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Enzo Ballotta

Publications and source records attributed to Enzo Ballotta.

At least 19 recordsLinked to original sources

High-grade symptomatic and asymptomatic carotid stenosis in the very elderly. A challenge for proponents of carotid angioplasty and stenting.

BACKGROUND: Carotid angioplasty and stenting (CAS) is often considered as the preferred treatment for severe carotid occlusive disease in patients labelled as "high risk", including those aged 80 or more. We analyzed 30-day stroke risk and death rates after carotid endarterectomy (CEA) for severe symptomatic or asymptomatic carotid disease in patients aged 80 or more, by comparison with the outcome of CAS reported in the recently- published literature. METHODS: A retrospective review was conducted on a prospectively compiled computerized database of all primary CEAs performed by a single surgeon at our institution from 1990 to 2003. Descriptive demographic data, risk factors, surgical details, perioperative strokes and deaths, and other complications were recorded. RESULTS: In all, 1260 CEAs were performed in 1099 patients; 1145 were performed in 987 patients less than 80 years old, and 115 were performed in 112 patients aged 80 or more. There were 11 perioperative strokes in the 1145 procedures in the younger group, for a stroke rate of 0.8%, and no strokes in the 115 procedures in the older group. The death rates were 0% for the octogenarians and 0.3% for the younger group. CONCLUSION: The conviction that older age means higher risk needs to be revised. Patients aged 80 or more can undergo CEA with no more perioperative risks than younger patients. Proponents of CAS should bear this in mind before recommending CAS as the best therapeutic option for such patients.

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Cerebral hemodynamics after contralateral carotid endarterectomy in patients with symptomatic and asymptomatic carotid occlusion: a 10-year follow-up.

We sought to investigate whether carotid endarterectomy (CEA) can achieve long-term cerebral hemodynamic improvement and reduce recurrence of cerebral ischemic events in symptomatic and asymptomatic patients with severe (>70%) carotid artery stenosis contralateral to carotid occlusion (CO). Thirty-nine patients with severe carotid lesion contralateral to CO were studied before (1 day) and after CEA (at 7 days, 1, 3 and 6 months, and then yearly thereafter). Collateral flow and cerebral vasomotor reactivity (VMR) were assessed by transcranial Doppler sonography (TCD). A total of 32 unoperated patients with severe carotid lesion contralateral to CO, who were comparable with respect to age and sex, served as a control group. The average period of TCD follow-up was 10 years and was obtained in all patients; during this period, major clinical events (stroke, acute myocardial infarction and death) were also recorded. The proportion of patients with collateral flow via the anterior communicating artery increased significantly from 61.5% before to 89.7% after CEA (P = 0.01). Cerebral VMR ipsilateral to CO improved in 85.7% of patients (30 of 35) within 30 days of CEA, and in all patients within 90 days. No significant spontaneous VMR recovery was recorded in the control group. After the initial recovery, no significant change in VMR was observed in the surgical group or the control group during the follow-up. In conclusion, in patients with severe carotid stenosis, CEA contralateral to symptomatic and asymptomatic CO determines a durable cerebral hemodynamic improvement not only on the side of the CEA but also on the contralateral side, with no difference between symptomatic and asymptomatic patients.

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Extracranial severe carotid stenosis and incidental intracranial aneurysms.

Among 474 patients having 547 carotid endarterectomies (CEAs) over an 80-month period, 11 (2.3%) with symptomatic (n = 8) and asymptomatic (n = 3) severe (>70%) carotid stenosis had 12 asymptomatic intracranial aneurysms (IAs). None had postoperative stroke or died, and none had surgical or endovascular IA treatment before or after CEA. In an average 5-year follow-up, no patients had subarachnoid hemorrhage. Having an IA does not seem to be an additional risk factor for CEA, nor does CEA seem to increase the chance of IA rupture.

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Prospective randomized study on asymptomatic severe carotid stenosis and perioperative stroke risk in patients undergoing major vascular surgery: prophylactic or deferred carotid endarterectomy?

