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Use of radial access for carotid interventions
with protection device
Piero Montorsi, MD
Associate Professor of Cardiovascular Diseases
Department of Clinical Sciences and Community Health, University of Milan
Director, 2nd dep’t Invasive Cardiology
Centro Cardiologico Monzino, IRCCS, Milan, Italy
Speaker name: Piero Montorsi, MD
Consultant for Boston Scientific, Medtronic
CAS through radial/brachial approaches
Is it a safe & effective technique?
N=382
2012
N=260
2014
We…
can…
do it !!
RSA-RCCA (TRA)
IA-LCCA (TRA)
Sharp angle +
lack of anatomic support +
CAS through the transradial approach
Why a difficult technique?
device stiffness
=
high rate of failure
Transradial/brachial CAS
The Monzino’s experience
0
15
30
45
60
75
90
105
120
’00
02
‘03 ‘04 ‘05 ‘06 ‘07 ‘08 ‘09 ‘10 ‘11 ‘12 ‘13 ‘14
TR/TBA/TU
267/926 (29%)
CASprocedures/year(n)
N=1197
‘15
TR/TB/TU w Filter
(n=191, 84% radial)
TR/TB w Mo.Ma
(n=76, 55% radial)
6/’16
66% (34/51 pts)
73%
Transradial/brachial CAS with proximal protection
Patient population ‘close-up’
 Number of pts: 76/267 (28.4%)
 Indications:
- Symptomatic pts
- Asymptomatic pts with high risk clinical and or
anatomic characteristics
 Vascular access:
- Radial/brachial approach (according to clinical
assessment and/or Doppler US)
 Type of PP: 8F Mo.Ma (Medtronic)
 Type of stent: 5F-compatible stents
 Anticoagulantion: Heparin (TR), Bivalirudin (TB)
 Closure: TR-band+’patent’ hemostasis (TR) and manual
compression (TB)
6F Sheath
(Avanti, Cordis)
11 cm
OD: 2.67mm
‘6F in 5’
(GSS, Terumo)
10 cm
OD: 2.46mm
+
GC 6F
+
CW7/Precise 8
Roadsaver
(any size)
8F Sheath
Avanti (Cordis)
OD: 3.3 mm
11 cm5.5 cm
CAS with Mo.Ma (8F)CAS with filter
Radial artery cannulation
RSA-RCCA
Bifurcation
(+ RICA stenosis)
LCCA take off from the
aortic arch
(+ LICA stenosis)
TR/TB CAS with proximal protection
Technical success/failure rate
LCCA take off from the
IA: BAAC
(+LICA stenosis)
First attempt failure rate
26/75 (34.6%)
0% 40% 80%Technical success 75/76 (98.6%)
Crossover rate: 1.3%
TR/TB CAS with proximal protection
LICA lesion in 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
TR CAS technical failure
Sharp angle between RSA-RCCA bifurcation
RICA stenosis
Right radial
approach
Attempt to position the Mo.Ma system over a .035’’
stiff wire (Supracore)  prolapse into the IA
Transradial CAS with proximal protection
The No.MA2 technique
26/75 (34.6%)
‘first attempt’ failure

Reduce the device stiffness

1. Mandrel removal
(5-10cm)
and try again
Transradial CAS with proximal protection
The No.MA2 technique
TS: 1/26 (3.8%)
Transradial CAS with proximal protection
The No.MA2 technique
0.035” Emerald wire
loaded into the working
channel (mandrel
withdrawn)
0.035” stiff wire
loaded into the
distal port
No.Mandrel 2 wires technique
(No.MA2 technique)
26/75 (34.6%)
first attempt technical failure

