Table S3. Studies’ inclusion, exclusion criteria. Choice of procedure and valve type.
Study (ref) | Inclusion criteria | Exclusion criteria | Selection criteria for the procedure | Selection criteria for the valve |
---|---|---|---|---|
Abdel-Wahab et al. 2016 (20) | Patients treated with new generation devices | Patients treated with new generation, self-expanding devices | Not reported | Not reported |
Fovino et al. 2017 (21) | All consecutive patients with symptomatic severe aortic stenosis undergoing transfemoral TAVI with Sapien 3 in the PUREVALVE registry (n=93) were matched with patients (n=222) undergoing transfemoral TAVI with the Lotus valve included in the RELEVANT study | A life expectancy of less than 1-year, congenital unicuspid or bicuspid aortic valve, severe peripheral artery disease (femoral artery lumen diameter <6.0 mm) and valve-in-valve procedure | Patients were candidate to TAVI by the local Heart Team on the basis of surgical risk score, as well as frailty and presence of comorbidities | Not reported |
Jarr et al. 2017 (23) | Not reported | Not reported | The decision regarding whether patients were scheduled for TAVI or SAVR was made by institution heart team | The decision regarding the valve type used was at the operator’s discretion |
Marzahn et al. 2018 (24) | Patients with high-grade aortic stenosis who underwent TAVI |
Not reported | All patients were evaluated for TAVI by an interdisciplinary heart | Prostheses were selected by the implanting cardiologist before intervention based on the patients’ morphology |
Pilgrim et al. 2016 (25) | Patients with severe aortic stenosis treated with the Edwards Sapien 3 prosthesis or the Lotus valve system | Not reported | Selection of TAVI candidates, device allocation, and periprocedural management was left to the discretion of the operators | Selection of TAVI candidates, device allocation, and periprocedural management was left to the discretion of the operators |
Schofer et al. 2018 (26) | Consecutive patients with severe symptomatic native aortic valve stenosis who were indicated to receive transfemoral TAVI either by using the Sapien 3 or the Lotus valve | Not reported | Based on an interdisciplinary heart team decision, patients were allocated to TAVI | Not reported |
Seeger et al. 2017 (27) | Not reported | Not reported | Decision about suitability for TAVI was assessed by the heart team | Sapien 3 was chosen in annulus diameter >27 mm and short distance annulus to coronary ostia; Lotus was chosen in severe left ventricular outflow tract calcification and thrombus in left atrial appendage |
Sinning et al. 2017 (28) | Not reported | Not reported | Not reported | Not reported |
Soliman et al. 2018 (29) | Patients who underwent TAVI because of severe aortic stenosis with either the Lotus or the Sapien 3 | Valve-in-valve procedure or TAVI because of aortic regurgitation or patients without echocardiographic follow-up | Eligibility for TAVI and vascular access (i.e., femoral, axillary and apex) was decided during the multidisciplinary valve team discussion | The choice of the valve type was at the operator’s discretion |
van Gils et al. 2017 (22) | All consecutive patients with preexistent right bundle branch block without a permanent pacemaker | Transcatheter heart valves with <10 cases | Not reported | Not reported |
Wöhrle et al. 2015 (30) | Patients with severe aortic stenosis in combination with the presence of clinical symptoms | Life expectancy of less than 12 months, congenital unicuspid or bicuspid aortic valve, acute myocardial infarction, stroke or severe gastrointestinal bleeding within the previous 3 months or severe peripheral artery disease favoring the transapical route for TAVI | The decision to perform TAVI was made by a multidisciplinary heart team including an interventional cardiologist and a cardiothoracic surgeon | Not reported |
PUREVALVE, Padua University REVALving Experirnce; RELEVANT, REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr; TAVI, transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement.