Temporary Reversal of Blood Flow During Transcarotid Artery Revascularization Does Not Change Brain Electrical Activity in Lead-In Cases of the ROADSTER 1 Multicenter Trial

Abstract

Purpose: To evaluate any intraoperative electroencephalographic (EEG) changes accompanying reversed flow with the ENROUTE Transcarotid Neuroprotection System during transcarotid artery revascularization (TCAR). Methods: A post hoc analysis was performed of the first 81 consecutive lead-in patients (mean age 72.8±8 years; 61 men) enrolled in the ROADSTER 1 trial at 5 participating institutions. All patients had high-grade carotid artery stenosis [53 (59.3%) left sided; 12 (14.8%) contralateral occlusions] and high-risk criteria for carotid endarterectomy. A third had symptoms of either stroke (13, 16.0%) or transient ischemic attack (14, 17.3%). This subset of early patients underwent EEG monitoring to detect any cerebral changes during reversed flow as an added safety measure mandated by the ROADSTER 1 trial protocol. Results: Mean flow reversal time was 12.9±8.2 minutes. The goal mean arterial pressure during reversed flow was 100 mm Hg, but 7 (8.6%) patients suffered hypotension. One (1.2%) patient had slight EEG changes secondary to blood pressure fluctuation; these resolved with blood pressure elevation. No other EEG changes were noted. One (1.2%) patient had a postoperative stroke and another (1.2%) had postoperative myocardial infarction (MI), leading to 2.5% 30-day stroke/death/MI rate. Conclusion: Temporary reversal of blood flow during TCAR is a safe maneuver and does not cause cerebral ischemia in the vast majority of patients, including those with contralateral carotid occlusion. Carotid stenting performed with reversed blood flow mitigates cerebral embolization and periprocedural stroke without concern for brain ischemia.

Keywords

carotid artery disease carotid stenting electroencephalography mortality occlusion safety stenosis stroke transcarotid artery revascularization transient ischemic attack

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References

HCUP National Inpatient Sample (NIS). Healthcare Cost and Utilization Project (HCUP). Overview of the National (Nationwide) Inpatient Sample (NIS). http://www.hcup-us.ahrq.gov/nisoverview.jsp . Accessed September 15, 2017.

Brott

Hobson

RWI

Howard

et al . Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010;363:11–23.

Fairman

Gray

Scicli

et al . The CAPTURE registry: analysis of strokes resulting from carotid artery stenting in the post approval setting: timing, location, severity, and type. Ann Surg. 2007;246:551–558.

Gupta

Corriere

Dodson

et al . The incidence of microemboli to the brain is less with endarterectomy than with percutaneous revascularization with distal filters or flow reversal. J Vasc Surg. 2011;53:316–322.

Bonati

Jongen

Haller

et al . New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS). Lancet Neurol. 2010;9:353–362.

Murad

Shahrour

Shah

et al . A systematic review and meta-analysis of randomized trials of carotid endarterectomy vs stenting. J Vasc Surg. 2011;53:792–797.

Bijuklic

Wandler

Hazizi

et al . The PROFI study (Prevention of Cerebral Embolization by Proximal Balloon Occlusion Compared to Filter Protection During Carotid Artery Stenting): a prospective randomized trial. J Am Coll Cardiol. 2012;59:1383–1389.

Kwolek

Jaff

Leal

et al . Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2015;62:1227–1234.

Malas

Leal

Kashyap

et al . Technical aspects of transcarotid artery revascularization using the ENROUTE transcarotid neuroprotection and stent system. J Vasc Surg. 2017;65:916–920.

10.

Alpaslan

Wintermark

Pinter

et al . Transcarotid artery revascularization with flow reversal. J Endovasc Ther. 2017;24:265–270.

11.

Ferguson

Eliasziw

Barr

et al . The North American Symptomatic Carotid Endarterectomy Trial. Surgical results in 1415 patients. Stroke. 1999;30:1751–1758.

