Aortic Valve System
Investigator Sponsored Research (ISR) or Investigator Initiated Trials (IIT)
ACURATE neo vs. Evolut R is associated with
- Lower New Pemanent Pacemaker Implantation (PPI)
- Major life-threatening bleeding
- Major vascular complication rates
- Reduced post-operative Length of Stay (LoS)
Moriyama N, Vento A, Laine M. Circ Cardiovasc Interv. 2019;12:e007756. DOI: 10.1161
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
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.
SELECT RBBB Registry (IIT): ACURATE neo vs. SAPIEN 3
Husser O, et a.: Clin Res Cardiol 108, Suppl 1, April 2019-V210
Comparable device failure rates and significantly lower pacemaker rates in ACURATE neo patients in entire patient population, confirmed in propensity matched population.
NEOPRO Registry (IIT): ACURATE neo vs. Evolut PRO
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
(PS-matched cohort, % of patients)
MORENA Study (IIT): ACURATE neo vs. SAPIEN 3
Husser O, et al.; JACC: Cardiovascular Interventions. 10. 2078-2087. 10.1016/j.jcin.2017.06.026.
ACURATE neo demonstrated:
- Comparable VARC-2 procedural, performance and safety outcomes
- Lower acute/30-day new permanent pacemaker rates
- Superior hemodynamic performance
PACEMAKER RATE & HEMODYNAMIC PERFORMANCE
(% of patients/mmHg)
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
Mauri V, et al.: Circ Cardiovasc Interv. 2017;10:e005013.
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)
"Prof. Dr. Tanja Rudolph, Uniklinik, Köln, Germany, explains the importance of excellent hemodynamic valve performance for TAVI patients."
Prof. Dr. Tanja Rudolph