to climb stairs, for example. The controller was the brainchild of McGowan Institute faculty member James Antaki, PhD (pictured right), associate professor in Biomedical Engineering at Carnegie Mellon University and adjunct professor in the University of Pittsburgh’s Departments of Surgery and Bioengineering.
UPMC was one of four centers that tested the device in seven patients who are candidates for heart transplantation. The device was evaluated initially for use as a bridge to heart transplantation, but its developers saw its eventual use for long-term support.
On January 20, 2010, Thoratec Corporation announced that it received FDA approval of its Pre-Market Approval (PMA) supplement, allowing the use of its HeartMate II LVAS for destination therapy (DT). With this approval, the HeartMate II can be used to provide long-term cardiac support for patients suffering from advanced-stage heart failure who are not eligible for transplantation. Thoratec said it will begin the rollout of the device for the DT indication immediately and has sufficient inventory to address the expected increase in demand. The device was approved for bridge-to-transplantation (BTT) in the U.S. under the original PMA in April 2008.
"What this approval does do for the field of engineered solutions to healthcare problems is perhaps the most important aspect of this outcome. Innovation and improvements in technology continue to be made, and I am convinced that even better designs are on the horizon," Dr. Kormos said.
The approval allows the HeartMate II to be used in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The PMA approval was based on a filing submitted in April 2009 that included 2-year data on a pivotal study cohort of 200 randomized patients enrolled at 38 centers. Patients in the HeartMate II DT trial were randomized to the HeartMate II or the HeartMate(R) XVE--the only other device approved for DT--on a 2:1 basis, respectively. Patients in the pivotal cohort ranged in age from 26-81 years old, with a median age of 64 years. Also included in the primary analysis were data on 24 small body surface area (BSA) patients who because of their body size could not be randomized to the larger HeartMate XVE. The filing also included data on adjunctive cohorts totaling an additional 409 patients, including those who had been originally supported by a HeartMate XVE, and based on the need for device replacement, elected to receive a HeartMate II, as well as patients enrolled under Continuous Access Protocols.
"This is truly a momentous day for the hundreds of thousands of underserved advanced-stage heart failure patients," noted Gary F. Burbach, president and chief executive officer of Thoratec. "Those who now have access to the device owe a great deal to the patients and clinicians who participated in this landmark trial.
"As the data from both the trial and the BTT commercial experience with the device demonstrate, the HeartMate II is a proven therapy that extends patients' lives while providing them a significantly improved quality of life. We have been laying the groundwork for the DT launch through both our device manufacturing initiatives and market development programs targeted to clinicians and the 76 centers that have received certification from Centers for Medicare and Medicaid Services or DT reimbursement. In addition, this approval will facilitate our initiatives to build upon our already strong presence in Europe," he added.
The HeartMate II and the HeartMate XVE are the only devices approved by the FDA for both DT and BTT. A continuous flow device, the HeartMate II is an implantable LVAS powered by a rotary pumping mechanism and is designed to have a much longer functional life than pulsatile devices and to operate more simply and quietly. The device provides blood flow through the circulatory system on a continuous basis with only one moving part. It is also smaller and easier to implant than previously approved pulsatile devices.
Illustration: McGowan Institute for Regenerative Medicine.
Thoratec Corporation Press Release (01/20/10)
UPMC Media Relations (04/14/04)
University of Pittsburgh Schools of the Health Sciences – HeartMate II Features (11/20/03)
Bio: Dr. Robert Kormos
Bio: Dr. James Antaki