L'articolo discute le controversie relative all'accettazione in pratica clinica dello stentig carotide

de Donato, Gianmarco

Setacci, Carlo

Sterpetti, Antonio

English

Carlo Setacci

Antonio Sterpetti

Gianmarco de Donato

Crossref

Seminars in Vascular Surgery

Introduction: Carotid endarterectomy versus carotid stenting—A never-ending story

Archivio della ricerca- Università di Roma La Sapienza

Available online at www.sciencedirect.comwww.elsevier.com/locate/semvascsurgS E M I N A R S I N V A S C U L A R S U R G E R Y 3 1 ( 2 0 1 8 ) 1 – 3https:/0895-7Introduction: Carotid endarterectomy versus carotidstenting—A never-ending storyStenosis of the internal carotid artery may be responsible for10% to 20% of all strokes or transient ischemic attacks. Itshould be borne in mind that stroke is the third leading causeof death and the most common cause of permanent disabilityin Western countries. Until the introduction of carotid arterystenting (CAS), carotid endarterectomy (CEA) was the onlysurgical solution to the potential embolic and thromboticload of the carotid plaque. During the past few years, medicaltherapy has made enormous progress with the introductionof new drugs and the widespread and more effective controlof vascular risk factors [1]. The choice of treatment betweenCEA, CAS, or medical therapy alone for any individual patientwith carotid stenosis remains a controversial issue. However,a simple complete method to independently stratify the peri-interventional neurologic outcomes of patients undergoingCAS is still lacking [2–5]. CEA has been used to treat carotiddisease for more than 50 years. During this period, CEA wasvalidated by large multicenter randomized clinical trials(RCTs) [6–10] as an effective method for stroke prevention.Indications for CEA have been defined, outcomes have mark-edly improved, and technical aspects have evolved. Despitethe wide acceptance of CEA, the ideal surgical technique tooptimize early outcomes and long-term durability of CEA hasyet to be determined. Consequently, as a practical matter,most vascular surgeons use a number of technical variationsfor CEA in their clinical practice and adapt their preference toeach particular situation. Conventional CEA, performedthrough a longitudinal arteriotomy of the internal carotidartery, followed by primary closure or patch angioplasty, isthe most frequently employed technique. A few prospectiverandomized studies have demonstrated that when data onthree principal outcomes (ie, perioperative strokes, earlycarotid occlusion, and restenosis 450%) are pooled, thestatistical results strongly favor patch over primary closure[11–17]. Eversion CEA was initially reported by De Bakey et al[13], later described by Etheredge [14], and finally adapted byRaithel and Kasprzak [15] as the simplified version usedtoday, which involves complete oblique transection of theinternal carotid artery at the bulb. Due to an oblique ratherthan a longitudinal arteriotomy, the technique should allow/doi.org/10.1053/j.semvascsurg.2018.03.001967/$ - see front matter & 2018 Elsevier Inc. All rights reserved.the artery to be less prone to restenosis, particularly whensutures are placed at the widest part of the artery (ie,common carotid artery or the base of carotid bulb). Althoughit is generally agreed that this technique is safe and effective[16,17], some concerns remains regarding the possibility thatit is more technically demanding, especially in the case of along stenosis plaque or clamping ischemia when a shunt isneeded.In the last several years, evolution in both stents andprotection devices, as well as in carotid stenting techniques,resulted in an important reduction in stroke rate in patientsundergoing CAS procedures. Carotid stenting, although it is amature technique, regularly applied, and with excellent out-comes in high-volume centers by expert operators, is strug-gling to find the consensus of the scientific community. Infact, the initial enthusiasm for CAS as a valuable and less-invasive alternative to CEA has been mitigated by the undis-putable gap in outcomes between the two strategies observedin RCTs. Inadequate requirements in terms of endovascularexpertise, potentially leading to an increased event raterelated to both insufficient technical skills and inadequatepatient selection, has been proposed as the main reason forthe unfavorable outcomes related to CAS. Despite the factthat high-quality multicenter registries and high-volume,single-center experiences have consistently described favor-able CAS outcomes, the evidence has not been consideredsufficient in the neurologist community to recommend CAS.Certainly a key issue to limit the periprocedural events to thelowest possible is to select the appropriate device for theappropriate patient anatomy and clinical syndrome. Severalstudies have shown that the so-called “tailored approach” forthe treatment of carotid disease may offer the best-availableresults in term of acute and long-term outcomes. The basicprinciple of the tailored approach [18] is the selection of theappropriate stent and protection device for a specific patientwith a specific lesion and vascular anatomy with the flex-ibility to use the most appropriate devices and techniques tomanage each individual patient without limitation of an RCTprotocol, such