We compared the perioperative (30-day) stroke risk in asymptomatic patients with severe carotid stenosis who underwent carotid endarterectomy (CEA) before or after major vascular surgery. Seventy-nine patients with asymptomatic severe carotid lesion were randomly assigned to group I (n = 40) or group II (n = 39) to receive prophylactic CEA (within 1 week before major surgery) or deferred CEA (between 30 days and 6 months after major surgery), respectively. All procedures were eversion CEAs performed under deep general anesthesia and cerebral protection involving continuous electroencephalographic monitoring for selective shunting. There were no perioperative deaths or strokes relating to the major surgical procedure in either group. All group II patients underwent deferred CEA as planned (median 47 days, range 38-94) with no subsequent perioperative deaths or strokes. Two of these patients (5.1%) suffered a minor stroke, however, 65 and 78 days after their major surgical procedure, while awaiting carotid revascularization. Although data emerging from this analysis indicate that severe asymptomatic carotid disease may be safely postponed in patients undergoing major noncarotid vascular surgery, only a multicenter prospective study could determine the most appropriate management of this subset of patients.

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Surgical vs medical treatment for isolated internal carotid artery elongation with coiling or kinking in symptomatic patients: a prospective randomized clinical study.

BACKGROUND: Whether surgically correcting symptomatic carotid elongation with coiling or kinking in the absence of an atherosclerotic lesion of the carotid bifurcation (isolated elongation) is effective in preventing stroke remains a controversial issue. The hypothesis behind this study was that surgical correction of symptomatic isolated carotid elongation with coiling or kinking could yield better results, in terms of stroke prevention and freedom from late stroke or carotid occlusion, than medical treatment. METHODS: We conducted a prospective clinical study randomly assigning symptomatic patients with isolated carotid elongation to undergo either elective surgery or medical treatment, with surgery reserved for any new onset or worsening of symptoms. The follow-up ranged from 1 month to 10 years (median, 5.9; mean, 6.2 years) and was obtained for all patients. The study end points were perioperative (30-day) stroke and mortality, late stroke, and stroke-related death and late carotid occlusions. RESULTS: Ninety-two patients were randomly assigned for surgery and 90 for medical treatment. Overall, 139 carotid surgical corrections were performed in 129 patients. All 92 patients in the surgical arm had an elective operation; 10 of these patients later developed symptoms on the opposite side (7 hemispheric and 3 retinal transient ischemic attacks) and had contralateral internal carotid artery surgery. An additional 37 patients (41.1%) randomly assigned to medical treatment crossed over to the surgical group within a mean of 16.8 months after randomization due to new hemispheric symptoms or worsening nonhemispheric complaints. There were no perioperative strokes or deaths. The incidence of late hemispheric and retinal transient ischemic attacks was significantly lower in the surgical than in the medical group, respectively, 7.6% (7 of 92) vs 21.1% (19 of 90) (P = .01) and 3.2% (3 of 92) vs 12.2% (11 of 90) (P = .03). Late strokes, 2 (2.2%) of which were fatal, occurred only in the medical group (6 of 90, 6.6%; P = .01). Late carotid occlusions also developed only in the medical group (5 of 90, 5.5%; P = .02). All surgically treated carotid elongations were analyzed histologically and 78 (56.%) of 139 showed atypical and typical patterns of fibromuscular dysplasia. CONCLUSIONS: The overall results of this trial indicate that surgical correction of symptomatic isolated carotid elongations with coiling or kinking is better for stroke prevention than medical treatment.

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Patency and limb salvage rates after distal revascularization to unclampable calcified outflow arteries.

