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Sutureless amniotic membrane transplantation for common disease
The document discusses the sutureless approach of amniotic membrane transplantation (AMT) using cryopreserved amniotic membrane (amniograft®), which is FDA approved for ocular surface reconstruction. It outlines various indications for AMT, its applications in treating conditions like chemical burns and conjunctivochalasis, and how it promotes healing and reduces inflammation and scarring. The document emphasizes the use of amniograft® as both temporary and permanent grafts, supported by clinical data and research findings.
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Sutureless amniotic membrane transplantation for common disease
- 1. Michael Duplessie MD. 6000Executive Blvd, Suite 525 N. Bethesda MD 20852 301.493.6404 Sutureless Approach of Amniotic Membrane Transplantation for Common Diseases
- 2. Disclosure and Acknowledgment •Cryopreserved amniotic membrane (AmnioGraft®) is obtained from Bio-Tissue. • Amniotic membrane transplantation for ocular surface reconstruction using AmnioGraft® is the ONLY one approved by FDA in 2001, and by Medicare for hospitals in Jan 2004 (CPT #65780) and for ASCs in July 2005. • Development of ProKera®, a sutureless AmnioGraft®, is supported by a SBIR grant from NIH, NEI, approved by FDA as a type II Device in Dec 2003, and is launched by Bio-Tissue in April 2005.
- 3. AMT Indications Corneal OtherDiseases, 262, 8%Conjunctivochalasis, 257, 8% Bullous Keratopahty, 229, 7% Conjunctival/Caruncle Lesion, 208, 6% Symblepharon, 132, 4% Limbal Stem Cell Deficiency, 100, 3% Glaucoma/Bleb Problems, 70, 2% Socket Problems , 60, 2% Lid Problems, 48, 1% Implant Problems, 36, 1% Scleral Diseases, 35, 1% Limbal Lesion Removal, 30, 1% With other Surgical Procedures, 11, 0% Corneal Defect and Ulceration, 724, 22% Pterygium & Pseudoterygium, 1152, 34% Pterygium & Pseudoterygium Corneal Defect and Ulceration Corneal Other Diseases Conjunctivochalasis Bullous Keratopahty Conjunctival/Caruncle Lesion Symblepharon Limbal Stem Cell Deficiency Glaucoma/Bleb Problems Socket Problems Lid Problems Implant Problems Scleral Diseases Limbal Lesion Removal With other Surgical Procedures N = 3,354 Data Source: Bio-Tissue, Inc. (2002)
- 4. Papilloma of theconjunctiva
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- 6. Provide aNew Basement Membrane Anti-inflammation Anti-scarring Anti-angiogenesis Amniotic Membrane: A New Strategy for Tissue Reconstruction and Engineering
- 7. The ONLY FDA- approvedAM graft A B
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- 9. Two Major Modesof AMT AM either dissolves or removed after healing Time of AM dissolution coincides with healing If AM dissolves in one week, suspect “exposure” problem Suture (10-0 nylon) purse- string running perilimbal sclera Prokera™ without sutures IOP by Tonopen and fluorescein staining without removing Prokera™ As a Temporary Graft (bandage or patch) AM does not dissolve but integrates into the host tissue (cornea or conjunctiva) One or multiple layers to fill in stromal defect as a filler for any irregular shape (the orientation matters only for the top layer with sticky side down) Suture (10-0 nylon) interrupted (bulbar) and 8-0 Vicryl over fornix, Fibrin Glue without sutures As a Permanent Graft
- 10. To reduceacute inflammation Chemical and Thermal Burns (Acute Stage) Stevens-Johnson Syndrome (Acute Stage) To reduce chronic and recalcitrant inflammation Herpes Zoster, Herpes Simplex, Vernal Keratitis To reduce acute inflammation induced by surgery or excimer laser High-risk PKP (neurotrophic) Excimer laser ablation (PRK/PTK) of the cornea AM as a Temporary Graft to Deliver Anti-inflammatory Action Kim et al, 1998; Meller et al, 2000; Sridhar et al, 2000; Choi et al, 1998; Park & Tseng, 2000; Wang et al, 2001; Heiligenhaus et al, 2001; Kenyon et al, 2003
- 11. AMT forAcute Chemical Burns & Acute SJS/TENS Kim et al, EER 70:329, 1998 Meller et al, Ophthalmology 107:980, 2000 John et al, Ophthalmology 109:351, 2002
- 12. Preop POD# 1 POD#1 Acute Chemical Burn
- 13. 1 wk 2 wk2wk 1 wk
- 14. 4 month 3 wk 5wk 5 wk
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- 16. Acute HZO ina Patient with HIV Preop 8 day
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- 22. 09.23.05 10 Daysafter Chemical Burn
- 23. 09.26.05 Day 3after 1st ProKera
- 24. 09.26.05 Day 3 09.28.05 Day 5 09.30.05 Day7 10.03.05 Day 10
- 25. 10.03.05 Day 10 10.05.05 Day 12 10.08.05 Day15 10.10.05 Day 17 Switcht to BCL
- 26. 09.23.05 10 Daysafter Chemical Burn 10.10.05 27 Days after Chemical Burn
- 27. 09.23.05 Day 0 09.26.05 Day 3 10.03.05 Day10 10.05.05 Day 12 What Happened in the Conjunctiva beyond ProKera?
