synergraft technology and usage of allograft patches
TRANSCRIPT
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 performance1,2
• Standard processed allografts have been shown to stimulate an immune response3,4
• Durability may subsequently be affected by the host immune response3,4
• Allosensitized patients requiring subsequent organ transplant may be more difficult to match5
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
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
Donor HeartHeart Dissection
Procedure
AntibioticTreatment
Hypotonic Lysis, Nuclease Digestion,Sequential Washing
Cryopreservation and Storage Recipient
Decellularization Steps
The SynerGraft® Process
SynerGraft vs. Standard Process Histological Comparison
Standard-Processed Pulmonary Valve
SynerGraft-Processed Pulmonary Valve
Leaflet
Leaflet
Myocardium Conduit
ConduitMyocardium
Congenital Heart DefectsBiostatistical 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
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
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
Hypoplastic Left Heart Syndrome
Incidence – 10% of CHDIncidence – 10% of CHD Most common cause of Most common cause of
cardiac death <1 monthcardiac death <1 month Abnormal development of Abnormal development of
the left side of the heartthe left side of the heart Absent or tiny mitral and Absent or tiny mitral and
aortic valvesaortic valves ASD and PDA for life ASD and PDA for life
supportsupport Univentricular heartUniventricular heart
Requires heart transplant Requires heart transplant or staged palliationor staged palliation
Three stages – Norwood, Three stages – Norwood, Glenn procedure (hemi-Glenn procedure (hemi-Fontan procedure), and Fontan procedure), and FontanFontan
Hypoplastic Left Heart Syndrome
Stage I - Norwood Procedure
Converts the right Converts the right ventricle into a single, ventricle into a single, systemic ventriclesystemic ventricle
Enlarge the ASDEnlarge the ASD Transect the pulmonary Transect the pulmonary
arteryartery Reconstruct the neo-Reconstruct the neo-
aorta using a homograft aorta using a homograft patchpatch
Ligate PDA and insert a Ligate PDA and insert a central shuntcentral shunt
Stage I - Norwood Procedure
Homograft Patch
Litwin, Bert, Color Atlas of Congenital Heart Surgery, Mosby-Year Book, 1996, pp. 202