Table 1. Baseline and procedural characteristics.
SAPIEN 3 (N=113) | Evolut R/PRO (N=123) | Lotus (N=92) | p-value | |
Male | 79 (70%)*¶ | 63 (51%)* | 44 (48%)¶ | 0.002 |
Age, years | 81 [78-85] | 80 [73-84] | 80 [76-84] | 0.26 |
STS score, % | 3.7 [2.4-6.5] | 3.6 [2.5-6.5] | 4.1 [2.8-6.2] | 0.69 |
BMI, kg/m² | 26 [24-29] | 26 [23-31] | 27 [24-30] | 0.45 |
Creatinine at baseline, umol/L | 101 [83-122]* | 86 [71-115]* | 95 [74-119] | 0.02 |
Hypertension | 78 (69%)¶ | 90 (74%) | 78 (85%)¶ | 0.03 |
Hypercholesterolaemia | 63 (56%) | 79 (66%) | 62 (67%) | 0.17 |
PAD | 50 (45%) | 42 (35%) | 38 (41%) | 0.26 |
Atrial fibrillation | 38 (34%) | 35 (29%) | 29 (32%) | 0.72 |
History of stroke | 8 (7%) | 13 (11%) | 13 (14%) | 0.26 |
History of TIA | 12 (11%) | 17 (14%) | 11 (12%) | 0.84 |
Diabetes | 30 (27%) | 39 (32%) | 32 (35%) | 0.43 |
Ischaemic heart disease | 53 (47%) | 41 (33%) | 41 (45%) | 0.08 |
Previous AVR/TAVI | 1 (1%)* | 12 (10%)* | 5 (5%) | 0.009 |
Femoral access | 110 (97%) | 123 (100%) | 92 (100%) | 0.06 |
Predilatation | 13 (12%) | 15 (13%) | 8 (9%) | 0.58 |
Post-dilatation | 22 (21%)*¶ | 52 (45%)*‡ | 1 (1%)¶‡ | 0.0005 |
Use of repositioning | – | 45 (37%) | 27 (29%) | – |
Once | – | 25 | 15 | – |
Twice | – | 11 | 7 | – |
Three times | – | 5 | 1 | – |
Four times | – | 3 | 4 | – |
LVOT calcification | ||||
None | 63 (56%) | 61 (51%) | 54 (61%) | 0.35 |
Mild | 26 (23%) | 33 (27%) | 19 (21%) | |
Moderate | 20 (18%) | 20 (17%) | 9 (10%) | |
Severe | 3 (3%) | 6 (5%) | 7 (8%) | |
Annulus calcification (Rosenhek grading) | ||||
None | 0 (0%) | 3 (2%) | 0 (0%) | 0.09 |
Mild | 3 (3%) | 8 (7%) | 4 (4%) | |
Moderate | 56 (50%) | 53 (43%) | 54 (59%) | |
Severe | 53 (47%) | 59 (48%) | 33 (36%) | |
Aortic valve Agatston score | 3,094 [2,081-4,181] | 2,538 [1,877-3,823] | 2,632 [1,769-3,806] | 0.24 |
(Functional) bicuspid | 16 (14%) | 14 (11%) | 9 (10%) | 0.59 |
Categorical variables are shown as n (%). Continuous variables are displayed as mean±SD or median (interquartile range). *, ¶, ‡ mean p<0.05 for ensuing pairwise comparisons with Bonferroni’s correction. For one patient who underwent Evolut R/PRO TAVI with repositioning, the number of attempts was unknown. AVR: aortic valve replacement; BMI: body mass index; LVOT: left ventricular outflow tract; PAD: peripheral arterial disease; STS: Society of Thoracic Surgeons; TAVI: transcatheter aortic valve implantation; TIA: transient ischaemic attack |