Table 1. Comparison of Baseline Characteristics Between Patients With Off-label vs On-Label TAVR Use.
| Characteristic | Patients, No. (%)a | |||
|---|---|---|---|---|
| Overall (n = 23 847) |
Off-label Use (n = 2272) |
On-label Use (n = 21 575) |
P Value | |
| Age, median (IQR), y | 84 (78-88) | 83 (76-88) | 84 (78-88) | <.001 |
| Male sex | 11 971 (50.2) | 1176 (51.8) | 10 795 (50.0) | .13 |
| Race | ||||
| White | 22 401 (93.9) | 2104 (92.6) | 20 297 (94.1) | .004 |
| Black | 888 (3.7) | 87 (3.8) | 801 (3.7) | |
| Insurance payor | ||||
| Private | 15 080 (63.2) | 1443 (63.5) | 13 637 (63.2) | .54 |
| Public | 8695 (36.5) | 823 (36.2) | 7872 (36.5) | |
| Prior PCI | 8481 (35.6) | 785 (34.6) | 7696 (35.7) | .31 |
| Prior CABG | 7516 (31.5) | 693 (30.5) | 6823 (31.6) | .27 |
| Prior aortic valve procedure | 3864 (16.2) | 452 (19.9) | 3412 (15.8) | <.001 |
| Surgical aortic valve repair or replacementb | 517 (13.4) | 90 (19.9) | 427 (12.5) | <.001 |
| Balloon aortic valvuloplastyb | 3333 (86.3) | 366 (81.0) | 2967 (87.0) | <.001 |
| TAVRb | 60 (1.6) | 11 (2.4) | 49 (1.4) | .11 |
| Prior stroke | 2917 (12.2) | 277 (12.2) | 2640 (12.2) | .95 |
| Prior CEA or CAS | 1790 (8.9) | 161 (8.7) | 1629 (9.0) | .66 |
| Porcelain aorta | 1655 (7.0) | 139 (6.1) | 1516 (7.1) | .10 |
| Peripheral arterial disease | 7519 (31.5) | 677 (29.8) | 6842 (31.7) | .06 |
| Current or recent smoker | 1253 (5.3) | 155 (6.8) | 1098 (5.1) | <.001 |
| Hypertension | 21 206 (88.9) | 1939 (85.3) | 19 267 (89.3) | <.001 |
| Diabetes | 8855 (37.1) | 756 (33.3) | 8099 (37.5) | <.001 |
| Dialysis | 976 (4.1) | 111 (4.9) | 865 (4.0) | .05 |
| Severe chronic lung disease | 3258 (13.7) | 321 (14.1) | 2937 (13.6) | .55 |
| Prior myocardial infarction | 6007 (25.2) | 578 (25.4) | 5429 (25.2) | .78 |
| NYHA class III or IV within 2 wk | 19 433 (81.5) | 1898 (83.5) | 17 535 (81.3) | .007 |
| Cardiogenic shock within 24 h | 118 (0.5) | 14 (0.6) | 104 (0.5) | .39 |
| Atrial fibrillation or flutter | 9726 (40.8) | 961 (42.3) | 8765 (40.6) | .14 |
| Predicted mortality, STS aortic valve replacement mortality model, median (IQR), % | 6.8 (4.5-10.4) | 7.2 (4.5-11.2) | 6.8 (4.5-10.3) | .003 |
| Creatinine level of 2 mg/dL | 2185 (9.2) | 211 (9.3) | 1974 (9.2) | .80 |
| LVEF<30% | 1686 (7.1) | 227 (10.0) | 1459 (6.8) | <.001 |
| Degenerative aortic valve disease | 22 395 (93.9) | 2032 (89.4) | 20 363 (94.4) | <.001 |
| Aortic valve mean gradient, median (IQR), mm Hg | 43 (36-52) | 41 (32-51) | 43 (36-52) | <.001 |
| Elective procedure status | 21485 (90.1) | 1960 (86.3) | 19 525 (90.5) | <.001 |
| Femoral access site | 14 331 (60.1) | 1380 (60.7) | 12 951 (60.0) | .51 |
| Device success | 22 160 (92.9) | 2090 (92.0) | 20070 (93.0) | .02 |
| Hospital Characteristics | ||||
| Location | ||||
| Urban | 17643 (74.0) | 1764 (77.6) | 15 879 (73.6) | <.001 |
| Suburban | 5129 (21.5) | 420 (18.5) | 4709 (21.8) | |
| Rural | 1075 (4.5) | 88 (3.9) | 987 (4.6) | |
| Type | ||||
| Private or community | 15 540 (65.2) | 1550 (68.2) | 13 990 (64.8) | .002 |
| University | 8037 (33.7) | 705 (31.0) | 7332 (34.0) | |
| Government | 270 (1.1) | 17 (0.8) | 253 (1.2) | |
| Teaching hospital | 17 389 (72.9) | 1656 (72.9) | 15 733 (72.9) | .97 |
| TAVR volume, median (IQR) | 110 (69-170) | 122 (74-171) | 107 (69-170) | .002 |
Abbreviations: CABG, coronary artery bypass graft; CAS, carotid artery stenting; CEA, carotid endarterectomy; IQR, interquartile range; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; STS, Society of Thoracic Surgeons; TAVR, transcatheter aortic valve replacement.
SI conversion factor: to convert creatinine to micromoles per liter, multiply by 88.4.
a
If the percentages do not add up to 100%, it is owing to missing values in the registry.
b
Assessed in patients with prior aortic valve procedure.