Intraoperative Innominate and Common Carotid Intervention Combined With Carotid Endarterectomy: A True Endovascular Surgical Approach

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1 258 J ENDOVASC THER TECHNICAL NOTE Intraoperative Innominate and Common Carotid Intervention Combined With Carotid Endarterectomy: A True Endovascular Surgical Approach David E. Allie, MD 1 ; Chris J. Hebert, RCIS 1 ; Mitchell D. Lirtzman, MD 1 ; Charles H. Wyatt, MD 1 ; Mohamed H. Khan, MD 2 ; Muhammad A. Khan, MD 1 ; Peter S. Fail, MD 3 ; Gary A. Chaisson, RCIS 3 ; V. Antoine Keller, MD 1 ; Dennis A. Vitrella, MBA 1 ; Sonja D. Allie, MBA 1 ; Adam A. Allie, MS 1 ; Elena V. Mitran, MD 1 ; and Craig M. Walker, MD 3 1 Cardiovascular Institute of the South, Southwest Medical Center, Lafayette, Louisiana, USA. 2 Opelousas General Hospital, Opelousas, Louisiana, USA. 3 Terrebonne General Medical Center, Houma, Louisiana, USA. Purpose: To report the technique of carotid endarterectomy (CEA) combined with retrograde balloon angioplasty and stenting of proximal tandem lesions in the supra-aortic trunk. Technique: Intraoperative techniques in 34 patients with 23 left common carotid artery (CCA) and 11 innominate artery lesions included general anesthesia, low-dose dextran, prosthetic patching, selective shunting, 8-F sheath entry into the native CCA before the CEA, manual CCA sizing, and balloon-expandable stent placement after predilation. The technique has a high procedural success rate (97%) and appears durable. Over a mean 34- month follow-up, 2 70% ostial CCA restenoses were found at 24 months. Conclusions: Intraoperative innominate or left CCA balloon angioplasty/stenting combined with carotid endarterectomy is safe, effective, and durable. J Endovasc Ther Key words: carotid occlusive disease, carotid endarterectomy, common carotid artery, innominate artery, supra-aortic vessels, balloon angioplasty, stent The effectiveness of carotid endarterectomy (CEA) in preventing stroke has been established in both symptomatic and asymptomatic patients. 1,2 Similar effectiveness has now been reported for balloon angioplasty and stenting of the internal carotid artery (ICA), 3,4 affording a viable nonsurgical treatment option. However, the risk of stroke from atherosclerotic occlusive disease in the primary vessels of the brachiocephalic or supra-aortic trunk (SAT) remains less well defined. Revascularization options for SAT disease range from open intrathoracic surgery or extrathoracic extra-anatomical bypass to balloon dilation alone or dilation/stenting via a transfemoral or transbrachial approach, but there remains no consensus on the treatment of choice. 5 8 A particularly difficult therapeutic dilemma occurs when patients present with significant Address for correspondence and reprints: David E. Allie, MD, Director of Cardiothoracic and Endovascular Surgery, Director of Peripheral Vascular Studies, 2730 Ambassador Caffery Parkway, Lafayette, LA USA. Fax: ; david.allie@cardio.com 2004 by the INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS Available at

2 J ENDOVASC THER CAROTID AND BRACHIOCEPHALIC REVASCULARIZATION 259 ipsilateral ICA and SAT disease, the so called tandem lesion. 9,10 Isolated brachiocephalic or proximal common carotid (CCA) disease is rarely detected, with a reported incidence of 1.8% and is reported even less frequently (0.6%) in patients with significant ICA disease treated with CEA. 11,12 Over a 7-year period, we have performed intraoperative SAT balloon angioplasty and stenting combined with CEA, refining the technique to achieve maximum efficacy and durability. TECHNIQUE In an endovascular operative suite equipped with C-arm fluoroscopy (OEC, GE Medical, Milwaukee, WI, USA), patients with dual lesions in the ICA and CCA or innominate artery are placed under general anesthesia. Heparin (8000 to 10,000 units) and methylprednisolone sodium succinate (500 mg) are administered intravenously; infusion of low-dose dextran 40 (20 ml/h) is begun. Balloon angioplasty and stenting is always performed first via a sheath placed in the CCA well below the planned CEA arteriotomy site. The sheath is not placed through the arteriotomy because it is cumbersome, injurious to the vessel, timeconsuming, and can result in problematic bleeding around the sheath. The proximal CCA is exposed 2 to 3 cm farther than for a standard CEA to allow ample distance (1 cm) between the sheath site and the CEA arteriotomy. The ICA and external carotid artery (ECA) are clamped in the exact positions necessary for the CEA, which traps any atherosclerotic debris resulting from the catheter