Abstract 18761: Improved Quality of Life and Functional Capacity for Patients Receiving the HVAD ® Pump

Abstract

Background: Patients with advanced heart failure experience significant impairment in quality of life (QoL) and functional capacity. Improved survival and longer waits for transplant following LVAD implantation means QoL and functional capacity outcomes are increasingly important. We reviewed the experience of patients receiving the HeartWare ® Ventricular Assist System (HVAD), a novel design continuous flow, centrifugal pump in the pivotal ADVANCE Bridge to Transplant (BTT) Trial and Continued Access Protocol (CAP) to explore changes in QoL and functional capacity. Methods: The QoL surveys analyzed in the combined BTT and CAP trials included the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary, and the EuroQOL-5D Visual Analog Scale (VAS). The 6 minute walk test (6MW) was used to determine functional capacity. Descriptive statistics were used to evaluate differences compared to baseline. Results: In the combined BTT and CAP study (N=332), between 44% and 55% of patients completed paired QoL measurements, at baseline (pre-implant) and 180 days post-implant. Patients unable to complete a test for any reason other than incomplete follow-up visit had imputed values of zero. Of 231 patients who were available for follow-up at 6 months (i.e., not transplanted, explanted for recovery, or dead and had reached the 6 month post-implant assessment), paired data were obtained on 184, 164 and 146 patients for the 6MW, KCCQ and VAS, respectively. Of patients completing the paired assessments, there was a statistically significant improvement of 195.9 meters in the 6 Minute Walk Test. Both the EQ-5D Visual Analog Scale and KCCQ Overall Summary also showed statistically significant improvements in their scores of 27.0 and 31.1 points, respectively. Conclusion: QoL and functional capacity was substantially improved at 6 months in bridge to transplant recipients of the HeartWare HVAD System.