A novel approach to high-grade carotid stenosis with concomitant extracranial carotid aneurysms using transcarotid artery revascularization.

We present the novel application of transcarotid artery revascularization (TCAR) in two high-risk patients with high-grade internal artery stenosis and concomitant atherosclerotic extracranial carotid artery aneurysms (ECAAs). ECAAs account for <1% of arterial aneurysms and are usually clinically silent at presentation. Historically, the treatment of ECAAs has been via open reconstruction or stent grafting. TCAR is an effective alternative for carotid revascularization in high-risk patients with high-grade carotid stenosis, but has not been widely used for aneurysmal management. We report two cases to describe our management of concomitant carotid stenoses and ECCA with TCAR.

Staged Combined Endovascular and Open Surgical Approach in a Patient with Takayasu's Arteritis.

Takayasu's arteritis (TA) is a systemic large vessel vasculitis that affects the aorta and its branches. Most patients with TA respond to medical therapy with a minority of patients requiring surgical intervention. In our report, we describe the case of a 59-year-old Caucasian female with TA who underwent revascularization due to cerebrovascular symptoms refractory to medical therapy. She initially presented with amaurosis fugax and developed episodes of syncope and slurred speech during corticosteroid tapering. Vascular studies showed right common carotid artery (RCCA), left internal carotid artery (LICA), and left subclavian artery (LSA) occlusion with the right vertebral artery (RVA) ostium stenosis, and retrograde flow through the left vertebral artery (LVA). The sole source of cerebral perfusion flowed through her stenosed RVA, so it was decided to first stent the RVA to restore adequate posterior cerebral circulation before creating a right subclavian artery to RCCA bypass to restore anterior circulation. This case represents the successful management of TA utilizing a two-staged combined endovascular and surgical approach.

Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal.

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.

Carotid angioplasty and stenting in anatomically high-risk patients: Safe and durable except for radiation-induced stenosis.

OBJECTIVE: Carotid angioplasty and stenting (CAS) is used in patients considered high-risk for carotid endarterectomy (CEA). Patients qualify as high-risk because of medical comorbid conditions or for anatomic considerations (previous CEA, radical neck dissection, radiation). We compared the technical feasibility and durability of CAS in medically high-risk patients (MED) vs anatomically high-risk patients (ANAT). METHODS: A retrospective review was performed of all consecutive patients undergoing CAS by a single vascular surgery group. All patients were high risk and evaluated with duplex ultrasound imaging and angiography. Primary end points were technical success, 30-day stroke, myocardial infarction (MI), death, and in-stent restenosis. Standard statistical analysis included Kaplan-Meier life tables. RESULTS: From January 2003 to December 2007, 230 CAS (98 ANAT, 132 MED) procedures were attempted. The ANAT cohort comprised 84 patients with a single anatomic risk factor: 71 with a previous ipsilateral CEA, 6 high lesions, 6 history of neck radiation, and 1 with a tracheostomy. Ten patients had two or three anatomic risk factors: nine with radical neck dissection and radiation and one with neck radiation and ipsilateral CEA. The mean age was 71.1 years for ANAT vs 73.9 years for MED (P = .021). Technical success rates were 98% in ANAT and 98.5% in MED (P = .76). Thirty-day stroke rate was 1.0% in ANAT and 5.3% in MED (P = .14); the mortality rate was 2.0% in ANAT and 0.8% in MED (P = .79). The 2-year survival free from stroke was MED, 93.6% and ANAT, 98.9% (P = .118); and from restenosis was MED, 91.9%; and ANAT, 91.0% (P = .98). Two-year overall survival was significantly better in ANAT (84.6%) vs MED (70.1%; P = .026). Four of the seven restenoses in the ANAT group occurred in patients with previous neck radiation. The restenosis rate for radiation-induced (RAD) stenosis treated with CAS was significantly higher at 22.2% (4 of 18) compared with 3.8% (3 of 78) in ANAT group patients without a history of radiation (non-RAD; P = .028). The 2-year restenosis-free survival was 72.7% in the RAD group vs 95.9% in the non-RAD group (P = .017). CONCLUSION: CAS is as technically feasible, safe, and durable in anatomically high-risk patients as in medically high-risk patients, with similar rates of periprocedural stroke and death and late restenosis. However, patients with radiation-induced stenosis appear to be at an increased risk for restenosis.