Use of Laser In BTK Disease (CLI) Click to edit academic affiliation, practice or hospital logo(s) of preference. Product and/or sponsor logos not permitted, per CME guidelines. Richard Kovach, MD, FACC, FSCAI, FACP Chair, Interven9onal Cardiology Director, Adult Cardiac Cath Laboratory Deborah Heart and Lung Center Browns Mills, New Jersey Clinical Professor of Medicine Philadelphia college of Osteopathic Medicine Philadelphia, Pennsylvania
Disclosures Spectranetics Corporation: Medical advisory board, consultant, speaker, educational grants, trainer, investigator Boston Scientific: Medical advisory board, speaker, fellow training faculty, educational grants, trainer, investigator Abbott: Medical advisory board, speaker, research funding, educational grants, trainer, investigator Medtronic Corporation: speaker, educational grants, investigator Angioscore (Spectranetics): speaker, trainer AngelMed/St Jude: investigator Avinger: investigator, speakers bureau Gore: investigator Bard/Lutonix: Medical Advisory Board, Continuum Study Clinical Events Committee Ostialcorp: Medical Advisory Board; stock holder Asia Pacific Medical Technologies: Stock Holder Endoshape, Inc.: Stock Holder
BTK intervention-the Problem: No Definitive "Best Therapy" By-pass surgery has mixed procedural durability and higher morbidity/mortality with higher costs and longer recovery times compared to endovascular techniques. Endovascular techniques in smaller vessels may have lower procedural durability, but also lower morbidity/ mortality and are repeatable with lower cost and shorter recovery times compared to by-pass surgery.
Current Treatment Options for BTK and CLI Surgical bypass or endarterectomy Endovascular intervention - Balloons, Stents, Atherectomy Becoming more prevalent Primary therapy option Post-failure surgical intervention Which has better outcomes? ( BEST CLI currently enrolling)
BTK Endovascular options POBA or focused force POBA (long term patency less than stellar even in short lesions) DEB: INPACT Deep: terminated early; Levant BTK in the process of enrolling. DES: OK for short distances proximally (noncompressable): no large randomized studies. SE stents: no small SE stents currently indicated for BTK; extremely limited BTK data
Atherectomy Devices: Directional atherectomy (Turbohawk ) Jetstream atherectomy Orbital athectomy Rotational atherectomy Phoenix device Laser atherectomy NB: ALL atherectomy devices embolize (some more than others) Distal protection is problematic below the knee because of vessel size.
Why Laser? Ability to address small vessel disease (0.9 and 1.4mm lasers ideal for BTK disease.)? Lower incidence of distal embolization (of particular concern in patients with single vessel run-off). Can be delivered via femoral, popliteal or even pedal access either bare-back or via small sheaths. Ability to address multiple lesion morphologies: thrombus, hard and soft plaque, even calcium to some degree
Available Data to support use: Limb Salvage Following Laser-Assisted Angioplasty for Critical Limb Ischemia Results of the LACI Multicenter Trial John R. Laird, MD; Thomas Zeller, MD; Bruce H. Gray, DO; Dierk Scheinert et al. (2006). Journal of Endovascular Therapy 13:1-11
Study Objec<ves Study Objective To evaluate the effectiveness of laser-assisted angioplasty for patients with CLI who were poor candidates for surgical revascularization Rutherford class 4 to 6 Multicenter prospective registry 14 sites (11 US and 3 Germany) 145 patients / 155 critical ischemic limbs 2011 Spectranetics All Rights Reserved. Approved for External Distribution D013742-00 032011
Angioplasty Technique Angioplasty Technique Technical Objective To achieve straight-line flow from the SFA origin to the foot through at least 1 tibial artery Treatment Standard guide wire to cross lesions in SFA, popliteal and tibials Excimer laser step-by-step procedure used with lesions resistant to guide wire Adjunctive PTA and optional stenting Included Catheters 0.9 2.5 mm Spectranetics peripheral laser catheters 2011 Spectranetics All Rights Reserved. Approved for External Distribution D013754-00 032011
