Key result
Continuing therapeutic anticoagulation during MICRA implantation resulted in a similar rate of major complications compared to no anticoagulation.
Why the study?
It is unclear whether performing MICRA leadless pacemaker implantation with uninterrupted anticoagulation exposes patients to increased risks given the 27 French introducer and delivery system.
Does uninterrupted active anticoagulation increase major complications in patients undergoing MICRA leadless pacemaker implantation?
Cohort (n=170)
No
Does uninterrupted active anticoagulation increase major complications in patients undergoing MICRA leadless pacemaker implantation?
Continuation of therapeutic anticoagulation during MICRA leadless pacemaker implantation appears safe and feasible without significantly increasing major periprocedural complications.
Answers are grounded in this paper and cite their sources.
May support uninterrupted anticoagulation for Micra in selected patients; leaves open need for randomized confirmation before practice change.
BACKGROUND: Implantation of the MICRA Leadless pacemaker requires the use of a 27 French 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.
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Kiani et al. (2019) conducted a cohort in MICRA leadless pacemaker implantation (n=170). Active anticoagulation (OAC) vs. Not anticoagulated (Off-OAC) was evaluated on Composite outcome of all major complications, including access site complications and pericardial effusion (p=0.761). Continuing therapeutic anticoagulation during MICRA implantation resulted in a similar rate of major complications compared to no anticoagulation.
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