Bibliographical noteFunding Information:
As noted previously, there are up to 70,000 patients per year who are potential candidates for mechanical assist device support. The majority have contraindications to cardiac transplantation, however, making them also ineligible for LVAD implantation. Encouraged by data from the bridge to transplantation population, trials are now underway to evaluate the permanent implantation of LVADs. Permanent implantation or destination therapy could be a potential alternative to cardiac transplantation. This would significantly relieve the current donor organ shortage and provide a possible solution for those patients who are not cardiac transplant candidates but are dying of heart failure. The first trial to evaluate permanent implantation is the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure. This is a multicenter study supported by the National Heart, Lung and Blood Institute. It is a prospective randomized trial comparing optimal medical therapy versus permanent LVAD implantation in patients with end-stage CHF who require but do not qualify for cardiac transplantation. Patients randomized to LVAD therapy receive a HeartMate VE device. The trial is currently ongoing and no results are available. The only other current study is the P neumatic H eartMate A ssist as D estination E valuation (PHADE) trial. PHADE is a single-center, nonrandomized safety study of permanent implantation of the HeartMate IP-LVAD. This study is open to 50 patients with end-stage heart disease who are not transplantation candidates. The PHADE trial is also ongoing with no results available.