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Objective Over the years where stents have been used to treat carotid lesions, a great deal has been learned about which anatomic characteristics lead to adverse outcomes. This review summarizes the anatomic and morphologic characteristics of the carotid vasculature that can help guide patient selection and clinical decision-making. Methods Each of the carotid artery anatomy and lesion characteristics that are relevant to carotid stenting is described in detail. These are accompanied with evidence-based outcomes and results. Results Data on the prevalence of carotid artery lesions that are unsuitable for stenting are summarized and the implications of these data for practice are discussed, especially as they pertain to transcarotid artery revascularization. Conclusions Carotid artery stenting can be a viable option for carotid revascularization, but the lesion must be acceptable and safe for stent placement. There should be thorough assessment to rule out the presence of severe tortuosity, long-segment disease, severe calcification (circumferential or exophytic), mobile plaque, swollen internal carotid artery sign, and carotid diameters outside the acceptable range. In carefully chosen lesions with the absence of the unfavorable characteristics described, transcarotid artery revascularization may offer improved periprocedural success and carotid artery stenting may attain better long-term durability.

Background and Purpose: Transcarotid artery revascularization (TCAR) is comprised of carotid artery stent placement with cerebral protection via proximal carotid artery clamping and reversal of cerebral arterial flow. The aim of the present study was to evaluate the safety and efficacy of TCAR performed by a broad group of physicians with variable TCAR experience. Methods: The ROADSTER 2 study is a prospective, open label, single arm, multicenter, postapproval registry for patients undergoing TCAR. Patients considered at high risk for complications from carotid endarterectomy with symptomatic stenosis ≥50% or asymptomatic stenosis ≥80% were included. The primary end point was procedural success, which encompassed technical success plus the absence of stroke, myocardial infarction, or death within the 30-day postoperative period. Secondary end points included technical success and individual/composite rates of stroke, death, and myocardial infarction (MI). All patients underwent independent neurological assessments before the procedure, within 24 hours, and at 30 days after TCAR. An independent clinical events committee adjudicated all major adverse events. Results: Between 2015 and 2019, 692 patients (Intent to Treat Population) were enrolled at 43 sites. Sixty cases had major protocol violations, leaving 632 patients adhering to the Food and Drug Administration-approved protocol (per-protocol population). The majority (81.2%) of operators were TCAR naïve before study initiation. Patients underwent TCAR for neurological symptoms in 26% of cases, and all patients had high-risk factors for carotid endarterectomy (anatomic-related 44%; physiological 32%; both 24%). Technical success occurred in 99.7% of all cases. The primary end point of procedural success rate in the Intent to Treat population was 96.5% (per-protocol 97.9%). The early postoperative outcomes in the Intent to Treat population included stroke in 13 patients (1.9%), death in 3 patients (0.4%), and MI in 6 patients (0.9%). The composite 30-day stroke/death rate was 2.3%, and stroke/death/MI rate was 3.2%. In the per-protocol population, there were strokes in 4 patients (0.6%), death in one patient (0.2%), and MI in 6 patients (0.9%) leading to a composite 30-day stroke/death rate of 0.8% and stroke/death/MI rate of 1.7%. Conclusions: TCAR results in excellent early outcomes with high technical success combined with low rates of postprocedure stroke and death. These results were achieved by a majority of operators new to this technology at the start of the trial. Adherence to the study protocol and peri-procedural antiplatelet therapy optimizes outcomes. Longer-term follow-up data are needed to confirm these early outcomes. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02536378.

In Case 1, A 65-year-old man with a family history of carotid body paraganglioma and no other risk factors was referred to the noninvasive vascular laboratory for a carotid duplex with complaints of left eye amaurosis fugax. In Case 2, an 84-year-old woman with a history of hypertension and hyperlipidemia presented to the noninvasive vascular laboratory for carotid duplex under the suspicion of a right hemisphere transient ischemic attack. Duplex sonography of both cases recorded minimal

Background Previously, the Stenting and Angioplasty with Protection of Patients with High Risk for Endarterectomy (SAPPHIRE) randomized trial showed that carotid artery stenting (CAS) was not inferior to carotid endarterectomy (CEA) in the treatment of high-surgical risk patients. Objective The primary objective of the SAPPHIRE Worldwide Registry is to evaluate 30-day major adverse events (MAE) after CAS performed by physicians with varied experience and utilizing a formal training program. Data will be analyzed on the overall patient population and by high-risk inclusion criteria. Methods SAPPHIRE Worldwide is a multicenter, prospective, postapproval registry to evaluate CAS with distal protection in patients at high-risk for surgery using the Cordis PRECISE Nitinol Stent and ANGIOGUARD™ XP/RX Emboli Capture Guidewire. Participating physicians are encouraged to treat patients according to their standard of practice and consistent with current Food and Drug Administration-approved labeling. Results Enrollment began in October 2006. Data are available on the first 2,001 patients enrolled and followed to 30 days. Of these patients, the mean age was 72.2 ± 9.75 yr; 62% were male; and 27.7% were symptomatic. Entry criteria for surgical high-risk included anatomic (n = 716), physiologic (n = 918), or both risk factors (n = 327). At 30-day follow-up, the MAE was 4.4% (death 1.1%, stroke 3.2%, MI 0.7%) for the overall population. Patients with anatomic risk had a significantly lower 30-day MAE than patients with physiologic risk (2.8% vs. 4.9%, P = 0.0306), respectively. Conclusions While the number of physicians performing CAS continues to increase, MAE rates seen in this registry (4.4%) are well within an acceptable range, as was first seen in the SAPPHIRE randomized trial (4.8%). A significant decrease in MAE was seen in patients with anatomic risk compared with physiologic risk factors. The SAPPHIRE Worldwide Registry supports the use of CAS as an alternative to CEA in patients who are at high-risk for surgery due to anatomic risk factors. © 2008 Wiley-Liss, Inc.

