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.
In addition to the HeartMate II, which is still available through the clinical trial, the U-M Center for Circulatory Support offers the CardioWest temporary total artificial heart or TAH-t, which was recently implanted in the second Michigan patient ever to receive the device. Soon, the U-M te
|Contact: Kara Gavin|
University of Michigan Health System