as the restricted use of a particular embolicprotection device and stent system. An important element ofS E M I N A R S I N V A S C U L A R S U R G E R Y 3 1 ( 2 0 1 8 ) 1 – 32this concept is the recognition of high-risk cases for CASdependent primarily on the skill of the interventional vascu-lar specialist, a factor that is substantially more relevant inthe field of CAS than other areas of percutaneous interven-tion. In fact, Pieniazek et al [19] demonstrated that tailoredCAS is associated with low complication rate and high long-term efficacy, indicating that operators should be familiarwith the use of different and multiple protection devices andstent systems in order to be able to use the most appropriateone. Other authors have written about tailored CAS, focusingtheir attention on the kind of stent and embolic protectiondevice used. Carotid stenting, although it is a mature techni-que regularly applied with excellent outcomes in high-volume centers by expert operators, is struggling to find theconsensus of the scientific community. The initial enthu-siasm for CAS as a valuable and less-invasive alternative toCEA has been mitigated by the undisputable gap in outcomesbetween the two strategies observed in RCTs. But in the lastseveral years, evolution in both the stents and protectiondevices, as well as in carotid stenting techniques, hasresulted in an important reduction in stroke rate in patientsundergoing CAS procedures. In fact, because embolizationthrough the stent struts is the primary suspected cause ofearly postoperative neurologic complications, surgical tech-nology has focused on the production of a new generation ofstents with a double layer of mesh to reduce the “free area” ofthe cells, and new embolic protection devices to reduce therisk of intraprocedural embolization to the brain. So althoughthere is still the need for level I evidence from RCTs testingthese new tools, we believe that new materials in the hand ofskilled operators who are able to choose the appropriatecarotid stent and protection device based on the plaquemorphology and patient’s anatomical characteristics maydefinitively fill the gap of CAS in comparison to CEA [20–23].There is great interest in the possibility of learning additionaldetails regarding the interaction between a carotid plaqueand a stent by optical coherence tomography, consideringthat plaque prolapse through the cell stents has been sug-gested as one of the major causes of post-procedural com-plications after CAS, and that available intraproceduralimaging systems (eg, angiography, intravascular ultrasound,and duplex ultrasound) may not be able to detect theseintravascular microdefects.The following key issues have been identified:1. CAS offers a potential alternative to CEA because it is lessinvasive, avoids most of the surgical complications, andprevents future stroke events.2. Data from RCTs demonstrate significant differencesbetween CAS and CEA in terms of early neurologic out-comes (from 0 to 30 days), although mid- and long-termneurologic results are indistinguishable.3. Microembolization through the stent struts is consideredthe primary suspected cause of early postoperative neuro-logic complication (ie, nondisabling stroke).4. Distal protection with filters or occlusive distal balloonshas several restrictions because it requires crossing thestenosis with the closed devices before protection isachieved, which increases the risk for embolization.5. Proximal embolic protection devices insulate the brain byinterrupting or reversing the blood flow at the level of thecarotid bifurcation at the time of the procedure. So there isthe crossing of the lesion under protected conditions.6. The double-layer stents or mesh stents are a new class ofcarotid stents that promise to offer higher scaffolding ofcarotid plaque in comparison to previous carotid stentdesigns, avoiding, or at least limiting, plaque prolapsethrough the cell struts.7. The basic principle of the tailored approach is the selectionof the appropriate stent and protection device for a specificpatient with a specific lesion and vascular anatomy.With recent stent device approvals, the CAS landscape maynow shift significantly from the individual practice level tothe global market. Examining what brought the field to itscurrent state is crucial for understanding possible futurechanges. It is in that spirit that this issue of Seminars inVascular Surgery focuses on revising the status of CAS, high-lighting the various state-of-the-art treatment modalitiescurrently available, and the preprocedural and intraproce-dural strategies that can assist in improving outcomes andreducing complications.In the first article of this issue, Alberto Cremonesi et aldescribe the tips and tricks for a correct CAS procedure,starting from basics and including specific anatomical sce-narios and tailored techniques for safe CAS. Next, PeterSchneider and Juan Carlos Parodi describe the importanceand proper use of embolic protection devices during CAS,including specific devices, as well as multiple anatomic andclinical factors. A number of suggestions about use in variousscenarios and how to improve outcomes are provided. MarcBosiers and colleagues report the impact on outcomes ofdifferent types of carotid stenting, underlying how in theperiprocedural phase (Day 0 through Day 30) there is stillsome room for improvement of CAS outcomes. To completethis special issue, Gianmarco de Donato and colleaguessummarize indications and results of an early CAS afteronset of neurologic symptoms, considering the newmaterials(carotid stents and cerebral protection systems) andenhanced techniques available.r e f e r e n c e s[1] Nanna MG, Gomes P, Njoh RF, et al. Carotid artery stentingversus carotid endarterectomy. Postgrad Med J 2016;92(1091):532–9.