Background: Vascular and bleeding complications during transcatheter aortic valve implantation (TAVI) are common and associated with the used primary access strategy. In 2021 the VARC-3 criteria were published and the subcategories of vascular and bleeding complications changed.

Objective:  The aim of this retrospective analysis was to investigate the incidence of vascular complications with the chosen access strategy, to differentiate between vascular complications of the primary and secondary access, and to evaluate the adjudication of bleeding complications according to the VARC-2 and VARC-3 criteria.

Methods: All TAVI procedures performed from 2014 to 2020 at the University Hospital Cologne were retrospectively reviewed. Patients were grouped according to the primary access strategy. Access and bleeding complications were classified in conformity with the VARC-2 and VARC-3 criteria.

Results: Overall 2869 TAVI procedures were performed. 2629 patients received transfemoral, 148 transapical, 65 transaxillary and 25 transaortal access.. According to the VARC-2 criteria 10.1% had a vascular complication. Distribution was as follows: 6.4% at the primary access, 2.3% at the secondary access, 0.5% at both sides and 0.9% had a non-access related vascular complication. After evaluating the vascular events according to the VARC-3 criteria, just 2% of the ratings were not concordant with their prior allocation. Furthermore, 5 cases of access-related non-vascular complications were reported.

Bleeding events according to the VARC-2 criteria were reported in 297 (10.4%) patients, of which 71 were life-threatening, 128 major and 98 were minor bleeding complications. In 75 patients bleeding was classified as type 1, in 108 as type 2, 89 as type 3 and 25 bleeding events led to death (type 4). The life-threatening bleedings were split up into 25 type 4 bleedings, 45 type 3 and one type two bleeding. Major bleedings were classified as 38 type 3 bleedings, 89 type 2 and one type 1 bleeding. Most minor bleedings were type 1(74), 18 were classified as type 2 and six as type 3 (table1; figure 1)

Conclusions: The amendment of VARC-2 to VARC-3 criteria resulted in an important change in perspective on bleeding events, but had not an apparent effect on the assessment of vascular complications. The new classification offers the possibility to clearly divide life-threatening and fatal bleeding into critical but controllable and fatal bleeding. This allows a more accurate estimation of potential harm. The assessment of the severity of some bleeding events and vascular complications changed and most resulted in a downgrade of such. Discussion and comparison of bleeding complications from prior TAVI trials in the context of ongoing and future clinical TAVI studies require re-classification of bleeding events to VARC-3 to create a homogenous outcome reporting and to draw valid conclusions.

Table1: Bleeding complications

Figure 1: Bleeding complications flowchart