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Next-Day Discharge with ACURATE neo vs. SAPIEN 3
ACURATE neo Aortic Valve System – Clinical Data
Clinical Highlights
Study Design
Safety of next-day discharge (NDD) after transfemoral transcatheter aortic valve replacement with a self-expandable vs. balloon-expandable valve prosthesis: ACURATE neo vs. SAPIEN 3
Moriyama N, Vento A, Laine M. Circ Cardiovasc Interv. 2019;12:e007756. DOI: 10.1161.
A total of 249 consecutive patients who underwent elective transfemoral-TAVI (146 ACURATE neo, 103 SAPIEN 3) using minimalist approach (local anesthesia, transthoracic echocardiogram, transfemoral access, and complete percutaneous vascular closing) between January 2017 and July 2018 at Helsinki University Central Hospital were reviewed. The objectives of the study were (1) to assess the success rate of NDD with ACURATE neo and (2) to evaluate the safety of NDD after ACURATE neo implantation compared with SAPIEN 3 after 90 days and after 1 year.
Rates of device success and NDD with ACURATE neo are comparable to SAPIEN 3. Additionally, ACURATE neo patients show similar in-hospital complication rates with no significant differences.
Length of hospital stay
after procedure, days
In-hospital mortality
PVL ≥ moderate
Major vascular
complications
Life-threatening or disabling
bleeding
New PPI after TAVI
Disabling stroke
ACURATE neo (n = 146) SAPIEN 3 (n = 103)
In-Hospital OutcomesDevice and NDD Success
% o
f pat
ient
s/da
ys
12.0
8.0
4.0
2.0
6.0
10.0
0.0
90 92
Device success
6055
NDD success
% o
f pat
ient
s
80
40
20
60
100
0
2.63.3
1.0
2.0
6.0
5.0
7.0
10.0
2.0
3.0
2.0
6.0
1.0 1.0
All trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device. Information for use only in countries with applicable health authority product registrations. Not intended for use or distribution in France, Japan, and the USA. SH-655402-AA Printed in Germany by medicalvision
ACURATE neo Aortic Valve System – Clinical Data
NDD with ACURATE neo is safe
ACURATE neo shows low 90-day complication rates in patients discharged next day after TAVR with no significant differences vs. SAPIEN 3. Moreover, the 1-year safety of NDD after ACURATE neo implantation is equivalent to that after SAPIEN 3 implantation.
ACURATE neo (n = 87) SAPIEN 3 (n = 57)
NDD – ACURATE neo
NDD – SAPIEN 3
90-Day Outcomes After NDD
All-Cause Mortality After NDD in Patients Receiving ACURATE neo or SAPIEN 3
0 0
3
1
4
0 0
2
0
7
Mortality Readmission New PPI after discharge
Stroke PVL ≥ moderate
% o
f pat
ient
sFr
eedo
m fr
om m
orta
lity
1
2
3
0.8
0.7
4
5
6
0.9
7
8
9
1.0
10
0
03 75 9 114 86 10 12
Follow-Up Month After TAVR
Log rank: P > 0.80
87 84 80 69 65 60 55 45 39 32
57 54 51 46 45 42 40 34 30 23
ACURATE neo
SAPIEN 3
www.bostonscientific.eu/ACURATEneo © 2019 Boston Scientific Corporation or its affiliates. All rights reserved. DINSH0244EA
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