Details

Autor(en) / Beteiligte

• Goldstein, Daniel J.
• Mehra, Mandeep R.
• Naka, Yoshifumi
• Salerno, Christopher
• Uriel, Nir
• Dean, David
• Itoh, Akinobu
• Pagani, Francis D.
• Skipper, Eric R.
• Bhat, Geetha
• Raval, Nirav
• Bruckner, Brian A.
• Estep, Jerry D.
• Cogswell, Rebecca
• Milano, Carmelo
• Fendelander, Lahn
• O’Connell, John B.
• Cleveland, Joseph

Titel

Impact of age, sex, therapeutic intent, race and severity of advanced heart failure on short-term principal outcomes in the MOMENTUM 3 trial

Ist Teil von

• The Journal of heart and lung transplantation, 2018-01, Vol.37 (1), p.7-14

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2018

Quelle

Elsevier ScienceDirect Journals Complete

Beschreibungen/Notizen

• Primary outcomes analysis of the Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM 3) trial short-term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary end-point) in patients receiving the HeartMate 3 (HM3) compared with the HeartMate (HMII). In this study we sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent [bridge to transplant/bridge to candidacy/destination therapy] and severity of illness) on primary end-point outcomes in MOMENTUM 3 patients implanted with HM3 and HMII devices. Cox proportional hazard models were used to analyze patients enrolled in the “as-treated cohort” (n = 289) of the MOMENTUM 3 trial to: (1) determine interaction of various subgroups on primary end-point outcomes; and (2) identify independent variables associated with primary end-point success. Baseline characteristics were well balanced among HM3 (n = 151) and HMII (n = 138) cohorts. No significant interaction between the sub-groups on primary end-point outcomes was observed. Cox multivariable modeling identified age (≤65 years vs >65 years, hazard ratio 0.42 [95% confidence interval 0.22 to 0.78], p = 0.006]) and pump type (HM3 vs HMII, hazard ratio 0.53 [95% confidence interval 0.30 to 0.96], p = 0.034) to be independent predictors of primary outcomes success. After adjusting for age, no significant impact of sex, race, therapeutic intent and INTERMACS profiles on primary outcomes were observed. This analysis of MOMENTUM 3 suggests that younger age (≤65 years) at implant and pump choice are associated with a greater likelihood of primary end-point success. These findings further suggest that characterization of therapeutic intent into discrete bridge-to-transplant and destination therapy categories offers no clear clinical advantage, and should ideally be abandoned.