The present study includes 157 consecutive patients scheduled for TAVI in a newly established TAVI centre at Oslo University Hospital, Ullevål, Norway, with intention of performing percutaneous mini invasive TF-TAVI. Six patients were excluded from the present study due to the following causes; subclavian artery access (n = 3), surgical femoro-iliac cut-down (n = 2), and one patient died during the procedure. The remaining 151 patients were treated between December 2015 and March 2018. All patients were classified by the Society of Thoracic Surgeons/American College of Cardiology transcatheter aortic valve replacement (STS/ACC TAVR) risk score (Arsalan et al. 2018).
All femoral punctures intended for large bore access were preplanned from CT angiography and access was obtained under fluoroscopy using a J-tip wire in the common femoral artery (CFA) at the puncture site, either introduced by a contralateral or an ipsilateral peripheral puncture. Ultrasound guidance was not systematically used. All punctures were made by the same three experienced interventionists (AA-A, AO or PH).
When applicable, anticoagulants were stopped three days prior to TAVI procedure. All patients received intravenous Heparin and activated clotting time (ACT) was targeted to 250–300 s. Vascular closing with both ProGlide and Manta were started after reversing the Heparin effect with intravenous Protamin 50 mg. For both VCDs the initial procedures were performed with a proctor or device specialist, as recommended by the respective vendor.
Vascular closure devices
The Perclose ProGlide (Abbot Vascular, USA) is a 6 Fr suture mediated closure system developed for closure of femoral artery punctures up to 8 Fr. When using larger access site diameters, 14–24 Fr, 2 ProGlide can be used in the same puncture site. The 2 ProGlides are placed as presutures with an angle of 30–45 degrees to each side. After completion of the TF-TAVI procedure the large bore sheath is removed and the preformed sutures are advanced and tightened to obtain hemostasis (Maniotis et al. 2017).
The Manta (Essential Medical Inc., USA) is a collagen based vascular plug for post procedure closure of large bore access sites. Briefly, the Manta VCD consists of a resorbable intraarterial toggle and an extravascular hemostatic collagen plug and a suture and a stainless steel suture lock which keeps the toggle and the collagen plug together, on each side of the arterial wall. The Manta components resorb within 6 months, but if earlier reintervention would be needed the puncture is clearly indicated by the stainless steel suture lock and can thus be avoided. The Manta is delivered in two sizes, 14 and 18 Fr, for punctures of 10–22 Fr (Van Gils et al. 2016).
This study focuses on ipsilateral large bore arterial access site complications during index hospitalization, which with a reasonable probability can be attributed to failure of the vascular closure device used. Bleedings included corresponded to Valve Academic Research Consortium (VARC)-2 “Major bleeding” while other complications like pseudoaneurysm best correspond to VARC-2 “Minor vascular complications” (Kappetein et al. 2012).
The endpoints were 1: vascular complications including bleeding, occlusion, flow limiting high grade stenosis or dissection, pseudoaneurysm or other complications directly attributable to the puncture site or the VCD used or 2: non-planned vascular surgery and / or use of endovascular stent or stentgraft or other endovascular intervention at the puncture site.
The separate components of the endpoints as bleeding, pseudoaneurysm, occlusion, flow limiting high grade stenosis or dissection at the puncture site and separate interventions as vascular surgery and / or use of endovascular stent or stentgraft or other endovascular intervention at the puncture site are also presented.
All eligible patients from one TAVI center were included in a non-randomized registry and analysed retrospectively. All patients were treated using self-expanding bioprostheses from Medtronic (Medtronic, USA); CoreValve, Evolut R or Evolut PRO. Initially, all 14–20 Fr closures were performed using the ProGlide. Sixty-nine consecutive patients were treated using the ProGlide VCD. In May 2017 the first TAVI procedure using Manta VCD was performed. Subsequently, all patients but seven have consecutively been treated using Manta. Of the seven later, non-consecutive ProGlide procedures four were performed due to availability and three due to operator preferences.
The ProGlide and the Manta groups have been compared for endpoints in the total cohort of patients. Further, both groups were divided into the first 25 patients with the respective VCD to access the learning period complications and into the remaining patients (51 for ProGlide and 50 for Manta) to assess the results during established use of the device.
The diameter and calcification was evaluated from contrast enhanced multislice computed tomography (CT) images performed as pre-procedural planning for the TAVI procedure. Smallest lumen diameter was measured in two planes in the external iliac artery and in the common femoral artery (CFA). The mean of these diameters is used as minimal diameter in the respective segment. Calcification was visually graded as none or mild (=0) or moderate or severe (=1). Measurements of lumen diameter and calcium scoring were performed by an external observer not involved in the choice of VCD. Procedure planning and choice of introducers was based on CT angiography. Procedures were performed using the Medtronic Sentrant sheath. The mean of the CFA inner diameter was also related to the sheath size to calculate a CFA/sheath size ratio.
All data are obtained retrospectively from a consecutive, non-randomized registry at a single TAVI center. In the endpoints, only the first complication and only the first treatment were included. If present, other vascular access site complications and treatments are presented in results but are not statistically analysed. Data were analysed using Excel (Microsoft, USA). Continuous data are presented as mean ± standard deviation (SD) and categorical variables are presented as number and percentages. Student’s t-test (two sided, non-paired observations) was used for analysis of continuous variables. Categorical variables were analysed by the Kji-square test. For both, p-value of < 0,05 was considered as significant.