Heart Patient Selection Criteria

Indications

1. Children and adults with irremediable terminal cardiac disease with severely compromised survival despite application of other available medical and surgical therapies. Survival estimates are based on standard heart failure risk assessments
2. Any patient who is continually on the waiting list for more than two years will require verification from the transplant team that he/she is still a candidate for transplantation and continues to meet the patient selection criteria as described below
3. Age 70 years or younger (older patients will be considered on a case-by-case basis)
4. Patient selection criteria as published in the September 2006 issue of “Journal of Heart and Lung Transplantation”, Vol. 25, pp. 1024-1042, is endorsed by the Ohio Solid Organ Transplantation Consortium

Contraindications

1. Absolute

   1. Significant active infection (unless related to an LVAD)
   2. Uncontrolled malignancy
   3. Diabetes with end organ damage other than non proliferative retinopathy or poor glycemic control despite optimal effort
   4. Clinically severe symptomatic cerebrovascular disease which is not amendable to revascularization
   5. Chemical use, including illegal narcotic usage, not consistent with screening criteria in Substance Use Disorder Addendum
   6. Absence of adequate external psychosocial support
   7. Irreversible hepatic or renal dysfunction unless patient is being considered for multiple organ transplant
   8. Non-compliance
   9. Smoking or tobacco use not consistent with screening criteria in the Addendum B Heart and Lung Patients Presenting with History of Tobacco Use

2. Relative

   1. BMI >35 kg/m2 (or) % BMI of >140%

Relative Contraindications for Pediatric Candidates (to be reviewed on a case by case basis)

1. Prematurity (less than 36 weeks gestation)
2. Small size (less than 2 – 2.5 kg)
3. Cardiac anatomic abnormalities
   1. Significant pulmonary artery hypoplasia
   2. Uncorrectable pulmonary venous abnormalities
   3. Ectopia cordis
4. Cardiac physiologic abnormalities
   1. Elevated pulmonary vascular resistance which is irreversible with pulmonary vasodilator testing
( > 6 Wood units per meter squared)
5. Impaired and/or irreversible dysfunction or abnormality of other organ system, eg: acute renal failure, acute hepatic failure, multisystem organ failure, severe dysmorphology or genetic abnormality, profound metabolic or neuromuscular/neurologic/CNS disorder
6. Severe or significant systemic illness, for example: active infection (pneumonitis, septicemia, fever of unknown origin), HIV infection, hepatitis B/ and possibly C infection, active malignancy
7. Psychosocial pathology including alcohol or substance abuse in parents or patient, child abuse or neglect, psychiatric illness in patient (or parents), strong, and irremediable history of non compliance
8. Parental non-compliance with physician recommendations for pediatric candidates to have all age appropriate immunizations
9. Other life limiting illnesses

Heart-Lung Patient Selection Criteria

General Indications

In the past, it has been shown that pulmonary transplant as a desperate attempt for deathbed rescue has been doomed to failure. Only with rigid selection criteria has clinical success been realized.

All patients considered for heart-lung transplantation shall be:

1. Less than 60 years of age
2. Free from other major organ failure
3. Expected to have a survival time of not more than 12 to 24 months without a transplant

Specific Indications

Patients with the following disease processes are considered as candidates for transplantation. They should be functionally limited, but not totally disabled. There is a “transplant window” during which the patient has a gradual decline from the natural history of his/her disease, but has not deteriorated so much that he/she is no longer a viable transplant candidate.

Patients to be considered include, but are not limited to, those with the following diagnoses:

1. Eisenmenger’s syndrome
2. Primary pulmonary hypertension
3. Cardiomyopathy with pulmonary hypertension
4. Emphysema
5. Alpha-1 antitrypsin deficiency
6. Pulmonary fibrosis
7. Cystic fibrosis
8. Bronchiectasis
9. Bronchopulmonary dysplasia
10. Post-transplant obliterative bronchiolitis
11. Pulmonary disease in young infant for technical surgical issues (typically due to the airway size)
12. Ischemic heart disease

