A prospective randomized trial on azathioprine addition to cyclosporine versus cyclosporine monotherapy at steroid withdrawal, 6 months after renal transplantation.

BACKGROUND: Many attempts have been made to withdraw steroid therapy in renal transplant patients in order to avoid its many side effects. Results have been, so far, controversial. In this randomized prospective study, we compare the efficacy of azathioprine adjuncts to cyclosporine at the time of steroid withdrawal, 6 months after transplantation, versus Cyclosporine monotherapy, in preventing acute rejection. METHODS: One hundred and sixteen kidney transplant patients with good and stable renal function (creatininemia <2 mg/dl) received, in the first 6 months, cyclosporine + steroid. They were then randomized into two groups (A and B), and steroid therapy was withdrawn over 2 months. Group A (58 patients) continued on cyclosporine monotherapy, whereas group B (58 patients) added azathioprine (1 mg/kg/day) at the beginning of randomization and continued on cyclosporine + azathioprine. In both groups, patients resumed steroid therapy at the first episode of acute rejection. Follow-up after randomization was 5.3+/-1.6 years. RESULTS: After 5 years, the incidence of steroid resumption was 57% in group A and 29% in group B (P<0.02); of those, 68% and 88% of them were within 6 months from randomization. Anti-rejection therapy was always successful. Five-year patient and graft survival rates were 90% and 88% in group A and 100% and 91% in group B. Creatininemia did not differ, at follow-up. Side effects differed only for mild and reversible leukopenia caused by azathioprine in group B. CONCLUSION: Cyclosporine plus azathioprine is more effective than cyclosporine monotherapy in reducing the incidence of acute rejection after steroid withdrawal. Graft loss as a result of chronic rejection, mild in both groups, did not differ. Steroid withdrawal is feasible and advantageous, and the addition of azathioprine allowed 71% of our selected patients to remain steroid-free.

Experience with cyclosporine.

Six hundred thirty-eight cadaveric kidney transplant patients between 1983 and 2001 were treated with cyclosporine (CsA) for 87 +/- 58 months. Among 571 patients with follow-up greater than 12 months, the 15-year renal function was investigated to assess the probability of a >30% increase in serum creatinine (sCr) above the month-6 value (baseline) and the impact on graft survival. At 15 years, patient and graft survival rates were 82.7% and 56.1%, respectively, with a 19.5-year half-life (censored for deaths). The main causes of graft loss were chronic rejection (33.0%) and patient death (24%). Cardiovascular disease and neoplasms were the main causes of death. Renal function remained stable in 266 patients (46.6%) with excellent sCr values observed even after a 15-year treatment period. An increased sCr was observed in 305 patients (53.4%) with a 15-year probability of 74%. In 178 patients (59.3%) it was self-limited; their grafts are still functioning well. One hundred three patients (32.8%) lost their graft which was more likely when the sCr had increased >45%. Twenty-four patients (7.9%) died with a functioning graft. Multivariate analysis showed the progression of graft deterioration to be related to proteinuria (P<.0001), a late acute rejection episode (P<.002), or the extent of sCr increase (P<.008). In conclusion, the long-term use of CsA has allowed us to achieve excellent long-term patient and transplant survival rates. Our data indicate a high 15-year probability of an increased sCr, but the rate of progression is slow.

Temporary axillo-femoral bypass graft for renal transplant protection during aortic aneurysm repair.

Aortic surgery in renal transplant recipients requires a method of maintaining intraoperative graft perfusion. Here we present a case in which temporary axillo-femoral bypass was used to perfuse a renal transplant during the aortic aneurysm repair; the rationale of inserting the temporary axillo-femoral bypass on transverse arteriotomies is pointed out. Other methods of renal graft perfusion are discussed.

Combined surgical approach for carotid and coronary stenosis. Sixty-four patients and review of literature.

