John E. Campbell, MD Assistant Professor of Surgery and Medicine Department of Vascular Surgery West Virginia University, Charleston Division

Size: px

Start display at page:

Download "John E. Campbell, MD Assistant Professor of Surgery and Medicine Department of Vascular Surgery West Virginia University, Charleston Division"

Marsha Foster
6 years ago
Views:

1 John E. Campbell, MD Assistant Professor of Surgery and Medicine Department of Vascular Surgery West Virginia University, Charleston Division

2 John Campbell, MD For the 12 months preceding this CME activity, I disclose the following types of financial relationships: Honoraria received from: Abbott Vascular Consulted for: Cook Medical and W. L. Gore & Associates, Inc. Held common stock in: None Research, clinical trial, or drug study funds received from: None I will be discussing products that are investigational or not labeled for use under discussion.

3 Includes Ischemic rest pain Ulceration Gangrene Symptoms must be present for at least 2 weeks

4 Grade Category Clinical 0 0 Asymptomatic I 1 Mild claudication I 2 Moderate claudication I 3 Severe claudication II 4 Ischemic rest pain III 5 Minor tissue loss III 6 Major tissue loss

5 Primary Treatment 1 Year Later Medical treatment only 25% Primary amputation 25% Revascularization 50% Alive and amputated 30% Continuing CLI 20% CLI resolved 25% Dead 25% Adapted from Norgren L, et al (TASC II). J Vasc Surg. 2007;45S:1-67

6 Remember that we are not just plumbers! Requires addressing multifactorial issues Optimize risk factor modification Antiplatelet therapy HgA1C 7% Statin therapy If tissue loss, assess for infection (? osteomyelitis or wet gangrene) Does the ulcer need off-loaded or protected from shear stress Treatment often requires a multidisciplinary approach

7 Prostanoids: administered parenterally TASC Recommendation Meta-analysis of the data demonstrated that patients on active treatment had a greater chance to survive and keep both legs during follow-up Previous studies with prostanoids in CLI suggested improved healing of ischemic ulcers and reduction in amputations (A) month follow-up However, recent trials do not support the benefit of prostanoids in promoting amputation-free survival (A) There are no other pharmacotherapies that can be recommended for the treatment of CLI (B) However, subsequent trial of lipo-ecraprost vs placebo failed to reduce death and amputation during 6- Direct-acting vasodilators: of no value and primarily increase blood flow to non-ischemic areas Anticoagulants: LMWH evaluated in 2 trials in patients with CLI and ulcers and demonstrated no benefit Vasoactive drugs: Both naftidrofuryl and pentoxifylline evaluated for treatment of CLI and have demonstrated no clear benefit Norgren L, et al (TASC II). J Vasc Surg. 2007;45S:1-67

8 Does the patient have venous conduit? Anatomical factors Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) Patient s preoperative risk Life expectancy of the patient

4-Year Primary Patency for Below-Knee Femoropopliteal Bypass Reverse saphenous vein 77% In-situ vein bypass 68% PTFE 40% 4-Year Primary Patency for Infrapopliteal

9 4-Year Primary Patency for Below-Knee Femoropopliteal Bypass Reverse saphenous vein 77% In-situ vein bypass 68% PTFE 40% 4-Year Primary Patency for Infrapopliteal Bypass Reverse saphenous vein 62% In-situ vein bypass 68% PTFE 21% Dalman RL. In Mills JL (ed): Management of Chronic Lower Limb Ischemia. London, Arnold, 2000, pp

10 TASC A lesions Single stenosis 10 cm in length Single occlusion 5 cm in length Adapted from Norgren L, et al (TASC II). J Vasc Surg. 2007;45S:1-67

11 Multiple lesions (stenoses or occlusions), each 5 cm Single stenosis or occlusion 15 cm not involving the infrageniculate popliteal artery Single or multiple lesions in the absence of continuous tibial vessels to improve inflow for a distal bypass Heavily calcified occlusion 5 cm in length Single popliteal stenosis Adapted from Norgren L et al (TASC II). J Vasc Surg 2007;45S:1-67

