Improved Mortality and Rehabilitation of Transplant Candidates Treated with a Long-Term Implantable Left Ventricular Assist System

TLDR

The study aimed to assess whether the HeartMate implantable pneumatic LVAS could provide adequate hemodynamic support to rehabilitate severely debilitated transplant candidates and lower mortality before and after transplantation. Seventy-five LVAS patients and 33 matched controls were enrolled across 17 U.S. centers, all transplant candidates meeting specific hemodynamic criteria and none excluded by predefined criteria. LVAS patients had markedly higher survival to transplantation (71% vs 36%) and at one year (91% vs 67%), better renal outcomes (58% vs 16% survival among those with renal dysfunction), and improved pump index relative to cardiac index, demonstrating effective hemodynamic support and rehabilitation.

Abstract

Objective This nonrandomized study using concurrent controls was performed to determine whether the HeartMate implantable pneumatic (IP) left ventricular assist system (LVAS) could provide sufficient hemodynamic support to allow rehabilitation of severely debilitated transplant candidates and to evaluate whether such support reduced mortality before and after transplantation. Methods Outcomes of 75 LVAS patients were compared with outcomes of 33 control patients (not treated with an LVAS) at 17 centers in the United States. All patients were transplant candidates who met the following hemodynamic criteria: pulmonary capillary wedge pressure ≥ 20 mm Hg with a systolic blood pressure ≤ 80 mm Hg or a cardiac index ≤ 2.0 L/minute/m2. In addition, none of the patients met predetermined exclusion criteria. Results More LVAS patients than control patients survived to transplantation: 53 (71%) versus 12 (36%) (p = 0.001); and more LVAS patients were alive at 1 year: 48 (91%) versus 8 (67%) (p = 0.0001). The time to transplantation was longer in the group supported with the LVAS (average, 76 days; range, <1–344 days) than in the control group (average, 12 days; range, 1–72 days). In the LVAS group, the average pump index (2.77 L/minute/m2) throughout support was 50% greater than the corresponding cardiac index (1.86 L/minute/m2) at implantation (p = 0.0001). In addition, 58% of LVAS patients with renal dysfunction survived, compared with 16% of the control patients (p < 0.001). Conclusions The LVAS provided adequate hemodynamic support and was effective in rehabilitating patients based on improved renal, hepatic, and physical capacity assessments over time. In the LVAS