Anuradha Lala1, Keyur B Shah2, David E Lanfear3, Jennifer T Thibodeau4, Maryse Palardy5, Amrut V Ambardekar6, Dennis M McNamara7, Wendy C Taddei-Peters8, J Timothy Baldwin9, Neal Jeffries10, Shokoufeh Khalatbari11, Cathie Spino12, Blair Richards11, Douglas L Mann13, Garrick C Stewart14, Keith D Aaronson5, Donna M Mancini15. 1. Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York, USA. 2. Department of Medicine, Division of Cardiology, Virginia Commonwealth University, Richmond, Virginia, USA. 3. Heart and Vascular Institute, Henry Ford Hospital, Detroit, Michigan, USA. 4. Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA. 5. Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan, USA. 6. University of Colorado, Boulder, Colorado, USA. 7. Department of Medicine, Division of Cardiology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. 8. Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland, USA. 9. Michigan State University, East Lansing, Michigan, USA. 10. Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland, USA. 11. Michigan Institute for Clinical and Health Research, University of Michigan, Ann Arbor, Michigan, USA. 12. Department of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA. 13. Cardiovascular Division, Washington University School of Medicine, Washington University School of Medicine, St. Louis, Missouri, USA. 14. Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA. 15. Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: donna.mancini@mountsinai.org.
Abstract
OBJECTIVES: This study sought to determine cardiopulmonary exercise (CPX) predictors of the combined outcome of durable mechanical circulatory support (MCS), transplantation, or death at 1 year among patients with ambulatory advanced heart failure (HF). BACKGROUND: Optimal CPX predictors of outcomes in contemporary ambulatory advanced HF patients are unclear. METHODS: REVIVAL (Registry Evaluation of Vital Information for ventricular assist devices [VADs] in Ambulatory Life) enrolled 400 systolic HF patients, INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profiles 4-7. CPX was performed by 273 subjects 2 ± 1 months after study enrollment. Discriminative power of maximal (peak oxygen consumption [peak VO2]; VO2 pulse, circulatory power [CP]; peak systolic blood pressure • peak VO2], peak end-tidal pressure CO2 [PEtCO2], and peak Borg scale score) and submaximal CPX parameters (ventilatory efficiency [VE/VCO2 slope]; VO2 at anaerobic threshold [VO2AT]; and oxygen uptake efficiency slope [OUES]) to predict the composite outcome were assessed by univariate and multivariate Cox regression and Harrell's concordance statistic. RESULTS: At 1 year, there were 39 events (6 transplants, 15 deaths, 18 MCS implantations). Peak VO2, VO2AT, OUES, peak PEtCO2, and CP were higher in the no-event group (all p < 0.001), whereas VE/VCO2 slope was lower (p < 0.0001); respiratory exchange ratio was not different. CP (hazard ratio [HR]: 0.99; p = 0.0010), VE/VCO2 slope (HR: 1.05; p = 0.001), and peak Borg scale score (HR: 1.20; p = 0.005) were significant predictors on multivariate analysis (model C-statistic: 0.80). CONCLUSIONS: Among patients with ambulatory advanced HF, the strongest maximal and submaximal CPX predictor of MCS implantation, transplantation, or death at 1 year were CP and VE/VCO2, respectively. The patient-reported measure of exercise effort (Borg scale score) contributed substantially to the prediction of outcomes, a surprising and novel finding that warrants further investigation. (Registry Evaluation of Vital Information for VADs in Ambulatory Life [REVIVAL]; NCT01369407).
OBJECTIVES: This study sought to determine cardiopulmonary exercise (CPX) predictors of the combined outcome of durable mechanical circulatory support (MCS), transplantation, or death at 1 year among patients with ambulatory advanced heart failure (HF). BACKGROUND: Optimal CPX predictors of outcomes in contemporary ambulatory advanced HF patients are unclear. METHODS: REVIVAL (Registry Evaluation of Vital Information for ventricular assist devices [VADs] in Ambulatory Life) enrolled 400 systolic HF patients, INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profiles 4-7. CPX was performed by 273 subjects 2 ± 1 months after study enrollment. Discriminative power of maximal (peak oxygen consumption [peak VO2]; VO2 pulse, circulatory power [CP]; peak systolic blood pressure • peak VO2], peak end-tidal pressure CO2 [PEtCO2], and peak Borg scale score) and submaximal CPX parameters (ventilatory efficiency [VE/VCO2 slope]; VO2 at anaerobic threshold [VO2AT]; and oxygen uptake efficiency slope [OUES]) to predict the composite outcome were assessed by univariate and multivariate Cox regression and Harrell's concordance statistic. RESULTS: At 1 year, there were 39 events (6 transplants, 15 deaths, 18 MCS implantations). Peak VO2, VO2AT, OUES, peak PEtCO2, and CP were higher in the no-event group (all p < 0.001), whereas VE/VCO2 slope was lower (p < 0.0001); respiratory exchange ratio was not different. CP (hazard ratio [HR]: 0.99; p = 0.0010), VE/VCO2 slope (HR: 1.05; p = 0.001), and peak Borg scale score (HR: 1.20; p = 0.005) were significant predictors on multivariate analysis (model C-statistic: 0.80). CONCLUSIONS: Among patients with ambulatory advanced HF, the strongest maximal and submaximal CPX predictor of MCS implantation, transplantation, or death at 1 year were CP and VE/VCO2, respectively. The patient-reported measure of exercise effort (Borg scale score) contributed substantially to the prediction of outcomes, a surprising and novel finding that warrants further investigation. (Registry Evaluation of Vital Information for VADs in Ambulatory Life [REVIVAL]; NCT01369407).
Authors: Virginia Mihalick; George Wohlford; Azita H Talasaz; Ai-Chen Jane Ho; Francine Kim; Justin M Canada; Salvatore Carbone; Dinesh Kadariya; Hayley Billingsley; Cory Trankle; Marco Giuseppe Del Buono; Francesco Moroni; Ross Arena; Antonio Abbate; Benjamin Van Tassell Journal: Am J Cardiol Date: 2022-04-25 Impact factor: 3.133