Role of Interventional Radiology in Diabetic Foot Clinic

Transcription

1 Role of Interventional Radiology in Diabetic Foot Clinic Gabriel Bartal MD, FCIRSE, FSIR Interventional Radiologist Director Dept. Medical Imaging, Meir MC, Kfar-Saba Clalit Health Services, Israel

2 Introduction Recent developments in imaging, endovascular intervention equipment and techniques as well as wound care techniques have opened new opportunities in the management of Peripheral Occlusive Arterial Disease (POAD). Diabetes is recognized as a leading risk factor for POAD, especially below the knee.

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4 Interventional Radiologist as Master of Imaging Invasive diagnostic peripheral as well as coronary angiography are gradually replaced by the noninvasive CTA and MRA Multidisciplinary team (MDT) should plan the appropriate treatment based on noninvasive imaging and clinical data No hurry!! Not the physician, nor the patient Patients have rights for 2 nd opinion!

5 Peripheral MRA

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8 Strategy of Endovascular Treatment The primary goal Re-establishment of perfusion To relieve from rest pain To achieve healing of ulcers and gangrene To achieve limb salvage To improve Quality of Life

9 Diagnostic Evaluation Prior to 1 st Key Procedure Less than ½ (49%) of the patients that eventually received a primary amputation had any diagnostic evaluation prior to their amputation! Not even a simple ABI! D.Allie

10 Classification of PVD: Selection Criteria for Percutaneous Therapy The choice is based primarily on the angiographic findings*, but a number of factors must be considered: severity of the symptoms durability and risks of each therapeutic alternative skills of the various specialists involved patient s preferences * CTA & MRA will replace diagnostic angiography

11 Critical Limb Ischemia (CLI) CLI is a sustained, severe decrease of leg blood flow which, if untreated, may lead to rest pain, ulceration and incipient limb loss. Graziani, 2005

12 Critical Limb Ischemia (CLI) Combination of excellent noninvasive imaging (CTA and MRA) and minimally invasive care will make a real difference to this patient group. Most patients that undergo amputation have a history of non-healing ischemic ulcer. PTA is the treatment of choice for diabetic ischemic foot revascularization. PTA is feasible in most patients, complications are infrequent and mortality is very low.

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14 Atherosclerosis is commonly found in more than one arterial bed in an individual patient Aronow WS, Am J Cardiol 1994; 74: 64 65

15 Restenosis Rate after Recanalization of Peripheral Arteries Friendly Conduits Carotid Arteries Internal carotid % PAOD or CLI is cardiac catastrophe of PAD Acceptable Conduits Renal arteries Pelvic Arteries Pelvic 5.0 >15% Renal % Bad Conduits SFA Tibial Arteries SFA 35 75% Tibial %

16 Bypass vs. PTA in Severe Ischaemia of the Leg (BASIL) :Lancet 2005; 366: Multicentre, Randomised Controlled Trial (5 5yrs) Bypass-surgery vs. PTA are associated with similar outcomes in terms of amputation-free survival In the short-term, surgery is more expensive than angioplasty

17 Transcatheter interventions for the treatment of peripheral atherosclerotic lesions: part I. Kandarpa K, et al. J Vasc Interv Radiol 2001; 12: The precise definition of "focal disease" is open to debate, however, and the threshold of what can be treated with endovascular procedures is shifting as more sophisticated devices appear on the market.

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20 Results: The limb salvage rate was 93% after a mean follow-up of 1048 days. Transcutaneous oxygen tension significantly increased after 1 month ( vs ; p < 0.05). After 1 year, target-vessel restenosis had occurred in 42% of the non-amputated limbs.

21 Results PTA was successful performed in 993 patients. Seventeen (1.7%) major amputations were carried out. One death and 33 non-fatal complications were observed.

