• Cardiology Clinical Trials
• Interventional Techniques & Devices
• Heart Failure

• Cardiology Clinical Trials
• Interventional Techniques & Devices
• Cardiology & Cardiovascular Medicine
• Heart Failure

Remote monitoring using a multiparametric alert algorithm in patients with heart failure (HF) and a cardiac resynchronization therapy device (CRT-D) or implanted cardiac defibrillator (ICD) results in a decrease in all-cause mortality. Gerhard Hindricks, MD, PhD, Herzzentrum Leipzig, Leipzig, Germany, presented data from a post hoc analysis of the Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function trial [IN-TIME; NCT00538356].

Patients with HF have a high risk of experiencing substantial morbidity, with a generally poor prognosis. Interestingly, certain clinical parameter trends frequently occur prior to patient re-hospitalization or death due to worsening HF [Hindricks G et al. ESC 2013]. The purpose of the IN-TIME trial was to evaluate the utility of remote monitoring on clinical outcomes using a multiparametric alert approach in patients with HF and a CRT-D or an ICD.

In the multicenter, open-label, Phase 4 IN-TIME trial, 664 patients with HF, who required a CRT-D or dual-chamber ICD, were randomly assigned to home monitoring (n=333) or to conventional monitoring (n=331) groups. Patients were classified as New York Heart Association (NYHA) Class II or III with a left ventricular ejection fraction (LVEF) of less than or equal to 35%, and were on stable drug therapy. Patients were excluded if they had permanent atrial fibrillation. The mean age of patients with a CRT-D was 67 years; of these, 78% were male, 26% were NYHA Class II, 61% had coronary artery disease (CAD), and 34% had renal insufficiency. The mean intrinsic QRS duration for these patients was 148 ms. By comparison, the mean age of patients with an ICD was 63 years; of these, 85% were male, 67% were NYHA Class II, 80% had CAD, and 24% had renal insufficiency. The mean LVEF in these patients was 27%, and the mean intrinsic QRS duration was 114 ms.

The primary end point was the modified Packer score—a clinical composite that comprises mortality, NYHA class global self-assessment, and the need for overnight hospitalization for worsening heart failure. The major secondary end point was all-cause mortality. The patient's condition was considered to be “worsened” if the following criteria occurred: death, overnight hospitalization for worsening HF, worsening in NYHA class, and deterioration in global self-assessment score.

There was no significant difference in the modified Packer score between patients in the conventional and home monitoring groups, regardless of the device type (30% vs 23%, p=0.10 for CRT-D; 23% vs 14%, p=0.06 for ICD). However, mortality rates was significantly lower for patients with CRT-D in the home monitoring group as compared with those in the conventional monitoring group (HR, 0.35; p=0.014; Figure 1); similar lower mortality rates were observed for patients with an ICD in the home monitoring group as compared with those in the conventional monitoring group.

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Figure 1.

Effect of Remote Home Monitoring on Mortality in Patients With CRT-D

CRT-D=cardiac resynchronization therapy device; HM=home monitoring.Reproduced with permission from G Hindricks, MD, PhD.

In patients with a CRT-D or an ICD in the home monitoring group, 1.7 and 1.1 clinical events per patient-year were detected, respectively. The commonly detected clinical events included atrial fibrillation, CRT (in CRT-D group) and lead parameters. In addition, technical and medical issues were identified in 291 and 146 of patients with a CRT-D and an ICD in the home monitoring group, respectively.

Prof. Hindricks concluded that there is a clinical benefit in using remote home monitoring for implantbased devices, regardless of the type of device employed (CRT-D or ICD).

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