Reduction of vascular complications in transfemoral Transcatheter Aortic Valve Implantation (TAVI) – comparison of radial access vs conventional femoral safety wire approach in a large patient cohort

Background and Objectives: The application of a “safety strategy” is a widely adopted practice in TAVR, wherein the primary large-bore femoral access is “secured” by introducing a safety wire across an additional ipsilateral distal or contralateral secondary femoral access (4-6F). This practice serves as a bailout strategy in case of major vascular complications. There is growing evidence, that a strict transradial approach as secondary access in TAVR omitting this “safety-wire” concept might be associated with a reduction in vascular and bleeding complications. As of 2021, our center has fully transitioned TAVR procedures to the 'radial first' approach, eliminating the mandatory safety wire. The objective of this study is to assess and compare the potential effects on vascular complications based on the selection of the “safety strategy”.

Methodology and Results: We performed a retrospective monocentric analysis of the periprocedural outcomes of 1480 patients, who underwent transfemoral TAVR at our center between January 2020 and August 2023. Among these, the entirety of 676 procedures conducted since November 23, 2021, were performed without an obligatory safety wire. Radial access was employed as the secondary access whenever feasible, designating this group as the 'voluntary safety wire' cohort. The number of femoral punctures to establish a safety wire decreased from 804 (100 %) to 27 (4 %) in the “voluntary safety wire” group. Vascular and bleeding complications were analyzed based on ICD-10 codes and evaluated in accordance with the Valve Academic Research Consortium-3 (VARC 3) criteria. Overall vascular complications significantly reduced from 11.3 % (91) to 6.1 % (41). While the proportion of major vascular complications did not show a significant difference between the two groups (p = 0.683), there was a significant reduction in minor vascular complications {68 (8.5 %) vs. 24 (3.6 %), p < 0.001}. The number of overall bleeding complications also significantly reduced in the group without the mandatory use of a safety wire (p = 0.002)

Conclusion: The implementation of a safety strategy, that promotes the use of radial secondary access whenever feasible coupled with the omission of a mandatory safety wire in transfemoral TAVR led to a significant reduction of vascular complications. The difference between the two groups was primarily driven by a significant decrease in minor vascular complications, particularly minor bleedings without increase in major vascular complications.