Biodisk: A New Device for Closure of Patent Foramen Ovale: A Feasibility Study in Swine
ABSTRACT To evaluate the feasibility, effectiveness, and safety of a porcine small intestinal submucosa (SIS)-covered Biodisk (BD) for the closure of patent foramen ovale (PFO) in swine.
Twelve piglets (9-30 kg) with PFO ranging in size from 6 to 12 mm were used for the in vivo testing. The BD device consisted of two basic nitinol wire components covered with platinum coil, a flexible SIS-covered ring, and an anchor. The BD was advanced through an 8-Fr sheath from the femoral vein. Nine acute animals were used to test the BD for deployment, stability, immediate shunt closure, and device repositioning before or after its detachment. To assess retrievability, four devices were deployed and intentionally embolized into the RA (n = 2) and LA (n = 2). The effectiveness of the device was evaluated by angiocardiography. EKG was recorded before and after PFO closure for 3 hr. From the 12 animals, nine were acute and three were followed; one for 6 weeks, one for 12 weeks, and one for 16 weeks.
Successful device implantation was achieved in all animals with no shunting of contrast media observed during follow-up in. One animal needed to have device repositioned for complete PFO occlusion because of suboptimal placement at the first attempt. The device was easily placed and retrieved before detachment in all nine animals in the acute study. None of the BDs spontaneously embolized during release or on follow-up. EKG did not demonstrate arrhythmias during or after treatment. Four intentionally embolized BDs were easily retrieved with an Amplatz goose neck snare. Macroscopic and histologic evaluation of the three long-term animals showed that devices were well incorporated in the atrial septum with complete shunt closure. The SIS showed progressive remodeling with the host cells. There was also progressive endothelization of the BD device.
The BD device deployment is feasible, safe, and effective. Long-term studies are needed to evaluate its long-term effectiveness.
- SourceAvailable from: Miran Jeromel
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- "An 8F sheath was used for Biodisk delivery. Initial testing in piglets showed its easy delivery, good retrievability and long-term effectiveness for closure of PFO measured with the 10–14 mm balloons.6 "
ABSTRACT: To 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. TS 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. ASD closure with the Double BioDisk is safe and effective in adult sheep.Radiology and Oncology 06/2012; 46(2):89-96. DOI:10.2478/v10019-012-0029-8 · 1.60 Impact Factor
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- "Awareness of the existence of these anomalies before femoral vein catheter advancement or other procedure through femoral vein would avoid unnecessary injury or undue delay. The recognition of this congenital venous anomaly (CVC/IVC interruption with azygos/hemiazygos continuation) is important for interventional radiologist and cardiologist, especially for conditions such as venous thromboembolism, IVC filter placement, transcatheter closure of the ASD, ventricular septal defect (VSD) patent foramen ovale (PFO) shunt22, or pacing and electrophysiology, cardiopulmonary bypass surgery, and palliative systemic venous-pulmonary artery shunt surgery. "
ABSTRACT: Swine are commonly used as a model to study congenital cardiovascular defects that occur in humans and these models have been both spontaneous and experimentally induced. Ventricular septal defect, patent ductus arteriosus, and atrial septal defect (ASD) are examples of experimentally induced models. Absence of caudal/inferior vena cava (CVC/IVC) with azygos/hemiazygos continuation is an uncommon vascular anomaly. The vascular anomaly presented in this case report was an incidental finding on a pig that was evaluated for experimental percutaneous atrial septal defect creation and its closure using a percutaneous femoral vein approach. Absence of CVC/IVC was confirmed by venography and necropsy. To the best of the investigators knowledge, this is the first report of absence of CVC/IVC with azygos/hemiazygos continuation in the swine.Radiology and Oncology 09/2010; 44(3):149-52. DOI:10.2478/v10019-010-0029-5 · 1.60 Impact Factor
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ABSTRACT: Disclosure: No potential conflicts of interest were disclosed. Background. Swine are commonly used as a model to study congenital cardiovascular defects that occur in hu-mans and these models have been both spontaneous and experimentally induced. Ventricular septal defect, patent ductus arteriosus, and atrial septal defect (ASD) are examples of experimentally induced models. Absence of caudal/ inferior vena cava (CVC/IVC) with azygos/hemiazygos continuation is an uncommon vascular anomaly. Case report. The vascular anomaly presented in this case report was an incidental finding on a pig that was evalu-ated for experimental percutaneous atrial septal defect creation and its closure using a percutaneous femoral vein approach. Absence of CVC/IVC was confirmed by venography and necropsy. Conclusions. To the best of the investigators knowledge, this is the first report of absence of CVC/IVC with azygos/ hemiazygos continuation in the swine.