Background: Although the femoral approach is the most common route utilised in transcatheter aortic valve implantation (TAVI), it still carries a substantial risk of severe bleeding and vascular complications.
Aim: The aim of our study was to compare the safety and efficacy of the complete percutaneous (CPC) approach with surgical cut-down and closure (SCC) in TAVI patients.
Methods: The study population comprised 683 patients with severe aortic stenosis, who underwent transfemoral TAVI. Bleeding and vascular complications were defined according to the Valve Academic Research Consortium (VARC-2) criteria. Propensity-matched cohorts were created to reduce the potential bias of non-random assignment to the type of vascular access technique (SSC, n = 203 vs. CPC, n = 203).
Results: The rate of minor vascular complications was higher in the CPC cohort (18.2% vs. 9.9%, p = 0.02). There were no differences in major vascular complications or in any type of bleedings between the two groups. Age (odds ratio [OR] 1.044; 95% confidence interval [CI] 1.003-1.09, p = 0.046), preprocedural haemoglobin (OR 0.849; 95% CI 0.760-0.944, p = 0.03), and baseline estimated glomerular filtration rate < 30 mL/min (OR 3.216; 95% CI 1.176-8.741, p = 0.021) were independent predictors of life-threatening/disabling and major bleedings. Diabetes remained the only independent predictor of major vascular complications (OR 1.695; 95% CI 1.014-3.156, p = 0.046).
Conclusions: In this retrospective analysis both vascular access and closure techniques were associated with a similar risk of severe bleeding and major vascular events. However, these findings should be further confirmed in a multicentre, randomised study.
Keywords: TAVI; bleeding complications; closure device; vascular access.