22 Angiography before PTA A.Z Rambam Health Care Campus

23 Balloon inflation A.Z Rambam Health Care Campus

24 Angiography after PTA A.Z Rambam Health Care Campus

25 BTK Intervention Trend Diabetic patients worldwide are more than 200 Mln. incidence growth 2.5%/year - (WHO data in 2003) Diabetes is the first cause of lower extremity amputation (LEA) in the World and Diabetics are at 15 to 46 times greater risk for LEA. (Lavery L.A. et al., Diabetes Care, 19:48, 1996) 40-45% amputees in diabetics had CLI 120, ,000 80,000 60,000 40,000 20,000 0 BtK Interventions 103,600 74,000 51,500 38,000 30,

26 Materials Europe 80% Antegrade access Interventional Materials: GW comp. Small Vessel Balloons GW comp. Balloons Stents (Balloon or Self Expandable, Drug eluting) Drug-eluting balloons Catheter Fibrinolysis or Aspiration Thrombectomy Atherectomy or cutting balloon Laser or Cryoplasty

27 US over 80% Contralateral Femoral Access (Crossover Technique) Most of the practices run by cardiologists High prevalence of Obese patients where ipsilateral femoral access is not an option Applying manual pressure for the management of puncture site Closure devices safer to use contralaterally

28 Drug Eluting Balloon: Concept Reducing cell proliferation initiated by vessel wall injury during angioplasty with short term drug release

29 DES vs. DEB (Local Drug Delivery) Drug-Eluting Stent Slow release Persistent drug exposure ~ µg dose Inhomogeneous drugdistribution Polymer Stent mandatory Drug-Eluting Balloon Immediate release Short-lasting exposure ~ µg dose homogeneous drug-distribution No polymers Premounted stent optional Heart 2007, 93:

30 Drug Eluting Balloon Published Clinical Evidence Significant, Consistent: Reduction in neointimal proliferation Clinical benefit in the short and mid term Depending on the vascular bed: Angiographic benefit (LLL) seems to fall between DES and BMS Clinical benefit holds promise to match best in class vascular therapy Promise to limit stent usage in some critical districts (ISR, Bif side branches, SFA,.) Promise to shorten dual antiplatelet therapy

31 Will Plain Old Balloon Angioplasty (POBA) regain its luster? Circulation 2008;118; Timothy D. Henry, Robert S. Schwartz and Alan T. Hirsch The next steps in vascular clinical research may potentially return the luster to the balloon and improve the prospects of achieving improved limb health for millions of individuals internationally.

32 Below the Knee (BTK) Tools Stiff, steerable guidewire Infrapopliteal Guidewire Crossability Low-profile OTW balloon with suitable sizes in balloon length and diameter. LONG BALLOONS Dedicated long stent systems Infrapopliteal PTA Balloon Catheter OTW Infrapopliteal Co-Cr Stent System OTW Crossing occlusions Avoiding abrasion damage and risk o dissection Bail-out situations Drug eluting Balloon Infrapopliteal self-expanding Stent System OTW Paclitaxel-eluting PTA balloon catheter Restenosis prevention

33 BTK treatment: step into the next dimension Dedicated low profile devices for successful BTK treatment

34 Short lesion Focal PTA technique Balloons Coronary type balloons L Ø cm mm Monorail systems Avoid oversizing Diameter & length!!! Ostial lesions Kissing balloon technique Passeo / OTW Passeo / OTW Elect Explorer / RX

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36 Cook Medical Advance 14LP For Infrapopliteal PTA

37 Diabetic Foot Ulcers ~24 million diabetic patients in US alone An estimated 15% of diabetic patients will develop serious DFU over course of their life 6-10 % will be hospitalized due to infection or ulcer-related complications DFU are responsible for almost 20% of all hospitalizations related to diabetes

38 Diabetic Foot Ulcers Over 80,000 chronic DFU patients result in amputations annually 30 50% first time amputees will undergo additional amputation within 1-3 yrs The cost of hospitalization associated with DFU is $2.5 billions Current annual cost of diabetic ulcers in the US > $10 billions

39 Wound Care and/or Recanalization In many cases a good wound care or a successful vascular recanalization are useless by themselves. The number of diabetic patients is increasing and the burden on the heath-care systems is a worldwide concern.

