Giuseppe Da Giau

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.

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.

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.

Infrapopliteal arterial revascularization for critical limb ischemia: Is the peroneal artery at the distal third a suitable outflow vessel?

PURPOSE Though the peroneal artery (PA) often remains patent despite disease or occlusion of other infrapopliteal arteries, there is skepticism about using the terminal PA as the outflow tract in distal revascularizations for limb salvage, especially when a patent inframalleolar artery is available. We analyzed our experience of using the distal PA and inframalleolar or pedal branches arteries as outflow tracts in revascularizations for critical limb ischemia. METHODS Over a decade, among 651 infrapopliteal arterial reconstructions performed in 597 patients, the PA was the outflow vessel in 214, its distal third being involved in 69 vein revascularizations (study group). During the same period, 187 vein bypass grafts were performed to 179 inframalleolar and 8 pedal branches arteries (control group). Patency, limb salvage and survival rates were assessed using Kaplan-Meier life-table analysis. Complete follow-up (range, 0.1-10.2 years; mean, 5.8 years) was obtained in 245 (95.7%) patients (66 were in the study group). RESULTS The distal PA was chosen as the target vessel: (1) because the proximal, mid-PA was occluded or severely diseased and no other adequate inframalleolar or pedal branches arteries were identified preoperatively (n = 30; 43.5%); (2) because an alternative inframalleolar target vessel was present but severely diseased (n = 9; 13%); (3) because of the length limitations of the available vein (n = 12; 17.4%; or (4) because of the presence of invasive infection or necrosis overlying the dorsalis pedis or posterior tibial arteries (n = 18; 26.1%). The study group was significantly younger than the control group (68 +/- 7 years vs 70 +/- 6 years, P = .039), and included significantly more patients with diabetes mellitus (65.2% vs 50.2%, P = .033) and insulin dependence (52.2% vs 37.9%, P = .041), dialysis-dependent chronic kidney disease (5.8% vs 1.1%, P = .047), and history of smoking (75.3% vs 58.2%, P = .012). None of the patients died in the perioperative period. Although the overall need for minor amputation was statistically higher in the PA group (78.2% vs 63.1%, P = .022), especially as concerns partial calcanectomy (8.7% vs 2.1%, P = .026), the proportion of wounds completely healed during the follow-up and the mean time to wound healing were comparable in the two groups. Kaplan-Meier analysis showed comparable long-term patency, limb salvage, and survival rates in the two groups. CONCLUSIONS Revascularization to the distal third of the PA can achieve much the same outcome in terms of patency and limb salvage rates, wound healing rate and timing, as when other inframalleolar or pedal branches are used. The skepticism surrounding use of the terminal PA as an outflow vessel appears to be unwarranted.

Early and long-term outcomes of carotid endarterectomy in the very elderly: An 18-year single-center study

OBJECTIVE To evaluate the perioperative (30-day) and long-term outcomes of carotid endarterectomy (CEA) in elderly patients with severe symptomatic and asymptomatic carotid disease. Although the efficacy of CEA in preventing stroke in selected patients has been clearly demonstrated, concern has been expressed about the role of CEA in people over 80 years old. METHODS An analysis was conducted on a prospectively compiled computerized database of all primary CEAs performed at our institution from 1990 to 2007. Descriptive demographic data, risk factors, surgical details, perioperative strokes and deaths, and other complications were recorded. All patients underwent postoperative duplex ultrasound scanning and clinical follow-up at one, six, and 12 months, and yearly thereafter. Survival analyses were performed using Kaplan-Meier life-tables. Long-term relative survival after CEA was assessed against age- and gender-matched controls. RESULTS In all, 1769 CEAs were performed in 1562 patients, 193 of them (207 CEAs; group I) were > or = 80 years old and 1371 were younger (1562 CEAs; group II). All CEA procedures were performed with patients under deep general anesthesia with continuous perioperative EEG monitoring for selective shunting. No strokes or deaths occurred in group I, whereas there were 11 perioperative strokes and three deaths in group II (1%). A complete follow-up (median, 5.2 years) was obtained in 185 elderly patients: no late occlusions or restenoses were detected, while the seven-year freedom from stroke and death were 96.6% and 52.4%, respectively. The relative seven-year survival rate was 99.8%. CONCLUSIONS CEA in elderly patients proved safe and effective, with an excellent long-term durability. The long-term relative survival after CEA in elderly patients was better than in an age-and gender-matched population, so the likelihood of living long enough to benefit from CEA is not jeopardized by being very elderly.

