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V Stancanelli

Publications and source records attributed to V Stancanelli.

At least 19 recordsLinked to original sources

Eversion versus conventional carotid endarterectomy: late results of a prospective multicenter randomized trial.

OBJECTIVE: The durability of carotid endarterectomy (CEA) may be affected by carotid restenosis. The data from randomized trials show that the highest incidence of restenosis after CEA occurs from 12 to 18 months after surgery. The optimal CEA technique to reduce perioperative complications and restenosis rates is still undefined. This study examines the long-term clinical outcome and incidence of recurrent stenosis in patients who undergo eversion CEA. Previously published perioperative results of this study did not show statistically significant differences in study endpoints between the eversion and standard techniques. METHODS: From October 1994 to March 1997, 1353 patients with surgical indications for carotid stenosis were randomly assigned to undergo eversion (n = 678) or standard CEA (n = 675; primary closure, 419; patch, 256). Withdrawal from the assigned treatment occurred in 1.6% of the patients (in 13 assigned to eversion CEA, and in nine assigned to standard CEA). The clinical and duplex scan follow-up examination was 99% complete, and the mean follow-up interval was 33 months (range, 12 to 55 months). The primary outcomes were perioperative and late major stroke and death, carotid restenosis (stenosis >/= 50% of the lumen diameter detected at duplex scanning), and carotid occlusion. The primary evaluation of study outcomes was conducted on the basis of an intention-to-treat analysis. RESULTS: Restenosis was found at duplex scanning in 56 patients (19 in the eversion group, and 37 in the standard group). Within the standard group, the restenosis rates were 7.9% in the primary closure population and 1.5% in the patched population. Of the patients with restenosis, 36% underwent cerebral angiography that confirmed restenosis in all cases. The cumulative restenosis risk at 4 years was significantly lower in the group that underwent treatment with eversion CEA as compared with the standard group (3.6% vs 9.2%; P =.01), with an absolute risk reduction of 5. 6% and a relative risk reduction of 62%. Eighteen patients would have had to undergo treatment with eversion CEA to prevent one restenosis during the 4-year period. The incidence rate of ipsilateral stroke was 3.3% in the eversion population and 2.2% in the standard group. There were no significant differences in the cumulative risks of ipsilateral stroke (3.9% for eversion, and 2.2% for standard; P =.2) and death (13.1% for eversion, and 12.7% for standard; P =.7)) in the two groups. Of the 18 variables that were examined for their influence on restenosis, eversion CEA (hazard ratio, 0.3; 95% confidence interval, 0.2 to 0.6; P =.0004) and patch CEA (hazard ratio, 0.2; 95% confidence interval, 0.07 to 0.6; P =. 002) were negative independent predictors of restenosis with multivariate Cox proportional hazards regression analysis. CONCLUSION: The EVEREST (EVERsion carotid Endarterectomy versus Standard Trial) showed that eversion CEA is safe, effective, and durable. No statistically significant differences were found in late outcome between the eversion and standard techniques at the available follow-up examination.

Actuarial Analysis↗

A randomized study on eversion versus standard carotid endarterectomy: study design and preliminary results: the Everest Trial.

PURPOSE: The EVEREST Trial was designed to determine whether the surgical technique influences the durability and complications of carotid endarterectomy (CEA). The current report focuses on the study design and preliminary results. METHODS: EVEREST is a randomized multicenter trial. A total of 1353 patients with carotid stenosis requiring surgical treatment were randomly assigned to received standard (n = 675) or eversion (n = 678) CEA. Primary end points included carotid occlusion, major stroke, death, and restenosis rate. RESULTS: The rate of perioperative major stroke and death (1.3 for each study group) and the incidence of early carotid occlusion (0.6% for eversion vs 0.4% for standard) were similar. No significant differences were found between eversion and standard CEA with respect to incidence of perioperative transient ischemic accident, minor stroke, cranial nerve injuries, neck hematoma, myocardial infarction, or surgical defects as detected with intraoperative quality controls. Clamping time was significantly shorter for eversion CEA compared with patch standard procedures (31.7 +/- 15.9 vs 34.5 +/- 14.4 minutes, p = 0.02). A shunt was inserted in 11% of patients undergoing eversion CEAs and in 16% of patients undergoing standard procedures. Overall 30-day events occurred in 13.3% of the eversion group and in 11.4% of the standard group (p = 0.3). At a mean follow-up of 14.9 months (range, 1 to 38 months), 16 (2.4%) restenoses occurred in the eversion group and 28 (4.1%) occurred in the standard group (odds ratio, 0.56; 95% confidence interval, 0.3 to 1.1; p = 0.08). CONCLUSION: The preliminary results of the EVEREST Trial suggest that eversion CEA is a safe and rapid procedure with low major complication rates. No significant differences in restenosis rates were observed between eversion and standard CEA at the available follow-up. Longer-term results are necessary to assess whether the eversion technique influences the durability of CEA.

Adult↗

Experience with the Stentor endograft at four Italian centers.

