NEJM publishes interim results of Micra Transcatheter Pacing Study

The study, conducted on 725 patients from 19 countries, revealed that the device was successfully implanted in 99 per cent of patients

The New England Journal of Medicine (NEJM) published the interim results from the ‘Micra Transcatheter Pacing Study’ which was done on patients with slow heart rate requiring a pacemaker. The study has used the Micra Transcatheter Pacing System’ (Micra TPS) in place of conventional pacemakers to treat patients with slow heart rate.

It is reportedly the smallest pacemaker in the world, less than one-tenth the size of conventional pacemakers. Once placed, it is attached to the heart wall and can be repositioned or taken out if needed. The miniature device, through its advanced pacing technology, enables the cardiologist to implant the TPS directly into the heart of the patient through minimally invasive access without the requirement of leads or surgical pocket. Avoidance of leads and the surgical pocket prevents potential complications like wound infections, lead dislodgement etc., which happens roughly in one of every eight patients implanted with a conventional pacemaker.

Moreover, the functionality and features that are present in the conventional pacemaker are also present in Micra TPS but self-contained in the device that is comparable in size to a large vitamin pill. Despite its small size, the Micra TPS has a battery life of 10 years. Patients implanted with Micra TPS can undergo MRI scans if needed. Many conventional pacemakers do not have MRI compatibility.

The study published in NEJM reports results on 725 patients from across 56 centres in 19 countries in North America, Europe, Asia, Australia, and Africa. It reveals that the device was successfully implanted in 99 per cent of patients. In six months follow up, the pacemaker was effective in its functioning in more than 98 per cent of patients and 96 per cent of patients had no major complications.

The Micra TPS was awarded CE mark in April 2015 allowing marketing of the device in the European Union. The study continues and is expected to be completed in approximately four years when the long term safety and effectiveness of the device will be evaluated.

Dr C Narasimhan MD DM, Director,  Electrophysiology and Arrhythmia Services, CARE Hospital, Hyderabad opined that this technique has the potential of improving the safety and reducing the complications. Reportedly, there were 10 implants performed at CARE Hospitals with no major complications.

Dr Narasimhan is the Lead Investigator, India, and Steering Committee Member-MicraTMTrancatheter Pacing Study and is one of the authors of the NEJM article.