Journal Pre-proof Endovascular treatment of spontaneous internal carotid artery dissection with proximal embolic protection device Felice Pecoraro, Ettore Dinoto, David Pakeliani, Francesca Ferlito, Domenico Mirabella, Mario Lachat, Arduino Farina, Guido Bajardi. PII: S0890-5096(19)31062-3 DOI: https://doi.org/10.1016/j.avsg.2019.12.019 Reference: AVSG 4831 To appear in: Annals of Vascular Surgery Received Date: 2 November 2019 Revised Date: 13 December 2019 Accepted Date: 15 December 2019 Please cite this article as: Pecoraro F, Dinoto E, Pakeliani D, Ferlito F, Mirabella D, Lachat M, Farina A, Bajardi. G, Endovascular treatment of spontaneous internal carotid artery dissection with proximal embolic protection device, Annals of Vascular Surgery (2020), doi: https://doi.org/10.1016/ j.avsg.2019.12.019. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Inc. 1 Title. Endovascular treatment of spontaneous internal carotid artery dissection with proximal 2 embolic protection device. 3 4 Authors. Felice Pecoraro,1,2 Ettore Dinoto,2 David Pakeliani,3 Francesca Ferlito,1 Domenico 5 Mirabella,2 Mario Lachat,4 Arduino Farina,1 Guido Bajardi.1,2 6 7 Affiliations. 8 1 9 Palermo, Italy. University of Palermo - Department of Surgical, Oncological and Oral Sciences (Di.Chir.On.S.), 10 2 Vascular Surgery Unit, AOUP “P. Giaccone”, Palermo, Italy 11 3 Vascular Surgery Unit, Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy 12 4 Aortic Center Hirslanden, Zurich, Switzerland 13 14 Corresponding. Felice Pecoraro 15 University of Palermo - Department of Surgical, Oncological and Oral 16 Sciences (Di.Chir.On.S.), 17 Via L. Giuffrè, 5 18 90100 – Palermo, Italy 19 mail: felice.pecoraro@unipa.it 20 phone: +39 3934069386 21 22 23 24 25 Keywords. internal carotid artery dissection; proximal embolic protection device; carotid artery 26 stenting; endovascular. 27 28 29 Abstract 30 Purpose. To report the feasibility and outcomes with the endovascular treatment of spontaneous 31 internal carotid artery dissections (ICAD) using proximal embolic protection device (EPD). 32 Materials and methods. Retrospective analysis from January 2017 to December 2018 of patients 33 treated for spontaneous symptomatic ICAD using proximal EPD. Indication for treatment was the 34 presence of neurological symptoms. Early outcomes measured included technical success, 35 perioperative mortality and major cardiovascular or cerebrovascular complications. Late outcomes 36 were recurrent neurological symptoms, patency and reinterventions. 37 Results. A total of 4 male patients with ICAD were included: A preoperative cerebral CT positive 38 for cerebral ischemic events was reported in all cases. In 3 patients the neurologic symptoms 39 consisted of a TIA, the remaining patient presented an amaurosis fugax and aphasia. In 2 patients 40 ICAD was associated to a carotid significant stenosis. In all patients the reported approach was 41 feasible with no complications and complete anatomic dissection resolution. At a mean follow-up of 42 18 months, all stents are patent and no restenosis recurrence or complications were registered. 43 Conclusion. The use of proximal EPDs allowed the treatment of ICAD under flow arrest 44 minimizing the risk of stroke during the endovascular maneuvers. Larger series are required to 45 validate this treatment strategy. 46 47 48 49 50 51 52 53 54 55 TEXT 56 Introduction 57 Internal carotid artery dissection (ICAD) is a rare disease that occurs spontaneously or following 58 traumatic injuries. Spontaneous ICAD incidence is reported in 2.6 per 100 000 patients.1,2 Despite 59 its rarity, ICAD represents a significant cause of cerebral events in young patients.3 Neurological 60 symptoms secondary to ICAD are an indication to repair over the medical management. 61 Endovascular solutions showed better outcomes when compared to conventional surgery due to a 62 reduced incidence of early occlusion, stroke, and cranial nerve injuries.4,5 63 Herein we report the feasibility and outcomes of endovascular treatment for spontaneous ICAD 64 using proximal embolic protection device (EPD). 65 Materials and methods 66 From January 2017 to December 2018 were retrospectively analyzed patients treated for 67 spontaneous symptomatic ICAD. Were excluded from the study patients presenting post-traumatic 68 ICADs; patients addressed by conventional open surgery and patients addressed by endovascular 69 solutions without proximal EPD. Neurological symptom was an indication for treatment in all 70 cases, including: stroke, transient ischemic attack (TIA), amaurosis fugax and aphasia. All patients 71 underwent preoperative CTA (figure 1-2). Measured metrics included early and late outcomes. 72 Early outcomes comprised technical success, perioepartive mortality and major cardiovascular or 73 cerebrovascular complications; late outcomes were recurrent neurological symptoms, patency and 74 reinterventions. Follow-up consisted of duplex ultrasound before dismission, at 1,6 and 12 months. 75 All patients received cardioaspirin and low-molecular-weight heparin therapy prior to the 76 procedure. 77 Informed consent for the treatment itself and the anonymous data collection and analysis was 78 obtained for each patient; approval of the Institutional Review Board was not required. 79 Technique. All procedures have been performed in the angio suite with a fixed equipment (Artis 80 Zeego, Siemens, Germany); under local anesthesia; and using a retrograde femoral access. After a 81 single perclose ProGlide (Abbott Vascular, Santa Clara, CA, US) access, a 9 Fr introducer sheath 82 (Avanti; Cordis Europe, Roden, the Netherlands) was placed and general heparinization 83 administered (5000 IU). The common carotid artery (CCA) was engaged and a carotid angiography 84 roadmap performed. Using a hydrophilic .035 guidewire (Radifocus guidewire, Terumo, Tokyo, 85 Japan) the external carotid artery (ECA) was cannulated and the hydrophilic wire exchanged to a 86 stiff wire (Amplatzer Super Stiff, Boston Scientific, Natick, MA, US). Over the stiff wire the 87 proximal EPD (MoMa, Invatec, Roncadelle, Italy) was advanced and positioned in correspondence. 88 Inflation of the ECA balloon was first performed until the balloon shape change; subsequently the 89 CCA balloon was inflated to arrest ICA antegrade circulation. A slow injection of 5cc 90 contrast/saline mixture is employed to confirm the CCA and ECA occlusion. Cerebral protection 91 was established before any wire passage across the carotid dissection. At this stage a floppy 92 steerable .014 wire (ATW, Cordis Europe Command) was employed to cross the carotid dissection 93 maintaining the true lumen. A primary carotid stenting (Carotid Wallstent, Boston Scientific) was 94 employed; stents were sized using the distal healthy carotid artery diameter as for carotid 95 atherosclerotic disease. Stent post-dilation was used in case of residual stenosis at operator 96 discretion. The removal of endovascular material was followed by the aspiration of 4 x 20 ml 97 syringes with the last aspirated syringe filtered through the 40 µm filter. In case of residual debris, 98 additional aspirations were performed until no debris were visible. During the procedure, 99 neurological status was checked for clamping intolerance especially in the phase of CCA balloon 100 insufflation by waiting for 60 seconds and during blood aspiration. ECA and CCA balloons were 101 sequentially deflated and a completion angiography performed (figure 3-4). 102 Results 103 In the study period were included a total of 4 male patients with a median age of 54 (IQR: 52-55) 104 years. In all patients the preoperative cerebral CT was positive for cerebral ischemic events. All the 105 treated patients reported neurological symptoms including a TIA in 3 patients and amaurosis fugax 106 and aphasia in 1 patient. CT angiography showed in all cases an ICAD; in 2 patients the ICAD was 107 associated to a significant ICA stenosis. The median dissection length was 20.1 (IQR: 18-21) mm. 108 No significant contralateral carotid disease was detectable in all patients. 109 Technical success was achieved in all cases without perioperative mortality, major cardiovascular 110 or cerebrovascular complications. A post dilation was employed in 2 patients presenting 111 preoperatively significant stenosis associated with ICAD. A complete anatomic resolution of the 112 dissection was achieved in all patients after stent placement with no residual stenosis after 113 treatment. The median operative time was 48 (IQR: 41-56) minutes; the median flow reversal time 114 7.5 (IQR: 7-9) minutes; the median fluoro time 7 (IQR: 7-9) minutes; the median contrast volume 115 34 (IQR: 30-38) ml; and the median radiation exposure 310 (IQR: 294-348) µGym2. Postoperative 116 medication regimen consisted of dual antiplatelet therapy for 6 months followed by single 117 administration. At a mean follow-up of 18 months, all stents are patent and no restenosis, recurrence 118 of neurological symptoms or reintervention were registered. 119 Discussion 120 Spontaneous ICADs are rare and have been associated to fibromuscular dysplasia, infections, cystic 121 medial necrosis and connective disease.6,7 Endovascular treatment in patients presenting ICAD has 122 been reported to be effective and safe.5,8 Surgical treatments, on the other hand, have been 123 associated with the worst outcomes compared to the best medical treatments or endovascular 124 solutions due to a higher risk of stroke and nerve injuries.4 It can be argued that also the 125 endovascular approach presents potential drawbacks including the risk of stroke when crossing the 126 dissected carotid artery as well as the risk of artery perforation in correspondence of the fragile 127 dissected artery.3 128 During carotid artery stenting procedures, proximal EPDs present some advantages over distal 129 filters or distal occlusion devices, including a reduced risk of distal embolization during the 130 procedure, mainly related to the flow arrest before lesion crossing. These advantages are even more 131 relevant in ICADs where wire navigation within the false lumen, without flow arrest, represents a 132 potential risk of distal embolization. Conversely proximal EPDs allow wire navigation and ICAD 133 crossing under flow arrest with a reduced risk of distal embolization. Moreover, in case of carotid 134 disruption during the endovascular ICAD treatment, the EPDs are useful reducing the bleeding and 135 allowing the use of covered stent-grafts under flow arrest. 