1. Mandrel removal (5-10cm)
and try againif fails

Improve wire support

TR CAS technical failure
Sharp angle between RSA-RCCA bifurcation
RICA stenosis
Right radial
approach
Attempt to position the Mo.Ma system over a .035’’
stiff wire (Supracore)  prolapse into the IA
Sharp angle between RSA-RCCA bifurcation
Mo.Ma placement with the No.Ma2 technique-1
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
Stiff Angled
Glide Wire
4MP, 125 cm
6 Guiding cath.
Sharp angle between RSA-RCCA bifurcation
Mo.Ma placement with the No.Ma2 technique-2
Cristallo Ideale
7-10x40mm
Postdil 5.5x20
Occlusion test8F Mo.Ma in place
ECA balloon inflation
and test for ECA
exclusion
Final result
Sharp angle of RSA-RCCA bifurcation
Mo.Ma placement with modified technique
78yom. Right hemisphere
minor stroke.
Right ICA ‘near-occlusion’
Right radial approach
5FRJ cath in RCCA
over .035’’ Terumo
wire
Terumo wire echanged
for a .035’’ stiff wire.
5FRJ removed.
Failure to advance the
8F Mo.ma device
Additional wire in ECA
through a coxial system
(4FMP125 + 6FRJ
guide)
Additional 0.035” Emerald wire below
bifurcation through 6FRJ guide
ECA
Both MO.MA
balloon inflated
Final result after
Cristallo stent 7-
10x40mm
Sharp angle of RSA-RCCA bifurcation
Mo.Ma placement with modified technique
LCCA
LSA
IA
HU: 34
Left ICA PSV: >4m/s
Sharp angle of IA-LCCA bifurcation
Mo.Ma placement with the No.Ma 2 technique
Sharp angle of IA-LCCA bifurcation
Mo.Ma placement with the No.Ma 2 technique
8F MO.MA
in place
Coaxial system: 6FRJ
guide+4FMP 125,
loaded on Terumo wire
from R brachial
approach
6FRJ
4FMP
125
6FRJ guide
in ECA. 4FMP
removed
Terumo wire
exchanged for .035”
standard wire +
.035”stiff wire
(Magic Torque, BSI).
6FRJ guide removed.
8F MO.MA loaded
on the 2 wires
(No.Ma technique)
Final
result
Sharp angle between RSA-RCCA bifurcation
Mo.Ma placement with the No.Ma2 technique-1
74yom. Recent right hemisphere minor stroke. Type III aortic arch. Failure
of CAS by femoral artery. Rescheduled from the right RA approach
Early arterial frame Late arterial frame
Sharp angle between RSA-RCCA bifurcation
Mo.Ma placement with the No.Ma2 technique-3
.035’’
Emerald
.035’’
Magic
Torque
5FIM
.035’’
Terumo
6FRJ
Sharp angle between RSA-RCCA bifurcation
Mo.Ma placement with the No.Ma2 technique-2
OA
STA
The No.Ma2 technique
Which type for the additional wire?
14 pts: 1 stiff + 1 Emerald wire
7 pts: 2 Emerald wire
2 pts: 2 Stiff wire
1 pt : 1 stiff wire + 1 Terumo wire
1 pt: 1 Emerald wire + 1 V18 wire
At least 1 stiff wire in 15/26: 61.5%
Transradial CAS with proximal protection
Bifurcation disease: potential issues
The ECA occlusion/stenosis:
 does not allow positioning of a stiff wire deep into this vessel to support any
device advancement (i.e. GC, sheath)
 does not allow the use of the standard proximal protection (Mo.MA 8F Ultra)
Up to
205
mm
15
mm
85 mm
Standard System set up
Y-connector+MO.MA w
mandrel
System set up variant #1
No Y-connector
System set up variant #2
Mandrel exchanged for
a 4F 125cm MP
Transradial CAS with proximal protection
Mo.Ma Ultra mono balloon: Instructions for use-1
Transradial CAS with proximal protection
Mo.Ma Ultra mono balloon: Instructions for use-1
The No Mandrel 2 wire technique (The ‘No.Ma2’ technique)
Stiff wire
0.035’’
Emerald wire
0.035’’
Type I aortic arch
LCCA from the aorta
LICA stenosis
1. Right fetal PCA
2. No left PCoA
3. Patent ACoA
ICA
ECA
ICA
CCA
CCA
ECA
1
2
3
Willis circulation
Transradial CAS with proximal protection
in bifurcation disease
Transradial CAS with proximal protection
in bifurcation disease
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
Transradial CAS with proximal protection
in bifurcation disease
CM injection (early to late frame) Spider Rx
filter,6 mm
CW 7x30
post-dil
5.5x20
Final result74mmHg
TR/TB CAS
Radiation exposure
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
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
Right TR CAS with Mo.MA for LICA stenosis and BAAC
Unusual technical failure: Mind the patient height!
ECA
CCA
balloon
5 cm to
bifurcation
Mo.MA system length: 95 cm
Patient’s height: 181 cm
If >170 cm
Brachial approach
or
high radial artery puncture
 Patients: 76/267 (28.4%, 42 RA, 34 BA)
 Crossover to FA: 1.3% (1/76)
 Crossover to filter: 6.5% (5/76)
- intolerance to occlusion: 4 pts
- Mo.Ma too short: 1 pts
 MACCE (PPA): 0% (0/71)
 Major vascular complications: 1.3% (1/76)
- brachial artery pseudoaneurysm
 Chronic artery occlusion (31d-F/u): 7.1%
- radial artery: 3/42
- brachial artery: 0/34
Transradial CAS with proximal protection
Personal Experience
September
23
2016
by Doppler US

