The absolute contraindications for lung transplantation are as follows:

• Active extrapulmonary infection
• Significant disease of other organ systems
• Current cigarette smoking
• Poor nutritional status
• Poor rehabilitation potential
• Significant psychosocial problems, substance abuse, or history of medical noncompliance

The lung transplant team evaluates each referral in view of potential risks and benefits to the patient and the ability and experience of the individuals at the transplant center. Some of the issues related to contraindications are discussed as follows:

• Age: Based on past experience, advanced age is associated with higher mortality rates. Recent pooled data have shown no statistical difference between patients younger than 65 years and patients older than 65 years, although a trend towards lower survival for recipients older than 65 years was present. Most centers have an age cut-off of 45 years for heart-lung transplantation, 50-55 years for bilateral sequential lung transplantation, and 60-65 years for SLT.
• Ventilator dependence: The limited data suggest that patients who are ventilator-dependent prior to the transplant have higher mortality rates. A prolonged wait while on a mechanical ventilator may lead to various complications such as infections, cardiovascular deconditioning, and muscle atrophy, all of which further compromise the outcome of the transplant.
• Malignancy: Most centers prefer a five-year interval between the treatment for malignancy and transplant consideration. A longer disease-free period may be required, depending on the type and treatment of the malignancy.
• Corticosteroid therapy: In the past, corticosteroid treatment was considered a contraindication to transplantation because of concerns about anastomotic dehiscence. Low-dose steroid therapy (i.e., <20 mg/d) is acceptable in a transplant candidate.
• Psychosocial issues: Individuals who currently smoke, abuse drugs, or drink alcohol heavily are not candidates for transplantation. Patients with other psychosocial issues, such as poor compliance and psychiatric disorders that may complicate post-transplant therapy, are not considered good candidates.
• Infection: In patients with cystic fibrosis, infection with B cepacia is associated with significant mortality rates because this organism is resistant to all antibiotics. Some centers do not offer transplants to patients infected with B cepacia. Also, patients who have active tuberculosis infection are not candidates for transplantation. Nontuberculous mycobacterial colonization is not a contraindication. Aspergillus fumigatus colonization of a patient with cystic fibrosis is only a relative contraindication. These patients are treated with itraconazole prior to transplant in an attempt to eradicate colonization with this fungus. Patients infected with HIV or hepatitis B are not accepted for lung transplantation.
• Body weight: Patients who have cachexia likely have poor nutritional status and would have a poor outcome following transplantation. Obesity also may be a concern because of postoperative atelectasis and pneumonia.
• Extrapulmonary organ dysfunction: Patients with a significant heart, liver, or kidney disease are not transplant candidates. The immunosuppressive drugs are nephrotoxic, and a creatinine clearance of less than 50 mL/min is a risk factor for subsequent development of renal failure. Significant coronary artery disease predisposes a patient to myocardial infarction in the perioperative period. A patient with severe left ventricular systolic or diastolic dysfunction is not a candidate for lung transplantation. The presence of significant liver disease, as indicated by a total bilirubin level of greater than 2 mg/dL, is associated with an unfavorable outcome following transplant. Although the practices of individual transplant centers may vary, patients with systemic connective tissue diseases do not necessarily have unfavorable outcomes if their disease is quiescent. These patients may be considered as transplant candidates on an individual basis.
• Severe osteoporosis is a risk factor for post-transplant complications, and this is a relative contraindication.

General Evaluation
Before you become a transplant candidate, your condition and prospects for success with transplants are thoroughly evaluated by our experienced Transplant Team. Evaluation may occur in the hospital or on an outpatient basis, depending on how well you are able to tolerate moving from one place to another and on the rules imposed by your insurance company.

