TABLE 1.

ENROLLMENT CRITERIA

Inclusion Criteria
• History and physical examination consistent with emphysema
• CT scan evidence of bilateral emphysema
• Prerehabilitation postbronchodilator TLC ≥ 100% predicted
• Prerehabilitation postbronchodilator RV ≥ 150% predicted
• Prerehabilitation FEV1 (maximum of pre- and postbronchodilator values) ≤ 45% of predicted and, if age ≥ 70 yr prerehabilitation, FEV1 (maximum of pre- and postbronchodilator values) ≥ 15% of predicted
• Prerehabilitation room air, resting PaCO2 ≤ 60 mm Hg (≤55 mm Hg in Denver)
• Prerehabilitation room air, resting PaO2 ≥ 45 mm Hg (≥30 mm Hg in Denver)
• Prerehabilitation plasma cotinine ≤ 13.7 ng/ml (if not using nicotine products)or prerehabilitation arterial carboxyhemoglobin ≤ 2.5% (if using nicotine products)
• Body mass index ≤ 31.1 (males) or ≤ 32.3 (females) as of randomization
• Nonsmoker (tobacco products) for 4 mo before initial interview
• Approval for surgery by cardiologist if any of the following: unstable angina, left ventricular ejection fraction cannot be estimated from the echocardiogram, left ventricular ejection fraction < 45%, dobutamine-radionuclide cardiac scan indicates coronary artery disease or ventricular dysfunction, >5 premature ventricular beats/min (rest), cardiac rhythm other than sinus or premature atrial contractions noted during resting EKG, S3 gallop on physical examination
• Completion of all prerehabilitation assessments
• Judgment by study physician that patient is likely to be approved for surgery on completion of the rehabilitation program
• Completion of NETT rehabilitation program
• Completion of all postrehabilitation and all randomization assessments
Exclusion Criteria
• CT scan evidence of diffuse emphysema judged unsuitable for LVRS
• Previous LVRS (laser or excision)
• Pleural or interstitial disease that precludes surgery
• Giant bulla (≥one-third of the volume of the lung)
• Clinically significant bronchiectasis
• Pulmonary nodule requiring surgery
• Previous sternotomy or lobectomy
• Myocardial infarction within 6 mo of interview and ejection fraction < 45%
• CHF within 6 mo of interview and ejection fraction < 45%
• Uncontrolled hypertension (systolic > 200 mm Hg or diastolic > 110 mm Hg)
• Pulmonary hypertension: mean Ppa on right heart catheterization ≥ 35 mm Hg (≥38 mm Hg in Denver) or peak systolic Ppa on right heart catheterization ≥ 45 mm Hg (≥50 mm Hg in Denver); right heart catheterization is required to rule out pulmonary hypertension if peak systolic Ppa on echocardiogram > 45 mm Hg
• Unplanned, unexplained weight loss > 10% usual weight in 90 d before interview or unplanned, explained weight loss > 10% usual weight in 90 d before interview
• History of recurrent infections with daily sputum production judged clinically significant
• Daily use of >20 mg of prednisone or its equivalent
• History of exercise-related syncope
• Resting bradycardia (<50 beats/min), frequent multifocal PVCs, or complex ventricular arrhythmia or sustained SVT
• Cardiac dysrhythmia that poses a risk to the patient during exercise testing or training
• Oxygen requirement during resting or oxygen titration exceeding 6 L/min to keep saturation ≥90%
• Evidence of systemic disease or neoplasia that is expected to compromise survival
• Any disease or condition that may interfere with completion of tests, therapy, or follow-up
• 6MWD ≤ 140 m postrehabilitation
• Inability to complete successfully any of the screening or baseline data collection procedures

Definition of abbreviations: 6MWD = 6-minute-walk distance; CHF = congestive heart failure; CT = computed tomography; EKG = electrocardiogram; LVRS = lung volume reduction surgery; NETT = National Emphysema Treatment Trial; Ppa = pulmonary arterial pressure; PVCs = premature ventricular contractions; RV = residual volume; SVT = supraventricular tachycardia; TLC = total lung capacity.

Modified from Reference 17.