The Mindguard Carotid The Mindguard Carotid Mesh Diverter to Prevent Mesh Diverter to Prevent Embolic Stroke Embolic Stroke Sievert S, Skowasch M, Römer A Sievert S, Skowasch M, Römer A CardioVascular Center Frankfurt CardioVascular Center Frankfurt Sankt Katharinen Sankt Katharinen Frankfurt, Germany Frankfurt, Germany CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
PRESENTER DISCLOSURE INFORMATION Name: Horst Sievert, M.D. Horst Sievert, M.D. Nothing to Disclose Related to this Presentation CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Emboli are the Major Cause Emboli are the Major Cause of Ischemic Stroke of Ischemic Stroke PFO and unknown 21% non embolic 40% Aortic Arch Atheroma 14% RHD, AF Aneurysm 15% 10% Stroke 1988;19:547 Data from NINCDS Stroke Data Bank Stroke 1999: 30:2513 Minnesota population based study NEJM 2000;342:1743 Framingham Study CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Anticoagulation Anticoagulation • Difficult to manage in clinical practice Difficult to manage in clinical practice • Risk of side effects Risk of side effects • Contraindicated in many patients Contraindicated in many patients • Probably not effective in aortic arch Probably not effective in aortic arch atheroma atheroma CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Mindguard Carotid Mesh Diverter Mindguard Carotid Mesh Diverter Concept: To divert emboli to a benign location Concept: To divert emboli to a benign location External External Carotid Carotid Internal Internal Artery Artery Carotid Carotid Artery Artery Common Common Carotid Carotid Artery Artery
The In-vitro Model Flow studies (CDPIV) were carried out to test global and local aspects of bifurcation filtration global local
Local Hemodynamics Thin struts Thick struts Thin struts Thick struts Pulsatile, Turbulence, laminar (Steady)
The Fine Wire Concept The Fine Wire Concept High porosity index High porosity index CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
> 200 Implantations in Animals > 200 Implantations in Animals N= 15 RSA Renal Carotid Iliac N= 26 N= 193 Femoral CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
The Diverter Patency The Diverter Patency weeks 2 weeks 4 weeks 2 weeks 4
The Diverter Patency The Diverter Patency weeks 5 weeks 5 CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
The Diverter Diverter Patency Patency The weeks 9 weeks 18 weeks 9 weeks 18
The Diverter Diverter Patency Patency The weeks 18 weeks 18 CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
The Diverter Diverter Patency Patency The
Proliferation and Neointima Coverage 35 Proliferation rate Neointima coverage 30 25 20 % 15 10 5 0 0 5 10 15 20 25 FU in weeks CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
METHODS Carotid Carotid Shunt Shunt Clamping GC Schematic description of the procedure, post deployment and shunt insertion
So we thought So we thought • The concept is good The concept is good • The device is good The device is good • We are good We are good • Let's go for a clinical trial Let's go for a clinical trial CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
E-DIRECT Study E-DIRECT Study E mboli mboli DI DI version and version and R R erouting to erouting to E the E E xternal xternal C C arotid artery arotid artery the T echnique echnique T CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Patient Selection Criteria Patient Selection Criteria • Atrial fibrillation Atrial fibrillation • High risk for stroke High risk for stroke • Non-candidates for oral Non-candidates for oral anticoagulants anticoagulants CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Case #1 Case #1 CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Case #1 Case #1 Before After Before After CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
FU 1 mo Duplex FU 1 mo Duplex CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
FU 3 mo Duplex FU 3 mo Duplex CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
FU 6 mo Duplex FU 6 mo Duplex CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
FU 9 mo Duplex FU 9 mo Duplex CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
CCA Diverter Diameter CCA Diverter Diameter (mm) (mm) 8 7 6 5 pat 1 4 pat 2 pat 3 3 2 1 0 predis. 1 w 1 m 3 m 6 m 9 m CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Syst. Peak Vel. ICA Syst. Peak Vel. ICA (m/sec) (m/sec) 0,9 0,8 0,7 0,6 pat 1 0,5 pat 2 0,4 pat 3 0,3 0,2 0,1 0 m m m m w . . s l p i d 1 1 3 6 9 m e i r e p r p CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Volume Flow (ml/min) ICA Volume Flow (ml/min) ICA 350 300 250 pat 1 200 pat 2 150 pat 3 100 50 0 pre predis. 1 w 1 m 3 m 6 m 9 m CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
% Volume Flow ICA / CCA % Volume Flow ICA / CCA 75 50 25 0 pre predis. 1 w 1 m 3 m 6 m 9 m CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Patient #3 Patient #3 • 57 vear old man 57 vear old man • Chronic atrial fibrillation Chronic atrial fibrillation • Surgical ASD occlusion 1971 Surgical ASD occlusion 1971 • Congestive heart failure ( EF 20 % ) Congestive heart failure ( EF 20 % ) • LV Thrombus LV Thrombus • Liver cirrhosis Liver cirrhosis 3 month FU normal 3 month FU normal 6 month FU postponed 6 month FU postponed 7 month 7 month symptom-free but ... symptom-free but ... CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Patient # 3 - 7 mo Duplex Patient # 3 - 7 mo Duplex Internal carotid artery occluded Internal carotid artery occluded CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Patient # 3 - 7 mo Duplex Patient # 3 - 7 mo Duplex Massive proliferation Massive proliferation CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Patient # 3 - 7 mo Duplex Patient # 3 - 7 mo Duplex Massive proliferation, stenosis at distal end of Diverter Massive proliferation, stenosis at distal end of Diverter CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Patient 3 - 7 mo Angiogram Patient 3 - 7 mo Angiogram What to What to do now? do now? CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Patient 3 - 7 mo Patient 3 - 7 mo 1.5 mm balloon 1.5 mm balloon 2 mm balloon 2 mm balloon CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Patient 3 - 7 mo Patient 3 - 7 mo 4 mm 4 mm 6 mm ECA 6 mm ECA CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
Take Home Messages Take Home Messages • The Diverter concept has been safe and The Diverter concept has been safe and effective in animal experiments effective in animal experiments • We can do this in humans We can do this in humans but but • Excessive intima proliferation may occur Excessive intima proliferation may occur • This was independed from flow and from This was independed from flow and from pore size of the Diverter pore size of the Diverter • Occlusion of the diverter can be treated by Occlusion of the diverter can be treated by catheter techniques catheter techniques • We need to learn more We need to learn more CardioVascular Center Frankfurt, Sankt Katharinen CardioVascular Center Frankfurt, Sankt Katharinen
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