ACURATE neo™

Aortic Valve System

Investigator Sponsored Research (ISR) or Investigator Initiated Trials (IIT)

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Kotronias et al. (IIT): ACURATE neo vs. Evolut R

Routine use of the ACURATE neo self-expanding valve is associated with improved procedural outcomes and reduced post-operative length of stay: Insights from a single-center registry (ACURATE neo vs. Evolut R) 
Kotronias RA, Banning AP, Kharbanda RK. Oxford University Hospital. Presented at EuroPCR 2019 by R. A. Kotronias

 
Single-center trial evaluating the impact of valve selection on procedural
outcomes and length of stay after TAVI. 231 patients from 03/2017 to 09/2018 at
Oxford University Hospitals.
 

ACURATE neo vs. Evolut R is associated with

  • Lower new Permanent Pacemaker Implantation (PPI)
  • Major life-threatening bleeding 
  • Major vascular complication rates
  • Reduced post-operative length of stay (LoS)
 
Procedural Outcomes & Post Operative Length of Stay
 

Laine et al. (IIT): ACURATE neo vs. SAPIEN 3

Safety of Next-Day Discharge after Transfemoral Transcatheter Aortic Valve Replacement with a Self-expandable vs. Balloon-expandable Valve Prothesis (ACURATE neo vs SAPIEN 3)
Moriyama N, Vento A, Laine M. Circ Cardiovasc Interv. 2019;12:e007756. DOI: 10.1161
 
Retrospective, single-center study (Helsinki University Central Hospital) evaluated in 249 consecutive patients who underwent minimalist TAVI between 01/2017 and 07/2018 the success rate and predictors of NDD after TAVI and the clinical outcomes after 90 days and 1 year.
 
 

Study confirmed that Next Day Discharge (NDD) with self-expandable ACURATE neo is safe for patients and economically cost effective.

ACURATE neo vs. SAPIEN 3 demonstrated:

  • Comparable device success and NDD
  • Similar in-hospital complication rates
  • Low 90-days complication rates in NDD patients
  • Equivalent 1-year safety for NDD patients
Device and NDD Success & In-Hospital Outcomes
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.
 
90-Day Outcomes after NDD
 
All-Cause Mortality After NDD in Patients Receiving ACURATE neo or SAPIEN 3
 

 

 

SELECT RBBB Registry (IIT): ACURATE neo vs. SAPIEN 3

Transcatheter Valve SELECTion in Patients with Right Bundle Branch Block and Impact on Pacemaker Implantations.
Husser O, et al. JACC: Cardiovasc Interv. SEPT 2019;12:1781–93.
 
Multicenter registry conducted in 7 centers in Germany and Switzerland evaluated the impact of ACURATE neo versus SAPIEN 3 on PPI. 4,305 consecutive patients were included in the analysis, of which 302 had pre-existing complete RBBB without a pacemaker prior to TAVI. Out of these patients, a total of 296 (98 ACURATE neo, 198 SAPIEN 3) were analyzed including a propensity matched population of 130 patients (65 ACURATE neo, 65 SAPIEN 3). 
 
 
Significantly lower pacemaker rates with excellent hemodynamics were observed in ACURATE neo patients vs. SAPIEN 3, while device failure rates remained similar in both cohorts. Results were confirmed in both the entire population and the propensity-matched population.
 
Comparable device failure rates and significantly lower pacemaker rates in ACURATE neo patients in entire patient population, confirmed in propensity matched population.
risk for permanent pacemaker implantation
 

NEOPRO Registry (IIT): ACURATE neo vs. Evolut PRO

Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices
A Multicenter, Retrospective, Propensity-Matched Comparisonof Evolut PRO Versus Acurate neo
Transcatheter Heart Valves

Pagnesi M, et al.:  JACC: Cardiovascular Interventions Mar 2019, 12 (5) 433-443; DOI:10.1016/j.jcin.2018.11.036 
International, multicenter, observational, retrospective NEOPRO Registry. A total of
1,551 patients (1,263 NEO, 288 PRO) treated at 24 centers between January 2012 and March 2018 were evaluated for this propensity score matching analysis. All consecutive patients treated with transfemoral TAVI for symptomatic, severe aortic stenosis of the native aortic valve with either NEO or PRO implantation were included.
 

VARC-2 Endpoints

(PS-matched cohort, % of patients)

In the PS-matched cohort, both devices show similar 30-day clinical outcomes for the VARC-2 device success and also the composite safety endpoint without any significant differences in the 30-day clinical outcomes.
Clinical outcomes chart
 

Paravalvular Leak Rates

(PS-matched cohort, % of patients)

 

MORENA Study (IIT): ACURATE neo vs. SAPIEN 3

Multicenter comparison of novel self-expanding vs. balloon-expandable transcatheter heart valves
Husser O, et al.; JACC: Cardiovascular Interventions.  10. 2078-2087. 10.1016/j.jcin.2017.06.026.
 
1:2 propensity-matched multicenter comparison of ACURATE neo (n = 311) and
SAPIEN 3 (n = 622) from three high-volume centers in Germany.

ACURATE neo demonstrated:

  • Comparable VARC-2 procedural, performance and safety outcomes 
  • Lower acute/30-day new permanent pacemaker rates 
  • Superior hemodynamic performance 
* Early safety composite endpoint includes all-cause mortality, stroke (disabling and non-disabling), coronary artery obstruction requiring reintervention, major vascular complication, life-threatening bleeding, acute kidney injury and valve-related dysfunction with BAV, TAVI or SAVR.

VARC-2 SAFETY & PERFORMANCE

(% of patients)

Varc2 Performance
 

PACEMAKER RATE & HEMODYNAMIC PERFORMANCE

(% of patients/mmHg)

Pacemaker rate & hemodynamic performance

Wrap-up interview – PCR London Valves 2017

"The data we have with the SAVI-TF Registry and MORENA study show that in daily life, ACURATE neo is a good, effective TAVI device"

Dr. Won-Keun Kim
Bad Nauheim, Germany


 

Mauri et al. Study (IIT): ACURATE neo vs. SAPIEN 3

Short-term outcome and hemodynamic performance of next-generation self-expanding versus balloon-expandable transcatheter aortic valves in patients with small aortic annulus: A multicenter propensity-matched comparison
Mauri V, et al.: Circ Cardiovasc Interv. 2017;10:e005013.
 
Retrospective, 1:1 propensity-matched multicenter comparison of ACURATE neo (n = 92) and SAPIEN 3 (n = 92) from 5 high-volume centers in Germany.

ACURATE neo demonstrated:

  • Comparable performance with no significant differences at 30 days and at 1 year in
    VARC-2 procedural performance and safety outcomes 
  • Superior hemodynamic performance in patients with a small aortic annulus
  • Lower rate of severe prosthesis-patient mismatch (PPM) 
 

Acurate and 30-Day Outcome Summary

(% of patients unless otherwise stated)

Morena Study Summary
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 degeneration.

Physician interview

"Prof. Dr. Tanja Rudolph, Uniklinik, Köln, Germany, explains the importance
of excellent hemodynamic valve performance for TAVI patients."

Prof. Dr. Tanja Rudolph
Köln, Germany


 
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