Mahmoud B Malas1, Jose Ignacio Leal Lorenzo2, Besma Nejim3, Todd M Hanover4, Manish Mehta5, Vikram Kashyap6, Christopher J Kwolek7, Richard Cambria8. 1. Vascular and Endovascular Research Center, Johns Hopkins University, Baltimore, Md. Electronic address: mmalas@ucsd.edu. 2. Vascular Surgery Section, Complejo Hospitalario de Toledo, Toledo, Spain. 3. Vascular and Endovascular Research Center, Johns Hopkins University, Baltimore, Md. 4. Academic Department of Surgery, Greenville Hospital System, Greenville, SC. 5. Albany Vascular Group, The Institute for Vascular Health and Disease, Albany, NY. 6. Vascular Center, Harrington Heart and Vascular Institute, University Hospitals Case Medical Center, Cleveland, Ohio. 7. Division of Vascular and Endovascular Surgery, Massachusetts General Hospital, Boston, Mass. 8. Division of Vascular and Endovascular Surgery, St. Elizabeth's Hospital, Boston, Mass.
Abstract
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.
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.
Authors: George Q Zhang; Sanuja Bose; David P Stonko; Christopher J Abularrage; Devin S Zarkowsky; Caitlin W Hicks Journal: J Vasc Surg Date: 2022-03-31 Impact factor: 4.860
Authors: Christina L Cui; Hanaa Dakour-Aridi; Jens Eldrup-Jorgensen; Marc L Schermerhorn; Jeffrey J Siracuse; Mahmoud B Malas Journal: J Vasc Surg Date: 2020-10-08 Impact factor: 4.268
Authors: Zachary Williams; Lindsey A Olivere; Brian Gilmore; Hope Weissler; Mitchell W Cox; Chandler Long; Cynthia K Shortell; Jacob Schroder; Kevin W Southerland Journal: Vasc Endovascular Surg Date: 2020-04-22 Impact factor: 1.089
Authors: Hanaa Dakour-Aridi; Christina L Cui; Andrew Barleben; Marc L Schermerhorn; Jens Eldrup-Jorgensen; Mahmoud B Malas Journal: J Vasc Surg Date: 2020-11-27 Impact factor: 4.860
Authors: Lindsey A Olivere; James Ronald; Zachary Williams; Mitchell W Cox; Chandler Long; Cynthia K Shortell; Kevin W Southerland Journal: J Vasc Surg Date: 2020-04-22 Impact factor: 4.268