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Editor's Choice – Early and Late Outcomes after Transcarotid Revascularisation for Internal Carotid Artery Stenosis: A Systematic Review and Meta-Analysis

Open ArchivePublished:March 02, 2021DOI:https://doi.org/10.1016/j.ejvs.2021.01.039

      Objective

      Transcarotid/transcervical revascularisation (TCAR) is an alternative to carotid endarterectomy (CEA) and transfemoral carotid stenting (tfCAS). This review aimed to evaluate pooled data on patients undergoing TCAR.

      Data sources

      Medline, Embase, Scopus, and Cochrane Library databases were used.

      Review methods

      This systematic review was conducted under Systematic Reviews and Meta-Analysis guidelines. Eligible studies (published online up to September 2020) reported 30 day mortality and stroke/transient ischaemic attack (TIA) rates in patients undergoing TCAR. Data were pooled in a random effects model and weight of effect for each study was also reported. Quality of studies was evaluated according to Newcastle – Ottawa scale.

      Results

      Eighteen studies (three low, seven medium, and eight high quality) included 4 852 patients (4 867 TCAR procedures). The pooled 30 day mortality rate was 0.7% (n = 32) (95% confidence interval [CI] 0.5 – 1.0), 30 day stroke rate 1.4% (n = 62) (95% CI 1.0 – 1.7), and 30 day stroke/TIA rate 2.0% (n = 92) (95% CI 1.4 – 2.7). Pooled technical success was 97.6% (95% CI 95.9 – 98.8). The cranial nerve injury rate was 1.2% (95% CI 0.7 – 1.9) (n = 14; data from 10 studies) while the early myocardial infarction (MI) rate was 0.4% (95% CI 0.2 – 0.6) (n = 16; data from 17 studies). The haematoma/bleeding rate was 3.4% (95% CI 1.7 – 5.8) (n = 135; data from 10 studies), with one third of these cases needing drainage or intervention. Within a follow up of 3 – 40 months the restenosis rate was 4% (95% CI 0.1 – 13.1) (data from nine studies; n = 64/530 patients) and death/stroke rate 4.5% (95% CI 1.8 – 8.4) (data from five studies; n = 184/3 742 patients). Symptomatic patients had a higher risk of early stroke/TIA than asymptomatic patients (2.5% vs. 1.2%; odds ratio 1.99; 95% CI 1.01 – 3.92); p = .046; data from eight studies).

      Conclusion

      TCAR is associated with promising early and late outcomes, with symptomatic patients having a higher risk of early cerebrovascular events. More prospective comparative studies are needed in order to verify TCAR as an established alternative treatment technique.

      Keywords

      This systematic review summarises the evidence for transcarotid revascularisation (TCAR) in patients with internal carotid artery stenosis. This technique offers an alternative strategy in patients where carotid endarterectomy (CEA) or transfemoral stenting face difficulties. This review evaluates early and late outcomes of the method in contrast to other similar reviews. Data indicate that TCAR is safe and efficient although symptomatic patients still carry a higher risk of early cerebrovascular complications. Prospectively designed studies comparing outcomes between TCAR and CEA in symptomatic patients are needed to further evaluate the benefit of this technique.

      Introduction

      Carotid endarterectomy (CEA) and transfemoral carotid stenting (tfCAS) are the two main procedures that are recommended for treatment of significant carotid artery stenosis.
      • Naylor A.R.
      • Ricco J.B.
      • de Borst G.J.
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      • de Haro J.
      • Halliday A.
      • et al.
      Editor’s Choice – Management of atherosclerotic carotid and vertebral artery disease: 2017 clinical practice guidelines of the European Society for Vascular Surgery (ESVS).
      Recent pooled data indicate that tfCAS is associated with a higher peri-operative death/stroke risk compared with CEA, especially in symptomatic and elderly patients.
      • Luebke T.
      • Brunkwall J.
      Carotid artery stenting versus carotid endarterectomy: updated meta-analysis, metaregression and trial sequential analysis of short-term and intermediate-to long-term outcomes of randomized trials.
      However, there is no difference regarding the long term ipsilateral stroke risk, for either symptomatic or asymptomatic patients.
      • Galyfos G.
      • Sachsamanis G.
      • Anastasiadou C.
      • Sachmpazidis I.
      • Kikiras K.
      • Kastrisios G.
      • et al.
      Carotid endarterectomy versus carotid stenting or best medical treatment in asymptomatic patients with significant carotid stenosis: a meta-analysis.
      ,
      • Jung J.M.
      • Choi J.Y.
      • Kim H.J.
      • Suh S.I.
      • Seo W.K.
      Long term durability and outcomes of carotid stenting and carotid endarterectomy.
      Both techniques have certain limitations. Open surgery is associated with higher surgical stress, and this could be the cause of the higher cardiac risk compared with stenting.
      • Galyfos G.
      • Sigala F.
      • Karanikola E.
      • Loizou C.
      • Toutouzas K.
      • Filis K.
      Cardiac damage after carotid intervention: a meta-analysis after a decade of randomized trials.
      Moreover, carotid bifurcation and plaque manipulation during CEA increase the risk of thrombo-embolic events
      • Fassaert L.M.
      • de Borst G.J.
      Technical improvements in carotid revascularization based on the mechanism of procedural stroke.
      as well as the risk of cranial nerve injuries.
      • Kakisis J.D.
      • Antonopoulos C.N.
      • Mantas G.
      • Moulakakis K.G.
      • Sfyroeras G.
      • Geroulakos G.
      Cranial nerve injury after carotid endarterectomy: incidence, risk factors, and time trends.
      On the other hand, manipulations with wires and endovascular devices during tfCAS could dislodge debris from a calcified aortic arch or cause dissections, leading to cerebrovascular events.
      • Moore W.S.
      • Popma J.J.
      • Roubin G.S.
      • Voeks J.H.
      • Cutlip D.E.
      • Jones M.
      • et al.
      Carotid angiographic characteristics in the CREST trial were major contributors to periprocedural stroke and death differences between carotid artery stenting and carotid endarterectomy.
      Additionally, chronic renal insufficiency is another established risk factor for endovascular techniques.
      • Brott T.G.
      • Hobson 2nd, R.W.
      • Howard G.
      • Roubin G.S.
      • Clark W.M.
      • Brooks W.
      • et al.
      Stenting versus endarterectomy for the treatment of carotid-artery stenosis.
      Therefore, transcarotid revascularisation (TCAR) has been introduced as an alternative approach to avoid the aforementioned limitations. The basic steps of this technique include a small cervical incision, dissection, and puncture of the proximal common carotid artery (CCA), and antegrade ICA stenting. The stenting is conducted mainly under proximal CCA clamping and ICA flow reversal in order to reduce the peri-procedural embolic risk.
      • Malas M.B.
      • Leal J.
      • Kashyap V.
      • Cambria R.P.
      • Kwolek C.J.
      • Criado E.
      Technical aspects of transcarotid artery revascularization using the ENROUTE transcarotid neuroprotection and stent system.
      Many studies have evaluated the efficacy and safety of this procedure in patients of high risk of CEA or tfCAS, with promising results.
      • Lackey A.R.
      • Erben Y.
      • Franco J.A.D.R.
      • Meschia J.F.
      • Lal B.K.
      Transcarotid artery revascularization results in low rates of periprocedural neurologic events, myocardial infarction, and death.
      This review aimed to evaluate pooled data on major outcomes of this procedure.

      Materials and methods

      Data sources and search

      This review was conducted according to established methods for systematic reviews (PRISMA).
      • Liberati A.
      • Altman D.G.
      • Tetzlaff J.
      • Mulrow C.
      • Gøtzsche P.C.
      • Ioannidis J.P.
      • et al.
      The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration.
      Medline, Embase, Scopus, and the Cochrane Library were systematically searched for clinical studies published up to September 2020 that evaluated early and/or late outcomes of patients treated with TCAR for ICA stenosis. All studies had to have evaluated both early mortality and stroke rates as an outcome. Early outcomes were defined as outcomes observed within 30 days from the procedure. Late outcomes were defined as outcomes observed more than 30 days post-operatively.
      The following medical subject terms (keywords) were used for the online search: “transcarotid” (non-MeSH), “transcervical” (non-MeSH), “carotid stenosis” (MeSH), “repair” (non-MeSH), “angioplasty” (MeSH), and “stenting” (MeSH). In addition to searching databases and reference lists of all included studies, meta-analyses and reviews were manually evaluated, including unpublished data. Only studies published in English were included in this review. References from eligible articles or textbooks were also reviewed to identify further potential sources.

