Table 1.
Clinical characteristics and outcomes of patients with heart failure based on Food and Drug Administration eligibility criteria for transcatheter mitral valve repair
| Variable | Overall (N = 50,841) | FDA+ (N = 2461) | FDA- (N = 48,380) | p-Value |
|---|---|---|---|---|
| Age, mean (SD), years | 75.5 (12.7) | 75.3 (12.7) | 75.5 (12.7) | 0.28 |
| Women, n (%) | 22,583 (44.4) | 1157 (47.0) | 21,426 (44.3) | <0.01 |
| Race/ethnicity, n (%) | <0.001 | |||
| Non-Hispanic White | 30,970 (60.9) | 1446 (58.8) | 29,524 (61.0) | |
| Non-Hispanic Black | 5228 (10.3) | 342 (13.9) | 4886 (10.1) | |
| Hispanic | 5839 (11.5) | 295 (12.0) | 5544 (11.5) | |
| Asian/Pacific Islander | 5726 (11.3) | 255 (10.4) | 5471 (11.3) | |
| Missing | 3078 (6.1%) | 123 (5.0) | 2955 (6.1) | |
| Past medical history, n (%) | ||||
| Heart failure hospitalization within prior 1 y | 1355 (2.7) | 1054 (42.8) | 301 (0.6) | <0.001 |
| STS Risk Score, mean (SD), %∗ | 4.6 (3.1) | 4.1 (2.7) | 4.6 (3.1) | |
| Atrial fibrillation and/or flutter | 25,027 (49.2) | 1422 (57.8) | 23,605 (48.8) | <0.001 |
| Coronary artery disease | 9984 (19.6) | 594 (24.1) | 9390 (19.4) | <0.001 |
| Acute myocardial infarction | 5649 (11.1) | 336 (13.7) | 5313 (11.0) | <0.001 |
| Prior coronary artery bypass grafting | 1809 (3.6) | 95 (3.9) | 1714 (3.5) | 0.41 |
| Prior percutaneous coronary intervention | 6820 (13.4) | 394 (16.0) | 6426 (13.3) | <0.001 |
| Implantable cardioverter-defibrillator | 2836 (5.6) | 285 (11.6) | 2551 (5.3) | <0.001 |
| Cardiac resynchronization therapy | 642 (1.3) | 8 (0.3) | 634 (1.3) | <0.001 |
| Ischemic stroke/transient ischemic attack | 7984 (15.7) | 439 (17.8) | 7545 (15.6) | <0.01 |
| Peripheral artery disease | 5167 (10.2) | 295 (12.0) | 4872 (10.1) | <0.01 |
| Chronic kidney disease | 25,948 (51.0) | 1450 (58.9) | 24,498 (50.6) | <0.001 |
| Chronic liver disease | 3281 (6.5) | 144 (5.9) | 3137 (6.5) | 0.21 |
| Chronic lung disease | 14,004 (27.5) | 668 (27.1) | 13,336 (27.6) | 0.65 |
| Anemia | 20,764 (40.8) | 1239 (50.3) | 19,525 (40.4) | <0.001 |
| Labs, median (interquartile range) | ||||
| B-type natriuretic peptide, pg/mL | 495 (231-1043) | 951 (462-1809) | 475 (222-998) | <0.001 |
| eGFR, mL/min/1.73m2, n (%) | <0.001 | |||
| ≥60 | 20,562 (40.4) | 849 (34.5) | 19,713 (40.7) | |
| 45-59 | 10,514 (20.7) | 496 (20.2) | 10,018 (20.7) | |
| 30-44 | 8746 (17.2) | 497 (20.2) | 8249 (17.1) | |
| 15-29 | 4399 (8.7) | 307 (12.5) | 4092 (8,5) | |
| <15 | 845 (1.7) | 46 (1.9) | 808 (1.7) | |
| Dialysis | 1408 (2.8) | 104 (4.2) | 1331 (2.8) | |
| Missing | 4331 (8.5) | 162 (6.6) | 4169 (8.6) | |
| Echocardiogram parameters | ||||
| Left ventricular end-systolic diameter, cm | 3.6 (2.9-4.4) | 4.4 (3.7-5.1) | 3.5 (2.9-4.3) | <0.001 |
