Influence of Home Monitoring on the Clinical Status of Heart Failure Patients
Hindricks et al., The Lancet 2014
Conclusion Home Monitoring reduces risk of worsened patients status and all-cause mortality for heart failure patients.
Indication for single chamber ICD, dual chamber ICD or CRT-D Chronic heart failure (≥ 3 months) NYHA Class II or III for 1 month prior to screening LVEF ≤ 35% within 3 months prior to screening Indication for therapy with diuretics Patient informed consent 18 years and older
Permanent atrial fibrillation Uncontrolled hypertension NYHA class I or IV Life expectancy < 1 year Restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, acute myocarditis Etc.
- Randomized, controlled, international, multicenter study
- Assesses the impact of BIOTRONIK Home Monitoring® on the clinical status of heart failure patients
- 664 patients at 36 centers
Study duration: July 2007 – December 2010
Key Result 1
At 12 months follow-up, significantly fewer patients in the BIOTRONIK Home Monitoring® group worsened according to the modified Packer score compared to the control group (18.9% vs27.5%; p<0.05).
Modified Packer Score
Patients are classified as “worsened” in case of:
- Overnight hospitalization for worsening heart
- Worsening in NYHA Class
- Deterioration in patient’s global self assessment
Key Result 2
Significant reduction of all-cause mortality in heart failure patients (> 50 %) and beneficial effect on the composite clinical score with implant-based (ICD or CRT-D) BIOTRONIK Home Monitoring® compared to standard care.
>50% Reduction of Mortality
- The IN-TIME study demonstrated improved clinical status for heart failure patients by implementing a remote monitoring system based on:
- A reliable transmission rate of 85%
- Clinical workflow that enables fast patient contact and follow-up within one to two working days
- The European Society of Cardiology added a clear recommendation for the use of implant-based remote follow-up to its guidelines1
- A clinically relevant set of rhythmological and technical parameters
CARDIAC RESYNCHRONIZATION THERAPY
BIOTRONIK offers an extensive product portfolio in the area of Cardiac Resynchronization.