proximal protection: finally the gold standard for …€¦ · 15. issam d. moussa - new york, ny...

PROXIMAL PROTECTION: FINALLY THE GOLD STANDARD FOR CEREBRAL PROTECTION

DURING CAS ?

Giancarlo Biamino

Disclosure

Speaker name:

.................................................................................

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

J.Mourinho insinuating his opinion about the performance of the referee

I share his attitude when people consider CAS

without cerebral protection or propose randomized

studies on the topic

NO PROTECTION NO CAS

Cerebral Protection Strategies

Distal Flow

Blockage Distal Filters

Proximal Protection

with Flow Reversal

Proximal Protection

with Flow Blockage

Mo.Ma CONCEPT proposed by G.Coppi in 2000

- Instead the conventional clamping during CEA

the Mo.Ma. System permits via two compliant balloons a controlled

endovascular clamping,

inducing a blockage of the antegrade blood flow.

- Name: Mo. = Mo.dena

Ma. = Ma……initials of his wife name

Patient History case 1

Patient demographics: Gender: Male Age : 81 yrs Risk factors: Hyperlipidaemia

Hypertension Smoking history

“Low-risk” CAS patient?

• Male, 67 years old

• Recurrent TIAs

• RICA focal stenosis

Echo-lucent lesion

High risk of massive embolization

• The surgical solution is likely the best one

• Avoid filter-wire protected CAS

• Proximal protection systems are recommanded

Courtesy of A. Cremonesi

THE Mo.Ma RESULTS

Montevergine Registry

on PEC protected CAS

From July 2004 to March 2009, 1300 patients

underwent CAS using PEC

All patients had a >80%, if asymptomatic, and >60%, if symptomatic, diameter stenosis of the internal carotid artery,

measured according to the NASCET criteria

The only exclusion criteria were the presence of critical

stenosis of the ipsilateral common carotid artery and/or the

occlusion of the ipsilateral external carotid artery

Patients received a detailed clinical assessment one

hour, twenty four hours and 30 days Stabile et al. JACC 2010

Patients Characteristics

% (n)

Male 71,7 (932)

Age (yr) 70 ± 7,6

Smoke history 69.4 (902)

Diabetes 32,9 (428)

Hypertension 88,7 (1153)

Hypercholesterolemia 71,1 (924)

History of CAD 35,4 (460)

Presence of significant CAD 66,5 (864)

Symptomatic Patients 23,7 (308)

Patients Selection

In the consecutive patients group, the only

exclusion criteria were the presence of stenosis

criticaly involving the common carotid artery

and/or the occlusion of the ipsilateral external

carotid artery

Consecutive Patients (93,9 % of CAS from 01/05 to 03/09)

MoMa

Other

Stabile et al. JACC 2010

Procedural Characteristics

% (n)

Controlateral ICA stenosis >70 % 8,5 (110)

Controlateral ICA occlusion 5 (65)

Ipsilateral ECA stenosis 8,3 (108)

Type of stent

- stainless steel

- open cells nitinol

- closed cells nitinol

- hybrid cells nitinol

2,0 (26)

62,2 (809)

2,3 (30)

33,5 (435)

Postdilation 100 (1300)

Procedure time (min) 18 ± 7

Clamping time (sec) 192 ± 51

Immediate Intolerance 0,3 (4)

MoMa size (fr)

-10

-9

-8

34,6 (450)

35,8 (465)

29,6 (385)


2

1

2

1

0

1

2

3

4

5

6

In Hospital 30 Days

CV Stroke NV

# D

eat

h

0

1

2

3

4

5

6

7

8

9

10

In Hospital 30 Days

Mayor Stroke Minor Stroke

# N

eur

olog

ic e

vent

s

Cumulative results at 30 days (MACCE = 1.3 %) No AMI !

Results


Principal Investigators:

Gary Ansel - Columbus (OH)

L. Nelson Hopkins – Buffalo (NY)

proximAl pRotection with the MO.ma device

dUring caRotid stenting

ARMOUR Study Overview

• Prospective multicenter (US and EU) single arm IDE trial to evaluate the safety and effectiveness of the MO.MA device for cerebral protection in high surgical risk CAS candidates with any FDA approved carotid stent

– Primary Endpoint: Major adverse cardiac and cerebrovascular events (MACCE: MI, stroke, death) at 30 days

– Nr of Investigational Sites: 25 (20 US + 5 EU)

– Nr of patients: 225 study subjects (ITT) + 37 roll-in

– Independent Clinical Event Committee, Data Safety Monitoring Board, Angio and DUS Core labs