      Data extraction – outcomes – definitions

      Four authors (G.C.G., I.T., G.G., and T.K.) were responsible for search and study selection. Disagreements were resolved by consensus or after review by the senior study author when necessary. Data were obtained from tables, graphs, and text. When data were presented as percentages, the absolute values were calculated. For each study, the following data were collected: first author, year of publication, country of publication, type of study (prospective, retrospective, or randomised), total number of patients included, total number of patients undergoing TCAR, mean follow up, basic demographics/comorbidities (gender, age [mean or median when available], risk factors), presence of symptoms, technical details of the procedure (type of anaesthesia, pre-dilation, flow reversal, mean duration of procedure, mean contrast volume), early and/or late outcomes, when reported in the studies. Early outcomes included the following: death, stroke/transient ischaemic attack (TIA) rate, myocardial infarction (MI), technical success, cranial nerve injury, haematoma/bleeding, other complications. Late outcomes included restenosis rate and other late complications.
      The following definitions were employed.
      • Symptomatic patients were defined as those presenting with symptoms within the last six months prior to the procedure.
      • Smoking was defined as history of smoking or current smoking.
      • The rest of the risk factors were defined according to each of the included studies.
      • Stroke was defined as an episode of focal neurological dysfunction, lasting over 24 hours, with evidence of cerebral ischaemia on imaging, as defined by each of the studies. A stroke was defined as minor with a National Institutes of Health Stroke Scale (NIHSS) score < 3, and as major with a NIHSS score > 3.
        • Sacco R.L.
        • Kasner S.E.
        • Broderick J.P.
        • Caplan L.R.
        • Connors J.J.
        • Culebras A.
        • et al.
        An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association.
      • TIA was defined as an episode of focal neurological dysfunction lasting less than 24 hours.
      • MI was defined as troponin levels increase plus/or electrocardiographic changes or clinical symptoms, according to each study.
      • Technical success was defined as ability to cross the target lesion with the wires and ability to successfully complete the procedure without the need to switch to open endarterectomy.
      • Restenosis was defined as reduction of the vessel lumen > 50%.
      • ICA stenosis was defined as an atherosclerotic stenosis located in the ICA from the level of the carotid bifurcation up to the basis of the skull (extracranial), according to the included studies.

      Quality assessment

      Three authors (G.C.G., I.T., T.K.) independently reviewed study eligibility and quality. Disagreements were resolved by consensus or after review by the senior author of the study, when necessary. The quality of each study was assessed based on well established criteria for non-randomised studies regarding selection, comparability and outcomes (Newcastle – Ottawa scale).
      • Stang A.
      Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses.
      Quality of each study was evaluated and reported as high, medium or low, based on study design and methodology according to the aforementioned criteria.
      • Stang A.
      Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses.

      Inclusion and exclusion criteria

      Studies included in this review met the following criteria: (1) clinical studies reporting early and/or late outcomes in patients undergoing TCAR for atherosclerotic ICA stenosis; (2) design of the study could be of any type (prospective or retrospective); (3) early mortality and stroke rates should be reported among the outcomes; (4) when a study compared outcomes among different groups (TCAR or tfCAS or CEA), these outcomes should be separately reported for the TCAR group; (5) patients should have undergone TCAR for primary atherosclerotic stenosis and not restenosis or other type of lesions; and (6) if more than one study report results from overlapping populations (from same institutions and during overlapping time periods), then the study with the largest number of patients and the largest time period of treatment was included in the review.
      Exclusion criteria included (1) types of publication other than clinical studies such as reviews, letters, meta-analyses, case reports or editorials; (2) series including fewer than 10 patients undergoing TCAR; (3) abstract only publications or abstracts from conferences; (4) studies not published in English; (5) studies not reporting outcomes separately for patients undergoing TCAR; (6) studies evaluating patients undergoing TCAR under percutaneous access and not under cut down access; (7) studies evaluating patients undergoing transcarotid repair for other diseases such as heart valvular disease, trauma or aneurysms; (8) studies evaluating transcarotid repair of atherosclerotic stenosis at other locations such as CCA, innominate artery or intracranial arteries; (9) studies not reporting 30 day mortality or stroke rates but other early outcomes after TCAR procedures.

      Statistical analysis

      Pooled effect sizes were calculated for each outcome using the StatsDirect® statistical tool (StatsDirect Ltd, Merseyside, UK). Values were expressed as proportions and 95% confidence intervals (CIs). Der Simonian – Laird weights of random effects model were applied for all meta-analyses and expressed as percentage proportions. Heterogeneity was calculated using the I2 test (I2 < 30% [low]; 30% < I2 < 60% [moderate]; I2 > 60% [significant]). Publication bias was assessed using the Egger test. Moreover, outcomes were compared between symptomatic and asymptomatic patients (when separately reported in the studies) in a random effect model, where pooled rates and pooled odds ratio were reported.