12.

Walker

Marler

Goldstein

et al . Endarterectomy for asymptomatic carotid artery stenosis. JAMA. 1995;273:1421–1428.

13.

Halliday

Harrison

Hayter

et al . 10-year stroke prevention after successful carotid endarterectomy for asymptomatic stenosis (ACST-1): a multicentre randomised trial. Lancet. 2010;376:1074–1084.

14.

Eckstein

Ringleb

Allenberg

et al . Results of the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial. Lancet Neurol. 2008;7:893–902.

15.

Mas

Chatellier

Beyssen

et al . Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006;355:1660–1671.

16.

Inoue

Tsutsumi

Ohwaki

et al . Stratification of intraoperative ischemic impact by somatosensory evoked potential monitoring, diffusion-weighted imaging and magnetic resonance angiography in carotid endarterectomy with routine shunt use. Acta Neurochir (Wien). 2013;155:2085–2096.

17.

Baker

Gluecklich

Watson

et al . An evaluation of electroencephalographic monitoring for carotid study. Surgery. 1975;78:787–794.

18.

Boysen

Collateral circulation during clamping of the carotid artery in patients subjected to carotid endarterectomy. The interrelationship between regional cerebral blood flow, internal carotid artery stump pressure, and EEG. Acta Neurol Scand Suppl. 1972;51:421–422.

19.

Callow

Matsumoto

Baker

et al . Protection of the high risk carotid endarterectomy patient by continuous electroencephalography. J Cardiovasc Surg (Torino). 1978;19:55–64.

20.

Jeleazcov

Schneider

Daunderer

et al . The discriminant power of simultaneous monitoring of spontaneous electroencephalogram and evoked potentials as a predictor of different clinical states of general anesthesia. Anesth Analg. 2006;103:894–901.

21.

Matsumoto

Baker

Watson

et al . EEG surveillance as a means of extending operability in high risk carotid endarterectomy. Stroke. 1976;7:554–559.

22.

Perez-Borja

Meyer

JS.

Electroencephalographic monitoring during reconstructive surgery of the neck vessels. Electroencephalogr Clin Neurophysiol. 1965;18:162–169.

23.

Sundt

Jr Sharbrough

Anderson

et al . Cerebral blood flow measurements and electroencephalograms during carotid endarterectomy. J Neurosurg. 1974;41:310–320.

24.

Florence

Guerit

Gueguen

Electroencephalography (EEG) and somatosensory evoked potentials (SEP) to prevent cerebral ischaemia in the operating room. Neurophysiol Clin. 2004;34:17–32.

25.

Pinkerton

JA.

EEG as a criterion for shunt need in carotid endarterectomy. Ann Vasc Surg. 2002;16:756–761.

26.

Ballotta

Saladini

Gruppo

et al . Predictors of electroencephalographic changes needing shunting during carotid endarterectomy. Ann Vasc Surg. 2010;24:1045–1052.

27.

Sridharan

Chaer

Thirumala

et al . Somatosensory evoked potentials and electroencephalography during carotid endarterectomy predict late stroke but not death. Ann Vasc Surg. 2017;38:105–112.

28.

Wang

Leung

Lownie

SP.

Circle of Willis collateral during temporary internal carotid artery occlusion II: observations from computed tomography angiography. Can J Neurol Sci. 2016;43:538–542.

29.

Poon

CM.

Intraoperative neuromonitoring in major vascular surgery. Br J Anaesth. 2016;117(suppl 2):ii13–ii25.

30.

Hans

Jareunpoon

Prospective evaluation of electroencephalography, carotid artery stump pressure, and neurologic changes during 314 consecutive carotid endarterectomies performed in awake patients. J Vasc Surg. 2007;45:511–515.

31.

Debette

Markus

HS.

The clinical importance of white matter hyperintensities on brain magnetic resonance imaging: systematic review and meta-analysis. BMJ. 2010;341:c3666.