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Rolf N. Barth, M.D. Department of Surgery University of Maryland School of Medicine

Innovations in Transplantation: Single-Port Donor Nephrectomy for Living-Donor Kidney Transplantation Face Transplantation: Preclinical and Clinical Trials. Rolf N. Barth, M.D. Department of Surgery University of Maryland School of Medicine AHRQ 2011 Annual Conference September 19, 2011.

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Rolf N. Barth, M.D. Department of Surgery University of Maryland School of Medicine

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  1. Innovations in Transplantation:Single-Port Donor Nephrectomy for Living-Donor Kidney TransplantationFace Transplantation: Preclinical and Clinical Trials Rolf N. Barth, M.D. Department of Surgery University of Maryland School of Medicine AHRQ 2011 Annual Conference September 19, 2011

  2. Single-Port Donor Nephrectomy for Living-Donor Kidney Transplantation

  3. Renal Transplantation as Therapy for End Stage Renal Disease2000 - 2009 The Organ Procurement and Transplantation Network (OPTN). www.optn.org. 2009.

  4. Rationale for Single-Port Donor Nephrectomy Program Advanced laparoscopic approach achieved with existing instrumentation and techniques Improved cosmetic appearance Potential for improved post-operative recovery Motivate recipient/donor combinations Encourage living kidney donation

  5. University of Maryland Experience • Performed 1300 laparoscopic donor nephrectomies • Preparation for single-port • Minimized ports on standard donor • Observed procedures • Animal lab • April 2009 initiated single-port donor nephrectomy as routine approach • Currently performed over 140 single-port donor nephrectomies

  6. Access Devices SILS Port Device (Covidien) Gelport/Gelpoint Device (Applied Medical)

  7. Transumbilical Renal ExtractionMinimizes apparent length of incision

  8. BMI 30 Healing POD 0 POD 15 POD 22

  9. 6 Months Post-Op

  10. 2 Years Post-Op

  11. Anatomical Variants 2 Arteries Lumbar Vein 2 Arteries

  12. Single vs. Multi-port

  13. Operative Time Learning Curve Single Port Donor Nephrectomy Trendline Average Multiple Port Donor Nephrectomy (2.6 hr)

  14. SF=36 and Survey Responses

  15. Conclusions • Single port donor nephrectromy is safe and may be accomplished in broad spectrum of donors with experienced team. • Patients report improved satisfaction with cosmesis and donation process with single port compared to multiple port technique. • No definite evidence regarding recovery time or pain. • Further investigation of implications: • Willingness of recipients to ask potential donors • Additional kidney donors to alleviate organ shortage

  16. Face Transplantation: Preclinical and Clinical Trials

  17. Incidence of Facial Trauma • Incidence of facial injury among soldiers in Iraq=30% (Colonel Mark Bagg MD, ASRM, Arizona, January 2006) • Incidence of facial injury at University of Maryland Shock Trauma Center= 15% (unreported data: ~ 7,000-10,000 admissions per year)

  18. Vascularized Composite Allograft (VCA) Composite tissue defined to elements of skin, muscle, bone Applications include: Limb transplantation Transplantation for soft tissue defects Facial transplantation for devastating burn/blast injuries Results are life-saving, limb-saving, allow for avoidance of permanent disability

  19. Barth et al, Plast. Reconstr. Surg. 123: 493, 2009.

  20. Prolonged Survival of Composite Facial Allografts in Non-Human Primates Associated With PosttransplantLymphoproliferative Disorder Donor Recipient Tumor= 87% Donor Barth et al, Trans. 2009, 88: 1242

  21. Vascularized Bone Marrow-Based Immunosuppression Inhibits Rejection of Vascularized Composite Allografts in Nonhuman Primates

  22. Vascularized Bone Marrow-Based Immunosuppression Inhibits Rejection of Vascularized Composite Allografts in Nonhuman Primates MRI of Vascularized Bone Marrow Histology of Vascularized Bone Marrow

  23. Facial CTA Summary

  24. Non-Human Primate Model of Fibula Vascularized Composite Tissue Allotransplantation Demonstrates Donor-recipient Bony Union Plastic Reconstructive Surgery, 2011

  25. Clinical CTA Strategies • Co-transplanted vascularized bone marrow may be permissive towards the development of prolonged graft survival. • CTA were rejected at early timepoints without calcineurin-based immunosuppression. • ‘Prope’ tolerance or minimal immunosuppression are the most attainable goals for widespread application of clinical CTA.

  26. Craniofacial Composite Tissue Allotransplantation 2009 2010 2011 2012 Phase 1 (Active): Research and Preclinical Model Phase 2 (Active): Clinical program development: IRB approved, DOD approval Phase 3 (Active): Active Clinical Center: Patient Listed for Transplant

  27. Minimizing Chronic Immunosuppression • Lymphocyte-depleting induction therapies • Lowest rates of acute cellular rejection • Steroid Avoidance or Weaning • Nearly all kidney, pancreas, and liver transplant patients have steroids eliminated between 3 and 21 days • Permissive of chronic therapy with 1 or 2 drugs • Future – costimulatory blockade reagents requiring once monthly treatment

  28. Immunosuppression Induction Humanized CAMPATH Antibody (Alemtuzumab) CD4 T cells depleted 99.7% 2 wks, 85% at 1 year, 69% at 2 years, and 63% at 3 years TxInt 19 (2006): 885-892

  29. CTA Immunosuppressive Regimen Day 0 C1H POD 21 Tacrolimus MMF Prednisone

  30. Instruments Multi-Organ Recovery Team Scrub Nurse Thoracic Team Abdominal Team CTA Team Mayo Stand CTA Team Thoracic Team Abdominal Team Anesthesia - Tracheostomy & Circuit

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