Potential lung transplant candidates must undergo detailed physical, laboratory, and psychological testing to ensure proper selection and therapy. During your evaluation you will be scheduled for some or all of the following tests:

• Heart catheterization
• Ventilation perfusion lung scan
• Pulmonary function tests
• Blood tests
• Echocardiogram
• Chest CT scan
• Gastric pH/Esophageal Manometry Testing

Other tests may be ordered as part of your lung transplant evaluation, depending on individual circumstances. It will also be important to be sure all your vaccinations are updated prior to having a transplant. During the evaluation, we will ask you about pneumonia, tetanus vaccine, hepatitis B vaccine and the flu vaccine (if in season). Females shall also have updated PAP smears and mammogram.

During your evaluation, you will also need to consider financial, housing, and transportation needs. The transplant financial coordinator and/or social worker can assist in this regard.

When all results are available, the Transplant Team workers will meet and discuss whether or not lung transplantation would be the best treatment for you.  We will communicate our recommendation to you and your physician following the completion of your evaluation. Patients who are not considered candidate for transplantation will be offered alternative medical surgical care if they are available.

Preoperative Evaluation Of Specific Diseases
The appropriate timing for referral to a transplant program is based on the patient’s functional status and life expectancy. A symptomatic patient who is New York Heart Association (NYHA) class III or has a life expectancy of one to two years should be referred for a transplant assessment. The natural history of the specific pulmonary diseases and the knowledge of survival outcome following transplant surgery help the transplant team determine the appropriate timing for placing a patient on a waiting list.

Obstructive airway diseases

In patients with emphysema, survival has improved significantly with long-term oxygen therapy. Forced expiratory volume in one second (FEV1) of less than 30 percent predicted is associated with a 60 percent to 80 percent two-year survival rate; therefore, lung transplantation should be offered to patients with emphysema who have an FEV1 substantially less than 30 percent predicted (i.e., 20 percent of predicted). Associated factors considered are hypoxemia and hypercapnia, weight loss, frequent hospitalizations, and repeated exacerbations.

Restrictive lung diseases
The natural history of various interstitial diseases is quite variable. Idiopathic pulmonary fibrosis is associated with a median survival of approximately five years from the time of diagnosis. Lack of response to steroid therapy and a forced vital capacity (FVC) of less than 67 percent predicted are associated with a 50 percent survival rate at two years. Total lung capacity (TLC) of less than 60 percent predicted is another indicator of poor survival; 60 percent of these patients die within two years. Therefore, severe restrictive disease, hypoxemia, and poor performance status are the criteria used for transplant considerations.

Pulmonary vascular diseases
The median survival for patients with primary pulmonary hypertension is 2.8 years. The indicators of poor survival are NYHA functional class III or IV, elevated mean right atrial pressure, elevated mean pulmonary arterial pressure and decreased cardiac index, and reduced diffusion. Mean pulmonary arterial pressure of greater than 85 mm Hg is associated with a median survival of less than 12 months. A response to vasodilator therapy is associated with improved survival.

Present treatment of choice for NYHA class III and IV patients with pulmonary hypertension is long-term prostacyclin therapy, especially if they fail to demonstrate vasoreactivity during formal vasodilator trial. Prostacyclin has demonstrated improved survival, improved exercise capacity, and better quality of life. Transplant is indicated only if the patients cannot tolerate or fail prostacyclin therapy. In patients who have developed severe right heart failure, the right heart pressures and functions return to near normal values following lung transplantation alone.

Cystic fibrosis and bronchiectasis
These patients develop a high risk of mortality when their FEV1 decreases to 30 percent or less. At this level of FEV, the mortality rate increases to 45 percent at two years. Other indicators of poor prognosis are weight loss, pneumothoraces, frequent hospitalization, hemoptysis (coughing up blood from the oral cavity, larynx, trachea, bronchi or lungs). These patients require bilateral lung transplantation, which may require a longer wait than SLT.

