Multiple leadless pacemakers implanted in the right ventricle of swine

Chen, Keping; Zheng, Xiaolin; Dai, Yan; Wang, Hao; Tang, Yue; Lan, Tingyu; Zhang, Jinping; Tian, Yantao; Zhang, Baojie; Zhou, Xin; Bonner, Matthew; Zhang, Shu

doi:10.1093/europace/euv418

Cited by 29 publications

(21 citation statements)

References 17 publications

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“…Previous studies examined the feasibility of implanting multiple intra-cardiac devices in the right ventricle. Chen et al 1 already showed that the implantation of two adjacent leadless pacing devices in a swine heart does not lead to dimensional or functional cardiac abnormalities. Omdahl et al 2 implanted three leadless pacemakers in a human cadaver heart (right ventricular apex, mid-septum, and outflow tract).…”

Section: Discussionmentioning

confidence: 99%

End-of-service management of leadless cardiac pacemakers: a case report

et al. 2019

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Section: Discussionmentioning

confidence: 99%

End-of-service management of leadless cardiac pacemakers: a case report

et al. 2019

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“…implanted two Micra TPS within 1 month in 14 pigs. 13 Of all pigs that underwent implantation procedures, five animals died prior to the end of the 6-month follow-up. Echocardiography was performed at baseline, at second implantation, and at the end of the 6-month follow-up.…”

Section: Nanostim Leadless Pacemakermentioning

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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“…Preclinical studies using swine and human cadaver hearts have demonstrated the feasibility of multiple right-ventricular Micra implants without affecting cardiac function. 32,33 ■ OTHER LIMITATIONS AND CAUTIONARY NOTES At present, leadless pacing is approved for single-chamber right-ventricular pacing. In the developed world, single right-ventricular pacing modes account for only 20% to 30% of new pacemaker implants, which total more than 1 million per year worldwide.…”

Section: Kiehl and Cantillonmentioning

confidence: 99%

Leadless cardiac pacing: What primary care providers and non-EP cardiologists should know

Kiehl

Cantillon

2016

CCJM

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Over the last 50 years, the use of transvenous pacemakers has been constrained by long-term complications that affect more than 1 in 10 patients, largely attributable to the endovascular leads and surgical pocket. Leadless cardiac pacing involves a self-contained pacemaker deployed directly into the heart without a lead or incisional access. The procedure has shown promise, eliminating pocket-related complications. Other advantages include postprocedural shoulder mobility and the ability to drive, shower, and bathe. Current devices are limited to single-chamber ventricular pacing. Future advances may allow atrial and dual-chamber pacing and combination with a subcutaneous defibrillator to deliver antitachycardia pacing and provide bradycardia backup.

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Multiple leadless pacemakers implanted in the right ventricle of swine

Abstract: Multiple leadless pacemakers implanted in the RV do not appear to impact cardiac function. Therefore, it appears safe to implant multiple leadless pacemakers in the same heart.

Cited by 29 publications

References 17 publications

End-of-service management of leadless cardiac pacemakers: a case report

End-of-service management of leadless cardiac pacemakers: a case report

End-of-life Management of Leadless Cardiac Pacemaker Therapy

Leadless cardiac pacing: What primary care providers and non-EP cardiologists should know

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