Learning curve in transradial carotid artery stenting: results from RADCAR - RADial access for CARotid artery stenting study

1. Learning curve in transradial carotid artery stenting
(results from RADCAR- RADial access for CARotid
artery stenting study)
Zoltán Ruzsa MD PhD et al.
AimRadial 2015

2. Potential conflicts of interest
Speaker's name: Zoltan Ruzsa
 I do not have any potential conflict of interest

3. Background
Severe access 1 Cannulation problems 2,3
1. Yoo BS. Catheter Cardiovasc Interv. 2002 Jun;56(2):243-5. 2. Gan HW. Catheter Cardiovasc Interv. 2010 Mar 1;75(4):540-3.
3. Shaw JA. Catheter Cardiovasc Interv. 2003 Dec;60(4):566-9.

4. Background (Transradial CAS)
Publication
year
Study Patient
No
Success (%) Cross over
(%)
Asympt
RAO
(n, %)
Major vasc
complication
MACCE
Pinter et al.
1
2007 Pilot 20 90 10 5 0 0
Folmar J et
al. 2
2007 Pilot 42 83 ? 0 0 2.3
Patel et al. 3 2010 Pilot 20 80 ? 0 0 5
Bakoyiannis
C et al. 4
2010 Pilot 9 100 0 0 0 0
Mendiz Oa
et al 5
2011 Pilot 79 98.8 ? 0 0 2
Ruzsa et al.
6
2012 Pilot 68 97.1 2.85 2.94 1.4 1.4
Etxegoien N
et al 7
2013 Pilot 382 91 ? 6 0 0.6
1. Pinter et al. J Vasc Surg. 2007 Jun;45(6):1136-41.
2. Folmar J et al. Catheter Cardiovasc Interv. 2007 Feb 15;69(3):355-61.
3. Patel et al. Catheter Cardiovasc Interv. 2010 Feb 1;75(2):268-75.
4. Bakoyiannis C et al. Int Angiol. 2010 Feb;29(1):41-6.
5. Mendiz OA. Vasc Endovascular Surg. 2011 Aug;45(6):499-503.
6. Ruzsa et al. Cardiologia Hungarica. 2012; 42 : 6–X
7. Etxegoien N. Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1081-7.

5. Study flow chart

6. Methods
Study population.
- The clinical and angiographic outcomes of 260 consecutive patients with high risk for carotid
endarterectomy (9) treated by CAS with cerebral protection were evaluated in a prospective randomized
multicenter study between 2010 and 2012.
- Patients were randomized to TR (n =130) or TF (n =130) groups.
Endpoints
The following parameters were applied to evaluate the potential advantages of TR access:
- Primary endpoint: MACCE, rate of major and minor access site complications.
- Secondary endpoints: angiographic outcome of the CAS, and consumption of the angioplasty equipment,
fluoroscopy time and X Ray dose, procedural time,cross over to another puncture site and hospitalisation
days.
Inclusion and exclusion criteria.
- Inclusion criteria were: (1) Symptomatic (history of stroke or transient ischemic attack within 6 months)
internal carotid artery stenosis (>70%) determided by magnetic resonance imaging or computer tomography
and (2) critical asymptomatic (80%) ICA stenosis.
-Exclusion criteria were: (1) history of acute or recent stroke (<2 months), myocardial infarction, and surgery
or trauma within the preceeding 2 months, (2) unconsiousness or unwillingness to undergo the procedure,
(3) known subclavian or brachiocephalic artery stenosis, (4) known iliac or common femoral stenosis, (5)
contraindications of the transradial access (Negative Allen test, non-palpable radial artery).
Statistical analysis
Proportions were compared using the chi-square test or Fisher’s exact test and continuous variables were
compared by t-test or Mann-Whitney U test as appropriate.
Annova and Kruskal Wallis test was used for column analysis.

