1. Criteria for establishment of a heart transplant center
The SCOT through specialized transplant committee has laid down certain criteria for establishment of heart transplant centers in the Kingdom of Saudi Arabia. They include:
1. Working staff:
1.1 Consultant cardiac transplant surgeons.
There should be a team of cardiovascular surgeons with good experience in performing open heart surgeries, who should have performed an adequate number of pump cases per year (more than 200) and who are fully certified and experienced from one of the recognized heart centers internationally.
1.2 ICU specialists.
An ICU specialist should have adequate experience in follow-up of patients after open heart surgery and preferably having adequate experience in follow-up of cardiac transplant recipients.
1.3 Consultants in cardiology.
They should have adequate experience in dealing with pre-and post-heart transplant patients as well as in performing all relevant cardiac investigations including endomyocardial biopsy.
1.4 Nursing staff.
They must be highly experienced in caring for the patients during and after heart transplantation.
1.5 A transplant coordinator.
1.6 A social worker.
1.7 A dietitian.
2. Technical facilities required:
The hospital in which the heart transplant center will be established should include:
2.1 Departments of Gastroenterology, Radiology, Hematology, Pathology laboratory, Biochemical laboratory, Nephrology with hemodialysis unit, and Immunology.
2.2 At least two fully equipped open-heart surgical theaters equipped with circulatory support systems, e.g., intra-aortic balloon pump, by-pass support systems, or mechanical assist devices with the availability of technicians necessary to handle them.
A fully equipped ICU should be available for management of patients after open-heart surgery with facilities to isolate patients as well as installation of pacemakers, both temporary and permanent.
2.3 The following specialists should be available in the hospital:
2.3.1 Fully certified nephrologists experienced in the follow-up of organ transplant recipients.
2.3.2 Immunologists experienced in follow-up of heart transplantation.
2.3.3 Certified pulmonologist.
2.3.4 Certified respiratory therapists.
2.3.5 Certified infectious disease specialist.
2.3.6 Team for infection control.
2.3.7 Certified pathologists with experience in interpreting myocardial biopsies.
2.3.8 Certified psychiatrist.
3. Support Services:
All routine investigations for the patients either before or after the transplantation must be available in the center.
Facilities to do tissue typing, cytotoxic antibodies, and blood levels of drugs including cyclosporine and similar drugs must be available in addition to other immunological tests.
Conventional X-ray, ultrasound, radioisotope scanning, and computerized axial tomography must be available in the hospital. There should be availability of bimodal echocardiography.
The following drugs must be continuously available in the center:
3.3.1 Immunosuppressive drugs:
· Cyclosporine, TACROLIMUS (FK 506)
· Azathioprine, MYCOPHENOLATE MOFETIL (MMF)
(RAPAMYCIN) · Other similar drugs.
3.3.2 Drugs for treating rejection episodes such as methylprednisolone, anti-lymphocyte or anti-thymocyte globulin and monoclonal antibodies.
3.3.3 Solutions for perfusing the organs like Eurocollins solution or Wisconsin University Solution, and HTK solution.
3.3.4 Drugs for treating bacterial, fungal, viral, or parasitic infections.
2 Indications for heart transplantation
The SCOT through its transplant committee has laid down indications for heart transplantation in the Kingdom as follows:
2.1 All patients who have end-stage cardiac disease unresponsive to adequately supervised medical or surgical treatment (left ventricular ejection fraction less than 20%).
2.2 Patients categorized in New York Heart Association (NYHA) functional class III-IV.
2.3 Patients having unresectable cardiac tumors.
2.4 Patients who fail to come off cardio-pulmonary bypass after any surgical procedure.
2.5 Patients who are at risk of death from acute myocardial infarction.
*(Appendix 18: investigations to be done on a potential recipient for cardiac transplantation)
3. Contra-indications for heart transplantation
3.1 Absolute contraindications:
3.1.1 High pulmonary vascular resistance of more than 4 wood units despite intensive cardiac management.
3.1.3 Collagen vascular disease.
3.1.4 Renal failure above and beyond the expected pre-renal failure.
3.1.5 Hepatic failure, which exceeds that explained by cardiac failure, or when accompanied by significant coagulopathy.
3.1.6 Other irreversible organ diseases such as emphysema, intractable systemic illness, or amyloidosis.
3.1.7 Infection with HIV.
3.1.8 History of substance abuse (alcohol or other drugs).
3.2 Relative contraindications*
3.2.1 Age more than 60 years.
3.2.2 Presence of peripheral arterial diseases
3.2.3 Diabetes mellitus, especially type I.
3.2.4 Peptic ulcer disease.
3.2.5 Unresolved pulmonary infarction.
3.2.6 Marked obesity.
3.2.7 Cachectic patients.
3.2.8 History of CMV, EBV, toxoplasmosis, sickle cell disease, or thyroid dysfunction.
3.2.9 Uncontrolled hypertension.
3.2.10 Presence of active systemic infection.
3.2.11 Patients where are emotionally unstable and may not cope with the demands and burdens of strict compliance with medications and follow-up requirements.
*Patients with positive PPD or clinical evidence of tuberculosis are to be treated prophylactically with INH for 12 months.
4 Priority criteria for heart transplantation
1 The transplant committee of the SCOT have laid down priority criteria for heart transplantation as follows:
1.1 Patients admitted in ICU on ventilator or on mechanical cardiac support and cannot be weaned off inotropic drugs.
1.2 Patients cannot be weaned from cardiopulmonary bypass (artificial heart-lung pump)
1.3 Patients withhigh PRA or cross match positive for at least 2 times.
1.4 Patients in the general or cardiology ward who require inotropic drugs, with no requirement for ventilation or mechanical cardiac support.
1.5 Patients who are on the waiting list and are waiting at home.
2 Distribution of hearts
Each harvested heart is distributed as follows:
2.1 Each heart transplant center should establish a local waiting list. A national waiting list should be made according to priority criteria. The heart transplant center should change the patient’s priority level between the previously mentioned categories according to the patient’s condition, after informing the SCOT.
2.2 All transplant centers should inform the SCOT about patients who need urgent heart transplantation so that they can be included in a special urgent waiting list.
2.3 Patients in the urgent waiting list have the absolute priority wherever they are, because patients with priority I do not follow the rota system.
2.4 If there is no suitable patient on the urgent waiting list, the heart will be transplanted in the heart transplant center according to the rota. If the center does not have a suitable patient, the heart will be given to the center which has a suitable patient, in which case the selection of the patient will be according to blood group and the date on which the patient was registered on the local waiting list.