      Results

      After applying the inclusion/exclusion criteria, 18 clinical studies
      • Chang D.W.
      • Schubart P.J.
      • Veith F.J.
      • Zarins C.K.
      A new approach to carotid angioplasty and stenting with transcervical occlusion and protective shunting: why it may be a better carotid artery intervention.
      • Pipinos II,
      • Bruzoni M.
      • Johanning J.M.
      • Longo G.M.
      • Lynch T.G.
      Transcervical carotid stenting with flow reversal for neuroprotection: technique, results, advantages, and limitations.
      • Alexandrescu V.
      • Ngongang C.
      • Proumen J.
      • Dejardin H.
      • Serbanescu R.
      • Horionet J.
      • et al.
      Filter-protected carotid stenting via a minimal cervical access with transitory aspirated reversed flow during initial passage of the target lesion.
      • Criado E.
      • Fontcuberta J.
      • Orgaz A.
      • Flores A.
      • Doblas M.
      Transcervical carotid stenting with carotid artery flow reversal: 3-year follow-up of 103 stents.
      • Faraglia V.
      • Palombo G.
      • Stella N.
      • Rizzo L.
      • Taurino M.
      • Bozzao A.
      Cerebral embolization during transcervical carotid stenting with flow reversal: a diffusion-weighted magnetic resonance study.
      • Pinter L.
      • Ribo M.
      • Loh C.
      • Lane B.
      • Roberts T.
      • Chou T.M.
      • et al.
      Safety and feasibility of a novel transcervical access neuroprotection system for carotid artery stenting in the PROOF Study.
      • Alvarez B.
      • Matas M.
      • Ribo M.
      • Maeso J.
      • Yugueros X.
      • Alvarez-Sabin J.
      Transcervical carotid stenting with flow reversal is a safe technique for high-risk patients older than 70 years.
      • Ortega G.
      • Alvarez B.
      • Quintana M.
      • Yugueros X.
      • Alvarez-Sabin J.
      • Matas M.
      Asymptomatic carotid stenosis and cognitive improvement using transcervical stenting with protective flow reversal technique.
      • Kwolek 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.
      • Alpaslan A.
      • Wintermark M.
      • Pintér L.
      • Macdonald S.
      • Ruedy R.
      • Kolvenbach R.
      Transcarotid artery revascularization with flow reversal.
      • Wang S.K.
      • Fajardo A.
      • Sawchuk A.P.
      • Lemmon G.W.
      • Dalsing M.C.
      • Gupta A.K.
      • et al.
      Outcomes associated with a transcarotid artery revascularization-centered protocol in high-risk carotid revascularizations using the ENROUTE neuroprotection system.
      • Lin J.C.
      • Kolvenbach R.R.
      • Pinter L.
      Protected carotid artery stenting and angioplasty via transfemoral versus transcervical approaches.
      • Feldtman R.W.
      • Buckley C.J.
      • Bohannon W.T.
      How I do it: cervical access for carotid artery stenting.
      • Palombo G.
      • Stella N.
      • Faraglia V.
      • Rizzo L.
      • Fantozzi C.
      • Bozzao A.
      • et al.
      Cervical access for filter-protected carotid artery stenting: a useful tool to reduce cerebral embolisation.
      • Schermerhorn M.L.
      • Liang P.
      • Eldrup-Jorgensen J.
      • Cronenwett J.L.
      • Nolan B.W.
      • Kashyap V.S.
      • et al.
      Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis.
      • Christopoulos D.
      • Philippov E.
      The results of a simplified technique for safe carotid stenting in the elderly.
      • Plessers M.
      • Van Herzeele I.
      • Hemelsoet D.
      • Patel N.
      • Chung E.M.
      • Vingerhoets G.
      • et al.
      Transcervical carotid stenting with dynamic flow reversal demonstrates embolization rates comparable to carotid endarterectomy.
      • Kashyap V.S.
      • Schneider P.A.
      • Foteh M.
      • Motaganahalli R.
      • Shah R.
      • Eckstein H.H.
      • et al.
      ROADSTER 2 investigators. Early outcomes in the ROADSTER 2 study of transcarotid artery revascularization in patients with significant carotid artery disease.
      were identified as appropriate for analysis and overall, 3 075 studies were excluded (Fig. 1). All included studies were published between 2004 and 2020 (Table 1, Table 2, Table 3, Table 4, Table 5, Table 6, Table 7, Table 8, Table 9).
      Figure 1
      Figure 1Preferred reporting items for Systematic Reviews and Meta-Analysis (PRISMA) flow diagram for studies of transcarotid revascularisation (TCAR) in patients with internal carotid artery stenosis. IA = innominate artery; CCA = common carotid artery.
      Table 1Characteristics of 12 uncontrolled cohort studies with patients undergoing transcarotid artery revascularisation
      StudyYearCountryDesignPatients/ProceduresMean follow up – moAge – yMalesSymptomatic patients (stroke/TIA/afx)Quality of study
      Chang et al.
      • Chang D.W.
      • Schubart P.J.
      • Veith F.J.
      • Zarins C.K.
      A new approach to carotid angioplasty and stenting with transcervical occlusion and protective shunting: why it may be a better carotid artery intervention.
      2004USAProspective20/21127317 (85)13 (65) (NR)Low
      Pipinos et al.
      • Pipinos II,
      • Bruzoni M.
      • Johanning J.M.
      • Longo G.M.
      • Lynch T.G.
      Transcervical carotid stenting with flow reversal for neuroprotection: technique, results, advantages, and limitations.
      2006USARetrospective38/3818NRNRNRMedium
      Alexandrescu et al.
      • Alexandrescu V.
      • Ngongang C.
      • Proumen J.
      • Dejardin H.
      • Serbanescu R.
      • Horionet J.
      • et al.
      Filter-protected carotid stenting via a minimal cervical access with transitory aspirated reversed flow during initial passage of the target lesion.
      2006BelgiumRetrospective28/2911.673.7 (54–98)17 (61)23 (82) (6/12/5)Medium
      Criado et al.
      • Criado E.
      • Fontcuberta J.
      • Orgaz A.
      • Flores A.
      • Doblas M.
      Transcervical carotid stenting with carotid artery flow reversal: 3-year follow-up of 103 stents.
      2007USA/SpainProspective97/1034072 (54–90)82 (85)37 (38) (23/14/0)Medium
      Faraglia et al.
      • Faraglia V.
      • Palombo G.
      • Stella N.
      • Rizzo L.
      • Taurino M.
      • Bozzao A.
      Cerebral embolization during transcervical carotid stenting with flow reversal: a diffusion-weighted magnetic resonance study.
      2009ItalyProspective48/48678.3 (73–86)35 (73)10 (21) (8/2/0)Medium
      Pinter et al.
      • Pinter L.
      • Ribo M.
      • Loh C.
      • Lane B.
      • Roberts T.
      • Chou T.M.
      • et al.
      Safety and feasibility of a novel transcervical access neuroprotection system for carotid artery stenting in the PROOF Study.
      (PROOF)
      2011GermanyProspective44/44NR71.4 (57–88)28 (64)4 (9) (2/1/1)High
      Alvarez et al.
      • Alvarez B.
      • Matas M.
      • Ribo M.
      • Maeso J.
      • Yugueros X.
      • Alvarez-Sabin J.
      Transcervical carotid stenting with flow reversal is a safe technique for high-risk patients older than 70 years.
      2012SpainProspective212/21918.879.9 ± 4.9168 (79)97 (46) (NR)Medium
      Ortega et al.
      • Ortega G.
      • Alvarez B.
      • Quintana M.
      • Yugueros X.
      • Alvarez-Sabin J.
      • Matas M.
      Asymptomatic carotid stenosis and cognitive improvement using transcervical stenting with protective flow reversal technique.
      2014SpainProspective25/25NR74 ± 822 (88)0 (0)High
      Kwolek et al.
      • Kwolek 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.
      (ROADSTER)
      2015Spain/USAProspective141/141 (pivotal phase)1272.9 ± 991 (65)36 (26) (NR)High
      Alpaslan et al.
      • Alpaslan A.
      • Wintermark M.
      • Pintér L.
      • Macdonald S.
      • Ruedy R.
      • Kolvenbach R.
      Transcarotid artery revascularization with flow reversal.
      2017German/USAProspective75/75NR72.645 (60)12 (16) (NR)Medium
      Wang et al.
      • Wang S.K.
      • Fajardo A.
      • Sawchuk A.P.
      • Lemmon G.W.
      • Dalsing M.C.
      • Gupta A.K.
      • et al.
      Outcomes associated with a transcarotid artery revascularization-centered protocol in high-risk carotid revascularizations using the ENROUTE neuroprotection system.
      2019USARetrospective75/75870.5 ± 9.461 (81)35 (47) (NR)High
      Kashyap et al.
      • Kashyap V.S.
      • Schneider P.A.
      • Foteh M.
      • Motaganahalli R.
      • Shah R.
      • Eckstein H.H.
      • et al.
      ROADSTER 2 investigators. Early outcomes in the ROADSTER 2 study of transcarotid artery revascularization in patients with significant carotid artery disease.
      (ROADSTER 2)
      2020USA/Germany/SpainProspective632/632 (per protocol – 692 in total)NRNR428 (68)166 (26) (102/54/10) (stroke or TIA/afx/combined)High
      Data are presented n (%), mean ± standard deviation or median (interquartile range) unless stated otherwise. NR = non-reported; TIA = transient ischaemic attack; afx = amaurosis fugax; SD = standard deviation.
      Table 2Characteristics of 4 studies comparing transcarotid artery revascularisation (TCAR) with transfemoral carotid stenting
      StudyYearCountryDesignPatients undergoing TCAR/All patientsMean follow up – moAge – yMalesSymptomatic patients (stroke/TIA/afx)Quality of study
      Lin et al.
      • Lin J.C.
      • Kolvenbach R.R.
      • Pinter L.
      Protected carotid artery stenting and angioplasty via transfemoral versus transcervical approaches.
      2005USAProspective31 (55)NRNRΝR18 (58) (NR)Low
      Feldtman et al.
      • Feldtman R.W.
      • Buckley C.J.
      • Bohannon W.T.
      How I do it: cervical access for carotid artery stenting.
      2006USARetrospective15 (50)3–18NRNRNRLow
      Palombo et al.
      • Palombo G.
      • Stella N.
      • Faraglia V.
      • Rizzo L.
