Table 1. Baseline Characteristicsa.
| Characteristic | Treatment group | |
|---|---|---|
| iNO (n = 98) | iEPO (n = 103) | |
| Patient characteristics | ||
| Age, median (IQR), y | 64 (54 to 68) | 64 (51 to 69) |
| Sex | ||
| Male | 59 (60.2) | 70 (68.0) |
| Female | 39 (39.8) | 33 (32.0) |
| Race and ethnicity | ||
| African American or Black | 12 (12.2) | 9 (8.7) |
| White | 83 (84.7) | 91 (88.3) |
| Otherb | 3 (3.1) | 3 (2.9) |
| BMI, median (IQR) | 25.0 (22.1 to 26.7) | 26.0 (22.8 to 27.3) |
| Hypertension | 48 (49.0) | 43 (41.7) |
| Pulmonary hypertension diagnosis | 42 (42.9) | 54 (52.4) |
| Severity of pulmonary hypertension | ||
| Mild | 6 (6.1) | 7 (6.8) |
| Moderate | 29 (29.5) | 33 (32.0) |
| Severe | 7 (7.1) | 14 (13.6) |
| Type 1 or 2 diabetes | 17 (17.3) | 25 (24.3) |
| COPD | 34 (34.7) | 45 (43.7) |
| Preoperative LVEF, %c | ||
| ≥50 (Normal) | 94 (95.9) | 100 (97.1) |
| 40-49 (Mild dysfunction) | 0 | 1 (1.0) |
| 30-39 (Moderate dysfunction) | 0 | 1 (1.0) |
| Previous sternotomy for cardiac surgery | 4 (4.1) | 2 (1.9) |
| Previous LT | 6 (6.1) | 4 (3.9) |
| Lung allocation score | 42.0 (36.9 to 51.9) | 42.8 (37.2 to 52.4) |
| Common indications for LT | ||
| Group A: obstructive lung disease | 21 (21.4) | 21 (20.4) |
| Group B: pulmonary vascular disease | 2 (2.0) | 1 (1.0) |
| Group C: infectious lung disease | 8 (8.2) | 15 (14.6) |
| Group D: restrictive lung disease | 63 (64.3) | 63 (61.2) |
| Otherd | 4 (4.1) | 3 (2.9) |
| Preoperative laboratory values | ||
| Estimated GFR, median (IQR), mL/min | 85 (70 to 98) | 88 (75 to 100) |
| Hemoglobin level, mean (SD), g/dL | 12.30 (1.65) | 12.57 (1.73) |
| Creatinine level, median (IQR), mg/dL | 0.9 (0.7 to 1.0) | 0.9 (0.7 to 1.0) |
| Class 1 PRA >0 | 17 (17.3) | 17 (16.5) |
| Class 1 PRA, median (IQR), % among those >0 | 17 (7 to 75) | 29 (17 to 57) |
| Class 2 PRA >0 | 13 (13.3) | 13 (12.6) |
| Class 2 PRA, median (IQR), % among those >0 | 38 (26 to 49) | 30 (22 to 40) |
| Right heart catheterization values | ||
| Cardiac index, median (IQR), L/min/m2 | 2.8 (2.5 to 3.2) | 2.9 (2.7 to 3.3) |
| Mean PAP, median (IQR), mm Hg | 22.8 (18.3 to 27.7) | 24.7 (20.0 to 29.7) |
| Procedural characteristics | ||
| Bilateral LTe | 84 (85.7) | 89 (86.4) |
| Obstructive lung disease | 26 (26.5) | 31 (30.1) |
| Restrictive lung disease | 52 (53.1) | 53 (51.5) |
| Pulmonary vascular disease | 2 (2.0) | 1 (1.0) |
| Other diagnosisf | 4 (4.1) | 4 (3.9) |
| Single LT for restrictive lung diseasee | 14 (14.3) | 14 (13.6) |
| Concurrent cardiac operation | 7 (7.1) | 7 (6.8) |
| Intraoperative CPB used | 19 (19.4) | 19 (18.4) |
| Intraoperative ECMO used | 33 (33.7) | 27 (26.2) |
| Ischemia time, single LT only, median (IQR), min | 325 (304 to 353) | 325 (261 to 340) |
| Ischemia time, second LT only, median (IQR), ming | 395 (349 to 489) | 432 (352 to 495) |
| Use of transmedics OCS/EVLPh | 4 (4.1) | 3 (2.9) |
| Donor characteristics | ||
| Age, median (IQR), y | 35 (26 to 46) | 35 (27 to 47) |
| Sex donor-to-recipient mismatch | ||
| Matched | 78 (79.6) | 69 (67.0) |
| Female donor to male recipient | 6 (6.1) | 16 (15.5) |
| Male donor to female recipient | 14 (14.3) | 18 (17.5) |
| Race and ethnicity | ||
| African American or Black | 16 (16.3) | 17 (16.5) |
| White | 72 (73.5) | 74 (71.8) |
| Otheri | 10 (10.2) | 12 (11.7) |
| BMI of donor-recipient mismatch, median (IQR), %j | –4.5 (–20.4 to 10.0) | –7.5 (–20.3 to 7.2) |
| Donor Pao2:Fio2 ratio, median (IQR) | 443 (396 to 494) | 425 (378 to 495) |
| Donor cigarette use >20 pack-years | 11 (11.2) | 10 (9.7) |
| Donation after cardiac death | 10 (10.2) | 13 (12.6) |
| Donation after brain death | 88 (89.8) | 90 (87.4) |
| Cause of brain death | ||
| Anoxia | 33 (33.7) | 30 (29.1) |
| CVA/stroke | 26 (26.5) | 29 (28.2) |
| Head trauma | 37 (37.8) | 41 (39.8) |
| CNS tumor | 1 (1.0) | 0 |
| Other | 1 (1.0) | 3 (2.9) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CNS, central nervous system; COPD, chronic obstructive pulmonary disease; CPB, cardiopulmonary bypass; CVA, cerebrovascular accident; ECMO, extracorporeal membrane oxygenation; EVLP, ex vivo lung perfusion; GFR, glomerular filtration rate; iEPO, inhaled epoprostenol; iNO, inhaled nitric oxide; LT, lung transplant; LVEF, left ventricular ejection fraction; OCS, organ care system; Pao2:Fio2, ratio of partial pressure of arterial oxygen to fraction of inspired oxygen; PAP, pulmonary arterial pressure; PRA, panel-reactive antibody.
SI conversion factors: To convert creatinine to μmol/L, multiply by 88.4; hemoglobin to g/L, multiply by 10.0.
Unless otherwise indicated, data are expressed as number (%) of patients. Percentages have been rounded and may not total 100.
Includes American Indian, Asian, multiple races/ethnicities, and unknown race or ethnicity.
Available in 94 of 98 patients in the iNO group and 102 of 103 participants in the iEPO group.
Includes diagnoses that were not otherwise classifiable under groups A to D.
Randomization strata are based on single or bilateral LT and primary diagnosis for LT.
Includes bronchiolitis obliterans syndrome (n = 2), occupational fiberglass exposure (n = 1), and adult respiratory distress syndrome (n = 1) in the iNO group and bronchiolitis obliterans syndrome (n = 2) and coal worker’s pneumoconiosis (n = 2) in the iEPO group.
By convention, for bilateral LT, the ischemia time of the second lung only is reported.
Organ care system (Transmedics OCS) use during lung-allograft transport after donor harvest has shown promise in reducing rates of grade 3 primary graft dysfunction.39
Includes Asian, Hispanic, and multiple races/ethnicities.
Negative percentage indicates recipient BMI is less than donor BMI.