Technique and outcomes of Laser-Atherectomy for calcified femoro-popliteal lesions

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1 Technique and outcomes of Laser-Atherectomy for calcified femoro-popliteal lesions Reza Ghotbi Helios Klinikum München West Akademisches Lehrkrankenhaus der LMU München

2 Disclosure Speaker name:...r. Ghotbi... I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) X X I do not have any potential conflict of interest 2

3 Medical Lasers: History 1917, Einstein established the theoretical foundations for the laser. 1960, Ali Javan constructed the first gas laser that was capable of continuous operation in the infrared. 1963, McGuff first used Laser for the experim. ablation of atherosclerotic plaques 1983, first clinical applications for PAD by Ginsburg. They all use the principle of selective photothermolysis : Getting the correct amount of laser energy with the correct wavelength to the correct tissue to damage or destroy only that tissue, and nothing else!

4 UV Lasers (10 to 400 nanometer) Excimer Laser: UV Laser, 308 nm Carry photon energies high enough to break molecular bonds (covalent) Have shallow absorption depth, <100 microns Reduces energy required to cut Reduces collateral tissue effects Allows coupling into fiber optics and delivery to the end of the catheter The very short actual working time, 2 µm vaporized during each puls preventing thermal damage of arterial structures. VS.

5 Excimer- Laser The size of the debris formed by excimer laser ablation of tissue is very small. Normal Fibrocalcific 5% 3% 45% 50% <1micron 1-5 micron >5 micron 54% 43% The debris is mostly cellular and subcellular components. Erythrocyt = 7.5 micron, Plattet= micron Particles of this size generally do not cause embolization

6 Atherectomy Devices - Point of ablation comparison Works at the tip No mechanical moving parts 1.4 cm Turbo-Elite TM (Spectranetics) Turbo-Tandem TM (Spectranetics) 2.36 cm Silver Hawk TM (Medtronic) Pantheris TM (Avinger) Rotarex TM (Straub) Jetstream TM (Boston Scientific) Phoenix TM (Volcano)

7 Laser atherectomy changes vessel compliance Vessel post pilot channel Vessel post laser atherectomy (Turbo Booster) 27.9mm mm 2 4.9mm 2 lumen 10.4mm 2 lumen Plaque 22.9mm 2 Vessel area Vessel area expanded Plaque was removed 20.5mm 2 As shown by IVUS core lab, of the lumen area increase post laser: 45% of the gain came from plaque removal 55% came from vessel compliance expansion

8 Technique; SIZE of the Laser Catheter The size of the laser catheter should not exceed 2/3 of the reference vessel diameter. Catheter Size 0.9mm 1.4mm 1.7mm 2.0mm 2.3mm 2.5mm Approximate Vessel Diameter > 1.4mm > 2.1mm > 2.6mm > 3.0mm > 3.5mm > 3.8mm In situations where a conservative approach is desired, size laser catheter to approximately ½ vessel size.

9 Technique; Saline Infusion In order to obtain an optimal contact between catheter tip and lesion it is mandatory to implement the saline infusion protocol. 20 ml saline bolus after each contrast injection 15 ml saline flush during every laser activation (5 sec) Removes Contrast from system Eliminates Blood from lasing field Reduced un-expected dissections!

10 Technique: Slow Advancement is KEY! FAST ADVANCEMENT ( 10

11 Technique; Slow Advancement is KEY! FAST ADVANCEMENT ( SLOW ADVANCEMENT 11

12 Technique; Slow Advancement is KEY! FAST ADVANCEMENT ( SLOW ADVANCEMENT less than 1 mm per second 6 cm lesion = 60 seconds = minimum of 1 minute to cross 12

13 Atherosclerotic Lesions composition; de novo Complex, Heterogeneous Morphology Composition ranges from soft necrotic core to hardened calcium crystal Dominated by soft- to moderate morphologies Fibrocalcific and compact calcium = 15-25% of average PAD lesion Compact calcium Fibrofatty Fibrotic Necrotic Core 15-25% Lipid-Rich Necrotic Core Compact Calcium 10-12% Fibrofatty 10-15% Fibrotic 0% 10% 20% 30% 40% 50% 60% Aboufakher R et al. (2009). J Invasive Cardiol., 21(10), Arthurs ZM et al. (2010). J Vasc Surg., 51(4): Singh T et al. (2011). J Invasive Cardiol., 23, Derksen et al. (2010). J. Vasc. Surg. 52(3):