12 Multiple stenoses or occlusions totaling >15 cm with or without heavy calcification Recurrent stenoses or occlusions that need treatment after 2 endovascular interventions Adapted from Norgren L, et al (TASC II). J Vasc Surg. 2007;45S:1-67

13 Chronic total occlusions of the CFA or SFA (>20 cm, involving the popliteal artery) Chronic total occlusion of popliteal artery and proximal trifurcation vessels Adapted from Norgren L, et al (TASC II). J Vasc Surg. 2007;45S:1-67

14 TASC A Single stenoses <1 cm in the tibial or peroneal vessels TASC B Multiple focal stenoses of the tibial or peroneal vessels, each <1 cm in length 1 or 2 focal stenoses, each <1-cm long at the tibial trifurcation Short tibial or peroneal stenosis in conjunction with femoropopliteal angioplasty TASC C Stenoses 1-4 cm in length Occlusions 1-2 cm in length of the tibial or peroneal vessels Extensive stenoses of the tibial trifurcation TASC D Tibial or peroneal occlusions >2 cm Diffusely diseased tibial or peroneal vessels Doormandy JA, et al. J Vasc Surgery. 2000;31:S1-S296

15 Black and white decision A: Endovascular surgery is the treatment of choice D: Surgery is the treatment of choice Gray decision B: Endovascular surgery preferred treatment C: Surgery is the preferred treatment for good-risk patients The patient s comorbidities, fully informed patient preference, and the local operator s long-term success must be considered Adapted from Norgren L, et al (TASC II). J Vasc Surg. 2007;45S:1-67

16 Bypass vs Angioplasty in Severe Ischaemia of the Leg Trial (BASIL) 452 patients enrolled over a 5 year period All patients with severe limb ischemia (rest pain or tissue loss) Randomly assigned to an initial treatment of either open surgery or balloon angioplasty Primary outcomes were amputation-free survival (AFS) and overall survival (OS) Bradbury AW, et al. J Vasc Surg. 2010;51:5S-17S

17 Follow-up: all patients for 3 years and 54% of patients for >5 years Entire cohort 56% dead at end of follow-up 38% alive without amputation 7% alive with amputation AFS and OS did not differ during follow-up For patients who survived 2 years from randomization Bypass surgery first was associated with a reduced HR of 0.85 (p =0.108) for subsequent AFS and for subsequent OS of 0.61 (p = 0.009) Mean OS was increased 7.3 months (p = 0.02) and mean AFS was increased 5.9 months (p = 0.02) during a mean follow-up of 3.1 yrs Bradbury AW, et al. J Vasc Surg. 2010;51:5S-17S

18 Only 10% of patients screened were enrolled in the trial Improvement in endovascular technology since enrollment ( ) Stents not used 20% immediate technical failure The use of prosthetic grafts for bypass surgery 75% of bypasses used GSV as conduit Few patients on optimal medical therapy at the time of randomization Only 1/3 of patients on statin! Bradbury AW, et al. J Vasc Surg. 2010;51:5S-17S

19 Class IIa Recommendations For patients with limb-threatening lower-extremity ischemia and an estimated life expectancy of 2 years or less or in patients in whom an autogenous vein conduit is not available, balloon angioplasty is reasonable to perform when possible as the initial procedure to improve distal blood flow (LOE B) For patients with limb-threatening ischemia and an estimated life expectancy of more than 2 years, bypass surgery when possible and when an autogenous vein conduit is available is reasonable to perform as the initial treatment to improve distal blood flow (LOE B) Rooke TW, et al. Vascular Medicine. 2011;16:

20 CLI Life expectancy >2yrs Life expectancy <2 years Suitable venous conduit No suitable venous conduit Endovascular surgery Consider Open surgery Consider endovascular surgery