      • Fantozzi C.
      • Bozzao A.
      • et al.
      Cervical access for filter-protected carotid artery stenting: a useful tool to reduce cerebral embolisation.
      2010ItalyRetrospective44 (135)NR72.1 (57–82)33 (75)14 (32) (NR)High
      Schermerhorn et al.
      • Schermerhorn M.L.
      • Liang P.
      • Eldrup-Jorgensen J.
      • Cronenwett J.L.
      • Nolan B.W.
      • Kashyap V.S.
      • et al.
      Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis.
      2019USARetrospective3 286 (6572)1271.7 ± 9.82114 (64)1822 (55) (1 071/751/0)High
      Data are presented n (%), mean ± standard deviation, or median (interquartile range) unless stated otherwise. NR = non-reported; TIA = transient ischaemic attack; afx = amaurosis fugax.
      Table 3Characteristics of 2 studies comparing transcarotid artery revascularisation (TCAR) with transfemoral carotid stenting and carotid endarterectomy
      StudyYearCountryDesignPatients undergoing TCAR/All ptientsMean follow up – moAge – yMalesSymptomatic patients (stroke/TIA/afx)Quality of study
      Christopoulos et al.
      • Christopoulos D.
      • Philippov E.
      The results of a simplified technique for safe carotid stenting in the elderly.
      2010GreeceRetrospective25 (132)97917 (68)18 (72) (0/18/0)Medium
      Plessers et al.
      • Plessers M.
      • Van Herzeele I.
      • Hemelsoet D.
      • Patel N.
      • Chung E.M.
      • Vingerhoets G.
      • et al.
      Transcervical carotid stenting with dynamic flow reversal demonstrates embolization rates comparable to carotid endarterectomy.
      2016BelgiumRetrospective16 (34)NR71.3 ± 9.513 (81)8 (50) (NR)High
      Data are presented n (%), mean ± standard deviation, or median (interquartile range) unless stated otherwise. NR = non-reported; TIA = transient ischaemic attack; afx = amaurosis fugax.
      Table 4Patient demographics in 12 uncontrolled cohort studies with patients undergoing transcarotid artery revascularisation
      StudyCADHNDMDyslipidaemiaSmokingGA/LRADuration of procedure – minContrast volume – mLPre-dilationFlow reversal
      Chang et al.
      • Chang D.W.
      • Schubart P.J.
      • Veith F.J.
      • Zarins C.K.
      A new approach to carotid angioplasty and stenting with transcervical occlusion and protective shunting: why it may be a better carotid artery intervention.
      5172NRNR0/21NRNRYesYes
      Pipinos et al.
      • Pipinos II,
      • Bruzoni M.
      • Johanning J.M.
      • Longo G.M.
      • Lynch T.G.
      Transcervical carotid stenting with flow reversal for neuroprotection: technique, results, advantages, and limitations.
      NRNRNRNRNR26/12134NRNRYes
      Alexandrescu et al.
      • Alexandrescu V.
      • Ngongang C.
      • Proumen J.
      • Dejardin H.
      • Serbanescu R.
      • Horionet J.
      • et al.
      Filter-protected carotid stenting via a minimal cervical access with transitory aspirated reversed flow during initial passage of the target lesion.
      NR1611211829/0NRNRNRYes
      Criado et al.
      • Criado E.
      • Fontcuberta J.
      • Orgaz A.
      • Flores A.
      • Doblas M.
      Transcervical carotid stenting with carotid artery flow reversal: 3-year follow-up of 103 stents.
      358122582531/7269 (20–180)51 (10–120)34Yes
      Faraglia et al
      • Faraglia V.
      • Palombo G.
      • Stella N.
      • Rizzo L.
      • Taurino M.
      • Bozzao A.
      Cerebral embolization during transcervical carotid stenting with flow reversal: a diffusion-weighted magnetic resonance study.
      15402126140/48NRNR1Yes
      Pinter et al.
      • Pinter L.
      • Ribo M.
      • Loh C.
      • Lane B.
      • Roberts T.
      • Chou T.M.
      • et al.
      Safety and feasibility of a novel transcervical access neuroprotection system for carotid artery stenting in the PROOF Study.
      (PROOF)
      13NR1314NR1/43NR18.2NRYes
      Alvarez et al.
      • Alvarez B.
      • Matas M.
      • Ribo M.
      • Maeso J.
      • Yugueros X.
      • Alvarez-Sabin J.
      Transcervical carotid stenting with flow reversal is a safe technique for high-risk patients older than 70 years.
      11618177114140/21940 (25–60)25 ± 15NRYes
      Ortega et al.
      • Ortega G.
      • Alvarez B.
      • Quintana M.
      • Yugueros X.
      • Alvarez-Sabin J.
      • Matas M.
      Asymptomatic carotid stenosis and cognitive improvement using transcervical stenting with protective flow reversal technique.
      122181280/25NRNRNRYes
      Kwolek et al.
      • Kwolek 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.
      (ROADSTER)
      59122521093267/7473.6 ± 30.7NRNRYes
      Alpaslan et al.
      • Alpaslan A.
      • Wintermark M.
      • Pintér L.
      • Macdonald S.
      • Ruedy R.
      • Kolvenbach R.
      Transcarotid artery revascularization with flow reversal.
      22218NRNRNRNRNRNRYes
      Wang et al.
      • Wang S.K.
      • Fajardo A.
      • Sawchuk A.P.
      • Lemmon G.W.
      • Dalsing M.C.
      • Gupta A.K.
      • et al.
      Outcomes associated with a transcarotid artery revascularization-centered protocol in high-risk carotid revascularizations using the ENROUTE neuroprotection system.
      446938NR2070/577.7 ± 30.724.8 ± 14.7NRYes
      Kashyap et al
      • Kashyap V.S.
      • Schneider P.A.
      • Foteh M.
      • Motaganahalli R.
      • Shah R.
      • Eckstein H.H.
      • et al.
      ROADSTER 2 investigators. Early outcomes in the ROADSTER 2 study of transcarotid artery revascularization in patients with significant carotid artery disease.
      (ROADSTER 2)
      92571221542492453/17974.6 ± 28.6NRNRYes
      Data are presented n, mean ± standard deviation or median (interquartile range) unless stated otherwise. NR = non-reported; TIA = transient ischaemic attack; GA = general anaesthesia; LRA = locoregional anaesthesia; CAD = coronary artery disease; HN = hypertension; DM = diabetes mellitus.
      Table 5Patient demographics in 4 studies comparing transcarotid artery revascularisation with transfemoral carotid stenting
      StudyCADHNDMDyslipidaemiaSmokingGA/LRADuration of procedure – minContrast volume – mLPre-dilatationFlow reversal
      Lin et al.
      • Lin J.C.
      • Kolvenbach R.R.
      • Pinter L.
      Protected carotid artery stenting and angioplasty via transfemoral versus transcervical approaches.
      NRNRNRNRNR0/3164 ± 20.168.3 ± 18NRYes
      Feldtman et al.
      • Feldtman R.W.
      • Buckley C.J.
      • Bohannon W.T.
      How I do it: cervical access for carotid artery stenting.
      NRNRNRNRNRNRNRNRNRYes
      Palombo et al.
      • Palombo G.
      • Stella N.
      • Faraglia V.
      • Rizzo L.
      • Fantozzi C.
      • Bozzao A.
      • et al.
      Cervical access for filter-protected carotid artery stenting: a useful tool to reduce cerebral embolisation.
      NRNRNRNRNR0/44NRNRNRNo (filter)
      Schermerhorn et al.
      • Schermerhorn M.L.
      • Liang P.
      • Eldrup-Jorgensen J.
      • Cronenwett J.L.
      • Nolan B.W.
      • Kashyap V.S.
      • et al.
      Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis.
      1 6102 9631 2722 8643 273NR68 (53–87)30 (20–45)NRNR
      Data are presented n, mean ± standard deviation or median (interquartile range) unless stated otherwise. NR = non-reported; TIA = transient ischaemic attack; GA = general anaesthesia; LRA = locoregional anaesthesia; CAD = coronary artery disease; HN = hypertension; DM = diabetes mellitus.
      Table 6Patients’ demographics in 2 studies comparing transcarotid artery revascularisation with transfemoral carotid stenting and carotid endarterectomy
      StudyCADHNDMDyslipidaemiaSmokingGA/LRADuration of procedure – minContrast volume – mLPre-dilationFlow reversal
      Christopoulos et al.
      • Christopoulos D.
      • Philippov E.
      The results of a simplified technique for safe carotid stenting in the elderly.
      1621815253/2246 (32–63)NR0Yes (+ filter)
      Plessers et al.
      • Plessers M.
      • Van Herzeele I.
      • Hemelsoet D.
      • Patel N.
      • Chung E.M.
      • Vingerhoets G.
      • et al.
      Transcervical carotid stenting with dynamic flow reversal demonstrates embolization rates comparable to carotid endarterectomy.
      NR11515NR4/1276.5 ± 20.7NRSelectiveYes
      Data are presented n, mean ± standard deviation, or median (interquartile range) unless stated otherwise. NR = non-reported; TIA = transient ischaemic attack; GA = general anaesthesia; LRA = locoregional anaesthesia; CAD = coronary artery disease; HN = hypertension; DM = diabetes mellitus.
      Table 7Outcomes in 12 uncontrolled cohort studies with patients undergoing transcarotid artery revascularisation
      Study30 day death30 day stroke/TIA30 day MITechnical success – %Cranial nerve injuryHaematoma/bleeding)Other 30 day complications>50% restenosisOther >30 day complications
      Chang et al.
      • Chang D.W.
      • Schubart P.J.
      • Veith F.J.
      • Zarins C.K.
      A new approach to carotid angioplasty and stenting with transcervical occlusion and protective shunting: why it may be a better carotid artery intervention.
      0001001NR1 amaurosis0NR
      Pipinos et al.
      • Pipinos II,
      • Bruzoni M.
      • Johanning J.M.
      • Longo G.M.
      • Lynch T.G.
      Transcervical carotid stenting with flow reversal for neuroprotection: technique, results, advantages, and limitations.
      00NR100NR4 (1 drainage)NR1 occlusionNR
      Alexandrescu et al.
      • Alexandrescu V.
      • Ngongang C.
      • Proumen J.
      • Dejardin H.
      • Serbanescu R.
      • Horionet J.
      • et al.
      Filter-protected carotid stenting via a minimal cervical access with transitory aspirated reversed flow during initial passage of the target lesion.
      00096 (1 conversion to CEA)NRNRNR14 deaths

