Trans-radial/brachial carotid artery stenting with proximal protection: pushing the boundaries of the technique while keeping both safety and efficacy

1. Trans-radial/brachial carotid artery
stenting with proximal protection:
pushing the boundaries of the
technique while keeping both safety
and efficacy
Montorsi P1, Galli S1, Ravagnani M1, Teruzzi
G1, Trabattoni D1, Lualdi A1, Fabbiocchi F1,
Caputi L2, Tresoldi S3, Bartorelli A1.
1. Dep.’t of Clinical Sciences and Community Health,
University of Milan, Centro Cardiologico Monzino, IRCCS,
Milan; 2. Dep.’t of Cerebrovascular Diseases «C.Besta»,
Milan, 3. Cardiology Dep.’t, Desio Hospital, Milan, Italy

2. Speaker name: Piero Montorsi, MD
Consultant
- Medtronic
- Boston Scientific

3. CAS through radial/brachial approaches
Background & Aim of the Study
 Interventional cardiologists are very familiar with radial approach
 Proved to be safe and effective in coronary PCIs (low profile caths)
 Specific anatomies and variants of the aortic arch and of the supra-aortic
vessels are associated with an increased risk of cerebral microembolization
during CAS by the femoral route
 Transradial CAS showed favorable results in single center series and RCT
 Transradial CAS is much more technically demanding requiring
dedicated systems and techniques and a steep learning curve
 Radial artery size may preclude the use of large device, such as
proximal protection (8F)
 The alternative role of brachial artery is hampered by historical high
rate of vascular complications

4. Transradial/brachial CAS
Methods: patient population
0
15
30
45
60
75
90
105
120
’00
02
‘03 ‘04 ‘05 ‘06 ‘07 ‘08 ‘09 ‘10 ‘11 ‘12 ‘13 ‘14
TR/TB CAS
214/856 (25%, range 12%-68%)
CASprocedures/year(n)
N=1127
7/15
TR/TB w Filter
(n=153)
TR/TB w Mo.Ma
(n=61, 28.5%)
% rate of trans-radial PCI in 2015: 70%

5. Bovine
aortic arch
+LICA
Type II-III
aortic arch
+RICA
‘Pongeant’
IA+RICA
Aortic arch
disease
+RICA/LICA
Peripheral arterial
disease
+RICA/LICA
Specific Vascular Anatomy (n=100)
All comers (n=114)
LearningCurve
1stpart2ndpart
Transradial/brachial CAS
Methods: procedural details


6. MO.MA (n=61)Filter (n=153)②
③
④
⑤
Brain Protection
Device
Vascular
approach
CAS equipment
Anticoagulation
+ TR-band
(patent hemostasis)
+ Manual compression
Heparin (iv. 5.000 U) Heparin (iv. 5.000 U) then
Bivalirudin (i.v. bolus+infusion)
Radial Brachial
Radial
(N=124)
Brachial
(N=29)
Radial
(N=30)
Brachial
(N=31)
CCA≤8mm
CW 7
Precise 8
CCA˃8mm
Cristallo
Ideale
CCA≤8mm
6F GC
+
CW 7
Precise 8
CCA˃8mm
6F IS
+
Any stent
size
Transradial/brachial CAS
Methods: procedural details

7. Terumo
Filter
Mo.Ma
CAS through radial approach
Procedural steps
0.035’’, 260 CM, Terumo wire
into the target vessel.
5F right Judkins
Diagnostic cath into the ECA
Terumo wire exchanged for a
0.035’’ stiff wire

8. Variables Mo.Ma (n=61) Filter (n=153) P value
Male gender 88% 65% 0.007
Age (y), ≥75 yrs 73±7, 41% 71±8, 34% ns
BSA (Kg/m2) 1.85±0.16 1.78±0.19 ns
Symptomatic 6.5% 4.5% ns
CAD 51% 56% ns
Diabetes type I & II 30% 27% ns
Hypertesnion 79% 82% ns
Smoking 48% 44% ns
Hypercholesterolemia 69% 80% 0.06
High-surgical-risk 72% 60% 0.08
Doppler PSV (m/s), %DS 3.6±09, 84±8 3.1±09, 76±12 <.0001
CTA MLA (mm2)*, %DS 3.7±1.9 88±7 4.8±2.0, 83±7 =.0014
=.0002
TR/TB CAS
Results-1
* ECST method

