New tiny pacemaker has high implant success rate

19th May 2017

The first study into the use of a tiny leadless pacemaker “in a real world setting” has shown a high implant success rate and a low risk of major complications in the first 30 days.

The data has come from a worldwide post registry study from a team including Dr Paul Roberts from Southampton General Hospital and reported in the Heart Rhythm Journal.

The Micra leadless pacemaker, which is placed directly into the heart, is the newest and smallest of Medtronic’s pacemakers. It was approved in the US last year.

Much smaller than a conventional pacemakers, the Micra is about the size of a large vitamin capsule. It is fitted via a vein in the leg and is completely self-contained in the heart. 

The makers believe it will lead to fewer medical complications and fewer post implant restrictions on patients’ activities.

The registry is an ongoing observational post approval study designed to assess the safety and effectiveness of the Micra.

The device was successfully fitted in 792 of 795 people (99.6%) by 149 implanters at 96 centers in 20 countries. In the 30 days after fitting there were, a total of 13 major complications in 12 patients, giving a major complication rate of 1.51 per cent.

The report concluded that the rates of excess fluid around the heart, device dislodgement, and infection were low, reinforcing the positive results seen in the investigational study.

Cardiomyopathy support nurse Robert Hall, from Cardiomyopathy UK, said: “This is an Interesting report with very promising results.”