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01 aimradial2016 fri2 Z Ruzsa
1. Transradial access
for femoral artery intervention
AimRadial
2016
Z. Ruzsa, R. Bellavics, B. Nemes,
F. Kuti, E.M. Végh, K. Hüttl, B. Merkely
2. Disclosure Statement of
Financial Interest
I, Zoltán Ruzsa MD. PhD.
DO NOT have a financial interest/arrangement or
affiliation with one or more organizations that
could be perceived as a real or apparent conflict of
interest in the context of the subject of this
presentation.
3. Background
• Limited data exists in the literature about
transradial femoral interventions 1,2
.
• The purpose of this pilot study was to evaluate
the acute success and complication rate of the
transradial access for femoral artery
intervention.
1. Lorenzoni R et al. J Endovasc Ther. 2014 Oct;21(5):635-40.
2. Lorenzioni R et al. EuroIntervention. 2011 Dec;7(8):924-9.
3. Hanna EB, Prout DL. J Endovasc Ther. 2016 Apr;23(2):321-9.
4. Routine access site selection- femoral
- Multilevel disease
Iliac + Femoral + BTK
- Multilevel disease
Iliac + Femoral + BTK
- Distal stenosis
- Non diseased
CFA
- Popliteal lesion
- Distal stenosis
- Non diseased
CFA
- Popliteal lesion
Anterograde
femoral
Anterograde
femoral
- SFA stenosis close
to the CFA
- Diseased CFA
- SFA stenosis close
to the CFA
- Diseased CFA
Cross over
possible
Cross over
possible
Brachial or radial accessBrachial or radial access
No cross over
-Scar
-Bypass
-Stents in the iliac ostium
-Extreme angulation
-Extreme tortuosity
No cross over
-Scar
-Bypass
-Stents in the iliac ostium
-Extreme angulation
-Extreme tortuosity
Is there a place for primary radial
access for femoral artery
intervention ???
Cross overCross over
- Complex CTO
(failed antegrade)
- Complex CTO
(failed antegrade)
Popliteal or
transpedal
Popliteal or
transpedal
yes
No
No No
5. Sheathless guiding
Coronary SG 8.5 F 100 cm
Internal D: 2.28 mm
External D: 2.8 mm
Peripheral SG 6F 120 cm
Internal D: 2.29 mm
External D: 2.8 mm
6. Methods
The clinical and angiographic data of 98 consecutive patients with symptomatic
femoral artery stenosis treated via transradial access using 6F sheathless
guiding between 2014 and 2016.09 were evaluated in a pilot study.
Inclusion criteria:
•Significant, isolated femoral artery stenosis or occlusion
•Intermittent claudication (Fontaine IIa-b)
•Critical limb ischemia (crural ulcer, pedal gangrene, ischemic rest pain)
Exclusion criteria:
•Contraindication of the transradial access (negative Allen test, radial artery
occlusion)
•Contraindication of the 6 F usage in the radial artery: very small radial artery
(<2 mm) and severe calcification or stenosis
•TASC D lesions
End points:
•Primary endpoint:
– major adverse events (MAE),
– rate of major and minor access site complications.
•Secondary endpoints:
– angiographic outcome of the femoral artery intervention,
– consumption of the angioplasty equipment
– X Ray dose, procedural time, cross over rate to another puncture site and
hospitalisation in days.
