Enzo Ballotta

Surgical Versus Conservative Management for Subclinical Cushing Syndrome in Adrenal Incidentalomas: A Prospective Randomized Study

Objective:To compare the clinical outcome of patients with subclinical Cushing syndrome (SCS) due to an adrenal incidentaloma (the autonomous hypersecretion of a small amount of cortisol, which is not enough to cause clinically-evident disease) who underwent surgery or were managed conservatively. Summary Background Data:The most appropriate management of SCS patients is controversial, either adrenalectomy or close follow-up being recommended for their treatment. Methods:Over a 15-year period, 45 SCS patients were randomly selected to undergo surgery (n = 23) or conservative management (n = 22). All surgical procedures were laparoscopic adrenalectomies performed by the same surgeon. All patients were followed up (mean, 7.7 years; range, 2–17 years) clinically by 2 experienced endocrinologists 6 and 12 months after surgery and then yearly, or yearly after joining the trial, particularly monitoring diabetes mellitus (DM), arterial hypertension, hyperlipidemia, obesity, and osteoporosis. The study end point was the clinical outcome of SCS patients who underwent adrenalectomy versus those managed conservatively. Results:All 23 patients in the surgical arm had elective surgery. Another 3 patients randomly assigned to conservative management crossed over to the surgical group due to an increasing adrenal mass >3.5 cm. In the surgical group, DM normalized or improved in 62.5% of patients (5 of 8), hypertension in 67% (12 of 18), hyperlipidemia in 37.5% (3 of 8), and obesity in 50% (3 of 6). No changes in bone parameters were seen after surgery in SCS patients with osteoporosis. On the other hand, some worsening of DM, hypertension, and hyperlipidemia was noted in conservatively-managed patients. Conclusions:Based on the results of this study, laparoscopic adrenalectomy performed by skilled surgeons appears more beneficial than conservative management for SCS patients complying with our selection criteria. This trial is registered with Australian Clinical Trials Registry number, ANZCTR12608000567325.

Carotid endarterectomy with patch closure versus carotid eversion endarterectomy and reimplantation: A prospective randomized study

BACKGROUND Although carotid eversion endarterectomy (CEE) has obtained consensus providing excellent early and late results, conventional carotid endarterectomy (CEA) with or without patching continues to be considered the gold standard surgical procedure. The few studies published to date comparing CEE with CEA in a small series of patients have failed to show substantial advantages of one technique over the other, and further randomized comparative studies are still required. The purpose of this study was to compare the outcome of CEA with routine patch closure (CEAP) with that of CEE and reimplantation (CEER) of the internal carotid artery in the common carotid artery. METHODS Three hundred thirty-six primary CEAs performed in 310 patients were randomized into 2 groups, 167 CEAPs and 169 CEERs. Surviving patients underwent duplex ultrasound scan control at 30 days, 6 months, 12 months, and every postoperative year thereafter. The mean follow-up was 34 months (range, 1 to 69 months). Demographic characteristics, risk factors, associated diseases, and indications for surgery were comparable in the 2 groups. RESULTS Although the rate of intraoperative electroencephalogram changes was comparable in the 2 groups, the incidence of shunting was statistically higher in the CEAP group (28.1% vs 1.2%, P < .00001). The carotid cross-clamping time was significantly lower in the CEER group (P = .01). Although all deaths were in the CEAP group, the overall perioperative death and stroke-related death rates were comparable in the 2 groups. The perioperative stroke rate was statistically higher in the CEAP group (2.9% vs 0%, P = .03). Although the recurrent stenosis rate was comparable in the 2 groups (1.2% vs 0%), the CEAP group had a statistically higher rate of combined recurrent stenoses and occlusions (4.9% vs 0%, P = .003). The late mortality rate was similar in both groups. CONCLUSIONS Although the outcome of CEAP in this series is consistent with that of the main reported trials, the CEER procedure is less likely than CEAP to cause perioperative stroke and death and seems superior in reducing the incidence of recurrent stenosis and late occlusive events.

