Double BioDisk: a new bioprosthetic device for transcatheter closure of atrial septal defects - a feasibility study in adult sheep

Abstract

BackgroundTo evaluate the long-term effectiveness and safety of a new Double BioDisk (DBD) device for closure of atrial septal defect (ASD).Materials and methods.ASD was created with transeptal needle (TS) followed by balloon dilatation in 12 sheep weighing 40.1 to 64 kg (mean 55.2 ± 7.1). The ASD diameters were measured after creation and two weeks later before DBD implantation. The DBDs consists of two nitinol rings 18 to 28 mm in diameter connected with small cannulas and covered with a porcine small intestinal submucosa (SIS). They were implanted via a 10 Fr sheath. DBD effectiveness was evaluated by angiocardiography and by intra-cardiac echogram (ICE) with Doppler studies. Two animals were acute, two were followed for 6 weeks, three for 3 months, three for 6 months and two for 12 months.ResultsTS punctures were successful in 10 sheep. In two sheep ASD was created by existing PFO dilation. The ASD size ranged from 13–15 mm (mean 14.1± 0.73 mm) after initial balloon dilation and from 9–13 mm (mean 10.06 ± 1.37 mm) after two weeks. In all animals none of the successfully implanted DBDs spontaneously embolized on release or on follow up. ICE demonstrated no shunting around the DBDs during follows ups. Macroscopic and histologic evaluation of the 6, 12, 24 and 52 weeks animals showed that DBDs were well incorporated in the atrial septum with complete shunt closure. The SIS showed progressive remodeling with the host cells, including endothelization of the DBD devices.ConclusionsASD closure with the Double BioDisk is safe and effective in adult sheep.

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

“…The BioDisk and Double BioDisk devices consist of nitinol rings and are covered with porcine small intestinal submucosa. After implantation in animal experiments, the small intestinal submucosa showed progressive remodeling with the host cells after 6 weeks [17,18]. However, the frame of these devices is composed of metallic materials and, hence, is nondegradable.…”

“…Some efforts have been made to develop biodegradable occlusion devices for the closure of ASDs, such as the BioSTAR, BioDisk, and Double BioDisk devices [13,14,15,16,17,18]. The BioSTAR device was the first septal defect occluder to use an absorbable matrix as a barrier membrane, which opened a new era of absorbable occluders.…”