Prostyle versus MANTA for large-bore femoral closure in transfemoral TAVI: a multicenter comparative study
L Lehto, Y Sugiyama, M Riihiniemi, J Pykari, D Sato, J Nieminen, T Vasankari, T Vahasilta, J Piuhola, M Jalanko, M Niemela, M SavontausAbstract
Background/Introduction
Transfemoral transcatheter aortic valve implantation (Tf-TAVI) requires large-bore femoral arterial access. Although the incidence of access-site complications has declined over time, vascular complications remain a clinically relevant challenge and are associated with significant morbidity and mortality. Reliable vascular closure devices (VCDs) are essential for safe large-bore access management. VCDs include plug-based and suture-based systems; however, comparative data—particularly for latest-generation devices—remain limited and partially conflicting.
Purpose
To compare the efficacy and safety of the latest-generation suture-based ProStyle device with the collagen plug–based MANTA device for large-bore femoral arteriotomy closure following transfemoral TAVI.
Methods
This multicenter retrospective registry included 900 consecutive transfemoral TAVI patients treated at three high-volume university hospitals between 2017 and 2023: 450 patients underwent closure with the MANTA device and 450 with the ProStyle device. All participating centers transitioned from MANTA to ProStyle as their primary vascular closure strategy during the study period. Each center contributed data on the last 150 consecutive patients treated with MANTA and the first 150 consecutive patients treated after adoption of ProStyle. All patients underwent systematic preprocedural computed tomography–based vascular assessment. The primary endpoint was modified vascular closure device failure, defined as the need for additional intervention to achieve hemostasis, device embolization, or hemodynamically significant stenosis attributable to the VCD. Manual compression and adjunctive Angio-Seal use was not considered VCD failure. Secondary endpoints included VARC-3–defined major and minor vascular access-site complications, VARC-3 bleeding, need for endovascular or surgical bailout, and length of hospital stay.
Results
Mean age was 79.6 ± 6.3 years; 45.8% were women. The primary endpoint occurred in 7.2% overall and was significantly more frequent with MANTA compared with ProStyle (11.3% vs. 3.1%; p<0.001). Both major (6.4% vs. 3.1%; p=0.018), and minor (8.7% vs. 3.5%; p=0.001) vascular complications were more frequent with MANTA. Endovascular bailout procedures were markedly more common in the MANTA group, including balloon angioplasty (32 vs. 1; p<0.01) and covered stent implantation (10 vs. 0; p<0.01). VARC-3 bleeding—particularly grade 3 bleeding—was also higher with MANTA (18 vs. 5 events). Median length of hospital stay was similar in both groups (3 [2–4] days).
Conclusions
In this large retrospective multicenter cohort, the ProStyle closure strategy was associated with significantly lower VCD failure rates and fewer major and minor vascular complications compared with MANTA following transfemoral TAVI. These findings suggest that a suture-based closure strategy may provide superior safety for large-bore femoral access management.