Contraindications

1. Absolute

   1. Significant systemic or multi-system disease
   2. Active or systemic infection limiting survival
   3. In general, a five year malignancy -free interval is prudent, This time frame may be modified in the setting of low grade malignancies with little to no risk of recurrence on a case-by-case basis.
   4. Major psychiatric illness
   5. Non-compliance

2. Relative

   1. Previous cardiac or thoracic surgery
   2. Diabetes mellitus
   3. Peptic ulcer disease
   4. Cachexia (<17 BMI) or obesity (>30 BMI: Patient medical summary shall provide details regarding the patient’s body composition)
   5. Corticosteroid therapy (>20 mg/day)
   6. Psychosocial issues
   7. Chemical use, including illegal narcotic usage, not consistent with screening criteria in Substance Use Disorder Addendum
   8. Smoking or tobacco use not consistent with screening criteria in the Addendum B Heart and Lung Patients Presenting with History of Tobacco Use

Single/Double Lung Patient Selection Criteria

General Indications

All patients considered for pulmonary transplantation shall be suffering from end-stage pulmonary disease and be:

All patients considered for heart-lung transplantation shall be:

1. Less than 65 years of age, patients older than 65 will be reviewed on a case-by-case basis
2. Free from other major organ failure
3. Free from major psychosocial problems
4. Capable of participating in pre- and post-operative rehabilitation programs and follow-up
5. Expected to have a survival time of less than 18 months without a transplant

Specific Indications

Patients with the following disease processes will be considered for lung transplantation:

1. Eisenmenger’s physiology, COPD, emphysema, Alpha-1 antitrypsin deficiency
2. Primary pulmonary hypertension
3. Pulmonary fibrosis (primary or secondary)
4. Cystic fibrosis
5. Bronchiectasis
6. Other–including, but not limited to, sarcoidosis, systemic lupus, pulmonary hemosiderosis, bronchiolitis obliterans, broncho alveolar carcinoma, etc.
7. Advanced pediatric lung disease

Contraindications

1. Absolute

   1. Significant systemic or multi-system disease
   2. Active or systemic infection limiting survival
   3. In general, a five year malignancy -free interval is prudent, This time frame may be modified in the setting of low grade malignancies with little to no risk of recurrence on a case-by-case basis
   4. Major psychiatric illness
   5. Non-compliance

2. Relative

   1. Previous cardiac or thoracic surgery
   2. Diabetes Mellitus
   3. Peptic ulcer disease
   4. Cachexia (<17 BMI) or obesity (>30 BMI: Patient medical summary shall provide details regarding the patient’s body composition)
   5. Corticosteroid therapy (>20 mg/day)
   6. Psychosocial issues
   7. Chemical use, including illegal narcotic usage (i.e. marijuana), not consistent with screening criteria in Substance Use Disorder Addendum
   8. Smoking or tobacco use not consistent with screening criteria in the Addendum B Heart and Lung Patients Presenting with History of Tobacco Use

Hepatic Patient Selection Criteria

Indications

In general, liver transplantation is indicated in children and adults suffering from irreversible liver dysfunction or the effects of liver dysfunction after alternative medical and surgical treatments have been utilized and where the benefits of transplantation out weigh the risk of alternative modalities.

