OCT T gui guided ded pr procedur edures es in n per peripher - PowerPoint PPT Presentation

OCT T gui guided ded pr procedur edures es in n per peripher pheral in inter erven entio tion Ulrich Sunderdiek, M.D., PhD. Interventional Radiology Marienhospital Osnabrueck, Germany ulrich.sunderdiek@mho.de

Recanalisation – Popliteal Artery AFS li. 76 yrs. male POBA DCB 2 Stents Rutherford Class 5 U. Sunderdiek Marienhospital Osnabrück, Germany

Endovascular Stent-Therapy 1 Year patency – SFA lenght dependent Studies - Comparison Patency rate (%) Lesion lenght (cm) U. Sunderdiek Marienhospital Osnabrück, Germany

Stent Implantation - SFA + Popliteal Artery 76 yrs. female AFS li. 2 Stents Rutherford Class 5 A. poplitea li. U. Sunderdiek Marienhospital Osnabrück, Germany

Leave nothing behind: Actual Data with DCB femoro-poplietal IN.PACT SFA TRIAL U. Sunderdiek Marienhospital Osnabrück, Germany

Endovascular Therapy CardioVascular and Interventional Radiology 2014; 37: 898-907 Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease F. Fanelli ,et al.

Femoralpopliteal Lesions Factors, which induce Restenois after peripheral Interventions: • Lesion Length 1 • Comorbidities, i.e. Diabetes, Nicotin... 2 • Long Occlusions 3 • Severe Calcifications 4 1. Norgren et al. Eur J Vas Endovasc Surg 33, S1-S75: 2007. 2. DeRubertis et al. J Vasc Surg 2008;47:101-108. 3. Lida et al. Cath and Cardiovasc Interven 2011 Oct 1;78(4):611-7. 4. Cioppa et al. CV Revasc. Med. 2012 Jul-Aug:219-23.

Endovascular Therapy Reduction the riskfactors for Restenosis? Make it open and keep it open! • Reducing of calcification • Plaquedebulking • Reducing exzentric lesions • Respectation of the distal motion segment FP Atherectomy U. Sunderdiek Marienhospital Osnabrück, Germany

Endovascular Therapy ‚low pressure‘ Angioplasty (3-6 atm), avoid ‚Overstretching‘ - Dissektion. U. Sunderdiek Marienhospital Osnabrück, Germany

Peripheral Atherectomy Different methods • Directional Atherectomy • Rotational Atherectomy • Transluminal Extraction Atherectomy (surgery) U. Sunderdiek Marienhospital Osnabrück, Germany

Directional Atherectomy Directional Systems: HawkOne, Turbohawk Medtronic Inc. Pantheris System Avinger Inc. U. Sunderdiek Marienhospital Osnabrück, Germany

Distal SFA – directional Atherectomy Technique: partial subintimal Recanalisation, Filterwire (NAV6 Abbott), HawkOne System (Medtronic), PTA with 1 Drug-eluting Ballons, 70 min. U. Sunderdiek Marienhospital Osnabrück, Germany

Overview of available Atherectomy Systems Device Jetstream Phoenix HawkOne Pantheris Laser Atherectomy Type Rotational Rotational Directional Directional Photoablative Eccentric lesion x x xx xx Soft/fibrotic plaque xx xx xx xx xx Thrombotic lesion xxx x x Highly calcific lesion xx x x x Chronic total occlusion xx xx x x xx In-stent restenosis x x x xx xx In-stent occlusion with xxx xx x xx thrombus U. Sunderdiek Marienhospital Osnabrück, Germany

