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Chronic leadless pacemaker can be retrieved successfully
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CHICAGO — Retrieval of a self-contained chronic leadless pacemaker was successful in 90% of cases, according to findings presented at the Heart Rhythm Society Annual Scientific Sessions.
“In December 2012, the Nanostim leadless pacemaker was the first leadless pacemaker implanted in humans, but in October of 2016, the manufacturer, St. Jude Medical, now Abbott, issued a worldwide guidance on the device, that there was a significant battery failure,” Vivek Reddy, MD, of the Mount Sinai Medical Center, New York, said during the presentation. “The purpose of this abstract is to discuss what we know about the battery failures, their frequency, their mechanism of failure and then what happened in terms of retrieval.”
Of the leadless pacemakers implanted worldwide (n = 1,423) as of March, 2.39% failed (n = 34) at a mean time of 2.9 years (range, 2.3-4 years). No associated patient injuries were reported.
Analysis of the failed devices revealed that impedance from insufficient electrolyte availability was the cause of battery failure, rather than the suspected malfunction of voltage depletion of the battery.
Before the advisory, 20 retrieval attempts occurred for various reasons, with a 95% success rate.
After the advisory, 88.7% (n = 47) of the retrieval attempts were successful (mean retrieval, 1.8 years after implantation; range, 0.2-4 years). Of the unsuccessful attempts, in five cases the leadless pacemaker’s proximal hub was inaccessible and in one case the docking button detached from the pacemaker during retrieval.
Overall, the success rate of the Nanostim leadless pacemaker is 90.4%. There was one case of arteriovenous fistula. In individuals who received an additional pacemaker after the advisory, there were no adverse device-to-device interactions, Reddy said during the presentation. – by Cassie Homer
Reference:
Reddy V, et al. LBCT03-02. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 10-13, 2017; Chicago.
Disclosure: Reddy reports financial ties with Abiomed, ACT, Acutus Medical, Apama Medical, Biosense Webster, Biotronik, BioSig Technologies, Boston Scientific, CardioFocus, CardioInsight Technologies, Cardionomics, Cibiem, Circa Scientific, Coherex Medical, DC Devices, EBR, Estech, GBS, Impulse Dynamics, Javelin, Keystone Heart, Magnetecs, Manual Surgical Sciences, Medtronic, Middle Peak Medical, NewPace Technology Development, Perseus PCI, St. Jude Medical and VytronUS.