Acurate neo

The Boston Scientific Acurate neo (Boston Scientific, Marlborough, MA, USA) THV has a SE nitinol frame carrying porcine pericardial leaflets in a supraannular position (Figure 1). The most important difference to other self-expanding platforms is the top-down deployment with minimal protrusion of the stent toward the left ventricular outflow tract. In addition, supraannular leaflet function provides very low gradients even in small anatomies (17 (link)) and the pericardial skirt in the new generation neo 2 design seals effectively against PVL. The transfemoral delivery system has a 18Fr outer diameter shaft. In detail, first the upper crown is opened, which guarantees stable positioning and supraannular anchoring of the valve. Then the flexible stabilization arches are opened, responsible for the self-aligning properties of the valve, thereby ensuring coaxial alignment. Finally, in step two the lower crown is deployed anchoring the device inside the annulus. The THV is available in three sizes for aortic annulus sizes from 20.0 to 26.3 mm and are labeled small (S: for aortic annulus sizes 20.0–22.4 mm), medium (M: for aortic annulus sizes 22.5–24.3 mm) and large (L: for aortic annulus sizes 24.4–26.3 mm) (16 (link), 18 (link)) in AS patients.

We conducted a single-centre, retrospective, observational study comparing the outcomes of patients with severe aortic stenosis (AS) who underwent TAVI with mechanically expandable intra-annular Lotus and Lotus Edge (Boston Scientific, USA) versus self-expandable supra-annular Evolut R (Medtronic, USA) and Acurate Neo (Boston Scientific, USA) transcatheter valves.

Consecutive patients with symptomatic severe native aortic stenosis who underwent transfemoral TAVI between May 2012 and July 2022 using the ACURATE neo (n = 2055) or ACURATE neo2 (n = 955) prosthesis (Boston Scientific, Ecublens, Switzerland) were retrospectively included from two high-volume German centers (Kerckhoff Heart Center, Bad Nauheim, Germany; St. Johannes Hospital, Dortmund, Germany). The design and implantation technique of this transcatheter heart valve design have been described previously [5 (link),6 (link)]. Baseline characteristics such as risk scores, comorbidities, MDCT (multidetector computed tomography), echocardiography, and cardiac catheterization data were recorded prospectively in a dedicated database as well as procedural data and complications from each participating center. Follow-up data were collected from recent medical reports, at outpatient visits, or by telephone interview. This study was conducted according to the Declaration of Helsinki. Due to its retrospective nature and anonymous data processing, ethical approval was waived by the respective local ethics committees.

Data of all patients who underwent transfemoral TAVI between 2014 and 2019 were extracted from the database of GARY which is a nationwide multicenter all-comers registry. The registry design has been previously published [12 (link)]. Prostheses studied in this analysis included the balloon-expandable SAPIEN 3 (Edwards Lifesciences, Irvine, CA, USA) and the self-expanding Acurate neo™ (Boston Scientific, Marlborough, MA, USA), Evolut™ R (Medtronic, Minneapolis, MN, USA) and Portico (Abbott). Prostheses selection was at the discretion of the operating physician.
Transvalvular gradients and paravalvular leakage were assessed pre-discharge by transthoracic echocardiography. Procedural data, procedural success and severe intraprocedural complications were analyzed.
Patients were followed-up at 30 days and one year regarding adverse clinical events and NYHA classification by phone interviews. One-year follow-up was not available in patients undergoing transfemoral TAVI in 2016 and 2017. The primary outcome was the mortality rate at one year.