Debulking Below the Knee: Devices & Techniques Jihad A. - PowerPoint PPT Presentation

Debulking Below the Knee: Devices & Techniques Jihad A. Mustapha, MD, FSCAI, FACC Advanced Cardiac & Vascular Centers for Amputation Prevention Grand Rapids, MI

Disclosures Bard Peripheral Vascular – Consultant Boston Scientific – Consultant, Scientific Advisory Board, Research CardioFlow – Equity, Research Cardiovascular Systems, Inc. – Consultant, Research Medtronic – Consultant Micromedical Solutions – Chief Medical Officer Philips – Consultant PQ Bypass – Research Reflow Medical – Chief Medical Officer Terumo - Consultant

Atherectomy Devices Peripheral Diamondback Rotablator™ 360™, Stealth SilverHawk™, Turbo-Elite™ Jetstream™ Rotational 360™ TurboHawk™ Laser Atherectomy Atherectomy Atherectomy Plaque Excision Atherectomy System System System System Catheter (Boston Scientific) (Boston (Cardiovascular (Covidien) (Spectranetics) Scientific) Systems, Inc) Front-Cutting ü ü N/A DifferentialCutting ü ü ü N/A Active Aspiration ü Concentric Lumens ü ü ü Lesion Morphology: Calcium ü ü ü ü ü Soft/Fibrotic ü ü ü Plaque Thrombus ü ü Sources: Endovascular Today Buyer’s Guide 2014. JETSTREAM System Brochure, Boston Scientific Website, 2014. Peripheral Rotablator product website, Boston Scientific, 2014. Diamondback 360 product website, CSI, 2014. Covidien website, Directional Atherectomy products, 2014. Turbo-Elite Laser Atherectomy Catheter Instructions for Use, May 2014.

The LACI Studies The LACI Trial: 6 Month Results • Laird et al • 145 pt, 155 critical ischemic limbs • 423 lesions • 41%SFA, 15% Popliteal, 41% Infrapop • 70% of Pts had combo occlusion and stenosis • 29% Rutherford Class 4 • 71% Rutherford Class 5 or 6 • Limb salvage 92% at 6 months

DEFINITIVE LE • Study Design and Oversight: • Prospective, non-randomized, global study • 800 subjects enrolled at 47 centers • CEC and Steering Committee oversight and CEC adjudicaiton • Angiographic and Duplex core laboratory analyses • Inclusion Criteria • RCC 1-6 • ≥ 50% stenosis • Lesion lengths up to 20cm • Reference Vessel ≥ 1.5 mm and ≤ 7.0 mm • Exclusion Criteria • Severe calcification • In-stent restenosis • Aneurysmal target vessel

Lesion Assessment Characteristic Claudication CLI All Subjects (RCC 1-3) (RCC 4-6) (RCC 1-6) Number of Patients 598 201 799 Number of Lesions 743 279 1022 Mean Length (cm) 7.5 7.2 7.4 Baseline Stenosis (%) 73 76 74 Occlusions (%) 17 30 21 Anatomic location based on proximal edge of lesion treatment, % (N) SFA 72% (536) 48% (135) 66% (671) Popliteal 15% (114) 17% (48) 16% (162) Infrapopliteal 13% (93) 34% (96) 18% (189) McKinsey JF et al JACC Interv 2014 Core lab reported

Primary Patency in Subgroups Subgroup Claudicants (n=743) CLI (n=279) Patency Lesion Patency Lesion (PSVR < 2.4) Length (cm) (PSVR < 2.4) Length (cm) All (n=1022) 78% 7.5 71% 7.2 Lesion type Stenoses (n=806) 81% 6.7 73% 5.8 Occlusions (n=211) 64% 11.1 66% 10.3 Lesion Location SFA (n=671) 75% 8.1 68% 8.6 Popliteal (n=162) 77% 6.0 68% 5.4 Infrapopliteal (n=189) 90% 5.5 78% 6.0

Primary Patency in Subgroups Subgroup Claudicants (n=743) CLI (n=279) Patency Lesion Patency Lesion (PSVR < 2.4) Length (cm) (PSVR < 2.4) Length (cm) All (n=1022) 78% 7.5 71% 7.2 By Lesion Length < 4 cm (n=318) 81% 2.2 84% 2.3 4-9.9 cm (n=418) 83% 6.5 62% 6.6 ≥ 10 cm (n=283) 67% 14.4 65% 15.1 SFA Only By Lesion Length < 4 cm (n=184) 78% 2.3 82% 2.3 4-9.9 cm (n=253) 83% 6.5 60% 6.9 ≥ 10 cm (n=232) 65% 14.6 63% 15.5

Jetstream System Overview JETSTREAM XC Catheters JETSTREAM SC Catheters XC 2.1/3.0mm SC 1.6mm XC 2.4/3.4 mm SC 1.85mm (SFA & Popliteal Sizes) (Tibial Sizes) Control POD Console Over-the-Wire Approved for use with BSC 0.014” 300cm Thruway Guidewire Approved for use with Atherectomy Lubricants, such as Rotaglide

