Simona Zannetti

Clinical experience with epidural cooling for spinal cord protection during thoracic and thoracoabdominal aneurysm repair

PURPOSE This report summarizes our experience with epidural cooling (EC) to achieve regional spinal cord hypothermia and thereby decrease the risk of spinal cord ischemic injury during the course of descending thoracic aneurysm (TA) and thoracoabdominal aneurysm (TAA) repair. METHODS During the interval July 1993 to Dec. 1995, 70 patients underwent TA (n = 9, 13%) or TAA (n = 61) (type I, 24 [34%], type II, 11 [15%], type III, 26 [37%]) repair using the EC technique. The latter was accomplished by continuous infusion of normal saline (4 degrees C) into a T11-12 epidural catheter; an intrathecal catheter was placed at the L3-4 level for monitoring of cerebrospinal fluid temperature (CSFT) and pressure (CSFP). All operations (one exception, atriofemoral bypass) were performed with the clamp-and-sew technique, and 50% of patients had preservation of intercostal vessels at proximal or distal anastomoses (30%) or by separate inclusion button (20%). Neurologic outcome was compared with a published predictive model for the incidence of neurologic deficits after TAA repair and with a matched (Type IV excluded) consecutive, control group (n = 55) who underwent TAA repair in the period 1990 to 1993 before use of EC. RESULTS EC was successful in all patients, with a 1442 +/- 718 ml mean (range, 200 to 3500 ml) volume of infusate; CSFT was reduced to a mean of 24 degrees +/- 3 degrees C during aortic cross-clamping with maintenance of core temperature of 34 degrees +/- 0.8 +/- C. Mean CSFP increased from baseline values of 13 +/- 8 mm Hg to 31 +/- 6 mm Hg during cross-clamp. Seven patients (10%) died within 60 days of surgery, but all survived long enough for evaluation of neurologic deficits. The EC group and control group were well-matched with respect to mean age, incidence of acute presentations/aortic dissection/aneurysm rupture, TAA type distribution, and aortic cross-clamp times. Two lower extremity neurologic deficits (2.9%) were observed in the EC patients and 13 (23%) in the control group (p < 0.0001). Observed and predicted deficits in the EC patients were 2.9% and 20.0% (p = 0.001), and for the control group 23% and 17.8% (p = 0.48). In considering EC and control patients (n = 115), variables associated with postoperative neurologic deficit were prolonged (> 60 min) visceral aortic cross-clamp time (relative risk, 4.4; 95% CI, 1.2 to 16.5; p = 0.02) and lack of epidural cooling (relative risk, 9.8; 95% CI, 2 to 48; p = 0.005). CONCLUSION EC is a safe and effective technique to increase the ischemic tolerance of the spinal cord during TA or TAA repair. When used in conjunction with a clamp-and-sew technique and a strategy of selective intercostal reanastomosis, EC has significantly reduced the incidence of neurologic deficits after TAA repair.

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.

Transcranial Doppler monitoring during carotid endarterectomy: Is it appropriate for selecting patients in need of a shunt?☆☆☆★

PURPOSE This report summarizes our experience in evaluating a series of 168 patients who underwent a total of 175 carotid endarterectomy procedures under local anesthesia. Patients were monitored by stump pressure (SP) measurement and transcranial Doppler scanning (TCD). The need for shunting was compared between SP/TCD flow velocity reduction and the awake response (gold standard). METHODS The study cohort represented 56% of all the carotid patients treated during the study period. Clamping ischemia was defined as the appearance of focal deficit (focal ischemia) or unconsciousness (global deficit) on carotid clamping. In the case of clamping ischemia, a shunt was inserted. To define the optimal value of SP and TCD flow velocity that is able to discriminate patients with clamping ischemia, a receiver operator characteristic (ROC) curve was constructed. Sensitivity and specificity tests, together with negative and positive predictive values (NPV and PPV), were calculated. Cutoff values were defined as the ROC curve values that correlated the highest sensitivity with the highest specificity for both SP and TCD. RESULTS Clamping ischemia was present in 18 procedures (10%) in which a shunt was used. No perioperative deaths were recorded. Major perioperative morbidity occurred in one patient (0.6%). Two nondisabling strokes were also recorded (1.8% overall rate of neurologic morbidity). Cutoff values for both SP and TCD, using the ROC curve, were < or = 50 mm Hg and > or = 70% flow velocity reduction from baseline, respectively. SP values of < or = 50 mm Hg or less showed a sensitivity of 100%, a specificity of 83%, a PPV of 40%, and an NPV of 100%. TCD flow monitoring (> or = 70% flow reduction) revealed a lower sensitivity (83%) but a greater ability to avoid false positive results (96% specificity), resulting in increased PPV (71%) and NPV (98%). Combining SP and TCD failed to provide better results in terms of specificity (81%) and PPV (38%). CONCLUSIONS SP measurement using a 50 mm Hg cutoff appears to be a reliable predictor of clamping ischemia but requires the use of a shunt in 17% of the patients who would otherwise not require this procedure. In contrast, TCD has greater specificity but is associated with a lower sensitivity, with 17% false negative results. In our experience, both SP and TCD show limitations, as they overestimate or underestimate carotid endarterectomy procedures in need of a shunt. We believe that sensitivity is more important than specificity in carotid endarterectomy, and thus conclude that TCD flow velocity measurement is not an optimal method for detecting clamping ischemia.

