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

doi:10.1016/j.hrthm.2021.10.023

Heart Rhythm

Volume 19, Issue 2, February 2022, Pages 228-234

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Background

Early results from the Micra investigational trial and Micra Post-Approval Registry (PAR) demonstrated excellent safety and device performance; however, outcomes based on anticoagulation (AC) status at implant have not been evaluated.

Objective

The purpose of this study was to report implant characteristics, perforation rate, and vascular-related events based on perioperative oral AC strategy in patients undergoing Micra implant.

Methods

We compared procedure characteristics, major complications, and vascular events, including pericardial effusion, stratified by any adverse event (including major complications, minor complications, and observations) or major complication only according to AC status in the Micra PAR.

Results

Among 1795 patients with AC status available, 585 were not on AC, 795 had AC interrupted, and 415 had AC continued during Micra implant. Non-AC patients tended to be younger, with less history of atrial fibrillation and chronic obstructive pulmonary disease, and more history of dialysis than interrupted and continued patients. The implant success rate was similar for all groups (99.1%–99.8%). Through 30 days postimplant, the overall major complication rate was 3.1% for the non-AC group, 2.6% for the interrupted group, and 1.5% for the continued group. The combined rate for any vascular or pericardial effusion adverse event did not differ significantly among AC strategies (6.5%, 4.8%, and 3.6%, respectively).

Conclusion

Implant of Micra seems to be safe and feasible regardless of an interrupted or continued periprocedural oral AC strategy, with no increased risk of perforation or vascular complications.

Introduction

Patients undergoing electrophysiological procedures often have comorbidities that require chronic anticoagulation (AC) therapy.¹ Interruption of AC before these procedures is no longer a common practice; rather, performing these procedures with uninterrupted AC is considered the standard of care in many situations.1, 2, 3 For example, performing atrial fibrillation (AF) ablation without interrupting direct oral anticoagulants (DOACs) or warfarin has been shown to be safe and to be associated with fewer embolic events.4, 5, 6 Similarly, the practice of implanting a cardiac implantable electronic device without interrupting DOACs or warfarin has been shown to be safe in selected patients.¹^,³

The Micra™ transcatheter pacing system (Medtronic, Inc., Minneapolis, MN) is a novel single-lead pacemaker often implanted in patients with AF and indications for AC.⁷^,⁸ Implanting Micra requires large-bore venous access and navigation of the delivery system in the right ventricle to implant the device.⁹ Hence, venous access complications and cardiac perforation are 2 potentially important complications of this procedure similar to what is encountered with other electrophysiological procedures.⁸ Two small, retrospective, single-center studies showed that implanting Micra without interruption of AC can be performed safely.¹⁰^,¹¹

We sought to assess the safety of implanting Micra in patients enrolled in a multicenter study without interruption of their chronic AC.

Section snippets

Study design

Patients undergoing Micra VR implant attempt who were enrolled in the Micra Post-Approval Registry (PAR) were included in this analysis.⁸ The Micra PAR inclusion and exclusion criteria in addition to a detailed description of this registry have been reported previously.⁸^,¹² In brief, the Micra PAR is a prospective, nonrandomized, registry study that enrolled patients with class I or II indications for pacing¹³ with no comorbidity restrictions. The institutional review board from each

Objective

The objective of this analysis was to compare the acute safety and performance of the Micra system by perioperative oral AC strategy. For the purposes of this analysis, patients were divided into 3 groups based on their perioperative chronic AC strategy as follows: group 1: patients not on AC; group 2: patients who interrupted AC in the perioperative setting; and group 3: patients who continued AC in the perioperative setting.

Acute safety was assessed by comparing the rate of any vascular

Baseline and implant characteristics

A total of 1811 patients were enrolled in the registry, and data on AC status were available for 1795 patients. The 16 patients with unknown AC status were excluded from subsequent analysis. Of the 1795 patients, 585 (32.6%) were not on AC (group 1), 795 (44.3%) were on AC but had it interrupted during the perioperative period (group 2), and 415 (23.1%) continued AC during the perioperative period (group 3). Baseline characteristics and comorbid conditions are summarized in Table 1. Patients in

Discussion

In this large multicenter registry, implantation of Micra without interruption of AC was not associated with an increased risk of complications. Importantly, we observed that the rate of pericardial effusion was similar regardless of AC strategy, ranging from 1.2% in group 1 to 0.5% in group 3 (P = .12). Moreover, the severity of pericardial effusion was not associated with AC status. Groin complications were similar among the 3 groups. Finally, it is important to note that similar results were

Conclusion

The overall incidence of vascular and pericardial effusion complications after Micra implant is low. Implantation of Micra using a strategy of uninterrupted AC seems to be safe, with no increased risk of vascular or pericardial effusion events compared to a strategy that relies on interruption of AC.

