Interventional Radiology Should Be The Initial Course Of

Interventional Radiology Should Be The Initial Course Of Management In Diabetic PVD For the motion Trevor Cleveland FRCS FRCR Consultant Vascular Radiologist Sheffield Vascular Institute Sheffield UK

Plan • Review IR options • Review the evidence • Problems faced by the diabetic patient • Conclusions

DM and PVD • Diabetic PVD – 10 x more likely to have an amputation than nondiabetic PVD patient – 5 x more likely CLI -> gangrene – smoking probably additive – earlier age • Non-diabetic CLI – >30% 2 year mortality

Pattern of PVD in DM • More hypertensives • More severe disease – PFA – Below knee segments – (still get SFA and iliac disease) • Higher mortality • Die younger Jude et al (Manchester) 2001

PVD - the problems • Patients tend to be – high co-morbidity • coronary disease • DM, renal – multi-level disease – need saphenous vein for CABG • Minimally invasive/endovascular appealing – relatively high recurrence rate

What are we looking for? • Minimal invasion • Low mortality/morbidity • Durable – perhaps less so in DM • Translates into good outcome – patient independent and at home – quality of life • Reasonable cost – Short hospital stay

IR Options • Segments – iliac • PTA • Stents – SFA • PTA • (stents) – Crural • PTA

Iliac stenosis • DIST 1990’s – Groups • PTA -> bail out stent • Primary stent – Outcome • no difference in patency

Iliac patency - TASC • 3 -5 year data PTA/stent Sx IC 72% 91% CLI 70% 87% (ABG) 20 -70% (extra)

TASC - 2000 - iliac • For IC – TASC A, B and C • most commonly treated by endovascular means – TASC D • preference for surgery – associated with AAA (aorto-uni-iliac) – both CIA and EIA (above) – both EIA’s (technically possible) » ? With additional risks i. e. DM

Contemporary practice - iliac • TASC –A –B –C –D Endovascular if possible Surgery if good life prognosis or endovascular not possible

Infrainguinal

PTA v bypass - fempop Indication PTA - stenosis PTA - occlusion Bypass - vein Bypass - PTFE AK Bypass - PTFE BK 5 year patency % 68 35 80 75 65

Meta-analysis 3 year results Primary patency PTA Stent IC + stenosis IC + occlusion 61% 54% 66% CLI + stenosis CLI + occlusion 43% 30% 65% 63%

Cost -effectiveness • Muradin and Hunink - 2001 • Cost and patency rate targets – fem-pop segment • $3000 endovascular device – compared • bypass surgery for CLI • PTA for disabling IC caused by a stenosis

Cost -effectiveness • CLI and bypass – 5 year patency 29 - 46% • Disabling IC and PTA – 5 year patency 69 - 86%

Self Expanding stents in SFA 12 month PP ITT UK Intracoil study (2000) Mewissen (2004) Vogel (2003) Pozzi (2003) Jahnke (2002) Lugmayr (2002) 76% (r) 76% 84% 67% 86% 76%

What are the costs? • Uncoated stent – $750 • Coated stent – $1000 • Drug eluting stent – $1500

Future

Idea Behind Coated Stents • The physical structure of the stent addresses elastic recoil • The drug/coating is designed to address the cellular response Lumen Post Stent Minimal Elastic Recoil Minimal Intimal Thickening Plaque Disease state

Agents used for coating stents • Biocompatible – silicon carbide, phosphorylcholine, carbon, gold • Anticoagulants – heparin • Steroid – dexamethasone, methylprednisolone • Antimitotics – Sirolimus, Paclitaxol, Tyrosine Kinase inhibitors

Cryoplasty • Mechanism – cooling • plaque expansion – micro fractures – weakening • reduce (temporarily) elasticity – reduce recoil • cause SMC apoptosis – reduced inflammatory response – less NIH

Laser • Over the wire – cross when wire fails • Cool laser – ultraviolet eximer • Pulsed energy – vaporizes plaque and thrombus – approx. 50 microns from tip • reimbursable in the USA

