Transfemoral Stenting Research Articles

Seven Years of the Transcarotid Artery Revascularization Surveillance Project, Comparison to Transfemoral Stenting and Endarterectomy

Seven Years of the Transcarotid Artery Revascularization Surveillance Project, Comparison to Transfemoral Stenting and Endarterectomy

Seven years of the transcarotid artery revascularization surveillance project, comparison to transfemoral stenting and endarterectomy

ObjectiveThis study utilizes the latest data from the Vascular Quality Initiative (VQI), which now encompasses over 50,000 transcarotid artery revascularization (TCAR) procedures, to offer a sizeable dataset for comparing the effectiveness and safety of TCAR, transfemoral carotid artery stenting (tfCAS), and carotid endarterectomy (CEA). Given this substantial dataset, we are now able to compare outcomes overall and stratified by symptom status across revascularization techniques. MethodsUtilizing VQI data from September 2016 to August 2023, we conducted a risk-adjusted analysis by applying inverse probability of treatment weighting to compare in-hospital outcomes between TCAR vs tfCAS, CEA vs tfCAS, and TCAR vs CEA. Our primary outcome measure was in-hospital stroke/death. Secondary outcomes included myocardial infarction and cranial nerve injury. ResultsA total of 50,068 patients underwent TCAR, 25,361 patients underwent tfCAS, and 122,737 patients underwent CEA. TCAR patients were older, more likely to have coronary artery disease, chronic kidney disease, and undergo coronary artery bypass grafting/percutaneous coronary intervention as well as prior contralateral CEA/CAS compared with both CEA and tfCAS. TfCAS had higher odds of stroke/death when compared with TCAR (2.9% vs 1.6%; adjusted odds ratio [aOR], 1.84; 95% confidence interval [CI], 1.65-2.06; P < .001) and CEA (2.9% vs 1.3%; aOR, 2.21; 95% CI, 2.01-2.43; P < .001). CEA had slightly lower odds of stroke/death compared with TCAR (1.3% vs 1.6%; aOR, 0.83; 95% CI, 0.76-0.91; P < .001). TfCAS had lower odds of cranial nerve injury compared with TCAR (0.0% vs 0.3%; aOR, 0.00; 95% CI, 0.00-0.00; P < .001) and CEA (0.0% vs 2.3%; aOR, 0.00; 95% CI, 0.0-0.0; P < .001) as well as lower odds of myocardial infarction compared with CEA (0.4% vs 0.6%; aOR, 0.67; 95% CI, 0.54-0.84; P < .001). CEA compared with TCAR had higher odds of myocardial infarction (0.6% vs 0.5%; aOR, 1.31; 95% CI, 1.13-1.54; P < .001) and cranial nerve injury (2.3% vs 0.3%; aOR, 9.42; 95% CI, 7.78-11.4; P < .001). ConclusionsAlthough tfCAS may be beneficial for select patients, the lower stroke/death rates associated with CEA and TCAR are preferred. When deciding between CEA and TCAR, it is important to weigh additional procedural factors and outcomes such as myocardial infarction and cranial nerve injury, particularly when stroke/death rates are similar. Additionally, evaluating subgroups that may benefit from one procedure over another is essential for informed decision-making and enhanced patient care in the treatment of carotid stenosis.

Female and male patients have similar outcomes after transcarotid artery revascularization in prospective trials

ObjectiveSex disparities in outcomes after carotid revascularization have long been a concern, with several studies demonstrating increased postoperative death and stroke for female patients after either carotid endarterectomy or transfemoral stenting. Adverse events after transfemoral stenting are higher in female patients, particularly in symptomatic cases. Our objective was to investigate outcomes after transcarotid artery revascularization (TCAR) stratified by patient sex hypothesizing that the results would be similar between males and females. MethodsWe analyzed prospectively collected data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All patients had verified carotid stenosis meeting criteria for intervention (≥80% for asymptomatic patients and ≥50% in patient with symptomatic disease), and were included based on anatomical or clinical high-risk criteria for carotid stenting. Neurological assessments (National Institutes of Health Stroke Scale, Modified Rankin Scale) were obtained before and within 24 hours from procedure end by an independent neurologist or National Institutes of Health Stroke Scale-certified nurse. Patients were stratified by sex (male vs female). Baseline demographics were compared using χ2 and Fisher's exact tests where appropriate; primary outcomes were combination stroke/death (S/D) and S/D/myocardial infarction (S/D/M) at 30 days, and secondary outcomes were the individual components of S/D/M. Univariate logistic regression was conducted. ResultsWe included 910 patients for analysis (306 female [33.6%], 604 male [66.4%]). Female patients were more often <65 years old (20.6% vs 15%) or ≥80 years old (22.6% vs 20.2%) compared with males, and were more often of Black/African American ethnicity (7.5% vs 4.3%). There were no differences by sex in term of comorbidities, current or prior smoking status, prior stroke, symptomatic status, or prevalence of anatomical and/or clinical high-risk criteria. General anesthetic use, stent brands used, and procedure times did not differ by sex, although flow reversal times were longer in female patients (10.9 minutes male vs 12.4 minutes female; P = .01), as was more contrast used in procedures for female patients (43 mL male vs 48.9 mL female; P = .049). The 30-day S/D and S/D/M rates were similar between male and female patients (S/D, 2.7% male vs 1.6% female [P = .34]; S/D/M, 3.6% male vs 2.6% female [P = .41]), which did not differ when stratified by symptom status. Secondary outcomes did not differ by sex, including stroke rates at 30 days (2.2% male vs 1.6% female; P = .80), nor were differences seen with stratification by symptom status. Univariate analysis demonstrated that history of a prior ipsilateral stroke was associated with increased odds of S/D (odds ratio [OR], 4.19; P = .001) and S/D/M (OR, 2.78; P = .01), as was symptomatic presentation with increased odds for S/D (OR, 2.78; P = .02). ConclusionsProspective TCAR trial data demonstrate exceptionally low rates of S/D/MI, which do not differ by patient sex.

