Table 6.
Independent prognostic determinants of long-term composite MACCE by univariate and multivariate analyses.
| MACCE (+) (N = 11) | MACCE (-) (N = 45) | Univariate P-value | Multivariate P-value | |
|---|---|---|---|---|
| Baseline characteristics | ||||
| Age, years | 71 ± 7 | 71 ± 13 | 0.912 | |
| Male, n (%) | 8 (73%) | 24 (53%) | 0.409 | |
| Body mass index, kg/m2 | 22.42 ± 2.91 | 24.19 ± 3.93 | 0.166 | |
| Body surface area, m2 | 1.66 ± 0.17 | 1.62 ± 0.17 | 0.481 | |
| Systemic hypertension, n (%) | 8 (73%) | 31 (69%) | 1 | |
| Diabetes mellitus, n (%) | 5 (46%) | 11 (24%) | 0.312 | |
| Dyslipidemia, n (%) | 7 (64%) | 16 (36%) | 0.175 | |
| Current smoker, n (%) | 1 (9%) | 2 (4%) | 1 | |
| Coronary artery disease, n (%) | 6 (55%) | 22 (49%) | 1 | |
| Previous myocardial infarction, n (%) | 2 (18%) | 4 (9%) | 0.727 | |
| Previous percutaneous coronary intervention, n (%) | 5 (46%) | 11 (24%) | 0.312 | |
| Previous coronary artery bypass grafting, n (%) | 1 (9%) | 2 (4%) | 1 | |
| Previous valve surgery, n (%) | 0 (0%) | 0 (0%) | - | |
| Carotid artery disease, n (%) | 0 (0%) | 4 (9%) | 0.709 | |
| Previous stroke, n (%) | 2 (18%) | 7 (16%) | 1 | |
| Peripheral vascular disease, n (%) | 1 (9%) | 5 (11%) | 1 | |
| Previous atrial fibrillation / atrial flutter, n (%) | 4 (36%) | 6 (13%) | 0.177 | |
| Previous permanent pacemaker implantation, n (%) | 0 (0%) | 3 (7%) | 0.894 | |
| Chronic obstructive pulmonary disease, n (%) | 2 (18%) | 2 (4%) | 0.351 | |
| Chronic kidney disease ≧ stage 3, n (%) | 5 (46%) | 9 (20%) | 0.174 | 0.159 |
| Renal dialysis, n (%) | 1 (9%) | 2 (4%) | 1 | |
| Heart failure, NYHA functional class III/IV, n (%) | 9 (82%) | 36 (80%) | 1 | |
| Syncope, n (%) | 1 (9%) | 6 (13%) | 1 | |
| STS-PROM score, % | 8.39 ± 10.07 | 5.45± 5.27 | 0.180 | 0.814 |
| Frailty score | 2.36 ± 1.36 | 1.80 ± 1.14 | 0.163 | |
| Baseline echocardiographic findings | ||||
| Mean gradient, mmHg | 45.18 ± 15.18 | 55.38 ± 24.67 | 0.197 | |
| Aortic valve area, cm2 | 0.64 ± 0.17 | 0.63 ± 0.18 | 0.932 | |
| Aortic regurgitation ≧ moderate, n (%) | 4 (36%) | 8 (18%) | 0.349 | |
| Mitral regurgitation ≧ moderate, n (%) | 3 (27%) | 14 (31%) | 1 | |
| Left ventricular ejection fraction, % | 45.36 ± 18.98 | 54.56 ± 14.58 | 0.083 | 0.713 |
| Pulmonary hypertension (PASP ≧ 60 mmHg), n (%) | 2 (18%) | 4 (9%) | 0.727 | |
| Bicuspid morphology (Sievers classification) | ||||
| Type 0, n (%) | 2 (18%) | 21 (47%) | 0.168 | |
| Type 1, n (%) | 8 (73%) | 22 (49%) | 0.278 | |
| Type 2, n (%) | 1 (9%) | 2 (4%) | 1 | |
| Bicuspid morphology (TAVR-Specific classification) | ||||
| Bicommissural non-Raphe-type, n (%) | 2 (18%) | 21 (47%) | 0.168 | |
| Bicommissural Raphe-type, n (%) | 8 (73%) | 22 (49%) | 0.278 | |