Study Investigators/ Core Laboratories

20 Sites US 1. Gary Ansel - Columbus, OH

2. Mike Bacharach - Sioux Falls, SD

3. Robert M.Bersin – Seattle, WA

4. Michael Dahn – Farmington, CT

5. Tony Das – Dallas, TX

6. Rajesh M. Dave – Harrisburg, PA

7. Bruce Gray – Greenville, SC

8. Richard Heuser – Phoenix, AZ

9. L. Nelson Hopkins - Buffalo, NY

10. Barry Katzen – Miami, FL

11. John R. Laird – Sacramento, CA

12. James R. Margolis – Miami, FL

13. Gregory J. Mishkel – Springfield, IL

14. Subbarao Myla – Newport Beach, CA

15. Issam D. Moussa - New York, NY

16. Stephen R. Ramee - New Orleans, LA

17. Kenneth Rosenfield – Boston, MA

18. Gary Roubin – New York, NY

19. Robert Safian - Royal Oak, MI

20. Lowell Satler – Washngton, DC

5 Sites EU 1. Alberto Cremonesi – Cotignola, Italy

2. Horst Sievert – Frankfurt, Germany

3. Dierk Scheinert – Leipzig, Germany

4. Paolo Rubino – Mercogliano, Italy

5. Dariusz Dudek – Kracow, Poland

Core Laboratories

1. VasCore – Michael Jaff, DO

2. Brigham & Women’s – Jeffrey

Popma, MD

225 Study Subjects

35%

65%

EU US

Baseline

Nr of Patients (ITT) 225 Male gender 66.7%

Age (mean ± SD) 74.66±8.54

Octogenarians 28.88%

Age > 75y 56.1% Symptomatic 15.1%

Diabetes 37.1%

Current Smokers 15.1%

Hypertension 87.1%

Demographics Clinicaland Lesion and Anatomy

Lesion length (mm) 13.37±5.57

%DS 72.15±10.50

Eccentric lesion 43.3%

Severe calcification 67.4%

Ulceration 7.8%

Right ICA (%) 54.0%

Aortic Arch Type I = 64%

Type II = 29.3%

Type III = 6.7%

Bovine = 16%

High Surgical Risk Distribution (ITT)

56,1%

14,5%

8,1%

4,5%

4,1%

2,7%

0,5%

0,0%

7,7%

5,0%

3,2%

2,7%

0,0%

Age > 75

CAD ≥ 2 vessels

LVEF < 35%

Severe Pulm. Dis.

CCS Angina 3-4 or UA

CHF III-IV

MI < 6w

Perm. Control. Nerve Injury

CEA Restenosis

Hostile neck

High cervical lesion

Cervical Immobility

Tandem Lesions

67%

20%

13%

High Surgical Risk Distribution

Clinical only (≥1)

Anatomic only (≥1)

Both

Lesion, Procedural Characteristics (ITT)

Procedural time (min) 38.35±21.20

Clamping time (min) 6.71±3.82

Collected debris 44%

Back Pressure (mm Hg) 55.38±24.19

Lesion pre-dilatation 57.1%

Stent post-dilatation 97.4%

Device Success 1 98.2%

Technical Success 2 94.6%

Procedural Success 3 93.2% 1. Device Success: ability to position, deploy and retrieve the intact MO.MA device during the index procedure

2. Technical Success: Device Success + ability to successfully implant a carotid stent and obtain a residual stenosis < 30%

during the index procedure (evaluated by the Angio Corelab)

3. Procedural success: Technical success without the occurrence of any MACCE or unresolved antegrade flow blockage

intolerance during the index hospitalization

36%

20%

35%

6% 4%

PRECISE

ACCULINK

XACT

PROTEGE

CAROTIDWALLSTENT

Carotid Stent Distribution

Results 1° Endpoint

MACCE rate (at discharge)

MACCE rate (procedural)

Death

Stroke

- Minor Stroke

- Major Stroke

Any myocardial infarction

30d MACCE rate

0.0% (0/37)

0.0% (0/37)

0.0% (0/37)

0.0% (0/37)

0.0% (0/37)

0.0% (0/37)

0.0% (0/37)

0.0% (0/37)

Roll-In

(N=37)

1.8% (4/225)

1.8% (4/225)

0.9% (2/220)

2.3% (5/220)

1.4% (3/220)

0.9% (2/220)

0.0% (0/220)

2.7% (6/220)

ITT

(N=220)

1.5% (4/262)

1.5% (4/262)

0.8% (2/257)

1.9% (5/257)

1.2% (3/257)

0.8% (2/257)

0.0% (0/257)

2.3% (6/257)

Full Analysis

(N=257)

