Effects of echo-optimization of left ventricular assist devices on functional capacity, a randomized controlled trial.

Abstract

AimsAfter the implantation of a left ventricular assist device (LVAD), many patients continue to experience exercise intolerance. VAFRACT trial evaluates the additional benefit of LVAD echo‐guided optimization (EO) on functional capacity (FC), measured by cardiopulmonary exercise test (CPET), and quality of life (QoL).Methods and resultsTwenty‐seven patients were randomized in a 1:1 ratio to EO (EO group) vs. standard settings (CONTROL group) at least after 3 months from LVAD implant procedure. The optimal device speed was defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation and preserving right ventricular function. The primary endpoint was peak oxygen uptake (VO2 peak) change after 3 months.Echo‐guided optimization significantly improves VO2 peak (from 13.2 ± 2.5 to 14.2 ± 2.5 mL/kg/min; P < 0.001), oxygen pulse (from 9.75 ± 1.46 to 10.75 ± 2.2 mL; P < 0.001), CPET exercise time (from 490 ± 98 to 526 ± 116 s; P = 0.02), 6 min walk distance (from 363 ± 54 to 391 ± 52 m; P = 0.04), and QoL, using EuroQol Five Dimensions 3L (from 0.796 ± 0.1 to 0.85 ± 0.08; P < 0.001) and the Kansas City Cardiomyopathy Questionnaire (from 81.6 ± 6.9 to 84.6 ± 5.6; P = 0.025).ConclusionsEcho‐guided optimization can significantly influence the FC and the QoL of LVAD patients. This procedure should represent a fundamental step in their clinical management, through the establishment of consolidated follow‐up protocols. Our study may represent a starting point for a future, adequately powered clinical trial with a longer term follow‐up.