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Table 8 shows the proportion of subjects with Procedure Success.
Procedure Success
Yes
Unknown*
*VASCADE MVP: One subject had final follow-up 20 days early (3 days post-procedure), and one subject was lost to follow-up | MC: One subject was lost to
follow-up.
Patient Satisfaction was evaluated for all subjects. Patients were given a Patient Experience Survey to complete after successful TTA
at the time of TTDE to characterise their comfort experience while on bedrest post-procedure. The completed Survey was collected
at the time of completion. The surveys were comprised of comparative study questions regarding patient actual experience (Table 9),
as well as questions for scenarios with hypothetically longer (device patients) or shorter (MC patients) bedrest periods (Table
all cases, patient satisfaction scores favoured the device over manual compression.
Bedrest Experience
All Patients, current procedure bedrest experience
N
Patient Reported
Duration
Satisfaction Scores
Discomfort
Pain
Scale 0–10 with 0
Patients with a previous ablation procedure, comparison to previous experience
as 'very
N
dissatisfied' and 10
Duration
as 'very satisfied'
Discomfort
Pain
Table 10: Patient Experience Survey Summary – Patient Preference for Hypothetically Longer or Shorter Bedrest Durations
Bedrest Experience
Patient Reported
Patients Randomised to VASCADE MVP, score if bedrest were hypothetically 2–3 hours longer
Satisfaction Scores
Duration (N)
Discomfort
Scale 0–10 with 0
Pain
as 'very
Patients Randomised to Manual Compression, score if bedrest were hypothetically 2–3 hours shorter
dissatisfied' and 10
Duration
as 'very satisfied'
Discomfort
Pain
SD = Standard Deviation
Pain medication administration during bedrest was measured as a secondary factor of patient satisfaction. Medication administered
for pain or anxiety while the subject was on initial bedrest (i.e. post-procedure through successful TTA) was recorded for all subjects.
In an ad-hoc analysis, it was found that there was a reduction in the use of pain medication for the treatment arm (see Table 11).
Use of Pain Medication
Yes
No
Additionally, anxiety medication was administered to 4.0% of the VVCS subjects and 1.9% of the manual compression subjects.
IFU 5686 AE, 2024-04
Table 8: Proportion of Procedure Success
VASCADE MVP (N=100)
98
2
Patient Experience Survey Results
Table 9: Patient Experience Survey – Comparative Experience
VASCADE MVP
(Mean +/- SD)
100
8.3 ± 2.4
7.2 ± 3.1
7.5 ± 3.2
30
7.9 ± 2.3
7.5 ± 2.1
7.7 ± 2.8
VASCADE MVP
Mean +/- SD (N)
Pain Medication Results
Table 11: Use of Pain Medication
VASCADE MVP
(N=100)
24
76
98%
2%
Manual Compression
(Mean +/- SD)
102
5.1 ± 3.4
5.3 ± 3.1
6.0 ± 3.4
39
5.6 ± 3.0
5.4 ± 2.8
5.5 ± 2.9 (N=38)
2.6 ± 3.1 (98)
2.7 ± 2.9 (98)
3.2 ± 3.4 (98)
-
-
-
Manual Compression
(N=104)
24%
51
76%
53
Manual Compression (N=104)
103
1
% Difference
(MVP-MC)/MC
63%
36%
25%
41%
39%
40%
Manual Compression
Mean +/- SD (N)
-
-
-
9.1 ± 1.7 (102)
8.4 ± 2.2 (101)
8.2 ± 2.5 (100)
% Improvement
49%
51%
51%
99%
1%
10
). In
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