Why the study?
Postimplantation peridevice leak of ≤5 mm was accepted as sufficient LAA closure in FDA trials, but the clinical consequences on subsequent thromboembolism remained poorly characterized.
Does the presence of a peridevice leak ≤5 mm increase the risk of thromboembolism and mortality at 5 years in patients who underwent LAA closure with the Watchman device?
Does the presence of a peridevice leak ≤5 mm increase the risk of thromboembolism and mortality at 5 years in patients who underwent LAA closure with the Watchman device?
A peridevice leak of ≤5 mm at 1 year after Watchman LAA closure is associated with an increased risk of thromboembolism, challenging the prior assumption that such leaks are clinically insignificant.
Answers are grounded in this paper and cite their sources.
Challenges acceptance of PDL≤5 as adequate LAA closure; leaves open whether leak elimination reduces thromboembolism.[[1]](https://www.jacc.org/doi/10.1016/j.jacc.2022.04.062)[[2]](https://www.sciencedirect.
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Dukkipati et al. (2022) studied this question.
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