9. TR/TB CAS
Results-2
Etxegoien 2012; Ruzsa 2014
End-points CAS w Mo.Ma
n= 61
CAS w Filter
n=153
Comparative studies
w Filter (n=512)*
Vascular Crossover
to FA
3.2% (2/61)
1 Hostile anatomy
1 Mo.Ma too short
7.1% (11/153)
Hostile anatomy in all
9.1% (35/382)
Hostile antomy in all
10% (13/130)
50% Hostile anatomy
Clinical Crossover to
Filter
4 (6.5%)
Acute intolerance
- -
MACCEs
(S/D/MI)
0% (0/55), ITT 2.8% (4/142), ITT#
1 Major S, 2 Minor S, 1 RE
1.7% (6/347), ITT
0.9% (1/117), ITT
Major Vascular
complications
TR 0% (0/30)
TB 3.2% (1/31)&
1 BA pseudoaneurism
TR 0% (0/124)
TB 10% (3/29)&
2 BA thrombosis
1 BA pseudoaneurism
TR 0.0% (0/347)
TR 0.9% (1/117)
1 Acute RAO
Radial artery
occlusion (31d-f/u)
6.6% (2/30)
8F sheath in all
3.2% (4/124)
6F sheath (85%)
6.0% (23/347)
5-6F IS (85%)
6.8% (8/117)
7F GC (90%)
End-points CAS w Mo.Ma
n= 61
CAS w Filter
n=153
Comparative studies
w Filter (n=512)*
Vascular Crossover
to FA
3.2% (2/61)
1 Hostile anatomy
1 Mo.Ma too short
7.1% (11/153)
Hostile anatomy in all
9.1% (35/382)
Hostile antomy in all
10% (13/130)
50% Hostile anatomy
Clinical Crossover to
Filter
4 (6.5%)
Acute intolerance
- -
MACCEs
(S/D/MI)
0% (0/55), ITT 2.8% (4/142), ITT#
1 Major S, 2 Minor S, 1 RE
1.7% (6/347), ITT
0.9% (1/117), ITT
Major Vascular
complications
TR 0% (0/30)
TB 3.2% (1/31)&
1 BA pseudoaneurism
TR 0% (0/124)
TB 10% (3/29)&
2 BA thrombosis
1 BA pseudoaneurism
TR 0.0% (0/347)
TR 0.9% (1/117)
1 Acute RAO
Radial artery
occlusion (31d-f/u)
6.6% (2/30)
8F sheath in all
3.2% (4/124)
6F sheath (85%)
6.0% (23/347)
5-6F IS (85%)
6.8% (8/117)
7F GC (90%)
End-points CAS w Mo.Ma
n= 61
CAS w Filter
n=153
Comparative studies
w Filter (n=512)*
Vascular Crossover
to FA
3.2% (2/61)
1 Hostile anatomy
1 Mo.Ma too short
7.1% (11/153)
Hostile anatomy in all
9.1% (35/382)
Hostile antomy in all
10% (13/130)
50% Hostile anatomy
Clinical Crossover to
Filter
4 (6.5%)
Acute intolerance
- -
MACCEs
(S/D/MI)
0% (0/55), ITT 2.8% (4/142), ITT#
1 Major S, 2 Minor S, 1 RE
1.7% (6/347), ITT
0.9% (1/117), ITT
Major Vascular
complications
TR 0% (0/30)
TB 3.2% (1/31)&
1 BA pseudoaneurism
TR 0% (0/124)
TB 10% (3/29)&
2 BA thrombosis
1 BA pseudoaneurism
TR 0.0% (0/347)
TR 0.9% (1/117)
1 Acute RAO
Radial artery
occlusion (31d-f/u)
6.6% (2/30)
8F sheath in all
3.2% (4/124)
6F sheath (85%)
6.0% (23/347)
5-6F IS (85%)
6.8% (8/117)
7F GC (90%)
End-points CAS w Mo.Ma
n= 61
CAS w Filter
n=153
Comparative studies
w Filter (n=512)*
Vascular Crossover
to FA
3.2% (2/61)
