|
General anaesthesia
|
19 (42)
|
|
Procedural imaging
|
Angiography+TTE
|
16 (36)
|
|
Standard TOE
|
19 (42)
|
|
Others
|
10 (22)
|
|
Primary access
|
Femoral artery
|
35 (78)
|
|
Radial artery
|
10 (22)
|
|
Secondary access
|
No
|
25 (55)
|
|
Arterial
|
15 (33)
|
|
Venous
|
5 (11)
|
|
Loop |
No
|
33 (75)
|
|
Arterio-arterial
|
11 (25)
|
|
Arteriovenous
|
1 (2)
|
|
Leak location
|
Non-coronary sinus
|
14 (31)
|
|
Left coronary
|
22 (49)
|
|
Right coronary
|
9 (20)
|
|
Number of paravalvular leaks
|
1
|
26 (61)
|
|
2
|
15 (33)
|
|
3
|
2 (4)
|
|
Catheter used during the procedure
|
Delivery (Destination, Flexor Shuttle)
|
16 (35)
|
|
Guiding
|
21 (47)
|
|
Diagnostic
|
8 (18)
|
|
Mother-and-child technique
|
12 (27)
|
|
More than one leak treated
|
6 (13)
|
|
Closure device
|
|
Amplatzer Vascular Plug
|
0
|
|
Amplatzer Vascular Plug II
|
0
|
|
Amplatzer Vascular Plug III
|
6/3 mm
|
4 (9)
|
|
10/5 mm
|
13 (30)
|
|
12/5 mm
|
2 (5)
|
|
14/5 mm
|
8 (19)
|
|
Amplatzer Vascular Plug 4
|
15 (33)
|
|
Others
|
1 (3)
|
|
Procedural success
|
42 (94)
|
|
Residual shunt
|
No
|
25 (60)
|
|
Intradevice
|
5 (12)
|
|
Peridevice
|
11 (28)
|
|
Residual aortic regurgitation
|
No
|
12 (29)
|
|
Mild
|
26 (62)
|
|
Moderate
|
4 (9)
|
|
Severe
|
0
|
|
Mean aortic gradient post-procedure, mmHg
|
6.5 (4.0-10.2)
|
|
Patients with procedure- or device-related SAEs ≤7 days*
|
5 (11)
|
|
Intraprocedural death
|
0
|
|
Cardiac tamponade
|
1 (3)
|
|
Stroke
|
1 (3)
|
|
Device embolisation
|
1 (3)
|
|
Major vascular complications
|
2 (5)
|
|
Major bleeding
|
0
|
|
Days until discharge after procedure
|
2 (1-6)
|
|
AT treatment at discharge
|
None
|
1 (2)
|
|
SAPT
|
14 (33)
|
|
DAPT
|
12 (29)
|
|
Warfarin
|
6 (14)
|
|
DOAC
|
9 (22)
|
|
Values are expressed as n (%) or median (IQR). *Subjects may have had more than one type of major SAE event. AT: antithrombotic treatment; DAPT: dual antiplatelet therapy; DOAC: direct oral anticoagulation; IQR: interquartile range; SAE: serious adverse event; SAPT: single antiplatelet therapy; SD: standard deviation; TOE: transoesophageal echocardiography; TTE: transthoracic echocardiography
|
