Table 1.
Baseline Participant Characteristics
| iNO (N=98) | iEPO (N=103) | |
|---|---|---|
| Patient Demographics and History | ||
| Age, years | 64 (54, 68) | 64 (51, 69) |
| Sex, male | 59 (60.2%) | 70 (68.0%) |
| Race | ||
| Caucasian/White | 83 (84.7%) | 91 (88.3%) |
| African American | 12 (12.2%) | 9 (8.7%) |
| Other | 3 (3.1%) | 3 (2.9%) |
| BMI | 25.0 (22.1, 26.7) | 26.0 (22.8, 27.3) |
| HTN | 48 (49.0%) | 43 (41.7%) |
| PH Diagnosis | 42 (42.9%) | 54 (52.4%) |
| Severity of PH | ||
| Mild | 6 (6.1%) | 7 (6.8%) |
| Moderate | 29 (29.5%) | 33 (32.0%) |
| Severe | 7 (7.1%) | 14 (13.6%) |
| DM (Types 1 or 2) | 17 (17.3%) | 25 (24.3%) |
| COPD | 34 (34.7%) | 45 (43.7%) |
| aPreoperative LVEF (%) | ||
| Normal (≥ 50%) | 94 (95.9%) | 100 (97.1%) |
| Mild Dysfunction (40%−49%) | 0 (0.0%) | 1 (1.0%) |
| Moderate Dysfunction (30%−39%) | 0 (0.0%) | 1 (1.0%) |
| Previous Sternotomy for Cardiac Surgery | 4 (4.1%) | 2 (1.9%) |
| Previous Lung Transplant | 6 (6.1%) | 4 (3.9%) |
| Lung Allocation Score | 42.0 (36.9, 51.9) | 42.8 (37.2, 52.4) |
| Common Indications for Lung Transplant. | ||
| Group A - Obstructive lung disease | 21 (21.4%) | 21 (20.3%) |
| Group B - Pulmonary vascular disease | 2 (1.9%) | 1 (1.0%) |
| Group C - Infectious lung disease | 8 (8.2%) | 15 (14.6%) |
| Group D - Restrictive lung disease | 63 (64.2%) | 63 (61.2%) |
| bOther | 4 (4.1%) | 3 (2.9%) |
| Preoperative Laboratory Values | ||
| Estimated GFR (ml/min) | 85 (70, 98) | 88 (75, 100) |
| Hemoglobin (g/dL) | 12.30 (1.65) | 12.57 (1.73) |
| Creatinine (mg/dL) | 0.9 (0.7, 1.0) | 0.9 (0.7, 1.0) |
| Class 1 PRA > 0 | 17 (17.3%) | 17 (16.5%) |
| Class 1 PRA % (among those >0) | 17 (7, 75) | 29 (17, 57) |
| Class 2 PRA > 0 | 13 (13.3%) | 13 (12.6%) |
| Class 2 PRA % (among those >0) | 38 (26, 49) | 30 (22, 40) |
| Right Heart Catheterization Values | ||
| Cardiac Index (L/min/m2) | 2.8 (2.5, 3.2) | 2.9 (2.7, 3.3) |
| Mean PAP (mm Hg) | 22.8 (18.3, 27.7) | 24.7 (20.0, 29.7) |
| Procedural Characteristics | ||
| cBilateral Lung Transplantation | 84 (85.7%) | 89 (86.4%) |
| Obstructive Lung Disease | 26 (26.5%) | 31 (30.1%) |
| Restrictive Lung Disease | 52 (53.1%) | 53 (51.5%) |
| Pulm. Vascular Disease | 2 (2.0%) | 1 (1.0%) |
| Other Diagnosisd | 4 (4.1%) | 4 (3.9%) |
| cSingle LT – Restrictive Lung Disease | 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, minutes | 325 (304, 353) | 325 (261, 340) |
| eIschemia time, 2nd Lung only, minutes | 395 (349, 489) | 432 (352, 495) |
| fUse of Transmedics OCS™/EVLP | 4 (4.1%) | 3 (2.9%) |
| Donor Characteristics | ||
| Age, years | 35 (26, 46) | 35 (27, 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 | ||
| Caucasian/White | 72 (73.5%) | 74 (71.8%) |
| African American/Black | 16 (16.3%) | 17 (16.5%) |
| Other | 10 (10.2%) | 12 (11.7%) |
| gBMI of donor-recipient % mismatch | −4.5 (−20.4, 10.0) | −7.5 (−20.3, 7.2) |
| Donor PaO2: FiO2 ratio | 443 (396, 494) | 425 (378, 495) |
| Donor cigarette use > 20 pack years | 11 (11.5%) | 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 (1.1%) | 0 (0.0%) |
| Other | 1 (1.1%) | 3 (2.9%) |
Preoperative LVEF available in 94/98 patients in iNO group and 102/103 participants from iEPO group
Includes diagnoses that were not otherwise classifiable under Group A-D
Randomization strata are based on single or bilateral LT and primary diagnosis for LT
Other Bilateral LT diagnosis in iNO group (N=4): Bronchiolitis obliterans syndrome (N=2), Occupational fiberglass exposure (N=1), Adult Respiratory Distress Syndrome (N=1);
Other Bilateral LT diagnosis in iEPO group (N=4): Bronchiolitis obliterans syndrome (N=2), Coal worker’s pneumoconiosis (N=2)
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 PGD-3 rates.39
Negative percent indicates recipient BMI is less than donor BMI.
BMI, Body mass index; CPB; Cardiopulmonary bypass; CNS, Central nervous system; CVA, Cerebrovascular Accident; ECMO, Extracorporeal membrane oxygenation; EVLP, Ex-vivo lung perfusion; LVEF, Left ventricular ejection fraction; GFR, glomerular filtration rate; OCS, Organ care system; PaO2:FiO2, Partial pressure of arterial oxygen-to-Fraction of inspired oxygen; PAP, pulmonary arterial pressure; PRA, panel-reactive antibody