MAL NCVH,2016. Yaron Almagor M.D Director Interventional Cardiology, SZMC Jerusalem

Transcription

1 MAL NCVH,2016 Yaron Almagor M.D Director Interventional Cardiology, SZMC Jerusalem

2 CAS Treatment CREST Data Carotid endarterectomy (CEA) associate with more MI Brott et al. NEJM, 2010;363 Carotid-artery stenting (CAS) associate with more minor stroke

3 CREST: 10 Years Follow-up

4 Suzuki M et al. ESC 2014 Eur Heart J. 2014;35(Abstr Suppl):178 Post-Procedural Plaque Prolapse Through Conventional Stent Struts 30.7% 1/3 stents = Precise 2/3 stents = Carotid Wallstent

5 Post-Procedural Plaque Prolapse Through Conventional Stent Struts De Donato et al. Eur J Vasc Endovasc Surg 2013;45:

6 Bosiers et al. Eur J Vasc Endovasc Surg 2007;33 Late Embolization - The Unmet Need No stent or current EPS protects against late embolization 2/3 MACCE events occur post-procedure

7 MicroNet Technology The MicroNet TM : Bio-stable mesh woven 20μm Single strand Polyethylene Terephthalate (PET). The MicroNet TM is designed to: Trap and seal thrombus and plaque against the vessel wall, preventing embolization. The MicroNet is sutured to both the distal and proximal crowns of the stent platform. Advantages of the technology: Flexible structure Does not promote thrombosis Minimal foreign body reaction Does not alter procedure Optimal pore size MicroNet technology supported by 6+ years of MGuard coronary data

8 Smart Fit Technology Eliminates need for straight and tapered versions MicroNet encapsulates struts mitigating fish scaling

9 Ideal Pore Size CGUARD *165µ 375µ 500µ 1050µ 1900µ Closed cell stent Open cell stent TERUMO GORE * Average in lesion at expanded state

10 Best of Both Worlds Smaller pore size Larger free cell area = Better plaque scaffolding Better flexibility. *Images almost to scale, but not exact Dr. Marc Bosiers, CACVS 2014

11 Late Embolization - The Unmet Need

12 Clinical Data

13 CARENET Study Details Study Design: Prospective, multi-center, single arm Objectives: To evaluate the periprocedural safety and efficacy of the CGuard stent in the treatment of carotid lesions in 30 consecutive patients with symptomatic and asymptomatic carotid artery stenosis, suitable for CAS Primary Endpoint: 30 day MACCE (death, stroke, MI) Schoferet et al. JACC 2015;8:

14 CARENET Baseline Characteristics Schoferet et al. JACC 2015;8: n=30 Age (years) 71.6 ±7.6 Male 63.4% Hypertension 83.3% (25) Hyperlipidemia 90% (27) Diabetes mellitus 23.3% (7) Cigarette smoking, current 13.4% (4) Prior myocardial infarction 26.7% (8) Prior TIA 13.3% (4) NIH stroke scale 1.37 ± 2.6

15 CARENET Procedural Results n=30 Femoral access 100% (30) Target vessel - Left ICA 33.3% (10) - Right ICA 66.6% (20) Protection used -Distal filter protection -Proximal balloon protection 96.6% (29) 3.4% (1) Pre dilatation 70.9% (22) Post dilatation 77.4% (24) Post dilatation pressure (ATM) 13.6 ±4.5 Procedure success 100% (30) Stent deployed 100% (30) Stent diameter (mean) 8.23mm ± 0.8 Stent length (mean) 34.8 mm ± 5.0 Schoferet et al. JACC 2015;8:

16 CARENET Angiographic Results Schoferet et al. JACC 2015;8: Baseline Final Lesion location in left/right ICA 33/67% - Lesion length in mm 16.94±4.7 - RVD in mm 6.18± ±0.70 MLD in mm 1.25± ±0.60 % in stent diameter stenosis 79.9± ±6.5 TIMI III flow in the ECA 100% 100%

17 CARENET Clinical Events 30 days (n=30) 6 months (n=28*) MACCE (MI, stroke, death) (0) 0.0% (1) 3.6% MI (0) 0.0% (0) 0.0% Stroke (0) 0.0% (0) 0.0% Death (0) 0.0% (1) 3.6% Comparative data from other CAS trials include higher 30 day and 6 month MACCE rates: 30 days** (14 trials, 5255 patients) * 2 patients exited the study ** Trials included in analysis: ARCHeR pooled, ARMOUR, BEACH, CABERNET, CREATE, EMPIRE, EPIC, MAVErIC 1+2, MAVErIC International, PRIAMUS, SAPPHIRE, SECURITY, PROFI, ICSS Values extrapolated from event curves 6 months (3 trials, 1053 patients) MACCE (MI, stroke, death) 5.72% 8.09%

