An update on the role of proximal occlusion devices in carotid artery stenting
2016; Elsevier BV; Volume: 65; Issue: 1 Linguagem: Inglês
10.1016/j.jvs.2016.09.048
ISSN1097-6809
AutoresDaniel S. Kassavin, Daniel G. Clair,
Tópico(s)Acute Ischemic Stroke Management
ResumoCarotid artery stenting performed with distal embolic protection devices continues to show elevated rates of periprocedural stroke, in particular with high-risk groups. This article discusses the factors associated with protection devices that may contribute to this complication, performs a literature review to assess outcomes of carotid stenting with proximal occlusion devices, and assesses the role of proximal occlusion devices in the management of patients with carotid artery stenosis. Carotid artery stenting performed with distal embolic protection devices continues to show elevated rates of periprocedural stroke, in particular with high-risk groups. This article discusses the factors associated with protection devices that may contribute to this complication, performs a literature review to assess outcomes of carotid stenting with proximal occlusion devices, and assesses the role of proximal occlusion devices in the management of patients with carotid artery stenosis. The Society for Vascular Surgery guidelines for the management of carotid artery stenosis recommend that carotid artery stenting (CAS) be reserved for symptomatic patients with >50% stenosis who are at high risk for carotid artery endarterectomy (CEA).1Ricotta J.J. AbuRahma A. Ascher E. Eskandari M. Faries P. Lal B.K. Society for Vascular SurgeryUpdated Society for Vascular Surgery guidelines for management of extracranial carotid disease.J Vasc Surg. 2011; 54: e1-e31Abstract Full Text Full Text PDF PubMed Scopus (224) Google Scholar With half a decade having passed since the publication of the Carotid Revascularization Endarterectomy vs Stenting Trial (CREST), the incidence of periprocedural stroke in the course of CAS with embolic protection devices (EPDs) remains largely unchanged, in particular in high-risk groups including patients with symptomatic carotid stenosis and septuagenarians and older. A comparison of registries, randomized controlled trials, and cohort studies from the last few years graphically demonstrates this in Fig 1,2Brott T.G. Hobson 2nd, R.W. Howard G. Roubin G.S. Clark W.M. Brooks W. et al.CREST InvestigatorsStenting versus endarterectomy for treatment of carotid-artery stenosis.N Engl J Med. 2010; 363: 11-23Crossref PubMed Scopus (2292) Google Scholar, 3Bonati L.H. Dobson J. Algra A. Branchereau A. Chatellier G. Fraedrich G. et al.Carotid Stenting Trialists' CollaborationShort-term outcome after stenting versus endarterectomy for symptomatic carotid stenosis: a preplanned meta-analysis of individual patient data.Lancet. 2010; 376: 1062-1073Abstract Full Text Full Text PDF PubMed Scopus (357) Google Scholar, 4Ederle J. Dobson J. Featherstone R.L. Bonati L.H. van der Worp H.B. de Borst G.J. et al.International Carotid Stenting Study investigatorsCarotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.Lancet. 2010; 375: 985-997Abstract Full Text Full Text PDF PubMed Scopus (1070) Google Scholar, 5Stabile E. Salemme L. Sorropago G. Tesorio T. Nammas W. Miranda M. et al.Proximal endovascular occlusion for carotid artery stenting: results from a prospective registry of 1,300 patients.J Am Coll Cardiol. 2010; 55: 1661-1667Abstract Full Text Full Text PDF PubMed Scopus (95) Google Scholar, 6Clair D.G. Hopkins L.N. Mehta M. Kasirajan K. Schermerhorn M. Schönholz C. et al.EMPiRE Clinical Study InvestigatorsNeuroprotection during carotid artery stenting using the GORE flow reversal system: 30-day outcomes in the EMPiRE Clinical Study.Catheter Cardiovasc Interv. 2011; 77: 420-429Crossref PubMed Scopus (114) Google Scholar, 7Ansel G.M. Hopkins L.N. Jaff M.R. Rubino P. Bacharach J.M. Scheinert D. et al.Investigators for the ARMOUR Pivotal TrialSafety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial.Catheter Cardiovasc Interv. 2010; 76: 1-8Crossref PubMed Scopus (176) Google Scholar, 8Bersin R.M. Stabile E. Ansel G.M. Clair D.G. Cremonesi A. Hopkins L.N. et al.A meta-analysis of proximal occlusion device outcomes in carotid artery stenting.Catheter Cardiovasc Interv. 