Why and how to prep the vessel
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- Brenda Hubbard
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1 Why and how to prep the vessel Drug elution in the SFA: Leave the right thing behind. Debating evidence to provide an answer Erwin Blessing, MD, FESC SRH Klinikum Karlsbad-Langensteinbach Germany
2 Disclosure Speaker name: Erwin Blessing I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company X Other(s): speakers honorarium: Cook I do not have any potential conflict of interest
3 Limitations of DCB angioplasty..addressed by lesion preparation/removal DCB is based on Angioplasty Elastic recoil High-grade residual stenosis Prepares the vessel with less/without overstretch Provisional Stent Rate increases with Lesion Length Reduces likelihood of bail-out stent & preserves native vessel Calcium May Limit Drug Effect Removes potential barriers for drug uptake
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5 Optimizing PTA with prolonged balloon inflations reduces dissection severity and rate and need for further intervention Peripheral PTA: Effect of Short vs Long Balloon Inflation Times on the Morphologic Results 1 Inflation Time (sec) P-Value Major dissection (grades 3 or 4) Minor or no dissection (grades 1 and 2) Further interventions (Stent, repeat dilatation, dilation with larger diameter) Residual stenosis (>30%) Complication (embolization, thrombosis) Mean ankle-brachial index (before, after intervention) , , 0.84 Inflation times of 180 seconds improve immediate infrainguinal PTA results vs. a short dilation strategy Significantly fewer major dissections and a modest reduction of residual stenoses are observed 1. 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
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7 Case example orbital atherectomy
8 Case example directional atherectomy Restenosis after 2x surgery Silverhawk After Silverhawk After In.Pact Admiral
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11 Case example scoring balloon angioplasty
12 Case example scoring balloon angioplasty long lesions pre 2 atm 4 atm Angiosculpt 5x200 8 atm
13 Case example scoring balloon angioplasty long lesions post Stellarex 5x120 Stellarex 5x120 final
14 PANTHER Evaluation of treatment of femoro Popliteal lesions with ANgiosculpT PTA Scoring Balloons HEidelberg Registry Real world registry Angiosculpt PTA in calcified femoropopliteal lesions Overall cohort 124 lesions Primary Patency Secondary Patency 91.8% 81.2%
15 2x Zilver PTX 6x120 mm
16 Potential treatment algorithm The Guide to Drug Elution POBA Vessel prep Unsuccessful PTA Calcium Dissection Recoil Successful PTA DES DCB
17 The ONLY SFA endovascular device with 5-year RCT results Current pivotal trial data: Duration based on completed follow-up.
18 Order Number Reference Part Number Accepts Wire Guide Diameter inch Balloon Inflated Diameter mm Balloon Length cm Compatible Sheath Fr 50 cm Catheter Length Advance Enforcer 35 Nominal Pressure atm Some products or part numbers may not be available FO CALin all FO markets. RCE P Contact TA BA your LLO local O N Cook C ATH representative ETER or Customer Service for details. Rated Burst Pressure atm G35248 ASB G35249 ASB G35250 ASB G35251 ASB cm Catheter Length G35252 ASB G35253 ASB G35254 ASB G35255 ASB cm Catheter Length G35257 ASB G35258 ASB G35259 ASB G35261 ASB M ED I C AL Customer Service EM EA: EDI Distributors: , ssc.distributors@cookmedical.com Austria: , oe.orders@cookmedical.com Belgium: , b e.orders@cookmedical.com Denmark: , da.orders@cookmedical.com Finland: , fi.orders@cookmedical.com France: , fr.orders@cookmedical.com Germany: , d e.orders@cookmedical.com Hungary: , hu.orders@cookmedical.com Ireland: , ie.orders@cookmedical.com Italy: , it.orders@cookmedical.com Netherlands: , nl.orders@cookmedical.com Norway: , no.orders@cookmedical.com Sp ain: , es.orders@cookmedical.com Sweden: , se.orders@cookmedical.com Switzerland French: , fr.orders@cookmedical.com Switzerland Italian: , it.orders@cookmedical.com Switzerland German: , d e.orders@cookmedical.com United Kingdom: , uk.orders@cookmedical.com o k m ed i cal.co m Americas: EDI Intended for percutaneous transluminal angioplasty of lesions in Phone: , , Fax: orders@cookmedical.com peripheral arteries including iliac, renal, popliteal, infrapopliteal, Australia: femoral and iliofemoral, as well as obstructive lesions of native or Phone: , synthetic , arteriovenous Fax: , dialysis fistulae. cau.custserv@cookmedical.com Accepts Wire Guide Single extrusion element Balloon Inflated Balloon Compatible Nominal Rated Burst COOK 2014 PI-GL EN
19 5-year Primary Patency (PSVR < 2.0) Primary Zilver PTX vs. Provisional Zilver PTX 90.3% 82.7% 83.4% 74.9% 81.6% 69.1% 74.8% 65.5% 72.4% 64.9% Provisional stenting: Stenting only allowed after failed PTA At least 2 min inflation! Adequate pressure to ensure full dilatation! Provisional Zilver PTX Primary Zilver PTX
20 Conclusions DCBs work less well in heavily calcified lesion Lesion preparation (prolonged inflation, high pressure dilation, scoring balloon angioplasty, debulking devices etc.) gains increasing recognition Lesion preparation with scoring balloons prior DCB (or DES) seems to be an (less expensive) alternative to debulking devices for calcified lesions Drug eluting stents as first line treatment after failed PTA (recoil, dissection etc.) despite lesion preparation? Already convincing Zilver PTX RCT data might have looked even better with the recent knowledge regarding importance of lesion prepararion prior stenting (learning curve)
21 Why and how to prep the vessel Drug elution in the SFA: Leave the right thing behind. Debating evidence to provide an answer Erwin Blessing, MD, FESC SRH Klinikum Karlsbad-Langensteinbach Germany
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