Cardiovascular device specialist Biotronik points us at clinical study results that are 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.
Biotronik Home Monitoring transmits patient and device data automatically and on a daily basis, thereby rapidly detecting deterioration in a patient’s clinical status. It might seem obvious that this heightened level of care would result in only good things for patients, but the need for evidence remains paramount. Now Biotronik, probably the best known developer of remote monitoring pacing devices, has seen data from a significant study published in The Lancet.
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.
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. Patients with a known history of atrial fibrillation especially benefited from Home Monitoring.
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.
“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 may need adjusting.”
“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.”