Objectives: This study sought to assess the impact of continuous flow left ventricular assist devices (LVADs) on functional capacity and heart failure-related quality of life. Background: Newer continuous-flow LVAD are smaller and quieter than pulsatile-flow LVADs. Methods: Data from advanced heart failure patients enrolled in the HeartMate II LVAD (Thoratec Corporation, Pleasanton, California) bridge to transplantation (BTT) (n = 281) and destination therapy (DT) (n = 374) trials were analyzed. Functional status (New York Heart Association [NYHA] functional class, 6-min walk distance, patient activity scores), and quality of life (Minnesota Living With Heart Failure [MLWHF] and Kansas City Cardiomyopathy Questionnaires [KCCQ]) were collected before and after LVAD implantation. Results: Compared with baseline, LVAD patients demonstrated early and sustained improvements in functional status and quality of life. Most patients had NYHA functional class IV symptoms at baseline. Following implant, 82% (BTT) and 80% (DT) of patients at 6 months and 79% (DT) at 24 months improved to NYHA functional class I or II. Mean 6-min walk distance in DT patients was 204 m in patients able to ambulate at baseline, which improved to 350 and 360 m at 6 and 24 months. There were also significant and sustained improvements from baseline in both BTT and DT patients in median MLWHF scores (by 40 and 42 U in DT patients, or 52% and 55%, at 6 and 24 months, respectively), and KCCQ overall summary scores (by 39 and 41 U, or 170% and 178%). Conclusions: Use of a continuous flow LVAD in advanced heart failure patients results in clinically relevant improvements in functional capacity and heart failure-related quality of life.
Bibliographical noteFunding Information:
Supported by Thoratec Corporation . Dr. Rogers reports receiving consulting and grant support from Thoratec . Dr. Aaronson has received a research grant from Thoratec , HeartWare , and Terumo , and is an unpaid consultant for Thoratec. Dr. Boyle receives consulting support from Thoratec . Dr. Russell is a consultant for and has received research support from Thoratec . Dr. Milano receives research and training grants from Thoratec , Abiomed , and St. Jude , and research grants from Edwards Life Sciences and Sorin . Dr. Pagani receives training and consulting support from Thoratec . Dr. John received a research grant from Thoratec . Dr. Conti is an investigator on the HM2 trial. Dr. Farrar is an employee of Thoratec with equity ownership in the company. Dr. Slaughter receives grant support from Thoratec and Heartware .
Copyright 2010 Elsevier B.V., All rights reserved.
- HeartMate II
- continuous flow
- functional status
- quality of life
- ventricular assist devices