Specific Indications

1. Acute hepatic fulminant failure
2. Extrahepatic biliary atresia or hypoplasia
3. Inborn errors of metabolism:
   1. Alpha-I antitrypsin deficiency
   2. Crigler-Najjar disease, Type I
   3. Byler’s disease
   4. Glycogen storage disease (O and IV)
   5. Wilson’s disease
   6. Hemochromatosis
   7. Tyrosinemia
   8. Wolman’s disease
   9. Familial amyloidotic polyneuropathy (FAP)
   10. Primary hyperoxaluria type 1
   11. Other
4. Sclerosing cholangitis
5. Hepatic vein thrombosis (Budd-Chiari)
6. Hepatocellular Carcinoma (HCC), Stage I or II, or: single lesion </= 6.5 cm, or multiple lesions (</=3) with the largest </= 4.5 cm with total maximum tumor diameter </= 8 cm (UCSF criteria)
7. Cirrhosis
   1. Alcohol cirrhosis (see Substance Use Disorder Addendum)
   2. Biliary cirrhosis (primary or secondary): Caroli, choledochal cyst, congenital cholestasis (PFIC), iatrogenic biliary tree injury/damage, trauma
   3. Chronic active hepatitis (A, B, C, non A, non B, autoimmune)
   4. Congenital biliary cirrhosis
   5. Cryptogenic cirrhosis
   6. Cystic fibrosis
   7. Hemochromatosis
   8. Alpha I Antitrypsin Deficiency
   9. NASH
   10. Viral cirrhosis
   11. Other
8. Congenital hepatic fibrosis
9. Controlled biliary sepsis resulting from acute (or chronic) hepatic artery thrombosis (ischemic coagulopathy)
10. Hepato-pulmonary syndrome, with cirrhosis
11. Polycystic liver disease with symptoms such as: portal hypertension, Budd-Chiari-like symptoms, refractory and unmanageable ascites following cyst fenestration
12. Porto-pulmonary hypertension in the presence of cirrhosis and mean pulmonary artery pressures of < 35 mm Hg

Indications for Retransplantation

1. Primary non-function
2. Irreversible vascular compromise of either the hepatic artery, portal vein, or hepatic vein
3. Recurrent primary disease
4. Intractable, acute, or chronic rejection
5. Biliary disease not correctable by any mechanism other than transplantation
6. Small for size syndrome
7. Poor early graft function (PEGF)

Indications Special Cases (To be reviewed on a case-by-case basis)

1. Stage III tumors outside UCSF
2. Slow-growing metastatic leiomyosarcoma, neuroendocrine tumors including metastatic carcinoid syndrome and hemangioendotheliomas
3. Cholangiocarcinoma transplanted under approved institutional protocol
4. Hepatitis C (retransplant within 1 year for recurrent disease)

Contraindications

1. Chemical use (see Substance Use Disorder Addendum)
2. Active infection outside hepatobiliary system limiting survival
3. Significant cardiac, pulmonary, or nervous system failure (this does not apply for patients being considered for heart and/or lung transplant)
4. Unstable current psychotic disease (pre-liver failure)
5. Uncontrolled malignancy
6. AIDS
7. Persistent pattern of non-compliance considered likely to interfere with following a disciplined medical regime

Pancreas Patient Selection Criteria

1. Group I:

Insulin-dependent Diabetes Mellitus Type I (JODM) with secondary complications but no renal or early renal involvement. Early pancreatic transplantation may be indicated for those who cannot be adequately controlled with insulin and/or with chronic complications of diabetes likely to be impacted by a pancreas transplant

2. Group II:

Insulin-dependent Diabetes Mellitus Type I with secondary complications and renal involvement in the absence of morbid obesity. Synchronous pancreatic and renal transplantation may be indicated

3. Group III:

Type I or Type II insulin-dependent diabetes mellitus with secondary complications, end-stage renal disease and previous renal transplant. Asynchronous pancreatic transplantation may be indicated

Contraindications

1. Absolute

   1. Chemical use, including illegal narcotic usage, not consistent with screening criteria in Substance Use Disorder Addendum
   2. Active sepsis
   3. End-stage organ dysfunction:
      1. Pulmonary
      2. Cardiac
      3. Cerebrovascular
      4. Hematological
   4. Inability to understand the transplant procedure and care for self after receiving a new organ
   5. Uncontrolled malignancy

2. Relative

   1. BMI >35
   2. Non-compliance

Pancreas Islet Patient Selection Criteria

1. All recipients must have Type I insulin-dependent Diabetes Mellitus with absent C-peptide
2. Previous kidney transplant (or kidney-pancreas transplant with failed pancreas with satisfactory kidney graft function)
3. GFR >50 based on calculated GFR, or based on a 24-hour urine study, or base on iothalamate clearance as appropriate (This is to only apply to patients who have not previously received a kidney transplant and are potential kidney recipients)
4. Kidney transplant candidates with Type I insulin-dependent Diabetes Mellitus

