Study of biodegradable occluder of atrial septal defect in a porcine model

Li, Bo‐Ning; Xie, Yumei; Xie, Zhaofeng; Chen, Xianmiao; Gui, Zhilun; Zhang, Deyuan; Liu, Xiangdong; Zhang, Zhiwei

doi:10.1002/ccd.27852

Cited by 15 publications

(21 citation statements)

References 34 publications

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“…Complete endothelialization and disk absorption were observed at 12 months and there was a distinct decrease in the molecular weight of the framework (to 9% of the initial) at 24 months after implantation. Our previous studies showed that endothelialization started at 1 month after PLLA device implantation and was completed at 3 months in a swine model . Furthermore, the results of the present study demonstrated almost complete degradation of the PLLA device by 36 months with very few inflammatory responses.…”

Section: Discussionsupporting

confidence: 73%

“…Our clinical study showed that one of the five patients (patient no. 1), with a 17‐mm ASD and was implanted with a 24‐mm PLLA device, exhibited a persistent mild residual shunt during follow‐up, while our previous preclinical study results showed that no residual shunt was detected in the experimental group at 1, 3, 6, and 12‐month follow‐up . The difference between these results may due in part to the different natures of the defects.…”

Section: Discussionmentioning

confidence: 79%

“…The macroscopic studies at the same time showed that the PLLA devices were still in a stable formation with no loss of integrity at the atrial septum. Details of the follow‐up results are reported in our previous studies …”

Section: Resultsmentioning

confidence: 99%

“…By controlling the locking system, the device can be in the “unlocked” or “locked” state (Figures and ). The details of the device structure are described in our previous preclinical study . The device is available in various sizes ranging from 6 to 32 mm at 2‐mm increments.…”

Section: Methodsmentioning

confidence: 99%

“…The 12‐month outcomes of our previous preclinical studies demonstrated that the implanted PLLA biodegradable device achieved good endothelialization and degradability in short and moderate term follow‐ups in a swine model of ASD …”

Section: Introductionmentioning

confidence: 96%

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Initial experiences with a novel biodegradable device for percutaneous closure of atrial septal defects: From preclinical study to first‐in‐human experience

Xie

et al. 2019

Cathet Cardio Intervent

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Objective: To evaluate the feasibility, safety, and effectiveness of a novel, absorbable atrial septal defect (ASD) closure device made of poly-L-lactic acid (PLLA) in a swine model of ASD and for the first time in humans.Methods: A preclinical safety study was conducted using a swine model of ASD. In a clinical setting, five pediatric patients underwent ASD closure with the PLLA device with fluoroscopic and transthoracic echocardiography guidance. The procedural results and clinical outcomes at 1 day, 30 days, 3 months, and 6 months after closure were analyzed. Results:The 24-and 36-month follow-up results of the preclinical study demonstrated that the PLLA device exhibited good endothelialization and degradability in the swine model. In the clinical study, successful device implantation was achieved in all five patients (median age, 3.6 years; range, 3.1-6.5 years). The mean defect size was (13.6 ± 2.7) mm. Follow-up at 30 days, 3 months, and 6 months was completed in all five cases. The complete defect closure rates with no residual shunt at 30 days, 3 months, and 6 months follow-up were 60% (3/5), 80% (4/5), and 80% (4/5), respectively. No device dislodgement, significant aortic valve or mitral valve regurgitation, new onset cardiac arrhythmia, or other adverse events were reported. Conclusion:The study results demonstrated that it is feasible to implant the PLLA device for closure of small to medium sized ASDs without significant residual shunts or severe adverse events in humans. The PLLA device exhibited good endothelialization and degradability in the swine model at 24 and 36 months. Further studies to evaluate long-term safety and effectiveness with the device in a large cohort of patients are warranted. K E Y W O R D Sabsorbable implants, catheterization closure, congenital heart defect, device

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Section: Discussionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 79%

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 96%

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Initial experiences with a novel biodegradable device for percutaneous closure of atrial septal defects: From preclinical study to first‐in‐human experience

Xie

et al. 2019

Cathet Cardio Intervent

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Development of Innovative Biomaterials and Devices for the Treatment of Cardiovascular Diseases

Wang

Yang

et al. 2022

Advanced Materials

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Cardiovascular diseases have become the leading cause of death worldwide. The increasing burden of cardiovascular diseases has become a major public health problem and how to carry out efficient and reliable treatment of cardiovascular diseases has become an urgent global problem to be solved. Recently, implantable biomaterials and devices, especially minimally invasive interventional ones, such as vascular stents, artificial heart valves, bioprosthetic cardiac occluders, artificial graft cardiac patches, atrial shunts, and injectable hydrogels against heart failure, have become the most effective means in the treatment of cardiovascular diseases. Herein, an overview of the challenges and research frontier of innovative biomaterials and devices for the treatment of cardiovascular diseases is provided, and their future development directions are discussed.

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Progress of biodegradable polymer application in cardiac occluders

Xu,

Fa,

Yang

et al. 2023

J Biomed Mater Res

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Cardiac septal defect is the most prevalent congenital heart disease and is typically treated with open‐heart surgery under cardiopulmonary bypass. Since the 1990s, with the advancement of interventional techniques and minimally invasive transthoracic closure techniques, cardiac occluder implantation represented by the Amplazter products has been the preferred treatment option. Currently, most occlusion devices used in clinical settings are primarily composed of Nitinol as the skeleton. Nevertheless, long‐term follow‐up studies have revealed various complications related to metal skeletons, including hemolysis, thrombus, metal allergy, cardiac erosion, and even severe atrioventricular block. Thus, occlusion devices made of biodegradable materials have become the focus of research. Over the past two decades, several bioabsorbable cardiac occluders for ventricular septal defect and atrial septal defect have been designed and trialed on animals or humans. This review summarizes the research progress of bioabsorbable cardiac occluders, the advantages and disadvantages of different biodegradable polymers used to fabricate occluders, and discusses future research directions concerning the structures and materials of bioabsorbable cardiac occluders.

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Study of biodegradable occluder of atrial septal defect in a porcine model

Cited by 15 publications

References 34 publications

Initial experiences with a novel biodegradable device for percutaneous closure of atrial septal defects: From preclinical study to first‐in‐human experience

Initial experiences with a novel biodegradable device for percutaneous closure of atrial septal defects: From preclinical study to first‐in‐human experience

Development of Innovative Biomaterials and Devices for the Treatment of Cardiovascular Diseases

Progress of biodegradable polymer application in cardiac occluders

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