How Do You Start an EVLP Program? Thomas C. Wozniak MD Surgical Program Director Thoracic Transplantation and Mechanical Circulatory Support Indiana University Health, Indianapolis IN 6/1/20161

Disclosures XVIVO NOVEL study participant Transmedics INSPIRE study participant Clinical instructor XVIVO Perfusion 6/1/20162

Introduction Donor lung shortage is a major limiting factor to lung transplantation EVLP – Ex Vivo Lung Perfusion –Evolving technology intended to increase the donor pool for lung transplantation –Allows for assessment of marginal donor lungs for suitability for transplant 6/1/20163

How to establish an EVLP program in 7 steps 1.Identify the need 2.Identify the physician leadership team 3.Sell the idea to hospital leadership 4.Build your own circuit 5.Identify your clinical team 6.Establish your staffing and training model 7.Purchase your machine 6/1/20164

1. Identify the need Lung transplant program with sufficient volume Willingness to pursue marginal donors Is there another EVLP program in close geographic proximity 6/1/20165

2. Identify the physician leadership team Lung transplant surgeon Lung transplant pulmonologist 6/1/20166

3. Sell the idea to hospital leadership Hospital administration –Capital investment –Return on investment –More patients served –Program visibility Transplant administration –More patients served –Program visibility –Reimbursement 6/1/20167

4. Build your own circuit Ventilator Oxygenator De-oxygenating gas Reservoir Perfusate Perfusion pack Heat exchanger Non-pulsatile pump Cannulae 6/1/20168

5. Identify your clinical team Perfusion Transplant OR staff Respiratory therapy Nursing Radiology Laboratory Research coordinator 6/1/20169

6. Establish your staffing and training model Lung transplant surgeon Lung transplant pulmonologist Transplant OR staff ECMO clinician or Perfusionist Resident/Fellow 6/1/201610

7. Purchase your machine XVIVO Transmedics 6/1/201611

Indiana University Health staffing and training model Lung transplant surgeon Lung transplant pulmonologist Resident/Fellow RT based ECMO clinician Donor perfusionist Research coordinator 6/1/201612

Indiana University Health staffing and training model ECMO clinician in-house 24-7 Wet labs Non-human lung perfusions (IACUC) 6/1/201613

Summary Significant capital investment Costly disposables Labor intensive Physician champion Competent team able to provide full-time coverage Ongoing competency training Hospital and transplant administrative support 6/1/201614

Thank You 6/1/201615