RESUMEN
Background: The Conformal Left Atrial Appendage System (CLAAS) is a transcatheter implant designed to occlude the left atrial appendage to prevent stroke in patients with nonvalvular atrial fibrillation. The implant incorporates a novel polyurethane polycarbonate-urea foam matrix to enhance device performance. The objective of this study was to characterize the thrombogenicity, sealing, implant integrity, local tissue response, and systemic toxicity of the implant in a healthy canine model. Methods: Devices were evaluated in a chronic canine model using echocardiographic and fluoroscopic guidance (n = 8). Postprocedural echocardiographic evaluation was performed at case completion and at 2, 45, 90, and 150 days. Animals were sacrificed at 90 (n = 4) and 150 (n = 4) days. Necropsy included gross, x-ray, and histologic examination. Results: CLAAS implants were implanted in all animals successfully on the basis of fluoroscopic, intracardiac echo, and transthoracic echo criteria. Although 2 animals were noted to have leaks (1 at implantation and 1 at day 90 post procedure before sacrifice), both were of <5 mm. All left atrial appendages were completely sealed on gross examination. No device-related thrombus, pericardial effusion, or evidence of distal organ emboli was observed. All implants maintained their structural integrity and were well integrated within the tissue. There was no histologic evidence of toxicity noted in the downstream organs or tissues. Conclusions: The CLAAS implant can be deployed providing a good seal for up to 150 days without signs of local or systemic toxicity in a canine model.