Objective This report presents the 30-day results of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial and evaluates the safety and efficacy of ENROUTE Transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif), a novel transcarotid neuroprotection system that provides direct surgical common carotid access and cerebral embolic protection via high-rate flow reversal during carotid artery stenting (CAS). Methods A prospective, single-arm, multicenter clinical trial was performed to evaluate the use of the ENROUTE Transcarotid NPS during CAS procedures performed in patients considered to be at high risk for complications from carotid endarterectomy. Symptomatic patients with ≥50% stenosis and asymptomatic patients with ≥70% stenosis were eligible to be treated with any U.S. Food and Drug Administration-approved carotid artery stent. The primary end point was the composite of all stroke, myocardial infarction (MI), and death at 30 days postprocedure as defined in the Food and Drug Administration-approved study protocol. Secondary end points included cranial nerve injury; 30-day stroke, death, stroke/death, and MI; acute device, technical, and procedural success; and access site complications. All major adverse events were adjudicated by an independent clinical events committee. Results Between November 2012 and July 2014, 208 patients were enrolled at 18 sites. Sixty-seven patients were enrolled as lead-in cases, and 141 were enrolled in the pivotal phase. In the pivotal cohort, 26% were symptomatic and 75% were asymptomatic. Acute device and technical success were 99% (140 of 141). By hierarchical analysis, the all-stroke rate in the pivotal group was 1.4% (2 of 141), stroke and death was 2.8% (4 of 141), and stroke, death and MI was 3.5% (5 of 141). One patient (0.7%) experienced postoperative hoarseness from potential Xth cranial nerve injury, which completely resolved at the 6-month follow-up visit. Conclusions The results of the ROADSTER trial demonstrate that the use of the ENROUTE Transcarotid NPS is safe and effective at preventing stroke during CAS. The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of CAS.

Further study is needed to determine which patient characteristics and lesion criteria derive the greatest benefit from carotid artery stenting (CAS). SAPPHIRE Worldwide is a large scale multicenter post-approval study to evaluate CAS with distal embolic protection using the Cordis PRECISE® Nitinol

Introduction: Percutaneous balloon mitral valvuloplasty (PBMV) is a well-established alternative to commissurotomy and is recommended for patients with Mitral stenosis (MS) and echocardiographic (ECHO) score b8 and no calcified mitral valves. However, the question remains whether simultaneous intracardiac echocardiography (ICE) is useful to perform PBMV in suboptimal candidates without provoking excessive mitral regurgitation (MR). Materials and Methods: Fifty-seven consecutive PBMV procedures under ICE guidance were performed under local anesthesia and mild sedation between May 2004 and October 2008 at University of Alabama at Birmingham. Left femoral vein was used for ICE insertion while the right was used for transseptal access. Transthoracic echocardiography was used to assess the mitral valve pre and post PBMV. The corresponding preand postPBMVmitral valve areas (MVA) were calculated. Inhospital adverse clinical events were collected. Results: There were 10 (18%) men. The mean age was 53.9±14 years (range, 26–94 years). Two thirds had ECHO score N8, and 33% had moderate to severe MR before PBMV. After PBMV, MVA increased from 1.1±0.29 cm to 1.8±0.9 cm (Pb.005) by planimetry, from 1.25±0.58 cm to 1.97±0.57 cm (Pb.005) by Gorlin's formula. The mean mitral valve gradient decreased from 14±5 mm Hg to 7±3 mm Hg (Pb.005). None had cardiac tamponade or died during the procedure. Fifty-two patients (91.2%) had successful PBMV without in-hospital adverse events. Three (5.2%) required MVR. Two patients developed flail MV leaflet due to rupture of chordae. The third with Grade 3 MR prior to PBMV had progressively worsening symptoms for 7 days requiring MVR. One patient, with prePBMV valve area of 0.6 cm had improvement in MVA to 1.4 cm but developed MRSA sepsis and acute renal failure, which resolved during her hospital stay. Conclusion: MS patients with poor MVanatomy and moderate to high risk for PBMV have been traditionally relegated to medical therapy. With ICE guidance, PBMV can be extended to these patients with unsuitable MV anatomy with reasonable procedural success and safety. To our knowledge, this is the largest case series reporting the use of ICE to facilitate PBMV in such moderate to high-risk patients