intervention. A circular 5-0 or 6-0 Prolene adventitial pursestring suture, with or without a small pledget, is placed at the intended sheath site for eventual closure. A needle (Cook Inc., Bloomington, IN, USA) and short J-tip guidewire are used to introduce an 8-F Brite tip introducer sheath (Cordis, a Johnson & Johnson company, Miami Lakes, FL, USA) into the CCA (Fig. 1). A small Silastic tourniquet should be cinched down on the sheath during the intervention to minimize bleeding and sheath movement. All angiography is performed through the sheath sidearm using hand injections of 10 to 20 ml contrast. Figure 1An 8-F sheath and wire are in place in the CCA, well below the planned arteriotomy for the CEA. Note the clamp on the CCA. A inch soft-tipped, steerable guidewire (Magic Torque, Boston Scientific, Natick, MA, USA) or a Wholey guidewire (Mallinckrodt, Inc., St. Louis, MO, USA) is used to cross the proximal lesion under fluoroscopic and angiographic guidance; hydrophilic wires are to be avoided, as they may be more likely to cause a dissection. It is our custom never to primarily stent SAT disease, as these lesions must be broken to facilitate appropriate stent sizing and wall apposition. The lesion is predilated with a balloon 1 to 2 mm smaller than the CCA (Fig. 2 A,B), which is accurately measured using a plastic vessel sizer (Boston Scientific/Medi-tech). Care should be taken not to overdilate the vessel, as these oftentimes highly calcified vessels may be prone to dissection or rupture. It is always easier to treat restenosis than rupture, especially in these SAT vessels. We always use a premounted stainless steel balloon-expandable stent (e.g, the Paramount double strut stent; ev3, Inc., Plymouth, MN, USA), not a nitinol stent, because these highly calcified, usually ostial lesions require precise stent deployment, so a stent with high radial force is necessary to avoid elastic recoil. The sheath is always advanced along with the stent well into the aorta, crossing the lesion first before positioning the stent at the deployment site (Fig. 2C). This maneuver will minimize the risk of dislodging the stent from the balloon. The sheath is retracted

3 260 CAROTID AND BRACHIOCEPHALIC REVASCULARIZATION J ENDOVASC THER Figure 2(A) Preoperative arch angiogram demonstrating a 98% ostial left CCA stenosis (arrow). (B) Predilation of the lesion with a balloon sized 1 to 2 mm smaller than the CCA. (C) Positioning of the balloon-expandable stent. (D) Postinterventional results. Note the proximity of the Brite tip marker sheath to the stent site. proximally to uncover the stent; an intraoperative angiogram is performed. The stent is precisely deployed using fluoroscopic and angiographic guidance. The stent must extend 1 to 2 mm into the aorta to assure ostial coverage. All retrograde contrast injections should be made with the sheath marker tip in close proximity to the lesion and/or stent to help overcome antegrade flow (Fig. 2 D). Our customary CEA techniques include Dacron patching and selective shunting in patients with contralateral occlusion or a 60% contralateral lesion if the ICA backflow is nonpulsatile. However, before the CEA arteriotomy is made, it is important to first flush the CCA antegrade to remove any embolic debris created by the intervention or debris trapped proximal to the clamped ICA. Next, the ICA is flushed retrograde, and a shunt is inserted if necessary. When significant contralateral ICA disease or occlusion is present, the intervention is completed as quickly as possible to minimize ipsilateral ischemic clamp time before the shunt is inserted. It is our opinion that shunting before or during the proximal intervention would significantly increase the procedural complexity and would not be protective from embolic debris during dilation/ stenting. Intraoperative anesthetic and pharmacological techniques are used to keep the mean systemic blood pressure 90 mmhg in an attempt to provide maximal contralateral intracranial blood flow during ICA clamping. The CCA is again flushed vigorously through the patched arteriotomy site at the termination of the CEA before removing the ICA clamp to insure removal of any debris or thrombus that may have accumulated on the stent during the endarterectomy, as persistent flow is diminished during the CEA clamp time. The heparin is partially reversed with a 50% protamine dose, and the low-dose dextran 40 is continued at 20 ml/h for 8 hours. We have used this technique in 34 patients (29 men; mean age years) presenting with significant (60%) tandem ICA and SAT disease, achieving a 97% procedural success rate. The single failure was a CCA dissection, which was treated successfully with an immediate carotid-subclavian bypass and CEA. This patient had no complications and had a normal 5-year postoperative duplex scan. Over a mean 34-month follow-up (range 6 84), no cerebral events, infections, or bleeding complications have been observed. Two 70% ostial left CCA restenoses were found at 2 years; both were successfully treated with repeat dilation/stenting. There was no CEA site restenosis. DISCUSSION The traditional transthoracic surgical approach to SAT lesions provides satisfactory functional results, but mortality rates as high as 22% are reported. 