Michelle M Kittleson1, Amrut V Ambardekar2, Lynne W Stevenson3, Nisha A Gilotra4, Palak Shah5, Gregory A Ewald6, Jennifer T Thibodeau7, Josef Stehlik8, Maryse Palardy9, Jerry D Estep10, Thomas M Cascino9, J Timothy Baldwin11, Neal Jeffries12, Shokoufeh Khalatbari13, Matheos Yosef13, Wendy Taddei Peters14, Blair Richards13, Douglas L Mann6, Keith D Aaronson9, Garrick C Stewart15. 1. Department of Cardiology, Smidt Heart institute, Cedars-Sinai, Los Angeles, California. Electronic address: michelle.kittleson@cshs.org. 2. Division of Cardiology, University of Colorado, Aurora, Colardo. 3. Section of Advanced Heart Failure and Transplant Cardiology, Division of Cardiovascular Medicine, Vanderbilt University Medical Center Nashville, Tennessee. 4. Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland. 5. Heart Failure & Transplantation, Inova Heart and Vascular Institute, Falls Church, Virginia. 6. Department of Medicine, Division of Cardiology, Washington University School of Medicine, St Louis, Missouri. 7. Division of Cardiology, The University of Texas Southwestern Medical Center, Dallas, Texas. 8. Division of Cardiovascular Medicine, University of Utah Health, University of Utah School of Medicine, Salt Lake City, Utah. 9. Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan. 10. Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio. 11. Michigan State University, East Lansing, Michigan. 12. Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland. 13. Michigan Institute for Clinical and Health Research, University of Michigan, Ann Arbor, Michigan. 14. Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland. 15. Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Abstract
INTRODUCTION: Patients with ambulatory advanced heart failure (HF) are increasingly considered for durable mechanical circulatory support (MCS) and heart transplantation and their effective triage requires careful assessment of the clinical trajectory. METHODS: REVIVAL, a prospective, observational study, enrolled 400 ambulatory advanced HF patients from 21 MCS/transplant centers in 2015-2016. Study design included a clinical re-assessment of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile within 120 days after enrollment. The prognostic impact of a worsening INTERMACS Profile assigned by the treating physician was assessed at 1 year after the Early Relook. RESULTS: Early Relook was done in 325 of 400 patients (81%), of whom 24% had a worsened INTERMACS Profile, associated with longer HF history and worse baseline INTERMACS profile, but no difference in baseline LVEF (median 0.20), 6-minute walk, quality of life, or other baseline parameters. Early worsening predicted higher rate of the combined primary endpoint of death, urgent MCS, or urgent transplant by 1 year after Early Relook, (28% vs 15%), with hazard ratio 2.2 (95% CI 1.2- 3.8; p = .006) even after adjusting for baseline INTERMACS Profile and Seattle HF Model score. Deterioration to urgent MCS occurred in 14% vs 5% (p = .006) during the year after Early Relook. CONCLUSIONS: Early Relook identifies worsening of INTERMACS Profile in a significant population of ambulatory advanced HF, who had worse outcomes over the subsequent year. Early reassessment of ambulatory advanced HF patients should be performed to better define the trajectory of illness and inform triage to advanced therapies.
INTRODUCTION: Patients with ambulatory advanced heart failure (HF) are increasingly considered for durable mechanical circulatory support (MCS) and heart transplantation and their effective triage requires careful assessment of the clinical trajectory. METHODS: REVIVAL, a prospective, observational study, enrolled 400 ambulatory advanced HF patients from 21 MCS/transplant centers in 2015-2016. Study design included a clinical re-assessment of Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile within 120 days after enrollment. The prognostic impact of a worsening INTERMACS Profile assigned by the treating physician was assessed at 1 year after the Early Relook. RESULTS: Early Relook was done in 325 of 400 patients (81%), of whom 24% had a worsened INTERMACS Profile, associated with longer HF history and worse baseline INTERMACS profile, but no difference in baseline LVEF (median 0.20), 6-minute walk, quality of life, or other baseline parameters. Early worsening predicted higher rate of the combined primary endpoint of death, urgent MCS, or urgent transplant by 1 year after Early Relook, (28% vs 15%), with hazard ratio 2.2 (95% CI 1.2- 3.8; p = .006) even after adjusting for baseline INTERMACS Profile and Seattle HF Model score. Deterioration to urgent MCS occurred in 14% vs 5% (p = .006) during the year after Early Relook. CONCLUSIONS: Early Relook identifies worsening of INTERMACS Profile in a significant population of ambulatory advanced HF, who had worse outcomes over the subsequent year. Early reassessment of ambulatory advanced HF patients should be performed to better define the trajectory of illness and inform triage to advanced therapies.
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