Does a fluoropolymer-coated WATCHMAN FLX device reduce thrombogenicity and improve endothelialization compared to an uncoated device in preclinical models?
A novel fluoropolymer-coated LAAC device demonstrated reduced thrombogenicity and improved endothelialization in preclinical models compared to the conventional uncoated device.
BACKGROUND: Device-related thrombus (DRT) after left atrial appendage closure (LAAC) procedures is a rare but potentially serious event. Thrombogenicity and delayed endothelialization play a role in the development of DRT. Fluorinated polymers are known to have thromboresistant properties that may favorably modulate the healing response to an LAAC device. OBJECTIVES: The goal of this study was to compare the thrombogenicity and endothelial coverage (EC) after LAAC between the conventional uncoated WATCHMAN FLX (WM) and a novel fluoropolymer-coated WATCHMAN FLX (FP-WM). METHODS: Canines were randomized for implantation with WM or FP-WM devices and given no postimplant antithrombotic/antiplatelet agents. The presence of DRT was monitored by using transesophageal echocardiography and verified histologically. The biochemical mechanisms associated with coating were assessed by using flow loop experiments to quantify albumin adsorption, platelet adhesion, and porcine implants to quantify EC and the expression of markers of endothelial maturation (ie, vascular endothelial-cadherin/p120-catenin). RESULTS: ; P = 0.03) and significantly less platelet adhesion (44.7% IQR: 27.2%-60.2% vs 60.9% IQR: 39.9%-70.1%; P < 0.01) on FP-WM. Porcine implants showed significantly greater EC by scanning electron microscopy (87.7% IQR: 83.4%-92.3% vs 68.2% IQR: 47.6%-72.8%; P = 0.03), and higher vascular endothelial-cadherin/p120-catenin expression after 3 months on FP-WM compared with WM. CONCLUSIONS: The FP-WM device showed significantly less thrombus and reduced inflammation in a challenging canine model. Mechanistic studies indicated that the fluoropolymer-coated device binds more albumin, leading to reduced platelet binding, less inflammation, and greater EC.
Saliba et al. (2023) studied this question.