      1 stroke
      Criado et al.
      • Criado E.
      • Fontcuberta J.
      • Orgaz A.
      • Flores A.
      • Doblas M.
      Transcervical carotid stenting with carotid artery flow reversal: 3-year follow-up of 103 stents.
      02/20100NR2 drainages4 dissections0NR
      Faraglia et al.
      • Faraglia V.
      • Palombo G.
      • Stella N.
      • Rizzo L.
      • Taurino M.
      • Bozzao A.
      Cerebral embolization during transcervical carotid stenting with flow reversal: a diffusion-weighted magnetic resonance study.
      01/11NR00NR0NR
      Pinter et al.
      • Pinter L.
      • Ribo M.
      • Loh C.
      • Lane B.
      • Roberts T.
      • Chou T.M.
      • et al.
      Safety and feasibility of a novel transcervical access neuroprotection system for carotid artery stenting in the PROOF Study.
      (PROOF)
      01/00950NRNRNRNR
      Alvarez et al.
      • Alvarez B.
      • Matas M.
      • Ribo M.
      • Maeso J.
      • Yugueros X.
      • Alvarez-Sabin J.
      Transcervical carotid stenting with flow reversal is a safe technique for high-risk patients older than 70 years.
      13/1196.3 (4 conversions to CEA)21NR59 (within 3 y)1 stroke
      Ortega et al.
      • Ortega G.
      • Alvarez B.
      • Quintana M.
      • Yugueros X.
      • Alvarez-Sabin J.
      • Matas M.
      Asymptomatic carotid stenosis and cognitive improvement using transcervical stenting with protective flow reversal technique.
      000NRNRNRNRNRNR
      Kwolek et al.
      • Kwolek 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.
      (ROADSTER)
      22/0199.31NR8 dissectionsNR1 stroke

