ACURATE neo

Aortic Valve System

Clinical Program Overview

TAVI Clinical Program Overview

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SAVI TF 1000 Registry:

Real world experience on 1000 patients:1

ACURATE neo™ Valve Implantation using TransFemoral Access

Study Design

  • Post-market registry, 1000 patients
  • October 2014 – April 2016; 25 EU sites

Endpoints

  • Primary
    • All cause mortality @ 30 Days
  • Secondary
    • Procedure success
    • Device performance @ 7 days and 12 months
    • VARC-2 safety @ 30 days and 12 months
    • NYHA class @ 30 days and 12 months

Baseline Characteristics: n = 1000

Age [years, mean±SD] (n=1000) 81.1 ± 5.2
Female [n/%] 612 / 61.2
Log. EuroSCORE I [%, mean ± SD]  (n=872) 18.1 ± 12.5
Log. EuroSCORE II [%, mean ± SD] (n=720) 6.6 ± 7.5
STS Score [%, mean ± SD] (n=630) 6.0 ± 5.6
∂P [mmHg, mean ± SD] (n=872) 42.7 ± 15.2
AVA [cm2, mean ± SD] (n=865) 0.72 ± 0.2
NYHA Class III/IV [n/%] (n=963) 782 / 81.2

Perfomance and Clinical Data

Procedural Characteristics n=1000
Predilatation
961 (96.1 %)
Valve size  
S 261 (26.1)
M 431 (43.1)
L 308 (38.0)
Device usage time [min:sec] 6:34±6:18
Deployed with rapid pacing 487 (48.7)
Post-dilatation 448 (44.8)
Mitral valve apparatus damage or dysfunction 0 (0.0)
Annular rupture 0 (0.0)
Ventricular septal perforation 0 (0.0)
Procedural/device success 987 (98.7)
Valve-in-valve 9 (0.9)
Conversion to surgery 3 (0.3)
Aborted procedure 1 (0.1)
Clinical Outcomes at 30 days n=998¹
VARC-2 Early Safety 86 (8.6)
Mortality
 - cardiovascular
14 (1.4)
10 (1.0)
Stroke
 - disabling
19 (1.9)
12 (1.2)
Life-threatening bleeding 13 (1.3)
Major bleeding 44 (4.4)
Acute kidney injury stage 2 or 3 13 (1.3)
Major vascular complication 32 (3.2)
Coronary obstruction requiring reint. 0 (0)
Repeat procedure 0 (0)
Myocardial infarction 3 (0.3)
Endocarditis 0 (0)
Valve thrombosis 0 (0)
Cardiac tamponade 4 (0.4)
New pacemaker implantation 83 (8.3)
1 1 patient withdrew consent after treatment; 1 did not return for 30 day visit.
 
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Echocardiographic Parameters at Follow-up 7 Days / discharge
Effective orifice area [cm²] n=416 1.77±0.46
Mean gradient [mmHg] n=807 8.4±4.0
Aortic regurgitation n=844
    ≤ Grade 1 (none to mild) 809 (95.9)
    Grade 2 (moderate) 35 (4.1)
    Grade 3 (moderate to severe) 0 (0)
    Grade 4 (severe) 0 (0)
 
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NYHA class: Baseline, 30 days, at 1 Year

NYHA class: Baseline, 30 days, at 1 Year
 
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SAVI-TF 30 Day and 12-Month Results Summary
(% of patients unless otherwise stated)

SAVI-TF 30 Day and 12-Month Results Summary
 

Key Findings

  • Strong, 98.6% survival rate at 30-days in this real-world patient population  
  • Low PVL rates, with 95.9% of patients showing no/mild PVL (based on site assessment of PVL)
  • Low 8.3% new pacemaker rates
  • Very low gradient (8.4 +/- 4.0 mmHg at 7-day discharge)

 

 

Multicenter Propensity-Matched Comparison

Multicenter Comparison of Novel Self-Expanding Versus Balloon-Expandable Transcatheter Heart Valves:2

 

Study Design

ACURATE neo vs. SAPIEN 3

  • Observational, propensity-matched multicenter comparison of ACURATE neo and SAPIEN 3 from 3 high volume centers in Germany (DHZ Munich, UK Regensburg, Kerckhoff Klinikum Bad Nauheim)
  • 1,121 consecutive patients between Jan. 2014 and Jan. 2016 with symptomatic, severe stenosis of the native aortic valve treated with transfemoral TAVI using ACURATE neo (n = 311) or SAPIEN 3 (n = 810)
  • To increase statistical power, a 1-to-2 nearest neighbor matching was used to identify 2 control cases treated with SAPIEN 3 (n = 622) for each case treated with ACURATE neo (n = 311)
  • Endpoints: device failure and early safety composite endpoint at 30 days according to VARC-2 criteria

Key Findings

ACURATE neo and SAPIEN 3 showed comparable VARC-2 procedural, performance and safety data

  • Comparable VARC-2 early safety composite endpoint (P=n.s.)
  • Comparable device failure composite endpoint (P=n.s.)

Safety and Performance Endpoints 

(% of patients)

ACURATE neo and SAPIEN 3 Safety and Performance Endpoints chart

ACURATE neo additionally showed lower rates of permanent pacemaker implantation and lower mean and less elevated transvalvular gradients, but slightly higher paravalvular leakage (PVL II+, 4.8% vs. 1.8%; p=0.01).

  • 54% reduced risk of elevated gradients
  • 36% reduced risk of new pacemaker implantations 
 

Pacemaker Rate and Hemodynamic Performance

(% of patients / mmHg)

 

 

Multicenter Comparison in Patients with Small Aortic Annulus

Outcome of Next‐Generation Transcatheter Valves in Small Aortic Annulus: A Multicenter Propensity‐Matched Comparison:3

 

Study Design

ACURATE neo vs. SAPIEN 3

Retrospective, 1:1 propensity‐matched multicenter comparison of ACURATE neo (n = 92) and SAPIEN 3 (n = 92) from 5 high volume centers in Germany

 

Key Findings

  • Similar performance for ACURATE neo and SAPIEN 3 with no significant differences at 30 days and 1 year in key safety data
  • ACURATE neo showed
    • Lower mean transvalvular gradients
    • Larger indexed effective orifice areas (iEOA)
    • Lower rate of total Prosthesis‐Patient Mismatch (PPM)
 

Acute, 30 day & 1-year Outcome Summary

(% of patients unless otherwise stated)

 
  • ACURATE neo and SAPIEN 3 showed comparable VARC‐2 procedural, performance and safety data and low, non‐statistically different mortality at 30 days and at 1 year
  • Both devices showed comparable rates of new permanent pacemaker implantation and moderate PVL; no severe PVL was observed with both devices
  • ACURATE neo patients showed significantly reduced risk of severe Patient‐Prosthesis mismatch and significantly lower Mean Gradients
  • Prosthesis‐patient mismatch is present when the effective orifice area of an implanted prosthetic valve is too small in relation to body size and has shown to be a strong predictor of short‐ and long‐term mortality and premature bioprosthetic degeneration4
 
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