BACKGROUND: The proper role of combined carotid endarterectomy (CEA) and coronary bypass (CABG) is still controversial. We contribute to the discussion through the critical evaluation of 64 consecutive patients, whose data have been collected in a prospective way. METHODS: Between 1990 and 1999, 64 patients presenting a critical coronary disease (unemendable by PTA) associated with severe carotid stenosis (= or >70% if symptomatic, = or >80% if asymptomatic), underwent combined CEA-CABG. Cardiological symptoms were evident in 90.6% of cases. Thirty-five patients (54.7%) had a three-vessel coronaropathy, 18 (28.1%) a two-vessel disease and 11 (17.2%) severe stenosis of the common trunk; furthermore 7 patients (10.9%) had a low ejection fraction (<50%). A positive neurologic history was present in 22 (44%) patients. Thirty-four patients (55%) had a carotid stenosis >90%; a significant disease of the contralateral carotid axis was observed in 53% of cases: stenosis >50% in 30 patients and thrombosis in 4. CEA was performed with somato-sensorial evoked potential monitoring. RESULTS: The hospital mortality rate was 6.2% (4 patients). The cause of death was cardiac in 2 cases (1 early bypass thrombosis and 1 irreversible coronary spasm) and related to a multiorgan failure in 2. The neurologic morbidity rate was 0%. CONCLUSIONS: Our data highlight that in these high-risk patients the combined approach dramatically reduces the stroke risk although the mortality rate is still higher than that observed after CEA or CABG.

[Results of elective open surgery for juxtarenal aortic aneurysms]. / I risultati del trattamento elettivo in open surgery degli aneurismi juxtarenali dell'aorta.

Review of the most significant surveys (data base: Pub Med on September 2003) of elective open surgery for Juxtarenal aneurysms and personal results of 106 cases (9.3% of AAA consecutively operated in the last 11 yrs.) are reported. Mortality and morbidity are discussed related to: technique of aortic cross-clamping; protective measures on splanchnic and renal perfusion; risks from previous CAD and chronic renal failure. Over all, the main predictive factor is the accuracy of the selected technique, without any difference among different approaches, and the same results of infrarenal aneurysms can be obtained.

[The role of magnetic resonance in the follow-up of aortofemoral prosthetic reconstructions]. / Ruolo della risonanza magnetica nel follow-up delle ricostruzioni protesiche aorto-femorali.

The authors report their experience with the use of Magnetic Resonance (MR) in the follow-up of patients undergone aortofemoral bypass or substitution procedures for aneurysmal and/or steno-occlusive lesions of the aortoiliofemoral vascular bed. Twenty-eight patients, at least 2 years from aorto-bifemoral revascularization were evaluated by means of coronal and parasagittal MR planes (mean follow up 78.9 months). One exam over 28 was found to be not diagnostic; whereas the technique showed great usefulness in the morphological and haemodynamic evaluation of each of the graft sites explored (proximal anastomosis, graft body and limbs, femoral anastomosis and periprosthetic tissues) in the remaining 27 cases. The use of this method, in spite of some setting up problems peculiar to the type of examination, according to the authors is very promising because of the chance to obtain morphological and functional data at once and because of the interesting current and future developments of this diagnostic device.

Limb salvage in lower-extremity sarcomas and technical details about vascular reconstruction.

Vascular surgery may allow limb salvage when a sarcoma of the lower limb involves the main vascular bundle. We present our experience and describe the techniques which have been employed for such surgery. From October 1995 to April 1999, vascular surgery procedures were employed in seven patients with sarcomas of the thigh: two complete subadventitia dissections of the main vascular trunks, four artery replacements (two polytetrafluoroethylene [PTFE] grafts and two autologous saphenous grafts), and five venous reconstructions (all with autogenous saphenous graft: three substitutions; two distal transpositions with one external rigid support at the anastomosis). Clinical and instrumental (sonogram, computed tomography [CT] scan, echodoppler) follow-up was carried out at 3, 6, and then every 12 months after surgery (mean, 25 months; range, 6-53 months). Operative mortality and morbidity were nil. All the grafts were patent (one arterial thrombosis was successfully treated on the first postoperative day). The functional result was good in six patients and fair in one. Two patients died, 24 and 13 months after surgery, with disseminated disease, but had no local recurrence. Five patients are alive and disease-free. Vascular techniques allow limb salvage with en-bloc resection of sarcomas of the thigh involving the main vessels. Venous reconstructions are indicated after removal of both the superficial and deep femoral veins. We suggest limiting the number of anastomoses (two transpositions in our series) and using external rigid support in those patients with a small saphenous vein graft (one patient in our series).

