Lithoplasty for BTK Pr Marianne Brodmann Univ Klinik
Lithoplasty for BTK Pr Marianne Brodmann Univ. Klinik für Innere Medizinische Universtität Graz
Disclosures Consulting for Bard, Medtronic, Spectranetics, Daiichi, Intact Vascular, Shockwave
Peripheral Intravascular Lithotripsy System: Clinical Programs DISRUPT PAD II DISRUPT BTK DISRUPT PAD III Pre Market Post Market Single Arm Randomized N = 35 N = 60 N = 20 N = 334 Study Completed Enrolling
DISRUPT PAD Study: Femoropopliteal Disease DISRUPT PAD I 35 subjects, 3 sites Jan 2014 – Sep 2014 DISRUPT PAD II 60 subjects, 8 sites Jun 2015 – Dec 2015 Objective: To study the safety and effectiveness of the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System in the treatment of calcified, stenotic infrainguinal peripheral arteries. • • Two-phase, prospective, non-randomized, multi-center study Monitoring with 100% source document verification Independent angiographic and duplex ultrasound core labs Independent clinical events committee
DISRUPT PAD I/II: Patient Demographics and Angiographic Findings† DISRUPT PAD I/II N = 95 Patients Included Calcification Angiographic Findings Rutherford 2 33. 7% (32) Rutherford 3 65. 3% (62) Rutherford 4 1. 1% (1) Rutherford 5 - Moderate 44. 2% (42) Severe 54. 7% (52) RVD (mm) 5. 3 Lesion length 71. 9 Calcified length 92. 5 CTO 18. 9% (18) †Core lab adjudicated DISRUPT PAD & DISRUPT BTK categorized calcified lesions as per PARC definitions. Both studies utilized independent core labs and clinical events committees. DISRUPT BTK data based on European studies.
DISRUPT PAD I/II: Safety & Effectiveness† DISRUPT PAD I/II N = 95 Dissections Safety Effectiveness 1% (1) Grade D or greater 1% (1) stent placed Embolization 0 Embolic Events 8% EPD Usage Perforations, abrupt closure, slow/no reflow or thrombosis 0 Complications Residual Stenosis 23. 8% Acute Gain 2. 9 mm 30 days 100% Freedom from TLR 100% Patency 6 months 96. 8% Freedom from TLR 76. 7% Patency Follow-Up †Core DISRUPT PAD & DISRUPT BTK categorized calcified lesions as per PARC definitions. Both studies utilized independent core labs and clinical events committees. DISRUPT BTK data based on European studies. lab adjudicated
Challenges Associated with Problematic Calcium: Below the Knee Most BTK vessels undergo significant elastic recoil following angioplasty 1 97% vessels had >10% recoil 15 m after POBA Initial Angiogram 29% av. vessel recoil 15 m after POBA Angiogram after 15 m Medial calcification produces vessel recoil and restenosis 2, 3, 4 Medial calcification Arterial Stiffness Vessel recoil Restenosis 1) Baumann et al, Early recoil after balloon angioplasty of tibial artery obstructions in patients with critical limb ischemia, J Endovasc Ther 2014 2) Guzman et al, Tibial artery calcification as a marker of amputation risk in patients with PAD, JACC 2008 3) Zettervall et al, Association of arterial calcification with CLI in patients with PAD, J Vasc Surg 2017 4) Mustapha et al, One-Month Duplex Ultrasound Evaluation of Vessel Recoil After Tibial Peripheral Vascular Intervention for Critical Limb Ischemia Predicts 12 m TLR, AMP 2017
OCT Analysis: Demonstrates IVL address both Intimal and Medial Calcium Holden, LINC 2018