7. Methods: Angioplasty technique
• Medical therapy
- Transradial cocktail (NaHeparin 5000 U and 2.5 mg Verapamil)
- Per os Aspirin and Clopidogrel
- Heparin up to 100 U/kg
• Patient positioning
– Right radial: Normal
– Left radial: Inverse
• Punction and cannulation
- Local anesthaesia and dedicated
5F TR sheath
• Diagnostic angiography
- 125 cm Pig tail catheter
9. Methods: Angioplasty technique
Cannulation of the iliac artery
-6 F 120 cm Asahi sheathless guiding over a long Starter or
Extra-support 0.035 GW (Jindo, Amplatz)
-6.5 F 90 cm Asahi sheathless coronary guiding catheter over a
long Starter or Extra-support 0.035 GW
-Telescoping technique with a MP 125 cm 5F catheter
Angioplasty
-„Road map imaging”
-Balloon angioplasty with long inflations (2-3 min)
-Focal stenting (Optimed stent with 180 cm long shaft)
-Alternative access site is the popliteal or transpedal access for
stenting----For DEB or DES and Stent with high radial force
(Supera)
-Femoral access site only in bail out cases
-Final angio
Postop treatment
-Non occlusive pressure bandage
-Immediate mobilisation
10. Results- Demographic dataDemographic and clinical data n (%)
Demographic data Age (years)
Male
Hypertension
Dyslipidaemia
Diabetes mellitus
-IDDM
-NIDDM
Weight (kg)
Height (cm)
Chronic obstuctive pulmonary disease
Renal insuffitiency (Cr >130 mmol/l)
Active smoking
66.7 ± 10.1
62 (63,2)
94 (95.9)
93 (94.8)
15 (15.3)
31 (31.6)
76.9 ± 15.9
167.0 ± 7.7
4 (4.0)
25 (25.5)
19 (19.4)
Cardiac and vascular
history
CAD
Previous PTA
Previous bypass
PAD
- IC
- CLI
- ALI
36 (36.7)
35 (35.7)
8 (8.2)
35 (35.7)
62 (63.2)
1 (1.0)
Fontaine classification I
IIa
IIb
III
IV
0 (0)
8 (8.2)
26 (26.5)
27 (27.5)
37 (37.8)
12. Results- Procedure
Angiographic result of the intervention
Successful
-Good result
-Satisfactory result
Unsuccessful
93 (94.9)
2 (2.0)
3 (3.1)
Primary Access:
- Radial n=96 (98%)
- Ulnar n= 2 (2%)
Side:
- Right side n= 76 (77.6%)
- Left side n= 22 (22.4%)
Secondary Access:
- Popliteal n= 1 (1.0%)
- Pedal n= 4 (4.1%)
Cross over to femoral
- to femoral n=3 (3.1%)
13. Results – Impact of the side selection
Left hand access
(n= 22)
Right hand access
(n= 76)
Procedure time (min) 32.05 [22.5-42.2] 29.87 [24.2-32]
Fluroscopy time (sec) 800.0 [423.6-936.6] 675.7 [541.2-744.1]
X Ray dose (Gy) 12.0 [7.9-15.5] ★★
25.4 [0.45-50.31]
Contrast consumption (ml) 100.77 [71.4-138.8] 105.0 [89.7-120]
Advantage of the left hand access:
- Easy access to the descendentic aorta
- Shorter delivery system is necessary
14. Follow up
• MAEs at 6 months: 1 pt (1.0%)
• TLR at 6 months: 2 pts (2.0%)
15. POC n (%)
Procedural complications
- Distal embolisation
- Other
Summary
0 (0)
0 (0)
0 (0)
Access site complications
RAO
Compartment syndrome
Spasm
Perforation
Summary
3 (3.1)
0 (0)
0 (0)
0 (0)
3 (3.1)
MAE at two month FU
- Death
- Major amputation
- Urgent operation or PTA
- Myocardial infarction
Summary
2 (2.0)
2 (2.0)
1 (1.0)
0 (0)
5 (5.1)
Perioperative complications
16. Limitations of the study
- The main limitaion is the lack of femoral
control group
- It is not a randomized study
• Technical
– We have no dedicated Drug eluting balloons
and stent with long shaft length, therefore
for these cases the transpedal and
transpopliteal access must be prepared
18. Access ??
- iliac stent
- diseases CFA
-Long SFA CTO
-Popliteal CTO
- ATA and ATP occl
TR access
-6F SG
-V18 GW 300
-Treasure12 300
-Invatec 5x150 180
-Invatec 6x150 180
-Optimed 6x80 180
Peroneal access
-Cook 4F
-Progress40 300
-Fox 4x80
Difficult case
-Multilevel
-Long CTOs
19. Conclusion
• Femoral artery angioplasty can be safely and
effectively performed using radial access and
sheathless guiding with acceptable morbidity and high
technical success.
• Although complication rates of the present pilot
register are promising, larger studies are needed to
determine the long term success rate of transradial
femoral PTA.