Reliability and validity of the cross-culturally adapted Italian version of the Core Outcome Measures Index.

Patient-orientated outcome questionnaires are essential for the assessment of treatment success in spine care. Standardisation of the instruments used is necessary for comparison across studies and in registries. The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument validated for patients with spinal disorders and is the recommended outcome instrument in the Spine Society of Europe Spine Tango Registry; currently, no validated Italian version exists. A cross-cultural adaptation of the COMI into Italian was carried out using established guidelines. 96 outpatients with chronic back problems (>3 months) were recruited from five practices in Switzerland and Italy. They completed the newly translated COMI, the Roland Morris disability (RM), adjectival pain rating, WHO Quality of Life (WHOQoL), EuroQoL-5D, and EuroQoL-VAS scales. Reproducibility was assessed in a subgroup of 63 patients who returned a second questionnaire within 1 month and indicated no change in back status on a 5-point Likert-scale transition question. The COMI scores displayed no floor or ceiling effects. On re-test, the responses for each individual domain of the COMI were within one category in 100% patients for "function", 92% for "symptom-specific well-being", 100% for "general quality of life", 90% for "social disability", and 98% for "work disability". The intraclass correlation coefficients (ICC(2,1)) for the COMI back and leg pain items were 0.78 and 0.82, respectively, and for the COMI summary index, 0.92 (95% CI 0.86-0.95); this compared well with 0.84 for RM, 0.87 for WHOQoL, 0.79 for EQ-5D, and 0.77 for EQ-VAS. The standard error of measurement (SEM) for COMI was 0.54 points, giving a ''minimum detectable change'' for the COMI of 1.5 points. The scores for most of the individual COMI domains and the COMI summary index correlated to the expected extent (0.4-0.8) with the corresponding full-length reference questionnaires (r = 0.45-0.72). The reproducibility of the Italian version of the COMI was comparable to that published for the German and Spanish versions. The COMI scores correlated in the expected manner with existing but considerably longer questionnaires suggesting adequate convergent validity for the COMI. The Italian COMI represents a practical, reliable, and valid tool for use with Italian-speaking patients and will be of value for international studies and surgical registries.

[Surgical tactics in the treatment of thyroid nodular pathology]. / Tattica chirurgica nel trattamento della patologia nodulare tiroidea.

The thyroid nodules represent the most frequent endocrinopathy, because clinically palpable nodules are detectable in 4-5% of the general population. Such pathological condition includes adenomas, carcinoma, intraglandular haematomas or cysts, focal thyroiditis, etc. Fine-needle aspiration cytology allows a correct diagnosis in about 90% of the cases, distinguishing focal thyroiditis from nodular goiter or thyroid malignancies. The new instrumental and cytological studies make the choice for surgical interventions more selective. At the Institution of General and Cardiovascular Surgery, University of Milan, 597 patients underwent surgery from 1966 to January 1988. The observed nodular (toxic or non toxic) thyropathies were 498 (83.4%). Cold nodules represented about a third (34%) of the nodular thyropathies. Thyroid carcinomas were 33 (5.6%). This study is aimed to analyze our surgical attitude with respect to nodular thyropathies, the surgical procedures adopted and the observed complications.

[Atherosclerotic aneurysm of a branch of the deep femoral artery]. / Un aneurisma aterosclerotico di un ramo dell'arteria femorale profonda.

Peripheral arterial aneurysms present characteristic locations. In the lower limbs, atherosclerotic aneurysms of the deep femoral artery are very rare. Authors report an interesting case of arteriosclerotic aneurysm of a branch of the profunda femoris artery observed in a 80 year-old man, and associated with an abdominal aortic aneurysm. Endo-aneurysmectomy was performed with a dacron patch interposition. Surgical treatment of this rate disease is discussed.

[Aneurysm of the popliteal artery. Prognostic and therapeutic criteria]. / Aneurismi dell'arteria poplitea. Criteri prognostici e terapeutici.

Experience of the management of 45 patients affected by popliteal artery aneurysms is reported. All patients, but one, underwent operative treatment. The importance of immediate surgical reconstruction whenever a popliteal artery aneurysm has been detected is stressed. In fact the most frequent complication represented by sudden thrombosis of the aneurysmatic sac and/or by peripheral embolization is generally followed by an irreversible closure of the vascular run off, determining the high rate of failures (28% in our experience) in spite of a prompt surgical reconstructive procedure.

