Article Text
PDF
Abstract
Vascular closure devices (VCDs) show fewer complications related to the puncture site than manual compression but can cause stenosis or occlusion of the common femoral artery (CFA). A patient in her 30s who underwent suture-mediated VCD for haemostasis at the right CFA puncture site after neurointervention showed occlusion of the right CFA on postoperative day 2. Endovascular treatment retrieved the thrombus from the occlusion site, and surgical removal of a suture causing stenosis between the dissected posterior wall intima and anterior wall allowed the resumption of full flow through the right CFA. This complication occurred because the VCD insertion angle was less than 45°, which allowed the footplate to deploy more perpendicularly, causing its posterior foot to snag and dissect the posterior wall intima. To mitigate the risk of such complications caused by the suture-mediated VCD, the surgeon should ensure that the entry angle of the puncture is not less than 45°.
- Neuroimaging
- Interventional radiology
- Neurosurgery
- Vascular surgery
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
Background
The femoral artery is the most common access site for therapeutic neurointervention. Vascular closure devices (VCDs) have been widely used as an alternative to manual compression of the puncture site after transfemoral access to reduce the need for bed rest and reduce discomfort. A large observational study of 84 172 patients undergoing peripheral vascular interventions with sheaths ≤8 Fr showed that haemostasis with a VCD, including collagen plug devices and suture-mediated devices, was associated with a lower risk of puncture site-related complications compared with manual compression.1 A subanalysis of that study found that the incidence of puncture site-related complications was lower under VCD use, ranging from 1.1% to 2.3% for mild and only 0.1%–0.3% for severe.1 Puncture-related complications resulting from suture-mediated VCD have been previously identified as haematoma, pseudoaneurysm, arteriovenous fistula, retroperitoneal haemorrhage, thrombosis and infection.2–4 However, the occurrence of femoral artery stenosis or occlusion due to suture-mediated VCD has been rarely documented,5–8 so the mechanism of occurrence is not yet fully recognised, and standard management practices have yet to be established.
We present a case of symptomatic femoral artery occlusion due to intimal dissection of the posterior wall of the vessel caused by suture-mediated VCD. Combined therapy with endovascular treatment to remove the thrombus from the occlusion site and subsequent surgical treatment to remove the causative suture successfully restored blood flow. In addition, we suggest methods of preventing the occurrence of this complication.
Case presentation
A patient in her 30s with no pre-existing medical conditions was referred to our institution with a newly diagnosed unruptured intracranial aneurysm. The maximum diameter of the aneurysm in the left internal carotid artery (ICA) was 7.6 mm (figure 1A). Flow-diverter stenting with adjunctive coiling was undertaken to prevent rupture. The patient had received dual antiplatelet therapy (aspirin, 100 mg/day; prasugrel, 3.75 mg/day) for 14 days prior to the procedure. Endovascular treatment via transfemoral access was performed under general anaesthesia. Heparin was administered during the procedure to maintain the activated clotting time at ≥300 s.
Findings of intracranial aneurysm and right common femoral artery. (A) Left internal carotid angiography shows an unruptured intracranial aneurysm of the left internal carotid artery with a maximum diameter of 7.6 mm. Upper panel: before treatment; lower panel: after treatment. (B) Precomplication of right femoral angiography shows no stenosis and calcification from the right EIA to CFA. The black arrow indicates the puncture point with a 7-Fr long sheath inserted. (C) Postcomplication of right external iliac arteriography shows occlusion from the right EIA to CFA. The white arrow indicates the occluded EIA to CFA. (D) Photograph shows the exposed right CFA with suture knots on the vessel surface. (E) Fluoroscopic view and photograph show the embolectomy catheter passing through the occlusion site and pulling on the inflated balloon of the embolectomy catheter, resulting in the retrieval of a large amount of dark-red thrombus. Inset shows the dark-red thrombus retrieved. (F) Photograph shows a small piece of dissected posterior wall intima along with the stitch. (G) Photograph shows severe stenosis in the vessel lumen due to suturing between the dissected posterior wall intima and anterior wall. The structure gripped by the forceps is the dissected posterior wall. (H) Right external iliac arteriography after treatment for complications shows complete restoration of blood flow in the right CFA. All photographs represent proximal at the top, distal at the bottom, medial at the right, and lateral at the left. CFA, common femoral artery; EIA, external iliac artery.
