Introduction
Methods
Results
Baseline characteristic | Total (n = 207) | Direct TAVR (n = 136) | Pre-implantation BAV (n = 71) | P value |
---|---|---|---|---|
Age, mean years ± SD | 77.6 ± 8.7 | 76.8 ± .5 | 78.9 ± 7.5 | 0.08 |
Body mass index, mean kg/m2 ± SD | 28.7 ± 5.7 | 29.1 ± 5.5 | 27.8 ± 6.2 | 0.12 |
Diabetes mellitus, n | 103 (49.7%) | 67 (49.3%) | 36 (50.7%) | 0.76 |
Peripheral vascular disease, n | 93 (44.9%) | 67 (49.3%) | 26 (36.6%) | 0.10 |
Coronary artery bypass grafting, n | 77 (37.2%) | 52 (37.4%) | 25 (35.2%) | 0.87 |
Percutaneous coronary intervention, n | 58 (28.0%) | 38 (27.9%) | 20 (28.2%) | 1.0 |
Stroke/transient ischemic attack, n | 32 (15.4%) | 20 (14.7%) | 12 (16.9%) | 0.70 |
Atrial fibrillation, n | 65 (31.4%) | 45 (33.1%) | 20 (28.2%) | 0.53 |
Chronic obstructive pulmonary disease, n | 77 (37.2%) | 50 (36.7%) | 27 (38.0%) | 0.88 |
Creatinine, mean mg/dl ± SD | 1.29 ± 0.85 | 1.30 ± 0.8 | 1.28 ± 0.4 | 0.89 |
Pre-operative echo | ||||
LVEF, mean mm Hg ± SD | 52.3 ± 10.4 | 52.3 ± 10.9 | 52.4 ± 9.4 | 0.94 |
Mean aortic valve gradient, mean mm Hg ± SD | 40.7 ± 12.2 | 39.1 ± 10.9 | 43.6 ± 14.0 | 0.01 |
Mean gradient < 40 mm Hg, n | 95 (45.9%) | 67 (51.6%) | 28 (40.9%) | 0.21 |
Pre-operative cath | ||||
SVi*, mean cc/m2 ± SD | 36.9 ± 9.5 | 37.6 ± 9.8 | 35.8 ± 8.7 | 0.18 |
SVi < 35 cc/m2, n | 91/205 (44.9%) | 58/135 (42.9%) | 33/70 (47.1%) | 0.65 |
Pulmonary pressure, mean mm Hg ± SD | 27.9 ± 10.2 | 27.5 ± 9.8 | 28.8 ± 10.9 | 0.47 |
Pulmonary pressure (mean ≥ 45 mm Hg)**, n | 10/153 (6.5%) | 6/101 (5.9%) | 4/52 (7.7%) | 0.73 |
Pre-operative CT | ||||
Valve area oversize ≥ 15%***, n | 63/179 (35.2%) | 38/114 (33.3%) | 32/65 (49.2%) | 0.001 |
Procedural details | ||||
General anesthesia, n | 134 (64.7%) | 72 (52.9%) | 62 (87.3%) | < 0.001 |
Conscious sedation, n | 73 (35.3%) | 64 (47.1%) | 9 (12.7%) | < 0.001 |
Native implant, n | 191 (92.3%) | 124 (91.2%) | 67 (80.3%) | 0.58 |
Valve-in-valve implant, n | 16 (7.7%) | 12 (8.8%) | 4 (6.6%) | 0.58 |
Trans-apical access, n | 21 (10.1%) | 12 (8.8%) | 9 (12.7%) | 0.63 |
Trans-femoral access, n | 170 (82.1%) | 109 (77.9%) | 61 (85.9%) | 0.63 |
Balloon expandable valve, n | 193 (93.2%) | 125 (91.9%) | 68 (95.8%) | 0.55 |
Sapien, n | 22 (10.6%) | 6 (4.4%) | 16 (22.5%) | < 0.001 |
Sapien XT, n | 52 (25.1%) | 11 (8.1%) | 41 (57.7%) | < 0.001 |
Sapien S3, n | 119 (57.5%) | 108 (79.4%) | 11 (15.5%) | < 0.001 |
Self expandable valve, n | 14 (6.8%) | 11 (8.1%) | 3 (4.2%) | 0.55 |
CoreValve, n | 9 (4.3%) | 8 (5.9%) | 1 (1.4%) | 0.2 |
Evolut R, n | 5 (2.4%) | 3 (2.2%) | 2 (2.8%) | 1.0 |
Evolut Pro | 0 (0%) | 0 (0%) | 0 (0%) | 1.00 |
Total pacing runs ≥ 2 | 130 (62.8%) | 60 (44.1%) | 70 (98.6%) | < 0.001 |
Contrast, mean cc ± SD | 128.9 ± 51.4 | 128.9 ± 55.7 | 128.7 ± 42.4 | 0.53 |
Total cohort (n = 189) | Direct TAVR (n = 128) | Pre-implantation BAV (n = 61) | P value | |
---|---|---|---|---|
Troponin T mean ng/ml ± SD | 0.10 ± 0.2 | 0.093 ± 0.20 | 0.13 ± 0.18 | 0.16 |
≥ 0.45 (> 15× ULN), n (%) | 5 (2.6%) | 2 (1.6%) | 3 (4.9%) | 0.33 |
≥ 0.3 (> 10× ULN), n (%) | 9 (4.8%) | 4 (3.1%) | 5 (8.2%) | 0.15 |
≥ 0.15 (> 5× ULN), n (%) | 41 (21.7%) | 23 (18.0%) | 18 (29.5%) | 0.09 |
≥ 0.09 (> 3× ULN), n (%) | 71 (37.6) | 42 (32.8%) | 29 (47.5%) | 0.06 |
≥ 0.03 (> ULN), n (%) | 138 (73.0%) | 87 (68.0%) | 51 (83.6%) | 0.02 |
(n = 207) | (n = 136) | (n = 71) | ||
30-day mortality, n (%) | 6 (2.9%) | 5 (3.7%) | 1 (1.4) | 0.66 |
1-year mortality, n (%) | 27 (13.0%) | 16 (11.8%) | 11 (15.5%) | 0.52 |
Periprocedural MI or 1-year mortality, n (%) | 30 (14.5%) | 17 (12.5%) | 13 (18.3%) | 0.30 |
Total cohort (n = 207) | Direct TAVR (n = 136) | Pre-implantation BAV (n = 71) | P value | |
---|---|---|---|---|
Immediate procedure success, n (%) | 202 (97.6%) | 132 (97.1%) | 70 (98.6%) | 0.66 |
30-day mortality, n (%) | 6 (2.9%) | 5 (3.7%) | 1 (1.4%) | 0.66 |
Cardiac mortality, n (%) | 3 (1.4%) | 3 (2.2%) | 0 (0%) | 0.55 |
Stroke, n (%) | 2 (1%) | 2 (1.5%) | 0 (0%) | 0.54 |
Major bleeding, n (%) | 2 (1.0%) | 1 (0.7%) | 1 (1.4%) | 1.0 |
Major vascular complication, n (%) | 4 (1.9%) | 1 (0.7%) | 3 (4.2%) | 0.12 |
Coronary artery obstruction, n (%) | 0 (0%) | 0 (0%) | 0 (0%) | 1.0 |
≥ Moderate paravalvular AI, n (%) | 3 (1.4%) | 0 (0%) | 3 (4.2%) | 0.04 |
Mild paravalvular AI, n (%) | 24 (11.6%) | 13 (9.6%) | 11 (15.5%) | 0.25 |