SynerGraft Technology and Usage of Allograft Patches.

SynerGraft Technology and Usage of Allograft Patches

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

Pediatric Reconstruction with Allograft Patches

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

Septal Defects

Increased blood flow to lungs

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

ToF Patch Repair

ToF Patch Repair

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

Stage II – Glenn or Hemi-Fontan Procedure

Stage III –Fontan Procedure