Solo Atherectomy – Study Data Study Type Patients Lesions Dissections BO Stent 30-day MAZE 1 year > 1 (*Core Lab) (>Grade D) year *Definite LE 1 DA 598 (RCC1-3) 743 2.2% (13/598) 3.2% 1.0% (6/598) 78% ? 201 (RCC 4-6) 279 2.5% (5/201) (33/1022) 3.5% (7/201) 71% *Definite CA 2 DA 133 168 0.8 % (1/131) 4.1% 6.9% (9/131) NR ? (7/168) Vision-IDE 3 OA 130 130 NR 4.0% 17.6% (6 mo) NR ? Oasis 4 OA 124 201 NR 2.5% 3.2% (4/124) NR ? (5/201) It is possible that atheretomy may complement DCB use in real world lesions by reducing Compliance 360 5 OA 25 38 NR 5.3% (2/38) NR 81.2% ? dissection rate and bail-out stenting Calcium 360 6 OA 25 29 3.5% (1/29) 6.9% (2/29) 0% NR ? *Pathway PVD 7 RA 172 210 9% (15/172) 7.0 % 1.0% (2/172) 61.8% ? (14/210) *Cello 8 Las 65 65 NR 23.2% 0% 54.3% ? (15/65) *Excite ISR 9 Las 169 169 2.4% 4.1% 5.8% (9/155) 71.1% ? (7/169) 1 McKinsey L, et al. JACC Cardiovasc Interv 2014 6 Shammas NW, et al. J Endovasc Ther 2012 2 Roberts D, et al. Cath Cardiovasc Interv 2014 7 Zeller T, et al. J Endovasc Ther 2009 3 Schwindt A, Presented at VIVA 2015. 8 Dave R, et al. . J Endovasc Ther 2009 4 Safian RD, et al. Cath Cardiovasc Interv 2009 9 Dippel EJ, et al. JACC Cardiovasc Interv 2015 5 Dattilo R, et al. J Invasive Cardiol 2014 U. Sunderdiek Marienhospital Osnabrück, Germany

Definite LE Study Inclusion Criteria (800 pts.) • RCC 1-6 • ≥ 50% stenosis • Lesion Length ≤ 20 cm • Reference Vessel ≥ 1.5 mm and ≤ 7.0 mm Exclusion Criteria • Severe calcification SilverHawk™ and TurboHawk ™ • In-stent restenosis Peripheral Plaque Excision Systems • Aneurysmal target vessel U. Sunderdiek Marienhospital Osnabrück, Germany

Definite LE Study 12 months Primary Patency at 12 Months (Diabetic vs. Non-Diabetic 100% Diabetic 90% 85% 84% Non-Diabetic 81% 77% 80% 71% 70% 64% 60% 50% 40% 30% 20% 10% 0% <4 cm 4-9,9 cm >10 cm U. Sunderdiek Marienhospital Osnabrück, Germany

Definite AR Study 12 months Aim of the study: Prospective, randomized multicenter-study. Comparison Directional Atherectomy and DCB (DAART) vs. DCB (DCB) alone 121 patients Multicenter Study (10 centers) • Infrainguinale lesions • Läesionlenght 7-15cm • Primary endpoint: Primary patency after12 months. T. Zeller, MD; VIVA 2014 U. Sunderdiek Marienhospital Osnabrück, Germany

Definite AR Study 12 months DUS-derived primary patency rate 96,8 100 DAART 93,4 89,6 DCB 90 85,9 80 70,4 70 Patency Rate (%) 62,5 60 50 40 30 20 10 0 All Patients Lesion > 10 cm All Severe Ca++ N=27 N=8 N=48 N=54 N=31 N=23 T. Zeller, MD; VIVA 2014 U. Sunderdiek Marienhospital Osnabrück, Germany

Definite AR Study 12 months Angiographic patency 100 DAART 90,9 90 DCB 82,4 80 71,8 68,8 70 Patency Rate (%) 58,3 60 50 42,9 40 30 20 10 0 All Patients Lesion > 10 cm All Severe Ca++ T. Zeller, MD; VIVA 2014 N=27 N=8 N=48 N=54 N=31 N=23 U. Sunderdiek Marienhospital Osnabrück, Germany

