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Posterior wall capture and resultant common femoral occlusion complicating StarClose access closure

2008; Elsevier BV; Volume: 48; Issue: 2 Linguagem: Inglês

10.1016/j.jvs.2008.03.013

1097-6809

Patrick A. Stone, John E. Campbell, Karinna H. Andrews, Mark C. Bates,

Venous Thromboembolism Diagnosis and Management

Vascular closure devices have been shown to decrease hemostasis and ambulation time after percutaneous transcatheter procedures. The StarClose Vascular Closure System (Abbott Vascular, Redwood City, Calif) is a shape memory clip–mediated device that is designed to provide extraluminal mechanical closure without compromising the arterial lumen. We report a case of iatrogenic arterial occlusion secondary to mechanical closure of the anterior and posterior walls of the common femoral artery with a StarClose device. We provide objective observations from the rescue surgical intervention and discuss potential mechanisms of device failure. Vascular closure devices have been shown to decrease hemostasis and ambulation time after percutaneous transcatheter procedures. The StarClose Vascular Closure System (Abbott Vascular, Redwood City, Calif) is a shape memory clip–mediated device that is designed to provide extraluminal mechanical closure without compromising the arterial lumen. We report a case of iatrogenic arterial occlusion secondary to mechanical closure of the anterior and posterior walls of the common femoral artery with a StarClose device. We provide objective observations from the rescue surgical intervention and discuss potential mechanisms of device failure. Vascular closure devices (VCDs) are frequently used after diagnostic and interventional percutaneous procedures. Studies have shown that the use of VCDs, in contrast to manual compression, decreases the time to ambulation and hemostasis.1Ansel G. Yakubov S. Neilsen C. Allie D. Stoler R. Hall P. et al.Safety and efficacy of staple-mediated femoral arteriotomy closure: results from a randomized multicenter study.Catheter Cardiovasc Interv. 2006; 67: 546-553Crossref PubMed Scopus (26) Google Scholar, 2Hermiller J.B. Simonton C. Hinohara T. Lee D. Cannon L. Mooney M. et al.The StarClose Vascular Closure System: interventional resuls from the CLIP study.Catheter Cardiovasc Intervent. 2006; 68: 677-683Crossref PubMed Scopus (92) Google Scholar, 3Baim D.S. Knopf W.D. Hinohara T. Schwarten D.E. Schatz R.A. Pinkerton C.A. et al.Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate and discharge (STAND I and STAND II) trials.Am J Cardiol. 2000; 85: 864-869Abstract Full Text Full Text PDF PubMed Scopus (152) Google Scholar Unfortunately, VCD adverse events can occur with significant short- and long-term implications.4Andreotti F. Lavorgna A. Coluzzi G. Vincenzoni C. Rebuzzi A.G. Porto I. et al.Lost and found: an unusual late complication of the angio-seal closure device.Int J Cardiol. 2007; 117: e1-e3Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar, 5Wille J. Vos J.A. Overtoom T.T. Suttorp M.J. van de Pavoordt E.D. de Vries J.P. Acute leg ischemia: the dark side of a percutaneous femoral artery closure device.Ann Vasc Surg. 2006; 20: 278-281Abstract Full Text Full Text PDF PubMed Scopus (62) Google Scholar, 6Katsouras C.S. Michalis L.K. Leontaridis I. Kolettis T. Naka K.K. Goudevenos J.A. 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: 268-270Crossref PubMed Scopus (19) Google Scholar, 7Smith T.P. Cruz C.P. Moursi M.M. Eidt J.F. Infectious complications resulting from use of hemostatic puncture closure devices.Am J Surg. 2001; 182: 658-662Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar, 8Heck D.V. Muldowney S. McPherson S.H. Infectious complications of Perclose for closure of femoral artery punctures.J Vasc Interv Radiol. 2002; 13: 430-431Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar There are currently no prospective randomized trials to show a reduction in arterial-related events comparing standard compression therapy and VCDs. The StarClose Vascular Closure System (Abbott Vascular, Redwood City, Calif) is a clip-mediated VCD that is designed to provide extraluminal mechanical closure of an arterial defect. The Clip Closure in Percutaneous Procedures (CLIP) study demonstrated noninferior results when the StarClose device was compared with manual compression, with none of the interventional or diagnostic cases experiencing abrupt closure.2Hermiller J.B. Simonton C. Hinohara T. Lee D. Cannon L. Mooney M. et al.The StarClose Vascular Closure System: interventional resuls from the CLIP study.Catheter Cardiovasc Intervent. 