136 Disadvantages of proximal EPDs in ICAD are the same reported for carotid artery stenting in 137 atherosclerotic disease, for instance: requirement of large introducer sheath, risk of CCA iatrogenic 138 injuries and reduced imaging availability during the intervention. Moreover it should be considered 139 the possibility of clamping intolerance, an higher risk of access complications, the risk of carotid 140 vacuum effect and arch/carotid anatomic variants.9 These proximal EPDs-related complications did 141 not occur in the present series. 142 To date, no papers reporting endovascular treatment of spontaneous ICADs with proximal EPDs 143 have been identified. In our limited experience, the stent of choice for ICAD was the Carotid 144 Wallstent (Boston Scientific) with the aim to exploit the closed-cell mesh and radial force 145 characteristics. The choice of this specific stent is consistent with most of experience reported and 146 analyzed in the systematic review.2 147 Conclusion 148 This initial experience with proximal EPDs and self-expandable carotid stents was safe and 149 effective for endovascular treatment of spontaneous ICADs. The potential advantages of proximal 150 EPDs seem to be amplified during ICADs, where the risk of distal embolization and arterial 151 disruption is high. Larger series are needed to validate this treatment strategy. 152 153 154 155 156 157 158 Conflict of interest Felice Pecoraro and other co-authors have no conflict of interest. 159 References 160 1. Schievink WI, Mokri B, Whisnant JP. Internal carotid artery dissection in a community. 161 Rochester, Minnesota, 1987-1992. Stroke. 1993 Nov;24(11):1678–80. 162 2. Pham MH, Rahme RJ, Arnaout O, Hurley MC, Bernstein RA, Batjer HH, et al. Endovascular 163 stenting of extracranial carotid and vertebral artery dissections: a systematic review of the 164 literature. Neurosurgery. 2011 Apr;68(4):856–66; discussion 866. 165 3. Rao AS, Makaroun MS, Marone LK, Cho JS, Rhee R, Chaer RA. Long-term outcomes of 166 internal carotid artery dissection. J Vasc Surg. 2011 Aug;54(2):370–4; discussion 375. 167 4. Müller BT, Luther B, Hort W, Neumann-Haefelin T, Aulich A, Sandmann W. Surgical 168 treatment of 50 carotid dissections: indications and results. J Vasc Surg. 2000 May;31(5):980– 169 8. 170 5. Fava M, Meneses L, Loyola S, Tevah J, Bertoni H, Huete I, et al. Carotid artery dissection: 171 endovascular treatment. Report of 12 patients. Catheter Cardiovasc Interv Off J Soc Card 172 Angiogr Interv. 2008 Apr 1;71(5):694–700. 173 174 6. Haneline M, Lewkovich GN. A narrative review of pathophysiological mechanisms associated with cervical artery dissection. J Can Chiropr Assoc. 2007;51(3):146–57. 175 7. Pecoraro F, Dinoto E, Pakeliani D, La Rosa G, Corte G, Bajardi G. Spontaneous symptomatic 176 common carotid artery pseudoaneurysm: case report and literature review. Ann Vasc Surg. 177 2015 May;29(4):837.e9-12. 178 8. Pacchioni A, Umemoto T, Penzo C, Saccà S, Ferro J, Fede A, Turri R, Reimers B. Successful 179 endovascular treatment of unbenign spontaneous dissection of the left internal carotid artery 180 combining advanced carotid and coronary techniques. JACC Cardiovasc Interv. 2015 Dec 181 21;8(14):e233-5. 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 9. Mousa AY, Campbell JE, Aburahma AF, Bates MC. Current update of cerebral embolic protection devices. J Vasc Surg. 2012 Nov;56(5):1429–37. 208 Figure Legend 209 Figure 1. Preoperative CT MPR (A) showing a spontaneous internal carotid artery dissection; 3D 210 curved MPR showing a complex spontaneous internal carotid artery dissection with significant 211 lumen reduction (B-D). 212 Figure 2. Preoperative CT MPR showing preoperative measurements including the intended stent 213 coverage length (A); and proximal and distal landing zones (B). 214 Figure 3. Intraoperative angiograms showing preoperative angiography (A); proximal embolic 215 protection device (EPD) positioning in correspondence of the external carotid artery (EIA) and 216 common carotid artery (CCA) (B); proximal EPD balloon inflating in correspondence of the EIA 217 and CCA (C); blood flow arrest check after balloon inflation (D); Wallstent placement and proximal 218 EPD balloon deflation (E); final angiography (F). 219 Figure 4. Intraoperative angiograms showing preoperative angiography (A); proximal embolic 220 protection device (EPD) positioning in correspondence of the external carotid artery (EIA) and 221 common carotid artery (CCA) (B); proximal EPD balloon inflating in correspondence of the EIA 222 and CCA (C); blood flow arrest check after balloon inflation (D); final angiography after Wallstent 223 placement (E); proximal and distal EPD balloon deflation (F).