Radial and ulnar approach for carotid artery stenting with Roadsaver™ double layer micromesh stent: Early and long-term follow-up.

AIMS: We aimed to evaluate the feasibility and safety of carotid artery stenting (CAS) with a newly designed double-layer micromesh stent using wrist approach in patients with significant carotid disease. MATERIALS AND METHODS: Between January 2016 and December 2021, 105 patients undergoing CAS with Roadsaver™ stent were enrolled in a single center prospective study. Follow-up assessments included neurological exams, duplex ultrasound (DUS), and 12-lead ECG. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarction. Secondary endpoints included procedure success, access site complications, device success, target lesion revascularization, and in-stent restenosis evaluated with DUS. Long-term outcomes up to 72 months of follow-up were assessed in all eligible patients. RESULTS: The study population was predominantly male (69.5%) with a median age of 68 ± 8 years. Patients were symptomatic in 80% of the cases, and 35% fulfilled the high-risk criteria for surgical endarterectomy. The right internal carotid artery was the target artery in 56 (53.4%), and the left in 49 (46.6%) of the cases. All procedures were successfully completed from the right wrist, with right radial access in 94 (89.5%) cases and ulnar artery access with previous radial artery occlusion in 11 (10.5%) cases. All patients were treated successfully with the study device. The primary endpoint was met with a 30-day major adverse event rate of 0.9% (1/105). Up to 72 months of follow-up (median 30 ± 20 months) there were no strokes, neurological deaths, or target lesion revascularization of the treated lesion. Doppler ultrasound examination revealed nonsignificant in-stent restenosis in two asymptomatic patients. There was no hand ischemia detected in any patient. CONCLUSION: Results from this study demonstrate the radial and ulnar access for CAS with double layer micromesh Roadsaver™ stent is safe and feasible and associated with favorable early and long-term follow-up.

Endarterectomía carotídea por eversión / Carotid endarterectomy by eversion

La técnica de la endarterectomía carotídea por eversión no es novedosa como pudiera parecer, pero es cierto que quedó en desuso, a pesar de los excelentes resultados, principalmente debido a la dificultad de inserción del shunt que en las décadas setenta y ochenta del siglo pasado se empleaba de forma rutinaria. Los autores de este artículo describen la modalidad que ellos realizan, una endarterectomía carotídea por eversión modificada, sin seccionar la arteria carótida en ningún momento, y que fue ya descrita por Cooley y modificada por Anderson. Ellos señalan cuidadosamente los pasos e indican los trucos para que el procedimiento sea satisfactorio. En la mayoría de los casos la realizan con anestesia local y hacen una arteriografía de control intraoperatoria.(AU)

The technique of carotid endarterectomy by eversion is not new as it might seem, but it is true that it stopped being used, despite the excellent results, mainly because the difficulty of inserting the shunt that in the seventies and eighties of the last century was routinely used. The authors describe in this paper the modality that they perform, a modified eversion carotid endarterectomy without sectioning the carotid artery at any time, and that was already described by Cooley and modified by Anderson. They carefully point out the steps and describe the tricks to make the procedure successful. In most cases, they do it under local anesthesia and systematically carry out an intraoperative control angiography.(AU)

Critical analysis of the literature and standards of reporting on stroke after carotid revascularization.

