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Vascular closure devices in TAVI: MANTA® versus ProGlide® in a propensity-matched population
Session:
Painel 11 - Cardiologia Intervenção 3
Speaker:
Gustavo Sá Mendes
Congress:
CPC 2020
Topic:
H. Interventional Cardiology and Cardiovascular Surgery
Theme:
25. Interventional Cardiology
Subtheme:
25.4 Interventional Cardiology - Other
Session Type:
Posters
FP Number:
---
Authors:
Gustavo Sá Mendes; Afonso Félix De Oliveira; Rui Campante Teles; Pedro de Araújo Gonçalves; João Brito; Henrique Gabriel; Luís Raposo ; Mariana Gonçalves; Pedro Lopes ; Henrique Figueiredo; Manuel Almeida
Abstract
<p><strong>Background:</strong> Vascular complications increase morbidity and mortality in transcatheter aortic valve implantation (TAVI). A collagen plug-based closure device - <em>MANTA®</em> was recently introduced as an alternative to the suture-mediated <em>ProGlide®</em> vascular closure device (VCD). Data regarding the efficacy and safety comparing both VCD is scarce. The present study sought to compare the effectiveness of both devices.</p> <p><strong>Methods:</strong> Single center retrospective analysis on prospectively collected data of 300 consecutive patients who underwent TAVI using <em>MANTA®</em> or <em>ProGlide®</em> since 2018. A 1:1 propensity-score matched population derived by a multivariate logistic regression model based on age, sex, body mass index, pre-procedural haemoglobin, EuroSCORE II, main access calcification and the sheath-to-artery ratio. The primary endpoint was the composite of major or life-threatening bleeding (VARC-2 definition), femoral artery stenosis/dissection, pseudoaneurysm and need for endovascular/surgical bailout intervention.</p> <p><strong>Results:</strong>The propensity score matching resulted in 129 matched pairs. The median age was 84 years old [IQR 80-87], 42% males with a median EuroSCOREII of 4.29% [IQR 3.05-6.24].</p> <p>There were no differences in the primary endpoint between MANTA ® and ProGlide® cohorts (3.9% vs 7.8%, p=0.287, respectively). The rates of the primary endpoint with the <em>MANTA®</em> device decreased with center experience, with relatively steep learning curve effect concerning device success.</p> <p>Major or life-threatening bleeding (3.1% vs 5.4%, p=0.540) and pseudoaneurysm (0.8% vs 2.3%, p=0.622) occurred less frequently in MANTA® cohort, but the differences did not reach statistical significance. Endovascular (stent or balloon) or surgical rescue intervention (9.3% vs 5.4%, p=0.341) and femoral artery stenosis/dissection (6.2% vs 3.1%, p=0.376), were also similar rates. In ProGlide® cohort, to achieve VCD success (without primary endpoint events), 15.5% needed more than 2 devices, significantly different from MANTA ® (p<0,001) . </p> <p><strong>Conclusions: </strong>In patients undergoing transfemoral TAVI, the <em>MANTA®</em> VCD showed a similar efficacy and safety compared to the <em>ProGlide® device </em>and it reduced significantly the need of additional VCDs for completion of hemostasis. These results were obtained despite a clear learning curve associated with MANTA.</p>
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