- 28. 10.10.05 Day 17 10.08.05 Day 15 10.03.05 Day10 10.12.05 Day 19Inject Kenalog
- 29. To reduceacute inflammation Chemical and Thermal Burns (Acute Stage) Stevens-Johnson Syndrome (Acute Stage) To reduce chronic and recalcitrant inflammation Herpes Zoster, Herpes Simplex, Vernal Keratitis To reduce acute inflammation induced by surgery or excimer laser High-risk PKP (neurotrophic) Excimer laser ablation (PRK/PTK) of the cornea AM as a Temporary Graft to Deliver Anti-inflammatory Action Kim et al, 1998; Meller et al, 2000; Sridhar et al, 2000; Choi et al, 1998; Park & Tseng, 2000; Wang et al, 2001; Heiligenhaus et al, 2001; Kenyon et al, 2003
- 30. Two Major Modesof AMT AM either dissolves or removed after healing Time of AM dissolution coincides with healing If AM dissolves in one week, suspect “exposure” problem Suture (10-0 nylon) purse- string running perilimbal sclera Prokera™ without sutures IOP by Tonopen and fluorescein staining without removing Prokera™ As a Temporary Graft (bandage or patch) AM does not dissolve but integrates into the host tissue (cornea or conjunctiva) One or multiple layers to fill in stromal defect as a filler for any irregular shape (the orientation matters only for the top layer with sticky side down) Suture (10-0 nylon) interrupted (bulbar) and 8-0 Vicryl over fornix, Fibrin Glue without sutures As a Permanent Graft
- 31. To Restore CornealIntegrity AM as a Permanent Graft (one or multiple layers) Persistent epithelial defect, ulcer, descemetocele, and perforation Painful bullous keratopathy Band keratopathy Recurrent corneal erosion Superficial keratectomy Lee et al, 1997; Kruse et al, 1999; Azuara-Blanco et al, 1999; Chen et al; 2000; Hanada et al, 2001; Letko et al, 2001; Su & Lin, 2000; Pires et al, 1999; Anderson et al, 2001; Kenyon et al, 2003
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- 33. Preop 1 Week 2Week 7 Month 20/70 Decemetocele following Pseudomonas Infection and Glaucoma Drainage Implant Solomon et al, Ophthalmology 109:694-703, 2002
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- 35. Follow-up 5 weeks CornealPerforation Restore stromal thickness
- 36. Before Band Keratopathy withPED 75 days28 days
- 37. OS PRE-OP Band and BullousKeratopathy with PED 1ST POP WEEK
- 38. OS PRE-OP Band and BullousKeratopathy with PED POP 2 MONTH
- 39. Reconstruct conjunctival surfacewithout conjunctival autograft during removal of large lesions if the surrounding host tissue is healthy AM as a Graft for Conjunctival Surface Reconstruction Tumor, CIN Conjunctivochalasis/SLK Scar or Symblepharon LOGIC Syndrome Pterygium Glaucoma bleb revision Scleromalacia Scleral melt Tseng et al, 1997; Prabhasawat & Tseng, 1997; Azuara-Blanco et al, 1999; Meller et al, 2000; Gabric et al, 1999; Mejia et al, 2000; Honavar et al, 2000; Paridaens et al, 2001; Prabhasawat et al, 1997; Solomon et al, 2001; Ma et al; 2000; Shimazaki et al, 1998; Budenz et al, 2000; Rodriquez-Ares et al, 1999
- 40. Differential Diagnosis Symptoms • Diurnal Variation •Worst Gaze • Increased Blinking ATD Dry Eye Worst in P.M. Up Gaze Improved Exposure Zone Improved Chalasis Dry Eye Same throughout the day Down Gaze Worsened Non-Exposure Zone Worsened Di Pascuale et al Br J Ophthalmol, 2004 Rose Bengal Punctal Occlusion
- 41. Di Pascuale etal Br J Ophthalmol, 2004 CCh Detected by Fluorescein
- 42. CCh Detected by RoesBengal
- 43. Anterior Migration ofMucocutaneous Junction and Regional “Blepharitis”
- 44. Normal Mild CCh Moderate CCh Severe CCh IncreasingConjunctival Redness as if “Conjunctivitis”
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- 48. Preop 1 wk 1.5month
- 49. Tenon’s Capsule Reinforcement andReplacement by AM “Tenting” Effect Created by Forceps under Topical Anesthesia
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- 51. Reconstruct conjunctival surfacewith or without conjunctival autograft and intraoperative application of 0.04% MMC to fornix if the surrounding host tissue is not healthy AM as a Graft for Conjunctival Surface Reconstruction Tumor, CIN Conjunctivochalasis Scar or Symblepharon LOGIC Syndrome Pterygium Glaucoma bleb revision Scleral melt Exposed implants Tseng et al, 1997; Prabhasawat & Tseng, 1997; Azuara-Blanco et al, 1999; Meller et al, 2000; Gabric et al, 1999; Mejia et al, 2000; Honavar et al, 2000; Paridaens et al, 2001; Prabhasawat et al, 1997; Solomon et al, 2001; Ma et al; 2000; Shimazaki et al, 1998; Budenz et al, 2000; Rodriquez-Ares et al, 1999
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- 55. OD OS PRE OP 4thPOP WEEK
- 56. Multi-Recurrent Pterygium with MotilityRestriction and Symblepharon
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- 63. Ocular surfacereconstruction can be augmented by AMT to restore a stroma with an intact basement membrane and reduced inflammation and scarring. AMNIOGRAFT® can be used as a permanent graft to restore the corneal and conjunctival integrity if the surrounding host cells (including stem cells) are normal. AMNIOGRAFT® can be used in conjunction with intraoperative application of MMC to restore conjunctival surface with abnormal inflamed host tissue. AMNIOGRAFT® can be used to restore stem cell stromal substrate or “niche” and help promote epithelial stem cell expansion in vivo and ex vivo. Fibrin glue simplifies AMNIOGRAFT® use as a “sutureless” permanent graft, PROKERA™ simplifies AMNIOGRAFT® ’s use as a “sutureless” temporary graft. Conclusion