Nanostim-leadless pacemaker

Abstract

Nanostim™ (St. Jude Medical Inc., Saint Paul, MN, USA; now Abbott Medical Inc. Abbott Park, IL, USA) was the first self-contained intracardiac pacemaker to be implanted in a human patient. A total of 1423 Nanostim devices were implanted worldwide between 2013 and 2016 and three clinical trials were initiated. Although the device was recalled in 2016 owing to rare but serious battery failures, the concept of leadless pacing has gained widespread acceptance and is expanding beyond the initial single-chamber devices to dual-chamber systems, biventricular pacing, and combinations with defibrillators. This review describes the design, results from initial clinical trials, and long-term experiences with Nanostim. It discusses the lessons learned from the pioneering device's successes and shortcomings, many of which are valid for leadless pacemakers in general. This article also considers the Nanostim experience in comparison with the early years of clinical use for other pioneering device therapies. Important questions include how to minimize the risk for short-term complications by appropriate operator training and evaluation of suitable patients, what the long-term performance tells us about safety, as well as the necessity and feasibility of device explantation.

Keywords: Cardiac resynchronization therapy; Implantable defibrillators; Leadless pacemaker; Nanostim™ study results; Safety aspects.