Animal Experimental Study of the Fully Biodegradable Atrial Septal Defect (ASD) Occluder

Abstract

This study was conducted to evaluate the feasibility, safety, biocompatibility, and degradation features of a fully biodegradable occluder for closure of atrial septal defect (ASD) in an acute canine model. The ASD was created in 20 healthy mongrel dogs by the brockenbrough needle, and the fully biodegradable occluders were implanted by self-made delivery system. The success rate and complications were observed. Acute ASD models were successfully created in 18 dogs, and 16 occluders were successfully implanted in the ASD models. Animals were sacrificed at different times after procedure. The cardiac gross anatomy showed that all occluders were stable in the interatrial septum, no vegetation or thrombus formation was observed on the surface of all occluders. They were embedded into endogenous host tissue gradually at 12-week follow-up. Different periods of pathological observations suggested that the occluders degraded gradually over about 24 weeks and essentially became an integral part of the septum. Transcatheter closure of ASD in acute canine model using the fully biodegradable ASD occluder has the potential of a high successful rate of technique, excellent biocompatibility, and fewer complications with adequate, immediate, and short-term results.

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

“…So far, some biodegradable ASD occlusion devices have been developed such as partially biodegradable devices including BioSTAR, Biodisk, and Double Biodisc devices, which have been discarded, and fully biodegradable devices including the Chinese Lantern (CL), the DU, PLGA/collagen membrane, and the polydioxanone (PDO), which are in progress . The “Chinese Lantern” device made of fully biodegradable polymers (copolymer of caprolactone and lactate) consists of a soft portion and a structural skeleton .…”

“…Finally, some patients would prefer not to remaining a foreign body in their heart indefinitely. To address these issues, researchers and clinicians have envisioned a biodegradable septal occluder device …”

“…To address these issues, researchers and clinicians have envisioned a biodegradable septal occluder device. [9][10][11][12][13][14][15][16] We presented the outcomes of an animal experiment in swine with our poly(L-lactic acid) (PLLA) biodegradable ASD devices in 2016. 17 Although the outcomes showed the basic feasibility of the PLLA device, the device was difficult to prepare and fold into a sheath.…”

A Novel-Design Poly-<smlcap>L</smlcap>-Lactic Acid Biodegradable Device for Closure of Atrial Septal Defect: Long-Term Results in Swine

“…Zhu et al [19] developed a biodegradable ASD occluder consisting of a PDO frame in 2010. Animal experiments confirmed its effectiveness and biological compatibility.…”

Recent development of transcatheter closure of atrial septal defect and patent foramen ovale with occluders

“…The left disc has a 15 mm diameter flat disk‐shaped structure whose edge slightly leans to close to the right interatrial, the right drive for the disc having a diameter of 10 mm. Both discs are filled with a polylactide non‐woven fabric to prevent blood flow …”