Endovascular stenting techniques for blunt carotid injury.

While methods of endovascular carotid artery stenting have improved over time, concerns surrounding the safety and efficacy of stenting for blunt carotid injury (BCI) remain. This study aims to present our approach to carotid artery stenting (CAS) by incorporating new technologies such as flow-diverting stents and circuits. There is no robust evidence to support routine carotid artery stenting; however, there are several therapeutic options and approaches for treating BCI that currently require an individualized approach. Endovascular stenting and specific stent selection are largely dictated by the disease process the surgeon intends to treat. We will discuss patient selection, medical management, and the most common revascularization techniques, including transfemoral stenting, trans-carotid arterial revascularization using flow reversal, and stent-assisting coiling. It must be stressed that endovascular intervention is not an alternative to or preclusive of antithrombotic or anticoagulant therapy. In the setting of BCI, transfemoral CAS is most appropriate in patients who are symptomatic, have a rapidly progressing or large lesion, and do not have a soft thrombus present due to risk of embolism. Unlike transfemoral CAS, TCAR offers an elegant solution for embolic protection when patients have a soft thrombus present. In the case of a large pseudoaneurysm, we perform stent-assisted coiling. We practice selective endovascular intervention, stenting lesions that are flow-limiting or have large or rapidly expanding pseudoaneurysms, and only in patients for whom anticoagulation and antiplatelet agents are not contraindicated. As technology and investigation progress, the concerns regarding the safety and the role of endovascular intervention in the treatment of BCI will be more clearly defined.

Use of Glycoprotein IIb-IIIa Inhibitors in Patients Undergoing Carotid Artery Stenting in the Vascular Quality Initiative

Antiplatelet therapies with thromboxane inhibitors and adenosine 5'-diphosphate antagonists have been widely used following carotid artery stenting (CAS). However, these therapies may not apply to patients who are intolerant or present acutely. Glycoprotein IIb/IIIa inhibitors (GPI) are a proposed alternative therapy in these patients; however, their use has been limited due to concerns of increased risk for intracranial bleeding. Thus, this study aims to assess the safety profile of GPI in patients undergoing CAS. All patients undergoing CAS in the Society of Vascular Surgery - Vascular Quality Initiative database from 2012 to 2021 was included and grouped into GPI versus non-GPI therapy (control). The primary outcome was in-hospital stroke or death, and secondary outcomes included in-hospital stroke/transient ischemic attack (TIA), death, myocardial infarction, and intracranial hemorrhage (ICH)/seizure. Patients were stratified by surgical approach (Transcarotid artery revascularization using flow reversal (TCAR) and transfemoral carotid artery stenting), and stepwise backward logistic regression analysis was conducted to evaluate major primary and secondary outcomes. A total of 50,628 patients underwent carotid revascularization. Of these, 4.4% of the patients received GPI. Mean age was similar between control versus GPI (71.35(9.67) vs. 71.36(10.20) years). Compared to the control group, patients who receive GPI are less likely to be on optimal medical therapy, including aspirin (83.0% vs. 88.1%), P2Y12 inhibitor (73.0% vs. 82.7%), and statin (82.3% vs. 86.0%) (All P<0.05). In addition, patients in the GPI group were more likely to undergo TCAR for carotid revascularization (52.2% vs. 48.4%) for emergent/urgent (29.4% vs. 16.8%) and symptomatic indications (55.5% vs. 49.7%) (All P<0.001). After stratifying by surgical approach, if patients underwent TFCAS and received a GPI, they were at increased odds of developing stroke/death (1.77(1.25-2.51)), death (odds ratio (OR) (95% CI): 1.67(1.07-2.61)), stroke/TIA (OR (95% confidence interval (CI)): 1.65(1.09-2.51)), and ICH/seizure (OR (95% CI): 2.13(1.23-3.68)) (All P<0.05). No difference was seen in outcomes between the 2 groups if undergoing TCAR. Patients who receive GPI were more likely to be symptomatic at presentation and less likely to be medically optimized before their carotid revascularization. Transfemoral access in patients receiving GPI was associated with increased odds of morbidity and mortality. However, this was not observed if undergoing TCAR. TCAR can be considered for its overall favorable results in high-risk patients who are not medically optimized.

