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Updates on Endovascular Revascularization for Lower Limb Peripheral Arterial Disease

Updates on Endovascular Revascularization for Lower Limb Peripheral Arterial Disease. DR NG WAI KIN. Introduction. With aging population and increasing prevalence of metabolic syndrome, peripheral arterial disease (PAD) becomes an important burden to developed cities and countries.

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Updates on Endovascular Revascularization for Lower Limb Peripheral Arterial Disease

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  1. Updates on Endovascular Revascularization for Lower Limb Peripheral Arterial Disease DR NG WAI KIN

  2. Introduction • With aging population and increasing prevalence of metabolic syndrome, peripheral arterial disease (PAD) becomes an important burden to developed cities and countries. • PAD can result in complications such as lifestyle-limiting claudication, critical limb ischemia (CLI) and amputation. • Treatment of PAD includes pharmacotherapy as well as endovascular and surgical revascularization

  3. Indication for Revascularization • Severe intermittent claudication failed conservative management (2) • Critical limb ischemia, salvageable and functional limb (3) • In patients with reasonable quality of life and life expectancy (2)

  4. Surgery vs Endovascular intervention

  5. BASIL Trial (5) • UK-based multicenter RCT • Intention-to-treat analysis • Study peroid 1999-2004 • 452 patients randomized to bypass surgery and endovascular group • Interim analysis at 2005, final analysis 2010 • Include patient with severe limb ischemia • Main end points: amputation free survival and overall survival

  6. Overall survival Amputation free survival P value: <2 years: 0.32 >2 years: 0.009 P value: <2 years: 0.85 >2 years: 0.11

  7. Limitation • High immediate failure rate of 20% in endovascular group • Most case only perform percutaneous transluminal angioplasty (PTA) with very low use of stent (only 9 cases) Technical Successful Rate >90% Much more then just a balloon

  8. Methods of Endovascular Intervention

  9. Endovascular Intervention Atherectomy DCB PTA Bioabsorbable stent Guidewire, microcatheter, re-entry device, Pedal puncture DES BMS SUPERA

  10. Endovascular Intervention PTA

  11. Percutaneous Transluminal Angioplasty (PTA) • Standard for revascularization in lower limb arteries • Repeatability, low complication rate, less invasive nature (7) • Initial success rate up to 90% (7)

  12. Percutaneous Transluminal Angioplasty (PTA) • High rate of restenosis up to 40-60% at 12-month follow-up (8) • Reintervention of restenosis is associated with worsened surgical outcomes and increased morbidity and mortality (9)

  13. Endovascular Intervention PTA BMS

  14. Bare Metal Stent • Self-expanding nitinol stent is most commonly used in lower limb arteries

  15. Stent or not? • Randomized control trials comparing PTA and primary stenting at SFA (10)

  16. Stent or not? • In general, stenting offers superior results to PTA in longer lesions (≥6 cm), in chronic total occlusions, and in heavily calcified arteries • Stenting is also indicated if there is a suboptimal result after PTA (10) • flow-limiting dissection after PTA • a residual stenosis <50% leading to flow limitation • acute or subacute recoil >50% leading to flow limitation • acute or subacute reocclusion after PTA.

  17. Stent Restenosis • Problems with stenting • Daily activities e.g. walking exert mechanical forces which can result in material fatigue and fracture of stents • Multiple overlapping stents may cause metal-to-metal hinge points that initiate the fracture process (26)

  18. Endovascular Intervention PTA BMS SUPERA

  19. SUPERA stent • Newly designed interwoven nitinol stent with the advantageof • Mimics natural structure and movement of vessel walls • High compression resistance, kink resistance and fracture resistance (37) • Improve patency rate for popliteal disease and heavily calcified lesions.

  20. Restenosis • Problems with stenting • Daily activities e.g. walking exert mechanical forces which can result in material fatigue and fracture of stents • Multiple overlapping stents may cause metal-to-metal hinge points that initiate the fracture process (26) • Micromovement of stent on the vessel wall creates repetitive friction and inflammation • Growth and migration of vascular smooth-muscle cells result in neointimal proliferation

  21. Endovascular Intervention PTA DES BMS SUPERA

  22. Drug-Eluting Stents (DES) • Immunosuppressants are used to inhibit restenosis via a coated stent platform • Local drug delivery can achieve higher tissue concentrations of drug without systemic effect (18)

  23. Drug-Eluting Stents (DES) • Initial result is not promising • SIROCCO trial (19, 20) • In-stent restenosis rate at 24-month, measured by duplex ultrasound • DES group: 22.9% • BMS group: 21.1% (P>0.05) • Limitation • Unexpectedly low restenosis rate of BMS group • Excessive stent fracture rate (36% in DES group)

  24. Drug-Eluting Stents (DES) • Paclitaxel-eluting stent (Zilver PTX) • Higher antiproliferative agent dosing density • Lack of binding polymer to reduce risk of mechanical stress • Zilver PTX Randomized Study (21) • 12-month patency rate • DES: 89.9% • PTA or provisional BMS: 73% • 5-year primary patency rate • DES: 66.4% • PTA or provisional BMS: 43.4% • Stent fracture rate 0.9% at 12-month

  25. Endovascular Intervention DCB PTA DES BMS SUPERA

  26. Drug-Coated Balloon (DCB) • Direct delivery of antiproliferative drug to vessel wall

  27. Drug-Coated Balloon (DCB) • Potential advantage (10) • Homogenous drug delivery (cf concentration gradients produced by DES) • Immediate drug release without the use of polymer that can induce chronic inflammation • Application in locations where stent implantation is not desirable (e.g. CFA, Popliteal artery)