2012; 80: 1072-1078Crossref PubMed Scopus (72) Google Scholar, 9Bisdas T. Egorova N. Moskowitz A.J. Sosunov E.A. Marin M.L. Faries P.L. et al.The impact of gender on in-hospital outcomes after carotid endarterectomy or stenting.Eur J Vasc Endovasc Surg. 2012; 44: 244-250Abstract Full Text Full Text PDF PubMed Scopus (34) Google Scholar, 10Sfyroeras G.S. Moulakakis K.G. Markatis F. Antonopoulos C.N. Antoniou G.A. Kakisis J.D. et al.Results of carotid artery stenting with transcervical access.J Vasc Surg. 2013; 58: 1402-1407Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar, 11Jim J. Dillavou E.D. Upchurch Jr., G.R. Osborne N.H. Kenwood C.T. Siami F.S. et al.SVS Outcomes CommitteeGender-specific 30-day outcomes after carotid endarterectomy and carotid artery stenting in the Society for Vascular Surgery Vascular Registry.J Vasc Surg. 2014; 59: 742-748Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar, 12Kwolek C.J. Jaff M.R. Leal J.I. Hopkins L.N. Shah R.M. Hanover T.M. et al.Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal.J Vasc Surg. 2015; 62: 1227-1234Abstract Full Text Full Text PDF PubMed Scopus (229) Google Scholar, 13Rosenfield K. Matsumura J.S. Chaturvedi S. Riles T. Ansel G.M. Metzger D.C. et al.ACT I InvestigatorsRandomized trial of stent versus surgery for asymptomatic carotid stenosis.N Engl J Med. 2016; 374: 1011-1020Crossref PubMed Scopus (385) Google Scholar, 14Metzger DC. Periprocedural outcomes after CAS with 21,000 patients: the SAPPHIRE Worldwide study. VIVA 15. Las Vegas, Nevada; November 2-5, 2015.Google Scholar with the incidence being most striking in symptomatic patients. Similar findings were made by Paraskevas et al in a systematic review of 21 registries, in which the incidence of stroke/death was found to remain higher in CAS relative to CEA with an absence in the decline of procedural risk of CAS with time.15Paraskevas K.I. Kalmykov E.L. Naylor A.R. Stroke/death rates following carotid artery stenting and carotid endarterectomy in contemporary administrative dataset registries: a systematic review.Eur J Vasc Endovasc Surg. 2016; 51: 3-12Abstract Full Text Full Text PDF PubMed Scopus (106) Google Scholar Notable in Fig 1 are those groups represented by the prospective registries, cohort studies, and retrospective meta-analyses in which proximal occlusion devices (PODs; blue markers within oval), with and without flow reversal, are used in place of EPDs (gray markers). Although these are smaller or nonrandomized studies, they have repeatedly demonstrated benefit in decreasing the incidence of periprocedural stroke in performance of CAS, in particular in what have historically been high-risk groups, including patients who are symptomatic and older than 70 years. In the meta-analysis of six prospective databases of CAS performed with two types of transfemoral PODs, incorporating either flow cessation or flow reversal and to be discussed further in this article, Bersin et al demonstrated a cumulative periprocedural rate of stroke of 1.71%. Outcomes were independent of symptomatic status, and although age continued to be an independent risk predictor of stroke, the incidence of stroke in octogenarians and older was only 2.38%. In patients 65 to 80 years, the incidence was 1.65%. The Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) prospectively evaluated the use of a transcervical POD with a flow reversal device (FRD) in 208 patients and found a cumulative periprocedural stroke rate of 1.41%, none of which occurred in symptomatic patients or those older than 75 years, those typically seen as highest risk. Although the studies describing the outcomes of PODs do not have the level of evidence of a randomized controlled trial, there is further evidence from studies of EPDs that can help explain the difference in periprocedural stroke when the two are compared. Cerebral embolization during CAS performed with EPDs may occur during every portion of CAS, including during crossing of the internal carotid stenosis, while the filter is being deployed as a result of filter malapposition or embolization of particulate through the filter pores, during angioplasty and stenting, and while the filter is being retrieved. Pore sizes on filters range from 100 to 200 μm; smaller pore sizes on filters are not employed as this results in increased risk of filter thrombosis. A meta-analysis by Stabile et al comparing EPDs with PODs demonstrated that in the POD group, there was a lower incidence of new ischemic lesions on diffusion-weighted magnetic resonance imaging and a lower incidence of contralateral lesions, likely because of the inclusion of CAS performed through a transcervical approach.16Stabile E. Sannino A. Schiattarella G.G. Gargiulo G. Toscano E. Brevetti L. et al.Cerebral embolic lesions detected with diffusion-weighted magnetic resonance imaging following carotid artery stenting: a meta-analysis of 8 studies comparing filter cerebral protection and proximal balloon occlusion.JACC Cardiovasc Interv. 