Recent Advances in Peripheral Salvage
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1 Recent Advances in Peripheral Salvage Dr Shaiful Azmi Yahaya, MD, MMed, FNHAM, FAsCC, FAPSIC Consultant Cardiologist and Peripheral Interventionist, Institut Jantung Negara
2 Disclosure I am proctoring for endovascular cases by Medtronic Handles peripheral intervention courses by Boston Sci, Medtronic, BBraun, Cook and Abbott device industries
3 Lecture Outline The diabetes endemic Managing diabetic foot ulcer (DFU) Endovascular devices and strategies
4 Treatment Options Decline as Disease Progresses Peripheral Vascular Disease (PVD) Symptomatic Disease Critical Limb Ischemia (CLI) Clinical presentation Silent Intermittent claudication Pain at rest, gangrene, ulceration Life-threatening infection Opportunity to intervene in disease course Pharmacological approaches Lifestyle modification Pharmacological approaches Lifestyle modification Endovascular revascularization Surgical revascularization Endovascular revascularization Surgical revascularization Amputation Amputation General practitioners Podiatrists Orthopedic surgeons Interventionalists Vascular surgeons
5 Doc, I get leg pain when I walk!!
6 Critical Limb Ischemia
7 Diabetes: The Endemic WHO projects diabetes will be the 7 th leading cause of death in 2030 Expected 592 million diabetics by 2035 More than 80% diabetic death occur in low and middle-income countries Diabetes is the leading causes of chronic disease and limb loss worldwide, affecting 382 million people Every year > 1,000,000 diabetics suffer limb loss (one case every 20 seconds!)
8 The Race has just started!
9 PAD is one of the most serious complications in diabetes 71,000 leg amputations every year in the US (60% are diabetes) About half of the amputees will die within 18 months For every 1% increase in HbA1c there is a corresponding 26% increased risk of PAD (Selvin E, et al. 2004). PAD in patients with diabetes is more aggressive compared to non-diabetics, with early large vessel involvement coupled with distal symmetrical neuropathy. This is contributed to by sensory neuropathy and decreased resistance to infection.
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11 NHLBI : PAD risk factors Smoking: The #1 risk factor for PAD. Age: One in every 20 Americans over the age of 50 has PAD. Diabetes: People with type 2 diabetes have three to four times the normal risk for PAD. Unhealthy cholesterol and lipid levels: The risk for PAD increases by 5 to 10 percent with every 10mg/dL increase in total cholesterol levels. Ethnicity: African-Americans are twice as likely to develop PAD as caucasians. Metabolic syndrome: Having any three of the five risk factors for metabolic syndrome (abdominal obesity, high triglycerides, low HDL cholesterol, hypertension and high fasting blood sugar) can increase the risk of PAD. Family history of any of the conditions listed above, or coronary heart disease or stroke can raise the risk of PAD.
