New ischemic brain lesions on DW-MRI after CAS with double layer stent

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1 New ischemic brain lesions on DW-MRI after CAS with double layer stent Maria Antonella Ruffino, MD, EBIR, Claudio Rabbia, MD Vascular Radiology Città della Salute e della Scienza San Giovanni Battista Hospital Torino, Italy

2 Disclosure Speaker name: Maria Antonella Ruffino I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

3 DAY 0: CAS 2x stroke rate of CEA - Catheterization of the arch - Plaque disruption - Suboptimal embolic protection - Suboptimal response to DAPT

4 DAY 1 30: CAS stroke rate still higher than CEA

5 Ann Surg Oct;246(4): % 60% ipsilateral 18% controlateral

6 Delayed stroke could be related to the failure of the stent in complete scaffolding of the plaque Stroke 2009;40: Higher risk of ipsilateral stroke or ispilateral stroke death in patients treated with an open cell stent (OR 2.13, 95% CI )

7 Dual layer design Open cell stent platform Nitinol - PET micronet Dual layer design Closed cell stent platform Nitinol micromesh

8

9 VASCULAR RADIOLOGY - TORINO INTRODUCTION Incidence of new METHODS ischemic lesions a e Caro d Artery Sten ng (CAS) s ll has a major rate of adverse neurological events in comparison to caro d endoarterectomy (CEA) at 30-days follow up due to distal cerebral emboliza on caused by poor plaque coverage by the stent. The CGuard Caro d Artery Stent (InspireMD, Israel) is a ni nol stent covered by 11 protected CAS with Cguard stent were performed in 11 pa ents. Pa ents data are reported in Table 1 and lesions characteris cs in Table 2. DWI-MR was performed hours before the procedure and at hours and 30 days a er CAS. Ischemic lesion loca on METHODS (ipsilateral, contralateral, and bilateral 11 protected hemisphere) CAS and with size Cguard were stent recorded. were performed in 11 pa ents. Pa ents data are CGuard dual layer design caro d sten Maria Antonella Ruffino, MD, EBIR ; Riccardo INTRODUCTION polyethylene terphtalate (PET). The pore size - 16 protected CAS with Roadsaver stent Caro on 16 consecutive patients of d the Artery mesh Sten is 150 ng to (CAS) 180 s μm. ll has This a major property rate should of adverse prevent neurological embolizaevents on by in plaque and comparison thrombus to par carocle d endoarterectomy during/a er CAS through (CEA) reported in Table 1 and lesions - 11 protected CAS with CGuard stent on 11 consecutive patients Table 2. Lesions characteris cs at 30-days the stent follow nets. up The due aim to distal of this cerebral study is to characteris cs in Table 2. emboliza determine on caused the incidence by poor plaque of new coverage ischemic - to determine the incidence of new ischemic by the ipsilateral stent. The lesions CGuard on diffusion-weighted Caro by d Artery means Stent of DWI-MR ROADSAVER STENT Vo pe (V de DWI-MR Variable was performed hours N = before 11 Th the procedure and at hours and 30 isc (InspireMD, magne Israel) c resonance is a ni (DWI-ME) nol stent covered in the first by 11 days aloca er CAS. on Ischemic lesion loca on we polyethylene pa ents treated terphtalate in our (PET). centre The with pore this size device. (ipsilateral, right contralateral, ICA and bilateral 8 (72.7) Co of the mesh is 150 to 180 μm. This property hemisphere) le and ICA size were recorded. 2 (18.2) no should TABLES prevent emboliza & FIGURES on by plaque and Primary stenosis 7 (63.6) Lil thrombus par cle during/a er CAS through W Table 1. Pa ents characteris cs Table 2. Plaque Lesions morphology characteris cs the stent nets. The aim of this study is to th Echolucent 6 (54.5) determine Variable the incidence of new ischemic N = 11 no Variable Echogenic N = 311 (27.3) ipsilateral lesions on diffusion-weighted Heterogeneous 2 (18.2) vo magneage c resonance (years) (DWI-ME) in the first 11 Loca Plaque on surface irregularity 3 (27.3) ac pa ents treated Mean ± in SD our centre with this 73.4±4.1 device. Plaque right ICA ulcera on 8 (72.7) 2 (18.2) (2 Male 10 (90.1) le ICA 2 (18.2) ra Length, mm 14.3±4.2 Symptoma c 3 (27.3) TABLES & FIGURES Primary stenosis 7 (63.6) wi Smokers 3 (27.3) Percentage of stenosis 83.5±4.1 fo Table 1. Former Pa ents smokers characteris cs 2 (18.2) Plaque morphology sig Diabetes 3 (27.3) ECA Echolucent patency 6 (54.5) 11 (100) Th Variable Hypertension N = 911 (81.8) Echogenic 3 (27.3) Hyperlipidaemia 7 (63.6) Anatomic Heterogeneous variable 2 (18.2) St Age (years) Previous TIA 3 (27.3) Plaque surface Bovine irregularity arch 3 (27.3) 2 (18.2) US Mean Previous ± SD myocardial infarc on 73.4±4.1 5 (45.5) Plaque ulcera Aor on c arch type I 2 (18.2) 6 (54.5) Male NIHSS 10 (90.1) Aor c arch type II 1 (9.1) 0 4 (36.4) Length, mm Aor c arch type III 14.3±4.2 2 (18.2) Symptoma 1 c 3 (27.3) 5 (45.5) ICA tortuosity 1 (9.1) A Smokers 2 3 (27.3) 2 (18.2) Percentage of stenosis (vessel kinking >60 ) 83.5±4.1 Former smokers 2 (18.2) Diabetes Values are mean ± devia on standards, 3 (27.3) number (%) ECA patency 11 (100) Hypertension 9 (81.8) Hyperlipidaemia 7 (63.6) Anatomic variable Previous Vascular TIA Radiology Unit Ci 3 (27.3) a della Salute e della Scienza S. Giovanni Ba sta Hospital Torino, B Bovine arch 2 (18.2) * Previous Radiology myocardial Unit infarc Department on 5 (45.5) of Surgical Science University Aor of c arch Torino type -AOU I Ci 6 (54.5) a della Salute e d NIHSS Aor c arch type II 1 (9.1) 0 4 (36.4) Aor c arch type III 2 (18.2) 1 5 (45.5) ICA tortuosity 1 (9.1) 2 2 (18.2) (vessel kinking >60 ) CGUARD STENT Values are mean ± devia on standards, number (%) Vascular Radiology Unit Ci a della Salute e della Scienza S. Giovanni Ba sta Hospital Torino, Italy * Radiology Unit Department of Surgical Science University of Torino -AOU Ci a della Salute e della S Patients and lesion characteristics F I A l

