CGuard MicroNet-Covered Embolic Prevention Stent System A Game Changer in Carotid Revascularization
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1 CARENET J Am Coll Cardiol 2015;66:B33 CGuard MicroNet-Covered Embolic Prevention Stent System A Game Changer in Carotid Revascularization Piotr Musialek, MD DPhil FESC Jagiellonian University Dept. of Cardiac & Vascular Diseases John Paul II Hospital, Krakow, Poland
2 CARENET J Am Coll Cardiol 2015;66:B33 CGuard MicroNet-Covered Embolic Prevention Stent System A Game Changer in Carotid Revascularization Piotr Musialek, MD DPhil FESC Jagiellonian University Dept. of Cardiac & Vascular Diseases John Paul II Hospital, Krakow, Poland
3 CARENET J Am Coll Cardiol 2015;66:B33 CGuard MicroNet-Covered Embolic Prevention Stent System A Game Changer in Carotid Revascularization Piotr Musialek, MD DPhil FESC Jagiellonian University Dept. of Cardiac & Vascular Diseases John Paul II Hospital, Krakow, Poland
4 Disclosures ABs / Research Support / Consulting / Speaker Bureau Abbott, Balton, InspireMD, Medtronic, Penumbra NB. The PARADIGM study has been Invesigator-Initiated and Investigator-Executed ( no industry support )
5 CGuard embolic prevention stent P. P. Musialek ICI TCT
6 P. ICI 2015
7 Mandatory DW-MRI P. ICI 2015
8 Mandatory DW-MRI CARENET , PJ (Krakow) P. ICI 2015 Prior to CAS 24h after 30 d after CAS
9 Mandatory DW-MRI CARENET , PJ (Krakow) P. ICI 2015 Prior to CAS Rec.Symptomatic LICA 24h after 30 d after CAS THR Note self-tapering
10 Mandatory DW-MRI CARENET , PJ (Krakow) P. ICI 2015 Prior to CAS Rec.Symptomatic LICA 24h after 30 d after CAS PARADIGM & PARADIGM-EXTEND STUDIES THR Note self-tapering
11 Mandatory DW-MRI CARENET , PJ (Krakow) Prior to CAS Rec.Symptomatic LICA 24h after 30 d after CAS PARADIGM & PARADIGM-EXTEND THR Note self-tapering Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
12 Mandatory DW-MRI CARENET , PJ (Krakow) Prior to CAS Rec.Symptomatic LICA 24h after 30 d after CAS PARADIGM & PARADIGM-EXTEND THR Note self-tapering Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
13 Mandatory DW-MRI CARENET , PJ (Krakow) Prior to CAS Rec.Symptomatic LICA 24h after 30 d after CAS PARADIGM & PARADIGM-EXTEND THR R O U T I N E CLINICAL PRACTICE Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
14 R O U T I N E CLINICAL PRACTICE P. ICI 2015
15 P. TCT 2015
16 CAS (and CEA) are and will remain emboli-generating procedures P. ICI 2015
17 CAS (and CEA) are and will remain emboli-generating procedures P. ICI 2015
18 CAS (and CEA) are and will remain emboli-generating procedures P. ICI 2015
19 CAS (and CEA) are and will remain emboli-generating procedures P. ICI 2015
20 CAS (and CEA) are and will remain emboli-generating procedures P. ICI 2015
21 Δ P. TCT 2015
22 P. ICI 2015
23 P. ICI 2015
24 Conventional Carotid Stent K. Mathias 2013 J. Schofer, P. Musialek et al. TCT 2014 P. TCT 2015
25 Conventional Carotid Stent Human Carotid OCT Image Courtesy Dr Juan Rigla, MD PhD Perceptual Imaging Lab, Univerity of Barcelona P. ICI 2015
26 P. ICI 2015 ANY data on the incidence of PLAQUE PROLAPSE in conventional carotid stents?
27 P. ICI 2015
28 P. ICI 2015 Post-procedural PLAQUE PROLAPSE through conventional stent struts De Donato et al. Eur J Vasc Endovasc Surg 2013;45:
