Is there a place for very distal BTK stenting? What are the options for acute PTA failure?

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1 Is there a place for very distal BTK stenting? What are the options for acute PTA failure? Dr. E. Puras Mallagray Hospital Universitario Quirón Madrid SPAIN

2 Faculty disclosure Enrique Puras I disclose the following financial relationships: Consultant for Abbott, Medtronic, Cook, Covidien, Biolitec Employee of CEVIFE Receive grant/research support from Covidien, Urgo, Astra Zeneca Advisory board of Abbott, Angiodynamics

3 BTK approach 2014 Endovascular first Straight line to the foot preferably through dorsalis pedis artery or plantar artery Aggressive angioplasty regardless CTO length Several techniques: Subintimal angioplasty, SAFARY, pedal-distal retrograde punctures Bailout stenting. Spot stenting Angiosome concept

4 BTK lesions Current endovascular strategy BTK for CLI-patients Short focal lesion Long diffuse lesion Calcified/Ostial Bail-out stenting with balloonexp stent PTA Bail-out stenting with self-exp stent PTA with long low-pressure balloons Focal stenting if residual flow-limiting lesion DEDICATED WOUND CARE

5 What should we do if out initial strategy in BTK PTA fails? 1.Unable to cross the lesion.what options do I have? Other GW? Other devices? Retrograde access? 2.Recoil, Dissection.Re- angioplasty? Same ballon or change size?, time? DEB? 3.Rupture, AVF, calcified lesion Stent?, What stent SE or BE?, in what position can we deploy safe? Appropriate technical endpoint for BTK intervention is remained unclear.

6 Unable to cross a lesion: GW Selection Dr M MANZI

7 UNABLE TO CROSS A LESION.

8 Not all crossing tools are created equal, and each has a place in an algorithmic approach to crossing complex CTOs Other devices that CAN help us crossing a BTK lesion: 1. Support catheters: CXI, TRAILBLAZER, Total Across crossing catheters 2. Low profile ballons, hydrophilic, trackability, pushability 3. Mechanical devices. No personal experience The TruePathTM CTO Device (Boston Scientific Corporation) The Phoenix Atherectomy System Peripheral Rotablator Rotational Atherectomy System Diamondback orbital atherectomy system (OAS) (Cardiovascular Systems Inc. [CSI], St. Paul, MN), Natick, MA)

9 Crossing devices can potentially improve procedural outcomes but also come with difficulties. The added cost of these devices can be significant, and some require capital equipment. Thomas P. Davis, MD EVT MAY 2013

10 Failed POBA, Challenges in BTK: Acute complications 1. GUIDEWIRE PERFORATION of the Vessel: - frequent, but not a problem in small vessels - when important / proximal: outside compression with blood pressure cuff - Option nº1 try re-enty and PTA - Option nº 2.retrograde access, trans-collateral

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12 Retrograde Pedal/tibial access to angioplasty : when to do it. Indications are limited to CLI patients with: Failure of antegrade approach No proximal stump at the origin of the target vessel Immediate origin of collateral at the reinjection-side (danger with antegrade approach to lose the collateral)

13 Pedal access to retrograde tibial angioplasty when to do it. ADVANTAGE DISADVANTAGE IMMEDIATE Already anaesthesia PLANNED Already roadmap Already on the table Good preparation of distal puncture side with doppler and disinfection No preparation of distal puncture side PREP Two times anaesthesia, two times roadmap/ contrast

14 Failed POBA, Challenges in BTK: 2. DISSECTION Acute complications - moderate frequent in vessels below the knee - Option nº 1: prolonged PTA +/-3-5 minutes insufflation time..deb? - Option nº 2: STENT ONLY WHEN FLOW LIMITATION/ Severe Recoil - Spot stenting; Avoid crushing Zones

