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
| Autor: | Douglas A. Horstmanshof, David J. Farrar, Jennifer A Cowger, Sean Pinney, Keith D. Aaronson, Ulrich P. Jorde, Yoshifumi Naka, Sirtaz Adatya, D. Rinde-Hoffman, Sanjeev K. Gulati |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Pulmonary and Respiratory Medicine medicine.medical_specialty Percentile Time Factors medicine.medical_treatment Cardiomyopathy 030204 cardiovascular system & hematology Young Adult 03 medical and health sciences 0302 clinical medicine Quality of life Internal medicine medicine Humans Prospective Studies 030212 general & internal medicine Adverse effect Aged Aged 80 and over Heart Failure Transplantation Heartmate ii business.industry Recovery of Function Middle Aged medicine.disease Clinical trial Treatment Outcome Walk test Ventricular assist device Quality of Life Cardiology Female Surgery Heart-Assist Devices Cardiology and Cardiovascular Medicine business |
| Zdroj: | The Journal of Heart and Lung Transplantation. 37:15-24 |
| ISSN: | 1053-2498 0222-4755 |
| DOI: | 10.1016/j.healun.2017.10.019 |
| Popis: | 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.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 6MWT300 meters) and HR-QOL (overall KCCQ50), was evaluated.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 (p0.05), there were no differences between devices (p0.05). 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 (p0.001), 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 p0.003). 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).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.MOMENTUM 3 clinical trial #NCT02224755. |
| Databáze: | OpenAIRE |
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