29 Conventional Carotid Stent K. Mathias 2013 J. Schofer, P. Musialek et al. TCT 2014 P. TCT 2015
30 Anti - Embolic Carotid Stent J. Schofer, P. Musialek et al. TCT 2014 P. TCT 2015
31 P. P. Musialek TCT ICI 2015 CGuard embolic prevention system
32 Specific, carotid-dedicated design NB. CGuard EPS is not yet available in the US P. ICI 2015
33 P. TCT 2015
34 P. TCT 2015
35 P. ICI 2015
36 P. ICI 2015 DW-MRI: the unforgiving testimony of what you ve done to the TARGET ORGAN...
37 P. ICI 2015
38 P. ICI 2015
39 P. ICI 2015
40 P. ICI 2015
41 P. ICI 2015
42 P. ICI 2015
43 P. ICI 2015
44 Anti - Embolic Carotid Stent K. Mathias 2013 J. Schofer, P. Musialek et al. TCT 2014 P. TCT 2015
45 Anti - Embolic Carotid Stent CGuard Embolic-Prevention Stent OCT Image (human, iv vivo) Courtesy Dr Juan Rigla, MD PhD Perceptual Imaging Lab, Univerity of Barcelona J. Schofer, P. Musialek et al. TCT 2014 P. ICI 2015
46 P. ICI 2015
47 Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
48 Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
49 Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
50 Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
51 Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
52 Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
53 Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
54 Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
55 Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
56 Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
57 Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66(suppl):B33 P. ICI 2015
58 * Emboshield (n=7); FilterWire (n=14); Spider (n=25) ** Gore FlowReversal (n=4) or flow reversal with MoMa (n=21) (NB. mean flow reversal time was 6min 48s, from 5min 18s to 11min 2s) # ø 4.5mm (n=5); ø 5.0mm (n=36); ø 5.5mm (n=29); ø 6.0mm (n=1); 30mm in 51 lesions; 40mm in 18 lesions (2 other lesions required two stents each) P. ICI 2015
59 Musialek P et al. Impact of routine micronet-covered embolic prevention stent system use on contemporary carotid revascularization: All-comer PARADIGM Study. JACC 2015;66:B33 P. ICI 2015
60 Evolving L Haemisph stroke Case # 063 (Krakow)
61 Case # 063 (Krakow) NO new brain lesions M. Urbanczyk, P. Banys, Dept. Radiology, JP2 Hospital, Krakow, Poland
62 R Haemisph minor stroke 4 d before, now recurrent TIAs Note self-tapering Case # 067 (Krakow)
63 R Haemisph minor stroke 4 d before, now recurrent TIAs Case # 067 (Krakow) NO new brain lesions NO new brain lesions M. Urbanczyk, P. Banys, Dept. Radiology, JP2 Hospital, Krakow, Poland
64 L Haemisph minor stroke 5 d before Case # 068 (Krakow)
65 L Haemisph minor stroke 5 d before Case # 068 (Krakow) NO new brain lesions NO new brain lesions M. Urbanczyk, P. Banys, Dept. Radiology, JP2 Hospital, Krakow, Poland
66 L Haemisph minor stroke 5 d before Case # 068 (Krakow) NO new brain lesions NO new brain lesions M. Urbanczyk, P. Banys, Dept. Radiology, JP2 Hospital, Krakow, Poland
67 L Haemisph minor stroke 5 d before Case # 67 (Krakow) M. Urbanczyk, P. Banys, Dept. Radiology, JP2 Hospital, Krakow, Poland
68 RICA 6.2/1.5 m/s Highly-calcific I Predilatation 3.0x20mm followed by NC 4.5x15/20atm CGuard 9.0x30mm, postdilated ø5.5x20mm/16atm A. Mazurek, P. Musialek epcr2015
69 Highly-calcific II NO brain lesions with CAS Predilatation 2.0x20 followed by NC 4.0x15, CGuard 8.0x40mm, postdilated ø 5.0mm/16 atm A. Mazurek, P. Musialek epcr2015
70 Highly-calcific III Note self-tapering Predilatation 2.5x15mm followed by 4.0x15, CGuard 9.0x30mm, postdilated ø5.0mmx20/24atm A. Mazurek, P. Musialek epcr2015
