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

Jennifer A. Cowger, Yoshifumi Naka, Keith D. Aaronson, Douglas Horstmanshof, Sanjeev Gulati, Debbie Rinde-Hoffman, Sean Pinney, Sirtaz Adatya, David J. Farrar, Ulrich P. Jorde

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalJournal of Heart and Lung Transplantation
DOIs
StateAccepted/In press - Jan 1 2017
Externally publishedYes

Fingerprint

Heart-Assist Devices
Quality of Life
Clinical Trials
Equipment and Supplies
Cardiomyopathies
Multicenter Studies
Disease-Free Survival
Technology
Walk Test

Keywords

  • Functional capacity
  • Health-related quality of life
  • Left ventricular assist system
  • Living well on LVAS
  • MOMENTUM 3
  • Serious adverse evens

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine
  • Transplantation

Cite this

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. / Cowger, Jennifer A.; Naka, Yoshifumi; Aaronson, Keith D.; Horstmanshof, Douglas; Gulati, Sanjeev; Rinde-Hoffman, Debbie; Pinney, Sean; Adatya, Sirtaz; Farrar, David J.; Jorde, Ulrich P.

In: Journal of Heart and Lung Transplantation, 01.01.2017.

Research output: Contribution to journalArticle

Cowger, Jennifer A. ; Naka, Yoshifumi ; Aaronson, Keith D. ; Horstmanshof, Douglas ; Gulati, Sanjeev ; Rinde-Hoffman, Debbie ; Pinney, Sean ; Adatya, Sirtaz ; Farrar, David J. ; Jorde, Ulrich P. / 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. In: Journal of Heart and Lung Transplantation. 2017.
@article{441a1344a7214dd8be017df9ad54ba71,
title = "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",
abstract = "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.",
keywords = "Functional capacity, Health-related quality of life, Left ventricular assist system, Living well on LVAS, MOMENTUM 3, Serious adverse evens",
author = "Cowger, {Jennifer A.} and Yoshifumi Naka and Aaronson, {Keith D.} and Douglas Horstmanshof and Sanjeev Gulati and Debbie Rinde-Hoffman and Sean Pinney and Sirtaz Adatya and Farrar, {David J.} and Jorde, {Ulrich P.}",
year = "2017",
month = "1",
day = "1",
doi = "10.1016/j.healun.2017.10.019",
language = "English (US)",
journal = "Journal of Heart and Lung Transplantation",
issn = "1053-2498",
publisher = "Elsevier USA",

}

TY - JOUR

T1 - Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months

T2 - A call for new metrics for left ventricular assist device patients

AU - Cowger, Jennifer A.

AU - Naka, Yoshifumi

AU - Aaronson, Keith D.

AU - Horstmanshof, Douglas

AU - Gulati, Sanjeev

AU - Rinde-Hoffman, Debbie

AU - Pinney, Sean

AU - Adatya, Sirtaz

AU - Farrar, David J.

AU - Jorde, Ulrich P.

PY - 2017/1/1

Y1 - 2017/1/1

N2 - 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.

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.

KW - Functional capacity

KW - Health-related quality of life

KW - Left ventricular assist system

KW - Living well on LVAS

KW - MOMENTUM 3

KW - Serious adverse evens

UR - http://www.scopus.com/inward/record.url?scp=85033799917&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85033799917&partnerID=8YFLogxK

U2 - 10.1016/j.healun.2017.10.019

DO - 10.1016/j.healun.2017.10.019

M3 - Article

AN - SCOPUS:85033799917

JO - Journal of Heart and Lung Transplantation

JF - Journal of Heart and Lung Transplantation

SN - 1053-2498

ER -