Laura Capoccia

1. Membrane meshcoveredstentshave a bright future the iron-guardstudy Laura Capoccia Vascular and Endovascular Surgery Division, Chief Prof. Francesco Speziale, Department of Surgery “Paride Stefanini”, Policlinico Umberto I, “La Sapienza” University of Rome, ITALY on behalf of the IRONGUARD Study Group Collaborators

2. Risk of embolism RISK OF CAS-RELATED EMBOLISM? Nitinol expansion Stent deployment Filter positioning Predilatation Time Postdilatation

3. Plaquehealing 28 days? OCT Plaque proplase and distal embolization through the stent struts during the first 30-day

4. Reductionofperioperativeneurologicembolization Membrane-coveredstent Distalembolicprotectiondevice stenting ballooning Flow-reversalembolicprotectiondevice time

5. IS A MESH-COVERED STENT ABLE TO CAPTURE EVERY KIND OF EMBOLISM?

6. EVEN THE “OFF-TABLE” ONE?

7. New generation stents IDEAL PORE SIZE Double-layers surface to prevent embolization CGUARD™ Closed cell stent Open cell stent TERUMO * Average in lesion at expanded state C-Guard stent is an innovative monorail, self-expanding, open cell, nitinol stent covered by a polyethylene terephthalate (PET) micromesh. GORE

8. Iron-guardstudy To report on outcomes in a prospective series of patients submitted to protected CAS with C-Guard stent (InspireMD, Boston, MA, USA) between 04-2015 and 06-2016 Primary endpoints Periop. Major Adverse Cerebrovascular Cardiac Event (MACCE) Procedure-related brain embolism (24/72hrs DWMRI) Secondary endpoints technical success, procedural success, 1 month MACCE Post-op and 12-month results analysis Speziale, Capoccia et al. EuroIntervention 2017

9. Iron-guardstudy Physician-initiated prospective multicenter registry 12 centers performing >50 CAS per year 200 patients enrolled • Inclusion Criteria: • ≥ 50% symptomatic stenosis, or ≥ 70% asymptomatic stenosis; • target lesion located in the distal CCA, ICA, or carotid bifurcation; • target vessel diameter between 4mm and 9mm; • life expectancy > 12 months; • willing and able to comply with follow-up requirements. Speziale, Capoccia et al. EuroIntervention 2017

10. Iron-guardstudy 12 centers Sapienza University of Rome University of Siena City Hospital, Civitavecchia Bel Colle Hospital, Viterbo Istituto Auxologico IRCCS, Milan Mauriziano Umberto I Hospital, Turin Cardinal Massaia Hospital, Asti Tor Vergata University of Rome San Filippo Neri Hospital, Rome Città della Salute Hospital, Turin City Hospital, Crema Santa Maria Hospital, Udine Speziale, Capoccia et al. EuroIntervention 2017

11. Iron-guardstudy demographics Speziale, Capoccia et al. EuroIntervention 2017

12. Iron-guardstudy Duplex ultrasound 68% Speziale, Capoccia et al. EuroIntervention 2017

13. Iron-guardstudy Preoperativecta Speziale, Capoccia et al. EuroIntervention 2017

14. Iron-guardstudy Intraoperativedetails *Dilatation time ranged between 2-30 sec Speziale, Capoccia et al. EuroIntervention 2017

15. Iron-guardstudy Perioperativeresults Technical Success: 100% 1/200 patients required additional stent because incomplete plaque coverage MACCE = 0 5 minor strokes 2 TIAs No complication No additional ECA occlusion Speziale, Capoccia et al. EuroIntervention 2017

16. Iron-guardstudy Dw-mriResults in 61 pts Pre and 24/72 hours postoperative DW-MRI SUBGROUP ANALYSIS New postoperative lesions in 12 patients (19.6%) 6 (9.8%) presented with ipsilateral-only 6 (9.8%) with contralateral or bilateral lesions Speziale, Capoccia et al. EuroIntervention 2017

17. Iron-guardstudy Dw-mriResults in 61 pts It was not possible to predict Embolic risk Speziale, Capoccia et al. EuroIntervention 2017

18. Iron-guardstudy Dw-mriResults in 61 pts Speziale, Capoccia et al. EuroIntervention 2017

19. Dw-mriResults CARENET TRIAL (InspireMD) New lesions in 37.0% in 30 patients JACC CardiovascInterv. 2015 Aug 17;8(9):1229-34. IRONGUARD ITALIAN REGISTRY (InspireMD) New lesions in 19.6% in 61 patients EuroIntervention, 2017 May 9 ROADSAVER ITALIAN REGISTRY(Terumo) New lesions not evaluated EuroIntervention. 2016 Aug 5;12(5):e677-83. Speziale, Capoccia et al. EuroIntervention 2017

20. conclusions Data from the present physician-initiated, real-life, multi-center study demonstrate 30-day efficacy and safety of CAS using exclusively the novel MicroNet-covered embolic prevention stent CGuard, with a significant reduction of post-procedural adverse neurologic events in a predominantly asymptomatic cohort.

21. The cas dilemma Is the C-Guard the answer …

22. The cas dilemma …to the “embolus-hunt”?

23. Is the c-guard the answer to the “embolus-hunt”? yes Because the embolism rate is extremely low (19.6%) no Because that embolism rate is observed at 24-72 hours postoperatively

24. plaquehealingperiod 28/30 days When is the best time to perform DWMRI? Do we need more than one DWMRI? Is DWMRI able to detect all we want to know about the after-CAS brain?

25. acknowledgments Francesco Speziale Carlo Setacci Laura Capoccia Wassim Mansour Chiara Pranteda Federico Accrocca Domenico Alberti Renato Casana Gianmarcode Donato Michelangelo Ferri Andrea Gaggiano Giuseppe Galzerano ArnaldoIppoliti Nicola Mangialardi Giovanni Pratesi Sonia Ronchey Maria Antonella Ruffino Andrea Siani Angelo Spinazzola Massimo Sponza

26. Symposium Chairman Francesco Speziale Scientific Secretariat Laura Capoccia Wassim Mansour Pasqualino Sirignano Vascular and Endovascular Surgery Division Department of Surgery “Paride Stefanini” “Sapienza” University of Rome Policlinico Umberto I e-mail: caput.meeting@gmail.com SAVE THE DATE 22-23 MAY 2018

27. Thanksforyourattention