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07 aimradial2016 fri2 P Montorsi

  • 1. Use of radial access for carotid interventions with protection device Piero Montorsi, MD Associate Professor of Cardiovascular Diseases Department of Clinical Sciences and Community Health, University of Milan Director, 2nd dep’t Invasive Cardiology Centro Cardiologico Monzino, IRCCS, Milan, Italy
  • 2. Speaker name: Piero Montorsi, MD Consultant for Boston Scientific, Medtronic
  • 3. CAS through radial/brachial approaches Is it a safe & effective technique? N=382 2012 N=260 2014 We… can… do it !!
  • 4. RSA-RCCA (TRA) IA-LCCA (TRA) Sharp angle + lack of anatomic support + CAS through the transradial approach Why a difficult technique? device stiffness = high rate of failure
  • 5. Transradial/brachial CAS The Monzino’s experience 0 15 30 45 60 75 90 105 120 ’00 02 ‘03 ‘04 ‘05 ‘06 ‘07 ‘08 ‘09 ‘10 ‘11 ‘12 ‘13 ‘14 TR/TBA/TU 267/926 (29%) CASprocedures/year(n) N=1197 ‘15 TR/TB/TU w Filter (n=191, 84% radial) TR/TB w Mo.Ma (n=76, 55% radial) 6/’16 66% (34/51 pts) 73%
  • 6. Transradial/brachial CAS with proximal protection Patient population ‘close-up’  Number of pts: 76/267 (28.4%)  Indications: - Symptomatic pts - Asymptomatic pts with high risk clinical and or anatomic characteristics  Vascular access: - Radial/brachial approach (according to clinical assessment and/or Doppler US)  Type of PP: 8F Mo.Ma (Medtronic)  Type of stent: 5F-compatible stents  Anticoagulantion: Heparin (TR), Bivalirudin (TB)  Closure: TR-band+’patent’ hemostasis (TR) and manual compression (TB)
  • 7. 6F Sheath (Avanti, Cordis) 11 cm OD: 2.67mm ‘6F in 5’ (GSS, Terumo) 10 cm OD: 2.46mm + GC 6F + CW7/Precise 8 Roadsaver (any size) 8F Sheath Avanti (Cordis) OD: 3.3 mm 11 cm5.5 cm CAS with Mo.Ma (8F)CAS with filter Radial artery cannulation
  • 8. RSA-RCCA Bifurcation (+ RICA stenosis) LCCA take off from the aortic arch (+ LICA stenosis) TR/TB CAS with proximal protection Technical success/failure rate LCCA take off from the IA: BAAC (+LICA stenosis) First attempt failure rate 26/75 (34.6%) 0% 40% 80%Technical success 75/76 (98.6%) Crossover rate: 1.3%
  • 9. TR/TB CAS with proximal protection LICA lesion in 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
  • 10. TR CAS technical failure Sharp angle between RSA-RCCA bifurcation RICA stenosis Right radial approach Attempt to position the Mo.Ma system over a .035’’ stiff wire (Supracore)  prolapse into the IA
  • 11. Transradial CAS with proximal protection The No.MA2 technique 26/75 (34.6%) ‘first attempt’ failure  Reduce the device stiffness  1. Mandrel removal (5-10cm) and try again
  • 12. Transradial CAS with proximal protection The No.MA2 technique TS: 1/26 (3.8%)
  • 13. Transradial CAS with proximal protection The No.MA2 technique 0.035” Emerald wire loaded into the working channel (mandrel withdrawn) 0.035” stiff wire loaded into the distal port No.Mandrel 2 wires technique (No.MA2 technique) 26/75 (34.6%) first attempt technical failure  1. Mandrel removal (5-10cm) and try againif fails  Improve wire support 
  • 14. TR CAS technical failure Sharp angle between RSA-RCCA bifurcation RICA stenosis Right radial approach Attempt to position the Mo.Ma system over a .035’’ stiff wire (Supracore)  prolapse into the IA
  • 15. Sharp angle between RSA-RCCA bifurcation Mo.Ma placement with the No.Ma2 technique-1 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 Stiff Angled Glide Wire 4MP, 125 cm 6 Guiding cath.
  • 16. Sharp angle between RSA-RCCA bifurcation Mo.Ma placement with the No.Ma2 technique-2 Cristallo Ideale 7-10x40mm Postdil 5.5x20 Occlusion test8F Mo.Ma in place ECA balloon inflation and test for ECA exclusion Final result
