Zoltán Ruzsa MD PhD

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

Crossing the aortic arch

Easy aortic

arch

Difficult

aortic arch

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

Femoral arteryCTO

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

Femoral artery intervention Optimal case

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

Patient with CCS 3 angina and rest pain

Right SFA recanalisationRight ulnar artery access

6F 120 cm SGStarter GWV18 GWPacific 180 cm 5x150 mm

Zilver PTX 6x120 mm

CASE – Pt with CLI and SFA occlusion

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.

Thank you for your attention !!!