18 CARENET DW-MRI Analysis incidence new ipsilateral lesions (%) volume new ipsilateral lesions (cm 3 ) DW-MRI 48 hours, n=27* CARENET PROFI Incidence of new ipsilateral lesions at 48 hours was reduced by almost half compared to published data, and volume was reduced almost 10-fold All but one lesion had resolved completely by 30 days. Schoferet et al. JACC 2015;8: Bijuklic et al. JACC, 2012;59 DW-MRI 30 days, n=25** Incidence of new ipsilateral lesions 4.0% Average lesion volume (cm 3 ) 0.08 ± 0.00 Permanent lesions at 30 days 1

19 CARENET 12 month follow-up Z E R O Z E R O Z E R O Z E R O Death cause: Stroke Strokes Deaths Device Related Deaths Stent Thrombosis 30 days (n=30) 6 months (n=28*) 1 pulmonary embolism 5 mo 1 respiratory failure 8 mo 12 months (n=27) MACCE (MI, stroke, death) (0) 0.0% (1) 3.6% (3) 11.1% MI (0) 0.0% (0) 0.0% (0) 0.0% stroke (0) 0.0% (0) 0.0% (0) 0.0% death (0) 0.0% (1) 3.6% (3) 11.1% * 2 patients exited the 6 month 1 malignant tumor 9 mo P. VEITH 2015

20 CARENET Ultrasound Analysis 30 days (n=28*) 6 months (n=26**) Internal carotid patent (28) 100% (26) 100% PSV (cm/sec) ± ± EDV (cm/sec) ± ± ICA/CCA PSV ratio 1.13 ± ± month ultrasound analysis is indicative of healthy healing without restenosis concern. * Excluding 2 patients who exited the study prior to the Ultrasound ** Excluding 2 additional patients (1 died, 1 not done within window)

21 CARENET: Selected Cases

22 CARENET: Selected Cases

23 CARENET Conclusions CGuard offers unique clinical benefits for patients undergoing CAS with unprecedented safety. CARENET trial demonstrated safety of the CGuard stent, with 30 day MACCE = 0%. Incidence of new ipsilateral lesions at 48 hours was reduced by almost half compared to published data, and volume was reduced almost 10-fold. All but one lesion had resolved completely by 30 days. 6 month ultrasound analysis is indicative of healthy healing without restenosis concern.

24 Prospective evaluation of All-comer percutaneous carotid revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis using CGuard Micronet-covered embolic prevention stent system: The PARADIGM Study P. MUSIALEK 1, A. MAZUREK 1, M. TRYSTULA 2, A. BORRATYNSKA 3, M. URBANCZYK 3, A. LESNIAK-SOBELGA 1, P. BANYS 3, A. BRZYCHCZY 2, L. PARTYKA 4, K. ZMUDKA 5, P. PODOLEC 1 (1) Dept Cardiac and Vascular Diseases, Jagiellonian University & John Paul II Hospital, (2) Dept Vascular Surgery, John Paul II Hospital; (3) John Paul II Hospital, Krakow; (4) Krakow Cardiovascular Research Institute (KCRI); (5) Dept Interventional Cardiology, Jagiellonian University & John Paul II Hospital, Krakow, POLAND Jagiellonian University Dept. of Cardiac & Vascular Diseases John Paul II Hospital, Krakow, Poland

25 Objective. to evaluate feasibility and outcome of routine anti-embolic stent system use in unselected, consecutive patients referred for carotid revascularization ( all-comer study)

26 . PARADIGM ASYMPTOMATIC patients treated interventionally. only if at stroke risk established lesion-level increased-risk crieria used: thrombus-containing tight, near-occlusive documented progressive irregular and/or ulcerated contralteral ICA occlusion/stroke asymptomatic ipsilateral brain infarct AbuRahma A et al. Ann Surg. 2003;238: Ballotta E et al. J Vasc Surg 2007;45: Kakkos SK et al. (ACSRS) J Vasc Surg. 2009;49: Lovett JK et al. Circulation 2004;110: Nicolaides AN et al. J Vasc Surg 2010;52: Taussky P et al. Neurosurg Focus 2011;31:6-17.

