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

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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

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