1st real-world analysis of device success and clinical safety in next-gen TAVI devices: the supra-annular ACURATE neo2 and intra-annular SAPIEN 3 Ultra valves.
STUDY DESIGN: 1:1 propensity-matched multicenter comparison of device success and clinical safety using the ACURATE neo2 (n = 230) and SAPIEN 3 Ultra (n = 492) valves. 178 total patient pairs were treated and tested at two high-volume centers in Europe.
The ACURATE neo2 Valve demonstrated similar rates of PVL and superior hemodynamics when compared to the SAPIEN 3 Ultra Valve.
1st real-world analysis of patient-specific implantation techniques using different devices. The study demonstrated that neo-commissural alignment and optimized valve design can improve procedural success.
STUDY DESIGN: Single-center analysis of commissural alignment results using patient-specific implantation techniques of self-expanding TAVI valves: the ACURATE neo2 (n = 20), Evolut R/PRO™ (n = 20), and Portico™ (n = 20) valves.
Best-in-class commissural alignment: ACURATE neo2 was the only self-expanding valve to 100% avoid commissural misalignment.
1st large, real-world clinical data on the ACURATE neo2™ Aortic Valve System*: The Early neo2 Registry
STUDY DESIGN: Core-lab adjudicated, single arm, multicenter registry that assessed the ACURATE neo2 Valve’s performance. 85% of the original patient population (N = 554) were analyzed by an echocardiographic core-lab analysis.
Low overall complication rates and demonstrated PVL improvement: study confirms the enhanced ability of the ACURATE neo2 Valve’s new Active PVseal™ sealing skirt to minimize paravalvular leak.
* Postoperative echo, core-lab assessed; † In-Hospital; ‡ 30-Days
1. Rück A. Early neo2 Registry. Full Core-Lab Adjudicated Results of TAVI With the New ACURATE neo2 valve. TVT Congress. 2021
1st systematically-evaluated analysis of coronary access before and after TAVR in an all-comers’ population.
STUDY DESIGN: Comparison of the ACURATE neo (n = 72; 24%), Evolut RTM/PROTM (n = 123; 41%) , SAPIEN 3TM/SAPIEN UltraTM (n = 96 patients; 32%), and PORTICO (n = 9 patients; 3.2%) valves. All patients underwent coronary angiography before and after TAVI (N = 300).
With 0 incidences of unsuccessful coronary cannulation, ACURATE neo demonstrated an extremely high coronary access success rate.
1st and largest real-world comparison of the ACURATE neo™ self-expanding and SAPIEN 3TM balloon expandable valves.
STUDY DESIGN: 1:2 propensity-matched multicenter comparison of the ACURATE neo (n = 311) and SAPIEN 3 (n = 622) valves
from three high-volume centers in Germany
1st comparison of the ACURATE neoTM self-expanding valve and SAPIEN 3TM balloon expandable valve in patients with small aortic annuli.
STUDY DESIGN: 1:1 propensity-matched multicenter comparison of the ACURATE neo (n = 92) and SAPIEN 3 (n = 92) valves
from five high-volume centers in Germany.
STUDY DESIGN: Analysis of 249 patients with the ACURATE neoTM (n = 146) and SAPIEN 3TM (n = 103) valves treated with TF TAVI using the minimalist approach at Helsinki University Central Hospital to assess the success rate and safety of NDD at 90 days
and 1 year post-implantation.
STUDY DESIGN: Analysis of 296 patients with pre-existing complete RBBB treated with the ACURATE neoTM and SAPIEN 3TM valves (N =296) in a propensity-matched population: ACURATE neo (n = 65) and SAPIEN 3 (n = 65).
Outcomes of two next-generation self-expanding TAVI valves in real-world patients.
STUDY DESIGN: 1:1 propensity-matched multicenter comparison of the ACURATE neo (n = 251) and Evolut PRO (n = 251) valves from 24 international centers
STUDY DESIGN: Single-center study from Oxford, Great Britain, evaluating the impact of valve selection on procedural outcomes, length of stay (LoS), and 30-day mortality in 231 patients treated with either the ACURATE neo (n = 143) or Evolut R (n = 88) valves.