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Medical Director of the Vascular Center
My Choice for the 2 cm Uncomplicated Symptomatic Proximal Popliteal Stenosis John R. Laird, MD Professor of Medicine Medical Director of the Vascular Center UC Davis Health System
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John R. Laird Jr. MD Consulting: Bard Peripheral Vascular, Inc., Boston Scientific Corporation, Medtronic, Inc., Covidien and Abbott Vascular Grant Support: Atrium Medical Corporation and W. L. Gore and Associates, Inc Honoraria: Volcano Therapeutics, Inc. Stocks, Stock Options, other ownership interest: AngioSlide, NextGen Healthcare Information Systems, Inc., BioCardia, Inc., Endoluminal Sciences and Syntervention Reflow Medical Off-Label: Off-label use of stents
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Popliteal Artery Direct extension of SFA as it passes through adductor canal Located between two heads of gastrocnemius muscle Anterior to popliteal vein Genicular and sural branches
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Popliteal Artery Pathologic Conditions: Atherosclerosis Aneurysm
Trauma Embolism Entrapment syndrome Cystic adventitial disease
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The Uncomplicated, Symptomatic 2 cm Proximal Popliteal Artery Stenosis
(Rare as Hen’s Teeth) Post PTA
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Cystic Adventitial Disease
Figure 14b. Case History 42 year old male runner Left lower extremity claudication Diagnosis? Treatment? Figure 14b. A 42-year-old male runner presented with acute claudication of the left lower extremity and was initially thought to have popliteal entrapment. (a, b) Stress (a) and nonstress (b) angiograms depict a similar hourglass-shaped stenosis. (c-e) Sequential axial T2-weighted MR images reveal extensive compression of the popliteal artery by CAD (arrow). Cystic Adventitial Disease
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Case History 72 yo male CAD s/p CABG, HTN, Hyperlipidemia
Lifestyle limiting claudication symptoms of right lower extremity Previous stenting of Left SFA Non-compressible arteries – ABI’s unreliable Duplex evidence of significant popliteal stenosis
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Angiography
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Treatment Options PTA Cutting/Scoring PTA
Excisional atherectomy (TurboHawk Calcium Cutter) Orbital/Rotational atherectomy Stenting
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Woven Nitinol Design
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Leipzig Supera Popliteal Registry N = 101
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Leipzig Supera Popliteal Registry N = 101
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Post PTA
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Diffuse Femoropopliteal Disease
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5 x 120mm Supera Stents (x2) Final
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Popliteal CTO: Interwoven Stents
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Final Runoff Bent-Knee Angio
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GORE® TIGRIS Vascular Stent Dual Component Stent Design
Clinically Proven Stent Frame Nitinol wire ePTFE Interconnecting Structure CARMEDA Bioactive Surface
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TIGRIS: Dual Component Stent Design
Designed to: Maximize flexibility while minimizing risk of stent fracture Allow axial compression while resisting stent elongation Naturally conforms and allows vessel movement 23
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ETAP Trial Multicenter, randomized trial of PTA vs. Stenting (LifeStent) for popliteal stenosis 1:1 Randomization 9 Centers in Europe, 246 patients Primary endpoint: restenosis rate at 24 months No restriction to lesion length
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ETAP Trial Technical success 100% in both groups
Stent fracture rate 3.8% at one year 12-Month Primary patency: LifeStent % PTA % 12-Month TLR Rate: LifeStent % PTA %
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Case History 72 yo male (retired radiologist)
Previous orbital atherectomy of popliteal artery calcified stenosis (over 2 years ago) Recurrent left calf claudication ABI: 0.60 Duplex: Popliteal PSV of 443 cm/sec (PSVR) > 3.5
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Left Lower Extremity Angio
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LEVANT 2 Study Procedural Technique
Cross stenosis/occlusion with guidewire and predilate with balloon 1mm < reference vessel diameter If no flow limiting dissection or residual stenosis > 70%, randomize to DEB vs. POBA Dilate with DEB matched 1:1 to RVD Post dilate with standard balloon as necessary to treat recoil/dissection to avoid cross over stenting
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DEFINITIVE LE Key Eligibility Criteria
Inclusion Criteria RCC 1-6 ≥ 50% stenosis Lesion Length ≤ 20 cm Reference Vessel ≥ 1.5 mm and ≤ 7.0 mm Exclusion Criteria Severe calcification In-stent restenosis Aneurysmal target vessel SilverHawkTM /TurboHawk™ Peripheral Plaque Excision Systems used in study
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Study Design and Primary Endpoints
800 patients 47 centers Claudicants (RCC 1-3) 598 patients* Primary patency by Duplex US at 12 mos CLI (RCC 4-6) 201 patients Freedom from major unplanned amputation at 12 mos *1 censored due to informed consent violation
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Baseline Demographics
Claudication (RCC 1-3) (n=598) CLI (RCC 4-6) (n=201) All Subjects (RCC 1-6) (n=799) Age (yrs)* 69 72 70 Female 44% 50% 45% History and Risk Factors Angina 23% 18% 22% Diabetes* 47% 69% 52% Hypertension 92% Hyperlipidemia* 86% 76% 84% Renal Insufficiency* 17% Current/Previous Smoker* 54% 36% 49% * p<0.05, claudicant vs. CLI
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Baseline Lesion Characteristics Core Lab Reported
Claudication (RCC 1-3) CLI (RCC 4-6) All Subjects (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)
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Peri-procedural Outcomes
Claudication (RCC 1-3) CLI (RCC 4-6) All Subjects (RCC 1-6) Device Success (≤30% stenosis after directional atherectomy) Investigator-Reported 87% Core Lab 76% 72% 75% Procedure Success (≤30% stenosis at end of procedure) 99% 98% 91% 83% 89% Therapy Pre-Directional Atherectomy PTA 9% Post-Directional Atherectomy PTA (no stent) 33% Mean pressure 6.6 atm Bail-Out Stent 3%
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Stent-like Primary Patency Claudicant Cohort
743 Lesions 7.5 cm Mean lesion length 72.7% Mean baseline stenosis PSVR ≤ 3.5 82% PSVR ≤ 2.4 78% 36 |
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Making Sense of it All For the uncomplicated 2 cm proximal popliteal stenosis – POBA is probably adequate Non-stent options reasonable – DCB, atherectomy Favorable early experience with newer, flexible nitinol stents (Supera stent for calcified/complicated lesions)
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