565773

research-article2014

JETXXX10.1177/1526602814565773Journal of Endovascular TherapySuri et al

Clinical Investigation

A Novel Technique to Retrieve a Maldeployed Vascular Closure Device

Journal of Endovascular Therapy 2015, Vol. 22(1) 71­–73 © The Author(s) 2015 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1526602814565773 www.jevt.org

Simrat Suri, MD1, Khanjan H. Nagarsheth, MD1, Sumeet Goraya1, and Kuldeep Singh, MD1

Abstract Purpose: To report a novel technique for endovascular retrieval of a maldeployed vascular closure device, obviating the need for a femoral cutdown. Technique: To remove a 6-F Angio-Seal device that embolized to the superficial femoral artery, the contralateral common femoral artery was accessed, and an 8-F, 65-cm-long sheath was inserted just proximal to the embolus. A second semistiff 0.035-inch buddy wire was advanced past the lesion along the sheath. A 0.014-inch wire was advanced past the embolus, and a SpiderFX embolic protection device was deployed 1 cm past the embolized Angio-Seal device. The sheath was advanced so as to push the embolus into the filter. The sheath and the filter containing the Angio-Seal device were then removed. Conclusion: Endovascular retrieval of an embolized Angio-Seal device can be done using an embolic filter device, restoring arterial flow to the limb. Keywords vascular closure device, collagen-based closure device, complication, embolization, retrieval technique, embolic protection filter

Introduction Hemostasis after percutaneous endovascular procedures can be secured with manual compression or any of a number of collagen-based, suture-based, or staple-/clip-based vascular closure devices (VCDs). VCDs are touted as being easy to deploy and safer and more effective than when manual compression is used alone.1 Although the use of VCDs is common, the devices are not without complications, including a risk of intra-arterial deployment and distal embolization.2 We describe a novel endovascular technique for retrieving a maldeployed VCD.

Technique The method is demonstrated in a 76-year-old woman who underwent an elective cardiac catheterization using a 6-F sheath in the right common femoral artery (CFA). The access site was closed with a 6-F Angio-Seal device (St Jude Medical, Minnetonka, MN, USA) after angiography revealed no significant iliofemoral artery disease (Figure 1A). Immediate hemostasis was achieved. Two hours after the procedure, the patient’s right foot was cool, with absent pedal pulse; duplex ultrasound revealed no flow in the right superficial femoral artery (SFA) and no evidence of a pseudoaneurysm. In the operating room, angiography revealed an isolated embolus in the mid SFA (Figure 1B). There was sluggish

flow past the embolus and 3-vessel runoff to the foot. The contralateral CFA was accessed, and an 8-F, 65-cm-long Destination sheath (Terumo Medical, Somerset, NJ, USA) was inserted, landing 2 cm proximal to the embolus. To maintain wire access, a second semi-stiff 0.035-inch buddy wire was advanced past the lesion along the sheath. A 0.014inch wire was advanced past the embolus, and a SpiderFX (Covidien, Mansfield, MA, USA) embolic protection device was deployed 1 cm past the embolized Angio-Seal device. The sheath was advanced so as to push the embolus into the filter, which was then pulled into the sheath but only partially because of the bulk of the embolus. The sheath and the filter containing the Angio-Seal device were removed (Figure 1C), and pressure was held while the sheath was reinserted over the buddy wire. A final angiogram (Figure 1D) revealed complete arterial patency in both lower extremities, with no extravasation of contrast and immediate return of pedal pulses. The sheath was removed, and manual compression was applied. The patient had no further complications and was discharged the following day. 1

Staten Island University Hospital, Staten Island, NY, USA

Corresponding Author: Simrat Suri, Division of Vascular Surgery, North Shore LIJ-Staten Island University Hospital, 501 Seaview Avenue, Suite 302, Staten Island, NY 10305, USA. Email: [email protected]

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Figure 1.  (A) Angiogram prior to deploying arterial closure device. (B) Initial angiogram with focal superficial femoral artery filling defect due to intra-arterial vascular closure device embolization. (C) Retrieved vascular closure device with SpiderFX distal embolic protection device. (D) Completion angiogram revealing patent superficial femoral artery without filling defect.

Discussion Vascular closure devices impart significant benefits, both to the patient and the surgeon. They provide more reliable hemostasis after arterial catheterization than manual compression alone and allow the patient to ambulate sooner.3,4 For these reasons, VCDs are used frequently by both vascular surgeons and interventionists. A meta-analysis of 34 available studies on VCD use revealed a trend toward lower complications with these devices compared to manual compression used alone to achieve hemostasis.5 A recent multicenter randomized controlled trial comparing VCDs to manual compression in 4524 patients undergoing coronary angiography with 6-F sheaths found a lower incidence of