  28. Drug-Coated Balloon (DCB) • THUNDER Trial (27) • 12-month binary restenosis rate • DCB 24% vs PTA 50% (P<0.05) • 5-year target lesion revascularization rate (TLR) • DCB 21% vs PTA 56% (p=0.0005) • FemPac Trial (28) • 24-month TLR • DCB 13% vs PTA 50% (p=.0001) • LEVANT 1/2 Trial (29, 30) • Highly powered 54-sited RCT, 476 patients in 2:1 ratio ramdonization • 12-month patency rate • DCB 65.2% vs PTA 52.6% (P=0.02)

  29. Drug-Coated Balloon (DCB) • Potential problem (10) • Failure to provide mechanical saffold for the prevention of acute recoil • Inability to treat dissection flaps • Low drug concentration reaching vessel wall due to calcified plaques

  30. Endovascular Intervention DCB PTA Bioabsorbable stent DES BMS SUPERA

  31. Bioaborbable DES • Most bioresorbable stents are made of polylactic acid, a naturally dissolvable material that is used in medical implants such as dissolving sutures. • No comparative analysis available now

  32. Drug-Coated Balloon (DCB) • Potential problem (10) • Failure to provide mechanical saffold for the prevention of acute recoil • Inability to treat dissection flaps • Low drug concentration reaching vessel wall due to calcified plaques

  33. Endovascular Intervention Atherectomy DCB PTA Bioabsorbable stent DES BMS SUPERA

  34. Atherectomy • Atherectomy is a endovascular technique where atheroma is excised • Principle base on plaque removal to increase the gain in lumen size • Particularly useful in restenosis or excessively calcified vessels

  35. Atherectomy • DAART:  Directional Atherectomy plus Anti-Restenotic Therapy • Aim at improving the acute procedural success and prepare the vessel for drug delivery • Pilot study: the DEFINITIVE AR Trial •  higher technical success rate in the DAART arm vs. DCB arm (89.6% vs. 64.2%, p = 0.004) • The incidence of flow-limiting dissection in the combination arm (DAART) was almost zero • Duplex Ultrasound patency at 12 month: 93.4% for DAART vs. 89.6% for DCB alone • Better patency rate in long lesions >10cm and heavily calcified lesions.

  36. How to improve successful rate

  37. Endovascular Intervention Atherectomy DCB PTA Bioabsorbable stent Guidewire, microcatheter, re-entry device, Pedal puncture DES BMS SUPERA

  38. Success of endovascular procedure • Passage of recanalization wire through the obstruction • Removal of obstruction by endovascular tool • Keeping the artery open in short and long term (10)

  39. Success of endovascular procedure • Passage of recanalization wire through the obstruction • Removal of obstruction by endovascular tool • Keeping the artery open in short and long term (10)

  40. Advancement in Guidewires • Variety of recanalization wires (0.035”, 0.018”, 0.014” systems) • Difference in tip load, wire coating, shaft stiffness • Development of micro-supporting catheters

  41. Re-entry device • Primary limitation for chronic occlusion is failure to re-enter the true lumen after subintimal crossing of occlusion • ~20% unsuccessful true lumen reaccess (34) • Re-entry device typically use a nitinol tip to help re-entry of guidewires to true lumen

  42. Pedal Puncture • Useful approach when (35) • antegrade recanalization fails • Occlusion being flush with the origin of a trifurcation artery • Difficult subintimal tract formation from antegrade approach due to heavily calcified plaque • Inability to reenter the true lumen • Can be performed using ultrasound or fluoroscopic guidance

  43. Conclusion • With the advancement of techniques and devices, endovascular revascularization becomes the first choice for revascularization in majority of cases • Enjoy the benefit of less invasive, lower operative risk, fewer surgical complication, with similar patency rate as surgical revascularization • However, surgical bypass still have a role in good risk patient with diffused and difficult lesions. • More researches is required on drug-eluting device and stent-less technology

  44. Don’t Forget • Smoking Cessation • Optimal control of BP, lipid level, DM • Supervised exercise program • Medication • Antiplatelet therapy • Cilostazol

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  49. Reference (Continued) • Sabri S S, Hendricks N, et. al. Retrograde Pedal Access Technique for Revascularization of Infrainguinal Arterial Occlusive Disease. J Vasc Radiol. 2015;26:29-38 • Matsagkas M, Kouvelos G, Arnaoutoglou E et al: Hybrid procedures for patients with critical limb ischemia and severe common femoral artery atherosclerosis. Ann Vasc Surg 2011; 25:1063–1069 • SUPERA 500: Werner, et al., Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding nitinol stent: midterm results for the Leipzig SUPERA 500 registry, EuroIntervention 2014:10:861-868. • http://www.hopkinsmedicine.org/healthlibrary/test_procedures/cardiovascular/angioplasty_and_stent_placement_for_the_heart_92,p07981/ • http://www.emsworld.com/article/11359780/understanding-restenosis-following-coronary-angioplasty-and-stenting • http://multimediacapsule.thomsonone.com/medtronic/medtronic-drug-coated-balloon-receives-fda-approval-for-treating-peripheral-artery-disease-in-upper-leg • https://lookfordiagnosis.com/mesh_info.php?term=atherectomy&lang=1 • http://www.nature.com/nmat/journal/v8/n6/fig_tab/nmat2462_F1.html • http://www.daviddarling.info/encyclopedia/S/stent.html • http://evtoday.com/images/articles/2014-10/werner-f1.jpg

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