2006; 68: 677-683Crossref PubMed Scopus (92) Google Scholar, 9Hermiller J.B. Simonton C. Hinohara T. Lee D. Cannon L. Mooney M. et al.Clinical experience with a circumferential clip-based vascular closure device in diagnostic catheterization.J Invasive Cardiol. 2005; 17: 504-510PubMed Google Scholar We report a case of acute limb ischemia after placement of a StarClose device after diagnostic coronary angiography. A 51-year-old woman with known hyperlipidemia, diabetes mellitus, and hypertension presented to the emergency department with a 48-hour history of diaphoresis and nausea with vomiting. An electrocardiogram showed ST elevations in leads V1 and V2, and serial troponin enzymes were suggestive of myocardial infarction. The patient subsequently underwent coronary angiography and was found to have a 90% ostial narrowing of the second diagonal branch and mild diffuse three-vessel disease. A small area of akinesis in the second diagonal distribution was noted, but overall left ventricular function was preserved and medical therapy was suggested. The catheterization was completed without incident, and after ipsilateral oblique femoral angiographic confirmation of middle anterior wall through a common femoral access, a StarClose device was deployed with immediate hemostasis. The deployment sequence included exchanging a 5F sheath with the StarClose sheath. The StarClose delivery shaft was then inserted into the StarClose sheath until the shaft and sheath "clicked," after the guidewire was removed. The shaft was held with the right hand and on the end of the shaft, the vessel locater was deployed by pressing the U-shaped button on the end of the shaft. The trigger on the inferior surface of the shaft is squeezed half way down to the skin, which split the sheath to this level. The shaft of the device was then maintained in the same angle as the tissue track and the shaft withdrawn until resistance was met with the vessel locater (located at the tip of the device within the artery) and the intima of the artery. The trigger was then completely pulled to finalize the sheath split. The shaft was then raised between 60° and 75°, and the was clip deployed by pushing the button on the left side of the shaft while applying slight forward pressure to allow the clip to capture the adventitia. The shaft was then removed and light pressure held for 2 minutes. The cardiologist had previously performed >100 cases without a complication. After arrival to the floor, the patient's right foot was cool, with decreased ipsilateral pedal pulses. Our team was consulted. An examination found the patient's left lower extremity had palpable pulses at the ankle level, but the right lower extremity had nonpalpable pulses from the groin to the ankle. Noninvasive studies suggested right external iliac artery/common femoral artery occlusion. In the angiography suite, the patient was evaluated for external iliac dissection and baseline ipsilateral circulation before surgical intervention. A right common femoral artery occlusion was confirmed by selective angiography from a contralateral access, without evidence of iliac artery dissection (Fig 1). The left groin sheath was removed and manual compression was performed. Treatment of the common femoral occlusion was not entertained by endovascular techniques because the patient was a good operative candidate. The patient was taken to the operating room where the femoral artery was exposed with a vertical groin incision. The StarClose device was found deployed in the anterior wall of the common femoral artery; however, the "tines" had also attached to the posterior wall of the common femoral artery, effectively causing occlusion of the artery proper (Fig 2). The device was removed from the artery, and patch angioplasty was performed using the proximal great saphenous vein. Subsequently the patient did well, with return of normal pulses to her lower extremity. Complications related to femoral artery closure devices are well known. Arterial laceration secondary to an anchor device rupturing an artery has been reported, but this is a rare complication.4Andreotti F. Lavorgna A. Coluzzi G. Vincenzoni C. Rebuzzi A.G. Porto I. et al.Lost and found: an unusual late complication of the angio-seal closure device.Int J Cardiol. 