PURPOSE: Severe circumferential calcification of the outflow artery during lower-extremity distal revascularization is considered a poor prognostic factor for bypass graft patency. The aim of this study was to assess the influence of circumferential infrapopliteal arterial calcification on bypass graft patency and limb salvage rates, comparing patency and limb salvage rates in unclampable calcified distal outflow arteries with those observed in uncalcified distal outflow arteries. METHODS: From July 1990 to July 1997, of 441 distal bypass graft procedures performed by the same surgeon, 69 (16%, group I) involved unclampable calcified outflow vessels, whereas 83 (19%, group II) outflow vessels were uncalcified; the other 289 (65%) had varying intermediate degrees of calcification and were not included in this analysis. All procedures were performed for limb-threatening ischemia and involved standard vein patch angioplasty of the distal anastomotic site, irrespective of the conduit used. Primary and secondary patency, limb salvage, and survival rates were assessed by using Kaplan-Meier analysis. RESULTS: Groups were similar with regard to age, sex, and atherosclerotic risk factors except for a higher incidence of diabetes mellitus (88% vs 65%, P =.001) and renal failure (17% vs 5%, P =.01), including dialysis dependency (P =.01) in group I. Gangrene as an indication for surgery was statistically more frequent in group I (49% vs 29%, P =.01). The distal anastomotic locations and types of conduit involved were similar in the two groups. The femoral inflow level was used more often in group II (63% vs 38%, P =.003), the popliteal in group I (32% vs 17%, P =.03). Follow-up ranged from 30 days to 144 months, with a mean of 69 months. None of the patients were lost during the follow-up period. None of the patients died during the perioperative (30-day) period. Primary patency rates at 1, 3, and 5 years were 84%, 65%, and 52% for group I and 89%, 76%, and 69% for group II (P =.07.). Secondary patency rates at 1, 3, and 5 years were 96%, 82%, and 78% for group I and 96%, 85%, and 82% for group II (P =.58). Limb salvage rates at 1, 3, and 5 years were 93%, 83%, and 81% for group I and 97%, 90%, and 86% for group II (P =.39). CONCLUSIONS: Distal revascularization to unclampable, severely calcified outflow arteries can achieve much the same results to those obtained in uncalcified outflow arteries. A circumferentially calcified distal recipient artery should not be considered a major obstacle to an attempt at limb salvage bypass graft surgery.

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Octogenarians with contralateral carotid artery occlusion: a cohort at higher risk for carotid endarterectomy?

PURPOSE: Carotid angioplasty and stenting has been proposed as a treatment option for carotid occlusive disease in patients at high risk, including those 80 years of age or older or with contralateral carotid occlusion. We analyzed 30-day mortality and stroke risk rates of carotid endarterectomy (CEA) in patients aged 80 years or older with concurrent carotid occlusive disease. METHODS: From a retrospective review of 1000 patients undergoing 1150 CEA procedures to treat symptomatic and asymptomatic carotid lesions over 13 years, we identified 54 patients (5.4%) aged 80 years or older with concurrent contralateral carotid occlusion. These patients were compared with 38 patients (3.8%) aged 80 years or older with normal or diseased patent contralateral carotid artery and 81 patients (8.1%) younger than 80 years with contralateral carotid occlusion. All CEA procedures involved either standard CEA with patching or eversion CEA, and were performed by the same surgeon, with the patients under deep general anesthesia and cerebral protection involving continuous perioperative electroencephalographic monitoring for selective shunting. Shunting criteria were based exclusively on electroencephalographic abnormalities consistent with cerebral ischemia. RESULTS: The 30-day mortality and stroke rate in patients aged 80 years or older with concurrent contralateral carotid occlusion was zero. CONCLUSIONS: The concept of high-risk CEA needs to be revisited. Patients with two of the criteria considered high risk in the medical literature, that is, age 80 years or older and contralateral carotid occlusion, can undergo CEA with no greater risks or complications. Until prospective randomized trials designed to evaluate the role of carotid angioplasty and stenting have been completed, CEA should remain the standard treatment in such patients.

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Durability of carotid endarterectomy for treatment of symptomatic and asymptomatic stenoses.

PURPOSE: Although many studies have well established that carotid endarterectomy (CEA) is beneficial in selected patients with severe carotid disease, only a few large studies have focused on the durability of the surgical procedure. Carotid artery angioplasty and stenting (CAS) has recently been proposed as a potential alternative to CEA. We analyzed the incidence of late occlusion and recurrent stenosis after CEA. METHODS: Over 13 years 1000 patients underwent 1150 CEA procedures to treat symptomatic and asymptomatic high-grade carotid stenosis. CEA procedures involving either traditional CEA with patching (n = 302) or eversion CEA (n = 848) were all performed by the same surgeon, with patients under deep general anesthesia and cerebral protection involving continuous electroencephalographic monitoring for selective shunting. All patients underwent postoperative duplex ultrasound scanning and clinical follow-up at 1, 6, and 12 months, and yearly thereafter. New neurologic events, late occlusions, and recurrent stenoses 50% or greater were recorded. Complete follow-up (mean, 6.2 years; range, 6-156 months) was obtained in 95% of patients (949 of 1000), for an overall average of 95% of procedures (1092 of 1150). Survival analysis was performed with the Kaplan-Meier life table method. RESULTS: Perioperative (30-day) mortality rate was 0.3% (3 of 1000), and stroke rate was 0.9% (11 of 1150), with a combined mortality and stroke rate of 1.2%. The incidence of late occlusion and recurrent stenosis 70% or greater was 0.6% and 0.5%, respectively, with a combined occlusion and restenosis rate of 1.1%. Kaplan-Meier analysis showed that the rate of freedom from occlusion, restenosis 70% or greater, and combined occlusion and restenosis 70% or greater at 12 years was 99,4%, 99.5%, and 98.8%, respectively. Occlusion and restenosis developed asymptomatically. CONCLUSIONS: CEA is a low-risk procedure for treating severe symptomatic and asymptomatic carotid disease, with excellent long-term durability. Proponents of CAS should bear this in mind before considering CAS as a routine alternative to CEA.

