vascular & interventional radiology unit department of radiological sciences “sapienza” –...
TRANSCRIPT
![Page 1: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/1.jpg)
Vascular & Interventional Radiology UnitDepartment of Radiological Sciences“Sapienza” – University of Rome
Fabrizio Fanelli
NEW TECHNOLOGIES: Wires, balloons, drug-eluting devices, ect.
![Page 2: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/2.jpg)
Small vessels
Long lesions
Occlusions > stenoses
More vessels
CalcificationsIliac Femoral Popliteal Peroneal Post Tib Ant Tib
0
100
200
300
400
500
600
700
Stenosis
Occlusion
L. Graziani – Eur J Vasc Endovasc Surg 2007
Below The Knee Arteries
![Page 3: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/3.jpg)
55% FEM-POP
96% BTK
5% ATG
CLI : Mean Length Treated lesions
185±121 mm
116±113 mm
63±61 mm
R.Ferraresi - oral presentation CICE 2012
![Page 4: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/4.jpg)
PTA F.U. PATENCY TLR
DEBATE 1 12 mos 28.0% 24.0%
Leipzig Registry2 3 mos 31.0 % 50.0%
DEBELLUM 3 12 mos 47.1% 47.0%
BMS F.U. PATENCY TLR
ACHILLES4 12 mos 57.1% 16.0%
DESTINY5 12 mos 54.3 % 33.6%
YUKON6 12 mos 55.6% 13.0%
3) F. Fanelli - oral presentation CIRSE 2012 2) A. Schmidt – JACC 2011
1) F. Liistro - oral presentation TCT 2012
6) A. Rastan – European Heart Journal 20115) M. Bosiers – J Vasc Surg 2012
4) K. Katsanos - oral presentation CIRSE 2011
![Page 5: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/5.jpg)
…. New Technologies ….
![Page 6: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/6.jpg)
Micro-puncture set
Guidewires
Micro-guidewires
Introducers
Support catheters
Low profile balloon catheters
Atherectomy devices
Drug eluting balloons (DEB)
Bare metal stents
Drug eluting stents (DES)
![Page 7: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/7.jpg)
Micro-puncture set
Guidewires
Micro-guidewires
Introducers
Support catheters
Low profile balloon catheters
Atherectomy devices
Drug eluting balloons (DEB)
Bare metal stents
Drug eluting stents (DES)
![Page 8: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/8.jpg)
Drug Eluting Balloons
In.Pact Amphirion – Medtronic /Invatec
Advance LP 18 PTX – Cook
Freeway II/Dior – Eurocor
Elutax – Aachen Medical
![Page 9: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/9.jpg)
Study type Prospective single center, single arm, investigator initiated study
Objective Assess IN.PACT Amphirion™ efficacy for the treatment of long BTK lesions occlusions
Population Symptomatic patients with CLI or severe claudication
Eligibility At least one lesion BTK ≥ 80 mm
Prim. Endpoint 3 month restenosis rate
Nr of patients 104 / 109 limbs
IN.PACT™ Amphirion inreal world BTK complex lesions
A. Schmidt – JACC 2011
DEB BTK Leipzig Registry
![Page 10: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/10.jpg)
DEB(angio
subgroup)
PTA(historical
group)
# patients / limbs 74 / 79 58 / 62
Male gender 51 (68.9%) 38 (65.5%)
mean age (y) 73.5 ± 9.3 70.5 ± 8.08
diabetics 54 (73%) 52 (89.7%)
Renal insuff. 34 (45.9%) 30 (51.7%)
RC 3 16 (20.3%) 0 (0%)
RC 4 14 (17.7%) 16 (25.8%)
RC 5 49 (62%) 46 (74.2%)
RC 6 0 (0%) 0 (0%)
avg lesion length 173 ± 87 mm 183 ± 75 mm
Tot occlusions 61.9% 64.9%
DEB(angio subgroup)
PTA(historical group)
3m Ang. FU
Restenosis (>50%) 27.4% 69%
Full-segment Resten. 10% 56%
Restenosis Length 64 mm 155 mm
12m Clinical FU
15m Clinical FU
Deaths 16.3% 10.5%
Limb Salvage 95.6% 100%
Clinical Improvement (1) 91.2% 76.5%
Compl. wound healing 74.2% 78.6%
TLR 17.3% 50%
(1) clinical improvement = reduction in size and/or depth of ulceration or improvement of rest-pain
vs historical PTA cohort (A.Schmidt - Cath. and Cardiovasc. Interventions
2010)
