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Biotronik announces new results from sub-analysis of TRUST trial

Biotronik, a manufacturer of cardiovascular devices, has announced new results from a sub-analysis of the landmark TRUST trial, published in the European Heart Journal.

This analysis examined recommended ICD follow-up methods by comparing patient adherence in two groups: those who were given remote follow-ups with Biotronik Home Monitoring and those who had calendar-based, in-person follow-ups.

Over the 15-month follow-up period, patient adherence was found to be 25% higher in the Home Monitoring group. This pointed to an optimized doctor-patient link, which can positively affect treatment success.

Implants with integrated remote monitoring technology transmit medical data as well as technical data about the implant to the physician daily and with full automaticity. This technology helps the physician keep continuous track of a patient’s health status and adapt therapy when necessary.

The TRUST study was a prospective, randomized, multi-center clinical trial that enrolled 1,450 patients at 102 North American sites. It demonstrated the safety and efficacy of Biotronik Home Monitoring in reducing in-office follow-ups by 45%.

Now, this sub-analysis shows that remote follow-ups with Home Monitoring also improve patient retention. Within the Home Monitoring group, there was an overall 25% greater adherence to all recommended follow-up evaluations.

There was also higher adherence to the yearly in-person evaluation when compared with conventional patient management, which was twice as likely to lead to a missed follow-up.

Dr Niraj Varma deom Cleveland Clinic, Ohio, US, said that more frequent conventional, routine in-person evaluations were shown to lead to patient attrition, as patients were perhaps more likely to drop out of the follow-up process when they viewed multiple follow-ups as unnecessary and intrusive.

"The TRUST study leads us to believe that we should re-evaluate the traditional standard of care based on in-office evaluation. Perhaps, instead of in-person follow-ups for post-implant patients, the new standard should be automatic, daily remote monitoring, which may lead to more effective patient treatment," Dr Varma added.