CRITICAL ISCHEMIA: DIAGNOSIS CRITERIA AND THERAPEUTICAL SOLUTIONS

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1 ORIGINAL ARTICLES CRITICAL ISCHEMIA: DIAGNOSIS CRITERIA AND THERAPEUTICAL SOLUTIONS Lucian S. Falnita 1, Mioara Cocora 1, Dan O. Nechifor 1, Ion Socoteanu 1, Doru Bordos 2 REZUMAT Obiectiv: În cadrul bolii arteriale periferice obstructive a membrelor inferioare, ischemia critic\ este o entitate clinico-terapeutic\ cu evolu]ie rapid\[i simptomatologie sever\, impunând de urgen]\ interven]ia de revascularizare, alternative fiind pierderea extremit\]ii. Scopul lucr\rii este de a prezenta statistic cazurile de ischemie critic\ operate în Clinica de Chirurgie Cardiac\ a Institutului de Boli Cardiovasculare Timi[oara în ultimii 4 ani, ]ncadrându-le pe modele lezionale [i tipuri de rezolvare chirurgical\. Material [i metode: Studiul cuprinde 226 pacien]i cu ischemie critic\, fie prezent\ la internare, fie ap\rut\ în perimetrul perioperator al chirurgiei cardiace, opera]i în clinica noastr\ între ianuarie ianuarie Rezultate: Paten]a reconstruc]iilor aorto-iliace la 6 luni a fost de 98,7%, iar a reconstruc]iilor infrainghinale de 96,5%. Rata de salvare a membrului la 6 luni în cazul reconstruc]iilor aorto-iliace a fost de 98,7%, iar în cazul reconstruc]iilor infrainghinale de 98,6%. Concluzii: Datorit\ caracterului de urgen]\ a tratamentului, leziunilor plurivasculare [i a bolilor asociate deseori întâlnite pacientul cu ischemie critic\ are o abordare terapeutic\ dificil\. Totu[i, tratamentul chirurgical neîntârziat [i adaptat particularit\]ilor cazului poate conduce la rezultate favorabile. Cuvinte cheie: schemie critic\, salvarea membrului inferior, chirurgie vascular\ ABSTRACT Objective: Incaseofperipheralarterialdisease(PAD), criticalischemiaisaclinical-therapeuticentitywithfastprogressionandseveresymptoms, imposingurgentrevascularization in order to save the limb. The aim of the paper is to present the results of the interventions for critical ischemia performed in the Cardiac Surgery Department of the Institute of Cardiovascular Diseases Timisoara in the last 4 years, and to classify them in lesional types and surgical treatment modalities. Material and methods: 226 cases of critical ischemia were studied in our clinic between January January Results: The patency of aorto-iliac revascularizations at 6 months was 98,7% and the patency of infrainguinal revascularizations was 96,5%. The limb salvage rate at 6 months for aorto-iliac revascularizations was 98,7%, and for infrainguinal revascularizations 98,6%. Conclusions: Because of the urgent need for treatment, multileveled and plurivascular lesions and numerous associated diseases, the therapeutical management of the critical ischemia patient is often difficult. Nevertheless, surgical treatment undertaken without delay and adapted to the particularities of the case can lead to good results. Key Words: critical ischemia, limb salvage, vascular surgery INTRODUCTION Critical ischemia of the lower limbs is defined as continuous rest pain, necessitating pain-relief medication for at least 2 weeks, ulcerations or gangrene, and an ankle systolic pressure lower than 50 mmhg (criteria not applicable in diabetics). Other criteria still studied are the concentration of lactate and glucose in tissues at different levels. Critical ischemia is a clinical-therapeutic entity, 1 Cardiac Surgery Department of the Institute of Cardiovascular Diseases Timisoara 2 Surgical Clinic 2 Victor Babes University of Medicine and Pharmacy Timisoara Correspodence to: Lucian Falnita Bld Cetatii nr. 20, ap7, Timisoara, Tel , lfalnita@cardiologie.ro situated between chronic ischemia and acute ischemia; it is a chronic ischemia with a fast progression, loud symptomatology and the urgent need for surgical treatment that characterize the acute ischemia. Recently, the term acquired a wider significance, including the 3rd and 4th stages from Fontaine s classification, or categories 4, 5, 6 from Rutherford s classification. The patients treated in this stage are usually old people, with diabetes and with multi-level vascular disease, located especially at the calf arteries. The fact that the vast majority of patients turn to the vascular surgeon at this advanced stage is due to the lack in medical education and to deficiencies in the relation between general medicine and vascular surgeons. The urgent management of critical ischemia consists of: 47