Transcarotid Revascularization Outcomes Are Not Affected by the Choice of Antiplatelet with Aspirin

Over one-third of transcarotid revascularization (TCAR) patients demonstrate mild to severe resistance to clopidogrel resulting in an increase in hematologic testing and potential healthcare costs. This investigation was completed to determine if the choice of the second antiplatelet in addition to aspirin affected perioperative outcomes. Consecutive carotid stenting procedures identified from the Vascular Quality Initiative (VQI) from January 2016 to September 2016 were captured. We excluded patients with nonatherosclerotic disease, intracranial disease, and tandem lesions. Two cohorts of patients maintained on dual antiplatelet therapy were compared consisting of aspirin + clopidogrel (AC) and aspirin + prasugrel/ticagrelor (APT). A 1:1 propensity score match including procedure characteristics, age, gender, race, symptomatic status, diabetes, coronary artery disease, prior coronary artery bypass grafting/percutaneous coronary intervention, congestive heart failure, chronic obstructive pulmonary disease, dialysis, smoking status, prior ipsilateral or contralateral coronary artery stenting/carotid endarterectomy, contralateral occlusion, preoperative anticoagulation, urgency, protamine use, and physician case volume was completed to compare perioperative results. Within the specified study period, we captured 38,813 carotid stenting patients on AC and 2346 patients maintained on APT (Table I). Of the AC patients, 25,293 received TCAR while the remaining 13,520 underwent transfemoral stenting. Similarly, 1308 APT patients underwent TCAR and 1038 received transfemoral stenting. Before propensity matching, the crude results noted that APT patients were more likely to experience in-hospital mortality (0.5% vs 1.1%; P < .01), but there was no difference in ipsilateral stroke (1.2% vs 1.1%; P = .62), any stroke (1.5% vs 1.4%; P = .84), or myocardial infarction (MI) (0.5% vs 0.7%; P = .31). After adjustment with our propensity match (Table II), 2047 unique subject pairs were generated. There was no statistical difference with respect to in-hospital mortality (0.6% vs 0.9%; P = .30), ipsilateral stroke (1.4% vs 1.0%; P = .41), any stroke (1.5% vs 1.3%; P = .85), MI (0.8% vs 0.8%; P = .84), or stent thrombosis (0.1% vs 0.3%; P = .18). Additionally, there was no difference in the combined outcomes of stroke/death (1.9% vs 2.0%; P = .63) or stroke/death/MI (2.6% vs 2.7%; P = .74). As testing for antiplatelet resistance has become more prominent in the last several years, we evaluated and noted no variability between study groups before or after a procedure date in 2019. No difference in perioperative stroke, death, and/or stent occlusion are noted after TCAR in patients maintained on AC compared to APT. Therefore, routine testing for clopidogrel resistance is an unnecessary healthcare cost which can be eliminated.Table IACAPTP valuen = 38,813 (94.3)2346 (5.7)Prasugrel346 (14.75)Ticagrelor2000 (85.2)Procedure<.001 Transcarotid artery revascularization25,293 (65.2)1308 (55.7) Transfemoral carotid artery stenting13,520 (34.8)1038 (44.3)Surgery year<.001 2016706 (1.8)37 (1.6) 20173044 (7.8)139 (5.9) 20184666 (12.0)199 (9.5) 20197066 (18.2)379 (16.2) 20207560 (19.5)457 (19.5) 20219836 (25.3)716 (30.5) September 20225935 (15.3)419 (17.9)AC, Aspirin + clopidogrel; APT, aspirin + prasugrel/ticagrelor. Open table in a new tab Table IIBefore PSM (crude outcomes)1:1 PSM (adjusted outcomes)aACAPTP valueACAPTOR (95% CI)bP valuen = 38,813 (94.3)2346 (5.7)n = 2047n = 2047In-hospital outcomes Death204 (0.5)25 (1.1)<0.0113 (0.6)19 (0.9)1.49 (0.70-3.18).30 Ipsilateral stroke457 (1.2)25 (1.1)0.6229 (1.4)21 (1.0)0.77 (0.42-1.43).41 Stroke549 (1.45)32 (1.40)0.8430 (1.5)27 (1.3)0.94 (0.53-1.67).85 MI204 (0.5)16 (0.7)0.3117 (0.8)16 (0.8)0.93 (0.45-1.91).84 Stroke/death680 (1.8)50 (2.1)0.1838 (1.9)41 (2.0)1.13 (0.69-1.83).63 Stroke/death/MI844 (2.2)65 (2.8)0.0653 (2.6)56 (2.7)1.08 (0.70-1.65).74 Bleeding requiring intervention229 (0.6)15 (0.6)0.7611 (0.5)14 (0.7)1.28 (0.56-2.84).54 Immediate restenosis/occlusion63 (0.2)7 (0.3)0.122 (0.1)6 (0.3)3.0 (0.60-14.8).18AC, Aspirin + clopidogrel; APT, aspirin + prasugrel/ticagrelor; CI, confidence interval; MI, myocardial infarction; OR, odds ratio; PSM, propensity score matching.Values are number (%) unless otherwise stated.aNo interaction between antiplatelet regimen and type of procedure in predicting outcome and between antiplatelet regimen and surgeries performed before or after 2019 (P > .10). Open table in a new tab

Risk of Reintervention Is Lower for Carotid Endarterectomy Than Carotid Artery Stenting