Common femoral artery endarterectomy for occlusive disease: An 8-year single-center prospective study

BACKGROUND Only a few operative or interventional studies have addressed the issue of isolated arterial occlusive disease at the femoral bifurcation, the early and late results reportedly being favorable in the former, controversial in the latter. The purpose of this study was to analyze the peri-operative (30-day) and long-term outcomes of isolated surgical endarterectomy in patients with occlusive disease at the common femoral artery (CFA), providing a baseline for comparison with emerging endovascular procedures. METHODS Over an 8-year period, all consecutive patients referred to our institution for claudication, rest pain, nonhealing ulcer(s), or minor tissue loss, with imaging findings of CFA occlusive disease (isolated or with additional infrainguinal lesions in the ipsilateral limb) amenable to endarterectomy of the CFA (isolated or combined with a profundoplasty or with the endarterectomy of the superficial or deep femoral artery first tract, not >1 cm long) were enrolled in the study. We excluded all patients with major tissue loss for which a contemporary infrainguinal revascularization was performed because treating the inflow disease alone would not be sufficient to heal the ischemic wound(s) owing to the presence of concomitant femoral and/or distal lesions, inadequate collateralization, or poor runoff. Descriptive demographic data, risk factors, clinical manifestations, and operative details were recorded. Primary patency (PP), assisted PP (APP), and limb salvage (LS) rates, freedom from additional proximal or distal revascularization in the ipsilateral limb, and survival were assessed using Kaplan-Meier life tables. Univariate and multivariate analyses were performed to identify which factors could influence CFA segment patency or other parameters. RESULTS In all, 117 patients were enrolled and underwent 121 CFA endarterectomies, 60.3% for claudication and 39.7% for critical limb ischemia (CLI); 30 patients were excluded because they underwent a contemporary infrainguinal revascularization. All procedures were performed with patients under regional anesthesia and took an average operating time of 1.3 +/- 0.7 hours. There were no perioperative deaths or major complications, but 8 (6.6%) local complications. A complete follow-up (mean 4.2 years) was obtained in 111 patients (115 limbs). The 7-year PP, APP, and LS rates were 96%, 100%, and 100%, respectively; the 7-year rates of freedom from further revascularization and survival were 79% and 80%, respectively. CONCLUSION Operative endarterectomy in patients with claudication or CLI for occlusive CFA disease proved safe, effective, and durable, and should provide a baseline for comparison with endovascular treatment. Proponents of endovascular procedures as a routine alternative treatment option should bear this in mind.

A prospective randomized study on bilateral carotid endarterectomy: patching versus eversion.

OBJECTIVE To compare the clinical outcome and restenosis incidence of patients who underwent carotid endarterectomy with patch closure (CEAP) on one side and carotid eversion endarterectomy (CEE) on the other. SUMMARY BACKGROUND DATA Although a few investigators have compared the results of CEAP versus CEE, no reports have compared the outcome of CEAP versus CEE in the same patient. METHODS Eighty-six patients were randomly selected for sequential surgical treatment involving either CEAP/CEE or CEE/CEAP. All patients underwent postoperative duplex ultrasound study and clinical follow-up at 1, 6, and 12 months and every year thereafter. Various factors were analyzed to ascertain any association with restenosis, and Kaplan-Meier analysis was used to estimate the risk of restenosis. RESULTS Demographic and clinical data were similar in the CEAP and CEE groups. The selective shunting rate was statistically higher in the CEAP group. There were no perioperative deaths. Although the incidence of perioperative ipsilateral stroke was not significant, CEAP patients had a rate of combined transient ischemic attacks and strokes that approached statistical significance. The mean follow-up was 40 months. CEAP patients had a significantly higher incidence of restenosis and combined occlusive events and restenoses. Kaplan-Meier analysis showed that CEE had a significantly better cumulative patency rate than CEAP and that freedom from restenoses at 24 and 36 months was 87% and 83% for CEAP and 98% and 98% for CEE, respectively. CONCLUSIONS CEE is less likely to cause perioperative neurologic complications and restenoses than CEAP. The significantly higher rate of unilateral recurrence suggests that local factors play a more important role than systemic factors in the occurrence of restenosis.

