OCT guided procedures in peripheral intervention

OCT guided procedures in peripheral intervention Ulrich Sunderdiek, M.D., PhD. Interventional Radiology Marienhospital Osnabrueck, Germany ulrich.sunderdiek@mho.de

Recanalisation Popliteal Artery AFS li. 76 yrs. male Rutherford Class 5 POBA DCB 2 Stents

Endovascular Stent-Therapy 1 Year patency SFA lenght dependent Studies - Comparison Patency rate (%) Lesion lenght (cm)

Stent Implantation - SFA + Popliteal Artery 76 yrs. female Rutherford Class 5 2 Stents AFS li. A. poplitea li.

Leave nothing behind: Actual Data with DCB femoro-poplietal IN.PACT SFA TRIAL

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

Endovascular Therapy low pressure Angioplasty (3-6 atm), avoid Overstretching - Dissektion.

Peripheral Atherectomy Different methods Directional Atherectomy Rotational Atherectomy Transluminal Extraction Atherectomy (surgery)

Directional Atherectomy Directional Systems: HawkOne, Turbohawk Medtronic Inc. Pantheris System Avinger Inc.

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

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 Chronic total occlusion In-stent restenosis In-stent occlusion with thrombus xx x x x xx xx x x xx x x x xx xx xxx xx x xx

Study (*Core Lab) *Definite LE 1 DA 598 (RCC1-3) 201 (RCC 4-6) Solo Atherectomy Study Data Type Patients Lesions Dissections (>Grade D) 743 279 2.2% (13/598) 2.5% (5/201) BO Stent 30-day MAZE 1 year > 1 year 3.2% (33/1022) *Definite CA 2 DA 133 168 0.8 % (1/131) 4.1% (7/168) 1.0% (6/598) 3.5% (7/201) 78% 71% 6.9% (9/131) NR? Vision-IDE 3 OA 130 130 NR 4.0% 17.6% (6 mo) NR? Oasis 4 OA 124 201 NR 2.5% (5/201) 3.2% (4/124) NR? ItCompliance is possible 360 that 5 OA atheretomy 25 may complement 38 NRDCB use 5.3% in (2/38) real worldnrlesions81.2% by reducing? 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 % (14/210) *Cello 8 Las 65 65 NR 23.2% (15/65) *Excite ISR 9 Las 169 169 2.4% 4.1% (7/169) 1.0% (2/172) 61.8%? 0% 54.3%? 5.8% (9/155) 71.1%? 1 McKinsey L, et al. JACC Cardiovasc Interv 2014 2 Roberts D, et al. Cath Cardiovasc Interv 2014 3 Schwindt A, Presented at VIVA 2015. 4 Safian RD, et al. Cath Cardiovasc Interv 2009 5 Dattilo R, et al. J Invasive Cardiol 2014 6 Shammas NW, et al. J Endovasc Ther 2012 7 Zeller T, et al. J Endovasc Ther 2009 8 Dave R, et al.. J Endovasc Ther 2009 9 Dippel EJ, et al. JACC Cardiovasc Interv 2015

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 In-stent restenosis Aneurysmal target vessel SilverHawk and TurboHawk Peripheral Plaque Excision Systems

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

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

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

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

Fluoroscopic DAAART Drawbacks Increased risk for adventitial injury (up to 50%) Repeated angiograms OCT real time vessel wall Increased need for contrast medium visualization? Increased radiation exposure Stavroulakis et al JEVT. 2017;24(2):181-188 Tariccone et al, JEVT 2015;22(5):712-5.

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

OCT real time vessel wall visualization

OCT guided debulking A direction of cutter blade passive mode B trough from previous passage, C - elastic lamina

SFA: OCT SNAPSHOTS Popcorn Calcium STOP: Layered Structures STOP: Layered Structures GO: Non-Layered Structures GO: Non-Layered Structures

OCT guided debulking PROXIMAL SFA DISTAL SFA 2 PRE POST PRE POST DCB

POST TREATMENT / TISSUE ANALYSIS Tissue weight 88.5 mg: Purple signifies calcium and very little medial/adventitial components

OCT VISION TRIAL Schwindt el al. JEVT 2017;24(3):355-366.

OCT guided DAART: The Münster experience De novo lesion 25 (68%) Common femoral artery SFA 1 SFA 2 SFA 3 P1 segment P2 segment P3 segment 2 (5%) 7 (19%) 12 (32%) 20 (54%) 8 (22%) 7 (19%) 5 (14%) Courtesy of A. Schwindt 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

OCT guided DAART: The Münster experience Endpoints/outcomes Result Lesion diameter post atherectomy (mean±sd), in mm 3.5±0.8 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%) Courtesy of A. Schwindt Type D-F 0 In-hospital reintervention 1 (3%) Ankle-brachial index at discharge (median, IQR)* 1 (0.97-1.00)

OCT guided DAART: The Münster experience Courtesy of A. Schwindt @12 Months PPR: 93% @12 Months Freedom from TLR: 100%

OCT guided treatment of ISR Courtesy of A. Schwindt post pre Pantheris

360 degree OCT-control after debulking with 7F Pantheris 3.0 troughs Struts Courtesy of A. Schwindt

Removal of a dissection flap OCT-guided Courtesy of A. Schwindt dissection Dissection flap removed

OCT image pullback with Pantheris

OCT guided atherctomy peripheral interventions Vessel preparation: Effective endoluminal, mechanical debulking of plaque materials. Treatment in critical motion segments. low pressure Angioplasty (3-6 atm). Avoidance of Stents.

OCT guided peripheral interventions OCT-guided atherectomy is save, with good standalone results >90% PP at 12 month in combination with DCB 5F device is in the pipeline opening new horizons for BTK and possible coronary applications Device performs best in fibrotic lesions whilst heavy calcium remains a drawback

Thank you! OCT guided procedures in peripheral intervention Ulrich Sunderdiek, M.D., PhD. Interventional Radiology Marienhospital Osnabrueck, Germany ulrich.sunderdiek@mho.de