Skip to main content
. 2020 Feb 1;9(2):397. doi: 10.3390/jcm9020397

Table A3.

Inclusion and exclusion criteria. Choice of procedure and valve-type.

Study [ref] Inclusion criteria Exclusion criteria Selection criteria for the procedure Selection criteria for the valve
Barth S et al. 2019 [15] Patients received either the ACURATE/ACURATE neo prostheses (n = 591) or the SAPIEN 3 prosthesis (n = 715). Through nearest neighborhood matching with exact allocation for access route and center, pairs of 329 patients (250 transfemoral, 79 transapical) per group were determined. Not reported. Not reported.
Costa et al. 2019 [16] All the patients treated with SAPIEN 3, Evolut R, or ACURATE neo, which could have indifferently received all the three devices according to manufacturer sizing indications. Patients who did not performed pre-TAVI multi-detector computed tomography assessment (n = 169), patients who had a valve-in- valve implantation in a failed aortic bioprosthesis (n = 21), patients with bicuspid aortic valve (n = 28), and pure aortic regurgitation (n = 1). Not reported. Not reported.
Husser O et al. 2017 [17] Patients with symptomatic, severe stenosis of the native aortic valve were treated with transfemoral TAVI using ACURATE neo (n = 311) or SAPIEN 3 (n = 810) at 3 centers in Germany. Not reported. The interdisciplinary heart team discussed all cases and consensus was achieved regarding the therapeutic strategy. The interdisciplinary heart team discussed all cases and consensus was achieved regarding the therapeutic strategy.
Lanz J et al. 2019 [14] Patients aged 75 years or older. With severe aortic stenosis defined by an aortic valve area (AVA) < 1 cm2 or AVA indexed to body surface area of < 0·6 cm2/m2. Symptomatic (NYHA functional class > I, angina or syncope). At increased risk for mortality if undergoing SAVR as determined by: - the heart team OR
- an STS-PROM score > 10% OR - a Logistic EuroSCORE > 20%. Heart team agrees on eligibility for participation. Aortic annulus perimeter 66–85 mm AND area 338–573 mm2 based on multi-slice computed tomography. Minimum diameter of arterial aorto-iliac-femoral axis on one side: ≥5·5 mm. Patient understand the purpose, potential risks and benefits of the trial, is able to provide written informed content and willing to participate in all parts of the follow-up. -Non-valvular, congenital or non-calcific acquired aortic stenosis, uni- or bicuspid aortic valve. -Anatomy not appropriate for transfemoral TAVR due to degree or eccentricity of calcification or tortuosity of aorto- and iliac-femoral arteries. -Pre-existing prosthetic heart valve in aortic or mitral position. -Emergency procedures, cardiogenic shock (vasopressor dependence, mechanical hemodynamic support), or severely reduced left ventricular ejection fraction (< 20%). -Concomitant planned procedure except for percutaneous coronary intervention. -Stroke or myocardial infarction (except type 2) in prior 30 days. -Planned non-cardiac surgery within 30 days after TAVR. -Severe coagulation conditions, inability to tolerate anticoagulation/antiplatelet therapy. -Evidence of intra-cardiac mass, thrombus or vegetation. -Active bacterial endocarditis or other active infection. -Hypertrophic cardiomyopathy with or without obstruction. -Contraindication to contrast media or allergy to nitinol. -Participation in another trial leading to deviations in the preparation and conduction of the intervention or the post-implantation management. The heart team or an STS-PROM score > 10% or a Logistic EuroSCORE > 20%. Heart team agrees on eligibility for participation. Patients were randomly assigned in a 1:1 ratio to undergo TAVI with either the ACURATE neo or the SAPIEN 3 system.
Mauri V et al. 2017 [18] Inclusion criteria were small annular dimension defined as an annulus area <400 mm2 and transfemoral TAVI with either an ACURATE neo size S or an Edwards SAPIEN 3 size 23 mm. Not reported. Eligibility of the individual candidate for TAVI had been decided within the local institutional heart team. Prosthesis selection was at the discretion of the operating physicians at each center.
Schaefer A et al. 2017 [19] A consecutive series of 104 patients received transfemoral TAVI using the ACURATE neo for treatment of severe symptomatic calcified aortic stenosis (study group) between 2012 and 2016. For comparative assessment, a matched control group of 104 patients treated by transfemoral TAVI using the Edwards SAPIEN 3 during the same time frame (2014 to 2016) was retrieved from dedicated hospital database containing a total of 1326 TAVI patients (210 SAPIEN 3 patients). Patients unsuitable for a retrograde transfemoral approach and all valve-in-valve procedures were excluded from analysis. Allocation of patients to TAVI followed current international recommendations after consensus of the local dedicated heart team. Not reported.