DISRUPT BTK Study: Infrapopliteal Disease Objective: To study the safety and performance of the Shockwave Medical Peripheral Intravascular Lithotripsy System in the treatment of calcified, stenotic infrapopliteal peripheral arteries. Design Key eligibility criteria • Rutherford category 1 -5 infrapopliteal disease • Infrapopliteal lesions ≥ 50% stenosis • RVD 2. 5– 3. 5 mm, ≤ 150 mm length • Moderate and severe calcification by angiography Endpoints Procedural • Primary Effectiveness: Acute reduction in % diameter stenosis Follow up: 30 days • Major adverse events (Death, MI, TLR, amputation)
DISRUPT BTK: Patient Demographics and Angiographic Findings† Baseline Characteristics Age, years, mean ± SD N = 20 79± 9. 6 Male Gender, % (n) 70. 0% (14) Diabetes, % (n) 40. 0% (8) Hypertension, % (n) 95. 0% (19) Hyperlipidemia, % (n) 75. 0% (15) Renal Insufficiency, % (n) 40. 0% (8) Coronary Artery Disease, % (n) 40. 0% (8) Current or Former Smoker, % (n) 25. 0% (5) Rutherford Class, % (n) RC 3 RC 4 RC 5 20. 0% (4) 5. 0% (1) 75. 0% (15) Pre-procedure Tibio-peroneal trunk Anterior tibial Posterior tibial Peroneal Popliteal artery below knee Reference vessel diameter, mm, mean ± SD (range) Lesion length, mm, mean ± SD (range) Calcified length, mm, mean ± SD (range) Calcification, % (n) Moderate Severe Mean luminal diameter, mm, mean ± SD (range) Diameter stenosis, % N=21 lesions, 19 subjects 9. 5% (2) 38. 1% (8) 9. 5% (2) 4. 8% (1) 3. 2 ± 0. 6 (2. 4 -4. 8) 52. 2 ± 35. 8 (13. 8 -144. 0) 72. 1 ± 37. 6 (12. 4 -172. 6) 52. 4% (11) 47. 6% (9). 9 ± 0. 6 (0. 0 -1. 9) 72. 6% Moderate Calcification: densities noted only prior to contrast injection. Severe Calcification: radiopacities noted prior to contrast injection generally involving both sides of the arterial wall †Core lab adjudicated Brodmann, M. Presentation, CIRSE, 2017
DISRUPT BTK: Safety & Effectiveness† Endpoint Primary Safety Endpoint: MAE rate @ 30 days Primary Effectiveness Endpoint: Acute reduction in % stenosis % (n) 0% (0/20) 46. 5% (19/19*) Secondary Endpoint: Post-IVL residual stenosis of ≤ 50% 100% (19/19*) *In 1 patient, the IVL catheter was unable to cross Final Procedure Mean luminal diameter, mm, mean ± SD (range) Diameter stenosis, % Diameter stenosis reduction, % Acute gain, mm, mean ± SD (range) Dissection Perforation Distal embolization Thrombus No reflow Abrupt closure †Core Brodmann, M. Presentation, CIRSE, 2017 N=21 lesions, 19 subjects 2. 4 ± 0. 5 (1. 5 -3. 6) 26. 2% 46. 5. % 1. 5± 0. 5 (0. 7 -2. 3) 4. 8. % (1) 0% (0) 0% (0) lab adjudicated
Diagnostic Angiogram Case Example IVL Procedure Final Result No vascular complications No post dilatation 2. 75 mm IVL Cath 120 pulses RVD = 2. 45 mm Pre %DS = 95. 82% Case Courtesy Pr Zeller %DS = 21. 76%
Case Example Diagnostic Angiogram 3. 3 mm RVD 96% stenosis 47. 8 mm length Calcification Procedural Angiogram 2. 5 x 60 mm IVL Catheter 2. 0 x 120 Armada PTA of TP Trunk Final Angiogram 17. 8% stenosis Acute gain 2. 3 mm
DISRUPT BTK: Summary • IVL is designed to treat both intimal and medial calcium allowing vessel expansion with minimal angiographic complications • Acute results show low residual stenosis with minimal vascular complications including no perforations, distal embolization, no reflow or abrupt closure • 30 day safety results report no MAE including revascularization or amputation. • Infrapopliteal results in a heavily calcified, CLI population are consistent with fempop IVL experience including low residual stenosis and minimal vascular complications.
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