22 May Novel Coating on Investigational WATCHMAN FLX™ Pro device May Reduce Risk of Embolism
MedicalResearch.com Interview with:
Aloke V. Finn MD
Medical Director/Chief Scientific Officer
CVPath Institute Inc.
Gaithersburg, MD 20878
MedicalResearch.com: What is the background for this study?
Response:Transcatheter left atrial appendageal closure (LAAC) has become an established therapeutic approach for prevention of stroke in subjects with non-valvular atrial fibrillation who are ineligible for long-term oral anticoagulation. Device-related thrombus (DRT), developing after LAAO procedures occurs in a small proportion but patients receiving these devices but is associated with critical embolic events such as ischemic stroke. Thrombogenicity and delayed endothelialization of fabric play a role in the development of DRT. Fluorinated polymers are known to have thromboresistant properties which may favorably modify blood biomaterial interactions of a LAAO device.
In this study we compared the thrombogenicity and endothelial coverage (EC) after left atrial appendage occlusion (LAAO) between a novel fluoropolymer-coated Watchman (FP-WM (Watchman FLX PRO) and the conventional uncoated Watchman FLX (WM).
MedicalResearch.com: What should readers take away from your report?
Response: Our study demonstrates superior thromboresistance and healing in FP-WM compared to WM, suggesting these modifications may substantially improve DRT after LAAO. This device modification may also allow to more simplified post-implant anti-coagulation regimens which should benefit patients receiving these devices.
MedicalResearch.com: What recommendations do you have for future research as a results of this study?
Response: Further clinical trials in humans will need to be conducted to see if results translate to patients receiving these devices and whether outcomes can be further improved.
Disclosures:
This study was funded by Boston Scientific Corp., Marlborough, MA, USA. CVPath Institute, Inc., Gaithersburg, MD, USA, provided full support for this work.
Dr. Finn has received consultant fees/honoraria from Abbott Vascular, Boston Scientific, Celonova, Cook Medical, BD, and Medtronic.
Citations:
1. Novel Coating for LAAO Device Combines Anti-Thrombogenic and Pro-Healing Properties
Heart Rhythm 2023 abstract presentation
https://eppro01.ativ.me/src/EventPilot/php/express/web/planner.php?id=HRS23
2. Walid I. Saliba, Kenji Kawai, Yu Sato, Edward Kopesky, Qi Cheng, Saikat Kumar B. Ghosh, Thomas J. Herbst, Rika Kawakami, Takao Konishi, Renu Virmani, Wael A. Jaber, Douglas N. Gibson, Manish Shah, Andrea Natale, Michael Gibson, David R. Holmes, Aloke V. Finn,
Enhanced Thromboresistance and Endothelialization of a Novel Fluoropolymer-Coated Left Atrial Appendage Closure Device,
JACC: Clinical Electrophysiology, 2023,
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