1 Hostile anatomy
1 Mo.Ma too short
7.1% (11/153)
Hostile anatomy in all
9.1% (35/382)
Hostile antomy in all
10% (13/130)
50% Hostile anatomy
Clinical Crossover to
Filter
4 (6.5%)
Acute intolerance
- -
MACCEs
(S/D/MI)
0% (0/55), ITT 2.8% (4/142), ITT#
1 Major S, 2 Minor S, 1 RE
1.7% (6/347), ITT
0.9% (1/117), ITT
Major Vascular
complications
TR 0% (0/30)
TB 3.2% (1/31)&
1 BA pseudoaneurism
TR 0% (0/124)
TB 10% (3/29)&
2 BA thrombosis
1 BA pseudoaneurism
TR 0.0% (0/347)
TR 0.9% (1/117)
1 Acute RAO
Radial artery
occlusion (31d-f/u)
6.6% (2/30)
8F sheath in all
3.2% (4/124)
6F sheath (85%)
6.0% (23/347)
5-6F IS (85%)
6.8% (8/117)
7F GC (90%)
End-points CAS w Mo.Ma
n= 61
CAS w Filter
n=153
Comparative studies
w Filter (n=512)*
Vascular Crossover
to FA
3.2% (2/61)
1 Hostile anatomy
1 Mo.Ma too short
7.1% (11/153)
Hostile anatomy in all
9.1% (35/382)
Hostile antomy in all
10% (13/130)
50% Hostile anatomy
Clinical Crossover to
Filter
4 (6.5%)
Acute intolerance
- -
MACCEs
(S/D/MI)
0% (0/55), ITT 2.8% (4/142), ITT#
1 Major S, 2 Minor S, 1 RE
1.7% (6/347), ITT
0.9% (1/117), ITT
Major Vascular
complications
TR 0% (0/30)
TB 3.2% (1/31)&
1 BA pseudoaneurism
TR 0% (0/124)
TB 10% (3/29)&
2 BA thrombosis
1 BA pseudoaneurism
TR 0.0% (0/347)
TR 0.9% (1/117)
1 Acute RAO
Radial artery
occlusion (31d-f/u)
6.6% (2/30)
8F sheath in all
3.2% (4/124)
6F sheath (85%)
6.0% (23/347)
5-6F IS (85%)
6.8% (8/117)
7F GC (90%)
End-points CAS w Mo.Ma
n= 61
CAS w Filter
n=153
Comparative studies
w Filter (n=512)*
Vascular Crossover
to FA
3.2% (2/61)
1 Hostile anatomy
1 Mo.Ma too short
7.1% (11/153)
Hostile anatomy in all
9.1% (35/382)
Hostile antomy in all
10% (13/130)
50% Hostile anatomy
Clinical Crossover to
Filter
4 (6.5%)
Acute intolerance
- -
MACCEs
(S/D/MI)
0% (0/55), ITT 2.8% (4/142), ITT#
1 Major S, 2 Minor S, 1 RE
1.7% (6/347), ITT
0.9% (1/117), ITT
Major Vascular
complications
TR 0% (0/30)
TB 3.2% (1/31)&
1 BA pseudoaneurism
TR 0% (0/124)
TB 10% (3/29)&
2 BA thrombosis
1 BA pseudoaneurism
TR 0.0% (0/347)
TR 0.9% (1/117)
1 Acute RAO
Radial artery
occlusion (31d-f/u)
6.6% (2/30)§
8F sheath in all
3.2% (4/124)
6F sheath (85%)
6.0% (23/347)
5-6F IS (85%)
6.8% (8/117)
7F GC (90%)
# The 4 MACCE occurred in the first 32 pts, then 0/169 pts
& All occurred during the first part of the learning curve (4/26, 2007-2009). No further complication up to
7/2015 (0/34) using bivalirudin+manual compression.
§ RA patency assessed by Doppler US
IS= introducer sheath; ITT= intention to treat analysis

