Duke Clinical Research Institute, Durham, North Carolina.
Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.
JAMA Cardiol. 2021 May 1;6(5):522-531. doi: 10.1001/jamacardio.2021.0372.
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.
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.
Change in health status, as defined by 12-month change in NYHA class or KCCQ-OS.
All-cause mortality, HF hospitalization, and mortality or HF hospitalization.
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).
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.
目前尚不清楚纽约心脏协会（NYHA）功能分级与心力衰竭（HF）患者的患者报告结局在当代美国临床实践中的关系。
描述 NYHA 分级与堪萨斯城心肌病问卷整体综合评分（KCCQ-OS）之间的纵向变化和一致性，并评估其与临床结局的相关性。
设计、设置和参与者：本队列研究纳入了 2015 年 12 月至 2017 年 10 月期间在 CHAMP-HF 注册中心登记的 145 家美国实践中心的 2872 例慢性射血分数降低型心力衰竭的门诊患者。所有患者在基线和 12 个月时均具有完整的 NYHA 分级和 KCCQ-OS 数据。检查了这两种测量方法的纵向变化和相关性。在 12 个月的时间点进行多变量模型分析，评估从基线到 12 个月时 NYHA 分级和 KCCQ-OS 的改善与 12 至 24 个月的临床结局之间的相关性。统计分析于 2020 年 3 月至 8 月进行。
健康状况的变化，定义为 12 个月 NYHA 分级或 KCCQ-OS 的变化。
全因死亡率、HF 住院率以及死亡率或 HF 住院率。
共有 2872 例患者纳入本分析（中位数[四分位数间距]年龄，68[59-75]岁；872 例[30.4%]为女性；2156 例[75.1%]为白种人）。基线时，312 例（10.9%）患者为 NYHA 分级 I，1710 例（59.5%）为 II 级，804 例（28.0%）为 III 级，46 例（1.6%）为 IV 级。对于 KCCQ-OS，1131 例（39.4%）评分在 75 到 100 分（最佳健康状况），967 例（33.7%）评分在 50 到 74 分，612 例（21.3%）评分在 25 到 49 分，162 例（5.6%）评分在 0 到 24 分（最差健康状况）。在 12 个月时，1002 例（34.9%）患者 NYHA 分级发生变化（599 例[20.9%]改善，403 例[14.0%]恶化），2158 例（75.1%）患者 KCCQ-OS 评分变化≥5 分（1388 例[48.3%]改善，770 例[26.8%]恶化）。NYHA 分级最常见的变化轨迹是无变化（1870 例[65.1%]），KCCQ-OS 最常见的变化轨迹是改善至少 10 分（1047 例[36.5%]）。经过调整，NYHA 分级的改善与随后的临床结局无关，而 KCCQ-OS 评分的改善≥5 分与死亡率降低独立相关（风险比，0.59；95%置信区间，0.44-0.80；P<0.001）和死亡率或 HF 住院率降低（风险比，0.73；95%置信区间，0.59-0.89；P=0.002）。
本队列研究的结果表明，在当代美国临床实践中，与 NYHA 分级相比，KCCQ-OS 对健康状况随时间的变化更为敏感。KCCQ-OS 的变化可能比 NYHA 分级的变化具有更高的预后价值。
