TY - JOUR
T1 - INTERMACS profiles and outcomes of ambulatory advanced heart failure patients
T2 - A report from the REVIVAL Registry
AU - for the REVIVAL Investigators
AU - Kittleson, Michelle M.
AU - Shah, Palak
AU - Lala, Anuradha
AU - McLean, Rhondalyn C.
AU - Pamboukian, Salpy
AU - Horstmanshof, Douglas A.
AU - Thibodeau, Jennifer
AU - Shah, Keyur
AU - Teuteberg, Jeffrey
AU - Gilotra, Nisha A.
AU - Taddei-Peters, Wendy C.
AU - Cascino, Thomas M.
AU - Richards, Blair
AU - Khalatbari, Shokoufeh
AU - Jeffries, Neal
AU - Stevenson, Lynne W.
AU - Mann, Douglas
AU - Aaronson, Keith D.
AU - Stewart, Garrick C.
N1 - Funding Information:
We thank the singular contributions of Laurie Rigan to the REVIVAL study. This study was supported by funding from the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI Contract Number: HHSN268201100026C) for REVIVAL and the National Center for Advancing Translational Sciences (NCATS Grant Number: UL1TR002240) for the Michigan Institute for Clinical and Health Research. The views expressed in this manuscript 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 US Department of Health and Human Services.
Funding Information:
We thank the singular contributions of Laurie Rigan to the REVIVAL study. This study was supported by funding from the National Institutes of Health , National Heart, Lung, and Blood Institute (NHLBI Contract Number: HHSN268201100026C ) for REVIVAL and the National Center for Advancing Translational Sciences (NCATS Grant Number: UL1TR002240 ) for the Michigan Institute for Clinical and Health Research . The views expressed in this manuscript 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 US Department of Health and Human Services.
Funding Information:
P.S. reports the following grant support: American Heart Association/Enduring Hearts Scientist Development Grant, Merck, Haemonetrics, and Medtronic. Consulting: NuPulse CV and Ortho Clinical Diagnostics. K.S. reports being a consultant for Medtronic and Syncardia. J.T. reports speaking and ad board with Medtronic. D.H. reports being a speaker and research grant for Abbott Medical. K.D.A. reports the following related to the submitted work: the National Institutes of Health/National Heart, Lung, and Blood Institute (contract) and outside the submitted work: Medtronic (research support and consultant [Independent Physician Quality Panel member]), Abbott (research support), Procyrion (consultant), NuPulseCV (consultant), Bioventrix (research support).
Publisher Copyright:
© 2019 International Society for Heart and Lung Transplantation
PY - 2020/1
Y1 - 2020/1
N2 - BACKGROUND: Ambulatory patients with advanced heart failure (HF) are often considered for advanced therapies, including durable mechanical circulatory support (MCS). The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles are a commonly used descriptor of disease severity in patients receiving MCS devices, but their role in defining the prognosis of ambulatory patients is less well established, especially for Profiles 6 and 7. METHODS: Registry Evaluation of Vital Information on Ventricular Assist Devices in Ambulatory Life is a prospective observational study of 400 outpatients from 21 MCS and cardiac transplant centers. Eligible patients had New York Heart Association Class II to IV symptoms despite optimal medical and electrical therapies with a recent HF hospitalization, heart transplant listing, or evidence of high neurohormonal activation. RESULTS: The cohort included 33 INTERMACS Profile 4 (8%), 83 Profile 5 (21%), 155 Profile 6 (39%), and 129 Profile 7 (32%). Across INTERMACS profiles, there were no differences in age, gender, ejection fraction, blood pressure, or use of guideline-directed medical therapy. A lower INTERMACS profile was associated with more hospitalizations, greater frailty, and more impaired functional capacity and quality of life. The composite end point of death, durable MCS, or urgent transplant at 12 months occurred in 39%, 27%, 24%, and 14% subjects with INTERMACS Profiles 4, 5, 6, and 7, respectively (p = 0.004). CONCLUSIONS: Among ambulatory patients with advanced HF, a lower INTERMACS profile was associated with a greater burden of HF across multiple dimensions and a higher composite risk of durable MCS, urgent transplant, or death. These profiles may assist in risk assessment and triaging ambulatory patients to advanced therapies.
AB - BACKGROUND: Ambulatory patients with advanced heart failure (HF) are often considered for advanced therapies, including durable mechanical circulatory support (MCS). The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles are a commonly used descriptor of disease severity in patients receiving MCS devices, but their role in defining the prognosis of ambulatory patients is less well established, especially for Profiles 6 and 7. METHODS: Registry Evaluation of Vital Information on Ventricular Assist Devices in Ambulatory Life is a prospective observational study of 400 outpatients from 21 MCS and cardiac transplant centers. Eligible patients had New York Heart Association Class II to IV symptoms despite optimal medical and electrical therapies with a recent HF hospitalization, heart transplant listing, or evidence of high neurohormonal activation. RESULTS: The cohort included 33 INTERMACS Profile 4 (8%), 83 Profile 5 (21%), 155 Profile 6 (39%), and 129 Profile 7 (32%). Across INTERMACS profiles, there were no differences in age, gender, ejection fraction, blood pressure, or use of guideline-directed medical therapy. A lower INTERMACS profile was associated with more hospitalizations, greater frailty, and more impaired functional capacity and quality of life. The composite end point of death, durable MCS, or urgent transplant at 12 months occurred in 39%, 27%, 24%, and 14% subjects with INTERMACS Profiles 4, 5, 6, and 7, respectively (p = 0.004). CONCLUSIONS: Among ambulatory patients with advanced HF, a lower INTERMACS profile was associated with a greater burden of HF across multiple dimensions and a higher composite risk of durable MCS, urgent transplant, or death. These profiles may assist in risk assessment and triaging ambulatory patients to advanced therapies.
KW - INTERMACS Profiles
KW - LVAD
KW - ambulatory heart failure
KW - death
KW - heart transplantation
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U2 - 10.1016/j.healun.2019.08.017
DO - 10.1016/j.healun.2019.08.017
M3 - Article
C2 - 31522912
AN - SCOPUS:85072193511
SN - 1053-2498
VL - 39
SP - 16
EP - 26
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
IS - 1
ER -