Table 1.
shows a summary of the design and main findings of included studies
| Study ID | Study Design | Population | Valve for TAVR | Follow up | Main Finding |
|---|---|---|---|---|---|
| I. Randomized Controlled Trials | |||||
| PARTNER II Trial [8] | Prospective, multicenter, randomized trials | Intermediate surgical risk patients who had senile degenerative aortic valve stenosis with Echo-derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area of <0.8 cm2. | Edwards SAPIEN XT | 2 years | SAVR and TAVR procedures were similar in the rate of mortality and disabling stroke. However, TAVR was associated with lower rates of bleeding, AKI, and new-onset AF, while SAVR was associated with lower rates of VAC and paravalvular AR. |
| STACATTO Trial [11] | Prospective, randomized trial | Operable patients, older than 75 years old with sever aortic stenosis (valve area < 1 cm2) | Edwards SAPIEN | 3 months | Despite the premature termination, the authors concluded that transapical TAVR has more complications and lower success rates than SAVR in low risk patients. |
| NOTION Trial [9] | Multicenter, randomized, superiority trial | Patients > 70 years old with severe aortic valve stenosis and no significant coronary artery disease | CoreValve | 2 years | After 2 years of follow up, the rates of mortality, stroke, and myocardial infarction were similar in both SAVR and TAVR groups. |
| US PIVOTAL Trial [10] | Multicenter, randomized, non-inferiority trial | Intermediate surgical risk patients with severe aortic stenosis and an aortic valve Area ≤ 0.8 cm2 or an AVA index ≤0.5 cm2/m2 | CoreValve | 2 years | The rates of 2-year death or stroke were lower in the TAVR group, compared to the SAVR group. |
| II. Observational (Prospective and Retrospective Studies) | |||||
| OBSERVENT Study [12] | Observational, prospective, multicenter cohort study | Adult patients with a diagnosis of severe AS and low surgical risk | Edwards SAPIEN XT, CoreValve | 3 years | SAVR patients are at a higher risk of blood transfusion, while TAVR patients have a higher risk of VAC, paravalvular AR, and atrioventricular block. |
| Osnabrugge et al. 2012 [21] | Prospective, Cohort study | Patient with severe aortic stenosis and an intermediate surgical risk | CoreValve | 1 year | At 1 year follow up, the costs of TAVR were significantly higher than SAVR in intermediate risk patients owing to the higher cost of the transcatheter valve. |
| Piazza et al. 2013 [22] | Prospective, cohort study | Intermediate surgical risk patients with severe aortic stenosis and an aortic valvular orifice area of <1.0 cm2 | CoreValve | 1 year | In intermediate risk patients, TAVR and SAVR had comparable rates of in-hospital and 30-day mortality, with more benefit of TAVR in women |
| Schymik et al. 2015 [24] | Prospective, cohort study | Patients ≥75 years old with sever aortic stenosis and less than high surgical risk | Edwards SAPIEN XT, CoreValve | 3 years | Both groups had comparable mortality rates. However, the rates of VAC, PPI, and AR were higher in the TAVR group and the risk of major bleeding was higher in the SAVR group. |
| Castrodeza et al. 2016 [18] | Prospective cohort study | Patients with severe aortic stenosis and low to intermediate surgical risk | Edwards SAPIEN XT, CoreValve | 1 year | In intermediate risk patients, TAVR is feasible and has comparable mortality and stroke rates to SAVR. |
| Latib et al. 2012 [19] | Case control study | Intermediate surgical risk patients with severe symptomatic aortic stenosis. | Edwards SAPIEN XT, CoreValve | 1 year | The rates of mortality and stroke were comparable in both groups; however, transfemoral TAVR group had a higher incidence of VAC and SAVR group had a higher incidence of AKI. |
| Möllmann et al. 2016 [20] | Retrospective cohort study | Patients with severe aortic stenosis at low, intermediate, and high surgical risk. | – | 1 year | Compared to SAVR, transfemoral TAVR has similar in-hospital mortality in low risk patients and lower in-hospital mortality in intermediate-to-high risk patients. |
Abbreviations : AF Atrial fibrillation, AKI Acute kidney injury, AR Aortic regurgitation, AVA Aortic valve area, PPI Permanent pacemaker implantation, SAVR Surgical aortic valve replacement, TAVR Transcatheter aortic valve replacement, VAC Vascular access complications