Leadless pacemaker implant, anticoagulation status, and outcomes: Results from the Micra Transcatheter Pacing System Post-Approval Registry

El‐Chami, Mikhael F.; Garweg, Christophe; Iacopino, Saverio; Alsamadi, Faisal; Martínez‐Sande, José Luis; Tondo, Claudio; Johansen, Jens Brock; Prat, Xavier Viñolas; Piccini, Jonathan P.; Mei, Yong; Grubman, Eric; Bordachar, Pierre; Roberts, Paul R.; Soejima, Kyoko; Stromberg, Kurt; Fagan, Dedra H.; Clémenty, Nicolas

doi:10.1016/j.hrthm.2021.10.023

Cited by 10 publications

(6 citation statements)

References 19 publications

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“…There was a very high implant success rate similar across all groups and the overall major complication rate was 3.1% for the no anticoagulation group and 2.6% for the interrupted group and 1.5% for the uninterrupted anticoagulation group. The rates of vascular or pericardial effusion events did not differ significantly among anticoagulation strategies (23). These studies further highlight the low complication rate associated with continued anticoagulation use (Table 2).…”

Section: Anticoagulation Management During Micra Implantmentioning

confidence: 56%

Anticoagulation Therapy in Patients Undergoing Micra Leadless Pacemaker Implantation

Kadado

Chalhoub

2022

Preprint

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Over the past decade, there has been significant improvement in the treatment of diseases of the conduction system and symptomatic bradyarrhythmias with the development of leadless pacemaker systems. The Micra transcatheter pacemaker system has been shown to mitigate a lot of the complications associated with traditional pacing systems, which are notably skin pocket and lead-related complications. Numerous studies have shown the low complication rates associated with Micra procedure; however, there have been no specific guidelines or recommendations surrounding periprocedural anticoagulant therapy. This is important because a significant percentage of patients requiring pacemaker therapy have an indication for anticoagulation therapy as well. Multiple studies have shown the safety of uninterrupted anticoagulation during Micra implant, however, there is insufficient high-quality data to recommend periprocedural systemic use of anticoagulation. In this paper, we review the available data surrounding anticoagulation therapy in patients undergoing Micra implantation and the potential bleeding risks associated with this procedure.

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Section: Anticoagulation Management During Micra Implantmentioning

confidence: 56%

Anticoagulation Therapy in Patients Undergoing Micra Leadless Pacemaker Implantation

Kadado

Chalhoub

2022

Preprint

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“…Implantation of a leadless pacemaker into the right ventricle via the femoral vein requires a large venous catheter, and it is unknown whether this may predispose the patient to a higher risk of bleeding, particularly at the vascular access site. According to the results of single cohort studies, the complication rate of leadless pacemaker implantation was low, and the continuous use of anticoagulants during the procedure was considered a safe strategy compared to their interruption [ 50 , 51 ]. Although larger clinical randomized trials are needed, from the available data it seems that the recommendations for the implantation of traditional devices could be applied to these devices, at least for the time being [ 52 ].…”

Section: Discussionmentioning

confidence: 99%

Anticoagulant therapy during cardiovascular implantable electronic device procedures

Daubaraitė,

Marinskis,

Račkauskas

2023

pwki

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Aim The objective of the study is to systematically evaluate the safety and efficacy of peri-procedural utilization of anticoagulation therapy during cardiovascular implantable electronic device procedures. Material and methods The review materials were based on comprehensive retrieval of randomized controlled trials and observational studies published until April 2023. Studies which compared different management strategies of long-term anticoagulation therapy during peri-procedural cardiac rhythm device implantation and compared the complications of bleeding and/or thromboembolic events were selected and reviewed. Results Studies analysing non-vitamin K oral anticoagulants interruption versus continuation during peri-procedural implantable cardiac device surgery found no statistically significant difference in bleeding or thromboembolic complications between these strategies. Studies comparing non-vitamin K oral anticoagulants with vitamin K antagonists also showed no statistically significant difference. One study comparing uninterrupted warfarin with interrupted warfarin with heparin bridging reported a reduced incidence of clinically significant device pocket haematoma in patients with continued warfarin treatment (relative risk = 0.19; 95% confidence interval: 0.10 to 0.36; p < 0.001). A sub-analysis of one study comparing dabigatran versus warfarin with heparin bridging and without bridging reported a lower risk of pocket haematoma with dabigatran when compared to warfarin with heparin bridging (risk difference: –8.62%, 95% confidence interval: –24.15 to –0.51%; p = 0.034). Both bleeding and thromboembolic complications were rare. Conclusions The traditional method of vitamin K antagonists interruption with heparin bridging is less safe than continuing vitamin K antagonists at therapeutic levels. Both continuation and interruption strategies of non-vitamin K anticoagulants during cardiac device surgery seem to be safe and appropriate.

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“…Indeed, the PAR registry reported pericardial effusion in 14 patients (0.78%), 8 requiring pericardiocentesis. Subanalysis of the PAR registry provides evidence that Micra implantation under uninterrupted anticoagulation is safe, and that Micra implantation in 105 patients extracted because of pre-existing CIED infection is not burdened by further device infection [59,60]. In 197 patients on hemodialysis there were no pacemaker infection, although 3 procedurerelated deaths were observed (2 perforations).…”

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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Leadless pacemaker implant, anticoagulation status, and outcomes: Results from the Micra Transcatheter Pacing System Post-Approval Registry

Cited by 10 publications

References 19 publications

Anticoagulation Therapy in Patients Undergoing Micra Leadless Pacemaker Implantation

Anticoagulation Therapy in Patients Undergoing Micra Leadless Pacemaker Implantation

Anticoagulant therapy during cardiovascular implantable electronic device procedures

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

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