  • 17. Sharp angle of RSA-RCCA bifurcation Mo.Ma placement with modified technique 78yom. Right hemisphere minor stroke. Right ICA ‘near-occlusion’ Right radial approach 5FRJ cath in RCCA over .035’’ Terumo wire Terumo wire echanged for a .035’’ stiff wire. 5FRJ removed. Failure to advance the 8F Mo.ma device Additional wire in ECA through a coxial system (4FMP125 + 6FRJ guide)
  • 18. Additional 0.035” Emerald wire below bifurcation through 6FRJ guide ECA Both MO.MA balloon inflated Final result after Cristallo stent 7- 10x40mm Sharp angle of RSA-RCCA bifurcation Mo.Ma placement with modified technique
  • 19. LCCA LSA IA HU: 34 Left ICA PSV: >4m/s Sharp angle of IA-LCCA bifurcation Mo.Ma placement with the No.Ma 2 technique
  • 20. Sharp angle of IA-LCCA bifurcation Mo.Ma placement with the No.Ma 2 technique 8F MO.MA in place Coaxial system: 6FRJ guide+4FMP 125, loaded on Terumo wire from R brachial approach 6FRJ 4FMP 125 6FRJ guide in ECA. 4FMP removed Terumo wire exchanged for .035” standard wire + .035”stiff wire (Magic Torque, BSI). 6FRJ guide removed. 8F MO.MA loaded on the 2 wires (No.Ma technique) Final result
  • 21. Sharp angle between RSA-RCCA bifurcation Mo.Ma placement with the No.Ma2 technique-1 74yom. Recent right hemisphere minor stroke. Type III aortic arch. Failure of CAS by femoral artery. Rescheduled from the right RA approach Early arterial frame Late arterial frame
  • 22. Sharp angle between RSA-RCCA bifurcation Mo.Ma placement with the No.Ma2 technique-3 .035’’ Emerald .035’’ Magic Torque 5FIM .035’’ Terumo 6FRJ
  • 23. Sharp angle between RSA-RCCA bifurcation Mo.Ma placement with the No.Ma2 technique-2 OA STA
  • 24. The No.Ma2 technique Which type for the additional wire? 14 pts: 1 stiff + 1 Emerald wire 7 pts: 2 Emerald wire 2 pts: 2 Stiff wire 1 pt : 1 stiff wire + 1 Terumo wire 1 pt: 1 Emerald wire + 1 V18 wire At least 1 stiff wire in 15/26: 61.5%
  • 25. Transradial CAS with proximal protection Bifurcation disease: potential issues The ECA occlusion/stenosis:  does not allow positioning of a stiff wire deep into this vessel to support any device advancement (i.e. GC, sheath)  does not allow the use of the standard proximal protection (Mo.MA 8F Ultra)
  • 26. Up to 205 mm 15 mm 85 mm Standard System set up Y-connector+MO.MA w mandrel System set up variant #1 No Y-connector System set up variant #2 Mandrel exchanged for a 4F 125cm MP Transradial CAS with proximal protection Mo.Ma Ultra mono balloon: Instructions for use-1
  • 27. Transradial CAS with proximal protection Mo.Ma Ultra mono balloon: Instructions for use-1 The No Mandrel 2 wire technique (The ‘No.Ma2’ technique) Stiff wire 0.035’’ Emerald wire 0.035’’
  • 28. Type I aortic arch LCCA from the aorta LICA stenosis 1. Right fetal PCA 2. No left PCoA 3. Patent ACoA ICA ECA ICA CCA CCA ECA 1 2 3 Willis circulation Transradial CAS with proximal protection in bifurcation disease
  • 29. Transradial CAS with proximal protection in bifurcation disease 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
  • 30. Transradial CAS with proximal protection in bifurcation disease CM injection (early to late frame) Spider Rx filter,6 mm CW 7x30 post-dil 5.5x20 Final result74mmHg
  • 31. TR/TB CAS Radiation exposure 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
  • 32. 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
  • 33. Right TR CAS with Mo.MA for LICA stenosis and BAAC Unusual technical failure: Mind the patient height! ECA CCA balloon 5 cm to bifurcation Mo.MA system length: 95 cm Patient’s height: 181 cm If >170 cm Brachial approach or high radial artery puncture
  • 34.  Patients: 76/267 (28.4%, 42 RA, 34 BA)  Crossover to FA: 1.3% (1/76)  Crossover to filter: 6.5% (5/76) - intolerance to occlusion: 4 pts - Mo.Ma too short: 1 pts  MACCE (PPA): 0% (0/71)  Major vascular complications: 1.3% (1/76) - brachial artery pseudoaneurysm  Chronic artery occlusion (31d-F/u): 7.1% - radial artery: 3/42 - brachial artery: 0/34 Transradial CAS with proximal protection Personal Experience September 23 2016 by Doppler US