OBJECTIVE: Mechanisms of procedural stroke after carotid endarterectomy (CEA) or carotid artery stenting are surprisingly underresearched. However, understanding the underlying mechanism could (1) assist in balancing the choice for revascularization vs conservative therapy, (2) assist in choosing either open or endovascular techniques, and (3) assist in taking appropriate periprocedural measures to further decrease procedural stroke rate. The purpose of this study was to overview mechanisms of procedural stroke after carotid revascularization and establish reporting standards to facilitate more granular investigation and individual patient data meta-analysis in the future. METHODS: A systematic review was conducted according to the PRISMA statement. RESULTS: The limited evidence in the literature was heterogeneous and of low quality. Thus, no formal data meta-analysis could be performed. Procedural stroke was classified as hemorrhagic or ischemic; the latter was subclassified as hemodynamic, embolic (carotid embolic or cardioembolic) or carotid occlusion derived, using a combination of clinical inference and imaging data. Most events occurred in the first 24 hours after the procedure and were related to hypoperfusion (pooled incidence 10.2% [95% confidence interval (CI), 3.0-17.5] vs 13.9% [95% CI, 0.0-60.9] after CEA vs carotid artery stenting events, respectively) or atheroembolism (28.9% [95% CI, 10.9-47.0]) vs 34.3 [95% CI, 0.0-91.5]). After the first 24 hours, hemorrhagic stroke (11.6 [95% CI, 5.7-17.4] vs 9.0 [95% CI, 1.3-16.7]) or thrombotic occlusion (18.4 [95% CI, 0.9-35.8] vs 14.8 [95% CI, 0.0-30.5]) became more likely. CONCLUSIONS: Although procedural stroke incidence and etiology may have changed over the last decades owing to technical improvements and improvements in perioperative monitoring and quality control, the lack of literature data limits further statements. To simplify and enhance future reporting, procedural stroke analysis and classification should be documented preemptively in research settings. We propose a standardized form enclosing reporting standards for procedural stroke with a systematic approach to inference of the most likely etiology, for prospective use in registries and randomized controlled trials on carotid revascularization.

Carotid Endarterectomy Using Lone Star Retractor System.

Cervical carotid disease is typical atherosclerosis, which is responsible for ischemic stroke. The effectiveness of carotid endarterectomy (CEA) for advanced carotid stenosis has been established in many large studies, and CEA is the gold standard in surgical treatment. On the other hand, endovascular carotid artery stenting (CAS) has become increasingly popular recently. It is very important to avoid any complications to maintain the effectiveness of CEA. The retractor device is important for the exposure of carotid arteries and for the safe surgical manipulation. We have started to use lone star retractor system (LSRS) to deploy the surgical field. LSRS provides the usability to handle and a shallower surgical field without the disturbance of surgical manipulation. And it can facilitate exposure of the distal internal carotid artery because surgeon can retract freely in whole circumference by towing with moderate strength. LSRS may bring the smoother and easier surgical manipulations in CEA.

Clinical trial of carotid artery stenting using dual-layer CASPER stent for carotid endarterectomy in patients at high and normal risk in the Japanese population.

BACKGROUND: The dual-layer nitinol CASPER stent was designed to prevent plaque prolapse into its strut and periprocedural stroke. OBJECTIVE: To conduct a clinical trial for government approval of the device in patients at either high or normal risk for carotid endarterectomy (CEA). METHODS: Eligible patients had ≥50% symptomatic stenosis or ≥80% asymptomatic stenosis according to the North American Symptomatic Carotid Endarterectomy Trial methods (peak systolic velocity 130 and 230 cm/s on ultrasonography, respectively). The primary endpoint was the lack of major adverse events (MAEs), defined as death, stroke, and myocardial infarction within 30 days, and ipsilateral stroke within 1 year. The performance goal was set at 90.5%. MAE rates were also compared between the CEA high- and normal-risk groups. RESULTS: 140 carotid artery stenting procedures, including 40% of patients at high risk and 60% at normal risk for CEA, were performed in 13 institutes. MAEs occurred in two cases (one intraprocedural and one postprocedural stroke), and the MAE rate was 1.4%. The non-MAE rate was 98.6% according to Kaplan-Meier analysis, which was superior to the previously set performance goal. The deployment success, target lesion revascularization (TLR), in-stent restenosis, and cerebrovascular event rates were 99.3%, 2.4%, 8.5%, and 7.2%, respectively. The MAE rate in patients with normal CEA risk was 1.2%, which was similar to the high-risk CEA group, with no significant difference due to the small number of MAEs. CONCLUSIONS: The MAE rate following use of the CASPER stent was low (1.4%). The MAE, deployment success, TLR, in-stenosis, and cerebrovascular event rates were similar to those of previous reports.

Benefit of selective shunt use during carotid endarterectomy under regional anesthesia.

