Rethinking access in TAVI: large multicenter cohort-based evaluation of a single access approach compared with standard bi-femoral strategy

Background Transfemoral approach has become the standard primary access for transcatheter aortic valve implantation (TAVI) due to low complication rates. An additional femoral secondary access (FSCA) is often used for angiographic guidance of the procedure. Recently, small single-center studies demonstrated feasibility of transfemoral TAVI through a single access (SA). However, comparative and large-scale data are missing. We assessed vascular and bleeding complications of FSCA and SA approaches in a large multicenter registry to evaluate both strategies. Methods The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 7,819 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. FSCA and SA were performed in 7071 (90%) and 748 (10%) patients, respectively. A propensity score was used to match 375 patients who received FSCA with 375 patients who received SA. Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions. In contrast to prior abstracts derived from the same registry, the present study examines a single access compared to a bi-femoral approach and includes extensive propensity-score matching as well as novel results all differing to previous analyses. Results Mean age was 81.7±3.6 years and 46.7% of patients were female (mean logistic EuroSCORE II >4: 35.3%). Groups were comparable regarding available baseline comorbidities, echo, computed tomography and procedural variables. Secondary access-related vascular complications occurred in 4.0% of patients with FSCA (major 1.6%; minor 2.4%) vs. none in SA. These were mainly characterized as pseudoaneurysms (2.9%) and bleeding (0.8%) mostly treated conservatively (2.4%), yet in some cases surgical repair was required (0.8%). Complications at the TAVI access did not differ significantly (8.0 vs. 6.4%, p=0.48). SA was associated with lower rates of stage III/IV acute kidney injury (5.1 vs. 2.1%, p=0.05). No significant difference was observed regarding type III/IV bleeding (2.7% vs. 4.3%, p=0.32), stroke rate (1.6% vs. 3.2%, p=0.23), procedural results, or all-cause 30-day mortality (2.9% and 4.8%, p=0.26) for FSCA and SA groups. Conclusion In patients treated with transfemoral TAVI, a single access approach was associated with lower rates of major and minor access-related vascular complications related to the secondary access, without compromising the procedure, suggesting potential benefits of a streamlined TAVI approach with the omission of additional vascular access.