Bryll, Amira

Gajos, Grzegorz

Latacz, Paweł

Piwowarczyk, Marek

Popiela, Tadeusz

Simka, Marian

Polish Archives of Internal Medicine

English

Jagiellonian Univeristy Repository

RESEARCH LETTER New ischemic cerebral lesions after interventional procedures 563It was planned to evaluate 50 patients present­ing with symptomatic lesions of the internal ca­rotid artery.The inclusion criteria were as follows: age ≥18 years; 60%–99% stenosis of the internal carotid artery; diameter of the target internal carotid ar­tery ≤7 mm; symptomatic lesion (history of ipsi­lateral stroke, transient ischemic attack, or revers­ible ischemic neurological deficit); localization and morphology of the lesion enabling surgical ever­sion endarterectomy or endovascular angioplas­ty with stenting; and written informed consent.The exclusion criteria comprised a target le­sion that has been previously stented or operat­ed; highly calcified lesions; occlusion of the con­tralateral carotid artery without adequate collat­eral circulation through the circle of Willis; ana­tomical contraindications for eversion endarter­ectomy; acute ipsilateral stroke; disabling stroke at any side; other severe pathologies of the brain, resulting in a significant loss of cerebral tissue and/or significant neurological deficits; history of hemorrhagic transformation of ischemic stroke; severe comorbidities; allergy to aspirin, clopido­grel, or ticlopidine; allergy to iodinated contrast media; pregnancy; and metallic implants or other known contraindications to magnetic resonance imaging. Women of reproductive age who did not use effective contraception were also excluded.Introduction Periprocedural cerebral microembo­lism associated with carotid artery revasculariza­tion does not usually manifest as a clinically overt stroke. Such microembolism can result in cogni­tive impairment, which is difficult to measure ob­jectively. Yet, neuropsychological disturbances resulting from these events represent an impor­tant clinical and socioeconomic problem.1,2 The­oretically, proximal protection, because of flow reversal during endovascular repair,3-10 should be associated with a decreased risk of periproce­dural microembolism when compared with sur­gical endarterectomy. In this trial, we demon­strated that there were indeed fewer microem­bolic cerebral ischemic lesions after stenting with a proximal protection device compared with sur­gical eversion endarterectomy, which—if proven by a larger study—would be of particular clini­cal significance.Methods CARECarotid (New Ischemic Cere­bral Lesions After Endarterectomy vs. Stent­ing for the Treatment of Symptomatic Carotid Stenosis) was a prospective randomized single­­center study, performed at the University Hos­pital in Kraków, Poland. The study protocol was approved by the Bioethical Committee of the Re­gional Board of Physicians in Kraków (approv­al no., 137/KBL/OIL/2015) and was registered at ClinicalTrials.gov (identifier, NCT03764306). RESEARCH LETTERCerebral ischemic lesions on diffusion ­weighted magnetic resonance imaging after carotid eversion endarterectomy vs carotid stenting with a proximal protection device: results of a randomized prospective trialPaweł Latacz1, Marian Simka2, Amira Bryll3, Marek Piwowarczyk4, Grzegorz Gajos5, Tadeusz Popiela31  Department of Neurology, University Hospital, Jagiellonian University Medical College, Kraków, Poland2  Department of Anatomy, University of Opole, Opole, Poland3  Department of Radiology, Jagiellonian University Medical College, Kraków, Poland4  Department of Vascular Surgery, University Hospital, Kraków, Poland5  Department of Coronary Artery Disease and Heart Failure, John Paul II Hospital, Jagiellonian University Medical College, Kraków, PolandCorrespondence to:Paweł Latacz, MD, PhD, Department of Neurology, Jagiellonian University Medical College, ul. Botaniczna 3, 31-503 Kraków, Poland, phone: +48 12 424 86 00, email: pawlat@me.comReceived: March 22, 2019.Revision accepted: April 26, 2019.Published online: May 8, 2019.Pol Arch Intern Med. 2019; 129 (7-8): 563-566doi:10.20452/pamw.14825Copyright by Medycyna Praktyczna, Kraków 2019POLISH ARCHIVES OF INTERNAL MEDICINE 2019; 129 (7-8)564to symptoms of moderate stroke. Similarly, in the stent arm, these scores varied from 0 to 5, with the mean (SD) score of 2 (1.18). The differ­ence in the NIHSS score between the study arms was not significant.In