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Herzschrittmachertherapie + Elektrophysiologie

, Volume 29, Issue 4, pp 327–333 | Cite as

Nanostim—leadless pacemaker

  • Johannes SperzelEmail author
  • Christian Hamm
  • Andreas Hain
Schwerpunkt
  • 233 Downloads

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

Leadless pacemaker Nanostim™ study results Safety aspects Implantable defibrillators Cardiac resynchronization therapy 

Nanostim – sondenloser Schrittmacher

Zusammenfassung

Nanostim™ (St. Jude Medical Inc., Saint Paul/MN, USA; jetzt Abbott Medical Inc. Abbott Park, IL, USA) war der erste sondenlose intrakardiale Herzschrittmacher, der 2013 einem Patienten implantiert wurde. Insgesamt wurden zwischen 2013 und 2016 weltweit 1423 Nanostim™-Geräte im Rahmen von 3 klinischen Studien implantiert. Obwohl die Implantationen 2016 aufgrund seltener, aber schwerwiegender Batterieausfälle gestoppt wurden, fand das Konzept der sondenlosen Stimulation breite Akzeptanz und wird bereits in ersten Studien bei 2‑Kammer-Herzschrittmachern, der linksventrikulären Stimulation und in der Kombination mit subkutanen Defibrillatoren angewendet. In der vorliegenden Arbeit werden das Design des Systems und die Ergebnisse der ersten klinischen Studien kritisch dargestellt. Viele Ergebnisse daraus sind für sondenlose Schrittmacher i. Allg. zutreffend. Die Erfahrungen mit dem Nanostim™-Gerät werden hier mit den ersten Jahren der klinischen Anwendung anderer neuartiger Therapiesysteme verglichen. Wichtige Fragen sind, wie das Risiko für periprozedurale Komplikationen durch entsprechende Schulung der Anwender und die Auswahl der geeigneten Patienten minimiert werden kann und was die Langzeitergebnisse über die Systemsicherheit aussagen können, einschließlich der Möglichkeit der Systemexplantation.

Schlüsselwörter

Sondenloser Herzschrittmacher Nanostim™-Device-Studienergebnisse Systemsicherheit Implantierbare Defibrillatoren Kardiale Resynchronisationstherapie 

Notes

Compliance with ethical guidelines

Conflict of interest

J. Sperzel, C. Hamm, and A. Hain declare that they have no competing interests.

This article does not contain any studies with human participants or animals performed by any of the authors.

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Copyright information

© Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2018

Authors and Affiliations

  • Johannes Sperzel
    • 1
    Email author
  • Christian Hamm
    • 1
  • Andreas Hain
    • 1
  1. 1.Abteilung für Kardiologie/ElektrophysiologieKerckhoff-Klinik GmbHBad NauheimGermany

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