15 Optimal plain balloon angioplasty Prolonged inflation (180 sec) improves the immediate result of BTK angioplasty compared to short dilation times (30 sec) Significantly fewer major dissections and a modest reduction of residual stenoses are observed N. Zorger et al. Peripheral Arterial Balloon Angioplasty: Effect of Short versus Long Balloon Inflation Times on the Morphologic Results. J Vasc Interv Radiol 2002

16 Current Evidence for DEB in BTK Leipzig Registry (Schmidt A, et al.) Large, singel-center CLI experience DEBATE-BTK (Liistro F, et al.) Small, single-center RCT with 2-year FU InPACT-DEEP (Zeller T, et al.) Large, multi-center, adjudicated (2 core labs) RCT with 1-year follow-up Biolux PII (Brodmann M, et al.) Small, multicenter, RCT bad good

17 Potential Advantage of DEB Ease of use & repeatable Favorable clinical results in fem-pop arteries in reducing restenosis & TLR Local delivery of anti-proliferative drug with nothing leave behind - Less neo-intimal hyperplasia than stents - Stent disadvantaged zones Treat long BTK lesion Preserve future treatment options Cassese S, et al. Circ Cardiovasc Interv. 2012;5(4):582-9

18 Chocolate BAR:

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21 Failed POBA,Challenges in BTK: Acute complications 3. AV-FISTULA - moderate frequent - Option nº1 : prolonged PTA (3-5 min) - STENT ONLY WHEN SEVERE 4. SPASM - Calcium antagonist selective in artery - Papaverine / Nitro μg ia

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23 BTK DES STENT TRIALS

24 BTK STENTS: ACTUAL PROBLEMS Long BTK segment disease vs currently available short stents Leaving a permanent implant stent induced inflammation, in-stent stenosis and thrombosis Poor runoff into foot stent patency Difficulty in monitoring stent patency COSTS!!!!

25 How distal can we stent a BTK vessel?????? When stenting distally, be sure that: Only stent proximal arteries the distal stent edge is at least 3 cm above the ankle joint to avoid stent injury Stent prone to crush in distal locations due to superficial course of tibial arteries as well as torsional movement It is advisable not to stent across major branches, when the vessel caliber is 2 mm or less, and when the distal runoff below the ankle is poor. Always preserve a distal landing zone (maintain an option for a distal bypass ) 3/4 cm

26 A NEW PARADIGM: VASCULAR REPARATIVE THERAPY BVS Stent Gradual disappearance of supportive structure

27 First experience with BVS in BTK Dr Ramon Varcoe Sydney, Australia LINC Asia-Pacific 18-MAR-2014 Single centre 3 Implanters Chronic lower limb ischemia: RC 3-6 De novo lesions; length 4cm, diameters mm Tibial arteries (distal P3) Sample size: 15 patients

28 Image courtesy Dr Ramon Varcoe

29 Image courtesy Dr Ramon Varcoe

30 RESULTS 10 patients 11 Limbs Age range 73-82yo M:F 60:40 14 Scaffolds Vessels treated ATA ; 2 PTA; 2 PA; 4 TPT; 8 (P3; 0) 100% Technical and Procedural success 1 Acute occlusion (day 1: no DAPT) First experience with BVS in BTK Dr Ramon Varcoe Sydney, Australia LINC Asia-Pacific 18-MAR-2014

31 Challenge in BTK: 5. Acute distal embolization from atherothrombotic debris -Prevention: Carotid Filters -THERAPY: Aspiration Embolectomy Thrombolysis Open Surgical Thrombectomy

32 Take Home message: development of the therapeutic strategy in BTK revascularization Knowledge/EVIDENCE GOOD Materials/TOOLS RESULTS Experience/Patient oriented Indications/LESION TAILORED BAD

33 When bypass is best??!! In cases of Endo-fail (technical, non healing, repeated intervention, mounting cost...) Long, calcified, multi-level disease Large tissue loss Distal target ok Going to live >2 years Those who have good veins. I AM STILL A (endo)surgeon