Telemonitoring in heart failure patients treated by cardiac resynchronisation therapy with defibrillator (CRT-D): the TELECART Study

Abstract

Aim: 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.

Methods: 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.

Results: 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.

Conclusions: Taken together, our data indicate the importance of TM in predicting heart failure hospitalisation in patients treated with CRT-D.

Figure 1

Schematic flowchart of the study. Two hundred and sixty patients have been screened because they presented chronic heart failure in New York Heart Association (NYHA) class 2,3, left bundle branch block, left ventricle ejection fraction (LVEF) < 35%. After this screening phase, 196 patients have been enrolled in the study (these patients met criteria reported in Methods). Of these patients four have refused to participate in the study and one has refused to be treated by cardiac resynchronisation therapy (CRT). After this phase, 191 patients have received a CRT, randomly divided to receive telemonitoring (TM) and traditional monitoring. 183 patients completed the follow-up, 89 in TM group and 94 in control group (four patients lost at follow-up in no TM group, two discontinued the study in TM group, two patients referred to other centres for follow-up visits in control group)