[2] Cremonesi A, Castriota F, Secco GG, et al. Carotid arterystenting: an update. Eur Heart J 2015;36:13–21.[3] Liu Z, Fu WG, Guo ZY, et al. Update systematic review andmetanalysis of randomized clinical trials comparing carotidartery stenting and carotid endarterectomy in the treatmentof carotid stenosis. Ann Vasc Surg 2012;26:576–90.[4] Illuminati G, Ricco JB, Greco C, et al. Systematic preoperativecoronary angiography and stenting improves postoperativeresults of carotid endarterectomy in patients with asympto-matic coronary artery disease: a randomised controlled trial.Eur J Vasc Endovasc Surg 2010;39:139–45.[5] Illuminati G, Ricco JB2. Long-term results of a randomizedcontrolled trial analyzing the role of systematic pre-operativeS E M I N A R S I N V A S C U L A R S U R G E R Y 3 1 ( 2 0 1 8 ) 1 – 3 3coronary angiography before elective carotid endarterectomyin patients with asymptomatic coronary artery disease. Eur JVasc Endovasc Surg 2015;50:26.[6] Eikelboom BC, Ackerstaff RG, Hoeneveld H, et al. Benefits ofcarotid patching: a randomised study. J Vasc Surg 1988;7:240–7.[7] Clagett GP, Patterson CB, Fisher DF Jr, et al. Vein patch versusprimary closure for carotid endarterectomy. A randomizedprospective study in a selected group of patients. J Vasc Surg1989;9:213–23.[8] AbuRahma AF, Khan JH, Robinson PA, et al. Prospectiverandomized trial of carotid endarterectomy with primaryclosure and patch angioplasty with saphenous vein, jugularvein, and polytetrafluoroethylene: perioperative (30-day)results. J Vasc Surg 1996;24:998–1006; discussion 1006–7.[9] Archie JP Jr. Prospective randomized trials of carotid endar-terectomy with primary closure and patch reconstruction:the problem is power. J Vasc Surg 1997;25:1118–20.[10] Lord RS, Raj TB, Stary DL, et al. Comparison of saphenousvein patch, polytetrafluoroethylene patch, and direct arter-iotomy closure after carotid endarterectomy. Part I. Perio-perative results. J Vasc Surg 1989;9:521–9.[11] Katz D, Snyder SO, Gandhi RH, et al. Long-term follow-up forrecurrent stenosis: a prospective randomized study ofexpanded polytetrafluoroethylene patch angioplasty versusprimary closure after carotid endarterectomy. J Vasc Surg1994;19:198–203; discussion 204–5.[12] Counsell CE, Salinas R, Naylor R, et al. A systematic review ofthe randomised trials of carotid patch angioplasty in carotidendarterectomy. Eur J Vasc Endovasc Surg 1997;13:345–54.[13] De Bakey ME, Crawford ES, Morris GC Jr, et al. Surgicalconsiderations of occlusive disease of the innominate, carotid,subclavian, and vertebral arteries. Ann Surg 1961;154:698–725.[14] Etheredge SN. A simple technique for carotid endarterect-omy. Am J Surg 1970;120:635–40.[15] Raithel D, Kasprzak PM. The eversion endarterectomy. A newtechnique. In: Greenhalgh RM, Hollier LH, et al., eds. Surgeryof Stroke. London, UK: WB Sunders; 1993:441–71.[16] Buerger R. Eversion endarterectomy of the carotid bifurcation.In: Veith FJ, ed, Current Critical Problems in Vascular Surgery,Vol 5. St Louis, MO: Quality Medical Publishing; 1993:441–7.[17] Cao P, Giordano G, De Rango P, et al. Eversion versusconventional carotid endarterectomy: a prospective study.Eur J Vasc Endovasc Surg 1997;14:96–104.[18] Nikas DN, Kompara G, Reimers B. Carotid stents: which is thebest option? J Cardiovasc Surg (Torino) 2011;52:779–779.[19] Pieniazek P, Musialek P, Ziembicka AK, et al. Carotid arterystenting with patient- and lesion-tailored selection of theneuroprotection system and stent type: early and 5-yearresults from a prospective academic registry of 535 consecutiveprocedures (TARGET-CAS). J Endovasc Ther 2008;15:249–62.[20] Setacci C, de Donato G. Carotid artery stenting renaissance:can tips, tricks and new devices fill the gap? J Cardiovasc Med(Hagerstown) 2016;17:855–6.[21] Setacci C, Speziale F, de Donato G, et al. IRON-Guard StudyGroup. Physician-initiated prospective Italian Registry of carotidstenting with the C-Guard mesh-stent: the IRON-Guard registry.Rationale and design. J Cardiovasc Surg (Torino) 2015;56:787–91.[22] de Donato G, Mazzitelli G, Ruzzi U, et al. Carotid arterystenting renaissance: is it safe and effective using newmaterials? J Cardiovasc Surg (Torino) 2016;57:769–83.[23] Setacci C, Mele M, de Donato G, et al. Device selection forcarotid stenting: reviewing the evidence. Expert Rev Cardio-vasc Ther 2017;15:787–96.Guest EditorsCarlo Setacci, Gianmarco de DonatoDepartment of Vascular SurgeryUniversity of SienaSiena, ItalyAntonio SterpettiDepartment of Vascular SurgeryUniversity Rome La SapienzaRome, Italy

Introduction. Carotid endarterectomy versus carotid stenting. A never-ending story

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Introduction. Carotid endarterectomy versus carotid stenting. A never-ending story

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