Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital, Saarland University, Homburg/Saar (J.W., V.P., F.M., M.B., C.U.).
Department of Internal Medicine II, Cardiology, Angiology and Pneumology, Klinikum Coburg GmbH, Coburg (J.B.).
Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e008693. doi: 10.1161/CIRCEP.120.008693. Epub 2020 Dec 10.
Impedance-based remote monitoring (RM) failed to reduce clinical events in the OptiLink heart failure (HF) trial. However, rates of alert-driven interventions triggered by intrathoracic fluid index threshold crossings (FTC) were low indicating physicians' inappropriate reactions to alerts.
We separated appropriate from inappropriate contacts to FTC transmissions in the OptiLink HF trial (Optimization of Heart Failure Management Using OptiVol™ Fluid Status Monitoring and CareLink™). Appropriate contacts had to meet the following criteria: (1) initial telephone contact within 2 working days after FTC transmission, (2) follow-up contacts according to study protocol, and (3) medical intervention initiated after FTC due to cardiac decompensation. We compared time to cardiovascular death or HF hospitalization between RM patients contacted appropriately or inappropriately and patients with usual care.
In the RM group, at least one FTC alert was transmitted in 356 patients (70.5%; n=505). Of note, only 55.5% (n=758) of all transmitted FTCs (n=1365) were followed by an appropriate contact. While 113 patients (31.7%; n=356) have been contacted appropriately after every FTC, in 243 patients (68.3%; n=356) at least one FTC was not responded by an appropriate contact. Compared with usual care, RM with appropriate contacts to FTC alerts independently reduced the risk of the primary end point (hazard ratio, 0.61 [95% CI, 0.39-0.95]; =0.027).
RM appropriate reactions to FTC alerts are associated with significantly improved clinical outcomes in patients with advanced HF and implantable cardioverter-defibrillators.
基于阻抗的远程监测(RM)未能减少 OptiLink 心力衰竭(HF)试验中的临床事件。然而,由于胸腔内液体指数阈值交叉(FTC)触发的警报驱动干预的发生率较低,这表明医生对警报的反应不当。
我们将 OptiLink HF 试验(OptiVolTM 液体状态监测和 CareLinkTM 优化心力衰竭管理)中的 FTC 传输的适当接触与不适当接触区分开来。适当的接触必须符合以下标准:(1)在 FTC 传输后 2 个工作日内进行初始电话联系,(2)根据研究方案进行随访接触,以及(3)由于心脏失代偿而在 FTC 后启动医疗干预。我们比较了 RM 患者与适当或不适当接触以及接受常规护理的患者之间发生心血管死亡或 HF 住院的时间。
在 RM 组中,356 名患者(70.5%;n=505)至少传输了一次 FTC 警报。值得注意的是,在所有传输的 FTC 中(n=1365),只有 55.5%(n=758))随后进行了适当的接触。虽然每传输一次 FTC 后,有 113 名患者(31.7%;n=356)得到了适当的接触,但在 243 名患者(68.3%;n=356)中,至少有一次 FTC 未得到适当的接触。与常规护理相比,RM 对 FTC 警报的适当反应独立降低了主要终点的风险(危险比,0.61 [95%CI,0.39-0.95];=0.027)。
RM 对 FTC 警报的适当反应与植入式心律转复除颤器的晚期 HF 患者的临床结局显著改善相关。