LEGFLOW RX/OTW®

Paclitaxel Releasing Peripheral
Balloon Dilatation Catheter

LEGFLOW; Selected patient cases of
’The Spanish Registry study on BTK lesion treatments.’

Case 1

Physician: Dr. Sirvent

Patient presentation:
73 years old female.
Risk factors: hypertension, Diabetes Mellitus II.
Medical history: chronic myeloid leukaemia, cardiac insufficiency.
Actual complaints: ulcers in first and second toes of the right leg. ABI 0’37.

Percutaneous intervention 28.10.2013

Anticoagulation: aspirin, clopidogrel and heparine.
5F short sheath antegrade approach.
Predilatation with 2 mm balloon anterior tibial and peroneal arteries and tibioperoneal trunk.
Treatment with different Legflow balloons at nominal pressure (4x40 mm in popliteal segment; 2.5x200 mm in anterior tibial and peroneal arteries and tibioperoneal trunk).

Outcome:
Successful recanalization. Post intervention there was no residual significant stenosis. No complications.

Available follow-up:
2 years: Asymptomatic. No ulcers. No adverse events. Pedal pulse present. ABI 1.

Figure 1-3. Basal angiography: short stenosis in P3; long occlusion of the anterior and posterior tibial and peroneal arteries; and foot vascularization.

Figure 4-7. Final angiography: double wire technique for protecting the ostiums and final outcome after treatment with Legflow balloons.

Case 2

Physician: Dr. Sirvent

Patient presentation:
62 years old male.
Risk factors: hypertension, diabetes mellitus II, hyperlipidaemia, former smoker.
Medical history: above the knee amputation right leg due to gangrene.
Actual complaints: dry gangrene in 2, 3, 4, 5 toes of the left leg. ABI 0’29.

Percutaneous intervention 14.01.2014

Anticoagulation: aspirin, clopidogrel and heparine.
5F short sheath antegrade approach.
Predilatation with 3 mm balloon P1-P2 and 2 mm balloon posterior tibial and peroneal arteries.
Treatment with different Legflow balloons at nominal pressure (4x40 mm in popliteal segment and 3mm in peroneal and posterior tibial arteries).
TMT amputation of his left foot.


Outcome:
Successful recanalization. Post intervention there was no residual significant stenosis. No complications.

Available follow-up:
20 months: Asymptomatic. TMT amputation of his left foot completely healed (2-3 weeks after intervention). Since then no new ulcers. No adverse events. Posterior tibial pulse present. ABI 1’03.

Figure 1-3. Basal angiography: short calcified stenosis in P1-P2; long occlusion of the anterior and posterior tibial arteries and short stenosis in peroneal artery; and foot vascularization.

Figure 4-6. Final angiography: double wire technique for protecting the ostiums and final outcome after treatment with Legflow balloons.

Figure 7-8. Final angiography: final outcome after treatment with Legflow balloons and foot vascularization.

Case 3

Physician: Dr. Sirvent

Patient presentation

89 years old female.
Risk factors: hypertension.
Medical history: atrial fibrillation; stroke with complete recovery 2007; POBA anterior tibial artery of the right limb three months ago (20.10.2014) due to ulcer above the ankle.
Actual complaints: persistence of the ulcer above the ankle and decrease of the ABI (from 0’85 post-intervention to 0’38).

Percutaneous intervention 12.01.2015

Anticoagulation: aspirin, clopidogrel and heparine.
4F short sheath antegrade approach.
Predilatation with 2 mm balloon anterior tibial artery.
Treatment anterior tibial artery with 3x150mm Legflow balloons at nominal pressure.

Outcome:
Successful recanalization. Post intervention there was no residual significant stenosis. No complications.

Available follow-up:
8 months: Asymptomatic. No ulcers. No adverse events. ABI 0’78.

Figure 1-3. Basal angiography (first revascularisation on 20.10.2014): total occlusion of the posterior tibial and peroneal arteries and occlusion around 15cm of the anterior tibial artery; and foot vascularization.

Figure 4-6. Final angiography (first revascularisation on 20.10.2014): outcome after treatment with POBA.

Figure 7-9. Basal angiography (second revascularisation on 12.01.2015): situation very similar to the basal angiography of the first revascularisation three months ago (figure 1-3).

Figure 10-12. Final angiography (second revascularisation on 12.01.2015): outcome after treatment with Legflow balloons.

Case 4

Physician: Dr. Sirvent

Patient presentation:
71 years old male.
Risk factors: diabetes mellitus II.
Medical history: chronic obstructive pulmonary disease; stenting fem-pop segment and failure to recanalization of the BTK vessels right leg in other hospital (27.02.14).
Actual complaints: severe rest pain and dry gangrene of all toes right leg. ABI 0’21

Percutaneous intervention 15.04.2014

Anticoagulation: aspirin, clopidogrel and heparine.
6F 90cm long sheath crossover approach.
Peroneal artery recanalization from antegrade.
Failure to recanalization posterior tibial artery from antegrade.
Combined approach (antegrade and retrograde) with puncture of the retromalleolar posterior tibial artery to achieve her patency.
Predilatation with 2 mm balloon peroneal and posterior tibial arteries.
Treatment these vessels with different 3x150mm Legflow balloons at nominal pressure.

Outcome:
Successful recanalization. Post intervention there was no residual significant stenosis. No complications.

Available follow-up:
17 months: Asymptomatic. No ulcers. No adverse events. ABI 0,82.

Figure 1-3. Basal angiography: crossover approach where we can see normal patency of iliofemoral segment (two stents placed to SFA on 27.02.14 in other hospital).

Figure 4-6. Basal angiography: complete occlusion of the anterior tibial and peroneal arteries; proximal occlusion of the posterior tibial artery; and poor foot vascularization.

