Key result
WATCHMAN occlusion achieves ~93% successful LAA sealing at 45 days with zero subsequent strokes.
Why the study?
Approximately 90% of left atrial thrombi in nonrheumatic AF patients are located in the LAA, motivating an assessment of the feasibility of implanting an LAA occlusion device to prevent thromboembolic stroke.
Is percutaneous implantation of the WATCHMAN Left Atrial Appendage System feasible and safe for sealing the left atrial appendage and preventing thromboembolic stroke in patients with atrial fibrillation?
Observational (n=66)
Yes
Is percutaneous implantation of the WATCHMAN Left Atrial Appendage System feasible and safe for sealing the left atrial appendage and preventing thromboembolic stroke in patients with atrial fibrillation?
This initial worldwide feasibility study demonstrated that percutaneous left atrial appendage occlusion with the WATCHMAN device is safe and feasible in patients with atrial fibrillation, laying the foundation for subsequent randomized trials against oral anticoagulation.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The committee did not review any data accrued from pilot studies conducted between 2002 and 2005, and if there were any reports describing the EU experience from 2005 to 2009, they were not presented to the committee.”
“A 2007 report describing the results of “initial worldwide experience” with the Watchman provided data on 75 patients, 66 of whom had received the device, including 53 who had received a second-generation system featuring design modifications.”
Supports early WATCHMAN feasibility in AF; hypothesis-generating for stroke prevention pending randomized trials.
Objectives This study assessed the feasibility of implanting a device in the left atrial appendage (LAA) in patients with atrial fibrillation (AF) to prevent thromboembolic stroke. Background Meta-analyses confirmed that in cases of left atrial thrombus in nonrheumatic AF patients approximately 90% of them are in the LAA. Methods The WATCHMAN Left Atrial Appendage System (Atritech Inc., Plymouth, Minnesota) is a nitinol device implanted percutaneously to seal the LAA. Patients were followed by clinical and transesophageal echocardiography at 45 days and 6 months with annual clinical follow-up thereafter. Results Sixty-six patients underwent device implantation. Mean follow-up was 740 +/- 341 days. At 45 days, 93% (54 of 58) devices showed successful sealing of LAA according to protocol. Two patients experienced device embolization, both successfully retrieved percutaneously. No embolizations occurred in 53 patients enrolled after modification of fixation barbs. There were 2 cardiac tamponades, 1 air embolism, and 1 delivery wire fracture (first generation) with surgical explantation but no long-term sequelae for the patient. Four patients developed a flat thrombus layer on the device at 6 months that resolved with additional anticoagulation. Two patients experienced transient ischemic attack, 1 without visible thrombus. There were 2 deaths, neither device related. Autopsy documented a stable, fully endothelialized device 9 months after implantation. No strokes occurred during follow-up despite >90% of patients with discontinuation of anticoagulation. Conclusions Preliminary data suggest LAA occlusion with the WATCHMAN System to be safe and feasible. A randomized study is ongoing comparing oral anticoagulation with percutaneous closure.
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Sick et al. (2007) conducted an observational in Atrial fibrillation (n=66). WATCHMAN Left Atrial Appendage System was evaluated on Successful sealing of the left atrial appendage at 45 days. Percutaneous left atrial appendage occlusion with the WATCHMAN System achieved successful sealing in 93% (54/58) of patients at 45 days with no strokes during a mean follow-up of 740 days.
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