PROXIMAL PROTECTION
FOR CAS:
THE SUPERIOR CONCEPT ?
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
Cerebral Protection Strategies
Distal Flow
BlockageDistal Filters
Proximal Protection
with Flow Reversal
Proximal Protection
with Flow Blockage
NO PROTECTION NO CAS
Filter Wire - Animation
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
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
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)
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
Proximal Protection meta-analysis (R.Bersin et al. CCI 2012)
The incidence of stroke was 1.71%
DESERVE STUDYDiffusion 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
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.
CONCLUSIONS
The Mo.Ma.
PROXIMAL PROTECTION DEVICE:
1. EASY TO USE2. SAFE (Arch I-III)3. EFFECTVE
4. AT THE MOMENT THE PROTECTION SYSTEM OF CHOISE
Post-procedural phase
Post-procedural
• The majority of strokes occur post-procedure (+/- 70%)
Capture trial (3500 pats)Timing of strokes
R. Fairman. Ann Surg 2007;246(4):551-556.
Post-procedural phase
ENDOVASCULAR Plaque protrusion!
Pre-op Post-stent IVUS
LN. Hopkins; presented at EURO-PCR 2008
RoadSaver® All ComersItalian Registry
- First results on 150 Patients -
Alberto Cremonesi MD, FESC
Roberto Nerla MD
THE GREAT SOLUTION ??
LINC 2016
Terumo® Carotid Stent
Roadsaver Stent Platform
Design Double layer, micromesh
Construction Braided mesh
Material Nitinol®
Stent Delivery System
Guide wire compatibility 0.014" (0.36mm)
Introducer sheathcompatibility
5Fr. (I.D.> 0.074")
Delivery systemconstruction
Rapid Exchange (RX), RX segment length 25cm
Rad
ial fo
rce
Plaque containment
Courtesy of A. Cremonesi
30 days (n=150)
MACCE (MI, stroke, death) 0
MI 0
Stroke 0
Death 0
Clinical events
Courtesy of A. Cremonesi
THE FUTURE OF CAS IS BRIGHT !!....???
GAPS IN CLINICAL EVIDENCEFOR CAS IN 2017
•NO data considering theability of the
interventionalist toproduce a complication-
free result.
PREREQUISITE TO BEING CONSIDERED A FIRST OPERATOR
At the beginning of your
experience avoid……….
Aortic Arch
Type II\III
Patient Tailored CAS:Physician training requirements
Addressing challengesCAS experience (no.)
<100 100-200 >200
Aortic arch: III No No Yes
Lesion anatomy: angled No Yes Yes
Vessel anatomy: severely tortuous No No Yes
Lesion
characteristics:
angled, severely calcified,
high grade, sub-occlusiveNo Yes Yes
Plaque
composition:
dis-homogeneous, soft,
ulceratedNo Yes Yes
Courtesy A. Cremonesi
Neurological complications
N= 124 TIAStroke Neuro
DeathMinor 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
“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
FUTURE of CAS
• Not only a problem of
–Approval
–Release
–Reimbursement
EDUCATION
PROXIMAL PROTECTION
FOR CAS:
THE SUPERIOR CONCEPT ?
Giancarlo Biamino