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

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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

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Ulrich Sunderdiek, M.D., PhD. Interventional Radiology Marienhospital Osnabrueck, Germany ulrich.sunderdiek@mho.de

OCT T gui guided ded pr procedur edures es in n per peripher pheral in inter erven entio tion

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  • U. Sunderdiek Marienhospital Osnabrück, Germany

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

Recanalisation – Popliteal Artery

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Endovascular Stent-Therapy

1 Year patency – SFA lenght dependent

Studies - Comparison Lesion lenght (cm) Patency rate (%)

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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Stent Implantation - SFA + Popliteal Artery

76 yrs. female Rutherford Class 5 2 Stents AFS li.

  • A. poplitea li.
  • U. Sunderdiek Marienhospital Osnabrück, Germany
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Leave nothing behind: Actual Data with DCB femoro-poplietal

IN.PACT SFA TRIAL

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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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.
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Femoralpopliteal Lesions Factors, which induce Restenois after peripheral Interventions:

  • Lesion Length1
  • Comorbidities, i.e. Diabetes, Nicotin...2
  • Long Occlusions3
  • Severe Calcifications4

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.

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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
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‚low pressure‘ Angioplasty (3-6 atm), avoid ‚Overstretching‘ - Dissektion.

Endovascular Therapy

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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Different methods

  • Directional Atherectomy
  • Rotational Atherectomy
  • Transluminal Extraction Atherectomy (surgery)

Peripheral Atherectomy

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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Directional Atherectomy

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

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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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
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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 thrombus xxx xx x xx

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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Solo Atherectomy – Study Data

Study (*Core Lab) Type Patients Lesions Dissections (>Grade D) BO Stent 30-day MAZE 1 year > 1 year *Definite LE1 DA 598 (RCC1-3) 201 (RCC 4-6) 743 279 2.2% (13/598) 2.5% (5/201) 3.2% (33/1022) 1.0% (6/598) 3.5% (7/201) 78% 71% ? *Definite CA2 DA 133 168 0.8 % (1/131) 4.1% (7/168) 6.9% (9/131) NR ? Vision-IDE3 OA 130 130 NR 4.0% 17.6% (6 mo) NR ? Oasis4 OA 124 201 NR 2.5% (5/201) 3.2% (4/124) NR ? Compliance 3605 OA 25 38 NR 5.3% (2/38) NR 81.2% ? Calcium 3606 OA 25 29 3.5% (1/29) 6.9% (2/29) 0% NR ? *Pathway PVD7 RA 172 210 9% (15/172) 7.0 % (14/210) 1.0% (2/172) 61.8% ? *Cello8 Las 65 65 NR 23.2% (15/65) 0% 54.3% ? *Excite ISR9 Las 169 169 2.4% 4.1% (7/169) 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

It is possible that atheretomy may complement DCB use in real world lesions by reducing dissection rate and bail-out stenting

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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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

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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Definite LE Study 12 months

77% 81% 71% 85% 84% 64%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% <4 cm 4-9,9 cm >10 cm

Diabetic Non-Diabetic

Primary Patency at 12 Months (Diabetic vs. Non-Diabetic

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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  • T. Zeller, MD; VIVA 2014

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.

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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  • T. Zeller, MD; VIVA 2014

Definite AR Study 12 months

DUS-derived primary patency rate

93,4 96,8 70,4 89,6 85,9 62,5

10 20 30 40 50 60 70 80 90 100 All Patients Lesion > 10 cm All Severe Ca++

Patency Rate (%)

DAART DCB

N=48 N=54 N=31 N=23 N=27 N=8

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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  • T. Zeller, MD; VIVA 2014

Definite AR Study 12 months

Angiographic patency

82,4 90,9 58,3 71,8 68,8 42,9

10 20 30 40 50 60 70 80 90 100

All Patients Lesion > 10 cm All Severe Ca++

Patency Rate (%)

DAART DCB

N=48 N=54 N=31 N=23 N=27 N=8

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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  • Increased risk for adventitial injury (up to 50%)
  • Repeated angiograms
  • Increased need for contrast medium
  • Increased radiation exposure

§ Stavroulakis et al JEVT. 2017;24(2):181-188 § Tariccone et al, JEVT 2015;22(5):712-5.

§ O C T r e a l t i m e v e s s e l w a l l v i s u a l i z a t i

  • n

?

Fluoroscopic DAAART Drawbacks

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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§ 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

Pantheris OCT atherectomy catheter

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

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

OCT – guided debulking

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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SFA: OCT SNAPSHOTS

STOP: Layered Structures

Popcorn Calcium

STOP: Layered Structures GO: Non-Layered Structures GO: Non-Layered Structures

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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2

PROXIMAL SFA POST PRE DISTAL SFA POST DCB PRE

OCT – guided debulking

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

POST TREATMENT / TISSUE ANALYSIS

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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OCT – VISION TRIAL

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

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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OCT – VISION TRIAL

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

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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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%) 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

  • U. Sunderdiek Marienhospital Osnabrück, Germany

Courtesy of A. Schwindt

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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 Type D-F 11 (30%) In-hospital reintervention 1 (3%) Ankle-brachial index at discharge (median, IQR)* 1 (0.97-1.00)

OCT guided DAART: The Münster experience

  • U. Sunderdiek Marienhospital Osnabrück, Germany

Courtesy of A. Schwindt

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OCT guided DAART: The Münster experience

@12 Months PPR: 93% @12 Months Freedom from TLR: 100%

  • U. Sunderdiek Marienhospital Osnabrück, Germany

Courtesy of A. Schwindt

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OCT guided treatment of ISR pre Pantheris

post

Courtesy of A. Schwindt

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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Struts troughs

360 degree OCT-control after debulking with 7F Pantheris 3.0

Courtesy of A. Schwindt

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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dissection Removal of a dissection flap OCT-guided Dissection flap removed

Courtesy of A. Schwindt

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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OCT–image pullback with Pantheris

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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OCT–image pullback with Pantheris

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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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 atherctomy peripheral interventions

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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

  • U. Sunderdiek Marienhospital Osnabrück, Germany
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Ulrich Sunderdiek, M.D., PhD. Interventional Radiology Marienhospital Osnabrueck, Germany ulrich.sunderdiek@mho.de

Thank you!

OCT guided procedures in peripheral intervention