Coagulation changes during thoracoabdominal aneurysm repair

PURPOSE The cause of coagulopathic hemorrhage during thoracoabdominal aneurysm (TAA) repair has not been well defined in human studies. We investigated changes in the coagulation system associated with supraceliac versus infrarenal cross-clamping to address this critical issue. METHODS Blood levels of fibrinogen, the prothrombin fragment F1.2, D-dimer, and factors II, V, VII, VIII, IX, X, XI, and XII were analyzed in 19 patients with TAAs and four patients with abdominal aortic aneurysms (AAAs) at: (A) induction; (B) 30 minutes into supraceliac (TAA) or infrarenal (AAA) clamping; (C) 30 minutes after release of supraceliac or infrarenal clamps; and (D) immediately after surgery. Preoperative and intraoperative variables, including but not limited to aneurysm type, pathologic findings, comorbid conditions, clamp times, volume and timing of blood products, and clinical outcome, were prospectively recorded. Significance was determined by analysis of variance, Students t test, and univariate linear regression. RESULTS Levels of fibrinogen and factors II, V, VIII, VIII, IX, X, XI, and XII decreased (p < 0.05) at time B versus time A and returned to near baseline by time D. D-dimer and F1.2 increased starting at time B and reached significance (p < 0.05) by time D. Data points were compared for the TAA and AAA groups. Although AAA groups demonstrated a trend to factor activity reduction and increased fibrinolysis, the effect was much less pronounced than in TAA and did not approach significance. No correlation of coagulation change with clamping time was present; however, visceral clamping times were all less than 65 minutes (mean, 44 minutes). Blood and factor replacement was initiated after time B. Univariate regression analysis of factor level versus total blood replacement demonstrated a significant (p < 0.04) correlation between the reduction in the levels of factors II, V, VII, VIII, X, and XII, and the increase in the level of D-dimer at time B and subsequent total blood replacement. CONCLUSIONS Thoracoabdominal aneurysm repair is associated with a reduction in clotting factor activity and an increase in fibrinolytic function, which occurs after placement of the supraceliac clamp. Explanations include visceral ischemia or a greater and longer ischemic tissue burden as the likely cause of coagulation alterations. Total blood replacement during TAA procedures was correlated to the degree of factor reduction and fibrinolysis at the time of visceral cross-clamping. An aggressive approach to early blood component replacement and to coagulation monitoring could lessen blood loss during TAA repair and avoid potentially disastrous bleeding complications.

Epidural anesthesia reduces length of hospitalization after endoluminal abdominal aortic aneurysm repair

PURPOSE The low invasiveness of endoluminal abdominal aneurysm repair (EAAR) appears optimal for the use of epidural anesthesia (EA). However, reported series on EAAR show that general anesthesia (GA) is generally preferred. To evaluate the feasibility and problems encountered with EA for EAAR, patients undergoing EAAR with EA and patients undergoing EAAR with GA were examined. METHODS From April 1997 through October 1998, EAAR was performed on 119 patients at the Unit of Vascular Surgery at Policlinico Monteluce in Perugia, Italy. Four patients (3%) required conversion to open repair and were excluded from the analysis because they were not suitable candidates for evaluating the feasibility of EA. The study cohort thus comprised 115 patients undergoing abdominal aortic aneurysm (AAA) repair with the AneuRx Medtronic stent graft. The incidence of risk factors and anatomical features of the aneurysm were compared in patients selected for EA or GA on the basis of intention-to-treat analysis. Intraoperative and perioperative data were compared and analyzed on the basis of intention-to-treat and on-treatment analysis. RESULTS Sixty-one patients (54%) underwent the surgical procedure with EA (group A), and 54 (46%) underwent the surgical procedure with GA (group B). Conversion from EA to GA was required in four patients (3 of 61 patients, 5%). There were no statistically significant differences between the two study groups in demographics, clinical characteristics, and American Society of Anesthesiology classification (ASA). There was no perioperative mortality. Major morbidity occurred in 3% of patients (group B). According to intention-to-treat analysis, no significant differences were observed between the two groups in mean operating time, fluoro time, blood loss, amount of contrast media used, mean units of transfused blood, need of intensive care unit, mean postoperative hospital stay, and postoperative endoleak. Conversely, significant differences were found by means of on-treatment analysis in the need of intensive care unit (0 vs 5 patients; P =.02), and length of hospitalization (2.5 vs 3.2 days; P =.04). Multivariate logistic regression analysis showed that GA and ASA 4 were positive independent predictors of prolonged (more than 2 days) postoperative hospitalization (hazard ratio, 2.5; 95% CI, 1.1 to 5.8; P =.03, and hazard ratio, 5.1; 95% CI, 1.5 to 17.9; P =.007, respectively). CONCLUSION EA for EAAR is feasible in a high percentage of patients in whom it is attempted, and it ensures a technical outcome comparable with that of patients undergoing EAAR with GA. Successful completion of EAAR with EA is associated with a short period of hospitalization.