      7 deaths
      Alpaslan et al.
      • Alpaslan A.
      • Wintermark M.
      • Pintér L.
      • Macdonald S.
      • Ruedy R.
      • Kolvenbach R.
      Transcarotid artery revascularization with flow reversal.
      01/0(contralateral)090.7 (1 conversion to CEA, 4 conversions to tfCAS)22NRNRNR
      Wang et al.
      • Wang S.K.
      • Fajardo A.
      • Sawchuk A.P.
      • Lemmon G.W.
      • Dalsing M.C.
      • Gupta A.K.
      • et al.
      Outcomes associated with a transcarotid artery revascularization-centered protocol in high-risk carotid revascularizations using the ENROUTE neuroprotection system.
      23/0 (1 contralateral)097.302NR02 strokes
      Kashyap et al.
      • Kashyap V.S.
      • Schneider P.A.
      • Foteh M.
      • Motaganahalli R.
      • Shah R.
      • Eckstein H.H.
      • et al.
      ROADSTER 2 investigators. Early outcomes in the ROADSTER 2 study of transcarotid artery revascularization in patients with significant carotid artery disease.
      (ROADSTER 2)
      14/0699.78NRNRNRNR
      Data are presented as n unless stated otherwise. NR = non-reported; TIA = transient ischaemic attack; CEA = carotid endarterectomy; tfCAS = transfemoral carotid stenting; MI = myocardial infarction.
      Table 8Outcomes in 4 studies comparing transcarotid artery revascularisation with transfemoral carotid stenting
      Study30 day death30 day stroke/TIA30 day MITechnical success – %Cranial nerve injuryHaematoma/bleedingOther 30 day complications>50% restenosisOther >30 day complications
      Lin et al.
      • Lin J.C.
      • Kolvenbach R.R.
      • Pinter L.
      Protected carotid artery stenting and angioplasty via transfemoral versus transcervical approaches.
      00/2090.3 (3 conversions to CEA)NR2 (1 drainage)4 bradycardiaNRNR
      Feldtman et al.
      • Feldtman R.W.
      • Buckley C.J.
      • Bohannon W.T.
      How I do it: cervical access for carotid artery stenting.
      11/0080 (3 conversions to CEA)0NRNR3NR
      Palombo et al.
      • Palombo G.
      • Stella N.
      • Faraglia V.
      • Rizzo L.
      • Fantozzi C.
      • Bozzao A.
      • et al.
      Cervical access for filter-protected carotid artery stenting: a useful tool to reduce cerebral embolisation.
      00/1010000NRNRNR
      Schermerhorn et al.
      • Schermerhorn M.L.
      • Liang P.
      • Eldrup-Jorgensen J.
      • Cronenwett J.L.
      • Nolan B.W.
      • Kashyap V.S.
      • et al.
      Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis.
      2544/22799.5NR116 (44 interventions)9 hyperperfusion syndromeNR5.1% death or stroke
      Data are presented as n unless stated otherwise. NR = non-reported; TIA = transient ischaemic attack; CEA = carotid endarterectomy; MI = myocardial infarction.
      Table 9Outcomes in 2 studies comparing transcarotid artery revascularisation with transfemoral carotid stenting and carotid endarterectomy
      Study30 day death30 day stroke/TIA30 day MITechnical success – %Cranial nerve injuryHaematoma/bleedingOther 30 day complications>50% restenosisOther >30 day complications
      Christopoulos et al.
      • Christopoulos D.
      • Philippov E.
      The results of a simplified technique for safe carotid stenting in the elderly.
      00/1096 (1 conversion to CEA)NR61 dissection0NR
      Plessers et al.
      • Plessers M.
      • Van Herzeele I.
      • Hemelsoet D.
      • Patel N.
      • Chung E.M.
      • Vingerhoets G.
      • et al.
      Transcervical carotid stenting with dynamic flow reversal demonstrates embolization rates comparable to carotid endarterectomy.
      000100ΝRNR2 dissectionsNRNR
      Data are presented as n unless stated otherwise. NR = non-reported; TIA = transient ischaemic attack; MI = myocardial infarction.
      In total, 8 473 patients were evaluated. Of the 8 473 patients, 4 852 patients underwent 4 867 TCAR procedures.
      • Chang D.W.
      • Schubart P.J.
      • Veith F.J.
      • Zarins C.K.
      A new approach to carotid angioplasty and stenting with transcervical occlusion and protective shunting: why it may be a better carotid artery intervention.
      • Pipinos II,
      • Bruzoni M.
      • Johanning J.M.
      • Longo G.M.
      • Lynch T.G.
      Transcervical carotid stenting with flow reversal for neuroprotection: technique, results, advantages, and limitations.
      • Alexandrescu V.
      • Ngongang C.
      • Proumen J.
      • Dejardin H.
      • Serbanescu R.
      • Horionet J.
      • et al.
      Filter-protected carotid stenting via a minimal cervical access with transitory aspirated reversed flow during initial passage of the target lesion.
      • Criado E.
      • Fontcuberta J.
      • Orgaz A.
      • Flores A.
      • Doblas M.
      Transcervical carotid stenting with carotid artery flow reversal: 3-year follow-up of 103 stents.
      • Faraglia V.
      • Palombo G.
      • Stella N.
      • Rizzo L.
      • Taurino M.
      • Bozzao A.
      Cerebral embolization during transcervical carotid stenting with flow reversal: a diffusion-weighted magnetic resonance study.
      • Pinter L.
      • Ribo M.
      • Loh C.
      • Lane B.
      • Roberts T.
      • Chou T.M.
      • et al.
      Safety and feasibility of a novel transcervical access neuroprotection system for carotid artery stenting in the PROOF Study.
      • Alvarez B.
      • Matas M.
      • Ribo M.
      • Maeso J.
      • Yugueros X.
      • Alvarez-Sabin J.
      Transcervical carotid stenting with flow reversal is a safe technique for high-risk patients older than 70 years.
      • Ortega G.
      • Alvarez B.
      • Quintana M.
      • Yugueros X.
      • Alvarez-Sabin J.
      • Matas M.
      Asymptomatic carotid stenosis and cognitive improvement using transcervical stenting with protective flow reversal technique.
      • Kwolek 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.
      • Alpaslan A.
      • Wintermark M.
      • Pintér L.
      • Macdonald S.
      • Ruedy R.
      • Kolvenbach R.
      Transcarotid artery revascularization with flow reversal.
      • Wang S.K.
      • Fajardo A.
      • Sawchuk A.P.
      • Lemmon G.W.
      • Dalsing M.C.
      • Gupta A.K.
      • et al.
      Outcomes associated with a transcarotid artery revascularization-centered protocol in high-risk carotid revascularizations using the ENROUTE neuroprotection system.
      • Lin J.C.
      • Kolvenbach R.R.
      • Pinter L.
      Protected carotid artery stenting and angioplasty via transfemoral versus transcervical approaches.
      • Feldtman R.W.
      • Buckley C.J.
      • Bohannon W.T.
      How I do it: cervical access for carotid artery stenting.
      • Palombo G.
      • Stella N.
      • Faraglia V.
      • Rizzo L.
      • Fantozzi C.
      • Bozzao A.
      • et al.
      Cervical access for filter-protected carotid artery stenting: a useful tool to reduce cerebral embolisation.
      • Schermerhorn M.L.
      • Liang P.
      • Eldrup-Jorgensen J.
      • Cronenwett J.L.
      • Nolan B.W.
      • Kashyap V.S.
      • et al.
      Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis.
      • Christopoulos D.
      • Philippov E.
      The results of a simplified technique for safe carotid stenting in the elderly.
      • Plessers M.
      • Van Herzeele I.
      • Hemelsoet D.
      • Patel N.
      • Chung E.M.
      • Vingerhoets G.
      • et al.
      Transcervical carotid stenting with dynamic flow reversal demonstrates embolization rates comparable to carotid endarterectomy.
      • Kashyap V.S.
      • Schneider P.A.
      • Foteh M.
      • Motaganahalli R.
      • Shah R.
      • Eckstein H.H.
      • et al.
      ROADSTER 2 investigators. Early outcomes in the ROADSTER 2 study of transcarotid artery revascularization in patients with significant carotid artery disease.
      Overall, there were 10 prospective and eight retrospective studies. No randomised trial was included. Among the 18 studies, there were 12 cohort studies evaluating TCAR only, four studies comparing TCAR with tfCAS, and two studies comparing TCAR with tfCAS and CEA (Table 1, Table 2, Table 3). Regarding the quality of the studies, there were three studies of low quality, seven studies of medium quality, and eight studies of high quality (Table 1, Table 2, Table 3, Table 10).
      Table 10Quality of 18 included studies per Ottawa–Newcastle criteria
      • Stang A.
      Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses.
      StudySelection
      Selection score = 0–4; comparability score = 0–4; outcomes score = 0–3. maximum total score = 9. low quality = 0–4; medium quality 5–7; high quality = 8–9.
      Comparability
      Selection score = 0–4; comparability score = 0–4; outcomes score = 0–3. maximum total score = 9. low quality = 0–4; medium quality 5–7; high quality = 8–9.
      Outcomes
      Selection score = 0–4; comparability score = 0–4; outcomes score = 0–3. maximum total score = 9. low quality = 0–4; medium quality 5–7; high quality = 8–9.
      Quality
      Chang et al.
      • Chang D.W.
      • Schubart P.J.
      • Veith F.J.
      • Zarins C.K.
      A new approach to carotid angioplasty and stenting with transcervical occlusion and protective shunting: why it may be a better carotid artery intervention.
      111Low
      Pipinos et al.
      • Pipinos II,
      • Bruzoni M.
      • Johanning J.M.
      • Longo G.M.
      • Lynch T.G.
