Leadless pacemaker safe, effective at 90 days

The use of a leadless, self-contained pacemaker was found to be safe and effective in a group of patients with an indication for single-chamber pacing who participated in a clinical trial. The study results were published online March 24 in Circulation.

The LEADLESS trial evaluated a leadless cardiac pacer (Nanostim), in 33 patients from three centers who needed right-ventricular pacing. The investigators, led by Vivek Y. Reddy, MD, of Mount Sinai School of Medicine in New York, followed the participants for 90 days after pacemaker implantation.

The primary safety endpoint was the complication-free rate. Secondary performance endpoints included implant success rate, implant time and device performance measures.

Thirty-one patients remained free of complications at 90 days (94 percent). The implant success rate was 97 percent and the average procedure time was 28 minutes. Pacing performance measures, which were sensing, impedance and pacing threshold, either improved or remained the same within the accepted range.

The authors acknowledged that extended follow-up could indicate whether mechanical or functional issues exist and also that this device is not appropriate for all patients who need pacing. While further research is warranted, they argued that the “absence of a transvenous lead and subcutaneous pulse generator could represent a paradigm shift in cardiac pacing.”

Nanostim provided the funding for this research.