Assessing the safety and efficacy of TAVR compared to SAVR in low-to-intermediate surgical risk patients with aortic valve stenosis: an overview of reviews

Background Transcatheter aortic valve replacement (TAVR) was initially introduced to treat patients with aortic valve stenosis (AS) at high-risk for surgical aortic valve replacement (SAVR). Today, there is ample evidence supporting TAVR in high-risk groups. However, in recent years TAVR has been extended to low-to intermediate risk groups and relevant clinical evidence is still emerging, leaving some uncertainties. Methods To obtain information on TAVR versus SAVR in low-to intermediate risk groups, we conducted an overview of systematic reviews according to PRISMA guidelines and based on a systematic search of EMBASE, MEDLINE, Cochrane and CRD databases. We focused on systematic reviews and meta-analyses of RCTs and/or observational studies evaluating efficacy and/or safety in low-to intermediate risk patients. We assessed mortality and VARC 2 as clinical outcomes. Methodological and evidence quality were rated using AMSTAR2 and GRADE. Results The majority of the 11 systematic reviews included in our study reported no statisticall significant differences in mortality between TAVR and SAVR at short and long term follow-up times up to 36 months. Two reviews that included the most recent RCTs on low-risk patients reported a decreased mortality risk with TAVR at one-year follow-up. Regarding the secondary endpoints of stroke and MI, the majority of studies presented similar results for TAVR and SAVR. Acute Kidney Injury, Bleeding Complications, Atrial Fibrillation were less frequent with TAVR, with lower risk of Aortic Regurgitation with SAVR. Conclusions Our overview indicated that TAVR is a promising intervention for low-to-intermediate surgical risk patients; however additional evidence from longer term follow-up is needed to confirm these findings. This overview highlights inconsistencies in regard to reporting and presentation of data, most notably limited clarity on effects of risk of bias on trial results.JRC.F.2-Consumer Products Safet