1 Western University London Ontario Canada.
2 Medtronic, Inc Minneapolis MN.
J Am Heart Assoc. 2019 Jul 16;8(14):e010998. doi: 10.1161/JAHA.118.010998. Epub 2019 Jul 11.
Background Heart failure remains a leading cause of morbidity and mortality. Clinical prediction models provide suboptimal estimates of mortality in this population. We sought to determine the incremental value of implantable device diagnostics over clinical prediction models for mortality. Methods and Results RAFT (Resynchronization/Defibrillation for Ambulatory Heart Failure Trial) patients with implanted devices capable of device diagnostic monitoring were included, and demographic and clinical parameters were used to compute Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) heart failure risk scores. Patients were classified according to MAGGIC score into low (0-16), intermediate (17-24), or high (>24) risk groups. Mortality was evaluated from 6 months postimplant in accordance with the RAFT protocol. In a subset of 1036 patients, multivariable analysis revealed that intermediate and high MAGGIC scores, fluid index, atrial fibrillation, and low activity flags were independent predictors of mortality. A device-integrated diagnostic parameter that included a fluid index flag and either a positive atrial fibrillation flag or a positive activity flag was able to significantly differentiate higher from lower risk for mortality in the intermediate MAGGIC cohort. The effect was more pronounced in the high-risk MAGGIC cohort, in which device-integrated diagnostic-positive patients had a shorter time to death than those who were device-integrated diagnostic negative. Conclusions Device diagnostics using a combination of fluid index trends, atrial fibrillation burden, and patient activity provide significant incremental prognostic value over clinical heart failure prediction scores in higher-risk patients. This suggests that combining clinical and device diagnostic parameters may lead to models with better predictive power. Whether this risk is modifiable with early medical intervention would warrant further studies. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT00251251.
背景 心力衰竭仍然是发病率和死亡率的主要原因。临床预测模型对该人群的死亡率提供了不理想的估计。我们试图确定植入式设备诊断相对于临床预测模型在死亡率方面的增量价值。
方法和结果 RAFT（心力衰竭患者的心脏再同步/除颤治疗试验）患者纳入了可进行设备诊断监测的植入设备，使用人口统计学和临床参数计算 Meta-Analysis Global Group in Chronic Heart Failure（MAGGIC）心力衰竭风险评分。根据 MAGGIC 评分，患者被分为低危（0-16 分）、中危（17-24 分）或高危（>24 分）组。根据 RAFT 方案，从植入后 6 个月开始评估死亡率。在 1036 例患者的亚组中，多变量分析显示，中危和高危 MAGGIC 评分、液体指数、心房颤动和低活动标志是死亡率的独立预测因素。一种包含液体指数标志和阳性心房颤动标志或阳性活动标志的设备集成诊断参数能够显著区分中危 MAGGIC 队列中死亡率较高和较低的风险。在高危 MAGGIC 队列中，这种效果更为明显，在该队列中，设备集成诊断阳性患者的死亡时间比设备集成诊断阴性患者短。
结论 使用液体指数趋势、心房颤动负担和患者活动相结合的设备诊断提供了比临床心力衰竭预测评分更高的风险预测价值。这表明，结合临床和设备诊断参数可能会导致具有更好预测能力的模型。是否可以通过早期医疗干预来改变这种风险，还需要进一步的研究。