7. Bovine arch- direct cannulation
Access: JR 7F
Guiding: 7F JR3,5
Guidewire: Filter wire
Stent: Carotis Wallstent 7x30 mm
Balloon: Sterling 4x20 and 6x20 mm

8. Left sided lesion- Indirect cannulation

9. Aortic arch II-Loop technique
Access: 7F
Guiding: 7F XF40
Guidewire: Filter wire
Stent: Carotis Wallstent 7x30 mm
Balloon: Sterling 5x20 mm

10. Loop technique

11. 11
Demographic and clinical data

12. Angiographic data
12

13. 13
Procedural
data

14. Procedural data
14

15. Complications
15

16. Cross over cases
16

17. Impact of the learning curve by year
Procedure time
0
1000
2000
3000
4000
5000
Year 1-2-3
PT(min)
17
Fluoro Time
0
500
1000
1500
2000
Year 1-2-3
FT(sec)
Contrast consumption (ml)
C
ontrast(m
l)
C
ontrast(m
l)
C
ontrast(m
l)
0
50
100
150
200
250
Year 1-2-3
Contrast(ml)
X Ray dose
0
200
400
600
800
Year 1-2-3
Dose(mGy)
*
*
* *
*
*

18. Impact of leaning curve by year (p values)
First year (n=29) Second year (n=33) Third year (n=68)
X Ray dose (mGy)
<0.001 0.093
0.517
Fluoroscopy time (sec)
0.100 0.002
0.039
Contrast volume (ml)
0.718 <0.001
<0.001
Procedure time (sec)
<0.001 0.915
0.005

19. Radial group
First year Second year Third year p Summary (n=130)
Successful puncture in all
patients n (%)
28 (96.6) 32 (97.0) 68 (100.0) 0.328 128 (98.5)
Successful cannulation n
(%)
26 (89.7) 28 (84.8) 65 (95.6) 0.178 119 (91.5)
Successful procedure
from primary access n
(%) 25 (86.2) 27 (81.8) 65 (95.6) 0.073 117 (90.0)
Cross over n (%) 4 (13.8) 6 (18.2) 3 (4.4) 0.073 13 (10.0)
Puncture time (sec)
30 (15-60) 20 (15-35) 15 (10-29) <0.001 20 (10-30)
Cannulation time (sec) 60 (30-116) 65 (35-120) 62 (20-180) 0.779 62 (30-180)
Procedure time (sec)
1920 (1500-2940) 1800 (1200-2100) 1500 (1155-1800) 0.002 1650 (1200-2100)
X Ray dose (mGy) 199 (121-344) 177 (130-282) 195 (134-273) 0.947 195 (130-288)
Fluoroscopy time (sec) 714 (510-863) 600 (452-729) 476 (361-630) 0.003 543 (402-759)
Contrast volume (ml)
135 (100-150) 140 (91-165) 100 (75-125) <0.001 120 (80-150)
Hospitalization days 2.2±5.4 1.3±0.5 1.2±0.4 0.151 1.4±2.6
Impact of learning curve (radial group)

20. Impact of the learning curve
Femoral group
p Summary (n=130)
Successful puncture in all
patients n (%)
102 (100.0) 18 (100.0) 10 (100.0) 1.000 130 (100.0)
Successful cannulation n
(%)
100 (98.0) 18 (100.0) 10 (100.0) 0.758 128 (98.5)
Successful procedure from
primary access n (%)
100 (98.0) 18 (100.0) 10 (100.0) 0.758 128 (98.5)
Cross over n (%) 2 (2.0) 0 (0.0) 0 (0.0) 0.758 2 (1.5)
Puncture time (sec)
20 (15-31) 15 (10-16) 25 (17-40) 0.008 20 (15-30)
Cannulation time (sec) 60 (55-120) 60 (60-75) 43 (18-83) 0.126 60 (60-120)
Procedure time (sec) 1590 (1200-2310) 1080 (900-1335) 1800 (1350-2055) 0.001 1500 (1080-2235)
X Ray dose (mGy) 174 (110-259) 103 (83-136) 121 (71-211) <0.001 150 (104-241)
Fluoroscopy time (sec) 534 (377-779) 423 (380-513) 558 (383-904) 0.148 513 (378-716)
Contrast volume (ml)
105 (87-137) 92 (79-106) 150 (65-166) 0.064 104 (82-137)
Hospitalization days 1.2±0.5 1.2±0.4 1.5±0.5 0.150 1.3±0.5

21. Dual center registry (2008-2014…)
21
Contrast consumption (ml)
0
100
200
300
Year (1-5 year)
Contrast(ml)

22. Conclusion
• Carotid artery stenting with cerebral protection devices
can be safely and effectively performed using radial
access with acceptable morbidity and high technical
success.
• Despite the promising early results the TF technique is
superior to TR technique, but the TR technique allows
earlier ambulation than the TF access
• Incorporation of the radial access approach for carotid
artery stenting led to a decrease in fluoroscopy time,
procedure time and contrast consumption over the last
3 years.
• Due to fast mobilisation the patient comfort is better