Perioperative outcomes for carotid endarterectomy (CEA) and carotid artery stenting (CAS) have been well-studied. Less is known about the durability and reintervention rates of each, particularly in the era of transcarotid artery revascularization (TCAR). We sought to compare real-world rates of ipsilateral reintervention, stroke, and death in patients undergoing CEA and CAS, with an additional analysis of CAS patients comparing reintervention between transfemoral stenting (TFCAS) and TCAR. The Vascular Quality Initiative (VQI) was matched to Medicare claims via the Vascular Implant Surveillance and Implantation Network database, and we identified patients who had primary carotid revascularization from December 2016 to December 2019. The primary outcome was ipsilateral reintervention, while secondary outcomes included stroke and mortality. After 1:1 greedy matching using propensity scores, patients who underwent CEA and CAS were compared within 6 months following the index procedure and from 6 months to 3 years separately using time-dependent Cox regression models. A separate propensity matched analysis was then performed to compare TFCAS and TCAR. Kaplan-Meier curves were compared using log-rank tests. We identified 27,944 patients undergoing CEA (n = 21,256) or CAS (n = 6688). After propensity matching, we compared 4705 patients in each group. Risk of reintervention was increased within 6 months for CAS (hazard ratio [HR], 1.97; 95% confidence interval [CI], 1.11-3.50; P < .05), but not beyond 6 months (HR, 1.08; 95% CI, 0.62-1.89; P = .79). The incidence of stroke prior to discharge was increased in patients undergoing CAS (5.4% vs 1.0%; P < .0001), and similarly was increased within 6 months (HR, 2.91; 95% CI, 2.42-3.48; P < .0001) but not beyond 6 months. However, mortality for CAS was increased both within 6 months (HR, 1.69; 95% CI, 1.38-2.07; P < .0001) and beyond 6 months (HR, 1.52; 95% CI, 1.27-1.81; P < .0001). When comparing TFCAS and TCAR (n = 2115 per group), there was a significantly increased risk of reintervention for TFCAS beyond 6 months (HR, 2.31; 95% CI, 1.05-5.11; P < .05), but not within 6 months (HR, 1.56; 95% CI, 0.71-3.43; P = .27) (Figure). CEA portends a lower risk of reintervention than CAS, particularly within the first 6 months after intervention. We also confirm prior data suggesting lower rates of ipsilateral stroke and death with CEA compared to CAS. On subgroup analysis of stenting modalities, TCAR had a lower rate of reintervention than TFCAS. CEA appears to be the most durable carotid revascularization strategy, with TCAR being more durable among stenting procedures.

Maybe asymptomatic carotid disease is not as benign as we think.

In this issue of JVS, Turner et al1Turner A.D. Zhu J. Rao A. Ting W. Han D. Tadros R. et al.Carotid stenosis patients with a remote history of cerebrovascular events have increased risk of major adverse events over asymptomatic patients.J Vasc Surg. 2022; 76: 1625-1632Google Scholar provide some additional insight into the impact of a remote history of cerebrovascular events as a marker for increased periprocedural adverse events after carotid stenting. The default definition of “asymptomatic” extracranial carotid disease is the absence of clinical signs and symptoms of a transient ischemic attack or stroke. As this report shows, although most asymptomatic patients are truly asymptomatic, a subset do indeed have a prior history of a neurologic event that occurred more than 180 days before an intervention but are still typically categorized as asymptomatic. This current report demonstrates that at least among patients treated with carotid stenting (transfemoral vs transcarotid), the periprocedural outcomes more closely resemble the symptomatic rather than the asymptomatic patient population. For years, we have tried a variety of imaging techniques to identify the unstable asymptomatic plaque including computed tomographic evaluation, magnetic resonance plaque characterization, ultrasound gray scale median, and transcranial Doppler.2Kakkos S.K. Griffin M.B. Nicolaides A.N. Kyriacou E. Sabetai M.M. Tegos T. et al.Asymptomatic Carotid Stenosis and Risk of Stroke (ACSRS) study group. The size of juxtaluminal hypoechoic area in ultrasound images of asymptomatic carotid plaques predicts the occurrence of stroke.J Vasc Surg. 2013; 57 (discussion: 617-8): 609-618.e1Abstract Full Text Full Text PDF PubMed Scopus (127) Google Scholar,3Saba L. Antignani P.L. Gupta A. Cau R. Paraskevas K.I. Poredos P. et al.International Union of Angiology (IUA) consensus paper on imaging strategies in atherosclerotic carotid artery imaging: from basic strategies to advanced approaches.Atherosclerosis. 2022; 354: 23-40Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar Unfortunately, none are broadly recognized as an accurate predictor. In my institution, transcranial Doppler is used quite frequently by the stroke neurologists, yet it has not made a noticeable impact on the current treatment algorithm for most patients. Hopefully, upcoming prospective studies such as the Carotid Artery Multimodality imaging Prognostic study may provide more valuable insight of the unstable asymptomatic plaque with contemporary imaging techniques.4Gargani L. Baldini M. Berchiolli R. Bort I.R. Casolo G. Chiappino D. et al.Detecting the vulnerable carotid plaque: the Carotid Artery Multimodality imaging Prognostic study design.J Cardiovasc Med (Hagerstown). 2022; 23: 466-473Crossref Scopus (1) Google Scholar Although the current report demonstrates improved outcomes among the transcarotid treated patient population vs transfemoral stenting using the Vascular Quality Initiative database, some concerns exist in regard to the data quality and sample size. Important unknowns include adherence and implementation of currently accepted optimal medical therapy, operator expertise, and objective neurologic assessment before and after the procedure. Nevertheless, the important message is that asymptomatic patients with any prior history of a remote neurologic event tend to have less favorable outcomes as compared those with no prior history of a neurologic event, and this information should be taken into consideration as part of the treatment algorithm. The opinions or views expressed in this commentary are those of the authors and do not necessarily reflect the opinions or recommendations of the Journal of Vascular Surgery or the Society for Vascular Surgery. Carotid stenosis patients with a remote history of cerebrovascular events have increased risk of major adverse events over asymptomatic patientsJournal of Vascular SurgeryVol. 76Issue 6PreviewAsymptomatic patients with a remote history of transient ischemic attack (TIA) or stroke are not well studied as a separate population from asymptomatic patients with no prior history of TIA or stroke. We compared in-hospital outcomes after transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TFCAS) among symptomatic patients, patients with a remote history of neurologic symptoms, and asymptomatic patients. Full-Text PDF