Role of surgical techniques and operative findings in cranial and cervical nerve injuries during carotid endarterectomy

OBJECTIVE To establish the incidence of cranial and cervical nerve injuries during CEA and their relationship to different surgical techniques and operative findings. DESIGN A prospective study. PATIENTS AND METHODS From January 1994 to April 1995, 187 consecutive patients undergoing 190 CEAs were evaluated. Pre- and postoperative cranial and cervical nerve assessments were carried out by a single otolaryngologist, blinded to the operative technique and findings. Deficits lasting more than 12 months were defined as permanent. Logistic regression analysis was performed to evaluate the influence of surgical technique, type of anaesthesia, neck haematoma, and plaque extension on the onset of nerve injuries. RESULTS Postoperatively, nerve lesions were identified in 51 CEAs (27%) and non-neurological injuries (hemilaryngeal ecchymosis or oedema) causing postoperative dysphonia were present in 80 CEAs (42%). All non-neurological injuries were transient and 98% disappeared within 1 month of surgery. Thirteen (7%) nerve lesions were permanent, but none were disabling. Vagus nerve lesions were significantly associated with long (> 2 cm) carotid plaque (OR = 3.5; CI 1.09-12.37; p = 0.03). Cervical branch lesions were associated with the presence of neck haematoma (OR = 1.9; CI 0.7-4.7; p = 0.05). The incidence of single cranial nerve injuries was higher in patch (OR = 2.7) and eversion (OR = 1.9) procedures than in primary closure. Multiple deficits (2 or more) were most frequent in eversion CEAs (OR = 2.8) and in cases complicated by neck haematoma (OR = 3.8). CONCLUSIONS Cranial and cervical nerve lesions during CEA are common. However, our data showed that the majority of local complications are related to transient hemilaryngeal ecchymosis or oedema and, when permanent, are neither clinically relevant nor disabling at 1 year of follow up. Carotid plaque extension and neck haematoma appear to increase the incidence of cranial and cervical nerve lesions during CEA.

Carotid endarterectomy contralateral to an occluded carotid artery: A retrospective case-control study

OBJECTIVES To analyse whether contralateral occlusion represents an additional perioperative risk factor in carotid endarterectomy (CEA), and whether long-term survival after surgery in patients with contralateral occlusion differs from that of patients without. DESIGN Retrospective clinical study. SETTING Vascular Surgery Unit, Department of Surgery, University of Perugia, Perugia, Italy. MATERIALS Fifty-five patients with carotid stenosis and contralateral occlusion undergoing CEA (Group 1) were compared with 110 patients (Group II), without contralateral occlusion selected from a cohort of 367 patients with a patent contralateral artery, matched for gender, age and ipsilateral symptoms. CHIEF OUTCOME MEASURES Perioperative stroke/death rate at 30 days and minor complications in Group I vs. Group II over a mean follow-up of 38 months. MAIN RESULTS The perioperative stroke/death rate at 30 days was 0% in Group I and 2.7% in Group II (p = 0.6) while minor complications amounted to 11% in Group I and 5% in Group II (p = 0.2). Survival rates of patients free from stroke, using Kaplan Meier curves, were 79.4% in Group I and 83.3% in Group II (p = 0.4); stroke free rates were 92.8% and 94.3% in Groups I and II, respectively. The incidence of late stroke, fatal or not, in patients who had undergone CEA with contralateral obstruction was the same as in similarly operated patients without contralateral obstruction (7% vs. 6%). However, the incidence of late vascular death, exemplified by a crude rate of 14% vs. 6% (p = 0.1; O.R. = 2.50; C.I. = 0.77-8.25) was greater in patients with contralateral occlusion. CONCLUSIONS In this study, CEA in patients with contralateral occlusion was not associated with an increased perioperative morbidity/mortality rate. The higher incidence of vascular death in the late follow-up of patients with contralateral carotid occlusion, although not statistically significant, could indicate the presence of more severe systemic vascular disease.

