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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

Histologic cross sections of the deployed double BioDisks into the adult sheep ASDs.A. At 3 months, the right atrial disk of the 18 mm device is apposed and the left atrial disk is incorporated into myocardium. The crossbar is incorporated into the right disk. The disk thickness ranges between 0.1 to 0.25 mm at the right atrial disk and between 1 to 2 mm at the left atrial disk. (Low magnification Hand E)B. At 3 months the center of the left disc is partially remodeled into neointima/connective tissue and contains no inflammatory cells. Remnant SIS is visible in the core of the leaflet. (H and E stain, 40x)C. At 6 months, the 18 mm disks are completely imbedded into myocardium and the distance between them ranges from 2 to 3 mm. The crossbar is incorporated into the right disk. Right atrial disk thickness ranges from 0.4 to 0.8 mm and left atrial disk thickness from 1.5 to 3 mm. (Low magnification Hand E)D. At 6 months the center of the right atrial disk is remodeled into mature neointima/connective tissue and contains no inflammatory cells. Remnant SIS is not visible. All luminal surfaces are lined by endothelium (H and E stain, 40x).
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f3-rado-46-02-89: Histologic cross sections of the deployed double BioDisks into the adult sheep ASDs.A. At 3 months, the right atrial disk of the 18 mm device is apposed and the left atrial disk is incorporated into myocardium. The crossbar is incorporated into the right disk. The disk thickness ranges between 0.1 to 0.25 mm at the right atrial disk and between 1 to 2 mm at the left atrial disk. (Low magnification Hand E)B. At 3 months the center of the left disc is partially remodeled into neointima/connective tissue and contains no inflammatory cells. Remnant SIS is visible in the core of the leaflet. (H and E stain, 40x)C. At 6 months, the 18 mm disks are completely imbedded into myocardium and the distance between them ranges from 2 to 3 mm. The crossbar is incorporated into the right disk. Right atrial disk thickness ranges from 0.4 to 0.8 mm and left atrial disk thickness from 1.5 to 3 mm. (Low magnification Hand E)D. At 6 months the center of the right atrial disk is remodeled into mature neointima/connective tissue and contains no inflammatory cells. Remnant SIS is not visible. All luminal surfaces are lined by endothelium (H and E stain, 40x).

Mentions: Histological sections through the center of the DBDs exhibited well covered ASDs by the device disks. At follow up, there was progressive device apposition and incorporation of disks with adjacent myocardium, progressive SIS remodeling into neointima-connective tissue and progressive SIS endothelization. At six weeks follow up, almost 85% of the rings on the right and 50% on the left atrial side were incorporated into the myocardium and surrounded by fibrous tissue less than 200 microns thick. The residual ring parts not embedded in the myocardium were surrounded by fibrous connective tissue and lined by endothelium. The SIS thickness ranged from 0.1 mm in the center to 2.5 mm near the rings and was covered by spindle shaped cells forming a neointima. Flat endothelium covered most of the SIS. The crossbars were surrounded by fibrous tissue. Only minimal inflammatory changes with a few lymphocytes were seen. At 3 months, approximately 95% of the rings on the right side and 60% on the left side were embedded into adjacent myocardium and surrounded by fibrous tissue less than 0.1 mm thick. The SIS showed progressive remodeling into fibrous connective tissue. The SIS disks were 0.1–0.5 mm thick at their centers and 1.5–3 mm at their periphery. The right disk was thinner than the left disk (Figure 3AB). All discs surfaces were covered by mature endothelium. Crossbars were surrounded by neointima and incorporated into disks. At 6 months, the disks apposition and incorporation into adjacent myocardium was almost complete, 96% in the right atrium and 85% in the left atrium (Figure 3C). The ring wires not embedded into the myocardium were surrounded by neointima lined by endothelium. The SIS discs were composed of mature neointima consisting of fibrous connective tissue. SIS collagen fibers were not observed indicating complete remodeling (Figure 3D). The disks were 0.4–0.9 mm thick at the center and 1.5–3mm at the periphery. The crossbars were incorporated into the disk (Figure 3C). All lumen surfaces of the discs and crossbars were covered by flat mature endothelium.


