Lung Transplantation Guidelines For Selection Milpark Hospital Transplant Unit Johannesburg, South Africa SATS Controversies Meeting May 2011

South African Guidelines based on : ATS - International Guidelines for the selection of Lung Transplant Candidates – 1998 ATS - International Guidelines for the selection of Lung Transplant Candidates – 1998 ISHLT – Update – 2006 ISHLT – Update – 2006 GENERAL GENERAL -Patient should be receiving or have received maximal medical therapy, but nevertheless have declining function, with a limited life expectancy ( <50% year survival). -The patient should have ambulatory and rehabilitation potential. -A satisfactory psycho-social profile with support systems is essential.AGE -Older patients have a significantly worse prognosis. -HLT<55 years. - BSLT <60 years. - SLT <65 years. BMI - 18 – 30%

Lung Transplantation as the sole form of therapy is potentially indicated in any irreversible condition, resulting in either one or both of the following disease entities: END STAGE RESPIRATORY FAILURE.END STAGE RESPIRATORY FAILURE. ( ICD 10 CODE: J96.1) PULMONARY ARTERIAL HYPERTENSION.PULMONARY ARTERIAL HYPERTENSION. ( ICD 10 CODE: I27.0) (ICD 10 CODE: Q20 – 28) Refer for Assessment at this Stage and Exclude Unsuitable Recipients following Review of Disease Specific Guidelines

A.End Stage Respiratory Failure Conditions grouped as follows: COPD (ICD 10 Code: J40 -J46) COPD (ICD 10 Code: J40 -J46) - Acquired. - Congenital (Alpha1 – Antitrypsin def.). Idiopathic Pulmonary Fibrosis (IPF). (ICD 10 Code: J80-J84) Idiopathic Pulmonary Fibrosis (IPF). (ICD 10 Code: J80-J84) Infective/Inflammatory. (ICD 10 Code: J47.xx, J60-J70,J85-J86 E84 & other) Infective/Inflammatory. (ICD 10 Code: J47.xx, J60-J70,J85-J86 E84 & other) - Cystic Fibrosis (CF). - Cystic Fibrosis (CF). - Bronchiectasis. - Bronchiectasis. - Sarcoidosis. - Sarcoidosis. - Other e.g. – LAM etc. - Other e.g. – LAM etc. B.Pulmonary Hypertension - Primary (PPH). - Primary (PPH). - Secondary. - Secondary.

Disease Specific Criteria COPD FEV¹ <25% of predicted. FEV¹ <25% of predicted. PaCO² > 55/PHT. PaCO² > 55/PHT. Progressive deterioration on Domiciliary Oxygen. Progressive deterioration on Domiciliary Oxygen. Frequent admissions with declining function. Frequent admissions with declining function. Patients with a high BODE index. Patients with a high BODE index. Patients not better served by LVRS. Patients not better served by LVRS.

Disease Specific Criteria – cont. IPF Symptomatic disease. Symptomatic disease. Exercise desaturation. Exercise desaturation. VC < 60 – 75% predicted. VC < 60 – 75% predicted. DLCO < 50 – 60% predicted. DLCO < 50 – 60% predicted.

Disease Specific Criteria – cont. Infective/Inflammatory (CF) FEV¹ < 30% predicted. FEV¹ < 30% predicted. High Risk Patients: High Risk Patients: -Young Females with a rapidly declining FEV¹. -Weight Loss. -Frequent Infective Exacerbations. -Haemoptysis.

Disease Specific Criteria – cont. PPH NYHA Class III/IV on optimal treatment – Epoprostanol/Sildenafil/Bosentan. NYHA Class III/IV on optimal treatment – Epoprostanol/Sildenafil/Bosentan. Declining Functional Capacity. Declining Functional Capacity.

Disease Specific Criteria – cont. EISENMENGERS SYNDROME (2° PAT) NYHA Class III/IV and Declining Functional Capacity. NYHA Class III/IV and Declining Functional Capacity.

Contra-indications HIV+ve/AIDS.HIV+ve/AIDS. Hepatitis B, Ag+ve.Hepatitis B, Ag+ve. Hepatitis C with biopsy proven liver disease.Hepatitis C with biopsy proven liver disease. Active malignancy.Active malignancy. Dysfunction of one or more major organ. systems other than lungs, e.g. renal failure.Dysfunction of one or more major organ. systems other than lungs, e.g. renal failure.

Relative Contra-indications In combination – increases risk of Tx In combination – increases risk of Tx Severe Osteoporosis.Severe Osteoporosis. Hypertension.Hypertension. Diabetes Mellitus.Diabetes Mellitus. Peptic Ulcer Disease.Peptic Ulcer Disease. Musculo-skeletal Disease eg. Kypho-scoliosisMusculo-skeletal Disease eg. Kypho-scoliosis Long term, high dose corticosteroids.Long term, high dose corticosteroids. Poor nutritional status.Poor nutritional status. Substance abuse.Substance abuse. Psychological disorders.Psychological disorders. Mechanical ventilation.Mechanical ventilation. Microbial colonisation.Microbial colonisation. T.B. (untreated).T.B. (untreated).

Conclusions Most patients with diagnosis of IPF/UIP SHOULD be considered for EARLY transplant listing – due to rapid progression of disease. Most patients with diagnosis of IPF/UIP SHOULD be considered for EARLY transplant listing – due to rapid progression of disease. Very FEW patients with COPD/Airway obstruction WOULD be considered suitable for listing – advanced age with co-morbid disease. Very FEW patients with COPD/Airway obstruction WOULD be considered suitable for listing – advanced age with co-morbid disease.

Conclusions Worldwide the percentage of patients Worldwide the percentage of patients undergoing transplantation with PAH is DIMINISHING due to improved prognosis with medical therapy. undergoing transplantation with PAH is DIMINISHING due to improved prognosis with medical therapy. A large and increasing percentage of CYSTIC FIBROSIS patients could potentially qualify for listing, although some patients currently elect not to follow this route. A large and increasing percentage of CYSTIC FIBROSIS patients could potentially qualify for listing, although some patients currently elect not to follow this route.

Conclusions Meeting disease specific criteria generally implies transplant ASSESSMENT is indicated. Meeting disease specific criteria generally implies transplant ASSESSMENT is indicated. Certain percentage will be excluded by Transplant Panel. It is in the interest of the Transplant Team to rigorously accept only ideal recipient. It is in the interest of the Transplant Team to rigorously accept only ideal recipient.