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SynerGraft Technology and Usage of Allograft Patches.

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Presentation on theme: "SynerGraft Technology and Usage of Allograft Patches."— Presentation transcript:

1 SynerGraft Technology and Usage of Allograft Patches

2 Standard-Processed Cryopreserved Human Heart Valves: Lessons Learned Heart valve of choice for pediatrics, women of child-bearing age, active adults, and endocarditis Reported clinical results demonstrate good durability and hemodynamic performance 1,2 Standard processed allografts have been shown to stimulate an immune response 3,4 Durability may subsequently be affected by the host immune response 3,4 Allosensitized patients requiring subsequent organ transplant may be more difficult to match 5 1 Brown et al., J Heart Valve Dis, 2006 2 Oswalt et al., Ann Thorac Surg, 2001 3 Smith et al., Ann Thorac Surg, 1998 4 Rajani et al., J Thorac Cardiovasc Surg, 1998 5 Hawkins et al., J Thorac Cardiovasc Surg, 2000

3 SynerGraft ® Technology: Development Rationale Create a foundation for the next generation of biological tissues Reduce allogeneic donor cells and cell remnants associated with standard processing techniques Maintain structural integrity of the biological matrix vital to long-term durability and function of the valve

4 Donor Heart Heart Dissection Procedure Antibiotic Treatment Hypotonic Lysis, Nuclease Digestion, Sequential Washing Cryopreservation and Storage Recipient Decellularization Steps The SynerGraft ® Process

5 SynerGraft vs. Standard Process Histological Comparison Standard-Processed Pulmonary Valve SynerGraft-Processed Pulmonary Valve Leaflet MyocardiumConduit Myocardium

6 Pediatric Reconstruction with Allograft Patches

7 Congenital Heart Defects Biostatistical Facts Effects 8 out of every 1,000 babies born 32,000 babies born each year with heart defects 35 types of defects 1,000,000 Americans alive today with heart defects Since the 1970’s death rates for congenital cardiovascular defects declined 25% (30% to 5%) American Heart Association

8 Overview of Uses of Allograft Patch Material Pulmonary Artery (PA) Reconstruction –Coarctation (Narrowing of an Artery) –Tetrology of Fallot –Truncus Arteriosus –Norwood –Hemi-Fontan Aortic Arch Reconstruction Septal Defects Conduit Extension

9 Septal Defects Increased blood flow to lungs

10 Tetralogy of Fallot (ToF) Incidence - 8% of CHD Four Components –VSD –Pulmonary stenosis –Right ventricle more muscular –Aorta lies directly over VSD Corrected with surgical repair of VSD, pulmonary enlargement, extra muscle excised Pulmonary valves and patches

11 ToF Patch Repair


13 Hypoplastic Left Heart Syndrome u Incidence – 10% of CHD u Most common cause of cardiac death <1 month u Abnormal development of the left side of the heart u Absent or tiny mitral and aortic valves u ASD and PDA for life support u Univentricular heart

14 u Requires heart transplant or staged palliation u Three stages – Norwood, Glenn procedure (hemi-Fontan procedure), and Fontan Hypoplastic Left Heart Syndrome

15 Stage I - Norwood Procedure u Converts the right ventricle into a single, systemic ventricle u Enlarge the ASD u Transect the pulmonary artery u Reconstruct the neo-aorta using a homograft patch u Ligate PDA and insert a central shunt

16 Stage I - Norwood Procedure Homograft Patch Litwin, Bert, Color Atlas of Congenital Heart Surgery, Mosby-Year Book, 1996, pp. 202

17 Stage II – Glenn or Hemi-Fontan Procedure

18 Stage III –Fontan Procedure

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