PROXIMAL PROTECTION FOR CAS: THE … Registry on PEC protected CAS From July 2004 to March 2009, 1300 patients underwent CAS using PEC All patients had …

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


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


FUTURE of CAS

• Not only a problem of

–Approval

–Release

–Reimbursement

EDUCATION

PROXIMAL PROTECTION

FOR CAS:

THE SUPERIOR CONCEPT ?

Giancarlo Biamino

PROXIMAL PROTECTION FOR CAS: THE … Registry on PEC protected CAS From July 2004 to March 2009, 1300 patients underwent CAS using PEC All patients had …

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