Initial experience with the WATCHMAN™ left atrial appendage system for stroke prevention in atrial fibrillation: A single-centre registry.

BACKGROUND: Left atrial appendage (LAA) closure using the WATCHMAN™ device (WM) may be considered in patients with non-valvular atrial fibrillation (AF) and a high-risk of stroke who are ineligible for long-term oral anticoagulation (OAC).

AIM: To report our single-centre preliminary experience, focusing on feasibility, safety and short-term efficacy of this procedure.

METHODS: Patients implanted from December 2013 to February 2014 were included. The procedure, performed under general anaesthesia, was guided by fluoroscopy and transoesophageal echocardiography (TOE). Efficacy was defined as the ability to implant the WM with no peridevice leak; safety was defined as the occurrence of in-hospital and 45-day events, including stroke, pericardial effusion and device migration.

RESULTS: Twenty-three patients (mean age: 77.6 years; 16 men [69.6%]; mean CHA2DS2-VASc score: 5) underwent WM implantation. The indication was gastrointestinal bleeding in 14 (60.9%) patients, cerebral haemorrhage in eight (34.8%) and need for long-term ticagrelor after stent thrombosis on clopidgrel in one (4.3%). Procedural success was 95.7% (95% confidence interval: 77.3-100.0); efficacy was 90.9% (95% confidence interval: 71.0-98.7). The size of the implanted WATCHMAN™ device was in agreement with the prespecified size, based on measurement of the LAA, in 56.5% of cases. In five cases, the criteria were not met, but the device was successfully implanted in four of these, with a good result (80.0%). Treatment at discharge was a reduced dose of anticoagulant plus aspirin in three cases (13.0%) or antiplatelet therapy alone in 20 cases (90.9%). No adverse event occurred during the index hospitalization or at 45 days. At 45 days, the LAA was sealed in 18/19 patients (94.7%) on TOE, with no difference between those who did or did not have an implanted device of the prespecified size.

CONCLUSION: When performed by an operator trained in the procedure, WM implantation appears to be safe and effective. This procedure may be considered in patients at high-risk of stroke who are ineligible for long-term OAC.