First results in human patients of a novel leadless pacemaker were presented last week at the HRS meeting in Denver by Vivek Reddy. Pacemaker leads are the most common source of complications associated with pacemakers today. The self-contained device is delivered via catheter to the right ventricle, to which it is attached with a fixation mechanism. The device is manufactured by Nanostim, Inc, a small company which is being acquired by St. Jude Medical.
Reddy reported on a feasibility study of 33 patients with indications for a VVI(R) pacemaker but who were not pacemaker dependent. The pacemaker was successfully implanted in 32 patients. One patient had a cardiac perforation and tamponade during the procedure. Five days after an uncomplicated surgical repair he had a large right-sided stroke and died.
During the course of the trial the procedure time shortened. Overall the mean procedure time was 28 minutes. At evaluations at 2 days, 2 weeks, 6 weeks and 3 months, pacing threshold, R-wave amplitude and impedance were all similar to conventional pacemakers.
The device is expected to be available in Europe later this year. The investigators hope to start a large multicenter trial in the US next year.
“Leadless pacemakers are a promising new technology that could eliminate one of the biggest complication risks with these life-saving devices – the lead,” said Reddy in an HRS press release. “Our initial experience indicates that the procedure is faster and minimally invasive compared to traditional implantation surgery, which may dramatically improve recovery times for patients.”