Outcome of abdominal aortic endografting in high-risk patients: a 4-year single-center study.

Purpose: To evaluate feasibility, safety, and effectiveness of endovascular abdominal aortic aneurysm (AAA) repair in patients whose fitness for surgery is questionable. Methods: Between April 1997 and December 2001, 389 consecutive patients underwent endovascular AAA repair. Of these, 51 (13.1%) were ASA grade IV. The perioperative and late outcomes of this group were compared to the remaining 338 patients with ASA grades <IV. Failure of AAA exclusion was defined as late conversion to open repair, AAA rupture, increased aneurysm diameter, or persisting graft-related endoleak. Gender, age, ASA grade IV, EUROSTAR class E, and AAA diameter were examined by logistic regression analysis for their influence on perioperative death, survival, and failure of AAA exclusion. Results: Four (7.8%) perioperative deaths occurred in the ASA IV group compared to 1 (0.3%) in the ASA <IV group (p=0.001). Median follow-up was 22 months (range 1–56). Failure of AAA exclusion occurred in 3 (5.9%) patients in ASA IV group and in 25 (7.4%) in ASA <IV group (p>0.05). Actuarial survival at 30 months was 62.9% in ASA IV group and 88.0% in ASA <IV group (p=0.001, log-rank test). There were no independent predictors for failure of AAA exclusion; ASA IV was independently associated with perioperative mortality (HR 17.8; 95% CI 1.6 to 188; p=0.016). Conclusions: Endovascular AAA repair in ASA IV patients is feasible and effective in preventing AAA rupture in the mid term. High-risk patients experience a worse prognosis than their good-risk counterparts. An individualized approach in selecting high-risk patients for endoluminal repair is mandatory.

Transcranial Doppler and Stump Pressure During Carotid Endarterectomy

To the Editor: We read with great interest the article by Finocchi et al.1 on the role of transcranial Doppler (TCD) and stump pressure (SP) during carotid endarterectomy (CEA). Having recently published a paper on the same subject,2 we would like to offer some considerations as an adjunct to the issues raised by Finocchi et al. We understand that it was the intention of the authors to assess the usefulness of SP as an indicator of hemodynamic changes predicting intraoperative cerebral ischemia. In order to do so, 112 patients who underwent CEA for symptomatic and asymptomatic severe carotid stenosis under general anesthesia were monitored by TCD and SP measurement. After examining duration of clamping, values of TCD flow reduction and of SP at clamping, microembolic signals, and perioperative complications, the authors concluded that the major complications of CEA may result from hemodynamic factors and that SP alone is not a reliable indicator of hemodynamic changes that predict clamping ischemia. In our study, we evaluated a series of 175 CEAs monitored by SP measurement and TCD and performed under local anesthesia. The need for shunting was compared between SP/TCD flow velocity reduction and the awake response. Since there is no general consensus on the appropriate SP cutoff value that indicates the need for shunting,3 4 5 we constructed a receiver operating characteristic (ROC) curve to determine the relationship between specificity and sensitivity of SP and TCD. Values that combined the highest sensitivity …

Carotid stenosis and coronary artery disease in the elderly: the vascular surgeon's point of view.

Surgical prevention of stroke is justified only when the perioperative morbidity and mortality rates are very low. Therefore, an accurate cardiac evaluation is essential for patients with a vascular disease like carotid stenosis, to reduce the surgical risk and improve prognosis. The aim of our retrospective study was to characterize subgroups of patients with high cardiac risk. From 1986 to 1993 at the Vascular Surgery Unit of the Department of Surgery and Surgical Emergencies at the University of Perugia, 857 carotid endarterectomies were performed on 739 patients. The stroke/death rate, at 30 days after surgery, was 2.16% per patient and 1.86% per procedure; cardiac mortality was 0. However, during follow-up 58 patients died: 55% of these deaths could be attributed to cardiac disease. No statistically significant differences emerged in cardiac mortality of patients with a positive history of cerebral vascular accident with respect to asymptomatics, neither among patients with carotid stenosis associated with complete contralateral occlusion nor among those without. Our group of patients had a 76% survival rate at 7 years after surgery, which is different from that reported by other studies. This may be due to some bias associated with the preoperative selection of the patients and the retrospective nature of our study. Nevertheless, in patients with carotid stenosis, the most important cause of death is cardiac ischemia, therefore a rigorous preoperative selection is mandatory particularly in elderly asymptomatic patients.