e-poster13 rusza aimradial20170922 hybrid approach
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Speaker's name: Zoltan Ruzsa
I do not have any potential conflict of interest to report:
Potential conflicts of interest
Access site selection for lower limb interventions
0
50
100
150
200
250
300
350
1 2 3 4 5 6
Femoral
Radial
Brachial
Dual- Radial + Femoral
Dual- Radial + Transpedal
Dual- Femoral + Transpedal
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.
Routine access site selection-femoral
- Multilevel diseaseIliac + Femoral + BTK
- Distal stenosis- Non diseased
CFA- Popliteal lesion
Anterograde femoral
- SFA stenosis close to the CFA
- Diseased CFA
Cross overpossible
Brachial or radial access
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 over
- Complex CTO(failed antegrade)
Popliteal or transpedal
yes
No
No No
Sheathless guidingCoronary SG 8.5 F 100 cmInternal D: 2.28 mm
External D: 2.8 mm
Peripheral SG 6F 120 cmInternal D: 2.29 mm
External D: 2.8 mm
Methods
The clinical and angiographic data of 141 consecutive patients with symptomatic femoral artery stenosis treated via transradial access using 6F sheathless guiding between 2014 and 2016.12 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
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.
Methods: Angioplasty technique
• Medical therapy
- Transradial cocktail (NaHeparin5000 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
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)
- Long 300 cm 0.18 or 400 cm 0.18 GW (Roadrunner, Cook)
- 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
Demographic and clinical data n (%)
Demographic data Age (years)
Male
Hypertension
Current smokers
Diabetes mellitus
- IDDM
- NIDDM
Weight (kg)
Height (cm)
Chronic obstuctive pulmonary disease
Renal insuffitiency
67.6 ± 9.8
89 (63.1)
136 (96.5)
22 (15.6)
74 (52.5)
25 (17.7)
49 (34.8)
79.4 ± 16.6
168.0 ± 8.2
8 (5.7)
31 (22)
Cardiac and vascular history CAD
Previous PTA
Previous bypass
Previous major amputation
PAD
- IC
- CLI
- ALI
47 (33.3)
52 (36.9)
15 (10.6)
0 (0.0)
57 (40.4)
82 (58.2)
2 (1.4)
Fontaine classification I
IIa
IIb
III
IV
0 (0)
11 (7.8)
45 (31.9)
34 (24.1)
51 (36.2)
Results- Angiographic dataAngiographic and procedural data n (%)
Quantitative measurements
Common femoral artery
Diameter stenosis (%)
Lesion length (mm)
Reference diameter (mm)
Superficial femoral artery
Diameter stenosis (%)
Lesion length (mm)
Reference diameter (mm)
Popliteal artery
Diameter stenosis (%)
Lesion length (mm)
Reference diameter (mm)
12.3 (29.3)
6.2 (19.7)
5.8 (0.8)
79.4 (27.6)
82.2 (67.2)
5.5 (0.6)
14.2 (33.4)
9.2 (28.6)
4.6 (0.5)
Angiographic and procedural data n (%)
Lesion type
Chronic total occlusion (%)
TASC A
TASC B
TASC C
TASC D
66 (46.8)
74 (52.5)
32 (22.7)
14 (9.9)
21 (14.9)
Angiographic result of the intervention
Successful
-Good result
-Satisfactory result
Unsuccessful
128 (87.2%)
11 (7.8%)
7 (5%)
Results- Procedure
Primary Access:
- Radial n=138 (97.9%)
- Ulnar n= 3 (2.1%)
Side:
- Right side n= 114 (80.8%)
- Left side n= 27 (19.2%)
Secondary Retrograde Access (DUAL):
- Popliteal and AFS n= 4 (2.8%)
- Pedal n= 14 (9.9%)
Cross over to Anterograde Femoral
- to femoral n=4 (2.8%)
Results- technique and devices
• POBA: 107 (75.9%)• 5 pts retrograde IMPACT
• Stenting: 34 pts (24.1%)• Anterograde 22 pts (64.7%)
• Retrograde 12 pts (35.9%)• 10 Supera
• 2 Zilver PTX
Results – Impact of the side selection
Left hand access
(n= 27)
Right hand access
(n= 114)
Procedure time (min) 35.5 27.7-43.3 34.9 30.3-39.5
Fluroscopy time (sec) 806.7 554.8-1059 723.2 601.7-844.8
X Ray dose (Gy) 14.09 10.4-17.7 23.5 8.3-38.6 ★
Contrast consumption (ml) 107.6 84.5-130.6 114.3 101.2-127.4
Advantage of the left hand access:
- Easy access to the descendentic aorta
- Shorter delivery system is necessary
Long term follow up• MAEs at 12 months: 33 pt (23.4%)
•TLR at 12 months: 10 pts (7.1%)
•Another PTA at 12 months: 17 (12.1%)
MAE (MACCE+ TLR + Amp) n (%)
- Death- AMI- Stroke- Amputation- rePTA- MAE- ALL MAE
10 (7.1)1 (0.1)2 (1.4)10 (7.1)10 (7.1)37 (26.2)33 (23.4)
MAE (n=33) n (%)
- IC- ALI- CLI
10 (30.3)1 (3)21 (63.6)
POC n (%)
Procedural complications - Distal embolisation
- Edge dissection and additional stent
Renal failure
Summary
1 (0.7)
5 (3.5)
0 (0)
Access site complications
Minor
RAO
Compartment syndrome Spasm
Perforation
Major
Summary
3 (2.1) 0 (0)
0 (0)
0 (0)
0 (0)
3 (2.1)
Perioperative complications
Limitations of the study
- The main limitation of the study is the lack of femoral control group
- It is not a randomized study
• Technical limitation:
– We haven’t drug eluting balloons and stents with long shaft length, therefore for these cases the transpedal and transpoplitealaccess must be prepared
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
Right SFA recanalisationRight ulnar artery access
6F 120 cm SGStarter GWV18 GWPacific 180 cm 5x150 mm
Conclusion• Femoral artery angioplasty can be safely and
effectively performed using radial access andsheathless guiding with acceptable morbidity and hightechnical success.
• Although complication rates of the present pilotregister are promising, larger studies are needed todetermine the long term success rate of transradialfemoral PTA.