The NYHA classification for heart failure (HF) may miss patients with a physician-defined “asymptomatic” functional class who are at substantial risk for adverse outcomes, according to a study published Dec. 7 in JAMA Cardiology.

Luis E. Rohde, MD ScD, et al., conducted a secondary analysis of 8,326 patients from the parallel-design double-blind PARADIGM-HF trial to assess the association between NYHA class and long-term prognosis. All patients were in NYHA class II or higher HF at baseline and were treated with sacubitril-valsartan during a six-to-10-week run-in period before randomization. Patients classified as NYHA class I, II, and III in the trial were compared at randomization.

Results showed that of 389 patients in NYHA class I at randomization, 228 (58%) changed functional class after the first year. Patients classified as NYHA class III had a higher rate of cardiovascular events (NYHA class III vs. class I, hazard ratio [HR], 1.84; 95% CI, 1.44-2.37; NYHA class III vs. class II, HR, 1.49; 95%CI, 1.35-1.64). Conversely, NYHA class I and class II patients had lower event rates (NYHA class II vs. class I, HR, 1.24; 95% CI, 0.97-1.58).

The level of NT-proBNP was shown to be a poor discriminator of classification for NYHA class. For NYHA class I vs. class II, the area under the curve was 0.51. NT-proBNP level estimated kernel density overlap was 93% for NYHA class I vs. class II, 79% for class I vs. class III, and 83% for class II vs. class III.

Stratification of NT-proBNP levels (<1600 pg/mL or ≥ 1600 pg/mL) found subgroups with distinctive risk, such that patients with NYHA class I and high NT-proBNP levels (n=175) had a numerically higher event rate than patients with low NT-proBNP levels from any NYHA class (vs. class I, HR, 3.43; vs. class II, HR, 2.12; vs. class III, HR, 1.37).

The authors write that their findings from this contemporary clinical trial of HF challenge the NYHA framework, and “suggest that novel criteria must be considered in selecting patients who may benefit most from modern HF therapies. It is reasonable to propose that apparently asymptomatic HF patients defined by subjective assessments should be “challenged” by patient-reported scores…”

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Cardiovascular System, Heart Failure, Physicians, Cardiology, Prognosis, Random Allocation, Patient Selection

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