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. |