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Endovascular maneuvers in treatment of lower extremity critical ischemia in patients with diabetes mellitus.

Introduction

According to WHO global prevalence of diabetes mellitus in 2011 was estimated at 366 million people, the real figure being underestimated at least in two. This figure is predicted to reach 552 million people by 2030, patients with type 2 diabetes mellitus constituting 80-90% of them (Dedov, Antsiferov, Galstyan, and Tokmakova, 1998; Dibirov and Briskin, 2001; Dudanov, Karpov, and Kapugin, 2008; Zatevakhin, Shipovskiy, and Magomedov, 2008; Faglia, Guiffrida, and Oriani, 1999).

In diabetes mellitus incidence of lesions in lower extremity arteries is estimated at 80%, in persons with 20-year disease duration the figure is much higher. Atherosclerotic damages of the vessel are quite peculiar in diabetes mellitus: early onset, rapid progression, multisegmentarity, symmetry of lesion in distal small and medium caliber arteries. Occurring in 8-80% of the patients with diabetes mellitus (Batrashov and Sidorov, 1996; Bensman, 2010; Karimov, Babadzhanov, and Islamov, 2003; Kaputin, Ovcharenko et al., 2009; Sobenin, 1999; Pokrovskiy, Dan, Chupin, and Khoroves, 1996; Lunuey, 1993), low extremity atherosclerotic lesions hamper collateral compensation.

Extended damage of distal arterial bed, disorders in microcirculation, overall severe condition of patients due to metabolic disorders and comorbidities restrict applicability of conventional restorative operations on diabetic angiopathy. In this context, the transluminal balloon angioplasty of lower extremity arteries in patients with diabetes mellitus is gaining popularity (Zufarov, Karimov, Saatov, and Salakhitdinov, 2003; Kaputin, Ovcharenko, and Bregovskiy, 2008; Shipovskiy, Zolkin, and Magomedov, 2008 2008; Levin and Neal, 1988). The work was initiated to assess efficacy of the procedure in treatment of lower extremity critical ischemia in the diabetics.

Materials and methods

We have assessed treatment efforts in 42 patients (22 men, 52.2% and 20 women, 47.8%, mean age 58.5 [+ or -] 4.6 years, ranging from 47 to 72) with neuroischemic diabetic foot syndrome complicated by toe and foot gangrene of various localizations. The patients were hospitalized at the Vascular Surgery Department, Republican Research Center of Emergency Medicine of Uzbekistan and Diabetic Foot Department, Center for the Scientific and Clinical Study of Endocrinology, Uzbekistan Public Health Ministry, with endovascular maneuvers performed within the period from January 2009 to December 2011. All the examinees had type 2 diabetes mellitus with duration ranging from 10 to 25 years and presented with hyperglycemia (>10 mmol/l) and some comorbidities, such as, hypertension (52.3%, n=22), ischemic heart disease (38.1%, n=16) and acute arrest of cerebral circulation (7.1%, n=3). All the patients were on insulin therapy.

Low extremities are more frequently affected in patients with diabetes mellitus duration more than 5 years. In 29 examinees (69.0%) ulcer necrotic process was found to affect the foot 2 months prior to their hospitalization, in 13 (31.0%) trophic damages registered even earlier. Pyonecrotic lesions of the foot tissues (III-IV grades) were found in all 42 patients (Table 1), wet and dry gangrene being registered in two thirds and one third of the patients, respectively.

Color duplex scanning, multi-slice spiral computed tomography (CT) and contrast angiography were the instrumental methods to assess circulation in the examinees' lower extremities by presence and character of pulses, color and temperature of skin integuments. By means of the methods above iliac and femoral segments were found respectively damaged in 7 (16.7%) and 20 (47.6%) patients, superficial and deep femoral arteries being, respectively, affected in 16 and 4. Popliteal damages were registered in 9 patients (21.4%). Crural and pedal arteries were found afflicted in 34 (81.0%); in 20 (47.8%) and 4 (9.5%) patients two and three arteries were damaged, respectively, in 13 (31.0%) persons multifocal involvement being registered. Conventional angiography was the terminal to determine localization, expansion and character of arterial damages in all 42 examinees. Ischemic calcaneal ulceration was found in 9 (21.4%); 33 patients (78.5%) having toe gangrene. Treatment of pyonecrotic lesions in patients with neuroischemic diabetic foot syndrome (DFS) was multicomponent one and included:

