Zhang Yiyi, Guallar Eliseo, Blasco-Colmenares Elena, Dalal Darshan, Butcher Barbara, Norgard Sanaz, Tjong Fleur V Y, Eldadah Zayd, Dickfeld Timm, Ellenbogen Kenneth A, Marine Joseph E, Tomaselli Gordon F, Cheng Alan
Departments of Epidemiology and Medicine, and Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University Bloomberg School of Public Health.
Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Heart Rhythm. 2015 Feb;12(2):360-6. doi: 10.1016/j.hrthm.2014.10.034. Epub 2014 Oct 30.
Implantable cardioverter-defibrillator (ICD) implantation is contraindicated in those with <1-year life expectancy.
The aim of this study was to develop a risk prediction score for 1-year mortality in patients with primary prevention ICDs and to determine the incremental improvement in discrimination when serum-based biomarkers are added to traditional clinical variables.
We analyzed data from the Prospective Observational Study of Implantable Cardioverter-Defibrillators, a large prospective observational study of patients undergoing primary prevention ICD implantation who were extensively phenotyped for clinical and serum-based biomarkers. We identified variables predicting 1-year mortality and synthesized them into a comprehensive risk scoring construct using backward selection.
Of 1189 patients deemed by their treating physicians as having a reasonable 1-year life expectancy, 62 (5.2%) patients died within 1 year of ICD implantation. The risk score, composed of 6 clinical factors (age ≥75 years, New York Heart Association class III/IV, atrial fibrillation, estimated glomerular filtration rate <30 mL/min/1.73 m(2), diabetes, and use of diuretics), had good discrimination (area under the curve 0.77) for 1-year mortality. Addition of 3 biomarkers (tumor necrosis factor α receptor II, pro-brain natriuretic peptide, and cardiac troponin T) further improved model discrimination to 0.82. Patients with 0-1, 2-3, 4-6, or 7-9 risk factors had 1-year mortality rates of 0.8%, 2.7%, 16.1%, and 46.2%, respectively.
Individuals with more comorbidities and elevation of specific serum biomarkers were at increased risk of all-cause mortality despite being deemed as having a reasonable 1-year life expectancy. A simple risk score composed of readily available clinical data and serum biomarkers may better identify patients at high risk of early mortality and improve patient selection and counseling for primary prevention ICD therapy.
预期寿命小于1年的患者禁忌植入植入式心脏复律除颤器（ICD）。
本研究旨在开发一种用于一级预防ICD患者1年死亡率的风险预测评分，并确定在传统临床变量中加入基于血清的生物标志物时辨别能力的增量改善情况。
我们分析了来自植入式心脏复律除颤器前瞻性观察研究的数据，这是一项对接受一级预防ICD植入的患者进行的大型前瞻性观察研究，这些患者针对临床和基于血清的生物标志物进行了广泛的表型分析。我们确定了预测1年死亡率的变量，并使用向后选择将它们综合成一个全面的风险评分结构。
在其治疗医生认为有合理1年预期寿命的1189例患者中，62例（5.2%）患者在ICD植入后1年内死亡。由6个临床因素（年龄≥75岁、纽约心脏协会III/IV级、心房颤动、估计肾小球滤过率<30 mL/min/1.73 m²、糖尿病和使用利尿剂）组成的风险评分对1年死亡率具有良好的辨别能力（曲线下面积为0.77）。加入3种生物标志物（肿瘤坏死因子α受体II、脑钠肽前体和心肌肌钙蛋白T）进一步将模型辨别能力提高到0.82。具有0 - 1、2 - 3、4 - 6或7 - 9个风险因素的患者1年死亡率分别为0.8%、2.7%、16.1%和46.2%。
尽管被认为有合理的1年预期寿命，但合并症较多且特定血清生物标志物升高的个体全因死亡率风险增加。一个由易于获得的临床数据和血清生物标志物组成的简单风险评分可能能更好地识别早期死亡风险高的患者，并改善一级预防ICD治疗的患者选择和咨询。