13,14 In 1967, Diethrich et al. 6 introduced the extra-anatomical (carotidsubclavian) bypass approach, which decreased the mortality rate to 5.6%, with excellent 5 to 8-year patency reported. 7,15 However, today, percutaneous endoluminal revascularization of proximal arch vessel disease is considered the treatment of choice in many centers. 8,16,17 Even though periproce-

4 J ENDOVASC THER CAROTID AND BRACHIOCEPHALIC REVASCULARIZATION 261 dural cerebrovascular events have been few, concern still exists regarding the distal embolic potential of these oftentimes calcified and ulcerative lesions. The 0.6% incidence of simultaneous significant ipsilateral SAT and ICA disease reported by Akers et al. 12 is likely higher since many patients today do not have preprocedural arch angiography or even carotid angiography before CEA, which is oftentimes recommended on duplex results alone. 12,18 In our own experience, we encountered 34 (4.3%) tandem lesions among 784 patients undergoing CEA in a 7-year period, which draws into question the recommendation of CEA based on duplex alone and the performance of selective carotid angiography without an arch angiogram. It is also likely that many significant SAT lesions that go undiagnosed could be a hidden source of perioperative or postoperative cerebrovascular events during CEA. For these reasons, all our patients who are evaluated for ICA disease undergo ICA/ CCA duplex scanning, arch angiography, and selective CCA angiography prior to CEA unless angiography is absolutely contraindicated or a highly stenotic or ulcerative SAT lesion is identified by duplex. A review of the literature identifies the therapeutic dilemma presented by these tandem lesions. In 1996, Diethrich and colleagues 11 reported simultaneous CEA and CCA stenting, but the proximal lesion was treated via a transfemoral approach. In 1998, Levien et al. 9 reported 44 patients treated with simultaneous CEA and intraoperative retrograde balloon angioplasty alone of a more proximal SAT lesion. At 18 months, they reported a 9.3% SAT restenosis rate; 4 patients required a carotid-subclavian bypass after the CEA. In the same year, Ruebben et al. 19 reported 8 patients with isolated innominate artery disease treated intraoperatively with retrograde balloon dilation/stenting after CCA surgical exposure, clamping, and flushing of the arteriotomy site before removal of the clamp to decrease embolic risks. These were considered extremely high-risk surgical candidates, so the procedures were performed under local anesthesia, with 100% technical success. There were no complications, but none of these 8 SAT intraoperative interventions was combined with a CEA. Combined CEA and intraoperative retrograde SAT dilation/stenting has been previously described only in isolated reports. 10,17,18 Arko et al. 18 treated 6 patients (1 left CCA and 5 innominate arteries) with 100% technical success and no complications, but they did not report their technique in detail. Sullivan et al. 17 reported 87 SAT patients treated with dilation/stenting over a 5-year period, but the majority of lesions (73/87) were in the subclavian arteries. In this report, 13 of 14 CCA vessels were treated intraoperatively with surgical CCA exposure, but only 2 cases were combined with CEA. Unfortunately, both patients with a combined procedure experienced a cerebrovascular accident, which prompted the authors to recommend,... perhaps combined lesions of the common and internal carotid arteries should be treated separately. They theorized that thrombus may have formed on the stent during brief periods of stagnant blood flow, contributing to the neurological event. This further underscores the recommendation and need for vigorous flushing of the CCA through the CEA arteriotomy site before final unclamping of the ICA. Several traditionally interventional issues deserve mention, including our preoperative use of clopidogrel and the role of distal protection devices. It is our opinion