OBJECTIVES: Carotid cross-clamping during endarterectomy exposes the patient to intraoperative neurological deficits due to embolism or cerebral hypoperfusion. To prevent further cerebrovascular incidents, resorting to shunt is frequently recommended. However, since this method is also considered a stroke risk factor, the use is still controversial. This study aims to shed some light on the best approach regarding the use of shunt in symptomatic cerebral malperfusion after carotid artery cross-clamping. METHODS: From January 2012 to January 2018, 79 patients from a tertiary referral hospital who underwent carotid endarterectomy with regional anesthesia for carotid artery stenosis and manifested post-clamping neurologic deficits were prospectively gathered. Shunt use was left to the decision of the surgeon and performed in 31.6% (25) of the patients. Demographics, comorbidities, imaging tests, and clinical/intraoperative features were evaluated. For data assessment, univariate analysis was performed. RESULTS: Regarding 30-day stroke, 30-day postoperative complications (stroke, surgical hematoma, hyperperfusion syndrome), and cranial nerve injury, no significant differences were found (P = 0.301, P = 0.460, and P = 0.301, respectively) between resource to shunt and non-shunt. Clamping and surgery times were significantly higher in the shunt group (P < 0.001 and P = 0.0001, respectively). CONCLUSIONS: Selective-shunting did not demonstrate superiority for patients who developed focal deficits regarding stroke or other postoperative complications. However, due to the limitations of this study, the benefit of shunting cannot be excluded. Further randomized trials are recommended for precise results on this matter with current sparse clinical evidence.

Carotid Endarterectomy Using a Flow-Reversal Technique in the Acute Period: A Novel Approach That May Reduce Intraoperative Cerebral Events.

Lesion manipulation during internal carotid artery (ICA) surgical dissection is the most crucial stage of carotid endarterectomy (CEA); a friable part of the carotid plaque or a thrombus may detach from the arterial wall, leading to cerebral embolism. Proximal protection devices used in carotid artery stenting reverse the blood flow to the brain eliminating, at least after their deployment, the chance of cerebral embolism. Based on the working principle of these devices, we propose a new approach to CEA making use of a flow-reversal technique, and we report its successful application in 2 high-risk patients with a soft and friable type 4 ICA plaque: a 62-year-old male patient presenting with crescendo transient ischemic attacks and a 61-year-old male patient presenting with a major stroke. Both were operated in the acute period. Once the reverse flow has been established, the surgeon can freely manipulate the carotid and perform a fast blunt dissection without the risk that the disturbance of the arterial wall may lead to cerebral embolism. A video recording of the procedure has been made and presented with this article. Despite the various limitations, including increased clamping time, transient intolerance to reverse flow, and increased blood loss, this technique may improve clinical outcomes, especially in symptomatic patients with friable plaque. A clinical trial is warranted to further study the results of the flow-reversal CEA.

Anatomic criteria in the selection of treatment modality for atherosclerotic carotid artery disease.

OBJECTIVE: Three procedures are currently available to treat atherosclerotic carotid artery stenosis: carotid endarterectomy (CEA), transfemoral carotid artery stenting (TF-CAS), and transcarotid artery revascularization (TCAR). Although there is considerable debate evaluating each of these in a head-to-head comparison to determine superiority, little has been mentioned concerning the specific anatomic criteria that make one more appropriate. We conducted a study to define anatomic criteria in relation to inclusion and exclusion criteria and relative contraindications. METHODS: A retrospective review was conducted of 448 carotid arteries from 224 consecutive patients who underwent a neck and head computed tomography arteriography (CTA) scan before carotid intervention for significant carotid artery stenosis. Occlusion of the internal carotid artery (ICA) occurred in 15, yielding 433 arteries for analysis. Anatomic data were collected from CTA images and demographic and comorbidities from chart review. Eligibility for CEA, TF-CAS, and TCAR was defined on the basis of anatomy, not by comorbidity. RESULTS: CTA analysis revealed that 92 of 433 arteries (21%) were ineligible for CEA because of carotid lesions extending cephalad to the second cervical vertebra. Overall, 26 arteries (6.0%) were not eligible for any type of carotid artery stent because of small ICA diameter (n = 11), heavy circumferential calcium (n = 14), or combination (n = 1). An additional 126 arteries were ineligible for TF-CAS on the basis of a hostile aortic arch (n = 115) or severe distal ICA tortuosity (n = 11), yielding 281 arteries (64.9%) that were eligible. In addition to the 26 arteries ineligible for any carotid stent, TCAR was contraindicated in 39 because of a clavicle to bifurcation distance <5 cm (n = 17), common carotid artery diameter <6 mm (n = 3), or significant plaque at the TCAR sheath access site (n = 20), yielding 368 arteries (85.0%) that were eligible for TCAR. CONCLUSIONS: A significant proportion of patients who present with carotid artery stenosis have anatomy that makes one or more carotid interventions contraindicated or less desirable. Anatomic factors should play a key role in selecting the most appropriate procedure to treat carotid artery stenosis. Determination of superiority for one procedure over another should be tempered until anatomic criteria have been assessed to select the best procedural options for each patient.