2 1. -pain control -infection control -prevention of onset or progression of thrombosis 2. detailed morphological investigation 3. making a therapeutical decision and applying it as soon as possible The preferred treatment for critical ischemia is revascularization, surgical or endovascular. The pharmaceutical approach is adopted only when the revascularization cannot be done. Drugs that can be used in that case (or in conjunction with surgical therapy) include: prostaglandins (Iloprost), antiagregants (Aspirin, Clopidogrel), anticoagulants, vasoactive drugs (Pentoxifilin), gene induced angiogenesis (VEGF). 1 In the case of aorto-iliac lesions, the surgical treatment most often applied is the aorto-bifemoral bypass. Other possibilities are represented by: aortofemoral bypass, femuro-femoral, axilo-femoral, thoraco-femoral bypass, endarterectomy. If aorto-iliac and infrainguinal lesions are associatedproximal revascularizations are sufficient in 75-85% of patients. Infrainguinal revascularization is necessary when: - the aorto-iliac lesion has a low hemodynamic significance 2 - occlusions exist at the level of the profundogeniculate collaterals - the popliteal artery or two of the calf arteries are occluded - there is major tissue loss or infection. The endovascular treatment of aorto-iliac disease offers a reduced mortality and morbidity, but a relative low patency (4-year patency for percutaneous transluminal angioplasty <PTA> is 53% and 67% for stents). 3 It is recommended for isolated stenoses of the iliac artery, shorter than 3 cm. In the case of infrainguinal lesions different types of bypasses can be performed, with the proximal anastomosis (in-flow) on the common or superficial femoral artery, and even on more distal vessels, such as the deep femoral artery or the popliteal artery, if they are stenosed less than 20%, and the distal anastomosis (out-flow) on the artery with better distal patency. Also, different types of grafts can be used. Infrainguinal percutaneous angioplasty gives good results in isolated lesions with good run-off; because critical ischemia is usually caused by diffuse lesions, angioplasty has a low applicability in this category of patients (a limb salvage rate of 50-77% at 2 years ). 4 A modern approach is the combination between the two procedures, in multilevel stenoses, using PTA and stenting for more proximal lesions (like superficial femoral artery stenosis) and after that microsurgery for the distal lesions (calf arteries obstructions). 5 Critical ischemia is frequently a challenge for the surgeon, due to the complexity of arterial lesions, the affected general health status of the patients and the urgent need for treatment. In this paper we analyze the cases of critical ischemia operated in the Cardiac Surgery Department of the Institute of Cardiovascular Diseases Timisoara in the last 4 years, classifying them into lesional types and surgical treatment modalities and presenting the results in terms of patency, limb salvage rate, complications, and mortality. MATERIAL AND METHODS In our clinic 226 patients with critical ischemia were operated (with onset of symptoms before the hospitalization or after cardiac surgery), between January 1999 and January patients were men (80.5%) and 44 (19.5%) women; with a mean age of 67 years (range: years).. Continuous rest pain was the diagnosis criterion for critical ischemia in 174 patients (77%) and tissue loss with fast progression in 52 patients (23%). The preoperative assessment was done using: - ultrasonography: carotid: 182 cases (80.5%) cardiac: in all cases - angiography: peripheral: in all cases carotid: 90 cases (39.8%) coronary: 136 cases (60%) In 141 cases (63.3%), critical ischemia emerged on the ground of isolated peripheral vascular lesions, in 85 (37.6%) cases in the context of plurivascular lesions: carotid lesions - 23 cases (19%), coronary artery disease - 52 cases (23%), carotid and coronary lesions - 10 cases (4.4%). The plurivascular context imposed the use of a therapeutical algorithm in which the carotid revascularization (3 cases) and the myocardial revascularization (2 cases) preceded the peripheral revascularization. The most frequent associated diseases were: diabetes - 38 cases (16.8%), arterial hypertension - 85 cases (37.6%), chronic renal failure - 5 cases (2.2%), COPD - 25 cases (11 %), gastro-duodenal ulcer - 15 cases (6.6%). Critical ischemia was caused by arterial lesions, single or multiple, situated at all levels, from abdominal aorta to calf arteries. The level of vascular lesions, as revealed by angiography, is displayed in Table 1. The lesions that produce more often critical ischemia are distal lesions (Fig.1) and multi-leveled lesions (Figs. 2, 3 and 4) TMJ 2004, Vol. 54, No. 1

