Biomedical Frontiers: Winter 1994, Vol.1, No.2
You Gotta Have Heart Assist Devices

Since only 2000 hearts are available for transplants and some 50,000 to 100,000 patients still need some form of cardiac replacement, doctors have tried artificial hearts, partially implantable devices, and cross-species transplants. But with limited success.

Until now. Dr. Eric Rose, chief of cardiothoracic surgery, has found partially implantable Left Ventricular Assist Devices (LVAD) work so well as a bridge to transplantation he is designing a clinical trial to test LVADs as a cardiac replacement therapy for patients with severe congestive heart failure. Thermo Cardiosystems Inc. (Woburn, MA), the LVAD manufacturer, is asking the Food and Drug Administration for investigational new device exemption for this indication. FDA currently permits LVADs as a bridge to human heart transplantation only on an experimental basis.

LVADs assist the pumping of oxygenated blood from the heart's left ventricle (LV), the heart's major pump, to the aorta, where it then travels to the rest of the body. In the LVAD, an implantable pump powered by an external battery pack is linked to the aorta and the LV by grafts.

FDA has been cautious about LVAD usage as a cardiac replacement end therapy. But Dr. Rose thinks the FDA should realize that the chronically ill are willing to risk hazards in a promising new procedure and should adjust its policy.

Dr. Rose's convictions reflect three years of experience with 16 patients utilizing LVADS as a bridge. Although five of 16 patients died on LVADs, the other 11 probably would have died without the LVAD because hearts were not available, says Dr. Rose.

Since LVADS were introduced less than a decade ago much has been learned and changed. Clots are no longer a problem. They are also less expensive than transplantation. A go-home LVAD is estimated to cost around $50,000-$70,000. A transplant costs around $200,000 plus an additional $25,000 in medical tests the first year.

Dr. Rose is planning a multicenter clinical trial, to be coordinated at CPMC, with LVAD usage in cardiac replacement, if the FDA approves. In 10 years, Dr. Rose predicts LVAD installation will be a common operation at CPMC. Although alternative treatments may prove to be medically useful someday, they face other hurdles. Cross-species transplants, for example, raise concern among animal activists.