ACURATE neo™

Aortic Valve System

Investigator Sponsored (ISR) and Initiated (IIT) Trials

Explore

 

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

SELECTion of Transcatheter Heart Valves in Patients with pre-existent Right Bundle Branch Block (RBBB) and Impact on Pacemaker Implantations (PPI) – The SELECT RBBB Multicenter Registry
Husser O, et al.: Clin Res Cardiol 108, Suppl 1, April 2019 - V210
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).
Pre-existing RBBB has consistently shown to be the strongest patient-related predictor for new PPI after TAVI with an up to 12-fold risk increase resulting in elevated PPI rates of up to 40%. No comparison of newer-generation transcatheter heart valves (THV) with regard to PPI in these patients exists. The aim of this study was to evaluate the impact of ACURATE neo versus SAPIEN 3 on PPI in patients with RBBB. 

Comparable device failure rates and significantly lower pacemaker rates in ACURATE neo patients in entire patient population, confirmed in propensity matched population

Clinical Results – Entire Patient Population

After Multi-variable Adjustment & Before Discharge

Results after multivariable adjustment in the entire patient population - before discharge

Clinical Results – Propensity-matched Patient Population

Before Discharge

Results 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.

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) 

Acute 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


 
Top