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Original Investigation
March 24, 2021

Comparison of New York Heart Association Class and Patient-Reported Outcomes for Heart Failure With Reduced Ejection Fraction

Author Affiliations
  • 1Duke Clinical Research Institute, Durham, North Carolina
  • 2Division of Cardiology, Duke University School of Medicine, Durham, North Carolina
  • 3Department of Medicine, University of Mississippi Medical Center, Jackson
  • 4Saint Luke’s Mid America Heart Institute and the University of Missouri–Kansas City, Kansas City
  • 5Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts
  • 6Nursing Institute and Heart, Vascular and Thoracic Institute, Cleveland Clinic Foundation, Cleveland, Ohio
  • 7Novartis Pharmaceuticals Corporation, East Hanover, New Jersey
  • 8Eshelman School of Pharmacy, University of North Carolina, Chapel Hill
  • 9Assistant Editor for Statistics, JAMA Cardiology
  • 10Mended Hearts, Huntsville, Alabama
  • 11Associate Editor, JAMA Cardiology
  • 12Ahmanson-UCLA Cardiomyopathy Center, University of California, Los Angeles, Los Angeles
  • 13Associate Editor for Health Care Quality and Guidelines, JAMA Cardiology
JAMA Cardiol. 2021;6(5):522-531. doi:10.1001/jamacardio.2021.0372
Key Points

Question  In routine US clinical practice, how does the New York Heart Association (NYHA) class compare with patient-reported outcomes for serial assessment of health status among patients with heart failure with reduced ejection fraction?

Findings  During outpatient follow-up of 12 months in this cohort study, 75% of 2872 patients had a clinically meaningful change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) of 5 or more points, whereas 35% had a change of 1 class or more in NYHA class. Improvement in KCCQ-OS of 5 or more points was independently associated with decreased mortality, whereas improvement in NYHA class was not.

Meaning  Compared with the clinician-assigned NYHA class, the patient-reported KCCQ-OS is more likely to detect meaningful change in health status over time, and changes in KCCQ-OS may have more prognostic value than changes in NYHA class.

Abstract

Importance  It is unclear how New York Heart Association (NYHA) functional class compares with patient-reported outcomes among patients with heart failure (HF) in contemporary US clinical practice.

Objective  To characterize longitudinal changes and concordance between NYHA class and the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS), and their associations with clinical outcomes.

Design, Setting, and Participants  This cohort study included 2872 US outpatients with chronic HF with reduced ejection fraction across 145 practices enrolled in the CHAMP-HF registry between December 2015 and October 2017. All patients had complete NYHA class and KCCQ-OS data at baseline and 12 months. Longitudinal changes and correlations between the 2 measure were examined. Multivariable models landmarked at 12 months evaluated associations between improvement in NYHA and KCCQ-OS from baseline to 12 months with clinical outcomes occurring from months 12 through 24. Statistical analyses were performed from March to August 2020.

Exposure  Change in health status, as defined by 12-month change in NYHA class or KCCQ-OS.

Main Outcomes and Measures  All-cause mortality, HF hospitalization, and mortality or HF hospitalization.

Results  In total, 2872 patients were included in this analysis (median [interquartile range] age, 68 [59-75] years; 872 [30.4%] were women; and 2156 [75.1%] were of White race). At baseline, 312 patients (10.9%) were NYHA class I, 1710 patients (59.5%) were class II, 804 patients (28.0%) were class III, and 46 patients (1.6%) were class IV. For KCCQ-OS, 1131 patients (39.4%) scored 75 to 100 (best health status), 967 patients (33.7%) scored 50 to 74, 612 patients (21.3%) scored 25 to 49, and 162 patients (5.6%) scored 0 to 24 (worst health status). At 12 months, 1002 patients (34.9%) had a change in NYHA class (599 [20.9%] with improvement; 403 [14.0%] with worsening) and 2158 patients (75.1%) had a change of 5 or more points in KCCQ-OS (1388 [48.3%] with improvement; 770 [26.8%] with worsening). The most common trajectory for NYHA class was no change (1870 [65.1%]), and the most common trajectory for KCCQ-OS was an improvement of at least 10 points (1047 [36.5%]). After adjustment, improvement in NYHA class was not associated with subsequent clinical outcomes, whereas an improvement of 5 or more points in KCCQ-OS was independently associated with decreased mortality (hazard ratio, 0.59; 95% CI, 0.44-0.80; P < .001) and mortality or HF hospitalization (hazard ratio, 0.73; 95% CI, 0.59-0.89; P = .002).

Conclusions and Relevance  Findings of this cohort study suggest that, in contemporary US clinical practice, compared with NYHA class, KCCQ-OS is more sensitive to clinically meaningful changes in health status over time. Changes in KCCQ-OS may have more prognostic value than changes in NYHA class.

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