DEB BTK Leipzig Registry
![Page 11: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/11.jpg)
DEB(angio
subgroup)
PTA(historical
group)
# patients / limbs 74 / 79 58 / 62
Male gender 51 (68.9%) 38 (65.5%)
mean age (y) 73.5 ± 9.3 70.5 ± 8.08
diabetics 54 (73%) 52 (89.7%)
Renal insuff. 34 (45.9%) 30 (51.7%)
RC 3 16 (20.3%) 0 (0%)
RC 4 14 (17.7%) 16 (25.8%)
RC 5 49 (62%) 46 (74.2%)
RC 6 0 (0%) 0 (0%)
avg lesion length 173 ± 87 mm 183 ± 75 mm
Tot occlusions 61.9% 64.9%
DEB(angio subgroup)
PTA(historical group)
3m Ang. FU
Restenosis (>50%) 27.4% 69%
Full-segment Resten. 10% 56%
Restenosis Length 64 mm 155 mm
12m Clinical FU
15m Clinical FU
Deaths 16.3% 10.5%
Limb Salvage 95.6% 100%
Clinical Improvement (1) 91.2% 76.5%
Compl. wound healing 74.2% 78.6%
TLR 17.3% 50%
(1) clinical improvement = reduction in size and/or depth of ulceration or improvement of rest-pain
vs historical PTA cohort (A.Schmidt - Cath. and Cardiovasc. Interventions
2010)
DEB BTK Leipzig Registry
![Page 12: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/12.jpg)
Investigator initiated, single center Study
Randomized (1:1) DEB vs. standard PTA
Primary Endpoint: 12-month Angiographic
Binary (>50%) Restenosis Rate
Secondary Endpoints: TLR and Reocclusion
CLI + Diabetes150 (Tibial) Lesions
DEB(75 lesions)
Std PTA(75 lesions)
12-month Angiographic
and Clinical follow-up
Aspirin + Clopidogrel (1 month)
24-month Duplexand Clinical follow-up
Random (1:1)
• Key Inclusions• RC 4-5-6 and Diabetes• Stenosis / occlusions >40 mm in at
least 1 tibial vessel with distal run-off• Key Exclusions
• Allergy to Paclitaxel• Contraindication for combined
antiplatelet treatment• Life expectancy <1 year
DEBATE BTK
F. Liistro - oral presentation TCT 2012
![Page 13: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/13.jpg)
DEB PTA p
Patients 65 67 /
Age 74±9.4 75±9.6 0.7
Smoke 13 (20%) 7 (10.4%) 0.1
Hypertension 46 (70.8%) 52 (77.6%) 0.4
Hypercholesterolemia 23 (35.4%) 16 (23.9%) 0.1
Diabetes 65 (100%) 67 (100%) 1
Obesity 23 (35.3%) 26 (38.8%) 0.5
Dialysis 7 (10.8%) 7 (10.4%) 1
Coronary artery disease 12 (18.5%) 10 (14.9%) 0.6
Limbs 71 72 0.9
Texas wound ulcer class. I C 1 (1.4%) 3 (4.2%)
0.5
II C 3 (4.2%) 5 (6.9%)
I D 7 (9.9%) 9 (12.5%)
II D 34 (47.9%) 32 (44.4%)
III D 26 (36.6%) 23 (31.9%)
![Page 14: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/14.jpg)
![Page 15: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/15.jpg)
• Key Inclusions– Fontaine Stage IIb, III, IV – SFA, popliteal and BTK lesions
either isolated or concomitant– De-novo lesions – Stenosis or occlusions 3 - 30 cm
Investigator initiated, single center Study
Randomized (1:1) DEB vs. standard PTA
Primary Endpoint: 6-month LLL
Secondary Endpoints: TLR, Primary Patency, Fontaine change, MAE at 6 and 12 months
DEBELLUM Drug Eluting Balloon Evaluation for Lower Limb mUltilevel treatMent
F. Fanelli - oral presentation CIRSE 2012
![Page 16: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/16.jpg)
analysis per lesion
12-mos TLR
![Page 17: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/17.jpg)
DEB PTA DEB PTA
Angio 6 mos Angio 6 mos Angio 12 mos Angio 12 mos
Restenosis rate 15.3% (2 lesions)
41.1% (7 lesions)
23.07% (3 lesions)
52.9% (9 lesions)
TLR 7.69% (1 lesion)
23.5% (4 lesions)
15.3% (2 lesions)
47.0% (8 lesions)
Occlusion rate 0 9.1% 0 9.1%
Death 0 0 0 0
Major amputation 10% (1 patient)
9.09% (1 patient)
10% (1 patient)
9.09% (1 patient)
Minor amputation 0 18.8% (2 patients)
0 18.8% (2 patients)
DEBELLUM - 12 mos F.U.
![Page 18: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/18.jpg)
• Prospective Randomized Multicenter Trial
• 50 pts.• RC: 4-6• >50% calcified stenosis• popliteal, tibial and peroneal aa.