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Prospective randomized study on reversed saphenous vein infrapopliteal bypass to treat limb-threatening ischemia: common femoral artery versus superficial femoral or popliteal and tibial arteries as inflow.

PURPOSE: Use of inflow sources distal to the common femoral artery (CFA) for bypass to infrapopliteal arteries is a compromise measure when the length of the vein is not adequate. The purpose of this study was to compare the clinical outcome of vein infrapopliteal bypass arising from the CFA and from the distal superficial femoral or popliteal and tibial arteries in patients with limb-threatening ischemia. METHODS: Over 13 years, 160 vein infrapopliteal vein bypass procedures (160 patients) were randomized into 2 groups, 80 with inflow arising from the CFA (group 1) and 80 with inflow from below the CFA (group 2). Patency and limb salvage rates were assessed with the Kaplan-Meier method. All patients underwent graft surveillance at discharge and at 30 days and 6 months after surgery, then every 6 months thereafter. Follow-up ranged from 30 days to 127 months (mean, 49 months). RESULTS: Groups were similar with regard to age, sex, and most atherosclerotic risk factors. Gangrene as an indication for surgery was statistically more frequent in group 1 (73.7% vs 48.7%; P = .002), whereas nonhealing ulcer and rest pain were statistically more frequent in group 2 (respectively, 51.2% vs 25%; P = .001 and 46.2% vs 28.7%; P = .03). No patients died during the perioperative (30 days) period. At 1, 3, and 5 years patency and limb salvage rates were comparable between groups, tending toward significance for the 5-year primary patency rate (73% vs 57%; P = .08). CONCLUSIONS: In the absence of significant proximal disease, infrapopliteal revascularization arising distal to the CFA can ensure patency and limb salvage rates statistically similar to those with use of the CFA. Moreover, procedures arising distal to the CFA required fewer graft revisions to maintain patency of failing grafts.

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Carotid endarterectomy in high-risk patients: a challenge for endovascular procedure protocols.

BACKGROUND: Many studies have sought to identify certain patient population subsets that may be more appropriate for carotid angioplasty and stenting (CAS). Current CAS protocols include "high-risk" patients. The goal of this study was to compare the perioperative outcome of carotid endarterectomy (CEA) between high-risk and non-high-risk patients. METHODS: During a 54-month period, 392 consecutive CEAs were performed in 363 patients (29 bilateral) by a single surgeon and entered prospectively into a registry. A high-risk patient subset (126, 35%) was defined by the presence of a severe medical comorbidity (ie, cardiac dysfunction, pulmonary dysfunction, renal insufficiency) or particular anatomic features (ie, contralateral carotid occlusion, ipsilateral carotid restenosis after CEA, and "high" carotid bifurcation). Of the 126 CEAs, 96 (76%) were performed for symptomatic lesions. Endpoints of the study were perioperative stroke, cardiac complication, or death. RESULTS: Overall, there were three ischemic strokes (1%) and four cardiac complications (1%). None of the patients died. The stroke and cardiac complication rates for the high-risk and non-high-risk groups were similar (1/126, 1% versus 2/237, 1% and 3/126, 2% versus 1/237, 1%, respectively), but the cardiac morbidity rate was statistically higher in patients with severe medical comorbidity (P=.03), especially in the subset with cardiac dysfunction (P=.005). CONCLUSIONS: CEA can be performed in high-risk patients with perioperative neurologic and cardiac complication rates comparable with those recorded in other patients. The definition of a "high-risk" patient should not be considered per se a reason to abandon CEA in favor of CAS.

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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.

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