Bilchick Kenneth C, Wang Yongfei, Cheng Alan, Curtis Jeptha P, Dharmarajan Kumar, Stukenborg George J, Shadman Ramin, Anand Inder, Lund Lars H, Dahlström Ulf, Sartipy Ulrik, Maggioni Aldo, Swedberg Karl, O'Conner Chris, Levy Wayne C
Department of Medicine, University of Virginia Health System, Charlottesville, Virginia.
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut; Department of Internal Medicine, Yale University, New Haven, Connecticut.
J Am Coll Cardiol. 2017 May 30;69(21):2606-2618. doi: 10.1016/j.jacc.2017.03.568.
Recent clinical trials highlight the need for better models to identify patients at higher risk of sudden death.
The authors hypothesized that the Seattle Heart Failure Model (SHFM) for overall survival and the Seattle Proportional Risk Model (SPRM) for proportional risk of sudden death, including death from ventricular arrhythmias, would predict the survival benefit with an implantable cardioverter-defibrillator (ICD).
Patients with primary prevention ICDs from the National Cardiovascular Data Registry (NCDR) were compared with control patients with heart failure (HF) without ICDs with respect to 5-year survival using multivariable Cox proportional hazards regression.
Among 98,846 patients with HF (87,914 with ICDs and 10,932 without ICDs), the SHFM was strongly associated with all-cause mortality (p < 0.0001). The ICD-SPRM interaction was significant (p < 0.0001), such that SPRM quintile 5 patients had approximately twice the reduction in mortality with the ICD versus SPRM quintile 1 patients (adjusted hazard ratios [HR]: 0.602; 95% confidence interval [CI]: 0.537 to 0.675 vs. 0.793; 95% CI: 0.736 to 0.855, respectively). Among patients with SHFM-predicted annual mortality ≤5.7%, those with a SPRM-predicted risk of sudden death below the median had no reduction in mortality with the ICD (adjusted ICD HR: 0.921; 95% CI: 0.787 to 1.08; p = 0.31), whereas those with SPRM above the median derived the greatest benefit (adjusted HR: 0.599; 95% CI: 0.530 to 0.677; p < 0.0001).
The SHFM predicted all-cause mortality in a large cohort with and without ICDs, and the SPRM discriminated and calibrated the potential ICD benefit. Together, the models identified patients less likely to derive a survival benefit from primary prevention ICDs.
近期的临床试验凸显了需要更好的模型来识别猝死风险较高的患者。
作者假设用于总体生存的西雅图心力衰竭模型（SHFM）以及用于猝死比例风险（包括室性心律失常导致的死亡）的西雅图比例风险模型（SPRM）能够预测植入式心律转复除颤器（ICD）带来的生存获益。
使用多变量Cox比例风险回归，将来自国家心血管数据注册库（NCDR）的一级预防ICD患者与未植入ICD的心力衰竭（HF）对照患者的5年生存率进行比较。
在98,846例HF患者中（87,914例植入ICD，10,932例未植入ICD），SHFM与全因死亡率密切相关（p < 0.0001）。ICD - SPRM交互作用显著（p < 0.0001），因此与SPRM五分位数1的患者相比，SPRM五分位数5的患者使用ICD后死亡率降低约两倍（校正风险比[HR]：0.602；95%置信区间[CI]：0.537至0.675对比0.793；95% CI：0.736至0.855）。在SHFM预测的年死亡率≤5.7%的患者中，SPRM预测的猝死风险低于中位数的患者使用ICD后死亡率没有降低（校正ICD HR：0.921；95% CI：0.787至1.08；p = 0.31），而SPRM高于中位数的患者获益最大（校正HR：0.599；95% CI：0.530至0.677；p < 0.0001）。
SHFM预测了有或无ICD的大型队列中的全因死亡率，SPRM区分并校准了ICD的潜在获益。这两个模型共同识别出从一级预防ICD中不太可能获得生存获益的患者。
