Patient-Reported Outcomes Best NYHA Class for Capturing Progression of Heart Failure

Stephen Greene, MD

While New York Heart Association (NYHA) class has been the standard for assessing progression of heart failure with reduced ejection fraction (HFrEF) for decades, new research suggests patient-reported outcomes (PRO) may be a more effective way to capture and depict a patient’s disease state over time.

An analysis of patients from within the CHAMP-HF Registry, the 2872-patient study suggests PRO, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, was more sensitive and better at tracking meaningful changes in health status over time when compared to use of NYHA class.

“Improvement in KCCQ-OS was independently associated with lower risk of subsequent mortality and the composite of mortality and HF hospitalization, whereas improvement in NYHA class was not associated with clinical outcomes,” wrote investigators.

With an interest in comparing the ability of the aforementioned scoring systems to characterize changes in disease state and their associations with clinical outcomes in HFrEF, the current study was designed by Stephen Greene, MD, of the Duke Clinical Research Institute, and a team of colleagues from multiple institutions, including Brigham and Women’s Hospital and University of Mississippi Medical Center. A prospective, noninterventional study inducted from December 2015-October 2017, the CHAMP-HF registry provided investigators with data related to more than 5000 patients with HF.

For inclusion in the current analysis, patients were required to have a diagnosis of chronic HF, a left ventricular ejection fraction of 40% or lower on most recent imaging within 12 months of enrollment, be receiving at least 1 oral medication at enrollment, and have completed data related to NYHA class and KCCQ-OS data at baseline and 12 months. Overall, 2872 patients met these criteria and were included in the study.

The median age of the study cohort was 68 years (IQR, 59-75 years), 30.4% were women, 75.1% identified as White, and the median ejection fraction was 30% (IQR, 23-35). Baseline assessments of NYHA class indicated 10.9% were NYHA class I, 59.5% were NYHA class II, 28.0% were NUHAclass III, and 1.6% were NYHA class IV. For KCCQ-OS, 39.4% scored between 75-100, 33.7% scored between 50-74, 21.3% scored between 25-49, and 5.6% of patients scored between 0-24.

At 12 months, 34.9% of patients had a change in NYHA, with 599 experiencing improvement and 403 experiencing a worsening score. For KCCQ-OS at 12 months, 2158 had a change of 5 or more, with 1388 experiencing an improvement and 26.8% experiencing a worsening score. Overall, the most common trajectory for KCCQ-OS was an improvement of 10 points or more (n=1047) and the most common trajectory of NYHA change was no change (n=1870).

In adjusted analyses, investigators found improvements in NYHA class were not associated with subsequent clinical outcomes, but an improvement of 5 or more points in KCCQ-OS was independently associated with decreased mortality (HR, 0.59; 95% CI, 0.44-0.80; P <.001) and mortality or hospitalization for worsening HF (HR, 0.73; 95% CI, 0.59-0.89; P=.002).

In an editorial comment, Paul Heidenreich, MD, MS, of the VA Palo Alto Health Care System, commended Greene and colleagues for their work and outlining the prognostic value of capturing RPO, but also noted real-world barriers to implementation need to be addressed to effectively implement capturing this data.

“The implication of the study by Greene et al is that the NYHA class should be reconsidered if it does not match the patient-reported data. When used together, prognosis assessment and treatment decisions will be improved,” wrote Heidenreich.

This study, “Comparison of New York Heart Association Class and Patient-Reported Outcomes for Heart Failure With Reduced Ejection Fraction,” was published in JAMA Cardiology.