The Mindguard Carotid The Mindguard Carotid Mesh Diverter to - - PowerPoint PPT Presentation

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

Nothing to Disclose Related to this Presentation Name: Horst Sievert, M.D. Horst Sievert, M.D.

PRESENTER DISCLOSURE INFORMATION

Emboli are the Major Cause Emboli are the Major Cause

• f Ischemic Stroke
• f Ischemic Stroke

PFO and unknown 21% Aortic Arch Atheroma 14% AF 15% non embolic 40%

RHD, Aneurysm 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

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

Mindguard Carotid Mesh Diverter Mindguard Carotid Mesh Diverter

Common Common Carotid Carotid Artery Artery

Internal Internal Carotid Carotid Artery Artery

External External Carotid Carotid Artery Artery

Concept: To divert emboli to a benign location Concept: To divert emboli to a benign location

global local

The In-vitro Model

Flow studies (CDPIV) were carried out to test global and local aspects of bifurcation filtration

Local Hemodynamics

Pulsatile, laminar Turbulence, (Steady)

Thin struts Thin struts Thick struts Thick struts

The Fine Wire Concept The Fine Wire Concept

High porosity index High porosity index

Iliac Femoral Renal Carotid

> 200 Implantations in Animals > 200 Implantations in Animals

RSA

N= 193 N= 26 N= 15

weeks 2 weeks 2 weeks 4 weeks 4

The Diverter Patency The Diverter Patency

weeks 5 weeks 5

The Diverter Patency The Diverter Patency

weeks 9 weeks 9 weeks 18 weeks 18

The The Diverter Diverter Patency Patency

weeks 18 weeks 18

The The Diverter Diverter Patency Patency

The The Diverter Diverter Patency Patency

Proliferation and Neointima Coverage

5 10 15 20 25 30 35 5 10 15 20 25

Proliferation rate Neointima coverage

FU in weeks %

METHODS

Schematic description of the procedure, post deployment and shunt insertion

Carotid Shunt Clamping GC Carotid Shunt

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

E-DIRECT Study E-DIRECT Study

E Emboli mboli DI DIversion and version and R Rerouting to erouting to the the E External xternal C Carotid artery arotid artery T Technique echnique

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

Case #1 Case #1

Case #1 Case #1

Before Before After After

FU 1 mo Duplex FU 1 mo Duplex

FU 3 mo Duplex FU 3 mo Duplex

FU 6 mo Duplex FU 6 mo Duplex

FU 9 mo Duplex FU 9 mo Duplex

1 2 3 4 5 6 7 8 predis. 1 w 1 m 3 m 6 m 9 m pat 1 pat 2 pat 3

CCA Diverter Diameter CCA Diverter Diameter

(mm) (mm)

0,1 0,2 0,3 0,4 0,5 0,6 0,7 0,8 0,9 p r e i m p l . p r e d i s . 1 w 1 m 3 m 6 m 9 m pat 1 pat 2 pat 3

• Syst. Peak Vel. ICA
• Syst. Peak Vel. ICA

(m/sec) (m/sec)

50 100 150 200 250 300 350 pre predis. 1 w 1 m 3 m 6 m 9 m pat 1 pat 2 pat 3

Volume Flow Volume Flow (ml/min)

(ml/min) ICA

ICA

25 50 75 pre predis. 1 w 1 m 3 m 6 m 9 m

% Volume Flow ICA / CCA % Volume Flow ICA / CCA

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 ...

Patient # 3 - 7 mo Duplex Patient # 3 - 7 mo Duplex

Internal carotid artery occluded Internal carotid artery occluded

Patient # 3 - 7 mo Duplex Patient # 3 - 7 mo Duplex

Massive proliferation Massive proliferation

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

Patient 3 - 7 mo Angiogram Patient 3 - 7 mo Angiogram

What to What to do now? do now?

Patient 3 - 7 mo Patient 3 - 7 mo

1.5 mm balloon 1.5 mm balloon 2 mm balloon 2 mm balloon

4 mm 4 mm ECA ECA 6 mm 6 mm

Patient 3 - 7 mo Patient 3 - 7 mo

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