Modifications in Near Infrared Spectroscopy for Cerebral Monitoring During Carotid Endarterectomy in Asymptomatic and Symptomatic Patients.

BACKGROUND: To evaluate trends and differences in Near Infrared Spectroscopy (NIRS) monitoring during carotid endarterectomy (CEA) in patients affected by asymptomatic and symptomatic carotid artery stenosis, to predict postoperative neurological complications (PNCs). METHODS: NIRS data of CEAs performed in a University Hospital were retrospectively reviewed. All the interventions were performed under general anesthesia and patients with intraoperative complications were excluded. Mean regional Oxygen Saturation Index (rSO2), pre-clamp values (mean baseline value, MBv and Single Mark Baseline value, SMBv) were collected and compared to the lowest rSO2 values during carotid cross-clamp (LSO2v) calculated within 3 min (percentage drop, PD). ROC curve analysis with Youden's Test was performed to determine the best threshold value of PD, in order to identify PNCs in both asymptomatic and symptomatic groups. RESULTS: Between 2007 and 2015, a total of 399 CEAs were consecutively performed with NIRS monitoring. Three-hundred-seventy-two CEAs in 355 patients were reviewed. Asymptomatic stenoses were 291 (81.9%), eleven (2.9%) PNC were registered (5 in asymptomatic and 6 in symptomatic group). Asymptomatic and symptomatic diseases had different MBv (69.5 ± 7.5 vs. 71.8 ± 6.9, respectively; P = 0.011) and similar rSO2 value during carotid clamping (63.7 ± 8.0 vs. 63.7 ± 6.7, respectively: P = 0.958). Asymptomatic patients experiencing PNCs had a greater PD than non-PNCs group (20.5 ± 10.2% vs. 12.5 ± 7.6%, respectively using MBv as baseline value; P = 0.002), in contrast, in symptomatic patients, in which a low PD was associated with PNCs, it does not reach statistical significance (using MBv, 12.6 ± 5.4% vs. 14.8 ± 6.7%, respectively; P= 0.476). In order to detect PNCs, ROC analysis revealed an optimal PD cut-off value of -17% in asymptomatic CEAs. (Sensibility (Se) 0.80, Specificity (Sp) 0.76, PPV 0.05, NPV 0.99, Youden's index 0.56; P = 0.020) In symptomatic a threshold value of -9% was found, without reaching statistical significance. CONCLUSIONS: NIRS as cerebral monitoring during CEA can predict PNCs in asymptomatic stenosis. Asymptomatic and symptomatic groups differ in baseline and intraprocedural cut-off values to detect an augmented PNCs risk.

Acute limb ischemia in patients with COVID-19 pneumonia.

Objective: The aim of our study was to determine the incidence, characteristics, and clinical outcomes of patients with the novel coronavirus (COVID-19) infection who had presented with and been treated for acute limb ischemia (ALI) during the 2020 coronavirus pandemic. Methods: We performed a single-center, observational cohort study. The data from all patients who had tested positive for COVID-19 and had presented with ALI requiring urgent operative treatment were collected in a prospectively maintained database. For the present series, successful revascularization of the treated arterial segment was defined as the absence of early (<30 days) re-occlusion or major amputation or death within 24 hours. The primary outcomes were successful revascularization, early (≤30 days) and late (≥30 days) survival, postoperative (≤30 days) complications, and limb salvage. Results: We evaluated the data from 20 patients with ALI who were positive for COVID-19. For the period from January to March, the incidence rate of patients presenting with ALI in 2020 was significantly greater than that for the same months in 2019 (23 of 141 [16.3%] vs 3 of 163 [1.8%]; P < .001)]. Of the 20 included patients, 18 were men (90%) and two were women (10%). Their mean age was 75 ± 9 years (range, 62-95 years). All 20 patients already had a diagnosis of COVID-19 pneumonia. Operative treatment was performed in 17 patients (85%). Revascularization was successful in 12 of the 17 (70.6%). Although successful revascularization was not significantly associated with the postoperative use of intravenous heparin (64.7% vs 83.3%; P = .622), no patient who had received intravenous heparin required reintervention. Of the 20 patients, eight (40%) had died in the hospital. The patients who had died were significantly older (81 ± 10 years vs 71 ± 5 years; P = .008). The use of continuous postoperative systemic heparin infusion was significantly associated with survival (0% vs 57.1%; P = .042). Conclusions: In our preliminary experience, the incidence of ALI has significantly increased during the COVID-19 pandemic in the Italian Lombardy region. Successful revascularization was lower than expected, which we believed was due to a virus-related hypercoagulable state. The use of prolonged systemic heparin might improve surgical treatment efficacy, limb salvage, and overall survival.