[The role of chronic renal insufficiency in the prognosis of surgical interventions in subrenal abdominal aortic aneurysm]. / Il ruolo dell'insufficienza renale cronica sulla prognosi di interventi di aneurismectomia dell'aorta addominale sottorenale.

Chronic renal insufficiency is one of the most important factors governing the immediate and long-term outcome after aneurysm repair. A total of 484 patients with abdominal aortic aneurysm (A.A.A.) have undergone elective surgical treatment in our Institution during the last 5 years. Of these, we selected 60 patients; 30 with a normal serum creatinine concentration and 30 with preoperative renal insufficiency (serum creatinine concentration greater than 2 mg/dl). In this second group, 23 patients (76.6%) were affected by slight or median renal insufficiency, 5 patients (16.6%) were affected by severe renal insufficiency (creatinine concentration greater than 4.5 mg/dl), and 2 patients (6.6%) had complete renal failure with dialytic treatment from 1.5 and 2 years respectively. We analyzed postoperative renal function in all 60 patients. In the first group, only 6 patients (20%) showed a transient renal insufficiency, without mortality and morbidity. In the second group, postoperative complications and mortality tended to occur more frequently in patients with a severe renal insufficiency than in patients with slight or median insufficiency or complete renal failure. The present data suggest that dialytic treatment might be necessary in patients with severe renal insufficiency before aneurysm repair.

[The physiopathology, clinical picture and therapy of chronic intestinal ischemia]. / Fisiopatologia, clinica e terapia dell'ischemia intestinale cronica.

Between January 1982 and April 1993, 8 patients suffering from a typical clinical picture of chronic intestinal ischemia, have been observed. All these patients were symptomatic and 7 cases presented stenosing or occlusive lesions of at least 2 of the 3 splanchnic trunks. 5 of these 7 patients underwent a corrective surgical procedure. 2 patients underwent percutaneous transluminal angioplasty. One patient affected by stenosis of the coeliac trunk due to external compression caused by the median arcuate ligament of the diaphragm was not operated because the symptomatology was atypical and the other 2 splanchnic trunks were perfectly patent. Three patients died following the therapeutic procedure: a woman in whom an aorto-mesenteric bypass graft was inserted, underwent, 4 months after, an intestinal infarction due to thrombosis of the graft; another woman, whose coeliac trunk and superior mesenteric artery were thrombosed and whose inferior mesenteric artery was reimplanted on the common iliac artery, died for acute hepatic failure, after 12 months of total parenteral nourishment; a third patient, successfully submitted to PTA of the superior mesenteric artery, died after 4 months due to the occurrence of acute renal insufficiency.

[Physiopathology of venous stasis at the microcirculation level]. / Fisiopatologia della stasi venosa a livello del microcircolo.

The division of the venous circulation in to two sectors, one constituted by the superficial and deep venous trunks (macrocirculation) and the other by the capillaries and precapillary venules (microcirculation), is surely schematical but aids the comprehension of many hemodynamic effects connected to hampered venous return and to the incompetence of the valvular devices. In fact many of the effects of stasis and venous hypertension (oedema, red cell diapedesis, skin dystrophies) cannot be explained merely by hydraulic mechanisms but require a primary alteration of the microvascular wall associated with structural changes of the perivascular connective tissue. The alterations that occur in microcirculation are of the utmost importance in the formation of the venules ulcerations. The passage of fibrinogen through large pores in the venules of the patients affected by venous hypertension derived from venous insufficiency creates a pericapillary fibrin deposition that cannot be removed because of inadequate blood and tissue fibrinolysis. This accumulation acts as a barrier to the diffusion of oxygen and other nutrients, determining a stasis dermatitis that may lead to tissue necrosis and ulceration. The more precise knowledge of the phenomena connected with the venous stasis at the level of microcirculation (pericapillary fibrin deposition, endothelial ischemia, blocked lymphatic drainage) will not only allow a deeper comprehension of the clinical signs but hopefully will lead to a more effective treatment of the postphlebitic syndrome.

