ClinicalDevicesLeadless pacemaker implant, anticoagulation status, and outcomes: Results from the Micra Transcatheter Pacing System Post-Approval Registry
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 ClinicsPeriprocedural anticoagulation therapy in patients undergoing micra leadless pacemaker implantation
2023, International Journal of CardiologyCitation 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.
Leadless transcatheter pacemaker: Indications, implantation technique and peri-procedural patient management in the Italian clinical practice
2022, International Journal of CardiologyCitation 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%.
Peri-Procedural Management of Direct-Acting Oral Anticoagulants (DOACs) in Transcatheter Miniaturized Leadless Pacemaker Implantation
2023, Journal of Clinical MedicineStrategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers
2023, Journal of Clinical MedicineAnticoagulant therapy during cardiovascular implantable electronic device procedures
2023, Postepy w Kardiologii Interwencyjnej
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.