Neurosonographic monitoring of 105 spontaneous cervical artery dissections A prospective study

Objective: To monitor the sonographic course of spontaneous cervical artery dissections (sCADs) and investigate their recanalization and recurrence rates. Methods: All consecutive patients with an MRI-proven sCAD were prospectively evaluated by neurovascular ultrasound (nUS) daily while in hospital, then monthly for the first 6 months after discharge and every 6 months thereafter, for a mean follow-up period of 58 months (range, 28–96 months). Results: A total of 105 sCADs were detected in 76 patients: 61 (58.1%) involved the internal carotid artery and 44 (41.9%) the vertebral artery, while multiple sCADs were found in 4 patients (5.3%). Follow-up was obtained in 74 patients (97.3%, 103 vessels). The complete and hemodynamically significant (<50% stenosis) recanalization rates were 51.4% (53/103) and 20.4% (21/103). All but one complete recanalization occurred within the first 9 months. There were early recurrences (while in hospital) in 20 previously unaffected arteries (26.3%) and late recurrences in 2 arteries (2.7%), site of a previous sCAD. All patients (n = 6) with a family history of arterial dissection had a sCAD recurrence (4 early and 2 late) as opposed to 16 (22.8%) among those with no known familial disease (p < 0.001). Conclusions: These results suggest that most lumen changes occur within the first few months after the initial event, but recanalization may occur even after 1 year. Early recurrence is not uncommon and usually involves arteries previously unaffected by dissection, while the risk of late recurrence is low. A family history of arterial dissection is strongly associated with sCAD recurrence.

Carotid Endarterectomy within 2 weeks of minor ischemic stroke: A prospective study

OBJECTIVE Data from multicenter symptomatic trials have shown that benefit from carotid endarterectomy (CEA) was greatest in patients with carotid disease operated within 2 weeks of their last ischemic event. We prospectively analyzed the safety and benefit of CEA performed within 2 weeks of a stroke. METHODS The study involved patients with acute minor stroke admitted to two stroke units who underwent CEA within 2 weeks of their last ischemic event, once they were considered neurologically stable. Preoperative workup included scoring ischemia-related symptoms according to a modified ranking scale (mRS), carotid duplex scan, transcranial Doppler ultrasound, and head computed tomography or magnetic resonance imaging. All patients underwent neurological assessment on admission, 1 day before and 2 days after CEA, and at discharge. A complete neurological and ultrasound follow-up was performed at 1, 6, and 12 months after CEA, then yearly. All procedures were eversion CEA under deep general anesthesia, with selective shunting. Endpoints were perioperative (30-day) stroke/mortality rate or cerebral bleeding and long-term stroke recurrence or cerebral hemorrhage. RESULTS Between 2000 and 2005, 102 patients with a mRS </= 2 underwent CEA within a median 8 days of acute ischemic stroke. Shunting and contralateral carotid occlusion were found significantly correlated. There were no perioperative strokes or deaths, or cerebral hemorrhage. All patients were followed up for a mean 34 months (range 1-66) with no recurrent stroke or cerebral bleeding. CONCLUSIONS CEA can be performed within 2 weeks of carotid-related ischemic stroke with no perioperative stroke or cerebral bleeding, preventing the risk of stroke recurrence.

Results of Electroencephalographic Monitoring during 369 Consecutive Carotid Artery Revascularizations

A continuous intraoperative EEG monitoring was performed in 369 consecutive carotid artery revascularizations (CARs) (321 patients) to minimize the intraoperative neurological morbidity. There were 227 carotid endarterectomies and patch graft angioplasty (198 patients), 79 carotid eversion endarterectomies (70 patients) and 58 internal carotid artery reimplantations into the common carotid artery (48 patients). Indications for CARs were TIAs (141, 43.9%), amaurosis fugax (60, 18.6%) and fixed or partial nonprogressing stroke (14, 4.3%). One hundred and six patients (33.1%) were asymptomatic. EEG abnormalities consistent with cerebral ischemia occurred in 97 (26.3%) operations. The indwelling shunt (IS) was used in 73 cases; in the remaining 24 (24.7%), IS was not used on purpose because the surgical procedure was carried out successfully within 5-6 min after the appearance of EEG changes. All patients awoke from the anesthesia without any neurological deficit. Five patients presented with a major stroke within postoperative day 1 and 2, and 1 patient died on postoperative day 10. In 2 of these cases, the intraoperative EEG monitoring was absolutely normal and the IS was not used: the carotid occlusion was due to technical errors. The most striking finding of this series is the absence of false-negative results in continuous EEG monitoring. EEG monitoring appears an available and useful method for the detection of cerebral ischemia secondary to carotid cross-clamping and contributes to put at zero the intraoperative complications of the surgical procedure.

Jugular veins in transient global amnesia: innocent bystanders.