all surgical patients, carotid endarterecto­my was performed using the eversion technique and cervical block anesthesia. Shunt was used only in 1 patient, as the other patients present­ed with adequate collateral circulation. All sur­gical endarterectomies fully restored blood flow through the target carotid artery. There were no perioperative complications in the surgical arm, except for 1 patient who required urgent angio­plasty and stent implantation due to dissection of the target artery, which was localized distally to the site of endarterectomy. Endovascular treat­ment restored proper flow and there were no fur­ther complications in this patient.All procedures in the stent arm were performed using the Mo.Ma proximal cerebral protection de­vice (Medtronic, Minneapolis, Minnesota, United States). We implanted stents that were tailored to the localization of the lesions and morphol­ogy of the carotid arteries. In the case of rath­er straight arteries, we used Carotid Wallstent stents (Boston Scientific, Massachusetts, Unit­ed States), while in patients with tortuous arter­ies, we implanted Precise Pro RX stents (Cordis, Fremont, California, United States) or Roadsav­er stents (Terumo, Tokyo, Japan). Carotid Wall­stent stents were used in 10 patients; Roadsaver, in 5 patients; and Precise Pro RX, in 2 patients. There were no technical failures associated with stent implantations.Magnetic resonance imaging Diffusion ­weighted magnetic resonance sequences of the brain were acquired using a GE 3 Tesla HDx magnetic reso­nance scanner (GE Healthcare, Chicago, Illinois, United States). In both arms of the trial, the im­aging was performed 1 to 3 days before the pro­cedure and 2 to 3 days after revascularization. The following sequences were acquired: stan­dard T1 and T2, axial diffusion ­weighted imaging, 3 ­dimensional time ­of ­flight, and the enhanced susceptibility ­weighted angiography. The imag­es were interpreted by a neuroradiologist who was blinded to the procedures. In order to secure the blinding, he did not see patients during imag­ing. Also, in order not to reveal stents, magnetic resonance scans did not cover the patients’ necks.Statistical analysis Categorical variables were compared between the groups the χ2 test or the extended Mantel–Haenszel χ2 for linear trend test. Continuous variables were compared using the independent sample t test or, in the case of nonnormal distribution, the Mann–Whitney test. The significance of the tests was set at a P value of less than 0.05.Results Diffusion ­weighted magnetic reso­nance imaging before surgical endarterectomy It was a randomized study with parallel groups. We used closed envelopes as a randomization tool. Patients were randomly assigned to one of the 2 treatment arms: surgical endarterectomy or carotid angioplasty with stenting under prox­imal protection. All patients provided written informed consent to undergo procedures and to participate in this trial.The study was conducted from May 2015 to March 2018. During this time, a total of 214 pa­tients in our center underwent either surgical (41 patients) or endovascular treatment (173 pa­tients) for carotid artery stenosis. However, only 31 patients met the inclusion and exclusion cri­teria of this trial. Due to problems with recruit­ment and also with financing interventional and diagnostic procedures, we terminated the study before the target number of 50 patients had been reached.Study endpoints The primary endpoint of this study was the proportion of patients who had new cerebral lesions on magnetic resonance im­aging 2 to 3 days after the procedure.Study definitions Patients were considered symp­tomatic if they had an ipsilateral neurological isch­emic event during 60 days before the planned pro­cedure. An ischemic lesion was considered ipsi­lateral if it occurred in cerebral tissue supplied by the target carotid artery. Surgical endarterecto­my was considered successful if there was no re­sidual stenosis after the procedure. Endovascu­lar angioplasty with stenting was considered suc­cessful if there was no residual stenosis greater than 20% and there was no dissection of the tar­get artery following the procedure.Patients After randomization, 14 patients were assigned to the surgical arm, and 17 patients, to the stent arm. The mean (SD) age of patients was 69 (7.7) years: 70.1 (7.7) years in the surgical arm and 68.1 (7.7) years