1. Diabetes compensation

2. Antibacterial and antithrombotic therapy

3. Foot off-loading and ulcer topical treatment

4. Surgical treatment of pyonecrotic damages

5. Transluminal balloon angioplasty of lower extremity (alone or combined with stenting)

6. Would closure or foot stump formation by means of reconstructive surgery.

Choice of modality aiming at preservation of the foot's bearing function depended on character of a local tissue lesion and condition of circulation in the damaged lower extremities. Indications for transluminal balloon angioplasty of lower extremity included crural artery stenosis as well as multiple short and expended occlusions in the crural arteries. Endovascular maneuvers under regional anesthesia were performed by transcutaneous puncture of the femoral artery on the side of the damage. Intraluminal recanalization, antegrade approach and stent implantation procedure were among the techniques to reconstruct lumens in the stenosed or occluded arteries.

Post-angioplasty residual stenosis greater than 30% of the artery lumen, arterial intima dissection hampering blood flow and atheromatous plaque moving to artery mouth were the indications for the stent implantation procedure.

Three days prior to the operation of plavix in the dose of 75 mg/d was given to the patients, post-operatively they received clexane in the dose of 0.4ml twice a day for 3-7 days. 5000 units of heparin were administered to all patients intraoperatively. 00.5% lidocaine solution was injected through the surgery to protect the arteries against spasms. Control angiography terminated the procedure.

The informed onsent fom all patients was obtained from all patients.

Results and discussion

We performed 58 endovascular maneuvers in 42 patients with lower extremity critical ischemia in various segments (Table 2). Stenting of the superficial femoral artery was carried out in 7 cases (12.0%), balloon angioplasty being done in other situations. We did not perform stenting of popliteal segment and crural arteries. Crural artery stenosis was registered in more than half of cases (53.4%, n=31); femoral (19.0%) and popliteal (15.6%) segments required dilation less frequently.

31 patients (73.9%) demonstrated excellent restoration of peripheral blood flow, good and satisfactory effect being reached in 9 (21.4%) and 2 (4.7%), respectively. Wet gangrene and phlegmons were the indications for surgical emergency for abscesses and burrowing pus to be opened. As a rule, secretion was sampled from the wound surface for culture and sensitivity test. Anaerobic-aerobic associations occurred most frequently, their species composition changing time and again. Quite frequently the therapy with broad spectrum antibiotics was initiated before the test data was obtained. Drug treatment was combined with step-by-step necrotomy until presentation of active granulations.

Following transluminal balloon angioplasty and stenting of lower extremity vessels clinical response manifesting either as withdrawal or as a reduction of dose of opioid analgesics was registered in 36 (86.0%) patients. Normalization of skin integuments, foot warming, perifocal inflammation arrest and demarcation as well as boundary epithelialization, secondary wound cleansing and active granulations were among the manifestations of distinct positive dynamics in wound process to make mention of. Regression in critical ischemia events was registered in 31 (73.9%) patients.

Management of patients with diabetic lesions of lower extremity arteries varied by modalities and priorities of manipulations depending on state of blood flow in the affected extremity and wound process activity (Table 3). Given the local conditions, multimodality therapy started from the extremity's revascularization producing significant effect on wound healing dynamics and ipso facto on topical therapy prognosis. In 18 (43.0%) cases angioplasty was the first step followed by surgical debridement, in 22 patients (52.3%) the procedures switched places. In two patients (4.7%) with tissue damage grade II by Wagner's classification of diabetic foot ulcer successful angioplasty was followed by drug therapy, requiring no surgery. We believe that adequate restoration of magistral blood stream in the damaged extremity is the key indication for foot plastic surgery, all maneuvers being carried out in 27 (64.3%) patients following transluminal balloon angioplasty.