Avaliação da resposta hemodinâmica cerebral através da monitorização com a espectroscopia próxima ao infravermelho (NIRS) em pacientes com doença aterosclerótica da artéria carótida submetidos a endarterectomia / Evaluation of the brain hemodynamic response by means of near-infrared spectroscopy (NIRS) monitoring in patients with atherosclerotic carotid disease undergoing endarterectomy

Resumo Contexto A espectroscopia próxima ao infravermelho (NIRS) é uma técnica não invasiva que detecta as alterações hemodinâmicas teciduais. A NIRS pode monitorar de forma contínua as informações fisiológicas vasculares intracranianas. Por ser portátil, ela pode ser utilizada à beira do leito e no centro cirúrgico. Objetivos Avaliar as possíveis alterações hemodinâmicas cerebrais durante a endarterectomia em pacientes com estenoses maiores que 70% utilizando NIRS. Métodos Foram avaliados 10 voluntários portadores de doença carotídea aterosclerótica com indicação de endarterectomia. Após a seleção dos pacientes, que responderam um questionário com dados epidemiológicos e informações referentes à presença de comorbidades, a doença foi confirmada por métodos diagnósticos. No procedimento cirúrgico, utilizou-se a NIRS para monitorização. Foram avaliadas as variáveis saturação de oxigênio (SatO2), hemoglobina total (HbT), hemoglobina reduzida (HbR) e hemoglobina oxigenada (HbO) nos três tempos cirúrgicos pré-, trans e pós-clampeamento carotídeo. Utilizou-se p < 0,05 como nível de significância. Resultados A avaliação dos resultados obtidos por meio das medidas registradas pela NIRS permite afirmar que HbR e SatO2 variam ao longo das etapas da cirurgia. Durante o clampeamento, a variável HbR mostra valores mais elevados que nas outras duas etapas da cirurgia. Por outro lado, a variável SatO2 mostra redução durante o clampeamento. Conclusões A NIRS é um método viável e aplicável de monitorização intracerebral, não invasivo e em tempo real, durante a endarterectomia carotídea, capaz de medir de forma precisa as mudanças das condições hemodinâmicas capilares intracerebrais.

Abstract Backgrounds Near-infrared spectroscopy (NIRS) is non-invasive technique that detects hemodynamic alterations in tissues. It enables continuous monitoring of intracerebral vascular physiologic information. Due to its portable nature, NIRS may be used bedside or in the operating room. Objectives To evaluate use of NIRS for intraoperative monitoring of the brain hemodynamic response, during carotid endarterectomy. Methods 10 patients with atherosclerotic carotid disease scheduled for endarterectomy were evaluated. After patients had been selected, they answered a questionnaire on epidemiological data and information about comorbidities and then carotid disease was confirmed with diagnostic methods. NRIS monitoring was used during the surgical procedure. The variables analyzed before, during and after carotid clamping were oxygen saturation (SatO2), total hemoglobin (THb), reduced hemoglobin (RHb), and oxyhemoglobin (OHb). A p value of <0.05 was considered statistically significant. Results The results obtained from NIRS show that RHb and SatO2 vary during the different stages of surgery. RHb levels are higher during clamping, when compared with the other two surgical stages. On the other hand, SatO2 is lower during clamping. Conclusions During carotid endarterectomy, NIRS is a feasible, real-time, and non-invasive intracranial monitoring method that accurately and reliably measures the changes in intracerebral capillary hemodynamic conditions.