[Current role of extra-anatomical revascularization of the lower limbs]. / Il ruolo attuale delle rivascolarizzazioni extra-anatomiche degli arti inferiori.

In vascular reconstructive surgery of the lower limbs for aorto-iliac disease the first choice procedure is TEA or aorto-femoral bypass. In "high risk patients" alternative procedures like extra-anatomical bypass (axillo-femoral or femoro-femoral bypass grafts) are available. In some cases, such us infection of a retroperitoneal prosthesis, an axillo-femoral bypass is mandatory in order to obtain revascularization of the lower limbs. In this article we report our late experience in this surgery and our opinion on the correct indication for the use of these procedures.

[Malignant neoplasms invading into the inferior vena cava. Surgical indications]. / Neoplasie maligne ed invasione della vena cava inferiore. Indicazioni chirurgiche.

Clinical conditions requiring resection and replacement of the inferior vena cava (IVC) are rare and have included tumors, traumatic or iatrogenic injuries. Intraluminal extension or direct mural involvement of the IVC is seen with a variety of tumors: renal cell carcinomas, adrenal cortical tumors, leiomyosarcomas and pheochromocytomas. Surgical treatment requires tumor resection with simultaneous en bloc resection of the involved IVC. Resection of the lower and middle segments of IVC is possible in nearly all cases and surgical reconstruction is generally made with a polytetrafluoroethylene (PTFE) tube graft. Resection at suprahepatic vein level is indicated only rarely: tumor invasion of the suprahepatic veins require liver transplantation. Venous bypasses have lower patency rates than prosthetic replacement because of the low pressure and lower-flow of the venous system.

[Isolated aneurysms of the internal iliac artery. A clinical contribution]. / Gli aneurismi isolati dell'arteria iliaca interna. Contributo clinico.

Five patients with isolated aneurysms of the internal iliac artery were identified and submitted to surgical procedure. Two patients were operated on in election, three in emergency with aneurysmatic rupture. The natural course of this pathology is one of progressive expansion and rupture. This lesion is often asymptomatic, but sometimes we found associated, compression symptoms of genito-urinary, intestinal tract and venous and neurological structures. Echography, CT scan and angiography are the most common and useful diagnostic procedure. Endoaneurysmectomy with proximal and distal suture of the stumps is the appropriate treatment in the majority of the cases.

[Intestinal infarction after ruptured aneurysm of the abdominal aorta. Clinical contribution]. / L'infarto intestinale dopo rottura di aneurisma dell'aorta addominale. Contributo clinico.

Acute mesenteric ischemia is a severe complication after aortic reconstructive surgery for AAA repair. This ischemic event, due to a poor intestinal perfusion especially in ruptured AAA in consequence of the hypotension and the hypovolemic shock, shows different clinical manifestations such as delayed canalization, ischemic colitis or more serious like intestinal infarction. Between 1989 and 1994, 965 cases of abdominal aortic aneurysms have been surgically treated in General and Cardiovascular Surgery Institute of University of Milan. Rupture had occurred in 150 patients, and intestinal infarction was observed in 6 cases (3.9%). Mortality rate of 33% was observed. Etiology and technical procedures to avoid this complication are discussed.

[Percutaneous angioplasty (PTA) in the treatment of non-penetrating injuries to the subclavian artery. A clinical case]. / Trattamento con angioplastica percutanea (PTA) di lesione da trauma non penetrante dell'arteria succlavia. Caso clinico.

Non penetrating injuries to the subclavian vessels are uncommon. We present a case of a young patient with an isolated blunt trauma of the right subclavian artery. The patient, a 25 year-old woman, was admitted to our Institute after a motor-vehicle accident, with a physical findings of absent peripheral pulses and right clavicular fracture, confirmed by non-invasive vascular evaluation and X-ray of the chest. Diagnosis was established by an urgent selective angiography that showed a subintimal hematoma with occlusion of the vessel and peripheral ischemia of the arm. The patient clinical status (hemodynamically stable) permitted a conservative management and a transluminal percutaneous angioplasty (PTA) with a trans-femoral catheter balloon. After radiologic treatment, the patient showed good palpable peripheral pulses. Clavicular fracture was treated by esternal stabilization. We believe that in selected patients, without other serious life-threatening injures, the intimal artery injury can be treated by a conservative and now also radiologic Therapy; PTA treatment avoids morbidity and mortality associated with surgical intervention.