Gender-based outcomes after eversion carotid endarterectomy from 1998 to 2009

BACKGROUND AND PURPOSE Although the benefit of carotid endarterectomy (CEA) in reducing the risk of stroke in selected symptomatic and asymptomatic patients has been well documented, the higher incidence of adverse events after CEA for women than for men remains controversial. The purpose of this study was to analyze the effect of female gender on perioperative (30-day) and long-term outcomes after eversion CEA (eCEA). METHODS Patients entered into a prospectively compiled computerized database of all primary consecutive eCEAs performed at our institution from September 1998 to December 2009 were analyzed. Endpoints were perioperative death and stroke, late carotid restenosis or occlusion, and long-term freedom from stroke and survival rates. Long-term follow-up was obtained in 96.8% of patients (97.5% of the women). RESULTS Among 1294 patients who underwent 1458 eCEAs under general anesthesia with continuous electroencephalographic monitoring and selective shunting, 409 (31.6%) were women (466 eCEAs). More women than men were over 80 years old (P = .001), and female patients were more likely to have arterial hypertension (P = .02) or hyperlipidemia (P = .006) than male patients. Preoperative statin medication (P = .01), contralateral carotid occlusion (P = .02), and shunting use (P = .03) were more frequent among female patients. No perioperative deaths occurred in the series as a whole, while the perioperative stroke risk (0.6% vs 0.5%), and the combined late carotid restenosis and occlusion rate (1.1% vs 0.4%) were comparable between female and male patients. The 7-year stroke-free survival and overall survival rates did not differ significantly between female and male patients (98.3% vs 98.8% and 87.2% vs 93.8%, respectively). CONCLUSIONS This single-center university hospital study shows that although women have a different cardiovascular risk profile from men when they undergo eCEA, there is no evidence of a different gender effect on perioperative and long-term outcomes.

Lower extremity arterial reconstruction for critical limb ischemia in diabetes

BACKGROUND The impact of diabetes mellitus on the technical and clinical outcomes of infrainguinal arterial reconstruction (IAR) for critical limb ischemia (CLI) remains controversial. This study analyzed the outcome of IAR in diabetic patients with CLI over a 17-year period. METHODS Details on all consecutive patients undergoing primary IAR at our institution were stored prospectively in a vascular registry from 1995 to 2011. Demographics, risk factors, indications for surgery, inflow sources and outflow target vessels, types of conduit, and adverse outcomes were analyzed. Postoperative surveillance included clinical examination, duplex scans, and ankle-brachial index measurements in all patients at discharge, 1 and 6 months after surgery, and every 6 months thereafter. End points were patency, limb salvage, survival, and amputation-free survival rates, and were assessed using Kaplan-Meier life-table analysis. The χ(2) or Fisher exact, Student t, and log-rank tests were used to establish statistical significance. RESULTS Overall, 1407 IARs were performed in 1310 patients with CLI by the same surgeon, 705 (50.2%) in 643 diabetic patients and 702 in 667 nondiabetic patients. Autogenous vein conduits were used in 87% of the IARs. There were no perioperative deaths. Diabetic patients had significantly more major (16.7% vs 11.8%; P = .02) and minor complications (9.7% vs 6.5%; P = .02) than nondiabetic patients. At 5 and 10 years, there were no significant differences between diabetic and nondiabetic patients in the rates of primary patency (65% and 46% vs 69.5% and 57%; log-rank test, P = .09), secondary patency (76% and 60% vs 80% and 68%; log-rank test, P = .20), limb salvage (88% and 76% vs 91% and 83%; log-rank test, P = .12) survival (51% and 34% vs 57% and 38%; log-rank test, P = .41), or amputation-free survival (45.5% and 27% vs 51% and 29%; log-rank test, P = .19). The type of conduit did not affect patency or limb salvage rates in either group. CONCLUSIONS Diabetic patients receiving IAR for CLI can have the same survival and amputation-free survival rates as nondiabetic patients. Their comparable technical and clinical outcomes strongly demonstrate that diabetics with CLI can expect the same quantity and quality of life as nondiabetics with CLI, and aggressive attempts at limb salvage in patients with diabetes mellitus, including distal and foot level bypass grafting, should not be discouraged.

Carotid endarterectomy and contralateral internal carotid artery occlusion: Perioperative risks and long-term stroke and survival rates ☆ ☆☆

BACKGROUND The aim of this article was to analyze the perioperative mortality and stroke risk rates and late benefits of carotid endarterectomy (CE) contralateral to an occluded internal carotid artery (ICA), on the basis of our surgical experience from July 1990 to June 1996. METHODS In 57 (14.7%) of 336 patients undergoing 388 CEs, the contralateral ICA was occluded (group I). All operations were performed under general anesthesia with selective shunting based on electroencephalographic criteria. Shunting was used in 36 (63.1%) of 57 revascularizations in group I and 47 (14.2%) of 331 operations performed on the remaining 279 patients with patent contralateral ICAs (group II) (p < 0.001). RESULTS Perioperative strokes occurred in two patients (3.5%) in group I and three patients (1%) in group II (difference not significant). The only perioperative death, which occurred in one patient (1.7%) in group I, was the result of a perioperative stroke; two patients (0.7%) in group II died within 30 days of operation (difference not significant). Life-table cumulative stroke-free rates at 1, 3, and 5 years were 95%, 95%, 95% in group I and 98.8%, 98.2%, and 98.2% in group II, respectively (p = 0.272). Life-table cumulative survival rates at 1, 3, and 5 years were 97.5%, 94.2%, and 78.1% in group I and 99.2%, 94.8%, and 71.7% in group II, respectively (p = 0.306). CONCLUSIONS The results of this analysis indicate that CE contralateral to an occluded ICA can be performed with acceptable perioperative mortality and stroke risk rates and late stroke-free and survival rates comparable to those seen in patients without contralateral ICA occlusion who have undergone operation. Nevertheless, we think it is misleading to imply that the risks of operating on the two groups are the same. Moreover, because no late stroke-related death occurred in patients with contralateral ICA occlusion, it would appear that superior late stroke-free rates did not translate into a prolonged survival advantage.