Primary Results on Safety and Efficacy From the LEADLESS II–Phase 2 Worldwide Clinical Trial

Reddy, Vivek Y.; Exner, Derek V.; Doshi, Rahul N.; Tomassoni, Gery; Bunch, T. Jared; Estes, N.A. Mark; Neužil, Petr; Paulin, Frédéric L.; Guerrero, Juan José García; Cantillon, Daniel J.; Investigators, Leadless Ii

doi:10.1016/j.jacep.2021.11.002

Cited by 51 publications

(76 citation statements)

References 2 publications

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“…Nanostim (St.Jude, Saint Paul, MN, USA), as the first commercially available LPM capable of the VVI(R) pacing mode, was launched in 2012; however, the use of Nanostim implantation was discontinued due to the detachment of the docking button and premature battery failures, which occurred at two years after implantation [ 11 ]. The Aveir VR (Abbott, Abbott Park, IL, USA) by Abbott, which is an improvement of the Nanostim LPM, received Food and Drug Administration (FDA) approval on April 2022, and it could provide an expandable platform to support dual-chamber pacing once approved by the FDA [ 12 ].…”

Section: Leadless Ventricular Pacemakersmentioning

confidence: 99%

“…A total of 196 patients were successfully implanted with the Aveir VR. For 95.9% of these patients, the pacing thresholds were less than 2.0 V at 0.4 ms and the R waves were greater than 5.0 mV at the 6 week follow-up [ 12 ]. However, no clear consensus has been determined in terms of the complication rate of LPMs when compared to TPMs.…”

Section: Leadless Ventricular Pacemakersmentioning

confidence: 99%

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Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers

Tong

Sun

2023

JCM

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Leadless pacemakers (LPMs) have emerged as an alternative to conventional transvenous pacemakers to eliminate the complications associated with leads and subcutaneous pockets. However, LPMs still present with complications, such as cardiac perforation, dislodgment, vascular complications, infection, and tricuspid valve regurgitation. Furthermore, the efficacy of the leadless VDD LPMs is influenced by the unachievable 100% atrioventricular synchrony. In this article, we review the available data on the strategy selection, including appropriate patient selection, procedure techniques, device design, and post-implant programming, to minimize the complication rate and maximize the efficacy, and we summarize the clinical settings in which a choice must be made between VVI LPMs, VDD LPMs, or conventional transvenous pacemakers. In addition, we provide an outlook for the technology for the realization of true dual-chamber leadless and battery-less pacemakers.

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Section: Leadless Ventricular Pacemakersmentioning

confidence: 99%

Section: Leadless Ventricular Pacemakersmentioning

confidence: 99%

Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers

Tong

Sun

2023

JCM

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“…18 It is possible that LCP devices are resistant to infection not only due to elimination of subcutaneous pocket, but also due to resistance to bacterial seeding as a result of less surface area and endovascular encapsulation. There are no reports of LCP related endocarditis involvement from the major clinical trials, 7,8 including 16 patients with recurrent bacteremia or endocarditis without evidence of involvement of the LCP itself. 19 There are only very few case reports available in the literature of documented LCP infection.…”

Section: Prior Cied Infectionmentioning

confidence: 99%

Leadless cardiac ventricular pacing using helix fixation: Step‐by‐step guide to implantation

Laczay

Aguilera

Cantillon

2022

Cardiovasc electrophysiol

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Introduction: Leadless cardiac pacemakers are an alternative modality to traditional transvenous pacemaker systems. Recently receiving Food and Drug Administration approval, the AVEIR VR leadless pacemaker system provides a helix based active fixation leadless pacemaker system. This step-by-step review will cover patient selection, preprocedural planning, device implantation technique, implant site evaluation, troubleshooting, short-and long-term complications as well as future directions for leadless pacing.Methods: We collected and reviewed cases from primary operators to provide a step-by-step review for implanters. Results:Our paper provides a guide to patient selection, pre-procedural planning, device im plantation technique, implant site evaluation, troubleshooting, short-and long-term complications as well as future directions for leadless pacing. Conclusion:The helix based active fixation leadless pacemaker system is a safe and efficacious way to provide pacing support to patients and provides an alternative to transvenous pacing systems. Our review provides a step-by-step guide to implantation.

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“…Owing to these issues, the newly developed leadless VVIR pacer Aveir TM by Abbott has substantial technical innovations: a standard transvenous pacemaker battery chemistry (Lithium Carbon-Monofluoride) with 12% longer battery life (1.1 years longer to 10.4 years), altered form factor (10% shorter, 1.5 Fr wider to 19.5 Fr), modified docking button (enabling retrievability), modified delivery system with an ergonomic design, and a new ASIC chip designed to provide an expandable platform (to later support a dualchamber pacing system once approved). The safety and efficacy have been recently reported on 200 patients (Table 2), highlighting that training to avoid complications remains a key aspect: 3 cardiac tamponades (2 requiring sternotomy), and 3 premature device deployments [55].…”

Section: Leadless Vvir Pacingmentioning

confidence: 99%

Bridging the future of cardiac stimulation: physiologic or leadless pacing?

Piemontese¹,

Toniolo²,

Biffi³

et al. 2022

Rev. Cardiovasc. Med.

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Cardiac simulation has moved from early life-saving pacemakers meant only to prevent asystole to current devices capable of physiologic stimulation for the treatment of heart rhythm and heart failure, that are also intended for remote patient and disease-progression monitoring. The actual vision of contemporary pacing aims to correct the electrophysiologic roots of mechanical inefficiency regardless of underlying structural heart diseases. The awareness of the residual cardiac dyssynchrony related to customary cardiac pacing has changed the concept of what truly represents "physiologic pacing". On a different perspective, leadless stimulation to abolish CIED surgery and prevent lead-related complications is becoming a priority both for young device recipients and for frail, elderly patients. Careful clinical evaluation attempts to bridge decision-making to patient-tailored therapy.

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Primary Results on Safety and Efficacy From the LEADLESS II–Phase 2 Worldwide Clinical Trial

Cited by 51 publications

References 2 publications

Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers

Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers

Leadless cardiac ventricular pacing using helix fixation: Step‐by‐step guide to implantation

Bridging the future of cardiac stimulation: physiologic or leadless pacing?

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