Table 1.
Patient Characteristics, Process Components, and Outcomes Across Development and Test Sets
| Overall Cohort (N = 8,332) | Development Set (n = 5,832) | Test Set (n = 2,500) | P Value | |
|---|---|---|---|---|
| Patient characteristics | ||||
| Age (y) | 79.53 ± 8.52 | 79.5 ± 8.54 | 79.61 ± 8.48 | 0.60 |
| Female | 3,662 (44) | 2,575 (44.2) | 1,087 (43.5) | 0.57 |
| STS risk score | 4.04 ± 3.65 | 4.02 ± 3.6 | 4.07 ± 3.75 | 0.56 |
| Preprocedural KCCQ-12 Overall Score | 51.99 ± 24.56 | 51.95 ± 24.62 | 52.11 ± 24.44 | 0.79 |
| Glomerular filtration rate (mL/min) | 66.02 ± 26.29 | 65.94 ± 26.14 | 66.23 ± 26.64 | 0.64 |
| Body mass index (kg/m2) | 27.81 ± 6.52 | 27.85 ± 6.48 | 27.71 ± 6.59 | 0.36 |
| Platelets (per μL) | 208,602 ± 71,218 | 208,882 ± 72,506 | 207,949 ± 68,128 | 0.58 |
| Body surface area (m2) | 1.32 ± 0.47 | 1.32 ± 0.47 | 1.32 ± 0.47 | 0.66 |
| Five-meter walk test (s) | 14.41 ± 18.36 | 14.22 ± 18.18 | 14.85 ± 18.75 | 0.15 |
| Ejection fraction (%) | 58.19 ± 12.54 | 58.18 ± 12.51 | 58.21 ± 12.6 | 0.93 |
| Conduction defect | 2,804 (33.7) | 1,942 (33.3) | 862 (34.5) | 0.30 |
| Atrial fibrillation/flutter | 2,651 (31.8) | 1,859 (31.9) | 792 (31.7) | 0.86 |
| Diabetes mellitus | 2,819 (33.8) | 1,975 (33.9) | 844 (33.8) | 0.93 |
| Prior stroke | 790 (9.5) | 548 (9.4) | 242 (9.7) | 0.69 |
| Prior pacemaker | 939 (11.3) | 662 (11.4) | 277 (11.1) | 0.72 |
| Acute coronary syndrome | 181 (2.2) | 122 (2.1) | 59 (2.4) | 0.44 |
| Prior cardiogenic shock | 23 (0.3) | 15 (0.3) | 8 (0.3) | 0.62 |
| Hostile chest | 393 (4.7) | 266 (4.6) | 127 (5.1) | 0.31 |
| Chronic lung disease | 1,914 (23) | 1,326 (22.7) | 588 (23.5) | 0.44 |
| Prior coronary artery bypass graft | 1,048 (12.6) | 706 (12.1) | 342 (13.7) | 0.05 |
| Prior percutaneous coronary intervention | 2,146 (25.8) | 1,484 (25.5) | 662 (26.5) | 0.32 |
| Prior cardiac arrest | 16 (0.2) | 10 (0.2) | 6 (0.2) | 0.51 |
| Infective endocarditis | 38 (0.5) | 31 (0.5) | 7 (0.3) | 0.12 |
| Current or recent smoker within 1 y | 362 (4.3) | 247 (4.2) | 115 (4.6) | 0.45 |
| Currently on dialysis | 309 (3.7) | 206 (3.5) | 103 (4.1) | 0.19 |
| Immunocompromised | 575 (6.9) | 406 (7) | 169 (6.8) | 0.74 |
| Transient ischemic attack | 599 (7.2) | 426 (7.3) | 173 (6.9) | 0.53 |
| Hypertension | 7,372 (88.5) | 5,158 (88.4) | 2,214 (88.6) | 0.88 |
| Peripheral arterial disease | 1,409 (16.9) | 982 (16.8) | 427 (17.1) | 0.79 |
| Number of previous cardiac surgeries | 0.17 ± 0.42 | 0.16 ± 0.42 | 0.18 ± 0.44 | 0.06 |
| Heart failure hospitalization in the past 2 weeks | 6,525 (78.3) | 4,558 (78.2) | 1,967 (78.7) | 0.59 |
| Previous implantable cardioverter-defibrillator | 183 (2.2) | 132 (2.3) | 51 (2) | 0.52 |
| Prior aortic valve procedure | 151 (1.8) | 96 (1.7) | 55 (2.2) | 0.08 |