Fluoroscopic DAAART Drawbacks • Increased risk for adventitial injury (up to 50%) l l a w l e s s e v • Repeated angiograms e m i t l a e ? r n T o C i O t a z i l a § u • Increased need for contrast medium s i v • Increased radiation exposure § Stavroulakis et al JEVT. 2017;24(2):181-188 § Tariccone et al, JEVT 2015;22(5):712-5. U. Sunderdiek Marienhospital Osnabrück, Germany

Pantheris OCT atherectomy catheter § 155μm optical fiber § 7F and 8F sheath § 0.014” rapid exchange wire lumen § OCT laser aperture on the cutter blade, 1.2mm proximal to the edge § Rotation with 1000 rpm § Continuous real-time OCT imaging during debulking U. Sunderdiek Marienhospital Osnabrück, Germany

OCT real time vessel wall visualization U. Sunderdiek Marienhospital Osnabrück, Germany

OCT – guided debulking A – direction of cutter blade – passive mode B – trough from previous passage, C - elastic lamina U. Sunderdiek Marienhospital Osnabrück, Germany

SFA: OCT SNAPSHOTS Popcorn Calcium STOP: Layered Structures STOP: Layered Structures GO: Non-Layered Structures GO: Non-Layered Structures U. Sunderdiek Marienhospital Osnabrück, Germany

OCT – guided debulking PROXIMAL SFA DISTAL SFA 2 PRE POST PRE POST DCB U. Sunderdiek Marienhospital Osnabrück, Germany

POST TREATMENT / TISSUE ANALYSIS Tissue weight 88.5 mg: Purple signifies calcium and very little medial/adventitial components U. Sunderdiek Marienhospital Osnabrück, Germany

OCT – VISION TRIAL Schwindt el al. JEVT 2017;24(3):355-366. U. Sunderdiek Marienhospital Osnabrück, Germany

OCT – VISION TRIAL Schwindt el al. JEVT 2017;24(3):355-366. U. Sunderdiek Marienhospital Osnabrück, Germany

OCT guided DAART: The Münster experience De novo lesion 25 (68%) Common femoral artery 2 (5%) SFA 1 7 (19%) SFA 2 12 (32%) SFA 3 20 (54%) P1 segment 8 (22%) P2 segment 7 (19%) P3 segment 5 (14%) Run-off arteries > 1 31 (84%) Calcification 8 (22%) Lesion length (median, IQR), in mm 70 (27-104) Chronic total occlusion 13 (35%) Reference vessel diameter (mean±SD), in mm 5.1±0.6 Courtesy of A. Schwindt U. Sunderdiek Marienhospital Osnabrück, Germany

Endpoints/outcomes Result OCT guided DAART: Lesion diameter post atherectomy (mean±SD), in mm 3.5±0.8 The Münster experience Lumen gain post atherectomy (mean±SD), in % 52±17 % Lesion diameter post DAART (median, IQR), in mm 4.6 (4.1-5.0) Lumen gain post DAART (median, IQR), in mm 68 (58-91) % Technical success 34 (92%) Procedural success 35 (95%) ASRC 6 (16%) Perforation 1 (3%) Embolization 2 (5%) Bail-out stent 1 (3%) Bail-out procedure 2 (5%) Dissection Type A-C 11 (30%) Type D-F 0 Courtesy of A. Schwindt In-hospital reintervention 1 (3%) Ankle-brachial index at discharge (median, IQR)* 1 (0.97-1.00) U. Sunderdiek Marienhospital Osnabrück, Germany

OCT guided DAART: The Münster experience Courtesy of A. Schwindt @12 Months PPR: 93% @12 Months Freedom from TLR: 100% U. Sunderdiek Marienhospital Osnabrück, Germany

OCT guided treatment of ISR Courtesy of A. Schwindt post pre Pantheris U. Sunderdiek Marienhospital Osnabrück, Germany