Transcarotid Artery Revascularization Can Be Safely Performed in Patients Undergoing Dialysis

Prior studies have documented worse outcomes for both carotid endarterectomy and transfemoral stenting for patients requiring hemodialysis. It has been established that transcarotid artery revascularization (TCAR) can be safely performed in high-risk patients such as octogenarians and patients with prior carotid endarterectomy, contralateral occlusion, and heavily calcified lesions. The purpose of this study was to investigate the TCAR outcomes in patients requiring dialysis.

Carotid Stenting: Flow Reversal Technique: 2-Dimensional Operative Video.

Management options for carotid stenosis include medical management, carotid endarterectomy, carotid stenting with distal filter protection, or stenting with either flow arrest or flow reversal techniques.1 Flow reversal with transcarotid artery revascularization (TCAR) technique represents a hybrid approach with surgical access to the common carotid for endovascular placement of a stent in the internal carotid artery. This direct access to the carotid artery avoids navigating the challenging anatomy of the aortic arch with endovascular devices.2 Compared to transfemoral stenting, TCAR possesses lower risk of transient ischemic attack and stroke, and compared to carotid endarterectomy, there is less risk of cranial neuropathy.3,4 We present the case of an 87-yr-old man with recurrent severe stenosis (85%) of the right internal carotid artery. The patient had a remote history of bilateral endarterectomies for asymptomatic stenosis and was found with recurrence and progression of right internal carotid artery stenosis. Options were discussed and decision was made to proceed with TCAR after he consented for the procedure. The patient tolerated the procedure well with satisfactory revascularization. Exam remained unremarkable prior to discharge on postoperative day 1 and during follow-up at 1 mo. Patient consented to the publication of their image.

Transcarotid artery revascularization versus carotid endarterectomy and transfemoral stenting in octogenarians

ObjectiveTransfemoral carotid artery stenting (TFCAS) has higher combined stroke and death rates in elderly patients with carotid artery stenosis compared with carotid endarterectomy (CEA). However, transcarotid artery revascularization (TCAR) may have similar outcomes to CEA. This study compared outcomes after TCARs relative to those after CEAs and TFCAS, focusing on elderly patients. MethodsWe included all patients with carotid artery stenosis and no prior endarterectomy or stenting who underwent either a CEA, TFCAS, or TCAR in the Vascular Quality Initiative from September 2016 (TCAR commercially available) to December 2019. We categorized patients into age decades: 60 to 69 years, 70 to 79 years, and 80 to 90 years. Outcomes included 30-day and 1-year composite rates of stroke or death. Cox proportional hazards models evaluated both outcomes after adjusting for patient demographics, clinical factors, symptomatology, hospital CEA volume, and clustering. ResultsWe identified 33,115 patients who underwent either a CEA, TFCAS, or TCAR for carotid artery stenosis (35% in their 60s, 44% in their 70s, and 21% in their 80s), where one-half (50%) were symptomatic. The majority of patients had CEAs (80%), followed by TFCAS (11%) and TCARs (9.1%). The overall rate of 30-day stroke/death was 1.5% and of 1-year stroke/death was 4.4%. Octogenarians had the highest 30-day and 1-year stroke/death rates relative to their peers (2.3% and 6.3%, respectively). Among all patients, the adjusted hazards of TCARs relative to CEAs was similar for 30-day stroke/death (hazard ratio [HR] 1.10; 95% confidence interval [CI], 0.75-1.62) and slightly higher for 1-year stroke/death (HR, 1.34; 95% CI, 1.02-1.76). Among octogenarians, however, the adjusted hazards of TCARs relative to CEAs was similar for both 30-day stroke/death (HR, 1.12; 95% CI, 0.59-2.13) and 1-year stroke/death (HR, 1.28; 95% CI, 0.85-1.94). TFCAS relative to CEAs had higher hazards of both 30-day stroke/death (HR, 1.78; 95% CI, 1.10-2.89) and 1-year stroke/death (HR, 1.85; 95% CI, 1.35-2.54) in octogenarians. ConclusionsTCARs had similar outcomes relative to CEAs among octogenarians with respect to 30-day and 1-year rates of stroke/death. TCAR may serve as a promising less invasive treatment for carotid disease in older patients who are deemed high anatomic, surgical, or clinical risk for CEAs.

