Background: Percutaneous aortic valve replacement (also transcatheter aortic valve implantation/ TAVI) means the insertion of a bioprosthesis into the aortic valve using a catheter. In contrast to the conventional method of open heart surgery, surgical aortic valve replacement (SAVR), TAVI is minimally invasive and can be performed with light sedation and without the use of a heart-lung machine. Since the introduction of TAVI in 2007 for patients with a high risk of surgery, the intervention has become increasingly common. The EUnetHTA report with a German-language summary analyses the results of 2 RCTs on patients with moderate surgical risk.

Methods: Systematic literature search in several databases, assessment of the risk of bias (RoB) with the Cochrane RoB tool, assessment of the quality of evidence with the GRADE method (Grading of Recommendations, Assessment, Development and Evaluation).

Results: Based on the available evidence from two RCTs, it can be summarised that the efficacy of TAVI in patients with severe aortic valve stenosis and moderate surgical risk is unlikely to be inferior to surgical aortic valve replacement (SAVR) in terms of 30-day all-cause mortality and cardiac mortality. In addition, TAVI might reduce the length of hospital stay compared to SAVR. However, significant uncertainties remain as to whether TAVI or SAVR is the better method to improve symptoms.

The qualitatively moderate evidence suggests that TAVI is likely to reduce atrial fibrillation and increase the risk of paravalvular regurgitation compared to SAVR. However, significant uncertainties remain with respect to the evidence of stroke, acute renal failure/injury, newly implanted permanent pacemaker, major vascular complications, aortic valve reintervention, and bleeding.

Conclusion: There are many uncertainties regarding the available evidence on medium-term outcomes of TAVI in patients with severe aortic stenosis, despite a moderate surgical risk.