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ePaper - CCN Ausgabe - Number 2013-3

IN-TIME: Survival Benefit for Heart Failure Patients with Remote Monitoring (nur in Englisch) | IN-TIME: Survival Benefit for Heart Failure Patients with Remote Monitoring

Ausgabe 3 - Number 3 · 2013 www.ccn-info.comwww.ccn-info.comwww.ccn-info.com CCNCCNCCNCCNCCNCCNCCNCCNCCNCCNCCNCCNCCCathlab &athlab &athlab & CCCardiovascularardiovascularardiovascularardiovascularardiovascularardiovascular NNNewsewsews PRODUCT NEWS IN-TIME:SurvivalBenefitforHeartFailurePatientswithRemoteMonitoring Professor Gerhard Hindricks from the Heart Center University Leip- zig presented during a hotline session at this years ESC (European Society of Cardiology) congress the first ground-breaking results from the IN-TIME study. The study reveals a significant survival benefit for heart failure patients with implanted devices using BIOTRONIK Home Monitoring® technology, compared to standard care. IN-TIME is the first randomized, controlled trial worldwide that demonstrated a significant reduction in all-cause mortality in heart failure patients with implant-based remote monitoring. In patients with severely depressed LV-function and NYHA II/III, a significant reduction of over 50% in all-cause mortality was observed, supported by implant-based BIOTRONIK Home Monitoring® as compared to standard care. The prospective, randomized, controlled, multi-center trial analyzed 664 patients with chronic heart failure, class II or III New York Heart Association (NYHA) symptoms, and a reduced left ventricular ejection fraction (LVEF) of≤35%. All patients had an indication for either a implantable cardioverter- defibrillator (ICD) or cardiac resynchroni- zation defibrillator (CRT-D). Most patients had ischemic heart disease (69%), mean LVEF was 26±6%, and heart failure medication diure- tics (93%), beta-blockers (91%), and ACE inhibitors or angiotensin receptor blockers (89%). A run-in phase of one month was used to optimize patients‘ heart failure therapy after which patients were randomized to either a Home Monitoring group (n=333) or standard care group (n=331). BIOTRONIK Home Monitoring® rapidly detects deterioration in patients’ clinical status and automatically transmits data on a dai- ly basis. Early detection of clinically relevant events, in particular asymptomatic atrial fibrillation, enables the physician to adapt pa- tient therapy at a very early stage. Data transmissions were initiated by time triggers, arrhythmic or technical events, and were transmit- ted from the patient‘s implanted device, via a wireless network to a central monitoring unit at the Heart Center Leipzig. Relevant obser- vations, such as frequency of ventricular extrasystoles, or atrial and ventricular tachyarrhythmias, were forwarded to the patient‘s physi- cian, which could lead to additional follow-up or therapy changes at the physician‘s discretion. In the standard care group, patients were treated according to the clinical standard at each participating centre. Interventions were either patientinitiated or triggered by in-office follow-ups. The primary endpoint of IN-TIME was a composite score (modified Packer score) reflecting improved or worsened clinical status; based on mortality, overnight hospitalization for worsened heart failure, change in NYHA class, and the patient’s global self assessment. The major secondary endpoint was all-cause mortality. At 12 months follow-up, significantly fewer patients in the Home Monitoring group had worsened clinical status compared to the standard group , according to the modified Packer score (18.9% vs 27.5%; p<0.05). Moreover, from an estimate based on the Kaplan- Meier curve the mortality at one year follow-up was 3.4% in the home monitoring group compared to 8.7% in patients with standard care (p<0.004). BIOTRONIK Home Monitoring based® detection of changes in clinical status or technical events can trigger medical action that prevents worsening of heart failure. 50years Celebrating of excellence Qualität - dem Leben verpflichtet Mein Team und ich engagieren uns jeden Tag für die höchste Zuverlässigkeit unserer Therapien. Wir sind stolz darauf, dass sich Ärzte und Patienten seit 50 Jahren jederzeit auf BIOTRONIK verlassen können. Frank Busch, Leiter Elektrodenfertigung, Berlin www.biotronik.com 41

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