Initial Experience With High-Risk Patients Excluded From Clinical Trials

Abstract

Background— The implantation of left atrial appendage closure device (WATCHMAN, Boston Scientific, Natick, MA) is an alternative option to oral anticoagulation (OAC) for stroke prevention in atrial fibrillation. Patients require short-term OAC after implantation to avoid device thrombosis. The 2 clinical trials that assessed this device excluded patients thought not to be candidates for OAC. As such, little is known about the safety of this strategy in patients with previous major bleeding events. Methods and Results— All 20 consecutive patients with history of spontaneous major bleeding while on OAC who had subsequently undergone WATCHMAN device implantation at our institution were included. A newly conceived multidisciplinary Atrial Fibrillation Stroke Prevention Center evaluated patients for candidacy for device implantation and subsequent antithrombotic therapy. The primary outcome was spontaneous major bleeding while receiving short-term postprocedural OAC. Median CHA 2 DS 2 -VASc and HAS-BLED scores were 5 (quartiles 5–6) and 5 (quartiles 4–5), respectively. Previous major bleeding events were major gastrointestinal bleeding, intracranial bleeding, spontaneous hemopericardium with cardiac tamponade, and hemarthrosis in 11, 7, 1, and 1 patients, respectively. None of the patients had spontaneous major bleeding during the course of OAC after device implantation. In 1 patient, OAC was discontinued after 40 days because of mechanical fall with head trauma resulting in subdural hematoma with no associated neurological deficits; this was managed conservatively. Conclusions— With careful multidisciplinary evaluation, a short course of OAC after WATCHMAN device implantation in patients with previous spontaneous major bleeding events is associated with low risk of recurrent spontaneous major bleeding.

Left atrial appendage occlusion: 2016 in review

“…MBE is defined as fatal bleed or symptomatic bleed in a critical area or organ such as: intracranial, intraocular, intra‐spinal, retroperitoneal, intraarticular, pericardial or intramuscular with compartment syndrome or bleeding with a drop in hemoglobin greater or equal to 2 gm/dL or bleeding requiring transfusion of more than or equal to two units of packed red blood cells. These patients underwent LAAO with the Watchman device with subsequent OAC therapy post implantation . No occurrence of spontaneous MBE occurred in any patient while receiving OAC post LAAO.…”