PURPOSE: To report the outcome of an Italian multicenter trial of endovascular abdominal aortic aneurysm (AAA) exclusion using the Stentor device. METHODS: Between April 1995 and July 1996, 66 patients (63 men; average age 69 years, range 53 to 84) with infrarenal AAAs meeting the inclusion criteria were enrolled. The average diameter of the aneurysm was 4.6 cm (range 4.2 to 7). Three (4.5%) of the 66 AAAs were anastomotic aneurysms. RESULTS: Sixteen (25%) tubular and 50 (76%) bifurcated endograft procedures were attempted; 4 (6.1%) were converted and 1 terminated owing to technical faults with the bifurcated graft's second limb. One tube graft was too short and failed to exclude an anastomotic aneurysm. Sixty (91%) endograft procedures were completed successfully. Six (9.1%) vascular complications occurred, three in one patient who subsequently died of pulmonary embolism 72 hours postoperatively (1.5% mortality). There were four (6.1%) proximal endoleaks; two sealed spontaneously in < 1 month, and a third was converted (7.6% conversion rate). The fourth is being observed. Clinical success (aneurysm exclusion with no death or endoleak) at 30 days was 86.3% (57/66). In the 23-month follow-up of 57 eligible patients, 2 patients died of unrelated causes and 1 graft limb thrombosed, requiring a crossover femoral bypass. One patient was converted to surgical repair at 5 months postoperatively when increasing aneurysm size signaled an undisclosed endoleak (1.8% late conversion rate). Five other secondary endoleaks were treated with endovascular techniques. CONCLUSIONS: The Stentor was technically feasible in 10% to 40% of AAA candidates in this study, although deployment of the second limb was problematic in the bifurcated device. Introduction of the second-generation Vanguard endograft brought this study to an end.

Aged↗

Totally laparoscopic aortobifemoral bypass: a review of 10 patients.

The main purpose of this study is to evaluate the feasibility of totally laparoscopic aortobifemoral bypass for occlusive aortoiliac disease. Ten patients who had incapacitating claudication have been included to date in this investigation. We have designed a transabdominal retroperitoneal technique that allows performance of the procedure without the problems associated with retraction of intraperitoneal organs. During the study, surgery time decreased from 510 to 245 min. Mean total aortic clamping time was 121 min, and the mean time required to perform the aortic anastomosis was 66 min. Mean blood loss was 820 ml. Three patients needed conversion. Postoperative complications developed in three patients. One had an aortoureteral fistula, which needed reoperation; one experienced complications related to a retroaortic left renal vein; and the third had a mild compartment syndrome of the right leg. Totally laparoscopic aortobifemoral bypass is feasible. Laparoscopic aortobifemoral bypass appears to ease the patient's postoperative course and could become in the not so distant future part of the repertoire of the surgeon performing vascular surgery.

Adult↗

European multicentre experience with modular device (Medtronic Aneurx) for the endoluminal repair of infrarenal abdominal aortic aneurysms.

OBJECTIVE: Transfemoral endoluminal repair of AAA, introduced for the first time in the early 90's, has become a very promising alternative to conventional open repair and more and more centers are reporting satisfactory postoperative results in a high percentage of cases. Straight and bifurcated grafts represent the devices available on the market at present and aortic, as well as iliac aneurysmal lesions can be safely treated through a transfemoral approach. The possibility to indicate an endovascular AAA repair is related to the configuration (length and size) of the proximal and distal necks, tortuosity and calcification of the access arteries and to vascular and non-vascular comorbidities, which afflict the patients. The objective of our study was to evaluate the early and late postoperative results in a series of patients affected by infrarenal AAA, who underwent endoluminal repair. MATERIALS AND METHODS: From December 1996 to 31 October 1997 in 5 different European Centers, 100 Medtronic AneuRx bifurcated stent grafts were implanted for infrarenal abdominal aortic aneurysms. The diameter of the AAA varied from 33 to 77 mm (average 64 mm) and the mean age of the patients was 70.8 years (51-87 years). In one patient with a 33 mm diameter of the aneurysm, the surgical procedure was indicated because the size of the aneurysm had increased by 5 mm, compared to the previous control made 2 months before. In addition the aneurysm became symptomatic. There were 92 male and 8 female patients. The average time of the surgical procedure was 150 minutes (75-480 minutes) with an average blood loss of 570 ml (100-2,600 ml).

Aged↗

Effect of different intravenous nutrients on metabolic changes in short-term fasted man.

It is well documented (1-3) that a balanced use of nutritive solutions is important to maintain metabolic homeostasis and a better control of nutrient flux in fasting patients. In this trial, 10 healthy males, aged 30-50 years, fasted for 12 h, were subjected to intravenous nutrient loads in three separate trials. In the first trial they received only a fat emulsion, in the second fat emulsion and L-amino acid solution, and in the third fat emulsion, L-amino acid solution and glucose solution, 240 and 480 min after intravenous infusion plasma triglycerides, serum cholesterol, free fatty acids, lactate, glucose and plasma amino acids were determined. Significant biochemical changes were detected with regard to triglycerides, lactic acid, free fatty acids, alanine, glutamine, lysine and proline concentrations, depending on the different mixtures utilized.

Adult↗

[Case contribution on intraoperative cholangiography].

An assessment is made of the systematic application of intraoperative cholangiography in the light of a consecutive series gathered over a period of four years. The importance of employing this technique as a routine measure is clearly demonstrated by the results. If properly performed, it greatly reduces unnecessary choledochotomy, diminishes the incidence of overlooked calculi, and leads to the detection of papillo-oddian diseases.

Ampulla of Vater↗