|
Procedural characteristics
|
|
Fluoroscopy time, min
|
17.2 (13.1, 24.6)
|
19.5 (14.5, 26.8)
|
0.04
|
|
Procedure time, min
|
75.0 (60.0, 95.0)
|
80.0 (65.0, 105.6)
|
0.01
|
|
Contrast, mL
|
178.0 (135.0, 224.1)
|
179.0 (139.4, 225.6)
|
0.43
|
|
Type of valve
|
Balloon-expandable¶
|
192 (53.6)
|
112 (31.3)
|
<0.001
|
|
Self-expanding#
|
148 (41.3)
|
187 (52.2)
|
0.004
|
|
Mechanically expandable◊
|
18 (5.0)
|
59 (16.5)
|
<0.001
|
|
Predilation
|
268 (75.1)
|
276 (77.5)
|
0.49
|
|
Ratio balloon pre/annulus size, %
|
–7.5±6.2
|
–8.8±5.2
|
0.01
|
|
Post-dilation
|
121 (34.0)
|
127 (35.8)
|
0.67
|
|
Ratio balloon post/annulus size, %
|
–0.0±5.1
|
–0.7±5.0
|
0.32
|
|
Oversizing, area %
|
13.7 (5.7, 22.4)
|
10.9 (3.7, 23.0)
|
0.12
|
|
CEP, %
|
49 (13.7)
|
75 (21.1)
|
0.01
|
|
Procedural outcome and complications
|
|
Technical success§
|
315 (89.0)
|
299 (84.5)
|
0.10
|
|
Valve-dislocation/malposition
|
6 (1.7)
|
10 (2.8)
|
0.44
|
|
Bail-out valve-in-valve
|
5 (1.4)
|
8 (2.3)
|
0.57
|
|
Aortic root rupture
|
0 (0)
|
2 (0.6)
|
0.48
|
|
Cardiac tamponade
|
1 (0.3)
|
1 (0.3)
|
1.00
|
|
Coronary artery obstruction
|
2 (0.6)
|
1 (0.3)
|
1.00
|
|
*Without ≤10 mm3 LVOT calcium volume. **With >10 mm3 LVOT calcium volume. §At exit from procedure room according to VARC-3 criteria.
¶SAPIEN 3; #Evolut R, Portico, ACURATE neo, ALLEGRA; ◊ LOTUS Edge. Values are mean±SD, n (%) unless otherwise indicated or median (interquartile range). CEP: cerebral embolic protection devices; LVOT: left ventricular outflow tract
|
