Author + information
- Received November 26, 2018
- Revision received March 13, 2019
- Accepted March 14, 2019
- Published online June 24, 2019.
- Merrill Thomas, MDa,
- Yevgeniy Khariton, MD, MSca,
- Gregg C. Fonarow, MDb,
- Suzanne V. Arnold, MD, MHAa,
- Larry Hill, PhDc,
- Michael E. Nassif, MD, MSd,
- Puza P. Sharma, MBBSe,
- Javed Butler, MDf,
- Laine Thomas, PhDc,
- Carol I. Duffy, DOe,
- Adam D. DeVore, MD, MHSc,g,
- Adrian Hernandez, MD, MScc,g,
- Nancy M. Albert, PhDh,
- J. Herbert Patterson, PharmDi,
- Fredonia B. Williams, EdDj,
- Kevin McCague, MAe and
- John A. Spertus, MD, MPHa,∗ (, )@jspertus
- aSaint Luke’s Mid America Heart Institute/University of Missouri–Kansas City, Kansas City, Missouri
- bAhmanson-UCLA Cardiomyopathy Center, Ronald Reagan UCLA Medical Center, Los Angeles, California
- cDuke Clinical Research Institute, Durham, North Carolina
- dWashington University School of Medicine in Saint Louis, Saint Louis, Missouri
- eNovartis Pharmaceuticals Corporation, East Hanover, New Jersey
- fUniversity of Mississippi, Jackson, Mississippi
- gDivision of Cardiology, Department of Medicine, and the Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
- hCleveland Clinic, Cleveland, Ohio
- iEshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina
- jMended Hearts, Huntsville, Alabama
- ↵∗Address for correspondence:
Dr. John A. Spertus, Saint Luke’s Mid America Heart Institute, 4401 Wornall Road, Kansas City, Missouri 64111.
Objectives The aim of this study was to use a multicenter, observational outpatient registry of patients with heart failure with reduced ejection fraction (HFrEF) to describe the association between changes in patients’ medications with changes in health status.
Background Alleviating symptoms and improving function and quality of life for patients with HFrEF are primary treatment goals and potential indicators of quality. Whether titrating medications in routine clinical care improves patients’ health status is unknown.
Methods The association of any change in HFrEF medications with 3-month change in health status, as measured using the 12-item Kansas City Cardiomyopathy Questionnaire Overall Summary Scale, was determined in unadjusted and multivariate-adjusted (25 clinical characteristics, baseline health status) models using hierarchical linear regression.
Results Among 3,313 outpatients with HFrEF from 140 centers, 21.9% had medication changes. Three months later, 23.7% and 46.4% had clinically meaningfully worse (≥5-point decrease) and improved (≥5-point increase) Kansas City Cardiomyopathy Questionnaire Overall Summary Scale scores. The 3-month median change in Kansas City Cardiomyopathy Questionnaire Overall Summary Scale score for patients whose HFrEF medications were changed was significantly larger (7.3 points; interquartile range: −3.1 to 20.8 points) than in patients whose medications were not changed (3.1 points; interquartile range: −4.7 to 12.5 points) (adjusted difference 3.0 points; 95% confidence interval: 1.4 to 4.6 points; p < 0.001). Among patients whose medications were adjusted, 26% had very large clinical improvement (≥20 points) compared with 14% whose regimens were not changed.
Conclusions In routine care of patients with HFrEF, changes in HFrEF medications were associated with significant improvements in patients’ health status, suggesting that health status–based performance measures can quantify the benefits of titrating medicines in patients with HFrEF.
- health status
- heart failure with reduced ejection fraction
- Kansas City Cardiomyopathy Questionnaire
Dr. Khariton is supported by the National Heart, Lung, and Blood Institute under award T32HL110837 (the content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health). Dr. Fonarow has received research support from the National Institutes of Health; is a consultant for Amgen, Janssen, Medtronic, Novartis, and St. Jude Medical; and has served on the Get With the Guidelines Steering Committee. Dr. Butler has received research support from the National Institutes of Health and the European Union; and serves as a consultant for Amgen, Bayer, Boehringer Ingelheim, Cardiocell, CVRx, Gilead, Janssen, Medtronic, Merck, Novartis, Relypsa, and ZS Pharma. Dr. Thomas has received research funding from Novartis Pharmaceuticals. Dr. DeVore has received research support from the American Heart Association, Amgen, the National Institutes of Health, and Novartis; and provides consulting services for Novartis. Dr. Hernandez has received research support from AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Luitpold Pharmaceuticals, Merck, and Novartis; and has received honoraria from Bayer, Boston Scientific, and Novartis. Dr. Albert is a consultant for Novartis and Boston Scientific; and has received honoraria from Novartis. Dr. Spertus has received grant funding from the National Institutes of Health, the Patient-Centered Outcomes Research Institute, Novartis, and Abbott Vascular; serves on a Scientific Advisory Board for United Healthcare; is a consultant for Novartis, Bayer, V-Wave, AstraZeneca, Janssen, Corvia, and Bayer; has intellectual property rights for the Kansas City Cardiomyopathy Questionnaire; and has an equity interest in Health Outcomes Science. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 26, 2018.
- Revision received March 13, 2019.
- Accepted March 14, 2019.
- 2019 American College of Cardiology Foundation
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.