Leg Descriptors 155 limbs Rutherford Category 4 29% 5 or 6 71% Reasons for poor surgical candidacy Absence of venous graj 32% Poor/no distal vessel 68% High surgical risk 46% Only one reason 61% Any two reasons 33% All three reasons 6%
Lesion Types Mean # of treated lesions/pt: 2.7 ± 1.4 (1-7) 80% 70% 60% % of Limbs 50% 40% 30% 20% 10% 0% stenoses occlusions stenoses and occlusions
Procedure Results Procedure Results Laser treatment delivered Adjunctive balloon Stent placement Procedure success <50% residual stenosis at final 99% (153 limbs/155) 96% (149 limbs/155) 45% (70 limbs/155) 85% (132limbs/155) 2011 Spectranetics All Rights Reserved. Approved for External Distribution D013754-00 032011
Results (cont) 93% Limb Salvage Rate! Results Occlusions were present in 92% of limbs. A mean of 2.7+ 1.4 lesions were treated per limb Total median treatment length was 11cm (mean 16.2, range 0.2-123) Stents were implanted in 45% of limbs. At 6-month follow-up Limb salvage was achieved in 110 (92%) of 119 surviving patients or 118/127 limbs (93%) 2011 Spectranetics All Rights Reserved. Approved for External Distribution D013754-00 032011
Limb Results at 6 Months Limb Results at 6-Months Total enrollment 155 limbs 15 deaths (17 limbs) 17 Limbs lost to follow-up 11 Reached 6-month follow-up 127 Major amputation among survivors 9 Survival with limb salvage 118/127 = 93% 93% Limb Salvage Rate! 2011 Spectranetics All Rights Reserved. Approved for External Distribution D013754-00 032011
LACI Phase 2 Registry Prospective, multi-center study Patients with CLI Rutherford Category 4-6 poor surgical candidates Treatment: LA of SFA, popliteal and/or infrapopliteal arteries, with adjunctive PTA and optional stenting Primary Endpoint: limb salvage at 6 months freedom from amputation at or above the ankle
Critical Limb Ischemia (CLI): LACI Phase 2 Results: (20 clinical sites, 169 patients) Procedural Success- 97% 6 month limb salvage - 93% Complications (minor) - 3% 7% Amputation Rate at 6 months!!
LACI Phase 2 Summary Treatment of complex disease multiple stenoses and occlusions High risk patient population poor candidates for surgical revascularization High procedural success with few in-hospital complications and short hospital stay Excellent limb salvage rate despite this highrisk patient cohort Incidence of surgical intervention is very low
OLD Laser Technology The Hot Tip Probe Continuous Wave Energy (YAG) resulted in vessel charring and poor outcomes Flushed with contrast crea<ng cavita<on and dissec<on Image Courtesy of Arizona Heart Institute - www.tctmd.com
Cool Laser Mechanisms of Ac4on Eximer Laser: 308nm light u Photochemical Breaking molecular bonds v Photothermal Producing thermal energy w Photomechanical Creating kinetic energy
Keys to laser success: Slow advancement (< or = 1mm/ sec) Saline flush 2/3 size rule Start at low energy and frequency Increase frequency 1 st followed by increased energy
Speed Rapid advancement increases the incidence of dissection Excessive pressure may deflect the tip and lead to exiting the true lumen Rapid advancement reduces the amount of true ablation Fast 2.3 Turbo Slow
Case Examples
Case 1 (proximal occlusion of trifurcation)
Pedal Access
Post laser and POBA
Case 2 (slides courtesy of Dr. Craig Walker) Occluded Posterior Tibial
Laser Atherectomy 0.9 mm Laser
Final Result Following Laser & PTA
Recanalization Technique step-by-step approach
Occluded Popliteal Artery
Conclusions Study Conclusion Excimer laser-assisted atherectomy for CLI offers high technical success and limb salvage rates in patients identified as poor candidates for traditional surgical revascularization Limb salvage rate of 93% in surviving patients is among the highest reported for endovascular therapy in complex infrainguinal and infrapopliteal disease 2011 Spectranetics All Rights Reserved. Approved for External Distribution D013754-00 032011
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