TY - JOUR
T1 - Outcomes with ambulatory advanced heart failure from the Medical Arm of Mechanically Assisted Circulatory Support (MedaMACS) Registry
AU - Ambardekar, Amrut V.
AU - Kittleson, Michelle M.
AU - Palardy, Maryse
AU - Mountis, Maria M.
AU - Forde-McLean, Rhondalyn C.
AU - DeVore, Adam D.
AU - Pamboukian, Salpy V.
AU - Thibodeau, Jennifer T
AU - Teuteberg, Jeffrey J.
AU - Cadaret, Linda
AU - Xie, Rongbing
AU - Taddei-Peters, Wendy
AU - Naftel, David C.
AU - Kirklin, James K.
AU - Stevenson, Lynne W.
AU - Stewart, Garrick C.
N1 - Funding Information:
A.D.D. reports receiving research support from the American Heart Association, Amgen, the National Institutes of Health (NIH), and Novartis, and serving as a consultant for Novartis. J.J.T. reports receiving advertising board and speaking honoraria from Medtronic, CareDx, and Abiomed, as well as receiving support from Abbott for the HeartMate 3 Clinical Events Committee. The remaining authors have no conflicts of interest to disclose.
Funding Information:
This project has been funded in whole or in part by federal funds from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Department of Health and Human Services (HHSN268201100025C), and the Board of Trustees of the University of Alabama for the University of Alabama at Birmingham; the American Heart Association (Scientist Development Grant to A.V.A.); the Boettcher Foundation's Webb-Waring Biomedical Research Program; and the STS INTERMACS registry (to J.K.K., which is paid to his institution); the NHLBI (HHSN268201100025C to L.W.S., as co-investigator for INTERMACS). The views expressed in this article are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; the National Institutes of Health; or the United States Department of Health and Human Services.
Funding Information:
This project has been funded in whole or in part by federal funds from the National Heart, Lung , and Blood Institute (NHLBI) , National Institutes of Health (NIH) , Department of Health and Human Services ( HHSN268201100025C ), and the Board of Trustees of the University of Alabama for the University of Alabama at Birmingham ; the American Heart Association (Scientist Development Grant to A.V.A.); the Boettcher Foundation's Webb-Waring Biomedical Research Program ; and the STS INTERMACS registry (to J.K.K., which is paid to his institution); the NHLBI ( HHSN268201100025C to L.W.S., as co-investigator for INTERMACS). The views expressed in this article are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; the National Institutes of Health; or the United States Department of Health and Human Services.
Publisher Copyright:
© 2018 International Society for Heart and Lung Transplantation
PY - 2019/4
Y1 - 2019/4
N2 - BACKGROUND: The outlook for ambulatory patients with advanced heart failure (HF) and the appropriate timing for left ventricular assist device (LVAD) or transplant remain uncertain. The aim of this study was to better understand disease trajectory and rates of progression to subsequent LVAD therapy and transplant in ambulatory advanced HF. METHODS: Patients with advanced HF who were New York Heart Association (NYHA) Class III or IV and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profiles 4 to 7, despite optimal medical therapy (without inotropic therapy), were enrolled across 11 centers and followed for the end-points of survival, transplantation, LVAD placement, and health-related quality of life. A secondary intention-to-treat survival analysis compared outcomes for MedaMACS patients with a matched group of Profile 4 to 7 patients with LVADs from the INTERMACS registry. RESULTS: Between May 2013 and October 2015, 161 patients were enrolled with INTERMACS Profiles 4 (12%), 5 (32%), 6 (49%), and 7 (7%). By 2 years after enrollment, 75 (47%) patients had reached a primary end-point with 39 (24%) deaths, 17 (11%) undergoing LVAD implantation, and 19 (12%) receiving a transplant. Compared with 1,753 patients with Profiles 4 to 7 receiving LVAD therapy, there was no overall difference in intention-to-treat survival between medical and LVAD therapy, but survival with LVAD therapy was superior to medical therapy among Profile 4 and 5 patients (p = 0.0092). Baseline health-related quality of life was lower among patients receiving a LVAD than those enrolled on continuing oral medical therapy, but increased after 1 year for survivors in both cohorts. CONCLUSIONS: Ambulatory patients with advanced HF are at high risk for poor outcomes, with only 53% alive on medical therapy after 2 years of follow-up. Survival was similar for medical and LVAD therapy in the overall cohort, which included the lower severity Profiles 6 and 7, but survival was better with LVAD therapy among patients in Profiles 4 and 5. Given the poor outcomes in this group of advanced HF patients, timely consideration of transplant and LVAD is of critical importance.
AB - BACKGROUND: The outlook for ambulatory patients with advanced heart failure (HF) and the appropriate timing for left ventricular assist device (LVAD) or transplant remain uncertain. The aim of this study was to better understand disease trajectory and rates of progression to subsequent LVAD therapy and transplant in ambulatory advanced HF. METHODS: Patients with advanced HF who were New York Heart Association (NYHA) Class III or IV and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profiles 4 to 7, despite optimal medical therapy (without inotropic therapy), were enrolled across 11 centers and followed for the end-points of survival, transplantation, LVAD placement, and health-related quality of life. A secondary intention-to-treat survival analysis compared outcomes for MedaMACS patients with a matched group of Profile 4 to 7 patients with LVADs from the INTERMACS registry. RESULTS: Between May 2013 and October 2015, 161 patients were enrolled with INTERMACS Profiles 4 (12%), 5 (32%), 6 (49%), and 7 (7%). By 2 years after enrollment, 75 (47%) patients had reached a primary end-point with 39 (24%) deaths, 17 (11%) undergoing LVAD implantation, and 19 (12%) receiving a transplant. Compared with 1,753 patients with Profiles 4 to 7 receiving LVAD therapy, there was no overall difference in intention-to-treat survival between medical and LVAD therapy, but survival with LVAD therapy was superior to medical therapy among Profile 4 and 5 patients (p = 0.0092). Baseline health-related quality of life was lower among patients receiving a LVAD than those enrolled on continuing oral medical therapy, but increased after 1 year for survivors in both cohorts. CONCLUSIONS: Ambulatory patients with advanced HF are at high risk for poor outcomes, with only 53% alive on medical therapy after 2 years of follow-up. Survival was similar for medical and LVAD therapy in the overall cohort, which included the lower severity Profiles 6 and 7, but survival was better with LVAD therapy among patients in Profiles 4 and 5. Given the poor outcomes in this group of advanced HF patients, timely consideration of transplant and LVAD is of critical importance.
KW - advanced heart failure
KW - cardiac transplantation
KW - mechanical circulatory support
KW - patient decision-making
KW - ventricular assist device
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U2 - 10.1016/j.healun.2018.09.021
DO - 10.1016/j.healun.2018.09.021
M3 - Article
C2 - 30948210
AN - SCOPUS:85055514372
SN - 1053-2498
VL - 38
SP - 408
EP - 417
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
IS - 4
ER -