21 Normal toe pressures vary from 60% to 80% of the ankle pressure TBI normal is 0.70 Wound healing If toe pressure is <30 mm Hg, then it is likely that the wound will not heal without revascularization If toe pressure is >50 mm Hg, then it is very likely with good wound care that the wound will heal Brooks B, et al. Diabet Med 2001;18:

22 Adequate inflow must be established prior to improvement in the outflow This sometimes requires staged procedures or can be often be performed simultaneously The goal is to restore pulsatile in-line flow to the level of the foot However, outcome is directly related to the number of patent infrapopliteal arteries after PTA 1-year limb salvage rates 0 arteries 56.4% 1 artery 73.1% 2 arteries 80.4% 3 arteries 83% Emerging data that direct revascularization of the artery supplying the angiosome with the wound may improve wound healing Peregrin JH, et al. Cardiovasc Intervent Radiol. 33: ; Neville RF, et al. Ann Vasc Surg. 23: ; Iida O, et al. J Vasc Surg. 55:33-370

segment Cutting balloon Atherectomy Cryoplasty

23 Angioplasty Stenting Self-expanding Can be covered with PTFE Balloon-expandable in the infrapopliteal segment Cutting balloon Atherectomy Cryoplasty Future technologies Drug-eluting balloon Bioabsorbable stents

24 Specific challenges High biomechanical stress associated with repetitive knee flexion 88% of healthy subjects have occlusion of the popliteal artery during maximal plantar flexion secondary to external compression Fracture Hoffman U, et al. J Vasc Surg. 1997;26:

25 Angioplasty of the Popliteal Artery Primary Patency at 2 years Secondary Patency at 2 years Claudication 86% 94% CLI 54% 83% Dalainas I, et al. Int J Angiol. 2007;16(2):47-49

Limb salvage rate 1/3 years Romiti et al. 2,557 58.1%/48.6% 68.

26 Results From Meta-Analysis of Angioplasty of the Infrapopliteal Arteries N (patients) 1 patency 1/3 years 2 patency 1/3 years Limb salvage rate 1/3 years Romiti et al. 2, %/48.6% 68.2%/62.9% 86%/82.4% Romiti M, et al. J Vasc Surg. 2008;47:

XCELL Trial Inclusion criteria included CLI with Rutherford Classification 4-6 120 patients (140

5% 12-month amputation-free survival of 78.3% 12-month freedom from major amputation 89.

27 XCELL Trial Inclusion criteria included CLI with Rutherford Classification patients (140 limbs) Required angiographic follow-up at 6 months Results 6-month binary restenosis of 68.5% 12-month amputation-free survival of 78.3% 12-month freedom from major amputation 89.6% 12-month complete wound healing rate 54.4% Rocha-Singh KJ, et al. Catheter Cardiovasc Interv. 2012; Epub ahead of print

28 Rastan et al compared drug-eluting balloon-expandable stents (DES) to balloon-expandable bare stents (BS) Double-blind, multicenter, randomized clinical trial 161 patients Patency at 1 year Primary DES (80.6%) BS (55.6%) p=0.004 Secondary DES (91.9%) BS (71.4%) p= No difference in limb salvage rate or mortality Rastan A, et al. Eur Heart J. 2011;32(18):

29 Non-Invasive studies: Unable to obtain ABI (Non-compressible) Left TBI 0.24 (33 mm Hg) Bypass graft velocities: Proximal anastomosis: 168 cm/sec Mid Graft: 68 cm/sec Distal Graft: 78.6 cm/sec The posterior artery appeared to be occluded

32 Should I have used DES instead of using angioplasty??? The primary patency at 1 year would probably be higher But it is off-label use It s expensive (multiple stents required) And does it really effect amputation free survival?

Disclosures. Talking Points. An initial strategy of open bypass is better for some CLI patients, and we can define who they are

Disclosures. Talking Points. An initial strategy of open bypass is better for some CLI patients, and we can define who they are An initial strategy of open bypass is better for some CLI patients, and we can define who they are Fadi Saab, MD, FASE, FACC, FSCAI Metro Heart & Vascular Metro Health Hospital, Wyoming, MI Assistant Clinical