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Preliminary Experience in the Use of an Extracellular Matrix (CorMatrix) as a Tube Graft: Word of Caution
Narutoshi Hibino, Patrick McConnell, Toshiharu Shinoka, Mahim Malik,
Mark Galantowicz
Department of Cardiothoracic Surgery, Nationwide Children’s Hospital
Columbus, OH
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Disclosure
Patrick McConnellGrant/Research Support- Cormatrix Cardioavascular, Inc; Thoratec CorporationConsultant- Q test Laboratories; Clear Catheter Systems, Inc
Toshiharu ShinokaGrant/Research Support- Gunze, Inc
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• There are no ideal materials for the repair of congenital heart disease
• Decellularized extracellular matrix from porcine small intestinal submucosa (CorMatrix) has been developed and commercialized
Background
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Our Preliminary Experience using CorMatrix as a Tube Graft
Central PA reconstruction N=10
Aortic arch interposition N=3
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The CorMatrix sheet was wrapped around Hegar dilator of the required size and the edge was sutured with 7-0 prolene
Creation of CorMatrix Tube Graft
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Patient Diagnosis
Age at surgery (month)
Diameter of tube (mm) Intervention for tube Results
1 HLHS 9 9 Stent Fontan2 HLHS 6 7 Stent Fontan3 DILV, TGA, IAA 6 9 NA Sudden death4 HLHS 8 9 NA Fontan5 HLHS 6 9 Stent Fontan
6 DILV, TGA, Arch hypoplasia 6 8 Stent Waiting Fontan
7 HLHS 5 8 Stent Sudden death
8 HLHS 8 8Stent, Central PA reconstruction with homograft
Waiting Fontan
9 HLHS 4 8 Balloon Waiting Fontan10 HLHS 5 8 Stent Waiting Fontan
Interposition CorMatrix Tube Graft for Central PA Reconstruction in Comprehensive Stage II Surgery
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Pt 4
Pt 9
OP Follow UP
Patent Graft in Central PA (N=2 of 10)
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Pt 1
Pt 7
OP Follow Up
Stenosed Graft in Central PA (N=8 of 10)
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Graft Occlusion → Angioplasty, Stent →Stent Occlusion
1st Cath
2nd Cath
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Graft Occlusion → Stent Occlusion → Graft Replacement with PA Homograft
Explanted graft
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0
1
2
3
4
5
6
7
8
9
10
Dia
met
er (m
m)
OP
Diameter Change of CorMatrix Tube Graft for Central PA Reconstruction
1st cath 2nd cath 3rd cath
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Patient DiagnosisAge at
surgery SurgeryDiameter of tube (mm) Results
1 IAA,AP window,VSD,ASD 6 day Repair IAA/AP window/VSD/ASD 12
No stenosis/ dilatation
2 IAA,VSD,Dextrocardia,Hypoplastic right lung 16 day Repair IAA/VSD 11
No stenosis/ dilatation
3IAA,VSD,Brain trauma with
depressed skull fracture, s/p PDA stent/bilatereal PAB
5 monthRepair
IAA/VSD/ASD, Removal PDA stent/PA band
11No
stenosis/ dilatation
Interposition CorMatrix Tube Graft for Aortic Arch Repair for Interrupted Aortic Arch
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10
10.5
11
11.5
12
12.5
Dia
met
er (m
m)
Op FU
OP 3 mo 1 year
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While angioplasty using CorMatrix as an interposition tube vascular graft is feasible and safe in aorta, long follow up is required to assess the potential for growth of arterial conduit.
A high rate of occurrence of intimal hyperplasia formation with significant stenosis was found in reconstructed pulmonary arteries supplied by venous circulation. CorMatrix may not be the ideal material as a conduit in venous circulation to provide long-term durable outcomes.
Conclusion
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Presentation Number: 99Title: Preliminary experience in the use of an extracellular matrix (CorMatrix) as a tube graft: Word of cautionSession Name: Wednesday, April 29, 2015Session Room: 612Session Date: Congenital Heart Disease Simultaneous Scientific SessionPresentation Time: 8:45 AM - 8:56 AMPresentation Format: You will have an 5 minute presentation followed by 6 minutes of discussion.Discussant Name: David Morales