Abstract

Abstract Background Although a 5-point change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores is widely recognized as representing a clinically meaningful change in symptoms and quality of life, it is not known how changes KCCQ scores relate to risk of hospitalization and death. Purpose To evaluate how changes in KCCQ summary scores relate to subsequent risk of hospitalization and death in a large cohort of patients with heart failure and reduced ejection fraction (HFrEF). Methods We used individual patient data from 3 HFrEF trials (ATMOSPHERE, PARADIGM-HF, and DAPA-HF) to examine the association between changes in KCCQ summary scores between baseline and 8-months and the subsequent risk of cardiovascular death or HF hospitalization, using Cox-proportional hazard models. Change in score was categorized as very small (>0 <5), small (> = 5 <10), moderate (> = 10 <20), and large (> = 20) points. We examined the KCCQ total symptom score (KCCQ-TSS), KCCQ clinical summary score (KCCQ-CSS), and KCCQ overall summary score (KCCQ-OSS). Results Among 15,892 participants with HFrEF, 1403 patients (8.8%) had a large deterioration in KCCQ score, 1688 (10.6%) a moderate deterioration, 1442 (9.1%) a small deterioration, 1527 (9.6%) a very small deterioration, and 2326 (14.6%) no deterioration. Conversely, 1836 patients (11.6%) had a very small improvement, 1732 (10.9%) a small improvement, 2202 (13.9%) a moderate improvement, and 1736 (10.9%) a large improvement. Patients with larger changes in KCCQ scores were older and more often female and had lower baseline summary scores and worse heart failure characteristics. Worsening heath status i.e., decrease in the KCCQ-TSS, was associated with a higher risk of the composite outcome (and each of its components), as well as all-cause mortality (Figure 1). On the contrary, improvements in KCCQ-TSS were not associated with better clinical outcomes (Figure 1). The findings were similar for 4-month changes of KCCQ-TSS, and changes in other KCCQ scores (KCCQ-CSS and KCCQ-OSS) at both 4 and 8-months. Conclusion Decreases (deterioration) in KCCQ summary scores during follow-up were associated with worse outcomes in patients with HFrEF but no association was seen between improvement in KCCQ scores and outcomes. These findings have potential implications for the interpretation of the effect of treatment on KCCQ scores.

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