      Transcervical carotid stenting with flow reversal for neuroprotection: technique, results, advantages, and limitations.
      221Medium
      Alexandrescu et al.
      • Alexandrescu V.
      • Ngongang C.
      • Proumen J.
      • Dejardin H.
      • Serbanescu R.
      • Horionet J.
      • et al.
      Filter-protected carotid stenting via a minimal cervical access with transitory aspirated reversed flow during initial passage of the target lesion.
      222Medium
      Criado et al.
      • Criado E.
      • Fontcuberta J.
      • Orgaz A.
      • Flores A.
      • Doblas M.
      Transcervical carotid stenting with carotid artery flow reversal: 3-year follow-up of 103 stents.
      222Medium
      Faraglia et al.
      • Faraglia V.
      • Palombo G.
      • Stella N.
      • Rizzo L.
      • Taurino M.
      • Bozzao A.
      Cerebral embolization during transcervical carotid stenting with flow reversal: a diffusion-weighted magnetic resonance study.
      222Medium
      Pinter et al.
      • Pinter L.
      • Ribo M.
      • Loh C.
      • Lane B.
      • Roberts T.
      • Chou T.M.
      • et al.
      Safety and feasibility of a novel transcervical access neuroprotection system for carotid artery stenting in the PROOF Study.
      (PROOF)
      422High
      Alvarez et al.
      • Alvarez B.
      • Matas M.
      • Ribo M.
      • Maeso J.
      • Yugueros X.
      • Alvarez-Sabin J.
      Transcervical carotid stenting with flow reversal is a safe technique for high-risk patients older than 70 years.
      222Medium
      Ortega et al.
      • Ortega G.
      • Alvarez B.
      • Quintana M.
      • Yugueros X.
      • Alvarez-Sabin J.
      • Matas M.
      Asymptomatic carotid stenosis and cognitive improvement using transcervical stenting with protective flow reversal technique.
      423High
      Kwolek et al.
      • Kwolek 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.
      (ROADSTER)
      423High
      Alpaslan et al.
      • Alpaslan A.
      • Wintermark M.
      • Pintér L.
      • Macdonald S.
      • Ruedy R.
      • Kolvenbach R.
      Transcarotid artery revascularization with flow reversal.
      222Medium
      Wang et al.
      • Wang S.K.
      • Fajardo A.
      • Sawchuk A.P.
      • Lemmon G.W.
      • Dalsing M.C.
      • Gupta A.K.
      • et al.
      Outcomes associated with a transcarotid artery revascularization-centered protocol in high-risk carotid revascularizations using the ENROUTE neuroprotection system.
      423High
      Kashyap et al.
      • Kashyap V.S.
      • Schneider P.A.
      • Foteh M.
      • Motaganahalli R.
      • Shah R.
      • Eckstein H.H.
      • et al.
      ROADSTER 2 investigators. Early outcomes in the ROADSTER 2 study of transcarotid artery revascularization in patients with significant carotid artery disease.
      (ROADSTER 2)
      423High
      Lin et al.
      • Lin J.C.
      • Kolvenbach R.R.
      • Pinter L.
      Protected carotid artery stenting and angioplasty via transfemoral versus transcervical approaches.
      121Low
      Feldtman et al.
      • Feldtman R.W.
      • Buckley C.J.
      • Bohannon W.T.
      How I do it: cervical access for carotid artery stenting.
      121Low
      Palombo et al.
      • Palombo G.
      • Stella N.
      • Faraglia V.
      • Rizzo L.
      • Fantozzi C.
      • Bozzao A.
      • et al.
      Cervical access for filter-protected carotid artery stenting: a useful tool to reduce cerebral embolisation.
      442High
      Schermerhorn et al.
      • Schermerhorn M.L.
      • Liang P.
      • Eldrup-Jorgensen J.
      • Cronenwett J.L.
      • Nolan B.W.
      • Kashyap V.S.
      • et al.
      Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis.
      443High
      Christopoulos et al.
      • Christopoulos D.
      • Philippov E.
      The results of a simplified technique for safe carotid stenting in the elderly.
      232Medium
      Plessers et al.
      • Plessers M.
      • Van Herzeele I.
      • Hemelsoet D.
      • Patel N.
      • Chung E.M.
      • Vingerhoets G.
      • et al.
      Transcervical carotid stenting with dynamic flow reversal demonstrates embolization rates comparable to carotid endarterectomy.
      442High
      Selection score = 0–4; comparability score = 0–4; outcomes score = 0–3. maximum total score = 9. low quality = 0–4; medium quality 5–7; high quality = 8–9.
      The mean patient age was 72.3 ± 6.2 years (range 54 – 90 years) (data from 14 studies), and 66.5% of patients were male (data from 15 studies). Regarding symptoms, 48.1% of patients were symptomatic (data from 16 studies) although only six studies reported the type of symptoms in detail (stroke, TIA or amaurosis). Among the 18 studies, seven studies reported early outcomes only (30 day), while the mean follow up ranged from three to 40 months in the remaining 11 studies. Basic patient characteristics/demographics are listed in Table 4, Table 5, Table 6.
      The pooled rates for the basic risk factors were: coronary artery disease 43.6% (n = 2 039; data from 12 studies), arterial hypertension 87.9% (n = 4 115; data from 13 studies), diabetes mellitus 37.4% (n = 1 768; data from 14 studies), dyslipidaemia 83.2% (n = 3 790; data from 11 studies), and smoking 85.8% (n = 3 921; data from 10 studies). Additionally, 45.9% (n = 684) of procedures from 15 studies were conducted under general anaesthesia although Schermerhorn et al.29 who presented the largest series of patients did not report on type of anaesthesia. Sixteen studies reported that they applied flow reversal, one study did not apply it and used a distal filter, and one study did not report on flow reversal at all.
      There were 32 deaths within 30 days (pooled mortality 0.7%; 95% CI [confidence interval] 0.5 – 1.0). The early stroke/TIA rate was 2.0% (95% CI 1.4 – 2.7) (n = 92), and the early stroke rate 1.4% (95% CI 1.0 – 1.7) (n = 62). The cranial nerve injury rate was 1.2% (95% CI 0.7 – 1.9) (n = 14; data from 10 studies) and MI rate 0.4% (95% CI 0.2 – 0.6) (n = 16; data from 17 studies). One hundred and thirty-five haematomas/bleedings were reported in 10 studies (3.4%; 95% CI 1.7 – 5.8), of which 35.5% needed drainage or intervention. Only 16 studies reported on technical success that ranged from 80% to 100% (pooled technical success: 97.6%; 95% CI 95.9 – 98.8). Other early complications were reported by seven studies: dissection (n = 15), amaurosis (n = 1), acute heart insufficiency (n = 1), bradycardia (n = 4) and hyperperfusion syndrome (n = 9). (Figure 2, Figure 3, Figure 4, Figure 5, Figure 6, Figure 7) (Table 7, Table 8, Table 9)
      Figure 2
      Figure 2Forest plot showing pooled rate for 30 day mortality after transcarotid revascularisation.
      Figure 3
      Figure 3Forest plot showing pooled rate for 30 day stroke/transient ischaemic attack (TIA) after transcarotid revascularisation.
      Figure 4
      Figure 4Forest plot showing pooled rate for 30 day myocardial infarction (MI) after transcarotid revascularisation.
      Figure 5
      Figure 5Forest plot showing pooled rate for 30 day cranial nerve injury after transcarotid revascularisation.
      Figure 6
      Figure 6Forest plot showing pooled rate for technical success after transcarotid revascularisation.
      Figure 7
      Figure 7Forest plot showing pooled rate for 30 day haematomas/bleeding after transcarotid revascularisation.
      When sensitivity analysis was conducted leaving out the largest study by Schermerhorn et al., similar pooled results were found: early mortality 0.6% (95% CI 0.3 – 1.0); early stroke/TIA rate 2.2% (95% CI 1.4 – 3.2); early stroke rate 1.3% (95% CI 0.8 – 2.0); early MI rate 0.8% (95% CI 0.4 – 1.4); cranial nerve injury rate 1.2% (95% CI 0.7 – 1.9); haematoma/bleeding rate 3.7% (95% CI 1.3 – 7.2); technical success 97.1% (95% CI 94.9 – 98.7)
      Within the follow up period, 64 patients presented with restenosis > 50% or total occlusion (pooled rate = 4%; 95% CI 0.1 – 13.1; data from nine studies; n = 64/530 patients). During follow up, a pooled death/stroke rate of 4.5% (95% CI 1.8 – 8.4) was calculated from five studies (n = 184/3 742 patients) (Figure 8, Figure 9).
      Figure 8
      Figure 8Forest plot showing pooled rate for late > 50% restenosis after transcarotid revascularisation.
      Figure 9
      Figure 9Forest plot showing pooled rate for late death/stroke after transcarotid revascularisation.
      Regarding the effect of pre-operative symptoms on early stroke/TIA rate, only eight studies reported on early stroke/TIA rate among symptomatic and asymptomatic patients separately. Subgroup meta-analysis revealed that symptomatic patients undergoing TCAR had a higher risk of early stroke/TIA than asymptomatic patients (2.5% vs. 1.2%; odds ratio [OR] 1.99; 95% CI 1.01 – 3.92; p = .046) (Fig. 10). However, when the comparison was conducted after omitting the study by Schermerhorn et al., no difference was found regarding early stroke/TIA risk (1.4% vs. 1.3%; OR = 1.00; 95% CI 0.28 – 3.61; p = .99).
      Figure 10
      Figure 10Forest plot showing the effect of pre-operative symptoms on early stroke/transient ischaemic attack (TIA) risk after transcarotid revascularisation.
      Regarding heterogeneity, I2 was null regarding early death, MI, stroke/TIA and cranial nerve injury risks. However, data for technical success, 30 day haematoma and late outcomes showed I2 values > 70%, indicating significant heterogeneity.

