Heart Transplantation is Not the Only Option for Patients with Advanced Heart Failure

Abstract

The conventional therapy for advanced medically refractory heart failure is heart transplantation, but donors are limited and most patients are not candidates due to signifi cant comorbidities. Until recently, therapeutic options for such patients have been limited and, frankly, palliative. For example, medically refractory advanced heart failure patients considered ineligible for transplantation (most commonly due to age) are often treated with chronic inotropic agents, which temporize their symptoms but are associated with an alarming 10% to 30% 1-year survival rate. Ventricular assist devices (VADs), or heart pumps, have changed the therapeutic landscape for these desperate patients. The pumps are surgically implanted, electrically driven devices that complement the cardiac output of the native but weakened heart (Figure 1). They can be used to support either the left (LVAD), right (RVAD), or both (BiVAD or total artifi cial heart [TAH]) ventricles. There are currently 3 major indications for VADs in advanced heart failure. Most commonly, VADs are used as a bridge to heart transplant when a patient becomes too ill to await transplantation on inotropic agents. Randomized trials have demonstrated the effectiveness of VADs in this capacity. Less commonly, VADs are used to hemodynamically support a patient with acute systolic heart failure and shock until the native heart recovers (ie, as a bridge to recovery). Finally, these devices have been used as a permanent therapy for patients with medically refractory advanced heart failure considered ineligible for transplantation, or so-called destination therapy. It is this last indication that represents a signifi cant change in paradigm for this technology. The principle that LVADs could be used as a “destination” therapy superior to conventional medical therapy was fi rst tested in the landmark Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) study, which used a fi rst-generation pulsatile pump. This study enrolled 129 patients with severe heart failure ineligible for transplantation, with the primary endpoint being death of any cause. There was a striking 48% reduction in mortality with the use of LVADs when compared with optimal medical management as well as marked improvements in functional status. This trial led to US Food and Drug Administration (FDA) approval in 2002 for the HeartMate XVE LVAD (Thoratec Corp., Pleasanton, CA) to be used as a permanent solution for transplant-ineligible patients with refractory heart failure. Recent technologic advances have led to a second generation of devices that provide continuous rather than pulsatile fl ow (eg, HeartMate II [Thoratec Corp., Pleasanton, CA]), which has decreased the size of the device and increased durability. It was this latest generation of LVADs that was used in the recent destination study by Slaughter et al. In this trial, patients with advanced refractory heart failure ineligible Julio A. Barcena, MD1,2 James Fang, MD1,2