The right common femoral artery (CFA) was punctured under ultrasound guidance using the single-wall arterial puncture technique, and a 7-Fr long sheath (Terumo, Somerset, New Jersey, USA) was inserted. Right femoral angiography found no obvious stenosis or calcification from CFA to the external iliac artery (EIA) (figure 1B). A 7-Fr balloon guide catheter (OPTIMO; Tokai Medical Products, Aichi, Japan) was then guided to the cervical segment of the left ICA. With one coil inserted into the aneurysm beforehand, a pipeline with shield technology (Medtronic, Dublin, Ireland) was placed from the supraclinoid segment to the cavernous segment of the left ICA with sufficient coverage of the aneurysm neck. Coil embolisation was completed with dome filling and a packing density of 16.6% without complications (figure 1A).
A suture-mediated VCD (Perclose ProStyle; Abbott-Vascular, Redwood, California, USA) was used for haemostasis at the puncture site. The entry angle of the 7-Fr long sheath was less than 45°, so the VCD exchanged with the sheath was also inserted at an angle less than 45°. When inserting the first VCD into the vessel for haemostasis, some resistance was encountered. As haemostasis with the first VCD failed, a second VCD was employed to stop the bleeding. The second VCD sheath had to be inserted far beyond the ‘Distal Guide’ before backflow of arterial blood from the ‘Marker Lumen’ was seen. Even with the VCD, arterial bleeding from the puncture site persisted, so manual compression was applied for 15 min to achieve haemostasis. After treatment, no neurological complications were observed. However, when walking was resumed 2 days after treatment, the patient complained of pain and numbness in the right lower extremity every time she walked approximately 10 m.
Investigations
In addition to the intermittent claudication, the right CFA and dorsal pedal artery pulses were not palpable. The ankle-brachial index was 0.51 in the right lower extremity and 1.22 in the left lower extremity, with a prominent decrease on the right side. Three-dimensional CT angiography revealed occlusion from the right EIA to the right CFA.
Treatment
Emergency vascular surgery was performed to recanalise the occluded vessels. After inserting a diagnostic catheter (Impress; Merit Medical, South Jordan, Utah, USA) via a cross-over approach from the left CFA to the right common iliac artery, right EIA angiography revealed that the right EIA to CFA was occluded proximal to the puncture point for the neurointervention (figure 1C). The right CFA was then directly exposed, showing the sutures on the surface of the CFA (figure 1D). Following transverse arteriotomy, an embolectomy catheter (LeMaitre Vascular, Burlington, Massachusetts, USA) was passed through the occlusion site and a large amount of dark-red thrombus was retrieved by pulling the inflated balloon of the embolectomy catheter (figure 1E). However, blood flow in the right CFA did not resume despite thrombus removal. Additional longitudinal arteriotomy was applied just distal to the suture knot, and dissection of the posterior wall intima was noted (figure 1F). The occlusion was duo to the suture between the dissected posterior wall intima and the anterior wall, severely narrowing the vessel lumen (figure 1G). When the suture thread was cut, stenosis in the lumen was completely resolved. Patch angioplasty was performed using bovine pericardium (XenoSure; LeMaitre Vascular). Blood flow in the right CFA was completely restored (figure 1H). The dorsal pedal artery pulse became palpable.
Outcome and follow-up
Following the resumption of blood flow in the occluded right CFA, the patient no longer exhibited intermittent claudication. The ankle-brachial index was 1.06 on the right lower extremity and 1.13 on the left lower extremity, with the right side improving to normal. Postoperative dual antiplatelet therapy was continued. The patient was discharged home 6 days after surgery without neurological sequelae. Ultrasound examination 3 months after treatment demonstrated artery patency from the CFA to the EIA, with no stenosis (figure 2). The patient has remained free of symptoms for 6 months as of the time of this report.
Ultrasound examination 3 months after treatment. Ultrasound examination images show that the area from CFA to EIA with patch angioplasty remains patent without stenosis or occlusion. CFA, common femoral artery; EIA, external iliac artery.
