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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)
Stabile et al. JACC 2010
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
Stabile et al. JACC 2010
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)
Results 1° Endpoint
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
Results 1° Endpoint
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
Results 1° Endpoint
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.
Results 1° Endpoint
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
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