The role of photoablation and DCB for in-stent restenosis
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1 The role of photoablation and DCB for in-stent restenosis
2 Disclosure Speaker name: Ulf Teichgräber, MD, MBA Potential conflicts of interest related to the presentation: o Research grant, honoraria: Spectranetics Potential conflicts of interest not related to the presentation: o o Consulting Fees, Honoraria, Research Grants, Advisory Boards: ab medica, Abbott, Angiodroid, Vascular, B.Braun Melsungen, Boston Scientific, Celonova, C.R. Bard, COOK, Endoscout, GE Healthcare, ivascular, Kimal, Maquet, Medtronic, Philips Healthcare, Siemens Heathcare, Spectranetics, W.L.Gore Master research agreements with Siemens Healthcare, GE Healthcare
3 Excimer Laser Atherectomy Catheters
4 Turbo Elite Laser Atherectomy Catheter Catheter Diameter (mm) Vessel Diameter (in mm) Max Guidewire (in inch) Sheath Compatibility 4F 5F 5F 6F 7F 8F 7F 8F
5
6
7 Excimer Laser over guidewire
8 How we do it? 1. Only full intraluminal passage (entire target lesion) 2. Slow advancing of the catheter with maximum 1mm/s forward push through the lesion 3. With a fluency of mj/mm² and repetition rate of ca. 40 Hz
9 Why Laterartherectomy? Vessel-preparation before PTA with reduction of thrombotic material Vaporisation of atherosclerotic material and calcium in occluded vessels Safe and effective method, distal embolization unlikely Better outcome than POBA alone
10 Current studies
11 Current studies Freedom from TLR after 6 month 79.8 % Laser + PTA: 79,8 % 63,7% PTA alone: 63,7 %
12 Current studies
13 Current studies Freedom from TLR at 6 and 12 months 87.8% and 64.4%
14 Current studies
15 Current studies Freedom from TLR 66.7% Laser-DCB 37.5% DCB alone
16 European Peripheral Excimer Laser Registry: Initial Results Multicentre prospective registry Patient enrolment started Nov still ongoing Endpoint classification: Safety and Efficacy
17 Involving Centres Universitätsklinikum Jena Helios Klinikum München West Heinrich-Braun-Klinikum Zwickau ggmbh Westküstenklinikum Heide Ameos Klinikum Bernburg Rhone Durance Avignon France CHU Bordeaux Pellegrin Herz und Gefäßzentrum Immenstadt Nicosia General Hospital UZ Leuven Ilmkreis-Kliniken Arnstadt-Ilmenau ggmbh QE Birmingham Klinikum Konstanz Klinikum Oldenburg
18 Study Description Primary Objective To evaluate the performance of the Spectranetics Excimer Laser Atherectomy (ELA) in the treatment of subjects with peripheral arterial disease (PAD). Secondary Objectives To characterize usage patterns, treatment approaches and targeted vessels To document treatment strategies, including specific techniques and adjunctive therapies To estimate the incidence of device intervention
19 Real World Patients Key Inclusion Criteria Subject treated with Excimer Laser Atherectomy
20 Patients characteristics Patient characteristics Total # of patients 293 Male 204 (69.6%) Age 70.5 ± 10.4 BMI 26.8 ± 4.7
21 Rutherford class Rutherford class n = (0%) 2 16 (6%) (44%) 4 59 (20%) 5 72 (24%) 6 0 (0%) Unknown 16 (6%)
22 Lesion Characteristics n = 293 Mean Lesion Length [cm] 11.4 ± 10.4 Diameter Stenosis [%] 94.5 ± 9.6 Reference vessel diameter [mm] 5.2 ± 1.0 Occlusion 56.7% Calcium None/Mild 11.6% Moderate 45.4% Severe 43.0%
23 Lesion Characteristics Lesion Length (range cm) n = 293 Mean Lesion Length [cm] 11.4 ± 9.3 TASC II A 48.1% TASC II B 23.2% TASC II C 12.6% TASC II D 8.2% Unknown 7.8%
24 Lesion Characteristics Lesion Type n = 293 De Novo 63.1% Restenotic 19.1% In-Stent Restenotic 17.7%
25 Procedure characteristics Adjunctive Therapies n = 293 Balloon angioplasty 285/293 (97.2%) POBA 171/285 (60.0%) DCB 114/285 (40.0%) Stenting 100/293 (34.1%)
26 Procedure sucess Residual Stenosis n = 293 Residual stenosis >30% 5.8 % Residual stenosis >50% 3.1 %
27 Follow up Data Follow Up 2 after 12 month n = 89 Freedom from Target Limb Revascularisation 78.7 % (19/89)
28 Follow up Data Freedom from TLR 12 Month n = 89 Allover 78.7% (70/89) POBA 80.0% (24/30) DCB 78.0% (46/59)
29 Freedom of TLR 100% yr 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%
30 Summary Laserartherectomy is a very safe atherectomy device with no distal embolisation protection device needed BTK rarely used, but can in some cases successfully performed without additional PTA especially in highly calcified lesion Good results after one year with Freedom from TLR 78,7% Promissing results for the combination of LASER atherectomy and DCB
31 The role of photoablation and DCB for in-stent restenosis
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