A worldwide experience of the management of battery failures and chronic device retrieval of the Nanostim leadless pacemaker.

Published

Journal Article

BACKGROUND: The Nanostim leadless pacemaker (LP) met the primary endpoints in an investigational device exemption trial, and was shown to be fully retrievable percutaneously. In October 2016, St Jude Medical issued a worldwide alert of a battery malfunction that caused lost pacing output and LP communication. OBJECTIVE: To report the battery failure mechanism and incidence and the worldwide patient management, including device retrieval experiences. METHODS: The affected LP battery is a custom lithium-carbon monofluoride cell. These were returned after failure and underwent analysis assessing electronics and battery performance. Data were collected in ongoing clinical studies when LPs were abandoned or retrieved. RESULTS: Of 1423 LPs implanted worldwide, there were 34 battery failures, occurring at 2.9 ± 0.4 years with no instances of associated patient injury. Analysis of returned batteries revealed an increase in battery resistance caused by insufficient electrolyte availability at the cathode/anode interface. A total of 66 of 73 retrieval attempts were successful (90.4%; implant duration range: 0.2-4.0 years). The LP docking button was inaccessible in 6 patients, and the docking button detached from the LP during retrieval in 1 patient. There was 1 case of arteriovenous fistula and another case of the LP docking button migrating into the pulmonary artery. There were also 115 non-LP retrieval patients after the advisory who received an additional pacemaker, with no adverse device-to-device interactions reported. CONCLUSION: As with standard pacers, LPs can have critical battery failures. Chronic retrieval of LPs is safe and efficacious.

Full Text

Duke Authors

Cited Authors

  • Lakkireddy, D; Knops, R; Atwater, B; Neuzil, P; Ip, J; Gonzalez, E; Friedman, P; Defaye, P; Exner, D; Aonuma, K; Doshi, R; Sperzel, J; Reddy, V

Published Date

  • December 2017

Published In

Volume / Issue

  • 14 / 12

Start / End Page

  • 1756 - 1763

PubMed ID

  • 28705736

Pubmed Central ID

  • 28705736

Electronic International Standard Serial Number (EISSN)

  • 1556-3871

Digital Object Identifier (DOI)

  • 10.1016/j.hrthm.2017.07.004

Language

  • eng

Conference Location

  • United States