Outcomes of Micra leadless pacemaker implantation with uninterrupted anticoagulation

Abstract

Background: Implantation of the MICRA Leadless pacemaker requires the use of a 27French introducer, blunt delivery system and device fixation to the myocardium via nitinol tines. While prior studies have proven its safety, it is unclear whether performing this procedure with uninterrupted anticoagulation exposes patients to increased risks. We sought to investigate the feasibility and safety of continuing therapeutic anticoagulation during the periprocedural period. Methods:We evaluated all patients undergoing MICRA placement at our institution between April 2014 and August 2018 with complete follow-up data (n = 170).Patients were stratified into two groups: those on active anticoagulation (OAC, n = 26), defined as having an International normalized ratio >2.0 or having continued a direct oral anticoagulant, and those not anticoagulated (Off-OAC, n = 144). We evaluated for a composite outcome of all major complications, including access site complications and pericardial effusion.Results: OAC and Off-OAC groups had similar mean age (74 ± 13 vs 75 ± 13 years; P = .914). The OAC group had a nonsignificantly lower prevalence of end-stage renal disease (8% vs 17%; P = .375) and aspirin use (27% vs 47%; P = .131). Those in the OAC group were more likely to be on warfarin than those in the Off-OAC group (81% vs 30%; P < .001). The rate of the composite endpoint was similar between the OAC and Off-OAC groups (3.8 % vs 1.4%, respectively; P = .761). Length of stay was similar between groups (1.3 ± 2.6 vs 2.3 ± 3.4 days; P = 0.108).Conclusion: Continuation of therapeutic anticoagulation during MICRA implantation appears to be feasible, safe and associated with shorter hospitalization among appropriately selected individuals. K E Y W O R D SClinical: Implantable devicespacemaker-bradyarrhythmias

Leadless pacing in the elderly: never too old for something new

“…Nevertheless, continuing anticoagulation has the specific aim to minimize disruption of therapy and avoid unnecessary exposure to the risk of thromboembolism. Micra-TPS implant with uninterrupted anti-coagulation therapy has been seen to be satisfactorily safe [17]: despite the large-bore vascular access, the reported rate of access relates complications among patients is low. In addition, the rate of pericardial effusion does not appear to be increase.…”

Peri-Procedural Management of Direct-Acting Oral Anticoagulants (DOACs) in Transcatheter Miniaturized Leadless Pacemaker Implantation

“…In the experience reported herein, which extends from September 2015 to the end of 2021, more than two-thirds of anticoagulated patients (68.1%) undergoing device implantation were under DOAC. This number is considerably higher compared with previously reported other single-center cohorts [7,8]. San Antonio and colleagues [8] reported that only around 20% of anticoagulated patients were under DOAC.…”

“…In a single-center, retrospective study, Kiani and colleagues [7] reported TPS implantation under uninterrupted vitamin-K antagonist (VKA). In this limited series (26 patients), no increased bleeding events were found with this strategy.…”

Anticoagulant therapy during cardiovascular implantable electronic device procedures

“…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 ].…”