The surgical procedure to implant any medical device is shaped partly by the design of the device and partly by the methods employed by the surgeons who implant it. The Jarvik 2000 FlowMakerŽ is designed to be easy to implant, and clinical experience has confirmed that it is. In a recent Associated Press article, the chief of cardiopulmonary transplantation at the Texas Heart Institute, Dr. O.H. Frazier, is quoted as saying that the Jarvik 2000's "many advantages — it's small size, less invasive surgery to install it — make it a better option than transplants for many patients."
During surgery, the pump is placed inside the left ventricle through a circular incision in the heart wall and sewn into place. There it is secured with a polyester sewing cuff and joined via the outflow graft to the aorta, the main artery that carries blood to the rest of the body. The surgeon then routes the power cable either through the abdominal wall or under the skin to a pedestal mounted on the skull, depending on whether the pump is being implanted permanently or as a bridge to transplant.
Before the pump is activated, all air is evacuated from the device, the left ventricle and the aorta. The pump is switched on, and if necessary, the patient is weaned from the heart-lung bypass machine. (The Jarvik 2000 can be successfully implanted without the use of a heart-lung machine.* It has also been implanted in a Jehova's Witness patient without the use of blood transfusion.)
Even before the incisions are closed, the Jarvik 2000 FlowMakerŽ goes to work moving blood through the heart and restoring a physiologic equilibrium to the body. The implantation process usually takes 2-5 hours.
As with open-heart surgery of any kind, there are risks. The risk of serious adverse events such as bleeding, infection, or stroke is present, but it remains low. The Jarvik 2000 requires a less invasive implantation procedure than the Heartmate or Novacor devices. Present data indicate that the risk of infection is also lower than with those devices, while the other risks are similar.
*"Implantation of the Jarvik 2000 left ventricular assist device without the use of cardiopulmonary bypass." O.H. Frazier, MD. Annals of Thoracic Surgery, 2003 (75:1028-30).