10. RSA-RCCA
Bifurcation
(+ RICA stenosis)
LCCA take off from
the aortic arch
(+ LICA stenosis)
TR/TB CAS with proximal protection
Is the carotid side an issue?
Failure rate at the first attempt
LCCA take off from
the IA: BAAC
(+LICA stenosis)
‘’First Attempt Failure’’ (16/56, 28.5%)
30 Mo.Ma (100%) 23 Mo.Ma (43%) 3 Mo.Ma (0%)
(13/26, 61%)

11. TR/TB CAS with proximal protection
BAAC
Type 2 bovine aortic arch
+ LICA stenosis.
CT-angio (LAO 45° view)
5F diag RJ in
LCCA through
right brachial
artery
8F MO.MA system
ECA+CCA balloons occlusion
(arrows)
Final result
CW (7x30), post-
dilated with a
5.5x20mm

12. Anatomic Issues: Bifurcation w sharp angles, lack of inferior anatomic support
+
Device issue: 8F stiff device

Increased rate of failure due to prolapse into IA/aortic arch
Solving: Mandrel removal + additional wire
RSA/RCCA bifurcation IA/LCCA bifurcation (no BAAC)
TR/TB CAS with proximal protection
1
1
2
2

13. Transradial CAS with proximal protection
The NO.MA technique
0.035” Emerald wire
loaded into the working
channel (mandrel
withdrawn)
0.035” stiff wire
loaded into the
distal portNO.MA = NO.MAndrel
Two wires technique
5/5 (100%) TS
at the 2nd attempt

13/13 (100%) TS
as 1° attempt

14. Sharp angle between RSA-RCCA bifurcation
Mo.Ma placement with the No.Ma technique-1
RICA stenosis
Right radial
approach
Attempt to position the Mo.Ma system over a .035’’
stiff wire (Supracore)  prolapse into the IA
Mo.Ma removed. 6FRJ
guide+4FMP125 into the
ECA
6FRJ GC
4FMP
125

15. Sharp angle between RSA-RCCA bifurcation
Mo.Ma placement with the No.Ma technique-2
6FRJ guide into ECA A second stiff wire was
positioned deep into ECA.
6FRJ guide removed
The 2 stiff wires loaded into the ECA channel and the
working channel, respectively and Mo.Ma system
positioned in RCCA

16. Sharp angle between RSA-RCCA bifurcation
Mo.Ma placement with the No.Ma technique-3
Cristallo Ideale
7-10x40mm
Postdil 5.5x20
Occlusion test8F Mo.Ma in place
ECA balloon inflation
and test for ECA
exclusion
Final result

17. R radial access.
5F Tiger into LCCA
 .035” standard
wire tip shaping
8F MO.MA mono
loaded on the 2
standard wires
(No.Ma technique)
Additional .035”
standard wire
through 6FRJ guide
5F Tiger exchanged
for coaxial system
(6FRJ+4FMP, 125 cm)
6FGC
4FMP
CTA (VR)
45°RAO view
CAS for LICA bifurcational disease (LCCA taking off from aorta)
Mo.Ma Mono balloon with the NO.MA technique-1

18. CM injection (early to late frame) Spider Rx
filter,6 mm
CW 7x30
post-dil
5.5x20
Final result74mmHg
CAS for LICA bifurcational disease (LCCA taking off from aorta)
Mo.Ma Mono balloon with the NO.MA technique-1

19. TR/TB CAS
Results-3
TR/B CAS w
Mo.Ma (n=61)
TR/B CAS w
Filter (n=153)
P value
Fluoroscopy time (sec) 780±361 957±511 0.018
DAP (Gym2) 6884±2964 7252±6052 0.66
Contrast medium (ml) 109±38 135±47 0.0003

20. Tranradial approach for CAS
Role of the learning curve on radiation exposure
Source DF Type III SS Mean
Square
F Value Pr > F
Year 1 5,3E+08 5,3E+08 20,19 <.0001
Group 1 4525130 4525130 0,17 0,6793
Source DF Type III
SS
Mean
Square
F Value Pr > F
Year 1 3,6E+07 3,6E+07 4,35 0,0418
Carotid side 1 3287317 3287317 0,4 0,5297
N=214 N=61Left
Right
Filter
Mo.Ma
Filter vs. Mo.Ma/year Right vs. left carotid w Mo.Ma/year

21.  Use of unconventional vascular access in selected patient and
anatomy is a safe and effective strategy that may turn a
complex CAS into a simple one
 Unconventional access should be seen as the natural completion
of CAS learning curve to provide a tailored treatment in each
patient
 Vascular access is only one of several variables that may affect
clinical oucome during CAS. Thus, the “right” vascular approach
should cope with the “right” brain protection device, stent and
pharmacology
 Needless to say: pre-CAS CTA and sound experience in extra-
femoral access PCI are mandatory
TR/TB CAS with proximal protection
Conclusions