Background and Purpose— Transient global amnesia (TGA) has been associated with an increased prevalence of internal jugular valve insufficiency and many patients report Valsalva-associated maneuvers before TGA onset. These findings have led to the assumption of hemodynamic alterations in intracranial veins inducing focal hippocampal ischemia. We investigated this hypothesis in patients with TGA and control subjects. Methods— Seventy-five patients with TGA and 75 age- and sex-matched healthy subjects were enrolled into a cross-sectional study. Extracranial and transcranial high-resolution venous echo-color-Doppler sonography was performed blindly in all patients and control subjects. Blood flow direction and velocities were recorded at the internal jugular veins, basal veins of Rosenthal, and vein of Galen, both at rest and during Valsalva-associated maneuvers. Results— Mean age of patients with TGA was 60.3±8.0 years (median, 60 years; range, 44–78 years); 44 (59%) were female (female/male ratio: 1.42). Internal jugular valve insufficiency (left, right, or bilateral) was found to be more frequent in patients with TGA than in control subjects: 53 (70.7%) versus 22 (29.3%; P<0.05). Blood flow velocities in the deep cerebral veins of patients with TGA did not differ from control subjects both at rest and during Valsalva-associated maneuvers. Intracranial venous reflux was neither observed in patients with TGA nor in control subjects despite unilateral or bilateral internal jugular valve insufficiency during prolonged and maximal Valsalva-associated maneuvers. Conclusions— This study, although confirming the association between TGA and internal jugular valve insufficiency, challenges the hypothesis that cerebral venous congestion plays a significant role in the pathogenesis of TGA.

Selective shunting with eversion carotid endarterectomy.

PURPOSE The consensus is that eversion carotid endarterectomy (CEA) is a safe, effective, and durable surgical technique. Concern remains, however, regarding insertion of a shunt during the procedure. We studied the advisability of shunting with eversion CEA by comparing patients who underwent eversion CEA with and without shunting. METHODS Over 9 years, 624 primary eversion CEAs were performed in 580 selected patients to treat symptomatic (n = 398, 63.8%) and asymptomatic (n = 226, 36.2%) carotid lesions. All eversion CEAs were performed by the same surgeon (E.B.), with the patient under deep general anesthesia, with continuous electroencephalographic (EEG) monitoring for selective shunting, based exclusively on EEG changes consistent with cerebral ischemia. A Pruitt-Inahara shunt was used in 43 eversion CEAs (6.9%). All patients underwent postoperative duplex ultrasound scanning and clinical follow-up at 1, 6, and 12 months and once a year thereafter. Mean follow-up was 52 months (range, 3-91 months). The main end points were perioperative (30-day) stroke and death, and recurrent stenosis. RESULTS No perioperative death occurred in this series. Overall, ischemic perioperative stroke occurred in 4 of 624 patients (0.6%). Two strokes were minor and two were major. Only one (major) stroke occurred in the group with shunt insertion (1 of 43, 2.3%; P = not significant); the everted internal carotid artery was patent. Long-term follow-up was performed in all living patients. There was no late recurrent stenosis (>50%), and one late asymptomatic occlusive event occurred in the group without shunt insertion. CONCLUSIONS Shunt insertion can be safely performed during eversion CEA. Perioperative mortality and morbidity after eversion CEA are not statistically modified with shunting.

Natural history of ascending thrombosis of the abdominal aorta

During 1980, 30 patients underwent successful operations for ascending thrombosis of the abdominal aorta in its three forms: low (below the inferior mesenteric artery, 11 patients); middle (above the inferior mesenteric artery, 6 patients); and high (at the level of the renal arteries, 13 patients). An angiogram that reveals high ascending thrombosis of the abdominal aorta is paradoxically more favorable than one that reveals middle or low ascending thrombosis of the abdominal aorta. In fact, the patient with a juxtarenal thrombosis has already overcome two of the three phases that constitute the critical moments of potential failure of the collateral circulation. Progressive ascending thrombosis with a poor prognosis and a rapidly downward course can cause acute ischemia with paraplegia of the legs and intestinal infarction. Most patients die suddenly in the emergency or intensive care unit from paraplegia, acute abdomen, or anuria; the latter is due to further progressive thrombosis with obstruction of the orifice of the renal arteries. On the basis of the angiogram only (apart from subjective symptoms), ascending thrombosis of the abdominal aorta constitutes an absolute indication for surgical treatment.