in the stent arm. There were no significant differences between the study arms regarding age and sex of patients or lateralization of the lesions. The mean (SD) length of the target lesion was 14.5 (2.5) mm in the surgical arm and 14.9 (5.9) mm in the stent arm. The mean (SD) degree of stenosis, assessed by Doppler sonogra­phy, computed tomography angiography, or cath­eter angiography, was 83.2% (5.7%) in the surgi­cal arm and 91.2% (10.8%) in the stent arm. These differences were nonsignificant.There were no significant differences between the groups regarding comorbidities. The medi­an time from symptoms to the procedure was 10 days in the stent arm and 12 days in the surgical arm. This difference was also nonsignificant and was probably associated with a more complex preparation of patients for surgical treatment. In the surgical arm, the National Institutes of Health Stroke Scale (NIHSS) scores varied from 0 to 5. The mean (SD) NIHSS score was 1.1 (1.8); thus, the neurological status ranged from no stroke RESEARCH LETTER New ischemic cerebral lesions after interventional procedures 565endarterectomy.11 Nonetheless, a majority of mi­croemboli is probably released during dissection of the carotid arteries. Novel surgical methods focus on no ­touch isolation technique for these arteries.12 Perhaps in future studies assessing the risk of postprocedural cerebral microembo­lism, patients should be managed using such a no­­touch surgical technique.ARTICLE INFORMATIONCONFLICT OF INTEREST None declared.OPEN ACCESS This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 Inter-national License (CC BY -NC -SA 4.0), allowing third parties to copy and re-distribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited, distrib-uted under the same license, and used for noncommercial purposes only. For commercial use, please contact the journal office at pamw@mp.pl.HOW TO CITE Latacz P, Simka M, Bryll A, et al. Cerebral ischemic lesions on diffusion -weighted magnetic resonance imaging after carotid eversion endarterectomy vs carotid stenting with a proximal protection device: re-sults of a randomized prospective trial. Pol Arch Intern Med. 2019; 129: 563-566. doi:10.20452/pamw.14825REFERENCES1 Witt K, Börsch K, Daniels C, et al. Neuropsychological consequences of endarterectomy and endovascular angioplasty with stent placement for treatment of symptomatic carotid stenosis: a prospective randomised study. J Neurol. 2007; 254: 1524-1532. 2 Paraskevas KI, Lazaridis C, Andrews CM, et al. Comparison of cogni-tive function after carotid artery stenting versus carotid endarterectomy. Eur J Vasc Endovasc Surg. 2014; 47: 221-231. 3 Pieniazek P, Musialek P, Kablak -Ziembicka A, et al. Carotid artery stent-ing with patient- and lesion -tailored selection of the neuroprotection sys-tem and stent type: early and 5 -year results from a prospective academ-ic registry of 535 consecutive procedures (TARGET -CAS). J Endovasc Ther. 2008; 15: 249-262. 4 Bijuklic K, Wandler A, Hazizi F, Schofer J. The PROFI study (Prevention of Cerebral Embolization by Proximal Balloon Occlusion Compared to Filter Pro-tection During Carotid Artery Stenting): a prospective randomized trial. J Am Coll Cardiol. 2012; 59: 1383-1389. 5 Latacz P, Simka M, Brzegowy P, et al. Patient- and lesion -tailored algo-rithm of endovascular treatment for arterial occlusive disease of extracrani-al arteries supplying the brain: safety of the treatment at 30 -day follow up. Postepy Kardiol Interwencyjnej. 2017; 13: 53-61. 6 Montorsi P, Caputi L, Galli S, et al. Microembolization during carotid ar-tery stenting in patients with high -risk, lipid -rich plaque. A randomized tri-al of proximal versus distal cerebral protection. J Am Coll Cardiol. 2011; 58: 1656-1663. 7 Cano M, Kambra A, de Cano S, et al. Randomized comparison of distal and proximal cerebral protection during carotid, artery stenting. JACC Car-diovasc Interv. 