Bypass is durable for Diabetic Ulcer

Munier Nazzal, MD, FRCS, FACSProfessor, Chief Division of Vascular/Endovascular &Wound

careMedical 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 peroneal arterial 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

In 10% of patients, a foot artery, usually the dorsalis pedis artery, is the only suitable outflow vessel.

an additional 15%, the dorsalis pedis artery will appear to be the best target vessel compared with other patent but diseased tibial vessels

Pomposelli FB et al . J Vasc Surg 1990;11: 745-51.

Mangement of CLI in DM

Medical therapy. Endovascular Surgery Combination of endovascular and surgery Primary amputation

Determinants in Selecting Primary Approach

Assessment of the patient’s: ambulatory function. quality of life. CLI severity. long-term survival. and periprocedural risks.

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

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 couldbe 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

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

DeRubertis BG. J Vasc Surg 2008;47:101-8.

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 DM5 years 10 years

Primary patency

56.8% 37.7%

Secondary patency

62.7% 41.7%

Limb salvage 78.2% 57.7% 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.

Pomposelli FB et al. J Vasc Surg 2003;37:307-15.

Prediction of amputation free survival following bypass

Diabetes is not one of them

Schanzer A et al. J Vasc Surg 2008;48:1464-71. Schanzer A,. J Vasc Surg 2009;50:769-75;

Effect of Diabetes on vein Bypass

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

Monahan & Owens CD. Semin Vasc Surg 2009;22:216-26.

Bypass: DM vs no DM

PREVENT III trial, JVS 2006

Endo vs open in DM

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.

Zhang et al JVS , 2012, 581,

Healing after intervention

In patient with wounds > 2 cm

142 bypasses and 148 endovascular procedures with 58% diabetic patients

Neville RF, et al: J Vasc Surg 516:11S-12S, 2010

Wound size

Neville RF, et al: J Vasc Surg 516:11S-12S, 2010

Larger wounds (more than 2 cm) heal better than smaller wounds

Rate of healing Faster healing rates.

Neville RF, et al: J Vasc Surg 516:11S-12S, 2010

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-arterialconnections for perfusion (Indirect).

Neville RF, et al: Ann Vasc Surg 2009.

Long Term results

BASIL (The only prospective study) 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

Bypass vs Endovascular

Intervention (BASIL) Two-year post hoc analysis revealed that

surgery was associated with a reduced risk of future amputation, or death, or both

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.

Bypass vs tibial angioplasty

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.Romiti M,et al. J Vasc Surg 47: 975-981, 2008

Do stents make a differnce?

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 metalBiondi-Zoccai et laJ Endovasc Ther 16:251-260, 2009

Stent vs no stent

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)

Bosiers Hart et al, Vascular 14:63- 69, 2006

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 theonly 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.

Fernando Gallardo Pedrajas, et al, Sem Vasc Surg, 2012

Open First

Faster healing. More healing Better long term results Less re intervention on patients who getting

older. No increased mortality or morbidity compared

to endoSurgery is not a death sentence