How delayed peridevice leak after LAAC affects patient outcomes
Delayed peridevice leak (PDL) is present in more than 10% of patients who undergo left atrial appendage closure (LAAC) with Boston Scientific’s Watchman devices (WD), according to new findings published in JACC: Clinical Electrophysiology. PDL is linked to worse clinical outcomes.
“Because of a geometric and morphologic mismatch between the WDs and the LAA, it is inevitable that some patients will have PD at the time of implantation or during follow-up,” wrote Muhammad R. Afzal, MBBS, a cardiologist at the Ohio State University Wexner Medical Center in Columbus, and colleagues. “Because the LAA is a contractile structure, especially in patients who are in sinus rhythm, it is conceivable that this contractility may cause the WDs to shift or ‘settle’ over time. PDL may also be underappreciated at the time of implant because of a lack of flow differential between a channel that is patent (leak) and the closed surface of the device (WD fabric). Without this flow differential, velocity acceleration may not be detected using color Doppler.”
Afzal et al. explored data from more than 1,000 patients who underwent a successful Watchman implantation at one of four facilities. All patients were treated from October 2016 to August 2020.
Overall, using transesophageal echocardiography, researchers identified new PDL in 10.5% of the patient population after 45 to 90 days. The average PDL was 3.2 mm, and it “regressed significantly” in many — but not all — patients with PDL of 3 mm or less. Among patients with PDL that was more than 3 mm, however, it did not significantly change over time.
“These data indicate that a large proportion of patients develop delayed PDL,” the authors wrote. “These leaks warrant periodic surveillance, maintenance of oral anticoagulation (OAC), and secondary LAA occlusion, depending on the size of the PDL.”
The study’s primary outcome was a composite of failing to stop OAC, transient ischemic attack or stroke during follow-up, device-related thrombi, and the need for endocardial PDL closure. That primary outcome occurred in 45% of all patients with delayed PDL, and it was much more frequent (69% vs. 34%) among patients with PDL more than 3 mm.
In addition, the authors noted, delayed PDL was associated with an increased risk of transient ischemic attack or stroke.
The study did have certain limitations. It was a retrospective analysis, for instance, and only represented the LAAC programs at four high-volume facilities.
“Despite these limitations, this is the first study showing temporal changes and long-term clinical significance of PDL as stratified by PDL size,” the authors concluded. “These results should be validated in future larger, multicenter, prospective studies that would include a standardized approach for continuing or stopping anticoagulation in the setting of a delayed PDL.”
The full study is available here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.