Contraindications

1. History of malignancy (except adequately treated localized basal cell carcinoma of skin without evidence of recurrence, or other cancers considered cured by therapy)
2. Patients with current episodes of acute renal allograft rejection
3. Patients with panel reactive antibody (PRA) level > 50%
4. Chemical use, including illegal narcotic usage, not consistent with screening criteria in Substance Use Disorder Addendum
5. Active infection
6. Non-compliance

Small Bowel Patient Selection Criteria

Background

Small bowel/intestinal transplantation, combined liver/intestinal transplantation, and multivisceral transplantation are operations that are reserved for life-threatening conditions, but no longer considered investigational. Worldwide, from the early 1980s until mid 2003, 61 centers had performed 989 transplants upon 923 patients. (433 isolated small intestinal, 386 liver/intestinal, and 170 multivisceral). Sixty one percent of all transplants have been performed upon children. In this era, one-year survival has remained between 65 and 70% and five-year survival is between 40 and 50%. When reserved for patients with no possibility of long-term survival without transplantation, the procedure should be strongly considered.

Factors governing success of the procedure will include the general health of the recipient before transplant, the size of the center, the experience of the physicians within that center with small bowel or liver transplantation and/or related procedures, and recent advances in surgical technique, graft monitoring techniques, immunosuppressive regimens, and antiviral therapies. The average length of stay varies from 55 days for small intestinal transplantation to 72 days for multivisceral transplantation. Success can be monitored by outcome-measures that include cost of the procedure and the morbidity and mortality of the patients undergoing the procedure.

Indications

Isolated small intestinal transplantation is an operation reserved for patients with irreversible short bowel syndrome (or intestinal failure despite intact intestinal length) associated with life-threatening complications due to either parenteral nutrition or the underlying disorders themselves. When prospects for weaning from parenteral nutrition are nil, or patients have experienced multiple serious episodes of septicemia, progressive loss of vascular access, are at risk for serious morbidity and mortality from disease itself, or are at risk for progressive cholestasis associated with parenteral nutrition, isolated small intestinal transplantation may be considered.

When candidates have suffered irreversible liver damage (usually associated with prolonged parenteral nutrition) in addition to irreversible intestinal failure, liver/small intestinal transplantation should be considered. If the candidate’s disease process is one which renders gastroduodenal function unacceptable, or when localized tumors or other causes of vascular occlusion seriously compromise the arterial blood supply to stomach, liver, small bowel, and pancreas, multivisceral transplantation may be performed.

Specific Indications

1. Surgical short bowel syndrome due to:
   1. Volvulus
   2. Gastroschisis
   3. Necrotizing enterocolitis
   4. Hirschsprung’s Disease
   5. Congenital atresias
   6. Crohn’s Disease
   7. Trauma
   8. Mesenteric vascular insufficiency
   9. Localized intra-abdominal tumors (such as desmoid tumors or inflammatory pseudotumor)
   10. Other causes of surgical short bowel syndrome
2. Secretory diarrhea associated with uncorrectable malabsorption
   1. Microvillus inclusion disease
   2. Tufting enteropathy
   3. Intestinal pseudo-obstruction
   4. Other life-threatening diarrheal disorders uncorrectable by medical or surgical means short of transplantation
3. Liver failure in association with intestinal failure
   1. TPN-associated liver failure
   2. Other causes of liver failure (such as primary sclerosing cholangitis or biliary atresia) in association with intestinal failure
4. Other Consortium-approved indications for transplantation

Contraindications

1. Chemical use, including illegal narcotic usage, not consistent with screening criteria in Substance Use Disorder Addendum
2. Active infection outside the hepatobiliary system limiting survival
3. Disseminated, non-resectable malignancy
4. Insufficient venous patency to guarantee central venous access
5. Severe dysfunction of other organ systems (cardiac, pulmonary, vascular, renal, neurologic), rendering transplantation risk unacceptable
6. Other life-threatening, uncorrectable illnesses not referable to the gastrointestinal system
7. Unstable, uncontrollable psychiatric illness
8. Proven non-compliance

Reference

“Intestinal Transplant Registry” David Grant MD. URL–https://www.intestinaltransplant.org/