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04 aimradial2016 fri2 A Roy / Y Louvard
1. Safety and efficacy of radial artery
access for aortoiliac and
femoropopliteal lesion
interventions
AK Roy, P Garot, A Neylon, M. Spaziano, F.
Sawaya, L. Fernandez, Y Roux, R Blanc, M Piotin, S
Champagne, O Tavolaro, B Chevalier, T Lefèvre, Y
Louvard, T Unterseeh
Departments of Cardiology and Interventional Radiology,
Ramsay Générale de Santé, Institut Cardiovasculaire
Paris-Sud - Hôpital Claude-Galien Quincy Sous-Senart
and Hôpital Privé Jacques Cartier, Massy, France
3. Background and Aim
Limited studies supporting the safety and efficacy of a
transradial approach for peripheral interventions.
Unlike transradial coronary interventions, uptake has been
slow, partly due to catheter and device limitations.
The aim was to compare technical and safety outcomes of
a radial vs femoral approach for patients undergoing
endovascular interventions for peripheral arterial occlusive
disease (Rutherford Classes II-IV).
4. Methods
Single center retrospective study
of patients with claudication or
critical limb ischaemia.
Lesions treated were TASC A +
B; TASC C and D lesions only if
surgery contraindicated.
Operator discretion for choice of
access.
Exclusion criteria TR: Raynaud’s
disease, Renal Failure with
planned dialysis, known upper
limb or aorta PAD, previous TR
failure.
n=188
patients
65
Transradials
attempted
123
Transfemorals84% TF
retrograde
26% TF
anterograde
22% Left
TR
78% Right
TR
5. Methods: Endpoint Definitions + Material
PARC criteria- degree of lesion calcification (focal, mild, moderate,
severe)
Standard vascular access-site and VARC major bleeding criteria
Commonly used delivery sheaths
Flexor Shuttle Sheath (Cook) 90-110cm
Epsylar (Optimed) 120cm
Destination (Terumo Corp) 45-90cm
6. Results
TR Failure = 16.9%, requiring
switch to femoral due to:
Supra-aortic tortuosity (n=2)
CTO (n=7)
SFA (n=1)
8. Results
N=188 Total Successful Radial
artery access
(n=54)
Femoral artery
access
(n=134)
P-value
Procedure time 49.2 ± 28.0 46.8 ± 25.1 50.0 ± 28.9 0.50
Contrast (mL) 107.3 ± 71.2 132.1 ± 98.2 99.9 ± 59.5 0.05*
Fluoroscopy Time (mins) 14.0 ± 12.9 14.56 ± 11.8 13.9 ± 13.2 0.77
Dose (Air Kerma) mGy 580.4 ± 752.0 605.7 ± 846.1 573.8 ± 728.4 0.82
Dose total (Dose Area
Product)
130.2 ± 150.4 172.8 ± 193.9 117.9 ± 133.6 0.09
Length of Stay (1 day <
24 hours).
2.16 ± 0.6 2.06 ± 0.3 2.19 ± 0.6 0.24
Increased contrast volumes for TR, but no differences in radiation or
lengths of stay
9. N=188 Total Transradial
(n=54)
Transfemoral
(n=133)
P-value
Stroke 0 0 (0.0) 0 (0.0) 1.0
Major Vascular Bleeding 0 0 (0.0) 0 (0.0) 1.0
Access-site complication 8 (4.2) 2 (3.7) 6 (4.5) 0.72
Arterial Occlusion 2 (1.1) 2 (3.7) 0 (0.0) 0.61
Pseudoaneurysm 6 (3.2) 0 (0.0) 6 (4.5) 0.02
Arterio-venous
Fistula
1 (0.5) 0 (0.0) 1 (0.7) 0.53
Haematoma > 5cm 1 (0.5) 0 (0.0) 1 (0.7) 0.11
Haemostasis closure device failure 8 (4.3) 0 (0.0) 8 (6.0) 0.03*
Roy AK et al. J Endovasc Ther 2016
Comparison of major vascular and access-site complications
for peripheral interventions using TR and TF approaches
10. Comparison of procedural radiation and contrast
exposure for right and left TR approaches
Procedural
parameters
Right radial
approach ± SD
Left radial approach 95% Confidence
Interval
P-value
Fluoroscopy (mins) 18.31 ± 13.08 9.39 ± 5.09 3.57-14.26 0.002*
Contrast (mLs) 135.93 ± 101.22 97.70 ± 40.44 -27.7-104.2 0.25
Dose Air Kerma
(mGy)
746.40 ± 983.22 292.37± 268.90 75.1-833.0 0.02*
Dose (Dose Area
Product)
201.69 ± 198.22 74.48 ± 48.01 57.2-197.2 0.001*
Roy AK et al. J Endovasc Ther 2016
11. Characteristics Odds Ratio 95% Confidence Interval P-value
Age 1.01 0.93-1.08 0.98
Female sex 0.90 0.17-4.67 0.90
Height 0.71 0.29-1.74 0.45
Chronic Total Occlusion 0.40 0.10-1.54 0.18
Total lesion length 1.03 0.97-1.09 0.34
Iliac Lesion 1.86 0.39-8.81 0.43
Superficial Femoral Artery Lesion 3.07 0.89-10.63 0.70
TASC C or D 0.32 0.15-6.58 0.46
Moderate to heavy lesion calcification 2.07 0.48-8.92 0.33
Multivariable model for predictors of transradial access failure
* Roy AK et al. J Endovasc Ther 2016
12. Conclusion
TR access for peripheral interventions is-
(i) safe
No strokes
No major access-site complications
Left TR associated with less radiation
(ii) feasible
84% success rate
Can treat all lesion subtypes
No singular predictors of TR failure
13. 200cm
150c
m
120c
m
PTA balloon*
SX stent*
Slender 6F
Guiding sheath*
7F Slender
guiding catheter*
*currently in
development
TR BandDCB*
Popliteal
150 or 180
cm
Common
femoral
120 or 150
cm
Common
iliac 105 or
125 cm
Superficial
femoral 130
or 170 cm
7-in-6
GlideSheath
Slender
Staniloae CS, et al Catheter Cardiovasc.Interv.
81, 1194–1203 (2013)
What does the future hold for TR peripheral interventions?
Hinweis der Redaktion
Rutherford= Classification des symptoms: R0-asymptomatic,R1-mild claudication,R2-moderate claudication at 200metres,R3- severe claudication,R4-rest pain, R5-ischaemic ulceration only of toes, R6-severe ischaemic ulcers or gangrene/necrosis of tissue
TASC=Trans-Atlantic Inter-Society Consensus / A group from Europe and North America who made a consensus document in 2000, for the classification and treatment of PAD. In 2007 this was updated, involving additional societies from Australia, South Africa, and Japan- this is now called TASC II. The TASC II guidelines recommend endovascular treatment for TASC grades A-C, and surgery for TASC grade D. Many operators now perform endovascular interventions for TASC A-D lesions.
PARC: Peripheral Academic Research Consortium, newly developed to standardize clinical and research endpoints for PAD interventions that satisfy the FDA regulation requirements for interventional studies
PARC calcification: focal (<180° of the vessel, and less than half the lesion length); mild (<180° of vessel, and more than half the lesion length); moderate (>180° of vessel and less than half of lesion); severe (>180° on both sides of vessel, and whole length of vessel).
VARC; life-threatening (fatal, major organ,need for >4 units transfusion); major bleeding (a drop in 3 units of Hb, or need for 2-3 units of transfusion), or minor bleeding
VARC: Valve Academic Research Consortium ; the same set of standardized clinical and research endpoints for valve studies
Both systems
Will be available in 120 and 150 cm
Have slender technology: thin wall compared to conventional guiding sheath / guiding catheter
Are compatible with these interventional products
Interventional devices: all 200 cm
PTA balloon
Drug coated balloon
SX Misago stent
For closure: our TR band