Assessment of degradability and endothelialization of modified poly L-lactic acid (PLLA) atrial septal defect (ASD) occluders over time in vivo

To evaluate the fiber-degradation and endothelialization of a modified poly L-lactic acid (PLLA) atrial septal defect (ASD) occluder for a long time in vivo.

A total of 57 New Zealand rabbits were selected to establish the vasculature implantation model, which would be used to characterize the mechanical properties and pathological reaction of PLLA filaments (a raw polymer of ASD occluder). In total, 27 Experimental piglets were used to create the ASD model for the catheter implantation of PLLA ASD occluders. Then, X-ray imaging, transthoracic echocardiography, histopathology, and scanning electron microscope (SEM) were performed in the experimental animals at 3, 6, 12, and 24 months after implantation.

In the rabbit models, the fibrocystic grade was 0 and the inflammatory response was grade 2 at 6 months after vasculature implantation of the PLLA filaments. The mass loss of PLLA filaments increased appreciably with the increasing duration of implantation, but their mechanical strength was decreased without broken. In the porcine models, the cardiac gross anatomy showed that all PLLA ASD occluders were stable in the interatrial septum without any vegetation or thrombus formation. At 24 months, the occluders had been embedded into endogenous host tissue nearly. Pathological observations suggested that the occluders degraded gradually without complications at different periods. SEM showed that the occluders were endothelialized completely and essentially became an integral part of the body over time.

In the animal model, the modified PLLA ASD occluders exhibited good degradability and endothelialization in this long-term follow-up study.