![Page 19: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/19.jpg)
OA + PTA PTA p
Stenting 6.9 % 14.3 % 0.44
Dissection 6 pts 1 pts ns
Perforation / 1 ns
Distal Embolization / 1 ns
Max Inflation Press <0.001
2 - 4 59.3 % 11.8 %
5 - 6 14.8 % 8.8 %
7 - 8 7.4 % 26.5 %
9 - 10 7.4 % 32.4 %
11 - 12 0 8.8 %
>12 11.1 % 11.8 %
Mean 5.9 ± 4.2 9.4 ± 3.8
![Page 20: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/20.jpg)
OA + PTA PTA p
Stenting 6.9 % 14.3 % 0.44
Dissection 6 pts 1 pts ns
Perforation / 1 ns
Distal Embolization / 1 ns
Max Inflation Press <0.001
2 - 4 59.3 % 11.8 %
5 - 6 14.8 % 8.8 %
7 - 8 7.4 % 26.5 %
9 - 10 7.4 % 32.4 %
11 - 12 0 8.8 %
>12 11.1 % 11.8 %
Mean 5.9 ± 4.2 9.4 ± 3.8
![Page 21: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/21.jpg)
Secondary Endpoints
![Page 22: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/22.jpg)
PTA F.U. PATENCY TLR
DEBATE 1 12 mos 28.0% 24.0%
Leipzig Registry2 3 mos 31.0 % 50.0%
DEBELLUM 3 12 mos 47.1% 47.0%
DEB F.U. PATENCY TLR
DEBATE 1 12 mos 71.0% 13.0%
Leipzig Registry2 3 mos 72.6 % 17.3%
DEBELLUM 3 12 mos 76.9% 15.3%
3) F. Fanelli - oral presentation CIRSE 2012 2) A. Schmidt – JACC 2011
1) F. Liistro - oral presentation TCT 2012
![Page 23: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/23.jpg)
What about Stent … ?
![Page 24: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/24.jpg)
DEB F.U. PATENCY TLR
DEBATE 1 12 mos 71.0% 13.0%
Leipzig Registry2 3 mos 72.6 % 17.3%
DEBELLUM 3 12 mos 76.9% 15.3%
BMS F.U. PATENCY TLR
ACHILLES4 12 mos 57.1% 16.0%
DESTINY5 12 mos 54.3 % 33.6%
YUKON6 12 mos 55.6% 13.0%
3) F. Fanelli - oral presentation CIRSE 2012 2) A. Schmidt – JACC 2011
1) F. Liistro - oral presentation TCT 2012
6) A. Rastan – European Heart Journal 20115) M. Bosiers – J Vasc Surg 2012
4) K. Katsanos - oral presentation CIRSE 2011
![Page 25: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/25.jpg)
DEB F.U. PATENCY TLR
DEBATE 1 12 mos 71.0% 13.0%
Leipzig Registry2 3 mos 72.6 % 17.3%
DEBELLUM 3 12 mos 76.9% 15.3%
DES F.U. PATENCY TLR
ACHILLES4 12 mos 75.0% 10.0%
DESTINY5 12 mos 85.2 % 8.7%
YUKON6 12 mos 80.6% 13.8%
3) F. Fanelli - oral presentation CIRSE 2012 2) A. Schmidt – JACC 2011
1) F. Liistro - oral presentation TCT 2012
6) A. Rastan – European Heart Journal 20115) M. Bosiers – J Vasc Surg 2012
4) K. Katsanos - oral presentation CIRSE 2011
![Page 26: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/26.jpg)
Everolimus-eluting stent vs. bare metal stent
103 pts. CLI
Angioplasty + Bailout stenting
JVIR 2009; 20(9):1141-1150
![Page 27: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/27.jpg)
D. Siablis – JVIR 2009; 20(9):1141-1150
HR: 4.8, CI 2.9-7.9 p<0.001 HR: 2.5, CI 1.3-5.0 p=0.006
![Page 28: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/28.jpg)
![Page 29: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/29.jpg)
Xcience-Prime Xcience-Prime
![Page 30: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/30.jpg)
Conclusions
DEB patency rate similar to DES but with the advantage
of
“nothing left behind”.
Efficacy of DEB in very calcified arteries still under
evaluation
Combined treatment with atherectomy must be
validated.
![Page 31: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/31.jpg)
The Future …
• Adaption to flexion, extension
•Overcome Stent fractures
•Positive Remodelling
•Might act as a transporter (Gen-
Therapy)
•Surgeon’s friend
Bioabsorbable Stent
![Page 32: Vascular & Interventional Radiology Unit Department of Radiological Sciences “Sapienza” – University of Rome Fabrizio Fanelli NEW TECHNOLOGIES: Wires,](https://reader035.vdocuments.site/reader035/viewer/2022062806/56649e385503460f94b289e9/html5/thumbnails/32.jpg)
Poly-L-lactide +
Everolimus
30 pts.
ABSORB Study
5-y F.U.
- No cardiac death
- No thrombosis
- MACE: 3.4 %
- LLL 0.27 mm