Transcatheter aortic valve implantation results are not superimposable to surgery in patients with aortic stenosis at low surgical risk

BACKGROUND: The aim of this meta-analysis was to compare the impact of transcatheter aortic valveimplantation (TAVI) vs. surgical aortic valve replacement (SAVR) in patients with severe aortic valvestenosis (AS) at low surgical risk. METHODS: All randomized controlled trials (RCTs) and observational studies (Obs) published fromJanuary 2014 until March 31st, 2020 were retrieved through the PubMed computerized database and at thesite https://www.clinicaltrials.com. The relative risk (RR) with the 95% confidence interval (CI) was usedto evaluate the effect of the intervention under comparison. The primary endpoints were all-cause 30-daymortality and 1-year mortality. The 30-day safety endpoints were: stroke, acute kidney injury stage 2 or 3,major bleeding, moderate/severe paravalvular leak, need for new permanent pacemaker (PM) implantation. RESULTS: After detailed review 9 studies, related to 4 RCTs and 5 Obs, were selected. The overallanalysis of RCTs plus Obs showed a significantly lower 30-day mortality for TAVI (RR = 0.55; 95% CI0.45–0.68, p < 0.00001; I2 = 0%). However, an increased risk of new PM implantation (RR = 2.87;95% CI 2.01–3.67, p < 0.00001, I2 = 0%) and of paravalvular leak (RR = 7.28; 95% CI 3.83–13.81,p < 0.00001, I2 = 0%) was observed in TAVI compared to SAVR. On the contrary, a lower incidenceof major bleeding (RR = 0.38; 95% CI 0.27–0.54, p < 0.00001, I2 = 0%) and of acute kidney injurywas observed (RR = 0.33; 95% CI 0.19–0.56, p < 0.0001, I2 = 0%) in TAVI. CONCLUSIONS: TAVI and SVAR in the treatment of AS in the patients at low surgical risk are not superimposable.In particular, if 30-day and 1-year mortality, major bleeding and acute kidney injury weresignificantly lower for TAVI, the need of new PM implantation and paravalvular leak were significantlylower in SAVR. Consequently, we suggest the need of more trials to evaluate the effectiveness of TAVI asroutine therapeutic procedure in the treatment of patients with low surgical risk AS.