| Process characteristics | ||||
| Anesthesia type: moderate sedation | 4,593 (55.1) | 3,215 (55.1) | 1,378 (55.1) | 1.00 |
| Cardiopulmonary bypass | 11 (0.1) | 8 (0.1) | 3 (0.1) | 0.84 |
| Carotid ultrasound | 352 (4.2) | 254 (4.4) | 98 (3.9) | 0.37 |
| Time elapsed between diagnostic catheterization and procedure (days) | 46.7 ± 65.23 | 46.13 ± 64.22 | 47.95 ± 67.51 | 0.24 |
| Closure device used | 7,166 (86.0) | 5,013 (86.0) | 2,153 (86.12) | 0.84 |
| Contrast volume (mL) | 97.9 ± 53.6 | 97.5 ± 53.4 | 98.9 ± 54.1 | 0.30 |
| Direct to step-down (bypass ICU) | 2,237 (26.9) | 1,555 (26.7) | 682 (27.3) | 0.56 |
| 5-m walk documentation compliance | 7,487 (89.9) | 5,249 (90) | 2,238 (89.5) | 0.5 |
| Foley catheter | 575 (6.9) | 409 (7) | 166 (6.6) | 0.54 |
| Intraprocedure inotrope positive | 2,151 (25.8) | 1,506 (25.8) | 645 (25.8) | 0.98 |
| KCCQ-12 documentation compliance | 7,854 (94.3) | 5,497 (94.3) | 2,357 (94.3) | 0.97 |
| Preprocedural length of stay (d) | 0.49 ± 7.22 | 0.55 ± 8.56 | 0.35 ± 1.65 | 0.24 |
| Mechanical assist device placed at start of procedure | 36 (0.4) | 23 (0.4) | 13 (0.5) | 0.42 |
| Pulmonary function testing | 1,318 (15.8) | 915 (15.7) | 403 (16.1) | 0.62 |
| Preprocedure testing | 718 (8.6) | 509 (8.7) | 209 (8.4) | 0.58 |
| Procedure day of the week | 0.90 | |||
| Monday | 1,799 (21.6) | 1,258 (21.6) | 541 (21.6) | |
| Tuesday | 1,315 (15.8) | 920 (15.8) | 395 (15.8) | |
| Wednesday | 2,703 (32.4) | 1,906 (32.7) | 797 (31.9) | |
| Thursday | 1,714 (20.6) | 1,186 (20.3) | 528 (21.1) | |
| Friday | 785 (9.4) | 549 (9.4) | 236 (9.4) | |
| Weekend | 16 (0.2) | 13 (0.2) | 3 (0.1) | |
| Procedure duration (min) | 0.91 ± 0.85 | 0.9 ± 0.82 | 0.94 ± 0.9 | 0.04 |
| Procedural start time (h) | 10.69 ± 2.8 | 10.66 ± 2.79 | 10.75 ± 2.83 | 0.18 |
| Sentinel Protect System | 1,671 (20.1) | 1,161 (19.9) | 510 (20.4) | 0.61 |
| Swan-Ganz catheterization | 540 (6.5) | 379 (6.5) | 161 (6.4) | 0.92 |
| TAVR and percutaneous coronary intervention during admission | 192 (2.3) | 157 (2.7) | 35 (1.4) | <0.01 |
| Valve sheath access method (percutaneous) | 8,249 (99) | 5,777 (99.1) | 2,472 (98.9) | 0.46 |
| Procedure location | 0.21 | |||
| Catheter lab | 2,608 (31.3) | 1,832 (31.4) | 776 (31) | |
| Hybrid cath lab suite | 2,499 (30) | 1,780 (30.5) | 719 (28.8) | |
| Hybrid OR suite | 3,225 (38.7) | 2,220 (38.1) | 1,005 (40.2) | |
| Valve type: balloon expandable | 6,965 (83.6) | 4,860 (83.3) | 2,105 (84.2) | 0.33 |
Values are mean ± SD or n (%). P values < 0.05 are indicated in bold.
ICU = intensive care unit; KCCQ12 = Kansas City Cardiomyopathy Questionnaire 12; OR = operating room; STS = Society of Thoracic Surgeons; TAVR = transcatheter aortic valve replacement.