Patient Characteristics • 241 patients (258 lesions) Overall (N=241) Age (years), mean ± SD 67.1 ± 9.8 Male 66.0% Medical History Hypertension 82.6% Hypercholesterolemia 66.8% Smoking 50.6% Heart Disease 47.7% Diabetes 41.1% Race Caucasian 80.1% African American 16.6% Native American 2.1% Other 1.2%

a Post hoc analysis of patients who received and did not receive adjunctive stents. b Calcium grading: 0= no visible calcification; 1= one individual segment of vessel calcification Lesion Characteristics representing <25% of the length of the entire segment; 2= aggregate calcification representing <50% of the segment length; 3= aggregate calcification representing >50% of the segment length; 4= dense circumferential calcification along the segment length. Overall Non-Stent a Stent a (N=258 lesions) (N=165 lesions) (N=93 lesions) Lesion location Superficial Femoral 75.6 % 72.1% 81.7% Common Femoral 10.9% 15.2% 3.2% Popliteal 13.6% 12.7% 15.1% Lesion length, mean ± SD 16.4 ± 13.6 cm 14.1 ± 12.6 cm 20.5 ± 14.4 cm Calcium Grade b 0 10.0% 10.2% 9.5% 1 16.2% 14.6% 19.0% 2 24.1% 17.8% 35.7% 3 28.2% 31.8% 21.4% 4 19.5% 21.0% 16.7% Lesion RVD, mean ± SD 5.7 ± 0.9 mm 5.5 ± 0.9 mm 5.9 ± 0.9 mm Occlusion (100% stenosis) 36.1% 28.7% 50.0% Pre-treatment stenosis estimate, mean ± SD 91.1% ± 9.8% 90.2% ± 10.0% 92.7% ± 9.4%

Procedures • 98.3% procedural success (≤30% Procedure time: 73.4 ± 37.5 min residual diameter stenosis post- Total Jetstream procedure) 4.7 ± 3.5 min run time: • 84 patients (35%) received Number of Passes adjunctive stents Blades Down: 2.0 ± 1.5 • Stent placement performed at operator’s discretion Blades Up: 1.8 ± 1.4 • Embolic protection used in 22.4% of cases Overall Non-Stent Stent (N=258 lesions) (N=165 lesions) (N=93 lesions) Post-treatment stenosis estimate, mean ± SD Post-Jetstream 44.4% ± 20.0% 38.5% ± 16.2% 54.8% ± 22.0% Post Adjunctive Treatment 9.8% ± 11.4% 11.6% ± 11.7% 6.6% ± 10.2%

Unique Mechanism of Action Preferential Sanding • Elastic healthy tissue “gives” and is not affected by diamond grit • Diseased tissue provides resistance and allows grit to “sand” the plaque Effective plaque removal No detrimental effect Diseased Tissue Compliant Tissue Diamond Grit

• 6 month data • 124 patients for infrapopliteal revascularization (201 lesions) • Claudicants 55% • CLI 45% • Treatment OA either stand alone or with adjuctive Rx

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LIBERTY 360 • Prospective, observational, multi-center clinical study to evaluate acute and long-term clinical, functional and economic outcomes of endovascular device intervention in patients with distal outflow peripheral arterial disease (PAD) • No inclusion and exclusion • Independent core laboratory analyses and adjudications • Angiographic • Duplex Ultrasound • Six Minute Walk Test • Health Economics • Includes separate analyses for • Claudicants • Critical limb ischemia (RB4 and 5) • Critical limb ischemia (RB6)

Device Usage by Lesion Balloon and/or atherectomy were preferred devices. Rutherford 2-3 (N=599) Rutherford 4-5 (N=754) Rutherford 6 (N=145) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Balloon Atherectomy Stent Bailout stent* *Bailout stent group is a subset of Stent group. Bailout stent defined as stent placed due to an angiographic complication or sub-optimal result (>50% stenosis). Comparison between Rutherford Core Lab reported lesions. categories significant (p< 0.05 ) Patients with reported values may be less than total number of patients enrolled in each arm.

Major Adverse Events (MAEs) to 6 Months High freedom from 6-Month Major Adverse Events (MAE), indicating even RC6 subjects can be treated with PVI. Product-Limit Survival Estimates Product-Limit Survival Estimates Major Adverse Event With Number of Subjects at Risk and 95% Confidence Limits With Number of Subjects at Risk and 95% Confidence Limits 1.0 1.0 + Censored defined as: 0.9 0.9 Survival Probability Survival Probability Death (within 30 days v 0.8 0.8 of the index 0.7 0.7 procedure) 0.6 0.6 Unplanned major v 0.5 0.5 amputation of the target limb (above the 2-3: Claudicants 2-3: Claudicants 499 499 484 484 450 450 414 414 4-5: CLI 4-5: CLI 589 589 554 554 479 479 406 406 ankle) 6: CLI 6: CLI 99 99 87 87 67 67 54 54 Clinically-driven TVR v 0 0 30 30 90 90 180 180 Time to MAE (Days) Time to MAE (Days) (inclusive of TLR) of Baseline Rutherford Classification Baseline Rutherford Classification the target limb 2-3: Claudicants 2-3: Claudicants 4-5: CLI 4-5: CLI 6: CLI 6: CLI Kaplan-Meier method used to obtain estimate of freedom from MAE. Greenwood’s method used to obtain the 95% confidence interval for the estimate. Pairwise Log-Rank P-values at 180-Days: RC2-3 vs. RC4-5, P<0.0001; RC2-3 vs. RC6, P<0.0001; RC4-5 vs. RC6, P=0.0453