Bypass is durable for Diabetic Ulcer Munier Nazzal, MD, FRCS, FACS Professor, Chief Division of Vascular/Endovascular &Wound care Medical Director of the Wound Care and Hyperbaric Center
The most important principle in treating foot ischemia in patients with diabetes is recognition that the etiology of this ischemia is macrovascular occlusion of the leg arteries due to atherosclerosis
Ischemia in Diabetic patients Diabetic patients typically have tibial and peronealarterial occlusive disease with relative sparing of the foot arteries. Ischemia in diabetes results from atherosclerotic macrovascular disease as well as from microcirculatory dysfunction LoGerfo FW, Coffman JD. N Eng J Med 1984;311:1615-9.
Arterial disease in Diabetes PomposelliFB et al . J VascSurg 1990;11: 745-51. In 10% of patients, a foot artery, usually the dorsalispedis artery, is the only suitable outflow vessel. an additional 15%, the dorsalispedis artery will appear to be the best target vessel compared with other patent but diseased tibial vessels
Mangement of CLI in DM Medical therapy. Endovascular Surgery Combination of endovascular and surgery Primary amputation
Determinants in Selecting Primary Approach Vascular anatomy plays a final critical role in decision-making, particularly in regard to the selection of endovascular vs surgical revascularization Michael S. Conte, JVS 2012 • Assessment of the patient’s: • ambulatory function. • quality of life. • CLI severity. • long-term survival. • and periprocedural risks.
Effect of initial treatment *patients who initially received a vein bypass graft fared significantly better than those who had received a prosthetic. *Patients who underwent bypass after failed angioplasty fared considerably worse than those who received a bypass graft initially. Bradbury et al, JVS 2010
Even in this era of “endovascular first,” it could be argued that in the setting of extensive tibial artery occlusive disease, the most appropriate revascularization involves bypass to the distal tibial arteries Nevile and Sidawy, Seminars in vascular surgery, 2012
Failed endovascular therapy might make a successful bypass more difficult and unlikely, it is important to identify those patients best treated with initial surgical bypass.
Endovascular interventions in DM DeRubertisBG. J VascSurg 2008;47:101-8. Endovascular interventions may be associated with worse patency rates in diabetic patients (53% vs 71% at 12 months, 49% vs 58% at 18 months; P .05) due to their higher prevalence of limb-threatening ischemia as the presenting symptom
Selection of approach: Endo vs Open Selection of a revascularization strategy between catheter-based and open surgical approaches is often considered as a trade-off between short-term risk and longer-term efficacy.
Result of bypass in DM Patient survival was 48.6% at 5 years and 23.8% at 10 years. perioperative mortality was only 0.9%. The popliteal artery was the source of inflow in 53.2% of patients. PomposelliFB et al. J VascSurg 2003;37:307-15.
Prediction of amputation free survival following bypass Diabetes is not one of them Schanzer A et al. J VascSurg 2008;48:1464-71. Schanzer A,. J VascSurg 2009;50:769-75;
Effect of Diabetes on vein Bypass Monahan & Owens CD. SeminVascSurg 2009;22:216-26. Diabetes is not a risk factor for vein bypass failure. In some studies graft failure was lower in diabetes: shorter bypass? In diabetes: long tem survival and limb salvage is reduced but not graft patency
Bypass: DM vs no DM PREVENT III trial, JVS 2006
Endo vsopen in DM Zhang et al JVS , 2012, 581, Limb salvage rates and wound healing trend comparable. There was a trend toward faster WHT for OPEN. There were no significant differences between groups regarding amputation-free survival rate, major adverse limb events, and major adverse cardiac events.
Healing after intervention Neville RF, et al: J VascSurg 516:11S-12S, 2010 In patient with wounds > 2 cm 142 bypasses and 148 endovascular procedures with 58% diabetic patients
Wound size Larger wounds (more than 2 cm) heal better than smaller wounds Neville RF, et al: J VascSurg 516:11S-12S, 2010
Rate of healing Neville RF, et al: J VascSurg 516:11S-12S, 2010 Faster healing rates.
Bypass to angiosomes Percentage of complete healing after revascularization of the artery feeding the angiosome in which the wound was located (Direct) versus an artery that did not supply the wound’s angiosome and relied on arterial-arterial connections for perfusion (Indirect). Neville RF, et al: Ann VascSurg 2009.
Long Term results For those patients who survived to 2 years or longer, which comprised 70% of the study population, open bypass was associated with improved survival and a trend of improved amputation-free survival. Bradbury et al, JVS, 2010 BASIL (The only prospective study) long term results:
Bypass vs Endovascular Intervention (BASIL) Adam DJ et al; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 2005;366:1925-34. Two-year post hoc analysis revealed that surgery was associated with a reduced risk of future amputation, or death, or both
Bypass vstibial angioplasty RomitiM,et al. J VascSurg 47: 975-981, 2008 Meta analysis of 30 studies. Compared popliteal–tibial bypass vs. tibial angioplasty. primary patency was better with bypass (72% v 49% at 3 years). Limb salvage was about the same (82%)in both groups at 3 years.
Do stents make a differnce? Biondi-Zoccai et laJEndovascTher 16:251-260, 2009 Meta analysis of 18 studies. Primary patency 79% and salvage 96% at 1 year. Stents mostly fro inadequate study. Sirolimus performed better than paxcil eluting stents. Both better than bare metal
Stent vs no stent Bosiers Hart et al, Vascular 14:63- 69, 2006 A nonrandomized trial of 79 patients with angioplasty versus 300 patients with angioplasty and stenting. 1-year patency rates were 69% for PTA and 76% for stenting (P NS) Limb salvage rates were 97%, and 99% (P NS)
Treatment in DM Each operation must be individualized according to the patient’s available venous conduit and arterial anatomy
Factors determining Choice of Approach • Vein Bypass first if: • Acceptable risk factors. • Expected long term survival • Adequate autogenous Vein conduit is available. • No infection or tissue problems at sites of bypass
Factors determining Choice of Approach • Endovascular Approach first: • High risk patients • Autogenous vein not present or inadequate. • In adequate tissue coverage for the bypass.
Factors determining Choice of Approach • Primary amputation first: • Major tissue loss . • Nonfunctional limbs with tissue loss
“Endo First” Not supported by the only prospective study. Might complicate proper surgical approach. Short term mentality is a disservice to patients who are candidates for long term solution. Unnecessary procedure with additional cost out of the system and patient but into the pockets for operators.
Endo first May violate the simplest surgical principle of doing no harm to the only available target vessel for bypass It is popularized by operators who never inside a vessel but looked at in black and white. Is the procedure of choice in patients who are not candidates for surgery.
Open First Surgery is not a death sentence Faster healing. More healing Better long term results Less re intervention on patients who getting older. No increased mortality or morbidity compared to endo