title: Preclinical assessment of a modified Occlutech left atrial appendage closure device in a canine model.
abstract: BACKGROUND
  LAA occlusion has a similar stroke prevention efficacy compared to anticoagulation treatment for non-valvular atrial fibrillation.
  
  
  OBJECTIVE
  The objective of this study was to assess the feasibility and safety of a modified Occlutech® left atrial appendage (LAA) closure device in a canine model.
  
  
  METHODS
  The device was implanted in 10 dogs (33±1kg) using fluoroscopy and transesophageal echocardiography (TEE) guidance. The modified Occlutech® LAA occlusion device was compared with the current version, the Watchman device, and the Amplazter cardiac plug (ACP). LAA occlusion and anchoring to the LAA were evaluated. All dogs were assessed using angiography, TEE, and a gross anatomy examination.
  
  
  RESULTS
  The 10 LAA occlusion devices were to be implanted into 10 dogs (5 modified Occlutech devices, 3 current version of Occlutech devices, 1 Watchman, and 1 ACP). LAA implantation was not performed in one dog due to transeptal puncture failure. The three current version of Occlutech devices were embolized immediately after implantation, so three modified devices of the same size were implanted securely without embolization. The mean implant size was 20.1±2.0mm. The devices chosen were a mean of 23.3±10.6% larger than the measured landing zone diameters. Post-implant angiography and TEE revealed well-positioned devices without pericardial effusion or impingement on surrounding structures.
  
  
  CONCLUSIONS
  The results of this acute animal study suggested that a modified Occlutech® LAA occlusion device was feasible and had greater anchoring performance in canines. Additional large clinical studies are needed to evaluate safety and efficacy.
authors.affiliation: Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea; Cardiovascular Product Evaluation Center.
authors.forename: Jung-Sun
authors.initials: JS
authors.lastname: Kim
authors.affiliation: Graduate Program in Science for Aging, Yonsei University, Seoul, Republic of Korea.
authors.forename: Seul-Gee
authors.initials: SG
authors.lastname: Lee
authors.affiliation: Graduate Program in Science for Aging, Yonsei University, Seoul, Republic of Korea.
authors.forename: Sung-Kyung
authors.initials: SK
authors.lastname: Bong
authors.affiliation: Cardiovascular Product Evaluation Center.
authors.forename: Se-Il
authors.initials: SI
authors.lastname: Park
authors.affiliation: Cardiovascular Product Evaluation Center.
authors.forename: Sung-Yu
authors.initials: SY
authors.lastname: Hong
authors.affiliation: Division of Cardiology, Department of Internal Medicine, NHIS Ilsan Hospital, Goyang, Republic of Korea.
authors.forename: Sanghoon
authors.initials: S
authors.lastname: Shin
authors.affiliation: Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Chi Young
authors.initials: CY
authors.lastname: Shim
authors.affiliation: Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Geu-Ru
authors.initials: GR
authors.lastname: Hong
authors.affiliation: Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea; Cardiovascular Product Evaluation Center.
authors.forename: Donghoon
authors.initials: D
authors.lastname: Choi
authors.affiliation: Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea; Cardiovascular Product Evaluation Center. Electronic address: jangys1212@yuhs.ac.
authors.forename: Yangsoo
authors.initials: Y
authors.lastname: Jang
authors.affiliation: Department of Cardiology, Angiology, and Pneumology, Coburg Hospital, 96450 Coburg, Germany; Department of Cardiology, Charite Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany. Electronic address: jai-wun.park@charite.de.
authors.forename: Jai-Wun
authors.initials: JW
authors.lastname: Park
mesh_terms: D000818:Animals; D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000601:surgery*; D004195:Disease Models, Animal; D004285:Dogs; D019919:Prosthesis Implantation / Q000295:instrumentation / Q000379:methods; D055989:Septal Occluder Device; D020521:Stroke / Q000517:prevention & control*
keywords: Canine model; Device study; Left atrial appendage