title: Percutaneous left atrial appendage closure with a novel self-modelizing device: a pre-clinical feasibility study.
abstract: The aim of the study is to evaluate the feasibility and safety of a new left atrial appendage (LAA) occluder. Twelve pigs were included. In 2 pigs the implantation process failed due to pericardial tamponade in 1 pig and device embolization in the other pig. The placement of the devices was controlled via TEE and fluoroscopy. After 6 weeks of implantation the hearts were explanted. The devices were found to be easy to deploy and showed a very good adaptation to the LAA tissue. Eight out of 10 pigs had full closure of the LAA directly after implantation. After six weeks, due to the self-modelizing properties of the device, all pigs had a full closure of the LAA. The macroscopic evaluation of the explanted hearts showed that all devices were securely integrated in LAA tissues. There was one case of mild pericarditis but no macroscopic signs of inflammation on the device surrounding endocardium. The explantation revealed that device loops had penetrated the LAA tissue in three pigs. However, no signs of bleeding, pericardial effusion, or other damage to the LAA wall could be detected and the pigs were in good condition with normal weight gain and no clinical symptoms. The Occlutech® LAA occluder achieved complete closure of the LAA in all pigs, and remained in the LAA, with benign healing and no evidence of new thrombus or damage to surrounding structures. Moreover, the uncompromised survival of all implanted pigs demonstrates the feasibility and safety of the device.
authors.affiliation: Department of Cardiology, Angiology, and Pneumology, Coburg Hospital, 96450 Coburg, Germany. Electronic address: jai-wun.park@klinikum-coburg.de.
authors.forename: Jai-Wun
authors.initials: JW
authors.lastname: Park
authors.affiliation: Department of Cardiology, Angiology, and Pneumology, Coburg Hospital, 96450 Coburg, Germany.
authors.forename: Mohammad A
authors.initials: MA
authors.lastname: Sherif
authors.affiliation: Department of Cardiology, Angiology, and Pneumology, Coburg Hospital, 96450 Coburg, Germany.
authors.forename: Konstantin
authors.initials: K
authors.lastname: Zintl
authors.affiliation: Cardiology Department, Chinese University of Hong Kong, China.
authors.forename: Yat-Yin
authors.initials: YY
authors.lastname: Lam
authors.affiliation: Department of Cardiology, Angiology, and Pneumology, Coburg Hospital, 96450 Coburg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Goedde
authors.affiliation: Institute for Biological Interfaces, Karlsruhe Institute of Technology (KIT), Karlsruhe, Germany.
authors.forename: Tim
authors.initials: T
authors.lastname: Scharnweber
authors.affiliation: Institute of Biomaterial Science, Berlin-Brandenburg Centre for Regenerative Therapies, Helmholtz-Zentrum Geesthacht, Teltow, Germany.
authors.forename: Friedrich
authors.initials: F
authors.lastname: Jung
authors.affiliation: University of Ulm, Department of Biomaterials, Ulm, Germany.
authors.forename: Ralf Peter
authors.initials: RP
authors.lastname: Franke
authors.affiliation: Department of Cardiology, Angiology, and Pneumology, Coburg Hospital, 96450 Coburg, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Brachmann
mesh_terms: D000818:Animals; D020517:Atrial Appendage / Q000000981:diagnostic imaging* / Q000601:surgery*; D006328:Cardiac Catheterization / Q000379:methods*; D017548:Echocardiography, Transesophageal / Q000379:methods; D005240:Feasibility Studies; D006325:Heart Atria / Q000000981:diagnostic imaging / Q000601:surgery; D055989:Septal Occluder Device; D013552:Swine
keywords: Animal study; LAA occluder; Left atrial appendage