Transcarotid artery revascularization (TCAR) – first experience

Abstract Objective In transcarotid artery revascularization (TCAR) the carotid stent used to treat carotid artery stenosis is introduced via a cut-down to the common carotid artery (CCA). Stent placement is performed during flow reversal using an external shunt to the femoral vein. The advantages compared to transfemoral carotid stenting are that the risks of embolization from the aortic arch and origin of the arch vessels are avoided and that clamping of the common carotid artery allows complete flow-reversal during stent placement. TCAR was developed in 2015 and is extensively used predominately in the USA. To our knowledge, TCAR has until now not been used in Switzerland. We present our first experience with TCAR. Methods Retrospective analysis of consecutive patients. Results We treated 4 patients with TCAR from Dec 2019 to May 2020. All patients were male, median age was 66y. All had high-grade internal carotid artery (ICA) stenosis (3 asymptomatic, 1 symptomatic). All procedures were performed in a hybrid operation room. Technical success was achieved in 3 patients. In these patients there was no peri-interventional stroke or TIA and duplex sonography 6 months postoperatively showed a patent stent without restenosis. In the fourth patient previous attempted transfemoral stenting for symptomatic ICA-stenosis had failed because of a very tortuous CCA. During TCAR, puncture of the CCA was difficult because of atherosclerotic thickening of the vessel wall, furthermore the tip of the guidewire for insertion of the dedicated sheath into the CCA needed to be placed in the CCA rather than in the external carotid artery (ECA) because of ECA occlusion. This led to inadvertent crossing of the stenosis with the guide wire. The procedure was abolished and converted to a conventional carotid endarterectomy. The patient had a perioperative minor stroke with signs of embolization into branches of the medial cerebral artery. He underwent transfemoral intracranial thrombectomy and eventually recovered with only minor deficits. Conclusion Our first experience with TCAR confirmed that patient selection is important: A combination of atherosclerotic disease of the CCA and occlusion of the ECA, both in themselves only relative contraindications to TCAR, led to technical failure and perioperative stroke. With good patient selection TCAR could be performed safely.

Carotid Web Is an Under-recognized and Devastating Cause of Ischemic Stroke

Carotid web is a rare form of fibromuscular dysplasia that can result in embolic stroke. Misdiagnosis is common and can lead to catastrophic neurologic events. Reports in the literature are scarce, and management remains controversial. Carotid web was defined as single, shelf-like, linear projection in the carotid bulb causing a characteristic filling defect on computed tomography angiography (CTA) or angiography (Fig). Cases at a single institution with a high-volume stroke center were identified retrospectively. Between 2016 and 2020, a total of 38 webs were identified in 32 patients; 22 (69%) were women. Average age was 48 years; 23 (72%) were African American. Symptomatic patients (26/32; 81%) initially presented with stroke (23/26; 88%) or transient ischemic attack (3/26; 12%). Webs were found incidentally in 6 of 32 patients (19%). Notably, the degree of stenosis was less than 50% in all patients, none were diagnosed with carotid ultrasound examination, and 16 of the 26 (62%) symptomatic webs were missed on initial CTA or cerebral angiography. Web-associated thrombus was observed radiographically or grossly upon carotid exploration in 13 of 26 (50%) symptomatic patients (Fig). Seven patients (27%) had a history of cryptogenic stroke and presented with ipsilateral recurrence at an average interval of 28 months. All seven were on dual antiplatelet and statin therapy prior to recurrence; four were left with permanent deficits. Definitive treatment in symptomatic patients was with transfemoral stenting in 19 of 25 (76%) or endarterectomy in 6 of 25 (24%). After an average follow-up of 19 months, there has been no reported stroke or mortality following intervention. Six patients with asymptomatic webs have been managed with antiplatelet and statin therapy for an average of 20 months. As the largest experience reported to date, our series demonstrates that carotid web is often missed on carotid duplex imaging, CTA, and cerebral angiography, and that devastating neurologic events occur if treatment is delayed after initial, web-related stroke. Symptomatic patients warrant aggressive intervention, as recurrent stroke occurred in all who were managed with medical therapy alone after initial ipsilateral stroke. A high index of suspicion and rigorous review of imaging are essential for accurate diagnosis, especially in younger, African American women who present with cryptogenic stroke and minimal carotid stenosis.