The Effect of Metabolic Syndrome on the Occurrence of Restenosis After Carotid Endarterectomy.

OBJECTIVES: The metabolic syndrome (MetS) is a cluster of risk factors for cardiovascular disease. The effect of MetS on clinical outcome in patients with cerebrovascular disease remains largely unknown because conflicting results have been published. This study aimed to determine the influence of MetS on the occurrence of restenosis after carotid endarterectomy (CEA). METHODS: All patients who underwent CEA between June 2003 and December 2014 in two tertiary academic referral centres in The Netherlands were included. MetS was defined if three or more of the following criteria were present: hypertension, obesity, high fasting serum blood glucose, high serum triglycerides, or low serum high density lipoprotein cholesterol. The primary outcome measure was the occurrence of ipsilateral restenosis after index surgery. The secondary outcome measure was (all cause) mortality during follow up. For the primary analysis, missing data were multiply imputed using multivariable imputation by chained equations. A Cox proportional hazards model was used to perform an adjusted analysis on the multiply imputed data sets. RESULTS: A total of 1668 CEA procedures (in 1577 patients) were performed. The presence or absence of MetS could not be determined in 263 patients because of missing data. There was no significant difference in freedom from restenosis in the MetS group vs. the no-MetS group (hazard ratio [HR], 1.10; 95% confidence interval [CI] 0.98-1.23; p = .10) or in all cause mortality (HR 1.20; 95% CI 0.94-1.54; p = .14). CONCLUSION: This study shows that MetS does not predict restenosis after CEA. Also, the presence of MetS did not influence patient survival negatively.

Stent Design, Restenosis and Recurrent Stroke After Carotid Artery Stenting in the International Carotid Stenting Study.

Background and Purpose- Open-cell carotid artery stents are associated with a higher peri-procedural stroke risk than closed-cell stents. However, the effect of stent design on long-term durability of carotid artery stenting (CAS) is unknown. We compared the medium- to long-term risk of restenosis and ipsilateral stroke between patients treated with open-cell stents versus closed-cell stents in the ICSS (International Carotid Stenting Study). Methods- Patients with symptomatic carotid stenosis were randomized to CAS or endarterectomy and followed with duplex ultrasound for a median of 4.0 years. We analyzed data from patients with completed CAS procedures, known stent design, and available ultrasound follow-up. The primary outcome, moderate or higher restenosis (≥50%) was defined as a peak systolic velocity of >1.3 m/s on ultrasound or occlusion of the treated internal carotid artery and analyzed with interval-censored models. Results- Eight hundred fifty-five patients were allocated to CAS. Seven hundred fourteen patients with completed CAS and known stent design were included in the current analysis. Of these, 352 were treated with open-cell and 362 with closed-cell stents. Moderate or higher restenosis occurred significantly less frequently in patients treated with open-cell (n=113) than closed-cell stents (n=154; 5-year risks were 35.5% versus 46.0%; unadjusted hazard ratio, 0.68; 95% CI, 0.53-0.88). There was no significant difference in the risk of severe restenosis (≥70%) after open-cell stenting (n=27) versus closed-cell stenting (n=43; 5-year risks, 8.6% versus 12.7%; unadjusted hazard ratio, 0.63; 95% CI, 0.37-1.05). The risk of ipsilateral stroke beyond 30 days after treatment was similar with open-cell and closed-cell stents (hazard ratio, 0.78; 95% CI, 0.35-1.75). Conclusions- Moderate or higher restenosis after CAS occurred less frequently in patients treated with open-cell stents than closed-cell stents. However, both stent designs were equally effective at preventing recurrent stroke during follow-up. Clinical Trial Registration- URL: http://www.isrctn.com/. Unique identifier: ISRCTN25337470.

Last neurologic event is associated with risk of in-hospital stroke or death after carotid endarterectomy or carotid artery stenting: Secondary data analysis of the German statutory quality assurance database.

