Aortic Valve System
Investigator Sponsored Research (ISR) or Investigator Initiated Trials (IIT)
Kotronias RA, Banning AP, Kharbanda RK. Oxford University Hospital. Presented at EuroPCR 2019 by R. A. Kotronias
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)
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 al. JACC: Cardiovasc Interv. SEPT 2019;12:1781–93.
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
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.
(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.
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
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