Transcarotid Artery Revascularization Versus Carotid Endarterectomy and Transfemoral Stenting in Octogenarians

OBJECTIVE Transfemoral carotid artery stenting (TFCAS) has higher combined stroke and death rates in elderly patients with carotid artery stenosis compared with carotid endarterectomy (CEA). However, transcarotid artery revascularization (TCAR) may have similar outcomes to CEA. This study compared outcomes after TCARs relative to those after CEAs and TFCAS, focusing on elderly patients. METHODS We included all patients with carotid artery stenosis, and no prior endarterectomy or stenting, who underwent either a CEA, TFCAS, or TCAR in the Vascular Quality Initiative from September 2016 (TCAR commercially available) to December 2019. We categorized patients into age decades: 60-69 years, 70-79 years, and 80-90 years. Outcomes included 30-day and one-year composite rates of stroke or death. Cox-proportional hazards models evaluated both outcomes after adjusting for patient demographics, clinical factors, symptomatology, hospital CEA volume, and clustering. RESULTS We identified 33,115 patients who underwent either a CEA, TFCAS, or TCAR for carotid artery stenosis (35% in their 60s, 44% in their 70s, and 21% in their 80s), where half (50%) were symptomatic. The majority of patients had CEAs (80%), followed by TFCAS (11%) and then TCARs (9.1%). The overall rate of 30-day stroke/death was 1.5% and of one-year stroke/death was 4.4%. Octogenarians had the highest 30-day and one-year stroke/death rates relative to their peers (2.3% and 6.3%, respectively). Among all patients, the adjusted hazards of TCARs relative to CEAs was similar for 30-day stroke/death (HR 1.10 [95%-CI 0.75-1.62]) and slightly higher for one-year stroke/death (HR 1.34 [1.02-1.76]). Among octogenarians, however, the adjusted hazards of TCARs relative to CEAs was similar for both 30-day stroke/death (HR 1.12 [0.59-2.13]) and one-year stroke/death (HR 1.28 [0.85-1.94]). TFCAS relative to CEAs had higher hazards of both 30-day stroke/death (HR 1.78 [1.10-2.89]) and one-year stroke/death (HR 1.85 [1.35-2.54]) in octogenarians. CONCLUSIONS TCARs had similar outcomes relative to CEAs among octogenarians with respect to 30-day and one-year rates of stroke/death. TCAR may serve as a promising less-invasive treatment for carotid disease in older patients who are deemed high anatomic, surgical, or clinical risk for CEAs.

Intravascular Lithotripsy During Transcarotid Artery Revascularization: A Novel Approach to Highly Calcified Lesions in High-Risk Patients

Introduced in 2009, transcarotid artery revascularization (TCAR) with flow reversal offers a less invasive option for carotid revascularization in high-risk surgical patients. In comparing in-hospital outcomes, TCAR had stroke/death/myocardial infarction rates similar to those of open CEA despite older and substantially higher risk patients (Schermerhorn et al, 2020). Compared with transfemoral stenting, TCAR had significantly lower in-hospital TIA/stroke/death rates despite a population with significantly more comorbidities (Malas et al, 2019). A relative contraindication to use of TCAR and carotid stenting in general is heavily calcified target lesions and lesions with circumferential calcification. Intravascular lithotripsy (IVL) has been introduced and approved for use in coronary artery and lower extremity arterial disease for endovascular treatment of heavily calcified lesions. IVL generates a sonic pressure wave that interacts with calcium, creating sheer stress that fractures the calcium. The objective of the study was to apply IVL to heavily calcified carotid lesions undergoing treatment with TCAR in high-risk surgery patients. This study represents a multicenter case series of seven patients undergoing TCAR with circumferential calcification of the target lesion. Treatment included off-label/off-instructions for use predilation or postdilation using IVL. Patients treated were considered high risk for carotid endarterectomy secondary to medical comorbidities in all cases. The primary end point was procedural success plus the absence of stroke in the immediate and 30-day postoperative period. The secondary end point was an improvement in the target lesion stenosis by North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria and nonsignificant (<50%) residual stenosis on follow-up imaging. Technical success was achieved in all cases. No patient suffered a stroke in the immediate or 30-day postoperative period. No cranial nerve abnormality, hematoma, wound infection, or other procedural complications was reported in the immediate postoperative period or at the first follow-up visit. By NASCET criteria, all patients had improvement in the target lesion stenosis, with all having nonsignificant stenosis on follow-up imaging. Dilation with IVL during TCAR is shown herein to be applicable safely without neurologic consequence in seven patients and has proved to be a technically feasible option in patients with extensive calcification of the target lesion. A larger study is needed to confirm the safety of applying IVL in the carotid vasculature in conjunction with TCAR. and longer follow-up data are needed to confirm the durability of these early results. The addition of IVL appears to increase the applicability of TCAR to highly calcified lesions and may offer expansion of indications for carotid stenting.