27 Study Flow Chart (1) 97 carotid stenosis patient referrals (external >> internal) * Neuro-Vascular Team.. Neurologist Interventional Angiologist Vascular Surgeon Cardiologist for carotid revascularization 73 patients NOT for carotid revascularization 24 patients n= 19: l esion increased risk and/or severity criteria not met n = 2: ICA totallyoccluded on verification n = 2: ICA functionallyocclded+ h/o prioripsil. largeinfarct withhemorrhagictransformation n = 1: severehaemodynamicinstability(ica stenosisa sympt.) Gupta K et al. A multispecialty consensus-based approach to carotid revascularization. J Invasive Cardiol. 2014;26: Tomai F et al. Carotid artery revascularization selected by consensus of a cardiovascular team. EuroIntervention 2014;9: Kole MK et al. A multidisciplinary carotid revascularization board. Surg Neurol Int. 2012;3:117. *Dept. of Cardiac & Vascular Dieases, John Paul II Hospital, Krakow, Poland;

28 Study Flow Chart (2) 73 Patients for carotid revascularization (92%) (1%) (7%) CAS in n=67 Patients (bilateral in 3) CAS + CEA in n=1 Patient (LICA-CEA and RICA-CAS) hybridmanagement 71 ICAs treated endovascularly in 68 patients CEA in n=5 Patients n = 1 egrf14 => no contrast n = 1 extremeaccesstortuousity n = 1 severeaortic valvedisease + calcificlica ( AVR + CEA ) n = 1 floating thrombus incca n = 1 ICA diameter <2.0 mm + contralat. occlusion

29 Clinical characteristics of study patients (n=68) age, mean±sd (min max) 69 ±7 (55 83) male, % (n) 66% (45) symptomatic, % (n) symptomatic 14 days, % (n) acutely symptomatic (emergent CAS), % (n) 53% (36) 28% (19) 9% (6) index lesion (CAS), % (n) RICA 52% (35) LICA 44% (30) RICA+LICA 4% (3) CAD, % (n) 65% (44) h/of MI, % (n) 27% (18) CABG or PCI in the past, % (n) 38% (26) PCI as bridge to CAS, % (n) 16% (11) AFib (h/o or chronic), % (n) 6% (4) diabetes, % (n) 35% (24) h/o neck or chest radiotherapy, % (n) 4% (3)

30 .. PARADIGM: Results Percutaneous treatment 100% using the intended MicroNet-covered embolic prevention stent system CGuard (ie, no other stents used during the study period) Device success 100% Procedure success 100% Transient Dopamine infusion Debris in EPD 19% (n=14) 18% (n=13) Access site complications 0% ( n=0 ) Vascular plug closure 45% (n=32)

31 PARADIGM: Results Index lesion qualitative characteristics (n=71 lesions) All (n=71) Symptomatic (n=37) Asymptomatic (n=34) p thrombus, % (n) 15% (11) 24% (9) 6% (2) near occl./string, % (n) 21% (15) 30% (11) 12% (4) proggressive*, % (n) 27% (19) 11% (4) 44% (15) ulcerated, % (n) 41% (29) 46% (17) 35% (12) irregular, % (n) 72% (51) 65% (24) 79% (27) contralateral occl., % (n) 17% (12) 22% (8) 35% (12) highly calcific, % (n) 23% (16) 14% (5) 35% (12) asymptomatic ipsilat. brain embolization/infarct N/A N/A 32% (11) N/A * veriified imaging Quantifieḍ. ICA reference diameter Lesion length 4.99 ± 0.36mm (from 4.27 to 6.02mm) 19.9 ± 5.8mm (from 8.19 to 30.25mm)

32 PARADIGM: Results.. 48h 0% 30d 0%

33 PARADIGM: Conclusions. >90% all-comer carotid artery stenosis patients, including >50% symptomatic presentations, can be treated endovascularly using the MicroNet-covered embolic prevention stent system CGuard.endovascular revascularization with routine use of the MicroNet- -covered embolic prevention stent system CGuard in an unselected patient polulation is extremely safe. use of the MicroNet-covered embolic prevention stent system enables endovascular reconstruction of the diseased carotid artery across a wide lesion spectrum (from extremely tight and thrombotic to highly calcific) in absence of periprocedual clinical complications procedural safety of the MicroNet-covered embolic prevention system extends.throughtout the stent healing period

34 Endovascular Reconstruction of the CarotidBifurcation CGuard: Endovascular Solution For All-comers 61 yo symptomatic LICA Piotr epcr yo asymptomatic RICA

35 MAL

36 MAL NCVH,2016 Yaron Almagor M.D Director Interventional Cardiology, SZMC Jerusalem