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

On behalf of the MOMENTUM 3 Investigators

Research output: Contribution to journalArticlepeer-review

29 Scopus citations

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)
Pages (from-to)15-24
Number of pages10
JournalJournal of Heart and Lung Transplantation
Volume37
Issue number1
DOIs
StatePublished - Jan 2018

Keywords

  • MOMENTUM 3
  • functional capacity
  • health-related quality of life
  • left ventricular assist system
  • living well on LVAS
  • serious adverse evens

ASJC Scopus subject areas

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

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