Table 1. Baseline Characteristics of All Patients by Treatment Group.
| Patient Characteristic | Patients, No. (%) | |
|---|---|---|
| IASD Group (n = 22) | Control Group (n = 22) | |
| Demographic factor | ||
| Age, median (IQR), y | 70.5 (67-75) | 71 (64-78) |
| Male | 14 (64) | 8 (36) |
| Race/ethnicity | ||
| Black or African American | 0 | 4 (18) |
| White | 19 (86) | 18 (82) |
| Other | 3 (14) | 0 |
| BMI, median (IQR) | 35.4 (33.4-39.1) |
35.2 (29.9-38.4) |
| Comorbidities/risk factors | ||
| Hypertension | 18 (82) | 20 (91) |
| Hyperlipidemia | 16 (73) | 16 (73) |
| Diabetes | 12 (55) | 12 (55) |
| Cardiopulmonary obstructive disease | 3 (14) | 7 (32) |
| Ischemic heart disease | 5 (23) | 5 (24)a |
| Prior myocardial infarction | 5 (23) | 4 (19)a |
| Prior coronary revascularization | 10 (48)a | 10 (46) |
| Atrial fibrillation | 12 (55) | 10 (45) |
| Atrial flutter | 1 (5) | 2 (9) |
| Stroke | 2 (9) | 3 (14)a |
| Transient ischemic attack | 3 (14) | 2 (9) |
| Peripheral arterial disease | 3 (14) | 2 (9) |
| Pulmonary embolism | 1 (5) | 1 (5) |
| Deep vein thrombosis | 3 (14) | 0a |
| Cardiac status | ||
| Left ventricular ejection fraction, site reported, median (IQR), % | 59.5 (56-65) | 60.0 (55-65) |
| New York Heart Association class | ||
| III | 22 (100) | 21 (96) |
| IV | 0 | 1 (5) |
| Loop diuretic dose (furosemide equivalents), median (IQR), mg | 40 (20-160) | 80 (40-160) |
| Hospitalization or emergency department/acute care visit for heart failure in the past 12 mo | 12 (55) | 16 (72.7) |
| Laboratory data, median (IQR) | ||
| Brain-type natriuretic peptide, pg/mLb | 89.6 (52.5-228.4) |
77 (51-120) |
| N-terminal pro–brain-type natriuretic peptide, pg/mLb | 298.5 (177-981.5) |
754 (236-1829) |
| Estimated glomerular filtration rate, mL/min/1.73 m2 | 50 (33-60) | 50.5 (41-57) |
| Quality of life and exercise tolerance, median (IQR) | ||
| Kansas City Cardiomyopathy Questionnaire, median (IQR) | ||
| Overall summary score | 38.4 (29.2-55.7) | 40 (27.6-53.3) |
| Clinical summary score | 44.3 (34.9-54.2) | 44 (32.8-61.5) |
| EQ-5D scale score, median (IQR) | 0.7 (0.6-0.8) | 0.7 (0.4-0.8) |
| 6-min Walk test distance, median (IQR), m | 299.5 (231-334) | 242.5 (137-320) |
| Echocardiography, median (IQR)c | ||
| LV end-diastolic volume index, mL/m2 | 65.3 (53.1-75.2) |
57.3 (49.4-62.4) |
| LV end-systolic volume index, mL/m2 | 34.6 (26-42.2) | 28.3 (24.2-33.1) |
| LV ejection fraction, % | 47.5 (42.2-53) | 49.5 (45.4-53.3) |
| LA volume index, mL/m2 | 45.6 (34.9-52.8) |
36.5 (28.9-48.4) |
| Septal e′ velocity, cm/s | 6 (5-8) | 6 (5-7) |
| Lateral e′ velocity, cm/s | 8 (7-8) | 6 (5-8) |
| Average E/e′ ratio | 15.2 (10.2-17.5) |
15 (13-17.9) |
| RV end-diastolic volume index, mL/m2 | 19.3 (15.5-24.2) |
17.9 (14.6-24.8) |
| RV end-systolic volume index, mL/m2 | 7.5 (4.8-8.5) | 8.3 (4.6-11.1) |
| RV ejection fraction, % | 65.5 (57.5-73.3) | 65.1 (55.4-70) |
| Tricuspid annular plane systolic excursion, cm | 1.9 (1.7-2.3) | 2 (1.6-2.5) |
| RA volume index, mL/m2 | 29.7 (24-33.6) |
26.1 (18.5-33.7) |
| Estimated RA pressure, mm Hg | 3 (3-3) | 3 (3-3) |
| Invasive hemodynamicsc | ||
| RA pressure, mm Hg | 10.5 (9-12) | 8.5 (6-13) |
| Mean PA pressure, mm Hg | 28 (22-40) | 28 (23-33) |
| Cardiac output, L/min/m | 5.1 (4.3-6.2) | 4.6 (3.9-6.7) |
| Pulmonary vascular resistance, Wood units | 1.9 (1.2-3.1) | 1.2 (1-1.8) |
| Pulmonary capillary wedge pressure, mm Hg | ||
| With legs down | 19 (15-30) | 19 (17-25) |
| With legs up | 26 (22-33) | 22 (15-32) |
| Peak exercise | 38 (34-42) | 35 (33-45) |
| Pulmonary capillary wedge pressure–right atrial pressure gradient at rest | 9 (6-18) | 11 (7-14) |
| Workload-corrected, mm Hg/W/kg | 81.1 (69-97) |
83.5 (62.3-116.9) |
| Exercise duration, min | 7.5 (6-10) | 9.5 (5-11) |
| Peak exercise workload, W | 40 (20-60) | 40 (20-60) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); IQR, interquartile range; EQ-5D, EuroQol 5-dimension scale.
SI conversion factor: To convert picomoles per milliliter to nanograms per liter, multiply by 1.0.
Total patients included in this category were 21 (not 22).
Natriuretic peptide levels were measured locally at each site based on the available type of measurement (brain-type natriuretic peptide or N-terminal pro–brain-type natriuretic peptide). There were no statistically significant differences levels between groups; N-terminal pro–brain-type natriuretic peptide was numerically higher in the control group, and brain-type natriuretic peptide was numerically higher in the interatrial shunt device group. z Scores were calculated and the data was combined so that all patients in the study could be compared on the same scale (ie, via z scores for natriuretic peptide). When examined this way, the 2 treatment groups had identical median values (control group: median [IQR] z score, −0.37 [−0.48 to 0.01]; IASD group: −0.37 [−0.48 to 0.18]).
Measurements were made by independent core laboratories.