0,9% 1,4% 0,9% 0,0%

0,9%

2,7%

0,8% 1,2% 0,8% 0,0%

1,2% 2,3%

0%

2%

4%

6%

Major Stroke Minor Stroke Death MI TIA 1° Endpointcumulative

MACCE

ARMOUR 30d ITT (220) ITT + Roll-in (257)


30d Results (ITT & Full Population)

2,3%

0,0%

2,7% 3,1%

1,9% 2,7%

0,0%

3,2% 3,1% 2,6%

0%

3%

6%

ALL Symptomatics Asymptomatics Octogenarians Age <80

30d Strokes 30d MACCE

30d Results by Symptoms and Age (ITT)

80y


2,3% 2,7%

0,0%

2,3% 2,1% 2,7% 3,2%

0,0%

2,3% 2,1%

0%

3%

6%

ALL Asymptomatics Symptomatics Age >75 Symptomatics &Age >75

30d Strokes 30d MACCE

30d Results (ITT & Full Population)

30d Results by Symptoms and Age (ITT)

75y

0,9% 1,4% 0,9% 0,0%

0,9%

2,7%

0,8% 1,2% 0,8% 0,0%

1,2% 2,3%

0%

2%

4%

6%

Major Stroke Minor Stroke Death MI TIA 1° Endpointcumulative

MACCE

ARMOUR 30d ITT (220) ITT + Roll-in (257)

Aim of the study

To evaluate the results

of the use of PEC in

octagenarians in a

multicenter registry

Death and Stroke

Frequency (n)

IP 0.0% (0)

PP 2.02% (4)

30 Day 0.5% (1)

Total 2.52% (5)

Pts # 198

Age (yr) 82 ± 2,2

Creatinine clearance >30 < 60 ml-min (%) (n)

68,8 (82)

Presence of significant CAD (%) (n) 58,8 (70)

Symptomatic Patients (%) (n) 35,9 (42)

Clinica Montevergine-VME-VMC

Registry

Pts # 198

Male (%) (n) 67,2 (80)

Age (yr) 82 ± 2,2

Smoke history (%) (n) 61,3 (73)

Diabetes (%) (n) 24,3 (29)

Hypertension (%) (n) 87,3 (104)

Hypercholesterolemia (%) (n) 67,2 (80)

Creatinine clearance < 30 ml-min (%) (n) 7,5 (9)

Creatinine clearance >30 < 60 ml-min (%)

(n)

68,8 (82)

Presence of COPD 21,8 (26)

Presence of significant CAD (%) (n) 58,8 (70)

Presence of significant PAD (%) (n) 18,5 (21)

Presence of Chronic Atrial Fibrillation (%)

(n)

10,9 (13)

Symptomatic Patients (%) (n) 35,9 (42)

Pts #

Clinica Montevergine 104

Villa Maria Cecilia Hospital 45

Villa Maria Eleonora Hospital 49

Population

Evolution of Carotid Stenting

4,8%4,4%

4,0% 4,2%

3,4%

2,9%

2,1% 2,2% 2,3%

1,7%

5,4%5,5%

6,9%

4,9%

0%

2%

4%

6%

8%

SECURITY

ARCHER II

ARCHER III

SAPPHIRE

CREATE I

CREATE II

MAVERIC

BEACH

CABERNET

EMPIRE

EPIC

PROTECT

ARMOUR

POD Meta

CAS maturity in the modern days:

• Higher operator’s experience

• Better Patient selection

• Technology improvement

• Proximal Protection

Mo.Ma :9 single-arm Studies author Biamino Reimers Coppi Cremonesi Stabile Stabile Ansel Micari Biamino

Enrolment year 2002 2002-2003 2001-2005 2001-2005 2004-2006 2004-2009 2007-2009 2005-2009 2008-2010

# patients 42 157 416 84 60 1300 225 (ITT) 198 127

% symptom. 26.2% 19.7% 63.5% 62.0% 23.3% 27.8% 15.1% 39.4% 12.6%

Elderllies na 4.5% >80y na na na 9.3% >80y 56.1% >75y 100% >80y na

Primary EP 3m MANE 30d MANE 30d MANE 30d MANE 30d MANE 30d MANE 30d MACCE 30d MANE DWMRI lesions