that decreasing the incidence of subacute stent thrombosis in our patient population is more beneficial than the potential for increased bleeding. Therefore, we recommend clopidogrel (75 mg) and aspirin (81 mg/d) for 1 week preoperatively. In our 34 patients, we have seen no stent thrombosis or bleeding complications; any additional intraoperative oozing can be easily controlled with local measures. Even though distal protection devices appear to be safe and effective in carotid bifurcation stenting, 20 the tortuosity of the SAT vessels, the potential for friable atherosclerotic debris and calcification, and the current designs of neuroprotection devices all preclude the use of distal protection and transfemoral dilation/stenting of these tandem lesions. In conclusion, simultaneous ICA and SAT

5 262 CAROTID AND BRACHIOCEPHALIC REVASCULARIZATION J ENDOVASC THER disease may be more common than previously reported and a clandestine source of mortality and morbidity in the CEA and carotid stent populations. Arch angiography should be considered in most patients with carotid artery disease. Combined intraoperative CEA with endoluminal revascularization of left CCA or innominate lesions is safe, effective, and durable and offers an excellent less invasive alternative than the more traditional transthoracic surgical approach to those patients presenting with simultaneous ICA and SAT disease. Acknowledgments: We thank Mrs. Kelly Tilbe for her technical help with manuscript preparation. REFERENCES 1. North American Symptomatic Carotid Endarterectomy Trial Collaborators. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991;325: European Carotid Surgery Trialists Collaborative Group. MRC European Carotid Surgery Trial: Interim results for symptomatic patients with severe (70 99%) or with mild (0 29%) carotid stenosis. Lancet. 1991;337: Yadav SS, Roubin GS, Iyer SS, et al. Elective stenting of the extracranial carotid arteries. Circulation. 1997;95: Wholey MH, Wholey MH, Jarmolowski CR, et al. Endovascular stents for carotid artery occlusive disease. J Endovasc Surg. 1997;4: Ligush J, Criado E, Keagy BA. Innominate artery occlusive disease: management with central reconstructive techniques. Surgery. 1997; 121: Diethrich EB, Garrett HE, Ameriso J, et al. Occlusive disease of the common carotid and subclavian arteries treated by carotid-subclavian bypass. Am J Surg. 1967;114: Fry WR, Martin JD, Clagett GP, et al. Extrathoracic carotid reconstruction: the subclavian-carotid artery bypass. J Vasc Surg. 1992;15: Becker GJ, Katzen BT, Dake MD. Noncoronary angioplasty. Radiology. 1989;170: Levien LJ, Benn CA, Veller MG, et al. Retrograde balloon angioplasty of brachiocephalic or common carotid artery stenoses at the time of carotid endarterectomy. Eur J Vasc Endovasc Surg. 1998;15: Sidhu PS, Morgan MB, Walters HL, et al. Technical report: combined carotid bifurcation endarterectomy and intra-operative transluminal angioplasty of a proximal common artery stenosis: an alternative to extrathoracic bypass. Clin Radiol. 1998;53: Diethrich EB, Marx P, Wrasper R, et al. Percutaneous techniques for endoluminal carotid interventions. J Endovasc Surg. 1996;3: Akers DL, Markowitz IA, Kerstein MD. The value of aortic arch study in the evaluation of cerebrovascular insufficiency. Am J Surg. 1987; 154: Crawford ES, DeBakey ME, Morris CG, et al. Surgical treatment of occlusion of the innominate, common carotid, and subclavian arteries: a 10-year experience. Surgery. 1969;65: Thompson BW, Read RC, Campbell GS. Operative correction of proximal blocks of the subclavian or innominate arteries. J Cardiovasc Surg (Torino). 1980;21: Vogt DP, Hertzer NR, O Hara PJ, et al. Brachiocephalic arterial reconstruction. Ann Surg. 1982;196: Criado FJ, Wilson EP, Martin JA, et al. Interventional techniques for treatment of disease in the brachiocephalic arteries (supra-aortic trunks). J Invasive Cardiol. 2000;12: Sullivan TM, Gray BH, Bacharach JM, et al. Angioplasty and primary stenting of the subclavian, innominate, and common carotid arteries in 83 patients. J Vasc Surg. 1998;28: Arko FR, Buckley CJ, Lee SD, et al. Combined carotid endarterectomy with transluminal angioplasty and primary stenting of the supraaortic vessels. J Cardiovasc Surg (Torino). 2000;41: Ruebben A, Tettoni S, Muratore P, et al. Feasibility of intraoperative balloon angioplasty and additional stent placement of isolated stenosis of the brachiocephalic trunk. J Thorac Cardiovasc Surg. 1998;115: Castriota F, Cremonesi A, Manetti R, et al. Impact of cerebral protection devices on early outcome of carotid stenting. J Endovasc Ther. 2002;9: