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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
Disclosures
• YL- no relevant disclosures
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).
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
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
Results
TR Failure = 16.9%, requiring
switch to femoral due to:
Supra-aortic tortuosity (n=2)
CTO (n=7)
SFA (n=1)
Results: Lesion complexity TR vs TF
N=188 Total Successful TR (n=54) Successful TF (n=134) P-value
Lesion length (cm) 6.19 ± 3.1 6.14 ± 3.2 6.3 ± 2.9 0.83
Total Occlusions (%) 84 (44.7) 22 (40.7) 62 (46.3) 0.99
Superficial Femoral Artery 59 (31.4) 3 (5.6) 56 (42.1) 0.01*
Aorto-Iliac Bifurcation 14 (7.4) 4 (7.4) 10 (7.5) 0.22
Iliac Artery 117 (62.2) 42 (77.8) 75 (56.0) 0.01*
Mulitvessel procedure 11 (5.9) 6 (11.2) 5 (3.7) 0.01*
TASC Grade
A
B
C
D
66 (35.1)
84 (44.7)
30 (16.0)
2 (1.1)
18 (33.3)
24 (44.4)
5 (9.3)
1 (1.9)
48 (35.8)
60 (44.8)
25 (18.7)
1 (0.7)
NS
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
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
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
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
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
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?
04 aimradial2016 fri2 A Roy / Y Louvard
04 aimradial2016 fri2 A Roy / Y Louvard
04 aimradial2016 fri2 A Roy / Y Louvard
04 aimradial2016 fri2 A Roy / Y Louvard
04 aimradial2016 fri2 A Roy / Y Louvard
04 aimradial2016 fri2 A Roy / Y Louvard
04 aimradial2016 fri2 A Roy / Y Louvard
04 aimradial2016 fri2 A Roy / Y Louvard
04 aimradial2016 fri2 A Roy / Y Louvard
04 aimradial2016 fri2 A Roy / Y Louvard
04 aimradial2016 fri2 A Roy / Y Louvard

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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
  • 2. Disclosures • YL- no relevant disclosures
  • 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)
  • 7. Results: Lesion complexity TR vs TF N=188 Total Successful TR (n=54) Successful TF (n=134) P-value Lesion length (cm) 6.19 ± 3.1 6.14 ± 3.2 6.3 ± 2.9 0.83 Total Occlusions (%) 84 (44.7) 22 (40.7) 62 (46.3) 0.99 Superficial Femoral Artery 59 (31.4) 3 (5.6) 56 (42.1) 0.01* Aorto-Iliac Bifurcation 14 (7.4) 4 (7.4) 10 (7.5) 0.22 Iliac Artery 117 (62.2) 42 (77.8) 75 (56.0) 0.01* Mulitvessel procedure 11 (5.9) 6 (11.2) 5 (3.7) 0.01* TASC Grade A B C D 66 (35.1) 84 (44.7) 30 (16.0) 2 (1.1) 18 (33.3) 24 (44.4) 5 (9.3) 1 (1.9) 48 (35.8) 60 (44.8) 25 (18.7) 1 (0.7) NS
  • 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

  1. 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
  2. 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.
  3. 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
  4. 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
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