A study conducted by a team from the University of Michigan and cardiologists from the Washington Hospital Center has shown that the HeartMate II from Thoratec increases life expectancy for those waiting for a new heart.
The new study included 133 patients, and assessed the device’s ability to support patients for six months, or until they received a transplant or recovered heart function, whichever came first. The researchers assessed patients’ functional heart status, as measured by their class of heart failure severity and their ability to walk for six minutes, as well as kidney (renal) and liver (hepatic) function, which are usually diminished by the decreased blood flow from a heart failure patient’s heart. The patients’ quality of life was measured using two standard questionnaires that assess everything from patients’ ability to enjoy social activities, to their physical day-to-day symptoms and mental health.
Three-quarters of the study participants were men, with an average age of 50. Two-thirds of the patients had heart failure not related to an ischemic cause such as a heart attack – and all were in the most severe stage of heart failure, called class IV. Many had already received other heart-assisting technologies including pacemakers and implanted defibrillators to regulate their heartbeats; 41 percent had pre-surgery help from an intraaortic balloon pump.
In all, 100 of the patients had successful outcomes by the end of six months, with 56 receiving transplants, 43 remaining on the device and one recovering enough to allow the device to be removed. But the 25 deaths in the study before six months, including 18 patients who died before leaving the hospital, show that serious complications do occur even with the newer generation of device due to the acuity of illness of these patients. Many patients experienced bleeding related to blood-thinning drugs used with the device.
But nearly all patients experience cardiac recovery so significant that by the end of three months they were moved to a less-severe stage of heart failure. There were significant improvements in quality of life scores and liver and kidney function.
Press release: U-M study: Device helps heart transplant candidates survive & regain heart function while they wait for donor
Flashbacks: HeartMate® II Left Ventricular Assist System, Canadian Receives HeartMate II Non-Pulsatile LVAD, Eh?