Right-fit care for patients with severe lung disease: From clinical trials to transplant

Dec. 28, 2021

Mayo Clinic sees patients for lung transplant consultations when their lungs aren't performing well: They don't oxygenate or ventilate well. These patients have severe shortness of breath that interferes with their ability to care for themselves or their home, work or family. They may also have damaged, infection-prone lungs, leading to multiple emergency department visits or hospital stays.

Collaborating to determine direction for a patient's treatment

Cassie C. Kennedy, M.D., a lung transplant pulmonologist at Mayo Clinic in Rochester, Minnesota, and Mayo Clinic Lung Transplant Program medical director, acknowledges she asks a lot from patients and families.

"Patients we see typically are on supplemental oxygen, sometimes on a breathing machine nightly, often taking multiple medications or inhalers, and most have limited exercise tolerance. It's challenging for patients to travel cross-country to see us in the lung transplant clinic with advanced lung disease," she says.

However, Dr. Kennedy says sometimes the hometown physician has reached the limit of locally available resources to help these patients, leaving them with poor quality of life and declining health. Mayo Clinic's lung transplant physicians collaborate with physicians at this crossroads to determine how to help patients feel better and potentially live longer, whether through lung transplant or an alternative treatment.

Mayo Clinic's transplant team assesses patients for all appropriate treatments, including available clinical trials, medical therapies, advanced lung procedures and transplant appropriateness. "We do right-fit care for patients. We try to maximize medical therapies, address oxygen needs, introduce pulmonary rehabilitations and offer clinical trials where appropriate," says Dr. Kennedy.

She explains that Mayo Clinic lung transplant specialists often evaluate patients who've exhausted other options and might be transplant candidates. "We've transplanted 29 patients in 2021," says Dr. Kennedy. "We are proud of our excellent one-year post-transplant survival, which is about 95%."

Lung transplant criteria

Although age doesn't automatically eliminate patients from lung transplant consideration, it's harder to be fit enough for the surgery after a certain age. Dr. Kennedy explains that some patients with advanced lung disease are referred for transplant evaluation when their health has significantly declined, and they may be too ill to benefit from transplant. Consequently, Mayo Clinic offers many types of transplant prehabilitation.

"If patients are frail as measured by the six-minute walk test, we'll try to improve their fitness so they can maximally benefit from transplant," she says. "Likewise, if patients are disqualified due to chemical dependence, we have programs to help those patients. If patients are too obese to meet national transplant surgery criteria, we try to help them lose weight so we can get them transplanted."

Most major lung diseases that may lead to transplant have their own guidelines for when transplant surgery evaluation is appropriate. Here are highlights Dr. Kennedy presented at the American Thoracic Society:

Chronic obstructive pulmonary disease (COPD)

  • Calculated BODE index, which considers body mass index, airflow obstruction, dyspnea and exercise, of 7 to 10
  • Frequent exacerbations (more than three in one year) or those requiring hospitalization for blood carbon dioxide level elevation
  • Elevated blood pressure in the lungs (secondary pulmonary hypertension) or right heart damage
  • Severe lung disease on pulmonary function tests (PFTs): forced expiratory volume (FEV1) less than 20% and diffusing capacity of the lung for carbon monoxide (DLCO) less than 20%

Cystic fibrosis

  • Severe lung disease by PFT (FEV1 less than 30% predicted) or rapid FEV1 decline
  • Significantly elevated blood carbon dioxide level
  • Exacerbation requiring intensive care unit or frequent antibiotics
  • Secondary pulmonary hypertension
  • Need for oxygen
  • Lung collapse (pneumothorax) or coughing up blood (hemoptysis)

Idiopathic pulmonary fibrosis (baseline factors)

  • Severe or worsening dyspnea
  • DLCO less than 40% predicted
  • Desaturation less than 88% during six-minute walk test (6MWT)
  • Secondary pulmonary hypertension
  • Severe or worsening scarring on chest CT scan
  • Forced vital capacity (FVC) decline by more than 10% or DLCO by more than 15%

Pulmonary arterial hypertension

  • Shortness of breath with minimal activity or at rest
  • 6MWT less than 350 meters or declining
  • Rapidly progressive disease
  • Certain right heart catheter measurements (cardiac index less than 2; right atrial pressure greater than 15)
  • Use of IV therapy for pulmonary arterial hypertension
  • Hemoptysis, fluid around the heart (pericardial effusion) or progressive right heart failure
  • Heart arrhythmias or fainting

Lung transplant contraindications

According to Dr. Kennedy's summary of a consensus document for lung transplant candidate selection, which was written by Lorriana E. Leard, M.D., and colleagues, and published in The Journal of Heart and Lung Transplantation, the following are absolute contraindications for — or considered very high risk of — lung transplant:

  • Malignancy with high risk of recurrence or death related to cancer
  • Poor kidney, heart or liver function unless multiorgan transplant candidate
  • Recent stroke or heart attack
  • Active sepsis or chronic infection with virulent or resistant organisms
  • Nonadherence or absence of social support
  • Progressive cognitive impairment
  • Substance addiction in past six months
  • Severely overweight or underweight: body mass index (BMI) is 35 kg/m2 or higher or under 16 kg/m2
  • Other severe medical condition limiting survival
  • Severely limited functional status with poor rehab potential
  • Poor esophageal function

How to make a referral

If you'd like a phone consult about next steps, from clinical trials to transplant, regarding a patient with lung disease, call 800-533-1564 or complete an online referral form at Mayo Clinic's website. Mayo Clinic also offers consults and referrals for potential dual listings and heart-lung transplants.

For more information

Lung Transplant Program. Mayo Clinic.

Kennedy CC. Chronic obstructive pulmonary disease. Presentation at: American Thoracic Society 2015 International Conference; May 15-20, 2015; Denver, Colo.

Leard LE, et al. Consensus document for the selection of lung transplant candidates: An update from the International Society for Heart and Lung Transplantation. Journal of Heart and Lung Transplantation. 2021;40:1349.

Transplant Medicine Referrals. Mayo Clinic.