10 Patients were scheduled to undergo clinical, duplex ultrasound and DWI-MR evaluations of their status at baseline, 24 h and at 30 days after the stenting ROADSAVER STENT CGUARD STENT - All patients received 100 mg acetylsalicylic acid and a loading dose of 375 mg clopidogrel, if they were not already on dual antiplatelet therapy for other reasons - After the procedure, a daily dose of 100 mg acetylsalicylic acid and 75 mg clopidogrel was administered for one month, after which only acetylsalicylic acid

11 INCIDENCE, NUMBER, SITE AND VOLUME OF NEW ISCHEMIC BRAIN LESIONS AT 24 HOURS DWI-MR

12 INCIDENCE OF NEW LESIONS

13 LESIONS VOLUME * the statistics presumably includes also the procedures with no lesions: in this case, our median volume would drop to reduced volume, i.e.for Roadsaver stent procedure to 0.03 cm 3 with TR= cm 3 study reports volumes as normal variables, i.e. as mean± standard deviation, even if the latter is twice as much as the former leading to virtual negative volumes

14 INCIDENCE OF NEW ISCHEMIC BRAIN mo.: 0% DWI-MR at the 1-month FU examination showed complete recovery of all lesions and no evidence of new acute ischemic lesions Clinical evaluation at 30 days excluded any major cerebrovascular event (MACCE rate 0%) At 30-days ultrasound examination, ECA was patent in all cases Stents were patent without in-stent restenosis.

15 CONCLUSIONS Protected CAS with available double layer stents is safe, with 30 day MACCE of 0% and patency of ECA after the procedure and at 30 days The procedure has a lower incidence of new ischemic cerebral lesion in comparison to previous studies with conventional carotid stents All lesions had completely recovered by the 1 month follow up without evidence of new ischemic lesions CAS procedure with micromesh Roadsaver Carotid Artery stent seem to be safe and effective in terms of reduction of delayed embolic events and new ipsilateral ischemic brain lesions on DWI-MR in comparison to conventional carotid stent The results obtained with this device are consistent with those of CGuard stent, not only in our experience, but also when compared to CARENET study results If these data will be confirmed by larger studies and longer follow ups, they could lead to a rehearsal of carotid artery stenting

16 New ischemic brain lesions on DW-MRI after CAS with double layer stent Maria Antonella Ruffino, MD, EBIR, Claudio Rabbia, MD Vascular Radiology Città della Salute e della Scienza San Giovanni Battista Hospital Torino, Italy

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