14 Restenosis; Lesions composition Different Morphology of restenisis Lesions have a significant hydrated collagen matrix component Water is attracted to voids in the cellular structure Degree of Intimal Calcium De Novo No Thrombus De Novo With Thrombus Restenotic All Lesions No Intimal Calcium 7.0% 11.0% 45.0% 63.0% MILD Calcium 6.0% 7.5% 2.0% 15.5% MODERATE Calcium 6.0% 5.0% 2.0% 13.0% SEVERE Calcium 4.0% 3.5% 1.0% 8.5% TOTAL Lesion Type 23.0% 27.0% 50.0% > 75% have no to mild intimal calcium Restenotic lesions; highly aqueous Hydrated collagen matrix 60-80% of restenotic volume Inoue (2002). J of Vasc Surg; 35:

15 Technique; Laser Settings, fluence, puls rate chose fluence and pulse rate according to lesion morphology Fluence (mj/mm2)& Repetition Rate (Hz)

16 Restenosis, Drug Eluting Technology Renaissance of old and new Atherctomy procedures, that combined with DEB may provide an Advantage, primarily due to antiproliferative effect of pactitaxel. DEB is simply not a recanalisation rather than an Application tool! Lumen preparation of the recanalized vessel & Application technique are important Aspects. 16

17 (Laser) atherectomy Studies 1. J. C. van den Berg, M. Pedrotti, R. Canevascini, S. Chimchila Chevili, L. Giovannacci, R. Rosso, Endovascular treatment of in-stent restenosis using excimer laser angioplasty and drug eluting balloons, The Journal of Cardiovascular Surgery 2012April;53(2): Kenagy RD et al. (2005). J Histochem Cytochem. 53(1); Gandini G. et al, Combined laser atherectomy and drug eluting balloon angioplasty for treatment of superficial femoral artery In-stent occlusion, presented by Costatino Del Giodice, EuroPCR Gandini R. et al., Treatment of Chronic SFA In-Stent Occlusion With Combined Laser Atherectomy and Drug-Eluting Balloon Angioplasty in Patients With Critical Limb Ischemia, J endovasc ther 2013;20: Zeller et al., Drug-Eluting Stents for Femoropopliteal ISR, JACC, vol 6. No. 3, Schmidt A, Zeller T, Sievert H, Krankenberg H, Torsello G, Stark MA, Scheinert D: Photo-Ablation using the Turbo-Booster and Excimer Laser for IN-Stent Restenosis Treatment:Twelve- Month Results From the PATENT Study, J. Endovasc. Ther. 2014; 21, pp Van den Berg J et al.: Oral Presentation, NCVH Excite Trial Clinical Study Report, Spectranetics data on file, July D , Step-By-Step Technique Laser Atherectomy for a refractory Occlusion 10. Steinkamp H.J., C. Wisgott, et al. (2002), Short (1-10 cm) SFA Occlusions: Results of Treatment with Excimer Laser Angioplasty,. Cardiovascular and Interventional Radiology. 25: Heuser R. (2008) Textbook of Peripheral Vascular Interventions. United Kingdom: informa Healthcare 12. Norgreen L, et al. (2007). TASC II. Inter-Society Consensus for the Management of PAD. From Aravinda Nanjundappa, MD, et al. Critical Limb Ischemia. Understanding the Scope of the Problem. Endovascular Today. (2006): Allie David E., et al. Critical limb ischemia: a global epidemic. A critical analysis of current treatment Unmasks the clinical and economic costs of CLI. EuroIntervention-Vol. 1, No. 1, May 2005pgs Jeffrey H. Freihage, MD and Robert S Dieter, MD, Endovascular Treatments for Critical Limb Ischemia. The past, present, and future of treating this disease. Endovascular Today. August pg Laird J., et al. LACI Multicenter Trial. Journal of Endovascular Therapy, Feb. 2006, Vol, 13, page Bosiers M., P Peeters et al., Excimer Laser-Assisted Angioplasty for Critical Limb Ischemia: Results of the LACI Belgium Study, European Journal of Vascular and Endovascular Surgery (June 2005) Vol. 29, pages Allie, D C. Herbert, C. Walker, et al. Excimer Laser-Assisted Angioplasty in Severe Infrapopliteal Disease and CLI: The CIS LACI Equivalent Experience Vascular Disease Management (October 2004) Vol. 1, pages Diamondback Instructions for Use, July Sultan Sherif, Wael Tawfick, Niamh Hynes, Cool Excimer laser-assisted angioplasty (CELA) and Tibial Balloon Angioplasty (TBA) in management of infragenicular arterial occlusion in critical lower limb ischeamia (CLI), European Journal of Vascular and Endovascular Surgery 47(3) , Mar 17,

18 Conclusions Laser Atherectomy effectively ablates and vaporizes a range of morphologies within denovo and restenotic lesions. Initial pre-clinical and clinical evidence suggest Laser + DCB as an effective combination to achieve superior and more durable results while avoiding additional stent layers 18

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