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

Lakkireddy, Dhanunjaya; Knops, Reinoud E.; Atwater, Brett D.; Neužil, Petr; Ip, John; Gonzalez, Elkin; Friedman, Paul A.; Defaye, Pascal; Exner, Derek V.; Aonuma, Kazutaka; Doshi, Rahul N.; Sperzel, Johannes; Reddy, Vivek Y.

doi:10.1016/j.hrthm.2017.07.004

Cited by 84 publications

(77 citation statements)

References 5 publications

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“…In this series, no major complications including perforation and device embolization were observed 24 . Lakkireddy et al 25 reported a similar safety profile involving retrieval of 66 Nanostim devices with implant durations of 1 to 4 years. The ability to use the leadless pacemaker as a temporary bridge, even in patients with biventricular pacing needs, was valuable in our experience.…”

Section: Discussionsupporting

confidence: 51%

Concomitant leadless pacemaker implantation and lead extraction during an active infection

Chang

Gabriels

Kim

et al. 2020

Cardiovasc electrophysiol

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Introduction The need for transvenous lead extractions due to cardiac implantable electronic device (CIED)‐related infections continues to rise. Current guidelines recommend complete device removal in the setting of an active infection, which can be challenging in pacemaker‐dependent patients. Methods We retrospectively reviewed all leadless pacemaker implants between January 2018 and November 2019 and identified a subset of patients who had undergone a concomitant CIED extraction in the setting of an active infection. Baseline characteristics, procedural details, and clinical follow‐ups were recorded. Results Seventeen patients received a leadless pacemaker during the same procedure as the CIED extraction. There were no procedural complications. All patients were being treated for an active CIED infection at the time of the procedure. Fourteen patients (82.4%) were completely pacemaker‐dependent and four patients (23.5%) had positive blood cultures at the time of the leadless pacemaker implantation. During a median follow‐up of 143 days (interquartile range: 57, 181 days), there were no recurrent infections. Conclusion Simultaneous leadless pacemaker implantation and CIED extraction are safe and feasible in the setting of an active infection. This strategy may be particularly useful in patients that are pacemaker‐dependent.

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Section: Discussionsupporting

confidence: 51%

Concomitant leadless pacemaker implantation and lead extraction during an active infection

Chang

Gabriels

Kim

et al. 2020

Cardiovasc electrophysiol

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“…Limited experience to date has suggested successful retrieval rates of 80 to 90% up to 4 years following device implantation. 21,22 Currently, due to the unknown longterm ability to retrieve a leadless pacemaker, the optimal end-of-life strategy is unclear. Two options are available -abandon the previously implanted end-of-life pacemaker and implant an additional device in the RV or extract the previously implanted leadless pacemaker at the time of replacement.…”

Section: Retrieve Vs Abandonmentioning

confidence: 99%

Leadless Cardiac Pacemaker Therapy. An Overview for the Hospitalist

Weachter¹

2018

Am J Hosp Med

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“…In a study by Lakkireddy et al, the worldwide experience on battery failure and Nanostim retrieval was evaluated. 16 An attempt for retrieval was performed in 73 patients following Nanostim LCP implantation. The time that the Nanostim LCP was implanted in the heart ranged from 0.2 to 4.0 years.…”

Section: Nanostim Leadless Pacemakermentioning

confidence: 99%

“…In a study by Lakkireddy et al no devicedevice related adverse events were reported in 115 patients in whom a new device was implanted adjacent to the abandoned Nanostim LCP. 16 Electrical interaction between the functioning and non-functioning device is unlikely; however, there is currently no long-term evidence to confirm this assumption. In selected cases, one can assume that attempting extraction of a fully encapsulated LP may have higher risk than leaving the device in place.…”

Section: Recommendations and Perspectivesmentioning

confidence: 99%

End-of-life Management of Leadless Cardiac Pacemaker Therapy

Beurskens

Tjong

Knops

2017

Arrhythmia &Amp; Electrophysiology Review

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DevicesAccess at: www.AERjournal.com Despite these promising results, there is an important challenge to consider: the end-of-life (EOL) management of LP therapy. The optimal approach at the end of service of conventional transvenous PM therapy has been studied in great detail. 7,8 The subcutaneous generator is readily accessible for replacement, leaving the leads in place. 7 PM lead extraction can be a high-risk procedure and is associated with serious complications, including cardiac perforation and death. 8 Up to three leads can be placed intracardially, without haemodynamic compromise. 7 Optimal EOL strategy of LP therapy is subject to debate. The estimated battery longevity of the LP ranges between 4.7 and 15 years, depending on pacing parameters. 2,3,9 Therefore, selected patients might require multiple devices over their lifespan. Once the EOL of the LP approaches, there are two options for implanting physicians to address this problem.LPs were designed so that they can be programmed in a non-functional mode. The LP can be abandoned and an additional device may be implanted adjacent to the non-functional LP. Important concerns have been raised regarding the aforementioned option. Multiple devices in the heart may compromise cardiac function, or be a source of interference. The second replacement strategy is to extract the LP and subsequently implant a new device. However, extraction may not be feasible due to encapsulation of the device, and this will probably be more prevalent with more chronic use of LP therapy. Of note, there are situations where extraction of the LP may be necessary, such as in infection or dislocation. Recently, a battery advisory was distributed by Abbott stating that 7 of 1423 (0.5 %) patients had a battery malfunction that occurred more than two years after Nanostim LCP implantation. This battery dysfunction has not been shown to affect Micra TPS.With the battery advisory and the more chronic use of LPs, recommendations for EOL management become increasingly important. Therefore, an up-to-date review of available evidence on retrieval of LPs is highly clinically relevant. In this review we describe the safety, feasibility and histopathological examination of LP retrieval. Leadless Pacemaker and Retrieval SystemsBoth LPs are cylindrical intracardiac devices; however, there are differences in design that merit emphasis. The Nanostim LCP is 42 mm long and 5.99 mm in diameter, whereas the Micra TPS measures AbstractThe clinically available leadless pacemakers for patients with a single-chamber pacing indication have shown to be safe and effective.However, the optimal end-of-life strategy of this novel technique is undefined. Suggested strategies comprise of (a) placing an additional leadless device adjacent to the leadless pacemaker, or (b) retrieving the non-functioning leadless pacemaker and subsequently implanting a new device. Although initial studies demonstrate promising results, early experience of acute and mid-term retrieval feasibility and safety remains mixed. We suggest th...

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

Cited by 84 publications

References 5 publications

Concomitant leadless pacemaker implantation and lead extraction during an active infection

Concomitant leadless pacemaker implantation and lead extraction during an active infection

Leadless Cardiac Pacemaker Therapy. An Overview for the Hospitalist

End-of-life Management of Leadless Cardiac Pacemaker Therapy

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