2007; 117: e1-e3Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar The two most common complications are infection and ischemia. Infection-related groin complications include groin abscess,7Smith T.P. Cruz C.P. Moursi M.M. Eidt J.F. Infectious complications resulting from use of hemostatic puncture closure devices.Am J Surg. 2001; 182: 658-662Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar mycotic pseudoaneurysm,7Smith T.P. Cruz C.P. Moursi M.M. Eidt J.F. Infectious complications resulting from use of hemostatic puncture closure devices.Am J Surg. 2001; 182: 658-662Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar and endarteritis.10Hollis H.W. Rehring T.F. Femoral endarteritis associated with percutaneous suture closure: New technology, challenging complications.J Vasc Surg. 2003; 38: 83-87Abstract Full Text Full Text PDF PubMed Scopus (41) Google Scholar, 11Cooper C.L. Miller A. Infectious complications related to the use of the angio-seal hemostatic puncture closure device.Cathet Cardiovasc Intervent. 1999; 48: 301-303Crossref PubMed Scopus (41) Google Scholar The preponderance of infection-related complications have occurred in suture-7Smith T.P. Cruz C.P. Moursi M.M. Eidt J.F. Infectious complications resulting from use of hemostatic puncture closure devices.Am J Surg. 2001; 182: 658-662Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar, 8Heck D.V. Muldowney S. McPherson S.H. Infectious complications of Perclose for closure of femoral artery punctures.J Vasc Interv Radiol. 2002; 13: 430-431Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar, 10Hollis H.W. Rehring T.F. Femoral endarteritis associated with percutaneous suture closure: New technology, challenging complications.J Vasc Surg. 2003; 38: 83-87Abstract Full Text Full Text PDF PubMed Scopus (41) Google Scholar, 12Carey D. Martin J.R. Moore C.A. Valentine M.C. Nygaard T.W. Complication of femoral artery closure devices.Cathet Cardiovasc Intervent. 2001; 52: 3-7Crossref PubMed Google Scholar and collagen-11Cooper C.L. Miller A. Infectious complications related to the use of the angio-seal hemostatic puncture closure device.Cathet Cardiovasc Intervent. 1999; 48: 301-303Crossref PubMed Scopus (41) Google Scholar, 12Carey D. Martin J.R. Moore C.A. Valentine M.C. Nygaard T.W. Complication of femoral artery closure devices.Cathet Cardiovasc Intervent. 2001; 52: 3-7Crossref PubMed Google Scholar mediated closure devices. We found no reports of StarClose infectious complications, and this is consistent with the anticipated lower infection risk of metal clip–based closure systems compared with the suture- and collagen-based systems. The second well-known complication related to VCDs is limb ischemia. Acute limb ischemia4Andreotti F. Lavorgna A. Coluzzi G. Vincenzoni C. Rebuzzi A.G. Porto I. et al.Lost and found: an unusual late complication of the angio-seal closure device.Int J Cardiol. 2007; 117: e1-e3Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar, 5Wille J. Vos J.A. Overtoom T.T. Suttorp M.J. van de Pavoordt E.D. de Vries J.P. Acute leg ischemia: the dark side of a percutaneous femoral artery closure device.Ann Vasc Surg. 2006; 20: 278-281Abstract Full Text Full Text PDF PubMed Scopus (62) Google Scholar, 6Katsouras C.S. Michalis L.K. Leontaridis I. Kolettis T. Naka K.K. Goudevenos J.A. 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: 268-270Crossref PubMed Scopus (19) Google Scholar, 12Carey D. Martin J.R. Moore C.A. Valentine M.C. Nygaard T.W. Complication of femoral artery closure devices.Cathet Cardiovasc Intervent. 2001; 52: 3-7Crossref PubMed Google Scholar, 13Derham C. Davies J.F. Shahbazi R. Homer-Vanniasinkam S. Iatrogenic limb ischemia caused by angiography closure devices.Vasc Endovasc Surg. 2007; 40: 492-494Crossref Scopus (24) Google Scholar secondary to arterial occlusion and intermittent claudication13Derham C. Davies J.F. Shahbazi R. Homer-Vanniasinkam S. Iatrogenic limb ischemia caused by angiography closure devices.Vasc Endovasc Surg. 2007; 40: 492-494Crossref Scopus (24) Google Scholar, 14Jang J.J. Kim M. Gray B. Bacharach J.M. Olin J.W. Claudication secondary to Perclose use after percutaneous procedures.Cathet Cardiovasc Intervent. 2006; 67: 687-695Crossref PubMed Scopus (40) Google Scholar secondary to arterial stenosis have both been reported. The risk of limb ischemia is theoretically decreased with the use of an extravascular clip compared with intravascular VCDs. To our knowledge, only one report has been published of a StarClose device causing acute limb ischemia, and this was secondary to external iliac artery occlusion.15Ratnam L.A. Raja J. Munneke G.J. Morgan R.A. Belli A.M. Prospective nonrandomized trial of manual compression and Angio-Seal and Starclose arterial closure devices in common femoral punctures.Cardiovasc Intervent Radiol. 2007; 30: 182-188Crossref PubMed Scopus (76) Google Scholar The authors concluded that the nitinol clip caused luminal narrowing leading to arterial thrombosis. There is also a report of significant claudication resulting from severe stenosis of the superficial femoral artery related to intravascular deployment of a StarClose device.16Stock U. Flach P. Gross M. Meyhofer J. Albes J. Butter C. Intravascular misplacement of an extravascular closure system: StarClose.J Interven Cardiol. 