Multistep surgery was found necessary in 36 (86.0%) patients, following transluminal balloon angioplasty complete epithelialization being performed in 6 (14.0%) by drug therapy.

To perform plastic wound closure in 36 patients we employed various methods, such as, local tissue plastic operation (with the sliding or inter-advancing skin flaps, flaps from previously amputated toe or Indian flaps), local tissue plastic operation with the controlled tissue tension, split-skin grafting or combined plastic operation. Wound closure by primary intention could be seen in 30 (83.3%) patients, the wound pyosis being observed post-operatively in 6 (16.7%).

Satisfactory outcome, that is, foot salvation within 12 months after transluminal balloon angioplasty and stenting of lower extremity arteries could be observed in 31 (73.8%) patients, 2 cases requiring reoperation. Within a year after the extremity revascularization there were 7 (16.7%) lethal outcomes, basically because of cardiovascular insufficiency.

Conclusion

Neuroischemic forms of diabetic foot syndrome satisfactorily respond to transluminal balloon angioplasty and stenting of lower extremity arteries. The procedures are indicated in high risk patients. Endovascular revascularization of the lower extremity dramatically limits pyonecrotic process facilitating wound closure and preservation of foot bearing function. Due to critical ischemia in the diabetics character and severity of occlusive-stenotic lesions are quite different from those in atherosclerosis, to make mention of basically multivascular lesions of crural and pedal arteries combined with collateral circulation decompensation at the femoral level. III grade lower extremity ischemia is more frequent in lesions of the superficial femoral artery and damage of the deep femoral artery's collateral function, IV grade ischemia induced upon occlusive-stenotic lesions of the peroneal artery. Transluminal balloon angioplasty is thought to be minimally invasive and efficient maneuver in treatment of critical ischemia of lower extremities, in some cases serving as an alternative of the surgical revascularization.

References

Batrashov, V. and Sidorov, A., 1996. "Incidence of obliterating atherosclerosis in lower extremities of patients with type 1 and 2 diabetes mellitus," [Chastota vozniknoveniya obliteriruyuschego ateroskleroza nizhnikh konechnostey u bolnykh sakharnym diabetom 1 i 2 tipa], in Russian, In: "Up-to-date aspects of diagnosis, treatment and prevention of lower extremity lesions in patients with diabetes mellitus", Proceedings of Scientific-Practical Conference, Moscow, pp.38-41

Bensman, V., 2010. Surgery of pyonecrotic complications in diabetic foot [Khirurgiya gnoyno-nekroticheskih oslozhneniy diabeticheskoy stopy], in Russian, Moscow: Medpraktika-M Publishing House

Dedov, I., Antsiferov, M., Galstyan, G., Tokmakova, A., 1998. Diabetic foot syndrome [Sindrom diabeticheskoy stopy], in Russian, Moscow: Universum Publishing House

Dibirov, M. and Briskin, B., 2001. Surgical treatment of diabetic angiopathy complications [Khirurgicheskoe lechenie oslozhneniy diabeticheskoy angiopatii], in Russian, Moscow: "Soviet writer" Publishing House

Dudanov, I., Karpov, A., Kapugin, M., 2008. Critical ischemia of lower extremities. 80 lectures on surgery [Kriticheskaya ischemiya nizhnikh konechnostey. 80 lektsiy po khirurgii], in Russian, Ed. by Saveliev V.S., Moscow: Litera Publishing House, pp.119-28

Faglia, E., Guiffrida G., Oriani G., 1999. The ischemic diabetic foot, Milano: Editrice Kurtis

Kaputin, M., Ovcharenko, D., Bregovskiy, V., 2008. "Transluminal balloon angioplasty in treatment of lower extremity critic ischemia," Med. Acad. Journal [Medicinskiy akademicheskiy zhurnal], in Russian, Vol.8(2), pp.84-91

Kaputin, M., Ovcharenko, D. et al., 2009. "Transluminal balloon angioplasty in treatment of lower extremity critic ischemia," Angiology and vascular surgery [Angiologiya i sosudistaya hirurgiya], in Russian, Vol.15(1), pp.142-45

