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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

The double BioDisk (DBD) ASD occlusive device 18 mm in diameter.A. Right atrial side with delivery bar.B. Oblique projection.C. Deployment of the left atrial DBD disk.D. Deployment of DBD across ASD with delivery bar still attached to the delivery wire.E. X-ray of DBD at 3 months.F. Intracardiac echocardiogram 6 months after DBD deployment shows device with thickened discs. No shunting was seen.
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f1-rado-46-02-89: The double BioDisk (DBD) ASD occlusive device 18 mm in diameter.A. Right atrial side with delivery bar.B. Oblique projection.C. Deployment of the left atrial DBD disk.D. Deployment of DBD across ASD with delivery bar still attached to the delivery wire.E. X-ray of DBD at 3 months.F. Intracardiac echocardiogram 6 months after DBD deployment shows device with thickened discs. No shunting was seen.

Mentions: The DBD were constructed as a joint effort between Cook Medical and the Dotter Institute specifications. The DBD consisted of two nitinol rings covered with platinum coil. Both flexible rings were connected with small cannulas and covered with SIS. The cross bar of the right atrial disk was the delivery bar. SIS was sutured with Prolene 6.0 to the radio-opaque rings (Figure 1AB). The DBD was lyophilized and then preloaded by the manufacturer into a 10 Fr cartridge. The delivery system was similar to the system used in the jugular Tulip filter delivery system (Cook Medical). The DBD is self-expanding and self-centering device. The DBD sizes for this study were 18 mm, 23 mm and 28 mm in diameter. Device to defect ratio of 1.8 or larger was used.


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)

The double BioDisk (DBD) ASD occlusive device 18 mm in diameter.A. Right atrial side with delivery bar.B. Oblique projection.C. Deployment of the left atrial DBD disk.D. Deployment of DBD across ASD with delivery bar still attached to the delivery wire.E. X-ray of DBD at 3 months.F. Intracardiac echocardiogram 6 months after DBD deployment shows device with thickened discs. No shunting was seen.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

f1-rado-46-02-89: The double BioDisk (DBD) ASD occlusive device 18 mm in diameter.A. Right atrial side with delivery bar.B. Oblique projection.C. Deployment of the left atrial DBD disk.D. Deployment of DBD across ASD with delivery bar still attached to the delivery wire.E. X-ray of DBD at 3 months.F. Intracardiac echocardiogram 6 months after DBD deployment shows device with thickened discs. No shunting was seen.
Mentions: The DBD were constructed as a joint effort between Cook Medical and the Dotter Institute specifications. The DBD consisted of two nitinol rings covered with platinum coil. Both flexible rings were connected with small cannulas and covered with SIS. The cross bar of the right atrial disk was the delivery bar. SIS was sutured with Prolene 6.0 to the radio-opaque rings (Figure 1AB). The DBD was lyophilized and then preloaded by the manufacturer into a 10 Fr cartridge. The delivery system was similar to the system used in the jugular Tulip filter delivery system (Cook Medical). The DBD is self-expanding and self-centering device. The DBD sizes for this study were 18 mm, 23 mm and 28 mm in diameter. Device to defect ratio of 1.8 or larger was used.

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