2014; 7: 1177-1183Abstract Full Text Full Text PDF PubMed Scopus (68) Google Scholar In a substudy of the International Carotid Stenting Study (ICSS), patients undergoing CAS with EPDs had a 73% incidence of new lesions on diffusion-weighted magnetic resonance imaging compared with 17% in the CEA group.17Bonati L.H. Jongen L.M. Haller S. Flach H.Z. Dobson J. Nederkoorn P.J. et al.ICSS-MRI study groupNew ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS).Lancet Neurol. 2010; 9: 353-362Abstract Full Text Full Text PDF PubMed Scopus (480) Google Scholar In a study validating the use of transcranial Doppler ultrasound for intraprocedural monitoring of embolic events during CAS, there was an increase in embolic signals during lesion crossing, before dilation, in stent placement, and after dilation in the CAS group using EPDs. Compared with the EPD group, the signal count was higher in the FRD group only during device removal.18Garami Z.F. Bismuth J. Charlton-Ouw K.M. Davies M.G. Peden E.K. Lumsden A.B. Feasibility of simultaneous pre- And postfilter transcranial Doppler monitoring during carotid artery stenting.J Vasc Surg. 2009; 49: 340-344Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar Transcervical access may reduce the incidence of cerebral embolization by avoiding a tortuous and atherosclerotic thoracic aortic arch. Up to 8% of strokes occur on the contralateral side of intervention,3Bonati L.H. Dobson J. Algra A. Branchereau A. Chatellier G. Fraedrich G. et al.Carotid Stenting Trialists' CollaborationShort-term outcome after stenting versus endarterectomy for symptomatic carotid stenosis: a preplanned meta-analysis of individual patient data.Lancet. 2010; 376: 1062-1073Abstract Full Text Full Text PDF PubMed Scopus (357) Google Scholar suggesting that embolization occurs during manipulation of wires and catheters within this area. It is thought that the greater tortuosity and atherosclerotic burden in the aortic arch of elderly patients contribute to the higher incidence of stroke in this subgroup undergoing CAS with EPDs. The ROADSTER trial, which bypassed the thoracic aorta through transcervical access, had no patients older than 75 years develop periprocedural stroke despite 47% of the study population's being older. The Mo.Ma Device (Medtronic Inc, Minneapolis, Minn) and Gore Flow Reversal System (W. L. Gore & Associates, Flagstaff, Ariz), the latter removed from the market, are transfemoral proximal occlusive devices. The Mo.Ma device is illustrated in Fig 2. The Mo.Ma and Gore devices are both 9F systems that incorporate occlusive balloons deployed in the external and common carotid arteries before any attempts are made at crossing the internal carotid stenosis. The use of the Mo.MA device may be precluded in cases of an occluded or atretic external carotid artery, requiring a 3- to 6-mm vessel. The common carotid artery must be 5 to 13 mm in diameter. The Mo.Ma device blocks common carotid antegrade flow and external carotid retrograde flow while allowing selective aspiration of the stationary blood column. The Gore Flow Reversal System provided continuous reverse blood flow from the internal carotid artery through the arterial sheath into an extracorporeal filter and then back into systemic circulation through a venous sheath. In cases of intolerance with cerebral perfusion being too slow to permit reverse flow in the Gore system, reverse flow could be stopped and suction performed manually through key parts of the procedure. The Enroute Transcarotid Neuroprotection System (Silk Road Medical, Sunnyvale, Calif) is an FRD that is placed into the common carotid through an open transcervical incision. It is composed of a circuit with recirculation of arterial blood from the common carotid artery being shunted to an extracorporeal filter and back into a femoral vein access site. Its components are illustrated in Fig 3. It requires a segment of the common carotid artery, free of atherosclerotic disease, 5 to 6 cm proximal to the carotid bifurcation. Clamping of the common carotid artery is followed by reversal of flow through both the internal and external carotid arteries with resulting cerebral protection. The system uses a Cordis (Bridgewater, NJ) Precise Pro Rx stent with a shortened delivery system, which may ease deployment. The Table summarizes the three described devices.TableOverview of proximal occlusion devices (PODs)DeviceManufacturerFDA approval yearAvailabilitySupporting clinical studies30-day stroke rate of supporting studiesMo.MaMedtronic2009YesARMOUR trial,7Ansel G.M. Hopkins L.N. Jaff M.R. Rubino P. Bacharach J.M. Scheinert D. et al.Investigators for the ARMOUR Pivotal TrialSafety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial.Catheter Cardiovasc Interv. 