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American Heart Association

Clinical Articles, Lead Article

Small wireless pacemaker is safe, effective in early testing

A new wireless self-contained pacemaker appears safe and feasible for use in patients, according to a study published recently in Circulation.1

Although traditional pacemakers pose minimal risk, patients are still vulnerable to complications stemming from the leads that run from the pulse generator through a vein to the heart, said lead author Dr Vivek Reddy (Mount Sinai Hospital, New York, USA).

However, the new pacemaker has no leads – its generator lies within the unit in the heart – and is placed without the need for surgery. It is faster and easier to implant than traditional pacemakers, Dr Reddy said, and is programmed and monitored similarly.

“While a much larger study is required to prove this, one may expect the leadless pacemaker to be associated with less chance of infection and lead-related problems such as lead fracture,” Dr Reddy said. “Overall, the self-contained pacemaker is a paradigm shift in cardiac pacing.”

The study was conducted in 33 Caucasian patients (average age 77, two-thirds men) at two hospitals in Prague, and one in Amsterdam. The self-contained pacemaker was successfully implanted in 32 patients (97%). 94% were free of complications through the three-month study period, the researchers found.

The new device is a self-modulating pacer guided into place using a catheter inserted in the femoral vein and is affixed to the heart in the right ventricle, the same place a standard lead would be located. The device is for patients who require single-chamber pacing. Patients who need dual-chamber pacing would still require traditional pacemakers, according to Dr Reddy.

After three months, the new pacemakers were functioning well, according to the researchers . They are continuing to track the patients and expect to report longer-term outcomes later this year. Meanwhile, a much larger study at multiple locations in the USA that will include longer-term follow-up is under way, Dr Reddy said.


1. Reddy VY, Knops RE, Sperzel J, et al. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation 2014.​CIRCULATIONAHA.113.006987

Published on: March 28, 2014

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