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Cited by (7)

Leadless Pacemakers in Patients with Congenital Heart Disease
2023, Cardiac Electrophysiology Clinics
Periprocedural anticoagulation therapy in patients undergoing micra leadless pacemaker implantation
2023, International Journal of Cardiology
Citation Excerpt :
In a review of the Micra Transcatheter Pacing System Post-Approval Registry, 1795 patients with anticoagulation status were available and included in the evaluation. Five hundred eighty-five (33%) patients were not on anticoagulation [23]. Of those on anticoagulation, 795 had anticoagulation interrupted and 415 had anticoagulation continued during Mica implant.
Over the past decade, there has been significant improvement in the treatment cardiac diseases 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.
Leadless transcatheter pacemaker: Indications, implantation technique and peri-procedural patient management in the Italian clinical practice
2022, International Journal of Cardiology
Citation Excerpt :
For T-PM implants, current guidelines provide specific recommendations suggesting that the procedures should be performed without interrupting VKAs and transiently interrupting DOACs (without heparin bridging) for a period of 24–48 h in most cases, depending on the characteristics of the anticoagulant [35]. No recommendations are currently provided on peri-procedural OAT management in L-PM procedures; however, the growing amount of data on safety of implantations under uninterrupted VKAs and temporarily discontinued DOACs suggest that the approach recommended in T-PMs patients may be safely used also in this group, until reliable data are available [36–38]. During follow-up we observed a rate of device-related complications of 0.9%.
Safety and efficacy of leadless pacemakers (L-PM) have been demonstrated in multiple clinical trials, but real-world data on patient selection, implantation technique, and peri-procedural patient management in a clinical practice setting are lacking.
Consecutive patients undergoing L-PM implantation in 14 Italian centers were followed in a prospective, multicentre, observational project. Data on baseline patient characteristics, clinical indications, implantation procedure, and peri-procedural patient management were collected. The rate and nature of device-related complications were also recorded.
A total of 782 L-PM patients (68.4% male, 75.6 ± 12.4 years) were included in the analysis. The main patients-related reason leading to the choice of implanting a L-PM rather than a conventional PM was the high-risk of device infection (29.5% of cases). The implantation success rate was 99.2%. The median duration of the procedure was 46 min. In 90% of patients the device was implanted in the septum. Of patients on oral anticoagulant therapy (OAT) (n = 498) the implantation procedure was performed without interrupting (17.5%) or transiently interrupting OAT without heparin bridging (60.6%). During a median follow-up of 20 months major device-related complications occurred in 7 patients (0.9%): vascular access-site complications in 3 patients, device malfunction in 2 patients, pericardial effusion/cardiac tamponade in one patient, device migration in one patient.
In the real world setting of Italian clinical practice L-PM is often reserved for patients at high-risk of infection. The implantation success rate was very high and the risk of major complications was low. Peri-procedural management of OAT was consistent with available scientific evidence.
Peri-Procedural Management of Direct-Acting Oral Anticoagulants (DOACs) in Transcatheter Miniaturized Leadless Pacemaker Implantation
2023, Journal of Clinical Medicine
Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers
2023, Journal of Clinical Medicine
Anticoagulant therapy during cardiovascular implantable electronic device procedures
2023, Postepy w Kardiologii Interwencyjnej

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: Funding Sources: Dr Piccini was supported by Grant R01HL128595 from the National Heart, Lung, and Blood Institute. Disclosures: The Micra Post-Approval Registry (ClinicalTrials.gov Identifier NCT02536118) is funded by Medtronic, Inc. Dr El-Chami reports consulting for Medtronic, Boston Scientific, and Biotronik. Dr Garweg reports research funding and speaker/consultancy fees from Medtronic. Dr Tondo reports honoraria from Abbott; and serving on the advisory board of Medtronic and Boston Scientific. Dr Johansen reports serving on a speakers bureau for Medtronic and Merit Medical; and honoraria/scientific board for Medtronic and Biotronik. Dr Piccini reports clinical research grants from Abbott, American Heart Association, Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, and Philips; and consulting for Abbott, Allergan, ARCA Biopharma, Biotronik, Boston Scientific, LivaNova, Medtronic, Milestone, MyoKardia, Sanofi, Philips, and Up-to-Date. Dr Roberts reports honoraria from Medtronic. Dr Soejima reports honoraria/lecturing for Medtronic Japan and Abbott Japan. Dr Stromberg is an employee/shareholder of Medtronic. Dr Fagan is an employee/shareholder of Medtronic. Dr Clementy reports consulting for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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

Background

Objective

Methods

Results

Conclusion

Introduction

Section snippets

Study design

Objective

Baseline and implant characteristics

Discussion

Conclusion

Heart Rhythm

Heart Rhythm

J Am Coll Cardiol

Heart Rhythm

Heart Rhythm

Heart Rhythm

Pacemaker or defibrillator surgery without interruption of anticoagulation

N Engl J Med

Continued vs. interrupted direct oral anticoagulants at the time of device surgery, in patients with moderate to high risk of arterial thrombo-embolic events (BRUISE CONTROL-2)

Eur Heart J

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