Recently, Theodore Liou and colleagues have validated a five-year survivorship model for cystic fibrosis. This model identified 8 characteristics in addition to FEV1 as a percentage of predicted normal values to accurately predict survival in patients with cystic fibrosis. The other variables included age, gender, weight-for-age z-score, pancreatic insufficiency, diabetes mellitus, infection with Staphylococcus aureus, and infection with Burkholderia cepacia, and annual number of acute pulmonary exacerbations (Liou, 2001). The authors also have developed two worksheets, which help calculate weight-for-age z-score and five-year predicted survival. This survivorship model has potential for use in investigating the effect of novel therapies and assignment of patients on lung transplantation waiting list.

New lungs mean new responsibilities. If we accept you as a transplant candidate, there are many considerations to be aware before making the commitment to a lung transplant.

Among the most important of these is your commitment to change harmful habits that may damage your new lungs. Our program does not consider patients who are currently smoking or who are dependent on alcohol or other mind altering drugs. We require potential recipients to be substance-free for at least six months before being listed for lung transplantation. The Lung Transplant Team at The Mount Sinai Medical Center has ZERO tolerance for tobacco use once a patient has been listed for lung transplantation.

When donor lungs become available for you, there is literally no time for delay. Therefore, you must be available to the Lung Transplant Team members at all times. Patients on the transplant waiting list should stay as healthy as possible. One of the eligibility factors for a transplant is your overall physical health. Follow these tips to stay healthy while you wait:

• See your primary care doctor on a regular basis
• Keep your weight as close to normal as possible
• Don’t miss appointments.  It is important that we maintain current and accurate information to ensure the best care
• Exercise if you’re in good shape – recovery following surgery will be easier
• Follow any recommendation the Transplant Team makes to you in terms of getting lab, x-ray or other tests done so that your transplant is not delayed
• Stay positive, even though it may feel like a long wait until an organ is available. Many studies show that a positive attitude translates into better health
• Make your plan for how you will get to the hospital at time of surgery and for your frequent follow ups

Let your transplant coordinator know if you:

• Change your doctor, insurance carrier, name, home address or phone
• Are admitted to the hospital
• Are, for any reason, not available for transplant
• Undergo any surgical procedure
• Start or stop medications

There are also many issues to consider regarding follow-up care after your transplant. These include:

• Medications: After a lung transplant, you will have many medications to take for the rest of your life. These medications are very expensive.
• Monitoring: You will be asked to record blood pressure, weight, temperature, and lung capacity each day.
• Healthful Habits: After the transplant you will be expected to maintain a well-balanced diet and exercise regularly to keep yourself in good physical condition. You will also be expected to abstain from the use of harmful substances.
• Frequent check-ups: You will need to come to The Mount Sinai Medical Center frequently for outpatient tests and Lung Transplant Clinic visits. We will expect you to keep in close contact with us regarding changes in your health status.

Individual approved for transplant are placed in the Active List and are notified when a donor becomes available. Transplant recipients usually have two to three hours to reach the hospital to prepare for surgery. Time is critical. The lung(s) must be transplanted into the patient receiving the organ ideally within four to six hours.

Depending on the recipient’s need, a single or double lung transplant may be performed. Double lung transplants involve an incision below the breasts and take about 6-12 hours of surgery. For single lung transplants, the incision is made on the side of the body where the lung is to be replaced; the operation takes about four to eight hours. Once the lungs are replaced, the blood vessels and airway are attached. In some cases where the heart has been weakened, both the heart and lungs will be replaced. Until 1989, combined heart-lung transplants were the most common form of lung transplantation. Since then, single lung transplants have become the most common form.

After he/she receives a notice that a compatible donor organ(s) is available, the patient will be admitted to the hospital and prepared for surgery. The transplant physician will do a final evaluation to ensure the patient is still an appropriate candidate for transplantation.