[Traumatic lesion of the subclavian and axillary arteries]. / Le lesioni traumatiche delle arterie succlavia ed ascellare.

This study comprises 11 patients with traumatic vascular injuries of the subclavian and axillary vessels treated in the last 13 years at the Institute of General and Cardiovascular Surgery of Milan. Nine patients were male and two were female. In two patients the cause of injury was a penetrating trauma; blunt trauma occurred in nine patients. The majority of injuries were caused by motor vehicle accidents. Two patients suffered complete brachial plexus palsies with complete transection of the median nerve. Seven patients were affected by multiple bone injuries, while major venous injury was present in one case. Diagnosis was established by angiography performed in all stable patients. Vascular repair was performed in 10 patients; 4 patients were treated by primary repair, and 6 patients by interposition grafts. In one case we performed a transluminal percutaneous angioplasty (PTA) during angiographic examination, with a good result. There were no postoperative vascular complications and no patient died.

[Secondary aorto-enteric fistula]. / Le fistole vasculo-enteriche secondarie.

Aortic graft fistula is a rare and life-threatening complication after aortic reconstruction. The incidence ranges from 0.5 to 4%, and even if the diagnosis and treatment is appropriate, the results of surgery are poor: mortality rate ranges from 14 to 70%. The optimal method of treatment is still controversial; prosthetic removal and extra-anatomic bypass has been advocated as the standard method, but more recently, because the high mortality rate associated with this procedure, some have prompted to recommend in situ aortic graft replacement as a more successful treatment. Personal experience with incidence (0.7%) outcome and mortality (57%) in 7 patients treated over a period of 6 years (1990-1996) is reported. Results from this group are compared with another group (6 patients) previously treated (1975-1982) for the same pathology. Our results after 10 years, show the same incidence (0.7 vs 0.6%) and an elevated and unchanged mortality (57 vs 66%). Better results in the management of aorto-enteric fistulas could be achieved with the removal of infected infrarenal aortic prosthetic grafts and in situ homografts replacement.

[So-called "spontaneous" lesions of the popliteal artery]. / Lesioni cosiddette "spontanee" dell'arteria poplitea.

The term "spontaneous", when attributed to a stenotic or obliterative arterial lesion, could seem ambiguous and doesn't completely explain the anatomical substrate that is the basis of this morbid condition. However, it is true that injuries can occur without the patient being aware of any traumatic event, and can cause a symptomatology arising suddenly and, apparently, "spontaneously". In this study, three cases of patients observed for acute or chronic lower limb ischemia are presented. All patients were male, young and underwent an angiographic examination that demonstrated, in an otherwise normal arterial tree, filling defects or obstruction involving the popliteal artery. Two patients underwent a reconstructive surgical procedure. The third was medically treated. CAT or MNR examinations were performed in order to exclude developmental defect such as an anomalous course of popliteal artery determined by a displacement due to medial head of the gastrocnemius muscle. Actually in these three cases, a definite etiology of the arterial damage was not demonstrated and therefore it is suggested that a physical effort could have injured an already weakened arterial structure.

[Renal arteriovenous fistulae]. / Fistole arterovenose renali.

Arteriovenous fistulas (AVFs) involving the kidney are rare. They are generally classified as congenital, idiopathic or acquired. The authors present 5 cases of renal arterio-venous communications observed in recent years. These cases don't include the congenital type and represent the forms of AVFs that are more frequently observed (1 idiopathic, 3 iatrogenic, 1 associated with malignancy). This study is aimed at examining the clinical picture and the procedures of detection and monitoring of renal AVFs. The various adopted therapeutic procedures (nephrectomy, surgical ablation, radiological embolization) are analyzed.

[Natural history and course of aneurysmal disease in patients operated on for abdominal aortic aneurysms]. / Storia naturale ed evoluzione della malattia aneurismatica in pazienti operati per aneurismi dell'aorta addominale.

