Sardu C, Santamaria M, Rizzo M R, Barbieri M, di Marino M, Paolisso G, Santulli G, Marfella R
Department of Arrhythmias and Electrophysiology, 'John Paul II' Research and Care Foundation, Campobasso, Italy.
Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, Second University of Naples, Naples, Italy.
Int J Clin Pract. 2016 Jul;70(7):569-76. doi: 10.1111/ijcp.12823. Epub 2016 Jun 13.
Telemonitoring (TM) is a safe and efficient monitoring system for internal cardioverter defibrillator device (ICD) recipients. TM has been used to track info on the clinical status of heart failure patients treated by ICD and/or cardiac resynchronisation therapy defibrillator (CRT-D). The aim of this study was to investigate the impact of TM on clinical outcomes in a population of CRT-D patients with heart failure.
In a multicentre, randomised study, patients with chronic heart failure, New York Heart Association (NYHA) functional class II or III, left bundle branch block, severe left ventricle ejection fraction reduction (LVEF < 35%) have been identified and screened.
One hundred and ninety-one patients have been randomised to receive either a CRT-D with TM or a CRT-D with traditional ambulatory monitoring (control group) and completed the 12-month study follow-up. Primary endpoints were all cause death, cardiac death and hospital admission for heart failure. Secondary endpoints were atrial fibrillation, sustained episodes, non-sustained and self terminated ventricular tachyarrhythmia, sustained ventricular tachycardia, and ventricular fibrillation, ICD shocks and percentage of CRT-D responder patients. Univariate analysis identified the following factors predicting hospitalisation: TM, age, chronic kidney disease, hypercholesterolaemia, LVEF and NYHA class. At multivariate analysis, TM was the only factor predicting heart failure hospitalisation (hazard ratio 0.6, 0.42-0.79, 95% CI, p = 0.002), without affecting overall mortality and cardiac deaths events.
Taken together, our data indicate the importance of TM in predicting heart failure hospitalisation in patients treated with CRT-D.
远程监测（TM）是一种用于植入式心脏复律除颤器（ICD）患者的安全有效的监测系统。TM已被用于追踪接受ICD和/或心脏再同步治疗除颤器（CRT-D）治疗的心力衰竭患者的临床状况信息。本研究的目的是调查TM对CRT-D心力衰竭患者临床结局的影响。
在一项多中心随机研究中，已识别并筛选出患有慢性心力衰竭、纽约心脏协会（NYHA）功能分级为II或III级、左束支传导阻滞、严重左心室射血分数降低（左心室射血分数<35%）的患者。
191名患者被随机分配接受带TM的CRT-D或传统动态监测的CRT-D（对照组），并完成了为期12个月的研究随访。主要终点为全因死亡、心源性死亡和因心力衰竭住院。次要终点为心房颤动、持续性发作、非持续性和自行终止的室性心律失常、持续性室性心动过速和心室颤动、ICD电击以及CRT-D反应者患者的百分比。单因素分析确定了以下预测住院的因素：TM、年龄、慢性肾病、高胆固醇血症、左心室射血分数和NYHA分级。多因素分析显示，TM是预测心力衰竭住院的唯一因素（风险比0.6，0.42 - 0.79，95%置信区间，p = 0.002），且不影响总体死亡率和心源性死亡事件。
综合来看，我们的数据表明TM在预测接受CRT-D治疗患者的心力衰竭住院方面具有重要意义。