OBJECTIVE: We sought to analyze the association between last neurologic event and the risk of stroke or death among patients treated with carotid endarterectomy (CEA) or carotid artery stenting (CAS) under routine conditions in Germany. METHODS: Secondary data analysis was performed based on the German statutory quality assurance database for carotid procedures. A total of 144,347 patients treated by CEA and 14,794 patients treated by CAS were included in the analysis. Primary outcome was any in-hospital stroke or death. To analyze the association between the last neurologic event and outcome, multilevel multivariable regression analysis was performed. RESULTS: In patients treated by CEA, raw risk for any in-hospital stroke or death was 2.0% (2923/144,347), with a risk of 1.4% in asymptomatic and 3.0% in symptomatic patients. In patients treated by CAS, raw risk for any in-hospital stroke or death was 3.6% (538/14,794), with a risk of 1.7% in asymptomatic and 6.1% in symptomatic patients. Regression analysis revealed that increasing severity of last neurologic event was significantly associated with an increasing risk of any in-hospital stroke or death in patients treated by both CEA and CAS (P < .004). However, the risk of any stroke or death did not significantly differ between asymptomatic patients and patients with amaurosis fugax before CEA or CAS (P = .219 for CEA, P = .124 for CAS). CONCLUSIONS: Increasing severity of last neurologic event is associated with an increasing risk of any in-hospital stroke or death in patients treated by CEA and CAS. The risk of any stroke or death did not differ between asymptomatic patients and patients with amaurosis fugax.

3D-fusion-imaging-assisted carotid artery stenting is safe and feasible.

BACKGROUND: Renal insufficiency and allergy to iodine contrast are relative contraindications to carotid artery stenting (CAS). The primary aim of this pilot study was to evaluate the feasibility and safety of the CAS assisted by 3D fusion of previously performed computed tomography (CTA) and magnetic resonance angiography (MRA) images and DynaCT, the secondary aim was to determine if 3D fusion decreases radiation exposure and the amount of contrast needed during the procedure. METHODS: Retrospective review of patients who underwent CAS between October 1st, 2012 and November 30th, 2014 was performed. CTA-assisted fusion was used in group A (CAS/CTA), MRA-assisted fusion in group B (CAS/MRA) and group C (control group) underwent CAS without fusion. No patient in the study had renal dysfunction, risk factors of contrast-induced nephropathy or insulin-dependent diabetes. Primary outcome was perioperative stroke or death, secondary outcome included technical success, radiation dose, exposure time and volume of contrast used. Statistical analysis was performed with Student's t-test, using the permutation methods. Level of significance was set at P<0.05. RESULTS: Fifty-seven patients (32 female, mean age: 69.4 years, range 61 to 82 years), underwent CAS (group A: 10 patients, group B: 10 patients, group C: 37 patients). Technical success was 100%. There was no 30-day mortality or stroke and there were no general, neurological or local complications. Mean contrast volume was significantly less in groups A and B, than in group C (15±5 mL and 16±4 mL vs. 51±16 mL, group A vs. C: t(43.35)=11.85; P<0.0001; group B vs. C: t(44.94)=12.23; P<0.00001). Radiation exposure time and dose were not statistically different between groups (group A vs. C: t(45)=0.95, P=0.3497 and t(45)=0.3, P=0.7694, respectively; group B vs. C: t(45)=0.93, P=0.3455 and t(45)=0.92, P=0.3644, respectively). CONCLUSIONS: Carotid stenting with 3D fusion in this pilot study was safe and feasible. 3D fusion techniques using either CTA or MRA allowed a significant reduction of contrast volume but did not reduce radiation dose or exposure time. Larger prospective studies of CAS with 3D fusion imaging in patients with renal insufficiency or mild allergy to contrast are warranted.

Preclinical and clinical evaluation of a novel synthetic bioresorbable, on-demand, light-activated sealant in vascular reconstruction.