TASC - 2000 • The risks of intervention have been significantly lowered by the advent of PTA • Complications of PTA are for the most part minor and typically do not require surgical treatment • A proportion of patients will achieve a satisfactory long term result after a second [endovascular] intervention

Endovascular Treatment • Inferior haemodynamic durability • Short term effects may -> healing – Re-occlusion may not -> deterioration – More likely to die than need re-intervention – Ray 1995 BJS • Limb salvage rates – Overall – Infrapopliteal 50 – 89% @ 2 years 44 – 96% @ 1 year

Peri-operative Issues In DM • Poor glucose control – dehydration – osmotic shifts • -> instability during anaesthesia • Wound infection • Poor wound healing • Increased myocardial strain – increased free fatty acids • Reduced renal function

Peri-operative Issues In DM • Poor glucose control – dehydration – osmotic shifts • -> instability during anaesthesia • Wound infection • Poor wound healing • Increased myocardial strain – increased free fatty acids • Reduced renal function

Contrast Media and DM • Normal renal function – little impact of different agents – Metformin • Renal insufficiency and DM – Low osmolar better than high osmolar – further benefit of iso-osmolar • NEPHRIC study • Chalmers (BJR-1999) randomised study – adequate hydration – dose limitation

Renal Function - IR • Imaging – Duplex and MRA • (MRA has problems in DM) • focus intervention (surgical and endovascular) • pressure measurements – iliac • Alternative contrast agents – CO 2 – Gd – Iodixanol (iso-osmolar, non-ionic dimer)

CO 2 Angiography • Negative contrast – injection method – imaging equipment • Benefits – Not nephrotoxic – almost limitless dose – cheap • Problems – no “roadmap”, but “smart mask” – may be uncomfortable/painful

Gd Angiography • MR contrast agent • Benefits – At “double dose” not nephrotoxic • 40 ml (80 ml of 50: 50) – can be used like conventional contrast • any equipment • Problems – relatively expensive – may feel warm

Infrapopliteal PTA for diabetic foot ulcers • 221 consecutive patients – Ischaemic foot ulcers • 191 PTA • 10 (5. 2%) amputation above ankle • Recurrence in 14 – 10 re PTA • Remaining 28 – 9 -> Sx (1 BKA, 1 death from MI) • 14 month FU –ulcers healed, 10 deaths Faglia J of Int Med 2002

Randomised data in CLI • Holm 1991 – 102 patients – 66% CLI • Wolfe 1993 – 263 patients – 73% IC • Significant improvement in QOL • No difference between Sx and Endovascular

What’s Happening? • Increasing trend to use PTA – Pell BJS 1994 – Varty BJS 1996 – Nasr EJVES • PTA as primary option – 1994 -5 44% – 1999 -9 69% – No difference in » Patient survival » Limb salvage

Complications of bypass - TASC • Infrainguinal – death – MI – Wound – Infection – Leg oedema – Acute ischaemia 1. 3 - 6% 1. 9 - 3. 4% 10 - 30% 1. 4 - 3. 6% 50 -100% 1 -2%

Cost • Distal bypass – In patient and rehab. • £ 4320 – Panayiotopoulos BJS 1997 • Uncomplicated bypass + swift healing – 16 out of 112 • Nicoloff JVS 1998 • Failed bypass -> higher level amputation – Esp. if infected prosthetic material • Abou-Zaman JVS 1997

Sell surgery • Offers – higher morbidity and mortality • often complicated – unsuitable for many patients – gives no outcome improvement • when both options available – when fails results in higher level of amputation • less favourable rehabilitation – requires in patient care

Interventional Radiology Should Be The Initial Course Of Management In Diabetic PVD

Interventional Radiology Should Be The Initial Course Of Management In Diabetic PVD • Of course it is

Interventional Radiology Should Be The Initial Course Of Management In Diabetic PVD • Of course it is • Surgery reserved for – unsuitable for PTA – endovascular treatments fail – reducing group