Discussion
In the present case, the lumen of the CFA was severely stenosed by sutures between the posterior wall intima dissected by the suture-mediated VCD and the anterior wall. The CFA was then completely occluded by thrombus formation at the stenosed lumen due to manual compression for haemostasis. Endovascular treatment to remove the thrombus and release the occlusion and surgical removal of the restrictive suture completely released the lumen stenosis and allowed the resumption of normal blood flow in the right CFA. The frequency of vascular occlusion after suture-mediated VCD is low. In a previous study of 2177 patients who underwent closure with Perclose devices after percutaneous coronary intervention, arterial occlusion or loss of pulse after percutaneous coronary intervention occurred in only 0.1% of cases.9 The mechanisms underlying femoral artery stenosis or occlusion caused by suture-mediated VCD have not yet been fully recognised, and standard management strategies have not been established.
Mechanism of femoral artery stenosis or occlusion by suture-mediated VCD
Mechanisms of femoral artery stenosis or occlusion caused by suture-mediated VCD have been proposed in a few different scenarios. Gemmete et al speculated that stenosis with a right superficial femoral artery origin after puncture site haemostasis with suture-mediated VCD could be due to an inflammatory reaction or thrombus formation due to trauma to the endothelium caused by puncture or device deployment.5 Park et al experienced occlusion of the right femoral artery after haemostasis with suture-mediated VCD. By surgical exploration, they found an intimal dissection of the anterior wall where the suture had been removed, while the posterior wall was intact. Based on these findings, they attributed the occlusion to the anterior foot of the device catching the anterior wall of the proximal vessel and dissecting because the insertion angle of the device to the artery was less than 45°.6 Youn et al illustrated that when pulling the suture-mediated VCD posteriorly near the bifurcation, the posterior footplate may catch on the side branch and the suture may penetrate the carina at the bifurcation. Under such a scenario, the posterior wall of the CFA and carina may be pulled towards the anterior wall or the anterior wall may be pulled posteriorly and downward and then intussuscepted when tying the suture.8 In addition, Archie et al demonstrated in a tube model that the footplate of the Perclose Proglide, a suture-mediated VCD, easily engages the bifurcation point and allows the needle to deploy through the posterior wall, thereby leaving the suture knot in the artery.7
In the present case, resistance to insertion of the first VCD into the CFA was likely to have caused injury to the intima of the posterior wall of the vessel. A second VCD was then inserted at an angle less than 45° to the artery. When the VCD is inserted at less than 45° to the vessel axis, the footplate deploys more perpendicularly rather than parallel to the vessel axis, increasing the likelihood that the edge of the posterior foot of the footplate will conflict with the detached intima and snag on the injured intima of the posterior wall of the vessel. (figure 3A). The posterior foot of the footplate in the device was retracted while hooked to the intima of the posterior wall of the vessel injured by the first VCD (figure 3A). Further, if the device was inserted at less than 45°, the sheath would have to be advanced a longer distance beyond the ‘Distal Guide’ to check for backflow of arterial blood from the ‘Marker Lumen’. This in turn increases the distance the footplate is pulled after deployment and increases the likelihood of trapping and dissection of the posterior wall intima of the vessel by the footplate. Subsequently, the dissected posterior wall was sutured to the anterior wall, causing severe stenosis in the vessel lumen (figure 3B). Finally, the gradual formation of a thrombus in the stenotic area led to occlusion.
Mechanism of CFA stenosis by suture-mediated VCD. (A) Schematic diagram demonstrating insertion of the VCD at less than 45° to the vessel axis, causing the footplate to deploy more perpendicularly rather than parallel to the vessel axis, and the edge of the posterior foot of the footplate to snag on the injured intima of the posterior wall of the vessel and dissect the intima during retraction. (B) Schematic diagram illustrating severe stenosis of the vessel lumen due to suturing of the dissected posterior wall to the anterior wall. (C) Schematic diagram depicting the parallel development of the footplate when the VCD is inserted at an angle of 45°. CFA, common femoral artery; EIA, external iliac artery; VCD, vascular closure device.