40 Caused By Impaired Immune Cell Function Inability to eradicate bacteria and damaged tissue Inability to stimulate new blood vessel and tissue formation Inability to provide a closed moist environment Inability to secrete factors required to create the environment for wound healing

41 Non-healing Cycle of the Chronic Wound The Clinical Cycle Microvascular damage Tissue damage Infection Chronic inflammation

42 How Does CureXcell Work? CureXcell is composed of white blood cells obtained from young healthy donor blood The white blood cells are activated by hypoosmotic shock. CureXcell is injected into the wound (as opposed to topical) to ensure that it reaches the area where it is most efficient, beyond the wound debris The activated cells provide the natural environment for wound healing and ensure that the appropriate cell activities and factor secretions are maintained Once the healing process is started, CureXcell stimulates the patient s own body to complete the healing process Separation of WBC from whole blood Activation of WBC by hypo-osmotic shock CureXcell ready to be injected to wound

43 To get out of this cycle and begin the healing process an environment conducive for healing has to be established Turn a chronic wound into an acute healing wound A complex process needs to be established

44 Traditional Treatments for Chronic Wounds Eradication of bacteria Tissue formation and angiogenesis Moist environment Secrete factor(s ) necessary for wound healing Antiseptics X X X Creams/gels X X X Various bandages X X X Primarily focused only on fighting bacteria or providing a moist environment

45 Advanced Treatments for Chronic Wounds Eradication of bacteria and debris Tissue formation and angiogenesis Moist environment Secrete factor(s ) necessary for wound healing Skin substitutes X +/- Negative pressure wound treatment X X Platelet rich plasma X X X Growth factor X X X Each available modality targets a different set of causes of the chronic wound, but NONE address all of them.

46 CureXcell in the Treatment of Chronic Wound Eradication of bacteria and debris Tissue formation and angiogenesis Moist environment Secrete factor(s ) necessary for wound healing CureXcell Treatment By replenishing the wound with allogeneic active immune cells, CureXcell addresses all of the causes of a chronic wound Full wound closure

47 Wound care and/or Recanalization Knowing that the vessel patency after successful recanalization could be limited in time Yet we can gain a time-window required for the wound healing, This will make the combination therapy the one that will eventually shift the paradigm of the diabetic foot management.

48 Diabetic Ulcers Ischemic Lower Limb After Failed Amputation weeks 3 2 weeks 18 weeks to full closure

49 It is not the strongest of species that survive, nor the most intelligent, but the ones most responsive to change Charles Darwin Evolution is so creative. That s how we got giraffes. Kurt Vonegut

50 Vascular Intervention Unit Fully integrated imaging system exceeds all clinical needs for diagnostic and interventional angiography by providing: Integrated knowledge in imaging (MRA, CTA, US) Cost effectiveness (wide patient mix) High-grade image quality (expensive equipment) Ease of positioning Low radiation doses An optimal venue for hybrid procedures when required

51 Interventional Radiologist Slow Suicide

52 Endovascular Center Model PVD & wound care lectures for GP s & others in the hospital Knowledgeable GP s PVD lectures Direct To Patients in the community by physicians Summoning interested listeners for free screening in the hospital Connect IR s to Diabetic and wound clinics as source for BTK patients (improve WC results, prevent amputation) Positive Diagnosis goes for proper treatment Advanced Imaging Conservative Surgery Endovascular peripheral intervention PVD=peripheral vascular disease IR= interventional radiologist BTK= below the knee WC= wound care GP= general practitioner

53 Vascular Interventional Practice Success requires: Individual hard work Team work Team commitment

54 Thank You for your attention!

55 We know & fight Turf Wars

56 Interventional Radiology Vascular Surgery Cardiology

57 Turf Battle A has X B wants X B feels entitled to X A defends ownership of X B takes X A attempts to re-contain X X becomes high profile

58 Turf Battle A and B fight over X C takes X while A and B are not looking X is so high profile, no one knows or cares who owned X first X is just X All compete for part of X because some of X is better than no X at all

59 Meanwhile D has Y Y maxes X obsolete A, B, and C adopt Y D claims ownership of Y

60 We cannot solve problems by using the same type of thinking we used when we created them. Albert Einstein

61 Thanks again!