Figure 7-9. Puncture of the retromalleolar posterior tibial artery and her recanalization from combined approach (antegrade and retrograde).

Figure 10-12. Final angiography: outcome after treatment with Legflow balloons.

Successful LEGFLOW performance of patient life cases presented at LINC (Leipzig Interventional Course) 2014/2015.

Case 1

Physicians: Dr. D.A.F van den Heuvel / Dr. J.P.P.M. de Vries
Date: October 22th 2012.

Patient presentation:
54 year old female.
Risk factors: Hypertension and smoking
Actual complaints: Intermittent and disabling claudication left leg, action radius 100 mtr, Rutherford 3

Percutaneous intervention:
Intention to treat by DEB and stenting (after randomisation)
Anticoagulation: Asprin, Clopidogrel and Heparine
6 Fr antegrade approach
Pre-dilatation with a 5 mm balloon
PTA with Legflow 5x80 and 5x100mm at nominal pressure
Stenting with 4x60 and 4x80mm Supera stent (IDEV)

Outcome:
Succesful recanalisation. Post intervention there were no residual stenoses. No complications.

Available follow-up:
Non

Figure 1: SFA lesion 15cm with a 6cm occlusion. No calcification.

Figure 2: After 4mm predilatation (not shown) PTA with a 5x80mm Legflow balloon.

Figure 3: Post Legflow inflation there is a patent segment but with significant recoil.

Figure 4: Post stenting (4x60mm Supera, IDEV) there is still a significantly stenosed proximal segment.

Figure 5: Single shot of Legflow balloon 5x100mm at nominal pressure.

Figure 6: After stenting there is an optimal result without residual stenosis.

Case 2

Physicians: Dr. D.A.F van den Heuvel / Dr. J.P.P.M. de Vries
Date: July 5th 2012.

Patient presentation:
76 year old male.
Risk factors: Hypertension, Diabetes Mellitus, smoking until 5 years ago.
Medical history: PTCA, CABG
Actual complaints: Intermittent and disabling claudication left leg, Rutherford 3.
Resting ABI 0.65

Percutaneous intervention:
Intention to treat by DEB and stenting (after randomisation)
Anticoagulation: Asprin, Clopidogrel and Heparine
6 Fr antegrade approach
Pre-dilatation with a 5 mm balloon
PTA with 6x150mm and 6x150mm Legflow balloon at nominal pressure
Stenting with 5x150mm and 5x120mm Supera stent (IDEV)

Outcome:
Succesful recanalisation. Post intervention there was no residual stenosis. No complications.

Available follow-up:
At one month there were no complaints of the treated leg. Duplex demonstrated no re-stenoses. ABI 1.0

Figure 1-3: Long SFA lesion with severe eccentric stenoses and calcifications. Occlusion length 7cm.

Figure 4-5: Predilatation with a 4mm balloon.

Figure 6-7: PTA with Legflow balloon 6x150mm 14 atm.

Figure 8: After PTA there are significant residual stenoses.

Figure 9: After stenting (5x150mm and 5x120mm Supera) there is an optimal result without residual stenosis.

Case 3

Patient presentation:
68 year old male.
Medical history: Hypertension and PTA with stent right common iliac artery.
Actual complaints: Intermittent and disabling claudication left leg, Rutherford 3.
ABI: 0.69
MRA: Long-segment occlusion of the SFA (see figure 1).

Percutaneous intervention:
Intention to treat by DEB and stenting
Anticoagulation: Asprin, Clopidogrel and Heparine
6 Fr antegrade approach
Pre-dilatation with a 4 mm balloon
DEB PTA with Legflow 5x150 and 5x40mm at 16 atm
Stenting with 5x150mm Supera (IDEV)

Outcome:
Succesful recanalisation. Post intervention there was no residual stenosis. No complications.

Available follow-up:
Patency confirmed at 1 month duplex scan.
No claudication of the legs, ABI 1.
No adverse events at 1 month FU.

Statement:
“The early experiences with the Legflow DEB are very promising.
High inflation pressures enables optimal vessel preparation for stenting. We believe this might be the longterm
solution to minimize in-stent stenosis of the SFA.”

Figure 1: SFA lesion 15cm with a 12cm occlusion. Severe calcification.

Figure 2: After predilatation there is total recoil of the lesion

Figure 3: Post Legflow inflation there is a patent segment but with significant residual stenoses. Note the severe calcification.

Figure 4: Post stenting an optimal result is achieved. No residual stenosis.

Figure 5: Single shot of Legflow balloon inflated at 16 atm.

Case 4

Physicians: Dr. D.A.F van den Heuvel / Dr. J.P.P.M. de Vries
Date: October 10th 2012.

Patient presentation:
72 year old male.
Risk factors: Hypertension, Diabetes Mellitus and smoking
Medical history: Open reconstruction of an infrarenal aortic abdominal aneurysm
Actual complaints: Intermittent claudication left leg, Action radius 50 meters. Rutherford 3
Imaging: MRA: long-segment stenosis with occlusion of the SFA

Percutaneous intervention:
Intention to treat by DEB and stenting
Anticoagulation: Asprin, Clopidogrel and Heparine
6 Fr cross-over approach
After predilatation with 5mm PTA with Legflow 6x150, 6x150mm and ….. at 16 atm
Stenting with 5x 200mm and 5x150mm Supera (IDEV)

Outcome:
Succesful recanalisation. Post intervention there was no residual stenosis. No complications.

Figure 1-3: Long SFA lesion with a 13cm occlusion.

Figure 4: Failure to re-entry.

Figure 5: Retrograde puncture distal SFA.

Figure 6-7: Predilatation 5mm of the occluded segment. Note severe calcification.

Figure 8-10: PTA with 6x150mm Legflow balloon inflated at 16 atm.