One-year outcomes after transcarotid artery revascularization (TCAR) in the ROADSTER 2 trial.

OBJECTIVES: Transcarotid artery revascularization (TCAR) is a carotid stenting technique that utilizes reversal of cerebral arterial flow to confer cerebral protection. Although carotid endarterectomy (CEA) remains the standard for treatment of symptomatic and asymptomatic carotid stenosis, the search for the optimal minimally invasive option for the high-risk surgical patient continues. The goal of the current study is to evaluate the 1-year safety and efficacy of TCAR in a prospective clinical trial. METHODS: ROADSTER 2 is a prospective, open-label, single-arm, multicenter, post-approval registry for patients undergoing TCAR. All patients were considered high risk for CEA and underwent independent neurological assessments preoperatively, postoperatively, and had long-term clinical follow-up. The primary end point was incidence of ipsilateral stroke after treatment with the ENROUTE Transcarotid Stent System. Secondary end points included individual/composite rates of stroke, death, and perioperative myocardial infarction. RESULTS: Between June 2016 and November 2018, 155 patients at 21 centers in the United States and one in the European Union were enrolled and represented a subset of the overall trial. Asymptomatic (n = 119; 77%) and symptomatic patients (n = 36; 23%) with high-risk anatomic (ie, high lesion, restenosis, radiation injury; 43%), physiologic (32%), or combined factors (25%) were enrolled. No patient suffered a perioperative myocardial infarction or stroke. Over the year, no patient had an ipsilateral stroke, but four patients died (2.6%), all from non-neurological causes. Additionally, a technical success rate of 98.7% with a low cranial nerve deficit rate of 1.3% was achieved. CONCLUSIONS: In patients with high risk factors, TCAR yields high technical success with a low stroke and death rate at 1 year. Further comparative studies with CEA are warranted.

Analysis of the ROADSTER pivotal and extended-access cohorts shows excellent 1-year durability of transcarotid stenting with dynamic flow reversal.

OBJECTIVE: We report the 1-year outcomes of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial. This trial introduced a novel transcarotid neuroprotection system (NPS), the ENROUTE transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif). Postoperative results demonstrated that the use of the ENROUTE transcarotid NPS is safe and effective. The aim of this study was to evaluate the safety of transcarotid artery revascularization (TCAR) and to present the 1-year outcomes. METHODS: This study is a prospective, single-arm clinical trial. Current enrollment occurs in 14 centers. Primary end points were incidence rates of ipsilateral stroke at 1 year after TCAR. Occurrence of stroke was ascertained by an independent Clinical Events Committee. Patients with anatomic or medical high-risk factors for carotid endarterectomy (CEA) were eligible to be enrolled in the ROADSTER trial. RESULTS: Overall, 165 patients were included in the long-term follow-up (112 of 141 patients from the pivotal phase and 53 of 78 patients from the extended access). Mean age was 73.9 years (range, 42.1-91.3 years). Patients aged 75 years and older were 43.3% of the cohort. The majority of patients were white (92.7%) and male (75.2%). Most patients were asymptomatic (79.9%). Anatomic risk factors were distributed as follows: contralateral carotid artery occlusion (11.0%), tandem stenosis of >70% (1.8%), high cervical carotid artery stenosis (25.0%), restenosis after CEA (25.6%), bilateral stenosis requiring treatment (4.3%), and hostile neck (14.6%). Medical high-risk criteria included two-vessel coronary artery disease (14.0%) and severe left ventricular dysfunction with ejection fraction <30% (1.8%). In general, 43.3% of patients had at least one anatomic high-risk factor, whereas 29.9% of patients had medical high-risk factors. Both subsets of factors were present simultaneously in 26.8% of the cohort. At 1-year follow-up, ipsilateral stroke incidence rate was 0.6%, and seven patients (4.2%) died. None of the deaths were neurologic in origin. CONCLUSIONS: TCAR with dynamic flow reversal had previously shown favorable 30-day perioperative outcomes. This excellent performance seems to extend to 1 year after TCAR as illustrated in this analysis. The promising results from the ROADSTER trial likely stem from the novel cerebral protection provided through the ENROUTE transcarotid NPS in comparison to distal embolic protection devices as well as the transcarotid approach's circumventing diseased aortic arch manipulation and minimizing embolization. TCAR offers a safe and durable revascularization option for patients who are deemed to be at high risk for CEA.

Comparison of Bypass with Endoscopically Harvested Internal Saphenous Vein versus Bypass with Surgically Harvested Internal Saphenous Vein for Lower Limb Arterial Disease.

BACKGROUND: Patients with lower limb arterial disease have a high risk for complications related with surgical wounds. The endoscopic extraction of the great saphenous vein (GSV) is a less invasive alternative to the conventional surgical extraction. METHODS: A clinical and ultrasonographic follow-up was carried out on the lower limb bypass with GSV performed in our institution between years 2007 and 2012. Patients were selected for open or endoscopic harvesting depending on the surgeon assigned (endoscopic or open surgeon). Follow-up was performed at 1, 3, 6, and 12 months after surgery and annually thereafter. All the GSV endoscopic harvestings (GSVEH) were performed by the same surgeon. Data for primary, assisted, and secondary patency and amputation-free survival were analyzed. Anatomopathalogic analysis were performed on pares of samples of the same vein dissected surgically and endoscopically from the same patient. RESULTS: Sixty bypass surgery has been performed on 60 patients (54 men and 6 women), 30 with GSVEH (50%), and 30 with GSV open harvesting (GSVOH). All patients were intervened for critical limb ischemia (Rutherford cathegory 4, 5, and 6). Significant differences were found between both groups for suture dehiscence (GSVEH 0%, GSVOH 20%, P = 0.01) and infection (GSVEH 3%, GSVOH 30% P, 0.006). No significant differences were found between both groups regarding to primary patency, assisted primary patency, or amputation-free survival. An anatomopathologic comparison of segments of veins extracted surgically and endoscopically of the same patients did not show any significant differences. CONCLUSIONS: Although no statistically significant differences were found between GSVOH and GSVEH bypass for lower limb revascularization, there is a trend toward poorer patency rates for the endoscopic technique. GSVEH lowers the risks for infection and dehiscence of surgical wounds.