| Left ventricular end-diastolic diameter, cm | 5.0 (4.4-5.6) | 5.6 (5.0-6.2) | 5.0 (4.4-5.6) | <0.001 |
| Missing, n (%) | 9530 (18.7) | 178 (7.2) | 9352 (19.3) | |
| Left ventricular ejection fraction, % | 54 (38-60) | 35 (25-45) | 55 (40-60) | <0.001 |
| Qualitative left ventricular systolic function assessment, n (%) | <0.001 | |||
| Preserved | 29,112 (57.3) | 0 (0.0) | 29,112 (60.2) | |
| Mildly reduced | 5826 (11.5) | 736 (29.9) | 5090 (10.5) | |
| Moderately reduced | 9936 (19.5) | 968 (39.3) | 8968 (18.5) | |
| Severely reduced | 5967 (11.7) | 757 (30.8) | 5210 (10.8) | |
| Mitral regurgitation severity, n (%) | <0.001 | |||
| Trace | 231 (0.5) | 0 (0.0) | 231 (0.5) | |
| Mild | 15,451 (30.4) | 0 (0.0) | 15,451 (31.9) | |
| Mild to moderate | 3776 (7.4) | 0 (0.0) | 3776 (7.8) | |
| Moderate | 3920 (7.7) | 0 (0.0) | 3920 (8.1) | |
| Moderate to severe | 2055 (4.0) | 1586 (64.4) | 469 (1.0) | |
| Severe | 1184 (2.3) | 875 (35.6) | 309 (0.6) | |
| None | 24,224 (47.6) | 0 (0.0) | 24,224 (50.1) | |
| Left atrium size, n (%) | <0.001 | |||
| Normal | 11,201 (22.5) | 364 (15.3) | 10,837 (22.9) | |
| Mildly dilated | 10,887 (21.9) | 463 (19.5) | 10,424 (22.0) | |
| Moderately dilated | 7522 (15.1) | 432 (18.2) | 7090 (15.0) | |
| Severe dilated | 13,472 (27.1) | 1104 (46.5) | 12,368 (26.1) | |
| Missing | 6654 (13.4) | 9 (0.4) | 6645 (14.0) | |
| Medications, n (%) | ||||
| ACEi/ARB/ARNi | 30,323 (59.6) | 1751 (71.1) | 28,572 (59.1) | <0.001 |
| β-blocker | 37,800 (74.3) | 2189 (88.9) | 35,611 (73.6) | <0.001 |
| Mineralocorticoid receptor antagonist | 5578 (11.0) | 507 (20.6) | 5071 (10.5) | <0.001 |
| Digoxin | 4615 (9.1) | 420 (17.1) | 4195 (8.7) | <0.001 |
| Nitrates | 8871 (17.4) | 677 (27.5) | 8194 (16.9) | <0.001 |
| Hydralazine | 6829 (13.4) | 484 (19.7) | 6345 (13.1) | <0.001 |
| Loop Diuretic | 30,870 (60.7) | 2008 (81.6) | 28,862 (59.7) | <0.001 |
| Outcomes, per 100 person years (95% confidence) | ||||
| All-cause ED visit | 196.1 (195.1-197.0) | 210.3 (205.1-215.6) | 193.6 (192.6-194.6) | <0.001 |
| HF ED visit | 8.2 (8.0-8.4) | 13.9 (12.6-15.3) | 7.7 (7.5-7.9) | <0.001 |
| All-cause hospitalization | 78.2 (77.5-78.8) | 86.8 (83.5-90.2) | 76.6 (76.0-77.3) | <0.001 |
| HF hospitalization | 3.8 (3.6-3.9) | 12.5 (11.3-13.8) | 3.8 (3.6-3.9) | <0.001 |
| All-cause death | 23.5 (23.1-23.8) | 39.2 (37.0-41.5) | 23.2 (22.9-23.6) | <0.001 |
Abbreviations: ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNi, angiotensin receptor-neprilysin inhibitor; ED, emergency department; eGFR, estimated glomerular filtration rate; FDA, Food and Drug Administration; HF, heart failure; n, number; SD, standard deviation; STS, Society of Thoracic Surgeons.
∗
Predicted 30-d mortality for isolated mitral valve replacement.