Karimov, Sh., Babadzhanov, B., Islamov, M., 2003. Treatment of diabetic gangrene in lower extremities [Lechenie diabeticheskoy gangreny nizhnikh konechnostey], in Russian, Tashkent: Shark Publishing House Levin, M., Neal, L., 1988. The diabetic foot, London

Lunuey, J., 1993. "Vascular management of the diabetic foot--a British view," Journ. Ann. of the Academy of Medicine, Singapore, Vol.22(6), pp.912-16

Pokrovskiy, A., Dan, V., Chupin, A., Khoroves, A., 1996. "Arterialization of foot venous system in treatment of critical ischemia upon distal arterial bed occlusion," Angiology and vascular surgery [Angiologiya i sosudistaya hirurgiya], in Russian, No.4, pp.73-93

Sobenin, I., 1999. "Diabetes mellitus and atherosclerosis," Angiology and vascular surgery [Angiologiya i sosudistaya hirurgiya], in Russian, No.5, pp.181-88

Shipovskiy, V., Zolkin, V., Magomedov, Sh., 2008. "Balloon angioplasty of crural arteries," Diagnostic intervention radiology [Diagnosticheskaya intervecionnaya radiologiya], in Russian, Vol.2(4), pp.55-62

Zatevakhin, I., Shipovskiy, V., Magomedov, V., 2008. "Outcomes of balloon angioplasty in tibial arteries," Angiology and vascular surgery [Angiologiya i sosudistaya hirurgiya], in Russian, Vol.15(2), pp.97-98

Zufarov, M., Karimov, Z., Saatov, P., Salakhitdinov, Sh., 2003. "Transluminal balloon angioplasty in patients with critical ischemia of lower extremities," Central Asian Medical Journal [Centralno-Aziatskiy Medicinskiy Zhurnal], in Russian, No.2, pp.33-36

Ravshan Asamov (1), Said Ismailov (2), Telman Kamalov (2), Bekzod Abdullaev (1), Amet Seidaliev (1)

(1) Republican Research Center of Emergency Medicine, Uzbekistan

(2) Center for the Scientific and Clinical Study of Endocrinology, Uzbekistan
Table 1. Distribution of patients by extent of lower extremity
tissue damage (Wagner's classification of diabetic foot ulceration),
abs. (%)

Wagner's grade    Number of patients   Dry gangrene   Wet gangrene

III                   28 (66.7)         10 (23.8)      18 (42.9)
IV                    14 (33.3)          4 (9.5)       10 (23.8)
Total                  42 (100)         14 (33.3)      28 (66.7)

Table 2. Endovascular maneuvers by the level of lesion

Level of lesion                    Character of maneuvers

                      Transluminal    Transluminal        Total
                         balloon        balloon         number of
                      angioplasty +   angioplasty       segments
                        stenting

                      Abs.      %     Abs.      %     Abs.      %

Iliac segment          --      --      --      --      --      --
Femoral segment         7     12.0     11     19.0     18     31.0
Popliteal segment      --      --       9     15.6      9     15.6
Crural arteries        --      --      31     53.4     31     53.4
Total                   7     12.0     51     88.0     35      100

Table 3. Surgical modalities in treatment of diabetic foot syndrome

Surgical modality                Number of patients

                                   Abs.        %

Transluminal balloon                18         43
angioplasty--debridement--
repeated debridement--foot
plastic surgery

Debridement--transluminal           9         21.4
balloon angioplasty--foot
plastic surgery

Debridement--transluminal           9         21.4
balloon angioplasty--repeated
debridement

Debridement--transluminal           4         9.5
balloon angioplasty--drug
therapy

Transluminal balloon                2         4.7
angioplasty--drug therapy
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Author:Asamov, Ravshan; Ismailov, Said; Kamalov, Telman; Abdullaev, Bekzod; Seidaliev, Amet
Publication:Medical and Health Science Journal
Article Type:Report
Date:Oct 1, 2012
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