Closure Devices Are Not Benign: Case Closed or Artery Closed?

The arterial access required during most invasive vascular procedures provides a common source of complications and morbidity. This problem has been aggravated by recent trends in earlier ambulation. Both suture mediated and collagen hemostasis devices are advantageous from the standpoint of earlier ambulation and patient comfort. They are associated with iatrogenic complications of their own with vascular occlusion and endovascular infection being the most dreaded. The incidence of major complications of closure devices is 1.2–1.4%, depending on the degree of concomitant anticoagulation and the device studied.¹ Major complications include need for surgical repair or transfusion. Minor complications like local infection, hematomas and small pseudoaneurysms range from 7–14%, depending on the study population and the device used.² In this case report, the delayed occurrence of an under-recognized complication of a suture mediated closure device is described. At the site of the Perclose Closer (Abbott Vascular, Abbott Park, Illinois) closure device deployment in the common femoral artery, a non-atherosclerotic lesion and dissection resulted in claudication in the involved extremity. The presentation was delayed and definitive treatment necessitated surgery. Case Report. A 60-year-old female with hypertension and hyperlipidemia underwent staged coronary intervention via the right femoral artery for symptoms of unstable angina. The procedures were 30 days apart. Arteriotomy closure devices were used during both procedures. A Perclose Closer suture mediated closure device was used following the second intervention and an Angio-Seal (St. Jude Medical, St. Paul, Minnesota) device was used following the first procedure. A sheath angiogram was performed prior to the deployment of both devices, and arteriotomy closure was successful and uneventful. The sheath angiogram in both instances suggested that the access was above the bifurcation of the SFA, and the vessel was healthy and of adequate size. The patient presented with symptoms of claudication 3 weeks following the second interventional procedure, and non-invasive imaging suggested a focal stenosis of the right common femoral artery with an ankle brachial index of 0.74. This warranted a peripheral angiogram, and a focal high grade napkin ring lesion was identified at the site of the right common femoral artery (Figure 1). The distal reference vessel and the lesion were interrogated with an intravascular ultrasound catheter (Figures 2A and 2B). The lesion was treated with angioplasty with contralateral approach using a 6 mm balloon. No waist in the balloon was noted, suggesting full expansion. The balloon:artery ratio was 1:1 (Figure 3). Following dilatation, the lesion appeared unchanged angiographically. The gradient across the lesion remained 20 mmHg. Given the location of the stenosis, nitinol stent deployment was not considered an option. The patient, therefore, underwent surgical exploration of the right femoral artery and a large posteriorly located elevated dissection flap identified which was almost occlusive. The patient underwent endarterectomy and patch angioplasty uneventfully and was discharged the following day. The patient continues to be asymptomatic at three month clinical follow-up with a repeat ankle brachial index in the right extremity having returned to normal. Discussion. Percutaneous devices to close arterial access puncture sites have the potential benefit of preventing arterial hemorrhage and facilitating rapid patient mobilization and discharge.^3,4 The infrequent vascular complications of these devices can be significantly more challenging to manage than vascular complications encountered before their introduction. Life-threatening complications from any form of vascular closure device include hemorrhage, endarteritis and acute vessel closure. Device specific complications include device retention and inadvertent intravascular delivery of collagen or thrombi, resulting in thrombosis of the vessel. Delayed complications are related to pseudoaneurysm formation and is as reported in this case, symptom limiting claudication. Based on published data, small size (5 None of these relative contraindications were noted in this patient. Additionally, the puncture site was above the bifurcation and in the common femoral artery. The patient was neither morbidly obese nor very thin, both of which have been associated with an increased rate of complications following suture-mediated closure. Re-access following use of the Angio-Seal Device has been described. Complete dissolution of the collagen plug occurs within 30 days and re-access at 30 days is considered safe.⁶ Given the findings at surgery, the re-access following the use of the Angio-Seal device did not appear to play a role in the occurrence of either the dissection or exuberant scar tissue noted at the site of the lesion. The tented flap from the posterior wall of the vessel presumably was related to the footpad of the Perclose Closer device scraping the posterior wall of the vessel and the non-absorbable braided suture in the vessel wall hastening the hyperplastic response to the injury resulting in flow limitation in the vessel within 3 to 4 weeks. Another possibility could be that the posterior wall was partially sutured to the anterior wall, resulting in flow limitation. This case highlights the need to be aware of delayed complications (3 to 4 weeks) following the use of closure devices. Also, the vascular surgeons need to be aware of the specifications of the available closure devices because they each pose a unique set of complications during surgical repair.

1. Chamberlin JR, Lardi AB, McKeever LS, et al. Use of vascular sealing devices versus assisted manual compression in transcatheter coronary interventions requiring abciximab. Cathet Cardiovasc Intervent 1999;47:143–148. 2. Sanborn TA, Gibbs HH, Brinker JA, et al. A multicenter randomized trial coparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Am Coll Cardiol 1993;22:1973–1979. 3. Aker UT, Kensey KR, Heuser RR, et al. Immediate arterial hemostasis after cardiac catheterization: Initial experience with a new puncture closure device. Cathet Cardiovasc Diagn 1994;31:228–1232. 4. Camenzind E, Grossholz, Urban P, et al. Collagen application versus manual compression: A prospective randomized trial for arterial puncture site closure after coronary angioplasty. J Am Coll Cardiol 1994;24:655–662 5. Starnes BW, O’Donnell SD, Gillespie DL, et al. Percutaneous arterial closure in peripheral vascular disease: A prospective randomized evaluation of the Perclose device. J Vasc Surg 2003;38:263–271. 6. Applegate RJ, Rankin KM, Little WC, et al. Restick following initial angio-seal use. Cathet Cardiovasc Intervent 2003;58:181–184.