Management of femoral artery stenosis or occlusion caused by suture-mediated VCD
Depending on the mechanism of occurrence, endovascular or surgical treatment can be applied to treat femoral artery stenosis or occlusion caused by suture-mediated VCD. Regarding endovascular treatment, Gemmete et al achieved improved blood flow by dilating the vessel with balloon angioplasty to address tight stenosis at the origin of the right superficial femoral artery associated with inflammatory reaction or thrombus formation caused by the suture-mediated VCD.5 Youn et al successfully reopened an occluded CFA in which the posterior foot was trapped within the side branch, causing dissection. In that case, the suture was cut by endovascular treatment with the rotational atherectomy device. However, the authors cautioned that the procedure raises concerns about distal embolisation of the suture material, vessel rupture and suture twisting around the atherectomy device. They noted that in limited cases, the procedure should be performed with caution after preparing a surgical backup in case of vascular rupture and placing a filter device to prevent embolism.8
On the other hand, in terms of surgical treatment, Park et al resolved an occlusion by direct surgical removal of the suture, causing occlusion by intussusception of the arterial vessel wall due to intimal dissection induced by the suture-mediated VCD.6 Based on the aforementioned findings, while vascular intervention may improve blood flow in cases where inflammation or thrombosis are the causative factors, suture-induced vascular stenosis or occlusion of the vessel can be difficult to address endovascularly and may require surgical removal of the suture, which is more invasive management.
In the present case, even after endovascular treatment to remove the thrombus and release the occlusion, severe vascular stenosis remained due to the suture between the dissected posterior wall intima and the anterior wall, so direct surgical removal of the suture was necessary. Consequently, stenosis of the lumen completely disappeared, blood flow in the right CFA was fully restored, and symptoms in the right lower extremity were completely resolved. Even if the CFA becomes occluded, prompt release of the occlusion can prevent neurological sequelae. Stenosis or occlusion of the vessel by sutures can be difficult to address with endovascular therapy and may require surgical excision of the sutured material, representing more invasive management.
Preventive measures to avoid femoral artery stenosis or occlusion by suture-mediated VCD
Based on the above mechanisms and management approaches, the most important preventive measure to avoid femoral artery stenosis or occlusion due to suture-mediated VCD is to insert the device so that the insertion angle is not less than 45°. The suture-mediated VCD is designed so that the footplate is deployed parallel to the vessel axis when inserted at a 45° angle (figure 3C). In that way, the risk of injuring the vascular intima can be minimised. On the other hand, device puncture angles less than 45° can cause hooking and dissection of the intima by the footplate, and subsequent suturing of the dissected intima can cause vascular stenosis or occlusion. To avoid stenosis or occlusion of the femoral artery caused by the suture-mediated VCD, surgeons should ensure that the entry angle for the device is not below 45°.
If injury to the posterior wall intima of the CFA is suspected, it is essential to evaluate both the presence of intimal dissection and the extent of vascular stenosis using ultrasound imaging. Additionally, the pulsation of adjacent peripheral arteries, such as the popliteal artery and the dorsal pedal artery, needs to be confirmed. Surgical intervention is warranted in cases where dissection results in flow-limiting stenosis. Haemostasis should be achieved by manual compression rather than by the use of suture-mediated VCDs in cases of injury to the posterior wall intima to minimise the potential risk of further injury to the intima.
Learning points
Suture-mediated vascular closure device (VCD) insertion at less than 45° to the femoral artery may cause the posterior foot of the device to retract while hooked to the intima of the posterior artery wall and contribute to dissection.
Use of a suture-mediated VCD with dissected posterior wall intima may cause stenosis or occlusion of the vessel lumen due to the suture between the dissected posterior wall intima and anterior wall.
Stenosis or occlusion of vessels associated with sutures between the dissected posterior wall intima and anterior wall can be completely restored by surgical removal of the sutures.
The surgeon should ensure that the entry angle for the device should not be below 45° to avoid stenosis or occlusion of the femoral artery caused by suture-mediated VCD.
Ethics statements
Patient consent for publication
Acknowledgments
Dr Akihiko Teshigawara of the Department of Neurosurgery, the Jikei University School of Medicine, Kashiwa Hospital, Chiba, Japan, drew the illustration in Figure 3 for this article. We would like to take this opportunity to express our sincere appreciation. We would also like to thank Dr Kostadin Karagiozov of the Department of Neurosurgery, the Jikei University School of Medicine, Tokyo, Japan, for English language editing.
Footnotes
Contributors The following authors were responsible for drafting of the text, sourcing and editing of clinical images, investigation results, drawing original diagrams and algorithms, and critical revision for important intellectual content: MF, IK, KS and YM. The following authors gave final approval of the manuscript: MF, IK, KS and YM.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Case reports provide a valuable learning resource for the scientific community and can indicate areas of interest for future research. They should not be used in isolation to guide treatment choices or public health policy.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.