Key result
Watchman LAAC yields comparable long-term ischemic stroke rates in small versus indicated LAA orifices.
Why the study?
The Watchman device is indicated for LAA orifice diameters between 17 and 31 mm, leaving the long-term safety and efficacy of LAAC in patients with small orifices (<17 mm) to be evaluated.
Does left atrial appendage closure with the Watchman device have comparable safety and efficacy in atrial fibrillation patients with small LAA (<17 mm) compared to those with indicated LAA (17-31 mm)?
Cohort (n=369)
Does left atrial appendage closure with the Watchman device have comparable safety and efficacy in atrial fibrillation patients with small LAA (<17 mm) compared to those with indicated LAA (17-31 mm)?
Absolute Event Rate: 4.5% vs 1.2%
p-value: p=.266
Left atrial appendage closure with the Watchman device appears to have comparable long-term safety and efficacy in atrial fibrillation patients with off-label small LAA orifices (<17 mm) compared to those with standard indicated sizes.
May support Watchman LAAC consideration in small LAA; hypothesis-generating and requires randomized confirmation before practice change.
BACKGROUND: The Watchman device is the most widely used occluder but is indicated in atrial fibrillation (AF) patients with a maximal left atrial appendage (LAA) orifice diameter between 17 and 31 mm. We aimed to compare the long-term safety and efficacy of left atrial appendage closure (LAAC) between patients with a small LAA (<17 mm) and those with an indicated LAA (17-31 mm) measured by transesophageal echocardiography (TEE). METHODS: A total of 369 AF patients treated with LAAC between March 2015 and February 2019 were included and divided into two groups based on the maximal LAA orifice diameter measured by TEE: small LAA group (n = 22) and indicated LAA group (n = 347). Periprocedural complications and long-term clinical outcomes were compared. RESULTS: The Watchman device was successfully implanted in all patients. Mean device compression was higher in the small LAA group. Four patients (1.2%) in the indicated LAA group experienced pericardial effusion, and none experienced pericardial effusion in the small LAA group. Device-related thrombus was detected in one (4.5%) patient in the small LAA group and five (1.4%) in the indicated LAA group (p = .310). After a mean follow-up period of 4.1 ± 1.6 years, one patient in the small LAA group (4.5%; 1.1/100 person-years) and four in the indicated LAA group (1.2%; 0.3/100 person-years) suffered an ischemic stroke (p = .266). CONCLUSIONS: The safety and efficacy of LAAC with the Watchman device were comparable between patients with small and indicated LAA orifice diameters measured by TEE.
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Wang et al. (2022) conducted a cohort in Atrial fibrillation (n=369). Left atrial appendage closure (Watchman device) in small LAA (<17 mm) vs. Left atrial appendage closure in indicated LAA (17-31 mm) was evaluated on Ischemic stroke (p=.266). LAAC with the Watchman device yielded comparable long-term ischemic stroke rates in patients with small (<17 mm) versus indicated (17-31 mm) LAA orifices (4.5% vs 1.2%; p=0.266).
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