Michelle M Kittleson1, Palak Shah2, Anuradha Lala3, Rhondalyn C McLean4, Salpy Pamboukian5, Douglas A Horstmanshof6, Jennifer Thibodeau7, Keyur Shah8, Jeffrey Teuteberg9, Nisha A Gilotra10, Wendy C Taddei-Peters11, Thomas M Cascino12, Blair Richards13, Shokoufeh Khalatbari13, Neal Jeffries11, Lynne W Stevenson14, Douglas Mann15, Keith D Aaronson12, Garrick C Stewart16. 1. Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA. Electronic address: michelle.kittleson@cshs.org. 2. Department of Medicine, Inova Heart and Vascular Institute, Falls Church, Virgina, USA. 3. Department of Internal Medicine, Mount Sinai Hospital, New York, New York, USA. 4. Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. 5. Department of Medicine, University of Alabama, Birmingham, Alabama, USA. 6. Interagency Autism Coordinating Committee Advanced Cardiac Care Deptartment, INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma, USA. 7. Department of Internal Medicine, University of Texas Southwest Medical Center, Dallas, Texas, USA. 8. Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virgina, USA. 9. Department of Medicine, Stanford University, Palo Alto, California, USA. 10. Department of Cardiology, Johns Hopkins Hospital, Baltimore, Maryland, USA. 11. Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland, USA. 12. Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan, USA. 13. Michigan Institute for Clinical and Health Research, University of Michigan, Ann Arbor, Michigan, USA. 14. Department of Medicine, Vanderbilt University, Nashville, Tennessee, USA. 15. Department of Internal Medicine, Washington University, St. Louis, Missouri, USA. 16. Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Abstract
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.
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.
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Authors: Michelle M Kittleson; Amrut V Ambardekar; Lynne W Stevenson; Nisha A Gilotra; Palak Shah; Gregory A Ewald; Jennifer T Thibodeau; Josef Stehlik; Maryse Palardy; Jerry D Estep; Thomas M Cascino; J Timothy Baldwin; Neal Jeffries; Shokoufeh Khalatbari; Matheos Yosef; Wendy Taddei Peters; Blair Richards; Douglas L Mann; Keith D Aaronson; Garrick C Stewart Journal: J Heart Lung Transplant Date: 2021-09-16 Impact factor: 10.247
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