Pr. EP Results 4.70% 5.70% 4.56% 2.40% 2.40% 1.38% 2.70% 2.52% 29.9%

30d Death 0.00% 0.60% 0.48% 1.20% 0.00% 0.61% 0.90% 0.51% 0.00%

30d Maj. Stroke 0.00% 0.60% 0.24% 0.00% 0.00% 0.46% 0.90% 1.01% 0.00%

30d Min. Stroke 4.70% 4.50% 3.84% 1.20% 1.67% 0.46% 1.40% 1.01% 2.40%

30d MI 0.00% 0.00% 0.00% 0.00% 0.00% na 0.00% na 0.00%

30d MANE 4.70% (3m) 5.70% 4.56% 2.40% 1.67% 1.38% 2.70% 2.52% 2.40%

Soft

plaque

US FDA

Trial

High Surg

Risk

1300

MO.MA

Stenotic

ECA

Octogen-

arians DW-MRI

2002 2005 2008 2010

Proximal Protection meta-analysis (R.Bersin et al. CCI 2012)

The incidence of stroke was 1.71%

GAPS IN CLINICAL EVIDENCE FOR CAS IN 2016

•NO data considering the ability of the

interventionalist to produce a complication-

free result.

Neurological complications

N= 124 TIA Stroke Neuro

Death Minor Major

Intra-procedural (%) 0,00 0,00 0,00 0,00

Post-proc. to discharge (%) 0,81 0,00 0,00 0,00

Discharge to 30 day fu (%) 0,81 0,00 0,00 0,00

Total 1,62 0,00 0,00 0,00

Primary

endpoint

CRISTALLO REGISTRY

POTENTIAL EMBOLISATIONS DURING CAS

Detection of Microembolic Signals

20

„Multi - Gate - Technique“

Schmidt et al. JACC 44, . 10, 2004

Patient – Characteristics

0 0 neurologic

complications

16 18 male

69 ± 9 70 ± 6 patient-age

6 7 symptomatic

85 ± 8 % 86 ± 9 % stenosis

21 21 n =

FILTER MO.MA

Measurement of MES during 5 phases:

1. Placement of the system, 2. passage of the stenosis,

3. stent-deployment, 4. ballon-dilatation, 5. removal of the system

MO.MA versus Filter-Protection

Mean MES - Count

0

10

20

30

40

50

60 Placement of the

protection-sytem

Passage of the

stenosis

MO.MA

Filter

Filter

MO.MA

18 ± 10 20 ± 15

1,8 ± 3,2

25 ± 22

P = 0,53 P < 0,0001

MO.MA- versus Filter-Protection

MES - Count during Stent-Deployment

0

20

40

60

80

100

120

140

MO.MA

Filter

P < 0,0001

11 ± 19

73 ± 49

DESERVE STUDY Diffusion Weighted-MRI based evaluation of the effectiveness of

endovascular clamping during Carotid Artery Stenting with the

Mo.Ma device

• Prospective, multicenter, single arm, European Study.

• Principal Investigator: Prof Giancarlo Biamino.

• 127 subjects included between February 2008 and October 2010.

• 6 sites (Italy, Germany, Poland):

• Dr. A. Cremonesi, Cotignola (Italy). • Prof. D. Dudek, Krakow (Poland). • Dr. B. Reimers, Mirano (Italy). • Prof. P. Rubino, Mercogliano (Italy). • Prof. D. Scheinert, Leipzig (Germany). • Prof. H. Sievert, Frankfurt (Germany).

Stabile,E. et al : Intern. J. of Cardiology, Vol174, 2, June 2014

Duration of Index procedure(min) 46:26±22:07

Clamping time (min) 4:46±2:31

Evidence of debris 33.9%

Clamping intolerance 11.8%

Resolved:100%

Total Amount of

contrast medium (ml) 152.3±59.3

Procedure


OVERALL % (N =127)

Pts with new” lesions”

Single “lesion”

29.9% (38)

43% (16)

TARGET SIDE % (N =127)

Pts with new “lesions”

Single “lesion”

26% (33)

46% (15)

CONTRALATERAL SIDE % (N =127)

Pts with new “lesions”

Single “lesion”

3.9% (5)

0.9% (1)

Conclusions

The DESERVE Study confirmed the safety and effectiveness of Mo.Ma proximal protection for CAS, showing a cumulative event rate of 2.4% at 30 days. The rate of new DW-MRI lesions post-procedure corresponds to the frequency of lesions documented in the literature after

supraortic diagnostic procedures.

N999 001 014

pre

post

N999 001 015

pre

post

N999 001 016

pre

post

CONCLUSIONS

The Mo.Ma.

PROXIMAL PROTECTION DEVICE:

1. EASY TO USE

2. SAFE (Arch I-III)

3.EFFECTVE

4. AT THE MOMENT THE PROTECTION SYSTEM OF CHOISE

January, 26 to 29 2016

proximal protection: finally the gold standard for …€¦ · 15. issam d. moussa - new york, ny...

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