| Tricommissural type, n (%) | 1 (9%) | 2 (4%) | 1 | |
| Distribution of calcium | ||||
| Calcified raphe >4 mm, n (%) | 7 (64%) | 12 (27%) | 0.032 | 0.029 |
| One leaflet, n (%) | 1 (9%) | 10 (22%) | 0.576 | |
| Two leaflets, n (%) | 9 (82%) | 34 (76%) | 0.966 | |
| One commissure, n (%) | 4 (36%) | 13 (29%) | 0.906 | |
| Two commissures, n (%) | 1 (9%) | 1 (2%) | 0.846 | |
| Asymmetrical distribution of calcium, n (%) | 9 (82%) | 33 (73%) | 0.846 | |
| Sino-tubular junction diameter, mm | 29.55 ± 3.76 | 31.45 ± 4.59 | 0.208 | |
| Sinus of Valsalva diameter, mm | 31.31 ± 3.17 | 32.62 ± 3.83 | 0.299 | |
| Left coronary height, mm | 13.70 ± 2.15 | 15.52 ± 3.88 | 0.045 | 0.314 |
| Right coronary height, mm | 16.84 ± 2.59 | 17.88 ± 3.82 | 0.396 | |
| Porcelain aorta, n (%) | 0 (0%) | 0 (0%) | - | |
| Aortic root angle, degree | 51.27 ± 7.50 | 55.36 ± 10.18 | 0.218 | |
| Ascending aorta, 3 cm above the annulus, mm | 39.37 ± 6.20 | 42.72 ± 6.26 | 0.118 | |
| Aortopathy (aortic diameter >4.5 cm), n (%) | 2 (18%) | 18 (40%) | 0.316 | |
| Transcatheter heart valve type | ||||
| ≦23 mm, n (%) | 6 (55%) | 19 (42%) | 0.690 | |
| ≧26 mm, n (%) | 5 (45%) | 26 (58%) | 0.690 | |
| Procedural characteristics | ||||
| Device type (Sapien 3), n (%) | 4 (36%) | 32 (71%) | 0.041 | 0.176 |
| Vascular access | ||||
| Trans-femoral access, n (%) | 11 (100%) | 43 (96%) | 1 | |
| Pre-dilatation, n (%) | 11 (100%) | 38 (84%) | 0.374 | |
| Post-dilatation, n (%) | 7 (64%) | 32 (71%) | 0.906 | |
| Implantation depth from annulus, mm | 2.18 ± 0.85 | 2.33 ± 1.48 | 0.746 | |
| Device success, n (%) | 9 (82%) | 42 (93%) | 0.541 | |
| Procedural success, n (%) | 11 (100%) | 44 (98%) | 1 | |
| 30-day VARC complications | ||||
| Major vascular access complication, n (%) | 0 (0%) | 0 (0%) | - | |
| Acute kidney injury, stage 3, n (%) | 0 (0%) | 0 (0%) | - | |
| Permanent pacemaker implantation for CAVB, n (%) | 1 (9%) | 3 (7%) | 1 | |
| 30-day NYHA functional class III/IV, n (%) | 2 (18%) | 3 (7%) | 0.541 | |
| Hemodynamics by echocardiography at 30-day | ||||
| Mean gradient, mmHg | 8.91 ± 2.84 | 1.47 ± 4.83 | 0.312 | |
| Aortic valve area, cm2 | 1.89 ± 0.33 | 1.87 ± 0.29 | 0.801 | |
| Aortic regurgitation ≧ moderate, n (%) | 2 (18%) | 2 (4%) | 0.351 | |
| Left ventricular ejection fraction, % | 52.55 ± 13.85 | 58.57 ± 11.37 | 0.141 | |
| Pulmonary hypertension (PASP ≧ 60 mmHg), n (%) | 0 (0%) | 3 (7%) | 0.894 |
MACCE, major adverse cardiac cerebral events; NYHA, New York Heart Association; STS-PROM, society for thoracic surgery-probability of mortality score; PASP, pulmonary artery systolic pressure; TAVR, transcatheter aortic valve replacement; VARC, valve academic research consortium; CAVB, complete atrioventricular block.