Immediate detection of postreconstructive ischaemia by intra-operative Doppler ankle pressure index monitoring during aortic reconstructions.

From March 1980 to February 1988, 368 aorto-iliac or aorto-femoral bilateral reconstructions were performed for aneurysmal or occlusive disease. In order to demonstrate early postreconstructive ischaemic complications, the intra-operative Doppler Ankle Pressure Index (API) was measured immediately before reconstruction (PRE), just after declamping (DEC) and 5, 15, 30 and 45 min thereafter. Each limb of the reconstruction (736) was considered individually and subdivided as follows: Group (A) 705 immediately successful (96% of limbs and 92% of patients); Group (B) 22 (3% of limbs and 5% of patients) in which, on the grounds of API data, an ischaemic complication was regarded as imminent and treated by graft revision or a peripheral thromboembolectomy (intra-operative corrections); Group (C) 9 (1% of limbs and 2% of patients) in which the diagnosis of ischaemic complications was made postoperatively when the patients underwent successful reoperation. All 736 reconstructions were patent and functional at discharge of the patient. By a retrospective analysis the intra-operative APIs were studied and the features (single or associated) suggesting an ischaemic complication examined. These were: (1) no flow at the time of declamping or its disappearance during the operation (10 cases, 1.25% of limbs) all detected and successfully corrected intra-operatively.(ABSTRACT TRUNCATED AT 250 WORDS)

Suprarenal aortic cross-clamping in elective abdominal aortic aneurysm surgery.

INTRODUCTION: this retrospective study was undertaken to evaluate whether suprarenal aortic cross-clamping increased the perioperative mortality and morbidity as compared to infrarenal clamping, in order to create the rationale for a more extensive application of this apparently more traumatic manoeuvre. MATERIALS AND METHODS: in a series of 734 elective aortic substitutions for abdominal aneurysm (AA), performed consecutively from January 1992 to June 1999, aortic cross-clamping was performed at a suprarenal level in 56 juxtarenal aneurysms, i.e. aneurysms extending to the lower edge of the renal arteries (8%, Group 1), and at an infrarenal level in 634 subrenal aneurysms (92%, Group 2). When analysing preoperative data, the diameter of aneurysms was larger in Group 1 than in Group 2 (p<0. 005). No significant differences were found between the two groups as regards age, sex, postinfarction cardiomyopathy, chronic obstructive pulmonary disease, chronic renal insufficiency and ASA classification of operative risks. RESULTS: the average time of renal exclusion in the juxtarenal aneurysms was 20 min (range 12-35 min). There is no difference between the two groups as regards the time of aortic clamping (mean 50 vs. 60 min) or the need for homologous blood transfusion (7% vs. 11% of patients). Perioperative (30 days) mortality did not differ: 3.6% vs. 1.9% (n.s.); nor did the incidence of acute myocardial infarction (3.6% vs. 2.3%). Renal function deteriorated in 8 (14%) vs. 0 (0%) (p<0.001) and 1 patient (2%) required permanent dialysis, as compared to 0% in Group 2. The incidence of ischaemic colitis was also significantly higher in Group 1 (7%) than in Group 2 (2%, p<0.01). CONCLUSION: this data shows that suprarenal clamping, which is necessary for the radical treatment of juxtarenal aortic aneurysms, can be performed with a low risk.