This study is aimed at analyzing our experience in the evolution of aneurysmatic disease after surgical treatment of the typical subrenal abdominal aortic aneurysm. In fact in some cases we reobserved these patients for the onset of a new important dilatation involving the proximal tract of the abdominal aorta or the common iliac arteries. From 1980 to December 1992, 24 patients out of a group of 1508 patients previously submitted to an aorto-aortic or aorto-iliac reconstructive procedure using dacron prosthetic grafts were reoperated for relapsing aneurysmatic disease. In six cases the dangerous ectasia was located above the proximal aortic anastomosis; in four patients the re-reconstructive procedure was performed clamping the subdiaphragmatic abdominal aorta and performing the proximal anastomosis just below the ostia of the renal arteries. In two cases the aneurysmatic process involved the origins of the visceral vessels and a left thoracophrenolaparotomic access was necessary in order to perform a thoracoabdominal reconstruction reimplanting the visceral arteries on the prosthetic graft. In 18 cases the progressive aneurysmatic process involved the common iliac axis provoking, in some cases, a kinking or a shortening of the aortic prosthetic graft. The results of these reintervention are good with no mortality at operation and a satisfactory middle term (average 3 years) follow-up. Our investigation demonstrates that in a small, but significant (1.6%) percentage of patients the aneurysmatic disease spreads upward and downward involving arterial segments formerly non affected.

[Critical ischemia of the lower limbs: pathogenesis, clinical course and therapy. Results of authors' experience in 337 cases]. / Ischemia critica agli arti inferiori: patogenesi, clinica e terapia. Risultati della nostra esperienza su 337 casi.

The definition of an ischaemic condition at lower limb level, may imply any different degree of the pathology, starting from a simple chronic slight claudication up to a severe ischaemia. Critical Limb Ischaemia is the term defined to identify an ischaemic condition, which endangers the limb or part of a limb and requires a prompt and appropriate treatment. However the pathophysiology of this condition remains to be well established and depends on various vascular factors. For the European Working Group on Critical Limb Ischaemia (Berlin 1989, Rudesheim 1991) the definition is strictly restricted to Fontaine's stage III B and IV, while in our opinion the definition could be very simple in all the patients with a prognostic limb-threatening condition (for localization and wide extension of the lesions) independent of the Fontaine's stage, which are going towards a future amputation if radical improvement of blood flow cannot be achieved with an adequate revascularization. In our five year late experience, we observed and surgically treated 337 patients with CLI (74% males and 80% atherosclerotic lesions). We discuss the preoperative findings, diagnostic procedures, surgical techniques and relate results.

[Vascular complications in drug addicts. Intermittent claudication in a HIV seropositive heroin addict]. / Complicanze vascolari in tossicodipendenti. "Claudicatio intermittens" in tossicodipendente da eroina sieropositiva per HIV.

The widespread use of heroin has revealed the growing life-threatening complications consequent on drug practice. The effects of heroin on the cardiovascular, pulmonary, renal and central nervous system have been well described in medical literature, but the vascular complication of chronic occlusive arterial disease of the lower limbs is rare. We report a case of a young female patient who was a chronic drug addict for over five years, with concomitant serum positiveness for HIV infection. The etiologic and pathogenetic mechanisms of such an uncommon vascular complication are discussed on the basis of the existing literature.

Acute vascular abdomen. General outlook and algorithms.

Acute vascular abdomen is a severe and life-threatening pathology due to arterial degeneration, leading to hemorrhage or arterial occlusion leading to ischemia. Differential diagnosis of patients with severe abdominal pain and/or shock include several vascular and traumatic diseases, the most common being rupture of abdominal aortic aneurysm (AAA), or less frequently rupture of visceral artery aneurysm. Also acute aortic dissection, iatrogenic injury and acute mesenteric ischemia may lead to acute vascular abdomen. Clinical evaluation of the haemodynamic status of the patient may be very difficult, and may require airway maintenance and ventilation with a rapid treatment of hemorrhagic shock. In the stable patient with an uncertain diagnosis, CT scan, NMR and selective angiography may be helpful in diagnosis before vascular repair. On the contrary, the unstable patient, after hemodynamic resuscitation, must be operated on expeditiously. We present our vascular algorithms, to assess timing of diagnosis and treatment of this severe acute disease.