Implantable ventricular assist devices: is it time to introduce them in Canada?
McGregor, M.
Canadian Journal of Cardiology 16(5): 629-640
2000
ISSN/ISBN: 0828-282X PMID: 10833542 Document Number: 515774
BACKGROUND: Implantable left ventricular assist devices (LVAD) are increasingly used in Europe and the United States. Any decision to use them in Canada requires estimates of their clinical value and costs. MATERIALS AND METHODS: No randomized controlled trials are available. Clinical value and costs, concerning principally the HeartMate and Novacor devices, were estimated based on reports of uncontrolled case series obtained through MEDLINE (1993 to 1999), review articles, three technology assessments and data supplied by the manufacturers. RESULTS AND DISCUSSION: Reasonably trouble-free device function can be expected for three to four years. The principal application is as a bridge to transplantation. Rarely, the heart recovers without transplantation. Use as 'permanent' support of the failing heart is still contentious. Approximately 70% of patients with an implanted LVAD survive until recovery or transplantation. Complications are hemorrhage, principally postoperative, 20% to 44%; thromboembolism, ranging from 5% to 15% for the HeartMate to 12% to 37% for Novacor; and significant infection, 50%. Quality of life is slightly inferior to that of patients with transplanted hearts. The direct cost to the health care system of installation is approximately dollar sign138,000. As a bridge to transplantation, the estimated cost effectiveness of elective interventions is dollar sign91,000 to dollar sign126,000 per life-year saved (dollar sign117,000 to dollar sign186,000, discounted at 5%), and as a permanent alternative to transplantation, the cost per life-year is dollar sign52,000 to dollar sign60,000 (dollar sign50,000 to dollar sign58,000, discounted at 5%), according to circumstances. As a bridge to 50 transplantations per year, the approximate annual cost would be dollar sign7 to dollar sign13 million (exclusive of transplantation costs). As 'permanent' support for 7000 patients per year, the approximate cost would be dollar sign2,661 million per year. CONCLUSIONS: Limited application in a limited number of centres with collection of all data is justifiable at this stage.