Perioperative and 1-year transcarotid revascularization outcomes in symptomatic patients

ObjectivePreviously published results of carotid revascularization with both transfemoral stenting and endarterectomy have demonstrated inferior perioperative stroke and death outcomes in neurologically symptomatic patients compared with those without symptoms. This study was completed to establish the real-world, symptom-based perioperative and follow-up outcomes for transcarotid artery revascularization (TCAR). MethodsAn institutional retrospective review of all TCARs performed outside of clinical trial regulations from 2016 to 2019 was completed. Eligible patients were classified as symptomatic or not based on a history of a unilateral neurologic deficit attributable to an extracranial carotid artery lesion within the previous 180 days. Univariate analysis consisting of Fisher's exact and Student t-tests, as appropriate, were performed between cohorts. Kaplan-Meier analysis was completed to estimate the stroke-free survival at 1 year postoperatively. ResultsWithin the investigational period, 167 patients (85 symptomatic) qualified for study inclusion. Baseline demographics were roughly equivalent, although symptomatic patients were more likely to be female (28.0% vs 9.4%; P < .01). Procedures in symptomatic patients were associated with higher estimated blood loss (41 mL vs 58 mL; P = .04) and operative time (67 minutes vs 75 minutes; P = .06). We did not find an increased incidence of macroscopic debris in the filter of symptomatic patients after stent deployment. For symptomatic patients, we observed a perioperative (30-day) ipsilateral stroke risk of 1.2% (vs 2.4% in asymptomatic patients; P > .99), a myocardial infarction risk of 0% (vs 0%; P > .99), and a mortality risk of 4.9% (vs 0%; P = .06). Most deaths occurred after procedure-related discharge; as such, in-hospital (from index TCAR) mortality in symptomatic patients was 1.2%. The four perioperative deaths observed in our population were secondary to hemorrhagic stroke, acute on chronic congestive heart failure (n = 2), and unknown causes in the last patient. At 1 year after the procedure, 114 patients (54 symptomatic) had available data. In addition to the perioperative risks, in symptomatic patients we observed a rate of reintervention of 0% (vs 0%; P > .99), ipsilateral stroke of 3.7% (vs 0%; P = .22), >50% in-stent restenosis of 1.9% (vs 0%; P = .47), stent thrombosis of 3.7% (vs 0%; P = .22), and all-cause mortality of 13.0% (vs 10.0%; P = .77). Last, no difference was noted with respect to the 1-year stroke-free survival (P = .17) by Kaplan-Meier estimates. ConclusionsIn this institutional series of patients undergoing TCAR, we found that symptomatic patients have a similar perioperative risk of stroke and myocardial infarction as asymptomatic patients. However, we did observe a strong statistical trend suggesting a higher mortality risk in symptomatic patients. There was no difference between cohorts with respect to 1-year stroke-free survival.

Perioperative and One-Year Transcarotid Revascularization Outcomes by Symptom Status

Previously published results of carotid revascularization with both transfemoral stenting and endarterectomy have demonstrated inferior outcomes in neurologically symptomatic patients. This study was completed to determine the real-world, symptom-based perioperative and 1-year outcomes for transcarotid artery revascularization (TCAR).

Cost-effectiveness of Carotid Surgery

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. 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%. 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). 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.

Transfemoral Stenting of Stenoses at the Common Carotid Artery Origin Using an Anchoring Technique With a Balloon Protection Device.

Transfemoral stenting of stenoses at the common carotid artery (CCA) origin is technically difficult because of poor stability of the guiding catheter. To describe an anchoring technique using a balloon protection device that provides excellent stability of the guiding catheter. Four patients (5 stenotic lesions) with stenosis of the CCA origin underwent transfemoral stenting with a balloon protection device (PercuSurge GuardWire; Medtronic, Santa Rosa, California). These 5 stenotic lesions of the CCA origin included 1 on the right side and 4 on the left side. Two of the stenoses were symptomatic, and 3 were asymptomatic. A balloon-expandable stent (Express LD stent; Boston Scientific, Natick, Massachusetts) was used in all patients. All stenoses were successfully dilated. With the balloon protection device as an anchor in all patients, the guiding catheter was highly stable during the procedure. There were no intraprocedural or periprocedural ischemic complications in any patients. None of the patients developed a stroke during a mean follow-up period of 8.4 months. The anchoring technique using a balloon protection device is useful for transfemoral stenting of stenoses at the CCA origin. CCA, common carotid arteryECA, external carotid arteryICA, internal carotid arteryPTA, percutaneous transluminal angioplasty.

Transfemoral Stenting of Stenoses at the Common Carotid Artery Origin Using an Anchoring Technique With a Balloon Protection Device

BACKGROUND: Transfemoral stenting of stenoses at the common carotid artery (CCA) origin is technically difficult because of poor stability of the guiding catheter. OBJECTIVE: To describe an anchoring technique using a balloon protection device that provides excellent stability of the guiding catheter. METHODS: Four patients (5 stenotic lesions) with stenosis of the CCA origin underwent transfemoral stenting with a balloon protection device (PercuSurge GuardWire; Medtronic, Santa Rosa, California). These 5 stenotic lesions of the CCA origin included 1 on the right side and 4 on the left side. Two of the stenoses were symptomatic, and 3 were asymptomatic. A balloon-expandable stent (Express LD stent; Boston Scientific, Natick, Massachusetts) was used in all patients. RESULTS: All stenoses were successfully dilated. With the balloon protection device as an anchor in all patients, the guiding catheter was highly stable during the procedure. There were no intraprocedural or periprocedural ischemic complications in any patients. None of the patients developed a stroke during a mean follow-up period of 8.4 months. CONCLUSION: The anchoring technique using a balloon protection device is useful for transfemoral stenting of stenoses at the CCA origin. ABBREVIATIONS: CCA, common carotid artery ECA, external carotid artery ICA, internal carotid artery PTA, percutaneous transluminal angioplasty