PMID- 29153637 OWN - NLM STAT- MEDLINE DCOM- 20191127 LR - 20191127 IS - 1557-3117 (Electronic) IS - 1053-2498 (Linking) VI - 37 IP - 1 DP - 2018 Jan TI - Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months: A call for new metrics for left ventricular assist device patients. PG - 15-24 LID - S1053-2498(17)32085-5 [pii] LID - 10.1016/j.healun.2017.10.019 [doi] AB - BACKGROUND: The Multicenter Study of MAGLEV Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) clinical trial demonstrated improved 6-month event-free survival, but a detailed analysis of health-related quality of life (HR-QOL) and functional capacity (FC) was not presented. Further, the effect of early serious adverse events (SAEs) on these metrics and on the general ability to live well while supported with a left ventricular assist system (LVAS) warrants evaluation. METHODS: FC (New York Heart Association [NYHA] and 6-minute walk test [6MWT]) and HR-QOL (European Quality of Life [EQ-5D-5L] and the Kansas City Cardiomyopathy [KCCQ]) assessments were obtained at baseline and 6 months after HeartMate 3 (HM3, n = 151; Abbott, Abbott Park, IL) or HeartMate II (HMII, n = 138; Abbott) implant as part of the MOMENTUM 3 clinical trial. Metrics were compared between devices and in those with and without events. The proportion of patients "living well on an LVAS" at 6 months, defined as alive with satisfactory FC (NYHA I/II or 6MWT > 300 meters) and HR-QOL (overall KCCQ > 50), was evaluated. RESULTS: Although the median (25th-75th percentile) patient KCCQ (change for HM3: +28 [10-46]; HMII: +29 [9-48]) and EQ-5D-5L (change for HM3: -1 [-5 to 0]; HMII: -2 [-6 to 0]) scores improved from baseline to 6 months (p < 0.05), there were no differences between devices (p > 0.05). Likewise, there was an equivalent improvement in 6MWT distance at 6 months in HM3 (+94 [1-274] meters] and HMII (+188[43-340 meters]) from baseline. In patients with SAEs (n = 188), 6MWTs increased from baseline (p < 0.001), but gains for both devices were less than those without SAE (HM3: +74 [-9 to 183] meters with SAE vs +140 [35-329] meters without SAE; HMII: +177 [47-356] meters with SAE vs +192 [23-337] meters without SAE, both p < 0.003). SAEs did not affect the 6-month HR-QOL scores. The "living well" end point was achieved in 145 HM3 (63%) and 120 HMII (68%) patients (p = 0.44). CONCLUSIONS: Gains in HR-QOL and FC were similar early after HM3 and HMII implant. 6MWT improvements were attenuated in patients experiencing SAEs, but HR-QOL metrics did not change. The development of left ventricular assist device-specific HR-QOL tools is needed to better characterize the effect of SAEs on a patient's well-being. CLINICAL TRIAL NO: MOMENTUM 3 clinical trial #NCT02224755. CI - Copyright (c) 2018 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved. FAU - Cowger, Jennifer A AU - Cowger JA AD - Cardiology, St. Vincent Hospital, Indianapolis, Indiana. Electronic address: jennifercowger@gmail.com. FAU - Naka, Yoshifumi AU - Naka Y AD - Department of Surgery, Columbia University Medical Center, New York, New York. FAU - Aaronson, Keith D AU - Aaronson KD AD - Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, Michigan. FAU - Horstmanshof, Douglas AU - Horstmanshof D AD - Cardiology, Integris Baptist Medical Center, Oklahoma City, Oklahoma. FAU - Gulati, Sanjeev AU - Gulati S AD - Cardiology, Carolinas Medical Center, Charlotte, North Carolina. FAU - Rinde-Hoffman, Debbie AU - Rinde-Hoffman D AD - Cardiology, Tampa General Hospital, Tampa, Florida. FAU - Pinney, Sean AU - Pinney S AD - Division of Cardiovascular Medicine, Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. FAU - Adatya, Sirtaz AU - Adatya S AD - Division of Cardiology, University of Chicago Medical Center, Chicago, Illinois. FAU - Farrar, David J AU - Farrar DJ AD - Abbott, Abbott Park, Illinois. FAU - Jorde, Ulrich P AU - Jorde UP AD - Division of Cardiology, Montefiore Einstein Heart and Vascular Center, Bronx, New York. CN - MOMENTUM 3 Investigators LA - eng SI - ClinicalTrials.gov/NCT02224755 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20171024 PL - United States TA - J Heart Lung Transplant JT - The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation JID - 9102703 SB - IM CIN - J Heart Lung Transplant. 2018 Jan;37(1):136-138. PMID: 29273215 MH - Adult MH - Aged MH - Aged, 80 and over MH - Female MH - Heart Failure/*surgery MH - *Heart-Assist Devices MH - Humans MH - Male MH - Middle Aged MH - Prospective Studies MH - *Quality of Life MH - Recovery of Function MH - Time Factors MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - MOMENTUM 3 OT - functional capacity OT - health-related quality of life OT - left ventricular assist system OT - living well on LVAS OT - serious adverse evens EDAT- 2017/11/21 06:00 MHDA- 2019/11/28 06:00 CRDT- 2017/11/21 06:00 PHST- 2017/07/22 00:00 [received] PHST- 2017/10/03 00:00 [revised] PHST- 2017/10/18 00:00 [accepted] PHST- 2017/11/21 06:00 [pubmed] PHST- 2019/11/28 06:00 [medline] PHST- 2017/11/21 06:00 [entrez] AID - S1053-2498(17)32085-5 [pii] AID - 10.1016/j.healun.2017.10.019 [doi] PST - ppublish SO - J Heart Lung Transplant. 2018 Jan;37(1):15-24. doi: 10.1016/j.healun.2017.10.019. Epub 2017 Oct 24.