2006; 19: 170-172Crossref PubMed Scopus (29) Google Scholar Treatment of arterial insufficiency secondary to vascular closure devices can be managed be endovascular or surgical intervention. If thrombosis occurs secondary to femoral artery occlusion, surgical intervention provides a long-term durable solution that usually requires endarterectomy and removal of the VCD, with or without patch angioplasty. In the acute setting, we advocate surgical intervention unless the patient is at high risk of surgical complications secondary to comorbidities. There have been case reports of endovascular techniques used to treat complications, including atherectomy with filter embolic protection and cutting balloon angioplasty to treat acute and late complications; however, these can be complex interventions with the potential of adverse events.17Lee J.H. Timinder S.B. Gimelli G. Treatment of an Angio-Seal–related vascular complication using the SilverHawk Plaque Excision System: a case report.Cathet Cardiovasc Intervent. 2007; : 141-145Crossref PubMed Scopus (12) Google Scholar, 18Tam J. Given M. Lutjen P. Thomson K. Lyon S. Iatrogenic stenosis following suture mediated closure device.Australas Radiol. 2007; 51: B319-B323Crossref PubMed Scopus (4) Google Scholar There has not been a previous publication of arterial occlusion secondary to the StarClose device capturing the posterior wall of the common femoral artery. The patient presented here was relatively young, and the anterior wall of the common femoral artery was soft with an associated hard posterior plaque. If too much forward pressure is applied during the delivery of the device, then compression of the artery can occur with the risk of "capturing" the back wall of the artery, which is what we believe occurred in this patient. This can be prevented by applying only light forward pressure when deploying the device and by taking extra precautions in young patients with relatively soft common femoral arteries. However, light forward pressure is subjective and part of the learning curve, in which device failure may occur if forward pressure is not adequately applied and the clip may be deployed into the extravascular soft tissue. Our stance on the use of VCDs is overall a conservative one. With previous meta-analysis providing evidence that pseudoaneurysm formation and groin hematoma are not reduced with VCD use, we reserve their use in patients who are at risk for compression failures.19Koreny M. Riedmüller E. Nikfardjam M. Siostrzonek P. Müllner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis.JAMA. 2004; 29: 350-357Crossref Scopus (499) Google Scholar We do believe there is a role for the use of VCDs, but overall, restrict their use to select circumstances, such as in patients who require continued anticoagulation, a body habitus (obese patients with large pannus) that makes compression difficult, and in patients with conditions such as back or neck disorders that limit their ability to maintain a supine position for 4 to 6 hours. The StarClose device is indicated for only maximum sheath size of 6F. As sheath size increases to larger than 9F, we recommend either suture-mediated closure devices or surgical cutdown. We have used the Perclose suture-mediated device (Abbott Vascular) when sheath sizes are 9F or larger, although the indication for use recommends maximum sheath size of 8F.20Abbott Vascular. Instructions for use.www.abbottvascular.com/ifuGoogle Scholar Routine angiography before deployment of a VCD is imperative. This should include an ipsilateral oblique femoral artery angiogram to identify the ostia of the superficial and deep femoral arteries. Vascular closure devices are contraindicated in small (<5 mm) common femoral arteries, high punctures (above the inguinal ligament), or low punctures (deep or superficial femoral arteries). Ultrasound-guided puncture of the common femoral artery can be used to ensure anterior wall puncture and avoid sheath placement in the deep femoral artery or superficial femoral artery. We do believe a subset of patients can benefit from the use of VCDs and that VCDs can be used safely, but it is important to recognize high-risk punctures where manual compression should be used. In addition, there should be a consideration for informed consent for these devices, because most patients may be unaware of their placement and the unique adverse event risk until the procedure is completed.