Oval device compression and subsequent peri device leaks (PDL) after Watchman FLX device implantation
Authors:
Verma Sumit, Mishra N, Alsheikh
Presented in Heart Rhythm Society (HRS) 2023 May
Link-HRS conference
Abstract:
Left atrial appendage closure with a Watchman device (WM) is recommended for AF patients with high CHADS2VASC scores who are intolerant to oral anticoagulants or at high risk of bleeding. LAAC can be challenging in some patients due to the anatomy of the LAA. Even in patients with successful WM deployment, some may develop PDL in the future. The factors resulting in the development of PDL are not well understood. It is possible that LAA ostial remodeling is related to device-LAA wall interactions and regional stress that is unevenly distributed.
Method:
We identified all patients in the past 2 years who underwent WM FLX device placement with reported new PDL on 6-week follow-up transesophageal echo (TEE) and compared it with a historical group who did not develop PDL. We evaluated the size of the LAA ostium measured by TEE before and immediately post-WM FLX implant. We hypothesized that the patients who develop PDL may have unequal compression of the WM device in different axes (Oval instead of circular compression) leading to remodeling that favors PDL development.
https://www.tctmd.com/news/fda-approves-next-generation-watchman-flx-device-laa-occlusion
Watchman device implant in the right Atrial Appendage
Timelines to the project:
I as an Observer/Clinical Researcher in 2022 -23 at Baptist Health Care, Pensacola, FL
Followed Dr. Sumit Verma, Cardiologist at Baptist Health Care.
I conducted the project with PI on 502 patients who underwent WM FLX device placement.
I visited the study site, and collected, and stored data in Excel format.
Cleaned all the missing values
Analyze the data after preparing IRB format and regulatory documents.
I ensured regulatory compliance by obtaining informed consent.
Timely, and in an accurate and efficient manner managed the medical health records (EHR) for data collection.
Submitted the IRB draft and the manuscript for the conference.