A Novel-Design Poly-L -Lactic Acid Biodegradable Device for Closure of Atrial Septal Defect: Long-Term Results in Swine
| Autor: | Liu Xiangdong, Jian Zhuang, Deyuan Zhang, Zhi-Wei Zhang, Gui Zhang, Chen Xianmiao, Shu-Shui Wang, Zhao-Feng Xie |
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| Rok vydání: | 2016 |
| Předmět: |
Poly l lactic acid
medicine.medical_specialty Heart septal defect business.industry 0206 medical engineering 02 engineering and technology Septal Occluder Device Long term results 030204 cardiovascular system & hematology medicine.disease 020601 biomedical engineering Atrial septum Surgery 03 medical and health sciences 0302 clinical medicine medicine Prosthesis design Pharmacology (medical) Cardiology and Cardiovascular Medicine business |
| Zdroj: | Cardiology. 135:179-187 |
| ISSN: | 1421-9751 0008-6312 |
| DOI: | 10.1159/000446313 |
| Popis: | Objectives: 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. |
| Databáze: | OpenAIRE |
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