3 Table 1. The level of vascular lesions Level No. of patients Abdominal aorta 2 Aorta + iliac arteries 14 Iliac + femoral ± popliteal arteries ± aorta 42 Iliac arteries 10 Superficial femoral artery occlusion 34 Superficial femoral artery occlusion + stenoses of the deep femoral artery 18 Superficial femoral artery occlusion + popliteal stenosis 26 Arteries of the calf 24 Diffuse lesions of femuro-popliteal and distal arteries 56 Figure 3. Superficial femoral artery occlusion in the same case Figure 1. Calf arteries occlusion Figure 4. Calf arteries stenoses in the same case Table 2. Surgical procedures Figure 2. External iliac artery stenosis The variety of peripheral lesions for the patients in this study led to the use of a wide range of revascularization procedures, isolated or associated, giving priority to the most severe lesions (Table 2). Procedure No. of cases aorto-bifemoral bypass ± abdominal 21 aorta de-obstruction + profundoplasty 12 aorto-bifemoral bypass 19 + profundoplasty 2 profundoplasty 4 ilio-femoral endarterectomy + profundoplasty 5 aorto-bifemoral bypass + femuro-popliteal bypass 18 aorto-femoral bypass + femuro-popliteal bypass 5 by-pass femuro-popliteal - proximal 20 -distal 68 distal bypass 40 femuro-popliteo-distal bypass 12 RESULTS The patency of reconstructions (evaluated clinically and ultrasonographically) was 99.5% at 30 days, the 49

4 mortality was 0% and morbidity 8%. The type and percent of complications were different for aorto-iliac revascularizations (Table 3) and infrainguinal revascularizations (Table 4). Figures 5 11show an angiographic aspect in a patient with critical ischemia, occlusion of abdominal aorta and bilateral superficial femoral arteries, with good evolution after aorto-bifemoral bypass. Table 3. Complications of aorto-iliac revascularizations Our results (%) Myocardial infarction 0 Death 0 Intestinal ischemia 1.2 Acute renal failure 3.6 Wound complications 6.1 Bleeding 3.6 Medular ischemia 0 Graft infection 0 Aorto- enteric fistula 0 Lymphatic fistula 0 False aneurism 0 Table 4. Complications of infrainguinal revascularizations Our results (%) Myocardial infarction 0 Death 0 Wound complications 4.1 Bleeding 1.4 Infection 0 Edema 55.5 Figure 5. Infrarenal aorta occlusion At 6 months there were 3 cases of amputation on limbs with patent reconstructions, 1 death, and the patency (evaluated only clinically improvement or no regression in symptoms from hospital discharge and ultrasonographically present Doppler flow at distal arteries) was 96.9% (Table 5). Table 5. Patency and limb salvage rate Limb 6 months salvage patency rate at 6 months Aort-iliac revascularizations ± extensions 98.7% 98.7% Infrainguinal revascularizations 96.5% 98.6% Figure 6. No evidence of patent femoral superficial arteries Table 6. Complications rates for aorto-iliac revascularizations found in literature Author (%) Our results (%) Myocardial infarction 6 Bunt T.J Death 7 Prendiville E.J. et al Intestinal ischemia 8 Ligush J. et al Acute renal failure 9 Brewster D.C. et al Medular ischemia 10 Gorecki J.P. et al Graft infection 11,12 Nevelsteen A., Bunt T.J. 0,1-1,3 0 Aorto- enteric fistula 13 Lazaro T. et al Lymphatic fistula 14 Tyndall S.H. et al False aneurism 11 Nevelsteen A. et al 2 0 Altered sexual function 15 Nevelsteen A. et al 20 - Wound complications Bleeding TMJ 2004, Vol. 54, No. 1

