SPC365

MANTA vascular closure device after transfemoral transcatheter aortic valve implantation: a universal closure for all patients

Session: Posters (Sessão 4 - Écran 6) - Intervenção Valvular Aórtica Percutânea 1
Speaker: João Borges Rosa

Congress: CPC 2023
Topic: F. Valvular, Myocardial, Pericardial, Pulmonary, Congenital Heart Disease
Theme: 15. Valvular Heart Disease
Subtheme: 15.4 Valvular Heart Disease – Treatment
Session Type: Pósters Electrónicos
FP Number: ---
Authors: João Borges-Rosa; Sofia Martinho; Ana Rita M. Gomes; Gustavo M. Campos; Ana Vera Marinho; Elisabete Jorge; Joana Delgado Silva; Luís Leite; Marco Costa; Lino Gonçalves

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:10.0pt"><span style="background-color:white"><span style="color:#202124">Introduction: Transcatheter aortic valve implantation (TAVI)</span></span></span><span style="font-size:10.0pt"> has revolutionized the treatment of symptomatic severe aortic stenosis and is usually performed via transfemoral access. However, the high rate of </span><span style="font-size:10.0pt">vascular complications (5-20%) at the large-bore access site might impair clinical outcomes. There are several options for access site closure, including MANTA vascular closure device (Teleflex, Morrisville, NC, USA) which showed promising results in trials. We aimed to evaluate </span><span style="font-size:10.0pt"><span style="color:black">the rate</span></span><span style="font-size:10.0pt"> of device failure and vascular complications <span style="color:black">in transfemoral TAVI patients treated by the MANTA device in a </span>real-world<span style="color:black"> cohort. </span></span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:10.0pt"><span style="color:black">Methods: We conducted a retrospective single-centre study with consecutive patients </span></span><span style="font-size:10.0pt">with </span><span style="font-size:10.0pt">symptomatic</span><span style="font-size:10.0pt"> severe aortic stenosis who underwent transfemoral TAVI and in whom the MANTA device was used to close the arterial large-bore femoral access, between March 2020 to March 2022. The primary endpoint was the rate of device failure and vascular/bleeding complications at the large-bore access site according to the Valve Academic Research Consortium (VARC)-3 definitions. Secondary endpoints were cardiovascular and non-cardiovascular mortality during index hospitalization and at 30-days follow-up.</span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:&quot;Times New Roman&quot;,serif"><span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif"><span style="color:black">Results:</span></span></span> <span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif"><span style="color:black">A total of 250 patients were included, mean age of 81.44 &plusmn; 6.11 years, 53.6% females, with a median EuroSCORE II of 3.15% (IQR 2.07 - 4.75). Nearly two-thirds were under antithrombotic treatment (35.6% anticoagulants and 32.0% antiplatelet). Mean femoral artery minimal diameter was 7.51 &plusmn; 1.42, 27.7% had moderate to severe calcification, and 10.7% had moderate to severe tortuosity. The Evolut R/PRO was the most frequently implanted (51.36%).&nbsp; </span></span></span><span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif">Successful closure of the large-bore access site<span style="color:black"> was accomplished in 92.4% (n=231) and only one patient with device failure required surgical closure. Vascular complications occurred in 9.20% (n=23), most related to the plug-based device (92.3%, n=21) and all minor:&nbsp; femoral artery stenosis (66.7%, n=14), hematomas (23.8%, n=5) and pseudoaneurysms (9.5%, n=2) of the common femoral artery. Bleeding complications occurred in 2.9% (n=7), all VARC type 1. </span>Both smaller <span style="color:black">minimal femoral artery diameter </span>(<span style="color:black">6.6 </span></span></span><span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif"><span style="color:black">&plusmn; </span></span></span><span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif"><span style="color:black">1.1 </span></span></span><span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif"><span style="color:black">mm vs </span></span></span><span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif"><span style="color:black">7.6 </span></span></span><span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif"><span style="color:black">&plusmn;</span></span></span><span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif"><span style="color:black"> 1.4mm, p&lt;0.01) and bigger sheath to femoral artery diameter</span></span></span> <span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif"><span style="color:black">ratio (0.78 </span></span></span><span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif"><span style="color:black">&plusmn; 0.16 vs </span></span></span><span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif"><span style="color:black">0.69 </span></span></span><span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif"><span style="color:black">&plusmn; 0.15, p=0.02) </span></span></span><span style="font-size:10.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif">predicted device failure. D<span style="color:black">evice failure did not prolong the length of hospital stay (4.00, IQR 3.00-5.00 days vs 4.00, IQR 3.00-5.00; p=0.77). From patients discharged, t</span>hirty-day mortality was 0.4% (<em>n</em>=1), from non-cardiovascular cause (urosepsis).</span></span></span></span></p>

<p style="text-align:justify"><span style="font-size:12pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:10.0pt"><span style="color:black">Conclusions: </span></span><span style="font-size:10.0pt">Our results suggest that in the real world, in very frail patients, the MANTA device is a safe and efficient option for closing large-caliber femoral arterial access after transfemoral TAVI.</span></span></span></p>