BACKGROUND: Synthetic vascular material use, particularly polytetrafluoroethylene- (PTFE) -based, can be associated with bleeding, which may increase operative time and blood loss. None of the commercially available sealants designed to ensure hemostasis combine bioresorption, high viscosity, hydrophobicity, and compliance with the underlying tissue and on-demand activation. METHODS: A study was designed to assess the biocompatibility and in-vivo performance and bioresorption of a new synthetic on-demand light-activated poly(glycerol-sebacate) acrylate- (PGSA) -based SETALIUM™ Vascular Sealant (TISSIUM, Paris, France) in three large animal studies of open vascular carotid and aortic surgery. The pre-clinical results were then translated into a clinical setting in a prospective, single-arm multicenter study in patients requiring carotid endarterectomy using an ePTFE patch. RESULTS: The biocompatibility testing showed that the PGSA-based SETALIUM™ Vascular Sealant did not induce any significant toxic reaction at a standard clinical dose nor at doses up to 40 times the equivalent intended clinical dose. The PGSA-based sealant was shown to be non-pyrogenic, non-sensitizing, non-irritant, non-clastogenic, and non-mutagenic. The animal studies showed excellent performance and safety results, with clinically significant hemostasis achieved in 100% of the animals in both carotid and aorta studies and excellent local tolerance. Histopathology and morphometric analyses showed surface-based gradual and sustained bioresorption of the PGSA-based sealant up to 86% at 12 months. In the clinical study, the application of the PGSA-based sealant resulted in good performance and safety, with immediate hemostasis achieved in 84% of the cases and no adverse event related to the sealant reported through the one-year follow-up. CONCLUSIONS: The new synthetic on-demand light activated PGSA-based SETALIUM™ Vascular Sealant investigated in our studies demonstrated good biocompatibility, sustained and gradual surface based bioresorption, and acceptable safety profile in animal studies. In addition, the first in-human use showed that the sealant is a safe and effective alternative to achieve fast and controlled hemostasis in vascular carotid reconstructions. A larger randomized controlled study will allow further validation of these encouraging preliminary results.

Cost-effectiveness of Carotid Surgery.

BACKGROUND: The purpose of this study is to determinate the cost-effectiveness of carotid endarterectomy (CEA) versus transfemoral stenting (TFS) and transcervical stenting (TCS) in a short- and long-term basis in symptomatic and asymptomatic patients. METHODS: From January 2003 to December 2014, patients from the vascular department, with symptomatic or asymptomatic carotid stenosis, who were clinically and anatomically suitable for TFS, TCS, or CEA, were included. Prospective cost data for each individual procedure and complication during follow-up were obtained from the diagnosis-related group. The quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios were estimated. Analysis of data was by treatment received. All statistical tests were two-sided. The significance level was 5%. RESULTS: A total of 349 patients were enrolled: 61 for CEA (17.5%), 159 for TFS (45.5%), and 129 for TCS (37%). A total of 220 (63%) patients were symptomatic and 129 (37%) were asymptomatic. The median procedural cost and overall cost were lower on CEA (5499€ and 5595€, respectively). However, QALYs, for symptomatic patients, were better on TCS (7.3), whereas for asymptomatic patients, QALYs were better on CEA (9.6). Cost-effectiveness for symptomatic patients was better with TCS (803€/QALY), and for asymptomatic patients, it was with CEA (654€/QALY). CONCLUSIONS: TFS and TCS were associated with clinical outcomes equivalent to CEA on both symptomatic and asymptomatic patients. Cost-effectiveness ratios for symptomatic patients were better on TCS, whereas the CEA showed the best results in asymptomatic patients.

Omnidirectional Malleable Ring Retractor: New Approach to Retraction During Carotid Endarterectomy.

OBJECTIVE: To resolve problems with retraction instruments in order to obtain shallow and flat operative field in procedures such as carotid endarterectomy, we developed a new malleable tin alloy omnidirectional retraction supporting (ORS) ring. METHODS: The new ORS ring has an ellipse-shaped (major axis: 275 mm; minor axis: 192 mm) bar frame (4 mm × 6 mm). The bar has 22 equidistant outward protrusions (length, 12 mm; diameter, 2.5 mm). The frame is made of tin alloy with approximately 1% silver, which provides sufficient malleability to fit different cervical surgical approaches. Rubber bands ending with hooks are attached around the protrusions. The new ORS ring can be placed closer to the skin surface, and skin incision edges are horizontally retracted by the hooks attached in the desired direction. The hooks are repositioned in a stepwise fashion at deeper layers of the surgical wound following dissection for carotid artery exposure. RESULTS: The tin alloy ORS ring was used in 30 carotid endarterectomies. As this ring could be closely positioned in all cases, the real depth of the operative fields (with all instruments in place) was reduced by the omnidirectional horizontal retraction without interference with surgical manipulations. Working on the distal internal carotid artery, such as putting a tacking suture in place and arteriotomy closure, could be easily performed. CONCLUSIONS: The newly developed malleable tin alloy ORS ring can be a valuable instrument for the easy performance of surgery for cervical carotid lesions. Considering its advantages, it is better than conventional retractors and existing stainless steel ORS rings.

