Table 1.
Baseline characteristics of patients and procedural details for the three self-expanding valves
| CoreValve (n = 116) |
Evolut R (n = 160) |
Evolut PRO (n = 92) |
p-value | |
|---|---|---|---|---|
| Baseline characteristics | ||||
| Male gender | 68 (59%) | 86 (54%) | 42 (46%) | 0.17 |
| Age (years) | 80 (75–84) | 79 (73–84) | 80 (74–85) | 0.32 |
| STS score (%) | 4.3 (3.1–5.7) | 4.2 (2.7–6.4) | 4.3 (2.5–6.5) | 0.86 |
| Creatinine at baseline (µmol/l) | 95 (75–128) | 98 (75–117) | 90 (74–117) | 0.56 |
| Body mass index (kg/m2) | 27 ± 4 | 27 ± 5 | 27 ± 5 | 0.78 |
| Ischaemic heart disease | 53 (46%) | 70 (44%) | 31 (34%) | 0.18 |
| History of AVR/TAVI | 5 (4%) | 14 (9%) | 7 (8%) | 0.36 |
| Diabetes mellitus | 38 (33%) | 44 (28%) | 29 (32%) | 0.66 |
| Hypertension | 87 (75%) | 121 (76%) | 71 (77%) | 0.93 |
| History of atrial fibrillation | 28 (24%) | 47 (29%) | 22 (24%) | 0.52 |
| History of stroke | 21 (18%) | 18 (11%) | 14 (15%) | 0.27 |
| Peripheral arterial disease | 43 (37%) | 80 (50%)c | 27 (29%)c | 0.003 |
| NYHA class ≥3 | 84 (75%)a | 93 (58%)a | 62 (68%) | 0.035 |
| Bicuspid valve (functional) | 9 (8%) | 10 (6%) | 7 (8%) | 0.92 |
| Moderate or severe annulus calcification (Rosenhek) | 92 (79%) | 126 (79%) | 77 (84%) | 0.46 |
| Moderate or severe LVOT calcification | 20 (17%) | 22 (14%) | 14 (15%) | 0.65 |
| Baseline conduction disturbances (alone or in combination) | ||||
| RBBB | 7 (6%) | 15 (10%) | 11 (12%) | 0.32 |
| LBBB | 18 (16%) | 11 (7%) | 6 (7%) | 0.03 |
| UIVD | 3 (3%) | 3 (2%) | 3 (3%) | 0.79 |
| AV1B | 26 (22%) | 28 (18%) | 21 (23%) | 0.52 |
| LAFB | 15 (13%) | 12 (8%) | 4 (4%) | 0.08 |
| LPFB | 1 (1%) | 1 (1%) | 0 (0%) | 0.69 |
| Procedural details | ||||
| Femoral access | 97 (84%)b | 142 (89%) | 89 (97%)b | 0.01 |
| Target access vessel diameter (mm) | 7.0 ± 1.6 | 6.7 ± 1.4c | 7.4 ± 1.3c | 0.002 |
| Sheath to femoral artery ratio | 1.03 (0.87–1.23)a,b | 0.87 (0.75–0.97)a | 0.80 (0.72–0.93)b | <0.005 |
| Valve sizes (mm) | – | |||
| 23 | 2 (2%) | 7 (4%) | 2 (2%) | |
| 26 | 27 (23%) | 49 (31%) | 30 (33%) | |
| 29 | 58 (50%) | 78 (49%) | 60 (65%) | |
| 31 | 29 (25%) | – | – | |
| 34 | – | 26 (16%) | – | |
| Perimeter derived annular diameter (mm) | 25.0 (23.4–26.7)a,b | 23.9 (22.4–25.5)a | 23.8 (22.5–24.9)b | <0.005 |
| Annular sizing ratio | 1.15 (1.10–1.20)a,b | 1.19 (1.15–1.23)a | 1.18 (1.14–1.21)b | <0.005 |
| Depth of implantation (mm) | 7.0 ± 3.2 | 7.0 ± 3.3 | 7.2 ± 2.6 | 0.85 |
| Pre-dilatation | 92 (79%)a,b | 12 (8%)a | 11 (12%)b | <0.005 |
| Post-dilatation | 32 (28%)a | 67 (42%)a | 38 (41%) | 0.03 |
| Repositioning used? | – | 56 (35%) | 17 (19%) | <0.005 |
| One time | 35 | 6 | ||
| Two times | 14 | 7 | ||
| Three times | 4 | 2 | ||
| Four times | 3 | 2 | ||
| Valve in valve during procedure | 8 (7%) | 6 (4%) | 4 (4%) | 0.47 |
| Number of valves implanted | 1, range 1–3 | 1, range 1–3 | 1, range 1–2 | 0.23 |
Categorical variables are shown as n (%). Continuous variables are displayed as mean ± SD, median (interquartile range) or median, range
STS Society of Thoracic Surgeons, AVR aortic valve replacement, TAVI transcatheter aortic valve implantation, NYHA New York Heart Association, RBBB right bundle branch block, LBBB left bundle branch block, UIVD unspecific intraventricular conduction defect, AV1B first-degree atrioventricular block, LAFB left anterior fascicular block, LPFB left posterior fascicular block
a, b, cp < 0.05 for pairwise comparisons with Bonferroni correction