Access Site Bleeding Complications with NOACs versus VKAs in Patients with Atrial Fibrillation Undergoing Cardiac Implantable Device Intervention.

Enrico Guido Spinoni,Eleonora Battistini,Giuseppe Patti,Stefano Porcellini,Gabriele Dell’Era,Federica De Vecchi,Chiara Ghiglieno,Simona Costantino,Matteo Santagostino,Giulia Renda

doi:10.3390/jcm11040986

Enrico Guido Spinoni, Eleonora Battistini + Show 8 more

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https://doi.org/10.3390/jcm11040986

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There are no data on procedure-related bleeding outcome with non-vitamin K antagonist anticoagulants (NOACs) versus vitamin K antagonist anticoagulants (VKAs) in patients with atrial fibrillation (AF) undergoing cardiac implantable electronic device (CIED) intervention. Our aim was to evaluate whether NOACs have a safety benefit even in terms of fewer hemorrhagic complications at the site of CIED implant. Consecutive AF patients receiving NOACs or VKAs at the time of CIED procedure were included in this observational, retrospective, and monocentric investigation. Primary endpoint was the incidence of post-intervention pocket hematoma. A total of 311 patients were enrolled, 146 on NOACs, and 165 on VKAs. The incidence of pocket hematoma was 3.4% in the NOAC versus 13.3% in the VKA group (p = 0.002). Primary outcome-free survival at 30-days was 96.6% in patients on NOACs and 86.0% in those on VKAs (p = 0.019). Multivariate analysis, adjusted by propensity-score calculation of inverse-probability-weighting, showed a significantly lower occurrence of pocket hematoma in patients receiving NOACs versus VKAs (HR 0.35, 95% CI 0.13–0.96, p = 0.042). Such NOACs benefit was confirmed versus patients on VKAs without peri-procedural bridging with low-molecular-weight heparin (HR 0.34, 95% CI 0.11–0.99, p = 0.048). The incidence of pocket infection, surgical pocket evacuation, ischemic events, and major bleeding complications at 30 days (secondary endpoints) was similar in the two groups. In conclusion, our data suggest that, among patients with AF undergoing implantable cardiac defibrillator or pacemaker intervention, the use of NOACs versus VKAs may be associated with significant reduction of post-procedural pocket hematoma, regardless of bridging with low-molecular-weight heparin in the VKA group. These results are hypothesis generating and need to be confirmed in a specific randomized study.

Highlights

Patients receiving a cardiac implantable electronic device (CIED) frequently present concomitant atrial fibrillation (AF) and are often on oral anticoagulant therapy (OAC) for the prevention of thromboembolic events [1]
The number of patient candidates to CIED having AF is expected to increase in the future, as the progressive aging of the population worldwide enhances the prevalence of AF and enlarges the proportion of individuals with indication to pacemaker or implantable cardiac defibrillator (ICD) implant [2,3]
Patients treated with non-vitamin K antagonist anticoagulants (NOACs) more frequently were males, had paroxysmal AF and received pacemaker implantation

Summary

Introduction

Patients receiving a cardiac implantable electronic device (CIED) frequently present concomitant atrial fibrillation (AF) and are often on oral anticoagulant therapy (OAC) for the prevention of thromboembolic events [1]. In patients undergoing CIED intervention, any anticoagulant treatment may increase the risk of procedure-related bleeding and pocket hematoma. This latter complication is relevant, as it predisposes patients to CIED infection [4,5,6]. In this setting, more recent evidence from clinical trials on patients receiving vitamin K antagonist anticoagulants (VKAs) showed no benefit on ischemic and bleeding events by a strategy of peri-procedural OAC interruption; of note, a significantly higher occurrence of hemorrhagic complications was observed in the subgroup undergoing VKA interruption and bridging with low molecular weight heparin (LMWH) [7,8]. An uninterrupted VKA treatment is recommended in AF patients undergoing CIED intervention [4,6]

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