      Discussion

      The present systematic review has shown that TCAR is associated with low early mortality and stroke/TIA rates as well as promising long term outcomes. Early stroke/TIA events were higher among symptomatic patients than among asymptomatic patients.
      In the literature, this is the most recent review evaluating the largest number of patients undergoing TCAR. In 2013, Sfyroeras et al. published the first systematic review including 739 TCAR procedures from 12 studies.
      • Sfyroeras 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.
      However, they included no study published after 2012, and did not report on comorbidities at all, in contrast to this review. The authors found a technical success of 96.3%, an early mortality of 0.41%, a stroke risk of 1.1% and a MI risk of 0.14%, agreeing with the results. Additionally, they did not apply strict inclusion criteria as they included studies that were excluded from the analysis. Such study by Mathieu et al.
      • Mathieu X.
      • Piret V.
      • Bergeron P.
      • Petrosyan A.
      • Abdulamit T.
      • Trastour J.C.
      Choice of access for percutaneous carotid angioplasty and stenting: a comparative study on cervical and femoral access.
      evaluated a cohort of patients undergoing percutaneous TCAR although only studies with cut down access were eligible for the present review. In another review by Luk et al., only eight studies were included.
      • Luk Y.
      • Chan Y.C.
      • Cheng S.W.
      Transcarotid Artery Revascularization as a New Modality of Treatment for Carotid Stenosis.
      Although the authors investigated 30 day outcomes, no long term outcomes or comorbidities were reported. Moreover, they presented only the range of values for any of the variables without calculating any pooled result. Finally, studies with overlapping populations
      • Schermerhorn M.L.
      • Liang P.
      • Eldrup-Jorgensen J.
      • Cronenwett J.L.
      • Nolan B.W.
      • Kashyap V.S.
      • et al.
      Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis.
      ,
      • Malas M.B.
      • Dakour-Aridi H.
      • Wang G.J.
      • Kashyap V.S.
      • Motaganahalli R.L.
      • Eldrup-Jorgensen J.
      • et al.
      Transcarotid artery revascularization versus transfemoral carotid artery stenting in the Society for Vascular Surgery Vascular Quality Initiative.
      were analysed by Luk et al. decreasing the credibility of their results.
      • Luk Y.
      • Chan Y.C.
      • Cheng S.W.
      Transcarotid Artery Revascularization as a New Modality of Treatment for Carotid Stenosis.
      There are three meta-analyses to date. Texakalidis et al. evaluated studies comparing TCAR with tfCAS.
      • Texakalidis P.
      • Giannopoulos S.
      • Kokkinidis D.G.
      • Charisis N.
      • Kakkar A.
      • Jabbour P.
      • et al.
      Direct transcervical access vs the transfemoral approach for carotid artery stenting: a systematic review and meta-analysis.
      In total, 11 592 patients undergoing 856 TCAR and 10 736 tfCAS procedures were included although some of the studies reported fewer than 10 TCAR procedures and some of the studies evaluated overlapping populations. This could question the strength of their results. However, they reported a pooled stroke risk after TCAR that was similar with to the present review and significantly lower than the risk after tfCAS (OR 1.98; 95% CI 1.08 – 3.63, p = .027). As aforementioned, this is justified as the aortic arch manipulation during tfCAS could lead to emboli dislodgement or dissections and further cause stroke or TIA.
      • Moore W.S.
      • Popma J.J.
      • Roubin G.S.
      • Voeks J.H.
      • Cutlip D.E.
      • Jones M.
      • et al.
      Carotid angiographic characteristics in the CREST trial were major contributors to periprocedural stroke and death differences between carotid artery stenting and carotid endarterectomy.
      Moreover, the proximal CCA is usually clamped and ICA flow is reversed during TCAR, thus, reducing the risk of cerebrovascular events.
      • Malas M.B.
      • Leal J.
      • Kashyap V.
      • Cambria R.P.
      • Kwolek C.J.
      • Criado E.
      Technical aspects of transcarotid artery revascularization using the ENROUTE transcarotid neuroprotection and stent system.
      More recently, Paraskevas et al. included a total of 18 studies in another review.
      • Paraskevas K.I.
      • Antonopoulos C.N.
      • Kakisis J.D.
      • Geroulakos G.
      An updated systematic review and meta-analysis of results of transcervical carotid artery stenting with flow reversal.
      However, the authors also evaluated studies with overlapping populations.
      • Kashyap V.S.
      • King A.H.
      • Foteh M.I.
      • Janko M.
      • Jim J.
      • Motaganahalli R.L.
      • et al.
      A multi-institutional analysis of transcarotid artery revascularization compared to carotid endarterectomy.
      ,
      • King A.H.
      • Kumins N.H.
      • Foteh M.I.
      • Jim J.
      • Apple J.M.
      • Kashyap V.S.
      The learning curve of transcarotid artery revascularization.
      Additionally, no data on comorbidities were presented in contrast to the review. Finally, only early results were evaluated and no long term data were presented. However, technical success (98.25%) and mortality rate (0.48%) were optimal agreeing with the present results. Finally, Naazie et al. tried to compare TCAR and tfCAS in another review.
      • Naazie I.N.
      • Cui C.L.
      • Osaghae I.
      • Murad M.H.
      • Schermerhorn M.
      • Malas M.B.
      A systematic review and meta-analysis of transcarotid artery revascularization with dynamic flow reversal versus transfemoral carotid artery stenting and carotid endarterectomy.
      Like the present study, the authors found similar early event rates after TCAR, but they did not evaluate late outcomes and did not examine the effect of pre-operative symptoms.
      • Naazie I.N.
      • Cui C.L.
      • Osaghae I.
      • Murad M.H.
      • Schermerhorn M.
      • Malas M.B.
      A systematic review and meta-analysis of transcarotid artery revascularization with dynamic flow reversal versus transfemoral carotid artery stenting and carotid endarterectomy.
      Regarding the technical characteristics, it was found that the majority of patients underwent local/regional anaesthesia. This type of anaesthesia is very useful especially for patients of increased surgical risk that need to avoid general anaesthesia. It also facilitates peri-operative assessment of the patient’s neurological status.
      • Lewis S.C.
      • Warlow C.P.
      • Colam B.
      • Rothwell P.M.
      • Torgerson D.
      • et al.
      GALA Trial Collaborative Group
      General anaesthesia versus local anaesthesia for carotid surgery (GALA): a multicentre, randomised controlled trial.
      It should be underlined that although the largest cohort
      • Schermerhorn M.L.
      • Liang P.
      • Eldrup-Jorgensen J.
      • Cronenwett J.L.
      • Nolan B.W.
      • Kashyap V.S.
      • et al.
      Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis.
      in this review did not report on the type of anaesthesia, Malas et al.
      • Malas M.B.
      • Dakour-Aridi H.
      • Wang G.J.
      • Kashyap V.S.
      • Motaganahalli R.L.
      • Eldrup-Jorgensen J.
      • et al.
      Transcarotid artery revascularization versus transfemoral carotid artery stenting in the Society for Vascular Surgery Vascular Quality Initiative.
      reported from the same registry a 79% general anaesthesia rate. Furthermore, mean procedural time was 68 minutes in the review that is similar to the tfCAS procedure time in the Vascular Quality Initiative (VQI) registry.
      • Schermerhorn M.L.
      • Liang P.
      • Eldrup-Jorgensen J.
      • Cronenwett J.L.
      • Nolan B.W.
      • Kashyap V.S.
      • et al.
      Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis.
      A low haematoma rate was also found, with one third requiring drainage or intervention. According to recent data from the United States, the haematoma/bleeding rate was 4.2% among 24 000 tfCAS procedures similar to the present findings.
      • Cole T.S.
      • Mezher A.W.
      • Catapano J.S.
      • Godzik J.
      • Baranoski J.F.
      • Nakaji P.
      • et al.
      Nationwide trends in carotid endarterectomy and carotid artery stenting in the post-CREST era.
      Texakalidis et al. also found a similar local haematoma rate after both type of procedures.
      • Texakalidis P.
      • Giannopoulos S.
      • Kokkinidis D.G.
      • Charisis N.
      • Kakkar A.
      • Jabbour P.
      • et al.
      Direct transcervical access vs the transfemoral approach for carotid artery stenting: a systematic review and meta-analysis.
      However, in the VQI registry, it is reported that more cases with a haematoma needed an intervention after TCAR compared with tfCAS (1.3% vs. 0.8% respectively; p = .040).
      • Schermerhorn M.L.
      • Liang P.
      • Eldrup-Jorgensen J.
      • Cronenwett J.L.
      • Nolan B.W.
      • Kashyap V.S.
      • et al.
      Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis.
      This could be explained by the access location. A cervical haematoma or haemorrhage could easily exert pressure on the adjacent trachea or other vital structures and necessitate immediate intervention. Finally, pooled technical success was high although Egger’s test was positive. This could be attributed to differences regarding the definition and measurement of technical success among the included studies.
      Considering long term outcomes, the mean restenosis rate was 4% among nine studies although there was significant heterogeneity regarding mean follow up reported by each separate study. However, the mean restenosis rate after tfCAS was 9.9% among randomised trials only.
      • Jung J.M.
      • Choi J.Y.
      • Kim H.J.
      • Suh S.I.
      • Seo W.K.
      Long term durability and outcomes of carotid stenting and carotid endarterectomy.
      Within a follow up ranging from three to 40 months, the stroke/death rate was 4.5% in the study. Although the long term ipsilateral stroke rate is about 3% after CAS, five year mortality reaches almost 20%.
      • Luebke T.
      • Brunkwall J.
      Carotid artery stenting versus carotid endarterectomy: updated meta-analysis, metaregression and trial sequential analysis of short-term and intermediate-to long-term outcomes of randomized trials.
      ,
      • Jung J.M.
      • Choi J.Y.
      • Kim H.J.
      • Suh S.I.
      • Seo W.K.
      Long term durability and outcomes of carotid stenting and carotid endarterectomy.
      Regarding CEA, only two eligible studies compared outcomes with TCAR.
      • Christopoulos D.
      • Philippov E.
      The results of a simplified technique for safe carotid stenting in the elderly.
      ,
      • Plessers M.
      • Van Herzeele I.
      • Hemelsoet D.
      • Patel N.
      • Chung E.M.
      • Vingerhoets G.
      • et al.
      Transcervical carotid stenting with dynamic flow reversal demonstrates embolization rates comparable to carotid endarterectomy.
      Although CEA remains the procedure of choice for treating a significant stenosis especially when this is symptomatic, it is associated with certain complications including cranial nerve injury.
      • Kakisis J.D.
      • Antonopoulos C.N.
      • Mantas G.
      • Moulakakis K.G.
      • Sfyroeras G.
      • Geroulakos G.
      Cranial nerve injury after carotid endarterectomy: incidence, risk factors, and time trends.
      However, TCAR uses a small cervical incision and avoids manipulations of the carotid bifurcation or the aortic arch. This could account for the very low stroke and cranial nerve injury rates after TCAR. These results were also confirmed by a large comparative study by Schermerhorn et al.
      • Schermerhorn M.L.
      • Liang P.
      • Dakour-Aridi H.
      • Kashyap V.S.
      • Wang G.J.
      • Nolan B.W.
      • et al.
      In-hospital outcomes of transcarotid artery revascularization and carotid endarterectomy in the Society for Vascular Surgery Vascular Quality Initiative.
      In this study, early stroke/death rates were similar after TCAR and CEA despite a substantially higher medical risk in patients undergoing TCAR. Moreover, TCAR was associated with one third of the risk of cranial nerve injuries compared with CEA.
      • Schermerhorn M.L.
      • Liang P.
      • Dakour-Aridi H.
      • Kashyap V.S.
      • Wang G.J.
      • Nolan B.W.
      • et al.
      In-hospital outcomes of transcarotid artery revascularization and carotid endarterectomy in the Society for Vascular Surgery Vascular Quality Initiative.
      In another study by Malas et al., TCAR was also associated with lower risk of post-operative hypertension and reduced length of hospital stay compared with CEA.
      • Malas M.B.
      • Dakour-Aridi H.
      • Kashyap V.S.
      • Eldrup-Jorgensen J.
      • Wang G.J.
      • Motaganahalli R.L.
      • et al.
      Transcarotid revascularization with dynamic flow reversal versus carotid endarterectomy in the Vascular Quality Initiative Surveillance Project.
      Regarding the effect of symptoms on major outcomes, an almost double early stroke/TIA risk was found in symptomatic patients compared with asymptomatic patients. This difference between symptomatic and asymptomatic patients is also observed among patients undergoing CEA or tfCAS.
      • Galyfos G.
      • Sigala F.
      • Karanikola E.
      • Loizou C.
      • Toutouzas K.
      • Filis K.
      Cardiac damage after carotid intervention: a meta-analysis after a decade of randomized trials.
      However, no difference was found when the study with the largest size effect on the analysis was left out. Hence, this study by Schermerhorn et al. evaluated patients from the VQI registry and was not a prospectively designed study.
      • Schermerhorn M.L.
      • Liang P.
      • Eldrup-Jorgensen J.
      • Cronenwett J.L.
      • Nolan B.W.
      • Kashyap V.S.
      • et al.
      Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis.
      Additionally, Cui et al. found that TCAR performed less than 48 hours from the onset of symptoms was associated with a threefold increased risk of in hospital stroke/death.
      • Cui C.L.
      • Dakour-Aridi H.
      • Eldrup-Jorgensen J.
      • Schermerhorn M.L.
      • Siracuse J.J.
      • Malas M.B.
      Effects of timing on in-hospital and one-year outcomes after transcarotid artery revascularization.
      However, increasing age seems not to affect neurological outcomes in contrast to tfCAS.
      • Dakour-Aridi H.
      • Kashyap V.S.
      • Wang G.J.
      • Eldrup-Jorgensen J.
      • Schermerhorn M.L.
      • Malas M.B.
      The impact of age on in-hospital outcomes after transcarotid artery revascularization, transfemoral carotid artery stenting, and carotid endarterectomy.
      Unfortunately, there is a lack of comparative studies in literature evaluating the effect of major prognostic factors such as pre-operative symptoms, early treatment or others.
      Therefore, it is reasonable to use certain criteria for selecting the optimal technique for each patient. tfCAS might be more appropriate for ICA restenosis or re-operated/radiated neck that increase the open repair risk. However, the presence of severe aorto-iliac occlusive disease, tortuous or calcified aortic arch and severe renal disease could be prohibitive for tfCAS.
      • Van den Berg J.C.
      Evidence overview: anatomical criteria determining patients at high risk for carotid stenting.
      TCAR seems to overcome such limitations. Even for renal insufficiency cases, the mean contrast volume needed for the procedure is less than half of the volume needed for tfCAS.
      • Schermerhorn M.L.
      • Liang P.
      • Eldrup-Jorgensen J.
      • Cronenwett J.L.
      • Nolan B.W.
      • Kashyap V.S.
      • et al.
      Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis.
      This review has certain limitations. First, the majority of studies were retrospective, although most of them were of medium to high quality. Second, almost three quarters of patients originated from the VQI registry that might affect the strength of conclusions. Third, data were lacking in order to conduct certain subgroup analyses such as for diabetic patients or for certain outcomes such as death. As also addressed by other authors, prospective studies comparing TCAR with CEA with regard to time of treatment or the effect of pre-operative symptoms are limited.
      • Coelho A.
      • Prassaparo T.
      • Mansilha A.
      • Kappelle J.
      • Naylor R.
      • de Borst G.J.
      Critical Appraisal on the quality of reporting on safety and efficacy of transcarotid artery stenting with flow reversal.
      Only after the completion of such studies, could safer conclusions on the benefit of TCAR be reached. Finally, there was data heterogeneity such as follow up duration or definition of technical success, and this led to significant heterogeneity of results especially for late outcomes.
      In conclusion, TCAR is a promising method for treating ICA disease as it is associated with a low rate of early death, stroke and other complications. However, symptomatic patients seem to have a higher early risk of cerebrovascular events. Long term durability seems to be acceptable although data are still lacking. More comparative studies are needed in order to assess whether TCAR could be established as a reliable alternative method, especially for symptomatic patients.

      Conflict of interest

      None.

      Funding

      None.

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