Preliminary Clinical Microneurosurgical Experience With the 4K3-Dimensional Microvideoscope (ORBEYE) System for Microneurological Surgery: Observation Study.

BACKGROUND: The exoscope has been reported as a novel neurosurgical instrumentation in clinical practice. OBJECTIVE: To investigate the possibility that ORBEYE (OE), a novel instrument that excludes eyepiece lenses and allows for microsurgery by observation of the 4K3D monitor, could replace microscopes. METHODS: We report 22 clinical cases by 5 experienced neurosurgeons and the comparative results of training 10 residents. An observation study with questionnaire survey was conducted on usability. Twelve items including image quality, eyestrain, and function of the arm were evaluated. RESULTS: The following 22 clinical procedures were conducted: surgery for intracranial hemorrhage (n = 2) and brain tumor (n = 8), laminectomy (n = 3), aneurysm clipping (n = 3), vascular anastomosis (n = 2), carotid endarterectomy (n = 2), and nerve decompression (n = 1). No complications were observed. The fluorescent study, including indocyanine-green and 5-aminolevunic acid, allowed for clear depiction on the 4K monitor. The surgeon could operate in a comfortable posture. Similar to the microscope, it was possible to change the optical and viewing axes with the OE, but the OE was switched to the microscope or endoscope in hematoma removal and pituitary surgery. Residents judged that eyestrain was strong (P = .0096). Experienced neurosurgeons acting as assistants judged that the scope arm's range of movement was narrow (P = .0204). Sixty percent of residents judged that the OE was superior to the microscope. CONCLUSION: Although based on limited experience, it was not possible to substitute the microscope with the OE in all operations; however, the OE surpasses the microscope in terms of ergonomic features.

Novel methods for the mechanical characterization of patches used in carotid artery repair.

Carotid endarterectomy (CEA) is one of the approaches available for the treatment of carotid artery disease, with carotid patch angioplasty the pertinent technique mostly preferred by vascular surgeons. This technique entails an arteriotomy succeeded by closure with a textile, polymer or biological tissue patch. In this work, we propose microbuckling and microindentation as novel methodologies for acquiring the mechanical properties of patches used in carotid artery repair. Regarding microbuckling, the patch is loaded by a sensitive dynamometer at one end and its motion is recorded, at three different levels of axial deformation: δ/ℓ = 0.1, 0.3 and 0.5 (in the post-buckling regime). The corresponding experimental loads are recorded, as well. Following pertinent closed-from equations, various material metrics are obtained, such as the Young's modulus of elasticity and the so-called frictional couple of the material. Regarding microindentation, the material's hardness number is measured with the aid of a durometer. Similar to microbuckling, indentation analytical expressions allow for the determination of key material properties, such as the modulus of elasticity, indentation forces and depths. Where possible, we perform microtension to verify acquired results. Results demonstrate that measured properties may vary substantially for materials which are of the same type, due to variations of the material microstructure, as observed with optical and scanning electron microscopes (SEM). Several commercial patches were tested in this work. To shortly present the main results, the microbuckling technique furnished (for the Young's modulus) 40.17 MPa for the B/Braun Aesculap cardiovascular patch and 71.49 MPa for the Vasutek Terumo, while the microindentation technique, for bovine patches, provided 6.356 MPa for the Xeno Sure and 4.701 MPa for the Vascu-Guard. A test type recommendation is provided, relating the type of the patch material to the method more plausible in each case, in order to achieve better measurement accuracy. Results of this study can contribute in establishing guidelines and criteria determining material selection in CEA.