title: A Novel-Design Poly-L-Lactic Acid Biodegradable Device for Closure of Atrial Septal Defect: Long-Term Results in Swine.
abstract: OBJECTIVE
  The aim of this study is to evaluate the long-term effectiveness and safety of a self-expandable, double-disk biodegradable device made of poly-L-lactic acid (PLLA) for closure of atrial septal defects (ASDs) in swine.
  
  
  METHODS
  ASDs were created by transseptal needle puncture followed by balloon dilatation in 20 piglets. The experimental group comprised 18 animals, while the remaining 2 animals were used as controls. Effectiveness and safety were evaluated by rectal temperature, leukocyte count, chest radiography, electrocardiogram, transthoracic echocardiography (TTE), intracardiac echocardiography (ICE), and histologic studies. Animals were followed up at 1, 3, 6, and 12 months.
  
  
  RESULTS
  An ASD model was successfully created in 19 animals; 1 piglet died during the procedure. The ASD diameters that were created ranged from 5 to 6.4 mm. Devices were successfully implanted in 17 animals. No animal died during the follow-up studies. Rectal temperatures and electrocardiograms were normal at follow-up, while leukocyte counts transiently increased from 1 to 6 months. Radiography, TTE, ICE, and macroscopic studies demonstrated that PLLA occluders were positioned well, with no shifting, mural thrombus formation, or atrioventricular valve insufficiency. Histologic evaluations showed that PLLA devices were partially degraded in the follow-up study.
  
  
  CONCLUSIONS
  ASD closure with the novel PLLA biodegradable device is safe and effective. Longer-term studies are needed to evaluate long-term biodegradability.
authors.affiliation: Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Key Laboratory of South China Structural Heart Disease, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
authors.forename: Zhao-Feng
authors.initials: ZF
authors.lastname: Xie
authors.forename: Shu-Shui
authors.initials: SS
authors.lastname: Wang
authors.forename: Zhi-Wei
authors.initials: ZW
authors.lastname: Zhang
authors.forename: Jian
authors.initials: J
authors.lastname: Zhuang
authors.forename: Xiang-Dong
authors.initials: XD
authors.lastname: Liu
authors.forename: Xian-Miao
authors.initials: XM
authors.lastname: Chen
authors.forename: Gui
authors.initials: G
authors.lastname: Zhang
authors.forename: Deyuan
authors.initials: D
authors.lastname: Zhang
mesh_terms: D020341:Absorbable Implants; D000818:Animals; D054087:Atrial Septum / Q000166:cytology / Q000000981:diagnostic imaging / Q000648:ultrastructure; D004452:Echocardiography; D006344:Heart Septal Defects, Atrial / Q000000981:diagnostic imaging / Q000628:therapy*; D007958:Leukocyte Count; D008297:Male; D008855:Microscopy, Electron, Scanning; D011091:Polyesters; D011474:Prosthesis Design; D011859:Radiography; D055989:Septal Occluder Device; D013552:Swine
chemical_list: D011091:Polyesters; C033616:poly(lactide)