71 CGuard P. ICI 2015
72 CGuard P. ICI 2015
73 P. ICI 2015 PARADIGM EXTEND
74 30d data P. ICI 2015 Z E R O Stroke/ MI/death
75 30d data P. ICI 2015 Z E R O Stroke/ MI/death 12mo data
76 30d data P. ICI 2015 Z E R O Stroke/ MI/death 2 asymptomatic 30 days 12mo data
77 30d data P. ICI 2015 Z E R O Stroke/ MI/death 2 asymptomatic 30 days 100% follow up of the remaining patients 12mo data
78 30d data P. ICI 2015 Z E R O Stroke/ MI/death 2 asymptomatic 30 days 100% follow up of the remaining patients 12mo data Z E R O Stroke Deaths Z E R O 12mo Per-Protocol independent neurological assessment
79 30d data P. ICI 2015 Z E R O Stroke/ MI/death 2 asymptomatic 30 days 100% follow up of the remaining patients Z E R O Stroke Deaths Z E R O Strokes 1 pulmonary embolism 5 mo 1 respiratory failure 8 mo 1 malignant tumor 9 12mo Per-Protocol independent neurological assessment
80 P. ICI NO device-related adverse events NO procedure-related events CARENET Multicenter Trial 12 mo data
81 Peak Systolic Velocity (cm/sec) CARENET in-stent Peak Systolic Velocities % in-stent stenosis threshold* d 6 mo 12 mo ECA patency 100% 100% 100% * Setacci et. Al.. Grading Carotid Intrastent Restenosis of 814 CAS patients Stroke 2008 P. ICI 2015
82 Peak Systolic Velocity (cm/sec) * Setacci et. Al.. Grading Carotid Intrastent Restenosis of 814 CAS patients Stroke 2008 P. VEITH 2015 CARENET in-stent Peak Systolic Velocities % in-stent stenosis threshold* d 6 mo 12 mo ECA patency 100% 100% 100%
83 Peak Systolic Velocity (cm/sec) * Setacci et. Al.. Grading Carotid Intrastent Restenosis of 814 CAS patients Stroke 2008 P. ICI 2015 CARENET in-stent Peak Systolic Velocities % in-stent stenosis threshold* NO in-stent restenosis concern d 6 mo 12 mo ECA patency 100% 100% 100%
84 Peak Systolic Velocity (cm/sec) * Setacci et. Al.. Grading Carotid Intrastent Restenosis of 814 CAS patients Stroke 2008 P. ICI 2015 CARENET in-stent Peak Systolic Velocities % in-stent stenosis threshold* NO in-stent restenosis concern NO CGuard ECA patency concern d 6 mo 12 mo ECA patency 100% 100% 100%
85 CAS (and CEA) are and will remain emboli-generating procedures amenable to elimination with MicroNet P. ICI 2015
86 P. ICI 2015 Endovascular Solution for All-Comers Note self-tapering Endovascular Reconstruction of the Carotid Bifurcation
87 P. ICI 2015
88 DW-MRI Evidence (CARENET) Clinical Evidence (CARENET, PARADIGM, PARADIGM-EXTEND) P. ICI 2015
89 P. ICI 2015
90 P. ICI 2015
91 P. ICI 2015
92 P. ICI 2015
93 P. ICI 2015
94 CGuard Embolic-Prevention Stent Image Courtesy Dr Juan Rigla, MD PhD Perceptual Imaging Lab, Univerity of Barcelona P. P. Musialek TCT ICI 2015
95 CAS 2010 VISION CGuard Embolic-Prevention Stent Image Courtesy Dr Juan Rigla, MD PhD Perceptual Imaging Lab, Univerity of Barcelona P. P. Musialek TCT ICI 2015
96 CAS 2010 VISION Carotid Revascularization R E A L I T Y CGuard Embolic-Prevention Stent Image Courtesy Dr Juan Rigla, MD PhD Perceptual Imaging Lab, Univerity of Barcelona P. P. TCT ICI 2015
97 CGuard Embolic-Prevention Stent Image Courtesy Dr Juan Rigla, MD PhD Perceptual Imaging Lab, Univerity of Barcelona P. P. Musialek TCT ICI 2015
98 Back-up slides
99 CREST 30 d P. ICI 2015
100 CREST CREST P. ICI 2015
101 CREST CREST P. ICI 2015
102 What would CREST show today CREST with 30 d P. ICI 2015
103 What would CREST show today CREST with instead of 30 d? P. ICI 2015
104 Feeding today s CGuard CAS data to CREST CREST 30 d would indicate CAS superiority P. ICI 2015
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