Coordination between the team of surgeons retrieving the organ and the team caring for the recipient patient is vital. Before making the final decisions to proceed with a transplant, the surgeon retrieving the lung carefully examines them and their function to make sure they are viable. Surgery on the transplant recipient is not begun until the surgeon retrieving the organ approves it for transplant. Therefore, a lung transplant candidate could be admitted to the hospital and could even be in the operating room when the procedure is canceled. Once the surgeon retrieving the organ determines that the donor lung is viable, the team will begin surgery. Meanwhile, the retrieval surgeon preserves the lung, transports it the hospital and joins the transplant surgery in progress.

Single Lung Transplant
If you are having a single lung transplant, your incision will be on your side. This is called a thoracotomy incision. It will either be on your right or left side, depending on which lung is being replaced. Once the transplant surgeons are notified that the donor lung is good, they will begin to remove your diseased lung. The diseased lung is totally removed only after the donor lung arrives in the operating room.

These connections, called anastomoses, attach the new lung. First, the donor’s main airway, or bronchus, is attached to your bronchus. Then the blood vessels are attached: first the pulmonary artery, then the pulmonary vein. Once all the connections are made, your chest is closed and you are taken to the Intensive Care Unit. You will be asleep and supported on a ventilator for several hours after the surgery is completed.

Bilateral Lung Transplant
If you are having a bilateral lung transplant, your incision will be across your chest just at the base of your breasts. This is called a transverse sternotomy incision. The bilateral lung transplant is done by replacing each lung separately. As in a single lung transplant, the surgeons do not begin to remove your lungs until they know that the donor lungs are good.

When the donor lungs arrive in the operating room, your first lung (the one with the poorest function) is removed. Once this first lung has been removed, a donor lung will be attached. Again, there will be the same three connections for each lung.

After the first new lung has been attached, your second diseased lung is removed.The other new lung is attached in exactly the same manner as the first. Once the second lung is completely connected, your chest will be closed and you will be taken to the Intensive Care Unit.

Occasionally, cardiopulmonary bypass is necessary to perform the transplant, as in patients with severe pulmonary hypertension or those patients who cannot tolerate single lung ventilation.

Because each individual’s situation is unique, we will address this important issue in the broadest terms. Patients are given many opportunities to discuss their needs and concerns with experienced physicians and caregivers during visits to the transplant center. The following general information usually applies:

• Postoperative Care: Lung transplant recipients usually stay in the hospital for three to four weeks. Education and physical rehabilitation begin soon after surgery and continue in the outpatient pulmonary transplant rehabilitation program after the patient leaves the hospital.
• After-Hospital Care: In the early post-hospital phase, The Mount Sinai Medical Center Transplant Team sees patients several times a week and closely monitor your status. Eventually these visits decrease to less and less frequency. Transplant recipients and their families participate in educational activities to help them feel comfortable with taking medications, monitoring blood pressure and measuring lung function.
• Post-Transplant Immunosuppression: Daily and lifelong immunosuppressive medication is required to prevent rejection of the transplanted lung. The threat of acute rejection is highest in the first 6 months after surgery. To screen for signs of rejection, transplant patients undergo routine chest x-rays and lung function measurements such as spirometry and pulse oximetry.
  If organ rejection is suspected, samples of lung tissue are tested to determine whether rejection has begun or another problem, such as infection, is developing. This procedure is called a bronchoscopy with transbronchial biopsies. Lung transplant patients undergo screening bronchoscopies and biopsies at 1, 3, 6 and 12 months after transplantation and when necessary if signs of rejection are present. These procedures are done under sedation to avoid discomfort.
  Most patients are treated with 3 immunosuppressive drugs to prevent rejection. These medications usually require frequent adjustments, especially soon after transplant. These medications must be given in doses high enough to avoid acute rejection but not so high that the patient becomes vulnerable to infections. Because the likelihood of developing infections soon after transplant is high, patients also are given protective antibiotics to prevent the most common infections that occur after transplant. After a few months, as the body becomes more tolerant of the newly implanted lung, doses of immunosuppressive drugs are progressively lowered, and that makes it possible to slowly discontinue antibiotics.
• Follow-up Care at Home: Once transplant recipients’ health is stable and they have returned home, they should see their primary care physician regularly. They should test their lung volume with a portable spirometry device every day. Each transplant patient is given the necessary equipment and is instructed in its correct use. These measurements provide important and objective information about how well the lungs are working. A decline in the measurements is a signal that patients should be evaluated.
  The Lung Transplant Team continues to care for transplant patients in coordination with their primary care physicians.
• Long-Term Health Issues and Complications of Lung Transplantation: Because transplant patients must take medications that suppress their immune system, they are vulnerable to developing complications from infections. Therefore, patient and their primary care physicians must be on the lookout for signs of potentially serious infections that should be treated early and aggressively.
  Additional complications of lung transplantation, usually caused by side effects of immunosuppressive therapy, include high blood pressure, poor kidney function, weak bones (osteoporosis), weight gain and diabetes. Medications are available to help manage these problems, but a healthy lifestyle, proper diet and exercise are equally important to prescriptions for transplant patients.
  Lung function is also monitored to identify and treat possible chronic rejection, also called obliterans, which is characterized by slowly progressive breathlessness.
  Immunosuppressive therapy also makes transplant recipients more prone to developing tumors and cancer. Therefore, a healthy lifestyle, proper diet, strict avoidance of tobacco products and regular checkups to screen for common preventable cancers, such as breast, cervix, colon, and prostate, are important.

