ABSTRACT

Left atrial appendage (LAA) occlusion with the Watchman device is a procedure
designed to reduce the risk of stroke and other embolic events in patients with non-
valvular atrial fibrillation (NVAF) who have contraindications to long-term oral
anticoagulation therapy. Atrial fibrillation is a heart rhythm disorder characterized by
irregular and rapid heartbeats that can increase the risk of blood clot formation in the
heart. In the case of non-valvular atrial fibrillation, there is no underlying valvular
heart disease contributing to the condition.

NVAF is common in patients with risk factors such as advanced age, hypertension,
previous heart disease, diabetes, and other medical disorders. These patients have
a higher risk of experiencing a stroke due to the possibility of clot formation in the
left atrium, especially in the left atrial appendage, which is a common site for blood
clot formation in individuals with atrial fibrillation.

Occlusion of the LAA with the Watchman device aims to prevent the formation of
blood clots within the appendage, thus reducing the likelihood of clot formation and
decreasing the risk of stroke and systemic embolism in patients with NVAF. By
effectively closing the LAA, the Watchman device offers an alternative strategy for
stroke prevention in individuals who cannot tolerate or have contraindications to
long-term anticoagulation therapy.

The EWOLUTION clinical study evaluated the efficacy and safety of LAA occlusion
with the Watchman device in patients with or without contraindications to oral
anticoagulation. This study provided important data on the implementation of this
technique in clinical practice and its short-term outcomes in patients with non-
valvular atrial fibrillation. Successful implantation of the Watchman device has been
observed in a high percentage of cases, with implantation success rates exceeding
95% in various studies. Additionally, the device has been reported to prevent clot
formation in the LAA, significantly reducing the risk of thromboembolic events, such
as strokes, in NVAF patients contraindicated for oral anticoagulation.

In summary, implantation of the Watchman device has been shown to be a safe and
effective option for reducing the risk of stroke and other embolic events in patients
with NVAF who cannot receive long-term oral anticoagulants. Studies such as
EWOLUTION and other clinical trials have evaluated the efficacy and safety of LAA
occlusion with the Watchman device in this patient population.