Ultrasound-Assisted Angio-Seal VIP Closure of Antegrade Femoral Access Following Lower Extremity Endovascular Interventions

Study design. This was a single-center, retrospective observational study. The study did not fall under the Medical Research Involving Human Subjects Act as accorded by the Medical Research Ethics Committees United and was approved by the local research department of the hospital. Patient informed consent was waived. Study data were extracted from electronic patient records. 

Study population. The study population consisted of all consecutive patients who had US-assisted antegrade femoral access closure with an Angio-Seal VIP, between January 2019 and January 2021 performed by a single operator. Antegrade femoral access included ipsilateral common femoral artery (CFA) and proximal superficial femoral artery (SFA) access regardless of the extent of calcium or diameter of the vessel. Lower extremity procedures for acute and chronic peripheral arterial disease were both included. Patients who had an antegrade and retrograde access in the same vessel segment during the same procedure or a recent access closure other than with an Angio-Seal VIP were excluded from analysis. 

Study data and endpoints. Patient demographics, procedural information, and information about the endpoints were collected. The primary endpoint was technical success which was defined as deployment of the Angio-Seal VIP with complete acute hemostasis. Other endpoints were Angio-Seal VIP related major complications defined as major adverse limb event (MALE, defined as above the ankle amputation or major reintervention), death or any complication requiring (acute) intervention (flow limiting dissection, thrombosis, embolization of plaque or the Angio-Seal VIP itself and major bleeding¹¹). Hemostasis and vessel patency were assessed directly after closure by the operator with Duplex Ultrasound (DUS). Bleeding complications were classified as minor or major according to the Bleeding Academic Research Consortium criteria (BARC).¹² Minor complications were also noted and defined as any complication not within the major criteria. Before hospital discharge, a physical examination, including inspection of the punctured groin, was performed. If an access site complication was suspected, a DUS was performed. Patients were routinely followed-up in the outpatient clinic by a vascular surgeon or interventional radiologist 6-8 weeks after the intervention. 

Statistical analysis. Baseline characteristics and procedural information are presented as descriptive outcomes. Continuous variables are expressed as mean along with the standard deviation. Categorical variables are expressed as number (%). 

Ultrasound-assisted Angio-Seal VIP closure technique. It is recommended to perform access under US guidance to ensure puncture of the CFA or proximal SFA at the twelve o’clock position. Ultrasound also helps to target the best vessel segment for the puncture avoiding calcified plaques and punctures considered to be too proximal. Furthermore, in obese patients the proximal SFA can be targeted for puncture to avoid steep CFA access and thus potential complications. Because the proximal SFA is of a smaller caliber compared to the CFA and can have significant plaque burden, US assessment of the proximal SFA prior to access is also recommended. 

Before exchanging the introduction sheath for the Angio-Seal VIP sheath, US evaluation of the access site needs to be performed to confirm visibility of the artery and sheath. Occasionally, visibility might be insufficient due to per-procedural hematoma formation. If this is the case, standard deployment of the Angio-Seal VIP or manual compression is recommended. 

The first step of US-assisted closure involves a deeper introduction of the delivery sheath than is prescribed in the instructions for use (IFU) (Figure 1). We typically use a short high supportive 0.035˝ guidewire for sheath introduction as well as for the introduction of the Angio-Seal VIP delivery sheath. This prevents kinking of the wire especially in hostile groins after previous surgery. After pulsatile flow is observed the sheath is advanced for an additional 5-10 cm. This will prevent dislocation of the delivery sheath when removing the guidewire in steeper punctures and it also facilitates visualization of the sheath because of the horizontal orientation in the SFA. In addition, in case of kinking of the sheath it offers the operator enough length to use the push and pull technique to deliver the Angio-Seal VIP. With this technique, the carrier is pushed forward while the sheath is pulled back. If the kinking is not resolved, Angio-Seal VIP closure is contraindicated. 

In the second step, the dilator and wire are removed (Figure 2). The carrier is introduced with the lips aligned with the holes in the hub and touching it but NOT fully advanced and locked (Figure 3). 

The third step is to pull the sheath back with the carrier fixed under US guidance until the tip of the sheath is 1-1.5 cm from the access point (Figure 4). With US, the anchor is visible while it is still in the sheath and can be seen at the tip where the indentation is. Next, pull the sheath back while advancing the carrier until it is locked (Figure 5). Ideally, this should deploy the anchor while keeping it in the same position within the artery lumen. 

The fourth and last step under US assistance is to pull the anchor against the anterior vessel wall (Figure 6). If the anchor should catch a plaque, the whole system can be advanced, rotated, and pulled back again. 

The final steps are without US assistance and are identical to the standard deployment. The carrier is locked, the whole system is pulled back and the plug is compressed on the vessel wall. 

After closure a target DUS is performed to confirm complete hemostasis and CFA-SFA patency. After six and seven French closures patients are ordered bedrest for two hours of which an hour supine. After an eight French closure, bedrest is four hours, of which two hours are in supine position.