2010; 76: 1-8Crossref PubMed Scopus (176) Google Scholar Stabile prospective review,5Stabile E. Salemme L. Sorropago G. Tesorio T. Nammas W. Miranda M. et al.Proximal endovascular occlusion for carotid artery stenting: results from a prospective registry of 1,300 patients.J Am Coll Cardiol. 2010; 55: 1661-1667Abstract Full Text Full Text PDF PubMed Scopus (95) Google Scholar Bersin meta-analysis8Bersin R.M. Stabile E. Ansel G.M. Clair D.G. Cremonesi A. Hopkins L.N. et al.A meta-analysis of proximal occlusion device outcomes in carotid artery stenting.Catheter Cardiovasc Interv. 2012; 80: 1072-1078Crossref PubMed Scopus (72) Google Scholar0.92%-2.30%Flow Reversal SystemGore2009Removed from marketEMPiRE trial,6Clair D.G. Hopkins L.N. Mehta M. Kasirajan K. Schermerhorn M. Schönholz C. et al.EMPiRE Clinical Study InvestigatorsNeuroprotection during carotid artery stenting using the GORE flow reversal system: 30-day outcomes in the EMPiRE Clinical Study.Catheter Cardiovasc Interv. 2011; 77: 420-429Crossref PubMed Scopus (114) Google Scholar Bersin meta-analysis8Bersin R.M. Stabile E. Ansel G.M. Clair D.G. Cremonesi A. Hopkins L.N. et al.A meta-analysis of proximal occlusion device outcomes in carotid artery stenting.Catheter Cardiovasc Interv. 2012; 80: 1072-1078Crossref PubMed Scopus (72) Google Scholar1.71%-2.90%Enroute Transcarotid Neuroprotection SystemSilk Road Medical2015YesSfyroeras meta-analysis,10Sfyroeras G.S. Moulakakis K.G. Markatis F. Antonopoulos C.N. Antoniou G.A. Kakisis J.D. et al.Results of carotid artery stenting with transcervical access.J Vasc Surg. 2013; 58: 1402-1407Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar ROADSTER trial12Kwolek C.J. Jaff M.R. Leal J.I. Hopkins L.N. Shah R.M. Hanover T.M. et al.Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal.J Vasc Surg. 2015; 62: 1227-1234Abstract Full Text Full Text PDF PubMed Scopus (229) Google Scholar1.10%-1.41%ARMOUR, Proximal Protection with the Mo.Ma Device During Carotid Stenting; EMPiRE, Embolic Protection with Reverse Flow; FDA, Food and Drug Administration; ROADSTER, Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure. Open table in a new tab ARMOUR, Proximal Protection with the Mo.Ma Device During Carotid Stenting; EMPiRE, Embolic Protection with Reverse Flow; FDA, Food and Drug Administration; ROADSTER, Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure. Findings of the Proximal Protection with the Mo.Ma Device During Carotid Stenting (ARMOUR) trial demonstrated that the Mo.Ma device could be positioned, deployed, and retrieved in 98.2% of cases. Intolerance to flow cessation occurred in 13.8% cases as defined by the development of neurologic symptoms with antegrade flow blockage or blood aspiration. Neurologic symptoms resolved within 20 minutes in 93.4% of patients, with an overall rate of 0.9% of unresolved intolerance. The Gore Flow Reversal System had a 96.3% technical success rate; 1.2% of patients had unresolved intolerance to flow reversal and 2.4% had tortuous vasculature preventing device delivery, damage to the balloon sheath component, and inability to position the balloon wire component. Another 1.2% of patients had initial intolerance that was managed and resolved, allowing case completion with flow reversal. None of the patients who had developed flow intolerance developed permanent deficit. Both devices could be used as sheaths to proceed with deployment of EPDs in cases in which flow reversal was not tolerated. Bersin's meta-analysis, which included the ARMOUR and Embolic Protection with Reverse Flow (EMPiRE) trials, found that 4.65% of patients had a contralateral carotid occlusion and that this finding was not predictive of flow cessation/reversal intolerance or of adverse events. This was likely due to the presence of adequate collateralization and the brief period of occlusion (3-15 minutes). Reverse flow intolerance or flow cessation can be managed by elevating mean arterial pressures to increase collateral circulation or by temporarily restoring antegrade flow and allowing the return of baseline neurologic functioning. Occlusion pressures <40 mm Hg appeared to be the best predictors of intolerance of either the Mo.Ma or Gore Flow Reversal System. The Enroute Transcarotid Neuroprotection System incorporates a flow rate regulator that can allow the regulation between high and low flow rates if high-flow reversal is not tolerated. There may be a subset of patients with an incomplete circle of Willis or posterior cerebellar arterial disease that may preclude the use of flow reversal or cessation. During the procedure, if neurologic symptoms develop, the primary method of dealing with this involves breaking the procedure into stages and providing flow reversal for the “steps” of the procedure. These steps include initial lesion wiring and prestent balloon inflation; placement of stent; poststent balloon inflation; and aspiration. Any of these steps can be combined and expedited to limit the amount of time a symptomatic patient has antegrade flow interrupted. Complications in the ROADSTER trial, which evaluated the transcervical Enroute Transcarotid Neuroprotection System, included common carotid dissections in 5.67% of patients, 63% of whom required no treatment. Of those patients treated, one required a second stent placement in the common carotid artery, one was converted to CEA, and another was surgically repaired at the index procedure. None of these complications were deemed to have resulted in a periprocedural stroke. These complications emphasize the importance of excluding a transcervical approach in patients who on preoperative imaging have significant findings of atherosclerotic burdens at the common carotid arteries. One patient developed an area of stenosis at the arteriotomy that required no further intervention. Surgical wound hematomas occurred in 4.2% of patients, of which 0.7% (one patient) required evacuation. Factors that may preclude the use of the Enroute Transcarotid Neuroprotection System include an inadequate length from the common carotid artery access site to bifurcation, a diseased common carotid artery, and factors precluding surgical dissection of the common carotid artery, such as the presence of infection. The importance of proper selection of patients in performing transcervical access for CAS cannot be understated as the sequela of access-related complications in the common carotid artery has the potential to undo the benefits of bypassing a diseased aortic arch. Given the current evidence, the use of PODs provides reduced stroke risk and embolic potential compared with distal protection devices. With today's technology, our current practice involves a femoral approach with proximal occlusion and aspiration with a femoral proximal occlusion system (Mo.Ma) unless the patient has unfavorable or concerning arch anatomy, in which case we believe flow reversal with a cervical approach provides the safest option. In patients who have arch factors that would prove high risk for a femoral approach (type III arch, severe calcification or atherosclerotic disease in the arch) and who do not meet criteria for use of the cervical approach, the patient must be evaluated for either CAS with distal filter protection or high-risk CEA. In summary, the benefits of PODs, with or without flow reversal, include redirecting embolic particulate from the brain, avoiding crossing of the carotid stenosis without protection, and providing an option for patients with anatomy that is not conducive for embolic protection, including those with a tortuous internal carotid artery. A transcervical approach avoids crossing a tortuous or diseased aortic arch and the concomitant risk of cerebral embolization. The encouraging results of PODs in CAS, including in historically high-risk groups such as symptomatic patients and those older than 70 years, suggest a growing role for FRDs and inclusion and evaluation in ongoing randomized controlled studies of CAS. Conception and design: DK, DC Analysis and interpretation: DK, DC Data collection: DK Writing the article: DK, DC Critical revision of the article: DK, DC Final approval of the article: DK, DC Statistical analysis: Not applicable Obtained funding: Not applicable Overall responsibility: DK
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