The International Society for Heart and Lung Transplantation and the St Louis International Lung Transplantation Registry report one-year survival rates of 71 percent and five-year survival rates of 45 percent following lung transplantation. Early mortality is caused by bacterial or CMV infections (35 percent), graft failure (13 percent), heart failure (9 percent), rejection (5 percent), bleeding (6 percent), anastomosis failure (5 percent), and other causes (27 percent).

Late mortality is caused by infections (30 percent), obliterative bronchiolitis (29 percent), malignancy (6 percent), respiratory failure (5 percent), bleeding (4 percent), and other causes (26 percent). Infections and obliterative bronchiolitis remain the 2 most challenging issues in the long-term follow-up of patients who have undergone lung transplants.

According to the registry of the International Society of Heart and Lung Transplantation, 1-year, 3-year, and 5-year actuarial survival rates after lung transplantation are 70.7 percent, 54.8 percent, and 42.6 percent, respectively. Median survival is 3.7 years. These rates lag behind those of heart and liver transplantation, for which 5-year actuarial survival is approximately 70 percent.

Whether lung transplantation truly increases survival over the natural history of the underlying disease remains difficult to ascertain in the absence of randomized trials. A survival advantage has been reported for patients with cystic fibrosis and pulmonary fibrosis who have received transplants, but this advantage has not been demonstrated for patients with emphysema.

Patients are referred for transplantation at a point in the course of their disease at which death is considered likely within several years. Therefore, transplantation would be expected to confer a survival advantage. Severe dyspnea and poor quality of life can be additional considerations for lung transplantation.

The mortality rates are highest in the year following transplantation. The leading causes of early death are infections and graft failure. No significant difference in survival exists between recipients of single lung transplants versus recipients of sequential double lung transplants.

Living lobar lung transplantation was developed as a procedure for adult and pediatric patients considered too ill to await cadaveric transplantation. Despite fairly extensive experience, no donor mortality has been reported, and morbidity has been relatively low. Compared to bilateral cadaveric lung transplants, long-term studies have shown that the relatively smaller-sized lobes can provide similar pulmonary function and exercise capacity. Living lobar lung transplantation should be considered in a patient with a clinically deteriorating condition. Although no deaths have been reported in the donor cohort, a risk of death between 0.5 percent and 1 percent should be quoted, pending further data. A case series of 128 living lobar lung transplantations performed in 123 patients between 1993 and 2003 was published. The actuarial survival among the living lobar recipients was 70 percent, 54 percent, and 45 percent, at one, three, and five years, respectively