5 Figure 7. After aorto-bifemoral bypass: proximal anastomosis Figure 9. Left femoral superficial artery occlusion with numerous collaterals from profundus femoral artery Figure 8. Left distal anastomosis Figure 10. Right distal anastomosis Table 7. Complications rates for infrainguinal revascularizations found in literature Author (%) Our results (%) Myocardial infarction 16 Taylor L.M. et al 1,9 0 Death 17 Wengerter K.R. et al 1,3 0 Wound complications 17,18 Wengerter K.R., Robinson J.G ,1 Bleeding 17 Wengerter K.R. et al 1,6 1,4 Infection 18 Feiberg R.L. et al 1,36 0 Edema 19 Shubart P.J. et al ,5 Table 8. Results of aorto-iliac revascularizations Author Particularities PATENCY Prendiville et al, Anastomosis on common femoral arteries 94% at 3 years 89% at 5 years Prendiville et al, Anastomosis on deep femoral arteries 95 % at 3 years 92% at 5 years Schneider et al, % at 3 years Van der Vleit et al, ,4% at 1 year Friedman et al, PTFE graft 98% at 5 years Friedman et al, Dacron graft 93% at 5 years 51

6 2. Results: The assessment of patency was made only clinically and without a systematic follow-up in order to asses the long-term patency. However, the early results in the treatment of critical ischemia are comparable, by extrapolation, with those reported in literature concerning the limb salvage and the patency for aorto-iliac (Table 8) and infrainguinal revascularizations (Table 9). CONCLUSIONS Figure 11.Right femoral superficial artery occlusion, with good flow from collaterals DISCUSSIONS 1. Complications: The complication rate found in the literature is compared with our data for aorto-iliac revascularizations (Table 6) and infrainguinal revascularizations (Table 7). The postoperative and in-hospital mortality was 0%, also the myocardial infarction, possibly due to the fact that our department involves both cardiac and vascular surgery, with specialists trained to avoid and treat cardiac and carotid comorbidities. As it concerns intestinal ischemia, acute renal failure, bleeding and edema, we had similar results. No cases of medular ischemia were observed due to accurate technique including short clamping times and end-to-side aortic anastomosis. Also, no graft infections were diagnosed and subsequently no complications related to that (fistulae, etc.) we rarely used synthetic grafts in infrainguinal revascularizations and we had the same aseptic conditions as for cardiac surgery. As for altered sexual function, the preservation of internal iliac flow, was made by using the end to side aortic anastomosis, not end to end; some patients were reluctant to discuss the subject. Critical ischemia appears in the majority of cases, on a background of multi-leveled vascular disease, peripheral and plurivascular (coronarian, carotidian, renal). Beside that, the patients are weakened by other diseases (diabetes, renal failure, COPD) and their management is difficult. An algorithm of diagnosis and therapy could be: Detailed anamnesis leads the surgeon to the diagnosis of other vascular diseases. In order to diminish the operative risk it is important to diagnose the coronary and/or carotid disease. Complementary Table 9. Results of infrainguinal revascularizations found in literature Author Particularities Patency Limb salvage rate Cervantes et al, Old patients 80,8% at1 year 82,8% at 1 year Illuminati et al Old patients + PTFE graft 67% at 2 years 77% at 2 years Zukauskas et al, Infra + suprapopliteal 91,4% at1 year 95,6% at 1 year Grego et al, Popliteo-distal 90,5% at 1 month - 83,9% at 1 year Pokrovsky et al, ,8% at 5 years 91,3% at 5 years Woelfle et al, ,5% at 1 year 84,7% at 1 year Ionac, Bordos et Al, Distal bypasses, conventional and by microsurgery 65% at 32 months 82,5% at 32 months TMJ 2004, Vol. 54, No. 1

7 investigations are necessary, because the peripheral arterial disease limits the effort, hiding the coronary symptomatology: ECG at all patients, exertion test, and thalium scintigraphy; in case of a positive result, coronarography is necessary. The suspicion of carotid artery disease, raised by anamnesis and clinical exam impose Duplex echography and carotid angiography to assess the severity and morphology of lesions. Coronary revascularization under cardiopulmonary bypass, even with good hemodynamic stability, worsens the peripheral tissue ischemia. In spite of the extended and multi-leveled vascular lesions, partial proximal revascularizations, have good results; for example, the aorta - deep femoral bypass keeps the role of limb salvage even in the presence of more distal lesions. The extensions of the bypass are necessary when the deep femoral artery is narrow and when the calf arteries are severely affected. 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