Table 1.
Baseline characteristics of study participants
| Validation cohort (n = 823) | ||||
|---|---|---|---|---|
| Derivation cohort (n = 604) | Medical University of Warsaw | Hospital Clinico San Carlos | P-value | |
| Age, years | 82 [77–86] | 81 [76–84] | 83 [79–83] | 0.37 |
| Females, n | 345 (57%) | 108 (52%) | 337 (55%) | 0.24 |
| Weight, kg | 73.5 ± 16 | 75 ± 15 | 71 ± 15 | 0.27 |
| Body mass index | 27.1 ± 5.3 | 27.2 ± 4.5 | 27.9 ± 5.2 | 0.41 |
| Bicuspid aortic valve | 53 (9%) | 17 (8%) | 43 (7%) | 0.50 |
| EuroScore II | 4.8 [3.0–6.3] | 5.1 [3.3–7.4] | 4.5 [2.9–7.3] | 0.29 |
| Comorbidities and past medical history | ||||
| Diabetes | 226 (37%) | 72 (35%) | 208 (34%) | 0.53 |
| Atrial fibrillation | 206 (34%) | 79 (38%) | 248 (40%) | 0.31 |
| History of ACS | 130 (21.5%) | 35 (17%) | 97 (16%) | 0.25 |
| History of PCI | 175 (29%) | 74 (36%) | 149 (24%) | 0.19 |
| History of CABG | 77 (13%) | 22 (11%) | 63 (10%) | 0.22 |
| History of valve surgery | 24 (4%) | 10 (5%) | 31 (5%) | 0.28 |
| History of pacemaker implantation | 86 (14%) | 36 (17%) | 82 (13%) | 0.33 |
| History of a cerebrovascular accident | 77 (13%) | 21 (10%) | 57 (9%) | 0.23 |
| Baseline biomarkers | ||||
| Creatinine, mg/dL | 1.1 [0.9–1.4] | 1.1 [0.8–1.5] | 1.0 [0.8–1.3] | 0.51 |
| eGFR, mL/m2 | 55 [42–70] | 54 [36–79] | 59 [44–74] | 0.38 |
| Haemoglobin, g/dL | 12.4 [11.2–13.3] | 11.4 [10.3–12.8] | 12.3 [11.0–13.3] | 0.43 |
| Platelets, n/dL | 174 [138–219] | 193 [150–231] | 187 [156–230] | 0.32 |
| Baseline echocardiography | ||||
| Left ventricular ejection fraction, % | 55 [50–65] | 58 [46–64] | 55 [50–65] | 0.26 |
| Effective orifice area, cm2 | 0.6 [0.5–0.8] | 0.7 [0.5–0.9] | 0.6 [0.5–0.8] | 0.36 |
| Peak transvalvular pressure gradient, mmHg | 86 [70–104] | 77 [61–96] | 76 [61–90] | 0.29 |
| Mean transvalvular pressure gradient, mmHg | 49 [39–62] | 43 [34–51] | 44 [38–55] | 0.27 |
| Procedure—valve implantation | ||||
| Contrast media volume, mL | 190 [150–200] | 200 [150–250] | 164 [137–200] | 0.38 |
| Fluoroscopy time, min | 24 [20–35] | 31 [21–45] | 25 [18–31] | 0.23 |
| Radiation dose, mGy | 1051 [608– 1737] | 1251 [810–2004] | 1134 [682–1680] | 0.28 |
| Peri- and post-procedural outcomes | ||||
| Major vascular complication | 30 (5%) | 12 (6%) | 25 (4%) | 0.27 |
| Minor vascular complication | 57 (9%) | 10 (5%) | 69 (11%) | 0.034 |
| Life threatening bleeding | 24 (4%) | 10 (5%) | 22 (4%) | 0.31 |
| Major bleeding | 80 (13%) | 21 (10%) | 27 (4%) | 0.001 |
| Minor bleeding | 86 (14%) | 19 (9%) | 95 (15%) | 0.11 |
| Total RBC concentrate transfused, units | 0 [0–1] | 0 [0–1] | 0 [0–1] | 0.38 |
| Peri-procedural myocardial infarction | 4 (1%) | 3 (1%) | 8 (1%) | 0.12 |
| Peri-procedural stroke | 11 (2%) | 3 (1%) | 9 (1%) | 0.38 |
| Coronary occlusion | 4 (1%) | 2 (1%) | 4 (1%) | 0.24 |
| Annulus rupture | 3 (1%) | 0 | 1 (0%) | 0.30 |
| Pacemaker implantation | 92 (15%) | 38 (18%) | 96 (16%) | 0.41 |
| Post-procedural biomarkers | ||||
| Minimum haemoglobin, g/dL | 10.2 [9.3–11.1] | 10.7 [9.7–12.0] | 10.1 [8.9–11.0] | 0.36 |
| Minimum platelets, n/dL | 105 [81–137] | 124 [96–162] | 116 [93–147] | 0.29 |
| Minimum eGFR, mL/m2 | 58 [42–84] | 52 [38–81] | 54 [37–70] | 0.34 |
| Post-procedural echocardiography | ||||
| Left ventricular ejection fraction, % | 60 [50–65] | 58 [48–65] | 60 [54–67] | 0.42 |
| Peak transvalvular pressure gradient, mmHg | 16 [12–23] | 14 [9–17] | 17 [12–23] | 0.26 |
| Mean transvalvular pressure gradient, mmHg | 7 [3–11] | 8 [6–11] | 8 [6–12] | 0.61 |
| Aortic insufficiency ≥ moderate | 85 (14%) | 18 (9%) | 82 (13%) | 0.16 |
| Hospitalization length (days) | 9 [7–15] | 8 [6–14] | 6 [5–9] | 0.07 |
Statistics presented: median [quartile 1–quartile 3], n (%). Abbreviations: ACS, acute coronary syndrome; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting; and eGFR, estimated glomerular filtration rate.