Daniel J Goldstein1, Mandeep R Mehra2, Yoshifumi Naka3, Christopher Salerno4, Nir Uriel5, David Dean6, Akinobu Itoh7, Francis D Pagani8, Eric R Skipper9, Geetha Bhat10, Nirav Raval11, Brian A Bruckner12, Jerry D Estep12, Rebecca Cogswell13, Carmelo Milano14, Lahn Fendelander15, John B O'Connell15, Joseph Cleveland16. 1. Department of Cardiothoracic Surgery, Montefiore Medical Center, Bronx, New York, USA. 2. Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts, USA. Electronic address: mmehra@bwh.harvard.edu. 3. Division of Cardiothoracic Surgery, Columbia University College of Physicians & Surgeons, New York, New York, USA. 4. Department of Cardiothoracic Surgery, St. Vincent Heart Center, Indianapolis, Indiana, USA. 5. Section of Cardiology, University of Chicago School of Medicine and Medical Center, Chicago, Illinois, USA. 6. Division of Cardiothoracic Surgery, Piedmont Heart Institute, Atlanta, Georgia, USA. 7. Division of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri, USA. 8. Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor, Michigan, USA. 9. Department of Thoracic and Cardiovascular Surgery, Danger Heart and Vascular Institute, Carolinas Medical Center, Charlotte, North Carolina, USA. 10. Division of Cardiology, Advocate Christ Medical Center, Oak Lawn, Illinois, USA. 11. Cardiology Department, Florida Hospital, Orlando, Florida, USA. 12. Department of Cardiology, Houston Methodist Hospital, Houston, Texas, USA. 13. Division of Cardiology, University of Minnesota, Minneapolis, Minnesota, USA. 14. Department of Surgery, Duke Heart Center, Duke University, Durham, North Carolina, USA. 15. Abbott, Chicago, Illinois, USA. 16. Division of Cardiothoracic Surgery, University of Colorado School of Medicine, Aurora, Colorado, USA.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Manal Alasnag; Alexander G Truesdell; Holli Williams; Sara C Martinez; Syeda Kashfi Qadri; John P Skendelas; William A Jakobleff; Mirvat Alasnag Journal: Curr Atheroscler Rep Date: 2020-04-23 Impact factor: 5.113
Authors: Silvia Mariani; Tong Li; Karl Bounader; Dietmar Boethig; Alexandra Schöde; Jasmin S Hanke; Jana Michaelis; L Christian Napp; Dominik Berliner; Guenes Dogan; Roberto Lorusso; Axel Haverich; Jan D Schmitto Journal: Ann Cardiothorac Surg Date: 2021-03