Journal of Endovascular Therapy 22(1) access-site complications at 30 days and shorter hemostasis times for the VCD group.6 The potential complications of access for endovascular procedures can include pseudoaneurysms, arteriovenous fistulas, arterial thrombosis, and retroperitoneal hemorrhage.7 Although VCDs may be deemed safer and more efficacious than manual compression, their use does impart a set of complications that are unique to this mode of therapy. One such complication is intra-arterial deployment of the VCD with distal embolization and/or arterial occlusion. This complication is understandably seen more often with devices that have an intra-arterial component, such as the collagen-based devices. It is difficult to explain why the Angio-Seal device was maldeployed in our case because the procedure was performed outside our group. We know only that the CFA was ~8 mm in diameter, making it adequate for VCD use. Moreover, an angiogram performed prior to device deployment showed no significant atherosclerotic disease that could account for the maldeployment. The CFA access site appeared to be appropriate based on fluoroscopic images, but no ultrasound guidance was used, so anterior wall calcification was not evaluated. The maldeployment may have resulted from operator inexperience because Angio-Seal has a proven record of low complication and device failure rates, as Kara et al8 demonstrated recently in a comparative analysis of 3 VCD models. Traditionally, an open embolectomy is performed to retrieve intra-arterially deployed devices,9,10 but there are multiple endovascular techniques that can be quick and effective in retrieving the embolus. Boersma et al11 discussed a technique whereby they retrieved a maldeployed VCD with a set of 3.3-F alligator tooth forceps, which are typically used in urologic procedures. This device has a high level of maneuverability, is visible under fluoroscopy, and has excellent grasping potential. They reported a good outcome using this method and avoided a cutdown. Others authors have reported the use of balloons, aspiration thrombectomy, thrombolysis, and wire snares to retrieve dislodged VCDs.7,12-15

Conclusion Intra-arterial deployment of a VCD can result in limbthreatening ischemia and necessitates expedient action. Endovascular retrieval of an embolized Angio-Seal device can be done using an embolic filter device, restoring arterial flow to the limb. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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Funding

8. Kara K, Mahabadi AA, Rothe H, et al. Safety and effectiveness of a novel vascular closure device: a prospective study of the ExoSeal compared to the Angio-Seal and ProGlide. J Endovasc Ther. 2014;21:822–828. 9. Prabhudesai A, Khan MZ. An unusual cause of femoral embolism: Angioseal. Ann R Coll Surg Engl. 2000;82: 355–356. 10. van der Steeg HJ, Berger P, Krasznai AG, et al. Acute arterial occlusion after deployment of the Angio-Seal closure device: is it as uncommon as we think? Eur J Vasc Endovasc Surg. 2009;38:715–717. 11. Boersma D, van Strijen MJ, Kloppenburg GT, et al. Endovascular retrieval of a dislodged femoral arterial closure device with alligator forceps. J Vasc Surg. 2012;55: 1150–1152. 12. Maxien D, Behrends B, Eberhardt KM, et al. Endovascular treatment of acute limb ischemia caused by an intravascularly deployed bioabsorbable plug of a vascular closure device. Vasa. 2013;42:144–148. 13. Katsouras CS, Michalis LK, Leontaridis I, et al. Treatment of acute lower limb ischemia following the use of the Duett sealing device: report of three cases and review of the literature. Cardiovasc Intervent Radiol. 2004;27:268–270. 14. Cahill TJ, Choji K, Kardos A. Fluoroscopy-guided snare retrieval of the celt ACD metallic vascular closure device following failed deployment. Catheter Cardiovasc Interv. 2014;83:556–559. 15. Schiele TM, Rademacher A, Meissner O, et al. Acute limb ischemia after femoral arterial closure with a vascular sealing device: successful endovascular treatment. Vasa. 2004;33:252–256.

The author(s) received no financial support for the research, authorship, and/or publication of this article.

References 1. Cikirikcioglu M, Cherian S, Keil V, et al. Surgical treatment of complications associated with the Angio-Seal vascular closure device. Ann Vasc Surg. 2011;25:557.e1–557.e4. 2. Lupattelli T, Tannouri F, Garaci FG, et al. Efficacy and safety of antegrade common femoral artery access closure using the AngioSeal device: experience with 1889 interventions for critical limb ischemia in diabetic patients. J Endovasc Ther. 2010;17:366–375. 3. Dregelid E, Jensen G, Daryapeyma A. Complications associated with the Angio-Seal arterial puncture closing device: intra-arterial deployment and occlusion by dissected plaque. J Vasc Surg. 2006;44:1357–1359. 4. Hoffer EK, Bloch RD. Percutaneous arterial closure devices. J Vasc Interv Radiol. 2003;14:865–886. 5. Das R, Ahmed K, Athanasiou T, et al. Arterial closure devices versus manual compression for femoral haemostasis in interventional radiological procedures: a systematic review and meta-analysis. Cardiovasc Intervent Radiol. 2011;34:723–738. 6. Schulz-Schüpke S, Helde S, Gewalt S, et al.; Instrumental Sealing of Arterial Puncture Site—CLOSURE Device vs Manual Compression (ISAR-CLOSURE) Trial Investigators. Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial. JAMA. 2014;312:1981–1987. 7. Tsetis D. Endovascular treatment of complications of femoral arterial access. Cardiovasc Intervent Radiol. 2010;33:457–468.

A novel technique to retrieve a maldeployed vascular closure device.

To report a novel technique for endovascular retrieval of a maldeployed vascular closure device, obviating the need for a femoral cutdown...
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