Role of preoperative serum creatinine and estimated glomerular filtration rate values in asymptomatic patients undergoing carotid endarterectomy.

BACKGROUND: The aim of this study was to evaluate the effect of chronic kidney disease (CKD), assessed by preoperative estimated glomerular filtration rate (eGFR) and serum creatinine (Cr), on postoperative outcomes and long-term survival in asymptomatic patients undergoing carotid endarterectomy (CEA). METHODS: We examined data about patients that underwent CEA between January 2002 and September 2014 in our Institution. Retrospective analysis to assess preoperative comorbidities and postoperative complications was performed. Modification of Diet in Renal Disease (MDRD) formula was used to calculate eGFR. Patients were divided into four groups based on values of preoperative eGFR: group A (≥90 mL/min/1.73 m2), group B (89-60 mL/min/1.73 m2), group C (59-30 mL/min/1.73 m2) and group D (≤29 mL/min/1.73 m2), and into two groups based on preoperative Cr values: group 1 (<1.5 mg/dL) and group 2 (≥1.5 mg/dL). Primary outcomes were death or the development of one or more postoperative major complications within 30 days after surgery, for each group. Survival curves of Kaplan-Meier were plotted for each group of patients to assess long-term mortality. RESULTS: During the study period, 853 CEAs in 808 patients were performed, of which 682 CEA in 645 patients for asymptomatic carotid artery stenosis. Symptomatic patients (19.58%) and patients receiving hemodialysis (0.46%) were excluded. Among CEAs analyzed, 678 (99.4%) had preoperative Cr values recorded and 637 (93.4%) had preoperative eGFR values recorded. The number of patients in each group according to eGFR values was 84 (13.2%) for group A, 250 (39.3%) for group B, 271 (42.5%) for group C and 32 (5.0%) for group D; according to Cr values was 609 (89.8%) for group 1 and 69 (10.2%) for group 2. One death and 24 (3.52%) postoperative major complications, of which 20 postoperative neurological events (NE) and 4 postoperative myocardial infarctions (MI), occurred within 30 days after surgery. The median follow-up was 55 months (IQR 27-84). Regarding general population, multivariate analysis with age found no significant correlation between Cr and primary outcomes, to the contrary of eGFR (OR=1.02; CI: 1.01-1.02; P<0.0001). No significant differences were observed concerning primary outcomes according to eGFR and Cr groups. Five-year survival rates for groups A, B, C and D were 98±0.02%, 90±0.02%, 80±0.03% and 56±0.12% respectively (P<0.0001) and 88±0.02% and 62±0.08% for group 1 and 2 respectively (P<0.0001). CONCLUSIONS: eGFR and Cr classes are not a dependable method in evaluating postoperative complications risk after CEA in asymptomatic patients, although preoperative eGFR values influence 30-days morbility. Both eGFR and Cr groups are reliable predictors to discriminate among asymptomatic patients candidates for CEA, based on their life expectancy.

Generics for the Treatment of Hepatitis C in Monoinfected and HIV-coinfected Patients: Pros and Cons.

The treatment of hepatitis C virus in monoinfected and HIV-coinfected patients has greatly changed over recent years as a result of the introduction of direct-acting antiviral agents (DAAs), which have revolutionized clinical outcomes and led to sustained virological response rates above 90-95%. The discovery of new molecules and the subsequent competition between pharmaceutical companies, together with the negotiated price policies pursued by many national health systems, have led to a gradual reduction in the cost of DAAs, and expand their use to an increasing number of patients, including those with mild liver damage. However, the cost of branded DAAs is still too high for many developing countries, and many patients are still left without therapy. In this context, the availability of generic DAAs certainly provides a major opportunity for further cost savings in industrialized countries and will ensure broader access to treatment elsewhere. However, their more widespread use must not lead to a reduction in pharmaceutical quality because this could result in serious clinical consequences, including high rat failures, and selection of drug resistance. It is therefore essential that all generic formulations of DAAs are pre-qualified by the World Health Organization, and that real-life studies are carried out to verify their pharmacokinetic bioequivalence (ideally in patients, and not just in healthy volunteers) and clinical effectiveness. In this regard, lessons from expanding access programs in the HIV field would be very helpful.