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

Pavcnik D, Tekulve K, Uchida BT, Luo ZH, Jeromel M, Van Alstine WG, Keller FS, Rösch J - Radiol Oncol (2012)

Bottom Line: DBD effectiveness was evaluated by angiocardiography and by intra-cardiac echogram (ICE) with Doppler studies.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.

View Article: PubMed Central - PubMed

Affiliation: Dotter Interventional Institute, Oregon Health Sciences University, Portland, Oregon, USA.

ABSTRACT

Background: 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.

Results: 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.

Conclusions: ASD closure with the Double BioDisk is safe and effective in adult sheep.

No MeSH data available.


Related in: MedlinePlus

Gross specimens of the deployed double Biodisks into the adult sheep ASDs.A. Three hours after deployment, thin layers of early thrombus cover right and left atrium disk of the 28 mm device.B. At 3 months, the 18 mm DBD is almost completely incorporated into myocardium. Glistening disk surfaces indicate complete endothelization.C. At 6 months, the DBD is almost completely incorporated into myocardium of the right and left atrium.D. At 12 months, the DBD is completely incorporated into myocardium of the right and left atrium.
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f2-rado-46-02-89: Gross specimens of the deployed double Biodisks into the adult sheep ASDs.A. Three hours after deployment, thin layers of early thrombus cover right and left atrium disk of the 28 mm device.B. At 3 months, the 18 mm DBD is almost completely incorporated into myocardium. Glistening disk surfaces indicate complete endothelization.C. At 6 months, the DBD is almost completely incorporated into myocardium of the right and left atrium.D. At 12 months, the DBD is completely incorporated into myocardium of the right and left atrium.

Mentions: The implanted DBDs in all animals, acute and chronic, were well self-centered and attached to the ASDs with good apposition to the interatrial septum and adjacent myocardium (Figure 2). Both discs were flattened against the intra-atrial septum and held in place by the connection between the DBD. The DBDs did not obstruct blood flow in to coronary sinus or pulmonary veins nor did it compromise mitral or tricuspid valves. In two acute animals euthanized 3 hours after DBD placement both discs were covered by thin red layer of early thrombus (Figure 2A). In two animals euthanized at 6 weeks, the SIS surfaces on both disks were shiny, transparent and without thrombus. Disks were partially incorporated into the myocardium. In three animals sacrificed at 12 weeks, DBD rings were almost completely incorporated into the myocardium wall. The SIS of the left and right atrium disks were well apposed to the myocardium excluding the ASD opening. The SIS was glistering and shiny indicating endothelization (Figure 2B). The SIS was less transparent than that at 6 weeks. At 24 weeks and 52 weeks DBDs were free from adjacent important cardiac structures in all of the specimens. The SIS membranes of the DBDs were positioned with a good apposition across the ASD and fused together with myocardium (Figure 2C). At 12 months, the disks apposition and incorporation into adjacent myocardium was complete, in the right and in the left atrium (Figure 2D). Glistening SIS surfaces were seen in all specimens. The delivery crossbars of the DBDs were covered with shiny tissue and partially fused with device.


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

Pavcnik D, Tekulve K, Uchida BT, Luo ZH, Jeromel M, Van Alstine WG, Keller FS, Rösch J - Radiol Oncol (2012)

Gross specimens of the deployed double Biodisks into the adult sheep ASDs.A. Three hours after deployment, thin layers of early thrombus cover right and left atrium disk of the 28 mm device.B. At 3 months, the 18 mm DBD is almost completely incorporated into myocardium. Glistening disk surfaces indicate complete endothelization.C. At 6 months, the DBD is almost completely incorporated into myocardium of the right and left atrium.D. At 12 months, the DBD is completely incorporated into myocardium of the right and left atrium.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC3472939&req=5

f2-rado-46-02-89: Gross specimens of the deployed double Biodisks into the adult sheep ASDs.A. Three hours after deployment, thin layers of early thrombus cover right and left atrium disk of the 28 mm device.B. At 3 months, the 18 mm DBD is almost completely incorporated into myocardium. Glistening disk surfaces indicate complete endothelization.C. At 6 months, the DBD is almost completely incorporated into myocardium of the right and left atrium.D. At 12 months, the DBD is completely incorporated into myocardium of the right and left atrium.
Mentions: The implanted DBDs in all animals, acute and chronic, were well self-centered and attached to the ASDs with good apposition to the interatrial septum and adjacent myocardium (Figure 2). Both discs were flattened against the intra-atrial septum and held in place by the connection between the DBD. The DBDs did not obstruct blood flow in to coronary sinus or pulmonary veins nor did it compromise mitral or tricuspid valves. In two acute animals euthanized 3 hours after DBD placement both discs were covered by thin red layer of early thrombus (Figure 2A). In two animals euthanized at 6 weeks, the SIS surfaces on both disks were shiny, transparent and without thrombus. Disks were partially incorporated into the myocardium. In three animals sacrificed at 12 weeks, DBD rings were almost completely incorporated into the myocardium wall. The SIS of the left and right atrium disks were well apposed to the myocardium excluding the ASD opening. The SIS was glistering and shiny indicating endothelization (Figure 2B). The SIS was less transparent than that at 6 weeks. At 24 weeks and 52 weeks DBDs were free from adjacent important cardiac structures in all of the specimens. The SIS membranes of the DBDs were positioned with a good apposition across the ASD and fused together with myocardium (Figure 2C). At 12 months, the disks apposition and incorporation into adjacent myocardium was complete, in the right and in the left atrium (Figure 2D). Glistening SIS surfaces were seen in all specimens. The delivery crossbars of the DBDs were covered with shiny tissue and partially fused with device.

Bottom Line: DBD effectiveness was evaluated by angiocardiography and by intra-cardiac echogram (ICE) with Doppler studies.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.

View Article: PubMed Central - PubMed

Affiliation: Dotter Interventional Institute, Oregon Health Sciences University, Portland, Oregon, USA.

ABSTRACT

Background: 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.

Results: 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.

Conclusions: ASD closure with the Double BioDisk is safe and effective in adult sheep.

No MeSH data available.


Related in: MedlinePlus