2013; 6: 1203-1209. or stenting revealed no significant differences regarding cerebral atrophy, leukoaraiosis, or foci of cerebral microinfarction. There was a trend to­wards more new posttreatment ischemic lesions in the surgical arm in comparison with the stent arm (50% vs 35.3% for all patients with new isch­emic lesions, and 35.7% vs 23.5% for ipsilateral lesions), but the differences were not significant. Yet, ipsilateral lesions larger than 1 cm in diam­eter were revealed only in the surgical arm, and this finding was significant. These lesions were differently localized within the brain but all were found in the cerebral territory supplied by the an­terior and / or middle cerebral arteries, and their macroscopic characteristics were suggestive of microembolism.The mean number of new ischemic lesions re­vealed by postprocedural magnetic resonance imaging was higher in the surgical arm (8.9 vs 2.7), but the difference was not significant. Im­portantly, all new ischemic lesions found in pa­tients managed with stents were smaller than 1 cm in diameter. There were no significant dif­ferences between the incidence of contralaterally localized lesions. Details are presented in TABLE 1.Discussion This prospective randomized trial demonstrated that there were fewer new large ischemic lesions after endovascular angioplasty with stenting with a proximal protection device in comparison with surgical eversion endarterec­tomy. However, there are some important limita­tions of our study. This was a single ­center study with a small sample size. Because of the problems with recruitment and financing, we were forced to terminate the study prematurely. Consequently, a trend could be demonstrated for some variables, however without statistical significance. Perhaps significance regarding small postprocedural isch­emic lesions could be confirmed in a larger cohort.It is known that the eversion technique is as­sociated with less frequent perioperative micro­embolic events when compared with standard TABLE 1 Results of diffusion -weighted magnetic resonance imaging after carotid eversion endarterectomy (surgical arm) and carotid stenting (stent arm) Characteristics on DW-MRI Surgical arm (n = 14)Stent arm (n = 17)P valuePatients with new ischemic lesions, n (%) 7 (50.0) 6 (35.3) NSPatients with new ipsilateral ischemic lesions, n (%) 5 (35.7) 4 (23.5) NSPatients with new contralateral ischemic lesions, n (%) 2 (14.3) 2 (11.8) NSPatients with new ipsilateral lesions smaller than 1 cm, n (%) 1 (7.1) 4 (23.5) NSPatients with new ipsilateral lesions larger than 1 cm, n (%) 4 (28.6) 0 0.02Total number of new lesions 62 16 NSNumber of new lesions in patients presenting with such lesions, mean (range)8.9 (1–22) 2.7 (1–6) NSTotal number of new ipsilateral lesions 57 14 NSTotal number of new ipsilateral lesions smaller than 1 cm 45 14 NSTotal number of new ipsilateral lesions larger than 1 cm 12 0 0.02Total number of new contralateral lesions 5 2 NSAbbreviations: DW, diffusion -weighted magnetic resonance imaging; NS, nonsignificantPOLISH ARCHIVES OF INTERNAL MEDICINE 2019; 129 (7-8)5668 Stabile E, Sannino A, Schiatterella GG, et al. Cerebral embolic lesions detected with diffusion -weighted magnetic resonance imaging following ca-rotid artery stenting: a meta -analysis of 8 studies comparing filter cerebral protection and proximal balloon occlusion. JACC Cardiovasc Interv. 2014; 7: 1177-1183. 9 Stabile E, Salemme L, Sorropago G, et al. Proximal endovascular occlu-sion for carotid artery stenting: results from a prospective registry of 1300 patients. J Am Coll Cardiol. 2010; 55: 1661-1667. 10 Hornung M, Bertog S, Franke J, et al. Evaluation of proximal protection devices during carotid artery stenting as first choice for embolic protection. EuroIntervention. 2015; 10: 1362-1367. 11 Gao MY, Sillesen HH, Lorentzen JE, Schroeder TV. Eversion carotid end-arterectomy generates fewer microemboli than standard carotid endarterec-tomy. Eur J Vasc Endovasc Surg. 2000; 20: 153-157. 12 Shukuzawa K, Ohki T, Kanaoka Y, et al. Outcomes of mini -incision ever-sion carotid endarterectomy combined with nontouch isolation technique of the internal carotid artery. J Vasc Surg. 2018; 67: 490-497. 

Cerebral ischemic lesions on diffusion-weighted magnetic resonance imaging after carotid eversion endarterectomy vs carotid stenting with a proximal protection device : results of a randomized prospective trial

https://ruj.uj.edu.pl/xmlui/bitstream/handle/item/256015/latacz_et-al_cerebral_ischemic_lesions_on_diffusion-weighted_magnetic_resonance_imaging_2019.pdf?sequence=1&isAllowed=y

Cerebral ischemic lesions on diffusion-weighted magnetic resonance imaging after carotid eversion endarterectomy vs carotid stenting with a proximal protection device : results of a randomized prospective trial

Abstract

Similar works

Full text

Available Versions

Jagiellonian Univeristy Repository