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)

Histologic cross sections of the deployed double BioDisks into the adult sheep ASDs.A. At 3 months, the right atrial disk of the 18 mm device is apposed and the left atrial disk is incorporated into myocardium. The crossbar is incorporated into the right disk. The disk thickness ranges between 0.1 to 0.25 mm at the right atrial disk and between 1 to 2 mm at the left atrial disk. (Low magnification Hand E)B. At 3 months the center of the left disc is partially remodeled into neointima/connective tissue and contains no inflammatory cells. Remnant SIS is visible in the core of the leaflet. (H and E stain, 40x)C. At 6 months, the 18 mm disks are completely imbedded into myocardium and the distance between them ranges from 2 to 3 mm. The crossbar is incorporated into the right disk. Right atrial disk thickness ranges from 0.4 to 0.8 mm and left atrial disk thickness from 1.5 to 3 mm. (Low magnification Hand E)D. At 6 months the center of the right atrial disk is remodeled into mature neointima/connective tissue and contains no inflammatory cells. Remnant SIS is not visible. All luminal surfaces are lined by endothelium (H and E stain, 40x).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

f3-rado-46-02-89: Histologic cross sections of the deployed double BioDisks into the adult sheep ASDs.A. At 3 months, the right atrial disk of the 18 mm device is apposed and the left atrial disk is incorporated into myocardium. The crossbar is incorporated into the right disk. The disk thickness ranges between 0.1 to 0.25 mm at the right atrial disk and between 1 to 2 mm at the left atrial disk. (Low magnification Hand E)B. At 3 months the center of the left disc is partially remodeled into neointima/connective tissue and contains no inflammatory cells. Remnant SIS is visible in the core of the leaflet. (H and E stain, 40x)C. At 6 months, the 18 mm disks are completely imbedded into myocardium and the distance between them ranges from 2 to 3 mm. The crossbar is incorporated into the right disk. Right atrial disk thickness ranges from 0.4 to 0.8 mm and left atrial disk thickness from 1.5 to 3 mm. (Low magnification Hand E)D. At 6 months the center of the right atrial disk is remodeled into mature neointima/connective tissue and contains no inflammatory cells. Remnant SIS is not visible. All luminal surfaces are lined by endothelium (H and E stain, 40x).
Mentions: Histological sections through the center of the DBDs exhibited well covered ASDs by the device disks. At follow up, there was progressive device apposition and incorporation of disks with adjacent myocardium, progressive SIS remodeling into neointima-connective tissue and progressive SIS endothelization. At six weeks follow up, almost 85% of the rings on the right and 50% on the left atrial side were incorporated into the myocardium and surrounded by fibrous tissue less than 200 microns thick. The residual ring parts not embedded in the myocardium were surrounded by fibrous connective tissue and lined by endothelium. The SIS thickness ranged from 0.1 mm in the center to 2.5 mm near the rings and was covered by spindle shaped cells forming a neointima. Flat endothelium covered most of the SIS. The crossbars were surrounded by fibrous tissue. Only minimal inflammatory changes with a few lymphocytes were seen. At 3 months, approximately 95% of the rings on the right side and 60% on the left side were embedded into adjacent myocardium and surrounded by fibrous tissue less than 0.1 mm thick. The SIS showed progressive remodeling into fibrous connective tissue. The SIS disks were 0.1–0.5 mm thick at their centers and 1.5–3 mm at their periphery. The right disk was thinner than the left disk (Figure 3AB). All discs surfaces were covered by mature endothelium. Crossbars were surrounded by neointima and incorporated into disks. At 6 months, the disks apposition and incorporation into adjacent myocardium was almost complete, 96% in the right atrium and 85% in the left atrium (Figure 3C). The ring wires not embedded into the myocardium were surrounded by neointima lined by endothelium. The SIS discs were composed of mature neointima consisting of fibrous connective tissue. SIS collagen fibers were not observed indicating complete remodeling (Figure 3D). The disks were 0.4–0.9 mm thick at the center and 1.5–3mm at the periphery. The crossbars were incorporated into the disk (Figure 3C). All lumen surfaces of the discs and crossbars were covered by flat mature endothelium.

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