BERLIN, Germany, August 15, 2014 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced the publication of the IN-TIME study results in the medical journal The Lancet today.1
The randomized, controlled trial is the first worldwide to demonstrate that automatic, implant-based remote monitoring leads to significant clinical benefits for heart failure patients. IN-TIME results show how BIOTRONIK Home Monitoring®
enables physicians to detect worsening heart failure at an early stage, facilitating early intervention and improved clinical outcomes.Home Monitoring reduced all-cause mortality by over 50 percent. Clinical status was also significantly improved. Only 18.9 percent of patients using Home Monitoring experienced the worsening of heart failure, compared to 27.2 percent in the control arm (p=0.013). Patients implanted with cardioverter defibrillators and cardiac resynchronization therapy defibrillators (ICDs and CRT-Ds) benefited equally from Home Monitoring.2
Patients with a known history of atrial fibrillation especially benefited from Home Monitoring.3
The BIOTRONIK-sponsored, prospective study randomized 664 patients with chronic heart failure, NYHA class II or III symptoms, ejection fraction ≤35 percent, and optimal drug therapy in groups with or without telemonitoring in a 1:1 ratio. Two hundred and seventy-four patients received an ICD and 390 patients received a CRT-D in adherence with European guidelines, and were followed for one year. The primary outcome, worsening heart failure, was based on a composite score including death, hospitalization, NYHA class and patient self-assessment. Secondary outcomes included all-cause mortality and hospitalization.“Reducing mortality by over 50 percent is an excellent outcome for any therapy. IN-TIME showed how important automatic, daily transmissions of clinical and device data are to patient management and outcomes,” explained coordinating investigator Dr. Gerhard Hindricks, University of Leipzig Heart Center, Germany. “Improvements in patients’ health are likely due to the early detection of the onset or progression of ventricular and atrial tachyarrhythmias and the early recognition of therapy settings that mayneed adjusting.”Home Monitoring transmissions proved reliable, occurring on 85 percent of days per patient year. Medical staff reacted quickly to events. The median reaction time after remote monitoring alert was one day to patient contact and two days to follow-up.“The effects of Home Monitoring depend on physicians’ and medical staff’s response to the remotely monitored data. By reacting quickly to notifications, we were able to follow up with patients exactly when they needed medical attention, and adapt their therapy accordingly,” said Dr. Peter Sogaard, Aalborg University Hospital, Denmark.“We were also able to divide work between a qualified nurse and myself, the overseeing physician, to improve our clinic’s workflow and ensure efficient patient management.”Heart failure affects approximately ten percent of adults aged 70 or older worldwide.4
The European Society of Cardiology estimates that in Europe alone, at least 15 million people suffer from heart failure.5
An increasing number of patients are being treated with cardiac devices that include some type of remote monitoring technology. The European Society of Cardiology has recently recommended remote monitoring of cardiac device patients for the early detection of clinical events and technical issues.6
- Hindricks G et al. The Lancet. 2014, 384(9943).
- The risk of clinical status worsening in the absence of telemonitoring was similar(p=0.58) for ICD (OR 1.83, 95% CI 0.98 – 3.41, p=0.058) and CRT-D patients (OR1.47, 95% CI 0.93-2.31, p=0.10).
- Heart failure patients with a known history of AF had an increased risk of a worseningclinical status in the absence of telemonitoring: OR 2.98, 95% CI 1.43 – 6.18,p=0.003.
- Within 51 countries representing a population of 900 million. Zannad F, Agrinier N and Alla F et al. Europace. 2009; 11(5).
- ESC 2013 Guidelines. Brignole M et al. European Heart Journal. 2013; 34.