Key result
Single access TAVI is linked to similar major but fewer minor complications vs secondary access.
Why the study?
Small single-center studies showed the feasibility of single-access transfemoral TAVI without a secondary access, but large-scale comparative data were missing.
Does a single access approach reduce vascular and bleeding complications compared to a secondary access approach in patients undergoing transfemoral TAVI?
Cohort (n=9,457)
Yes
Does a single access approach reduce vascular and bleeding complications compared to a secondary access approach in patients undergoing transfemoral TAVI?
Absolute Event Rate: 4.8% vs 6.1%
p-value: p=0.20
In patients undergoing transfemoral TAVI, a single access approach is associated with fewer minor vascular complications compared to using a secondary access, without compromising overall safety or 30-day mortality.
Background The transfemoral approach has become the gold standard primary access for transcatheter aortic valve implantation (TAVI) due to low complication rates. An additional secondary access (ScA) is used for angiographic guidance of the procedure. Recently, small, single-center studies demonstrated feasibility of single-access for transfemoral TAVI without a secondary access. However, comparative and large-scale data are missing. Purpose We assessed vascular and bleeding complications of ScA and Single access (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 10,120 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. In 9,457 patients who qualified for analysis ScA (80.7% femoral, 19.3% radial) were performed in 8709 (92%) and SA in 748 (8%). Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions. Results Median age was 81.9[IQR 78.2, 85.1] years and 48.9% of patients were female (median logistic EuroSCORE II: 3.3% [IQR 2.1, 5.6]). Peripheral artery disease was comparable between groups (13.5 vs. 14.0%, p=0.73). While overall major access-related vascular complications did not differ significantly (6.1% vs. 4.8%, p=0.20), there was a higher incidence of minor complications for ScA compared to SA (9.0% vs. 2.8%, p<0.001). Secondary access complications amounted to 2.7% in the ScA group and were mainly characterized as bleeding (1.2%) and pseudoaneurysms (1.2%) mostly treated conservatively (1.2%), yet in some cases surgical repair was needed (0.8%). No significant difference was observed regarding type III/IV bleeding (4.1% vs. 4.3%, p=0.91), stroke rate (2.4% vs. 3.6%, p=0.05), stage III/IV acute kidney injury (2.4% vs. 2.4%, p=1.00) or all-cause 30-day mortality (5.8% and 5.7%, p=0.99) for ScA compared to SA groups. Conclusion In patients treated with transfemoral TAVI, a single access approach was associated with lower rates of minor access-related vascular complications without compromising overall outcomes, suggesting potential benefits of a minimally-invasive TAVI approach with the omission of additional vascular access.
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Grundmann et al. (2024) conducted a cohort in Transcatheter aortic valve implantation (TAVI) (n=9,457). Single access (SA) vs. Secondary access (ScA) was evaluated on Major access-related vascular complications (p=0.20). A single access approach for transfemoral TAVI yielded similar major vascular complications (4.8% vs 6.1%, p=0.20) and fewer minor complications (2.8% vs 9.0%, p<0.001) compared to secondary access.
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