12 CPG on diabetic foot, SVS 2016 J Vasc Surg 2016;63:3S-21S
13 Diabetic foot ulcer (DFU) 80% of diabetes-related lower limb amputation are preceded by DFU DFU is a personal tragedy for the patient and family Financial burden 25% would not heal and results in amputation Combination of intensive glycemic control and optimal foot care is cost-effective
14 Diabetic foot: prevention and care
15 Recommendations 1. prevention of diabetic foot ulceration 2. Off loading diabetic foot ulcer 3. Diagnosis of diabetic foot osteomyelitis 4. Wound care for Diabetic foot ulcer 5. Peripheral artery disease and diabetic foot ulcer
16 Endovascular intervention Endovascular recanalization of tibial vessels and foot arteries should be the first line treatment in patients with CLI, because of its good technical and clinical outcomes. Endovascular treatment is possible in most cases, with the known low complication rate of PTA. In cases in which endovascular revascularization failed, all surgical options remain open. The primary indications for tibial and foot arteries intervention is LIMB SALVAGE, to avoid amputations. Unfortunately, not much data on endovascular intervention versus surgery in diabetics
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20 Multilevel atherosclerotic disease SFA and below knee
21 Angioplasty Balloon to Left SFA
22 Angioplasty in diabetic foot ulcer: short and intermediate result
23 Atherectomy Device
24 Aspiration Device
25 Stents
26 Available Stents in The Market Standard Nitinol Stents Wire Interwoven Covered/Stent (SNS) Stents Grafts Smart (Cordis) SUPERA (Abbott) Viabahn (Gore) Protégé Everflex (ev3) LifeStent (Bard) Luminexx (Bard) Absolute (Abbott) Xpert (Abbott) Zilver / PTX (Cook) Complete SE (Medtronic) Misago (Terumo) FlexStent (Flexible Stent Tech) Fluency (Bard)
27 Stents Balloon and self expandable
28 Binary 12 months (%) Comparison of SFA Trials PTA ALONE PTA PLUS PROVISIONAL STENT PRIMARY STENT DES VIABAHN RESILENT ZILVER PTX Balloon suboptimal ASTRON ABSOLUTE SUPERA RESILIENT FAST ZILVER Balloon optimal KEDORA & MCQUADE 25 CM FAST RESILIENT PTA plus stent ZILVER PTX ASTRON ABSOLUTE VIPER & VIASTAR 19cm FISCHER SUPERA Shillinger & Baumgartner 2010 Length of the lesion (cm)
29 Balloons
30 Drug-Coated Balloons offer physicians an attractive value proposition for the treatment of lower limb disease Encouraging results have been seen in de novo, restenotic lesions, in-stent restenosis, & in A-V access stenosis. Some logical indications might include: no-stent zones e.g. CFA lesions segments prone to restenosis e.g. long AK lesions Benefits Anti-proliferative therapy while leaving nothing behind Broad anatomical applicability Easily repeatable Avoid stent fracture and ISR burden Preserve future options Matches patient s quality of life expectations (improvement in walking capacity, Rutherford class) Limitations Not proven in highly calcified lesions When provisional stent is required= higher procedural cost
31 DCB clinical study results illustrate performance differences Passeo-18 Lux (3µg/mm²) Lutonix (2µg/mm²) In.Pact (3.5µg/mm²) 100% 80% 60% 40% 88.5% 84.3% 97% 77% 72% 65.2% 91.4% 82.2% 59% 83.7% 20% 0% Study Name Vessels Time-Point BIOLUX P-I SFA 6m BR BIOLUX P-II BTK 6m TLP Myers NSW SFA-ISR 27m PP LEVANT I SFA 6m PP LEVANT II SFA 12m PP PACIFIER SFA 6m BR In.PACT I SFA 12m PP In.PACT Deep BTK 12m PP In.PACT SFA-IT SFA 12m PP What coating technology factors could influence clinical results? Drug Concentration: 3-3.5µg/mm² vs. 2µg/mm² Excipient: Hydrophobic vs. hydrophilic
32 Access No access, no intervention!
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35 A B
36 Retrograde Access
37 Peripheral Vasc Lab, IJN
38 Retrograde Popliteal access and balloon
39 Micropuncture
40 BTK anatomy
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42 Wiring - Intimal Resistance
43 Subintimal wiring
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45 Re-entry devices
46 Laser Atherectomy
47 Surgical Intervention Arterial bypass graft SVG PTFE Surgery for wound Reconstructive surgery Amputation
48 Reconstruction similar long term outcomes of revascularisation in patients with and without diabetes Karacagil S et al. Diabet Med 1995; 12:
49 Surgery for the infected diabetic foot
50 Forefoot amputation
51 Below knee amputation
52 SUMMARY Patients with diabetes are at particularly high risk of developing peripheral artery disease and later, critical limb ischaemia All patients with PAD should receive aggressive modification of cardiovascular risk factors and diabetes control Refer all patients with rest pain, ulceration, or gangrene for specialist assessment Many devices are available for intervention but mostly expensive Crossing lesion and adequate intervention with sufficient arterial flow is key to limb salvage
53 Thank You
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