Abstract

Abstract Background Patients with atrial fibrillation (AF) having high thromboembolic risk and either a history of major bleeding or very high bleeding risk form a treatment challenge. Percutaneous left atrial appendage closure (LAAC) offers a feasible option for stroke prevention in these patients. However, the optimal treatment strategy for AF patients with contraindications to oral anticoagulation (OAC) remains unclear. Purpose To study periprocedural and late events after LAAC in AF patients with contraindications to OAC therapy. Methods Data were collected into a prospective registry from all consenting AF patients who underwent LAAC from February 2009 to August 2018. Follow-up data was gathered during scheduled clinical visits, annual phone calls and by reviewing electronic patient records. Only AF patients with contraindications to OAC were considered for the present analysis. Results LAAC using mainly Amplatzer Cardiac Plugs (98.2%) was attempted in a total of 172 patients (mean age 74 years; 60 women). The mean CHA2DS2-VASc score was 3.8±1.5 and HAS-BLED score 4.0±1.0. Contraindications to OAC were prior intracranial bleeding in 112 (65.1%), other major bleeding in 33 (19.2%) and high bleeding risk in 27 patients (15.7%). Procedure was technically successful in 166 (96.5%) patients. Clinically significant in-hospital complications were as follows: two patients (1.2%) had cardiac tamponade, which was fatal in one case, one (0.6%) had device embolization and eight (4.7%) had major access site-related bleeding events. None of the patients had in-hospital thromboembolic complications. After successful implantation, 152 patients (91.6%) were discharged on aspirin. Single antiplatelet therapy was more common than dual or triple antiplatelet therapy (74.7% vs. 18.1% vs. 1.8%, respectively), while 8 patients (4.8%) received no antiplatelet therapy. The length of initial antiplatelet therapy ranged from 0.5 to 12 months and long-term antiplatelet therapy was prescribed in 53 patients (31.9%). After a median follow-up of 33 months (interquartile range 12–49) there were 29 deaths (17.5%), 16 thromboembolic events (9.6%), consisting of 11 strokes (6.6%) and 5 transient ischemic attacks (3.0%). At the time of thromboembolic event, 10 patients (62.5%) were on antithrombotic therapy. Eighteen patients (10.8%) had at least one major bleeding event after the index hospitalization. Intracranial bleeding occurred in 7 patients (4.2%) and 6 of them (85.7%) were on antithrombotic therapy when the event occurred. Most thromboembolic events (68.8%) and intracranial bleedings (57.1%) occurred after one year of follow-up. One patient (0.6%) had an asymptomatic device embolization detected at 3-month control visit. No predictive factors for thromboembolic or major bleeding events were identified. Conclusion The early outcome of this challenging patient group is good after LAAC, but thromboembolic and major bleeding events are not uncommon during later follow-up.

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