Peripheral Interventions: Unmet needs! Ralf Langhoff, MD Center for Vascular Medicine Berlin-Wilmersdorf St. Gertrauden Hospital Charité, CC11 Academic Teaching Hospitals ― Charité Berlin

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Medical needs! Scientific needs! Peripheral trials differ from cardiological trials! Can we trust the data? Economic needs/ristrictions! Even if a therapy is superior - can we afford it? Public relation/awareness needs!

Medical Needs How to treat long SFA occlusions?

SFA loading creates risk of kinking and vessel injury

3D stent geometry accommodates loading in SFA Ideal mechanical implant would mimic rather than resist the vessel

What Is the Effect of Oversizing? In-Stent Restenosis Response to injury? or to radial force, to chronic outward force, to…?

Self-Expanding Stents Exert Chronic Outward Force Nominal Stent Diameter COF Lesion Stent placement After balloon post-dilatation Lesion

Medical Needs How to treat long SFA occlusions? Full metal Jacket results in ISR! Spot-Stenting (Tack-it or Multi-Loc???) TOBA-Trial may give an answer, if spot stenting is the way to go

Are DEBs effective in long SFA lesions? No data, yet! (Levant I &II, Thunder, Fempac, Biolux PI Adavance PTx,…< 10 cm) LIMITATIONS OF DEB Up to 15 % of SFA lesions are calcified! Calcified lesions respond better to stents! (Combination therapy DEB with atherectomy?) Flow-limiting dissections Sub-optimal PTA or lesions refractory to POBA

Medical Needs Still in-stent-restenosis (ISR) is the main draw-back in SFA stenting? Open Question: What is the optimal solution for in-stent-restenosis (ISR)? Cryo, PCB did not show any improvement to POBA! DEB, DES, Covered Stents with ‚good‘ results Debulking plus DEB could be an even better solution?

Zilver PTX Trial FAIR Trial (ZILVER DES) (In.pact DEB) TLR @12 month LL~8 cm

Reline Trial 6 month PPR LL~19 cm (covered stent, Viabahn) 6 month PPR

Can we improve something in our Procedure Techniques?

Medical Needs We do not have a strict POBA protocol! Balloon expansion mechanism cause significant shear stress and trauma and can lead to High dissection rate, elastic recoil and abrupt closure During Inflation End of Inflation Folded balloon Plaque Blood vessel Shear stress formation Half- inflated balloon Dissection Inflated balloon Before Inflation

Long Balloon Inflation Time Improves Outcomes Inflation Time (sec) p-value 30 (n = 37) 180 (n = 37) Major dissection (grades 3 and 4) 16 5 0.010 Minor or no dissections (grades 1 and 2) 21 32 0.010 Further Interventions Stent Further dilation (prolonged dilation, dilation with larger diameter) 20 4 16 9 1 8 0.017 Residual stenosis (>30%) 12 5 Complication (embolization, thrombosis) 1 1 Mean ankle-brachial index (before, after intervention) 0.66, 0.87 0.65, 0.84 0.97 Zorger N, et al. J Vasc Interv Radiol. 2002 Apr;13(4):355-9. 16 EU382 12/13

Medical Needs Iliacs? Cobest Trial Only few open questions! Covered Stents? Cobest Trial

Medical Needs BTK ? POBA still is the mainstay! DES in case of a PTA failure (focal lesions)! but what about DEB (latest Medtronic RCT …) Is this a class effect, device effect,….? ….still a lot of interesting scientific work to do (excipient, cristalline vs. non-cristalline….) Angiosome?

Angiosome

Amputation Free Survival and Freedom from Major Amputation 82% 49% 68% 29% Iida et al, J Vasc Surg 2012

Angiosome–targeted infrapopliteal endovascular revascularisation for treatment of diabetic foot ulcers Overall series 84 propensity matched pairs N=250 N=168 Söderström M, J Vasc Surg Feb 2013

Scientific Needs Scientific Needs Cardiology Trials: e.g. GUSTO1, n= 41.021 STEMI COMMIT/CCS2, n= 46.000 STEMI PAOD Trials: e.g. BASIL, n= 452 most RCTs include n~ 100 We need working groups and no vain PI‘s!

Economic needs/ristrictions Economic needs/ristrictions Even if a therapy is superior, can we afford it? In Germany a salary may be related to cost effectifness! The DRG System is far from being fair and there is no real interest in medical needs!

Economic needs/ristrictions PR and Awareness needs! Economic needs/ristrictions Economic needs/ristrictions Every patient knows the impact of coronary artery disease but what is PAOD? Intermittent claudication? We need a new wording! PAOD is a ‚marker disease‘ and clearly related to an increase in mortality rate (more than numerous cancers)! We need support by the health care providers and health care insurance system to become aware! No frontiers between surgery and interventionists – there is enough work to do and no time for competition!

Thank You For Your Attention! Ralf Langhoff, MD Center for Vascular Medicine Berlin-Wilmersdorf St. Gertrauden Hospital Charité, CC11 Academic Teaching Hospitals ― Charité Berlin