Background Tocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients. Methods A multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival. Results In the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6–24.0, P = 0.52) and 22.4% (97.5% CI: 17.2–28.3, P < 0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline. Conclusions Tocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline. Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092).
Objectives The Amplatzer Vascular Plug (AVP) is a vascular occlusion device designed to provide optimal embolization in several fields of the endovascular surgery. A full literature review was conducted to analyze AVPs in comparison with coils for the prevention of endoleaks during endovascular abdominal aortic aneurysm repair. Methods A systematic review was designed under PRISMA statement guidelines for systematic reviews and meta-analyses. The results were updated with a subsequent electronic search using Medline and Scopus databases up to December 2019. Results Eighteen articles making this comparison were found. In 79.7% of the cases, the target vessel was the internal iliac artery; in 1.6%, the common iliac artery; and in 16.7%, the inferior mesenteric artery. Risk of complications (buttock claudication, groin hematoma, endoleaks, and erectile dysfunction) after AVP was low. A cost comparison revealed that the mean cost for coils was around US$2262, while the average cost for the AVP was US$310. Conclusions The AVP is an effective and safe device for occluding peripheral vessels, proved to have lower complications rates. Compared with coil embolization, the AVP technique is potentially associated with lower procedural costs.
Background: To investigate the effects of the COVID-19 lockdowns on the vasculopathic population. Methods: The Divisions of Vascular Surgery of the southern Italian peninsula joined this multicenter retrospective study conducted through cross-sectional survey. Each received a 13-point questionnaire, investigating the hospitalization rate of vascular patients in the first 11 months of the COVID-19 pandemic and in the preceding 11 months. Results: 27 out of 29 Centers were enrolled. April-December 2020 (7092 patients) vs 2019 (9161 patients): post-EVAR surveillance, treatment for Rutherford category 3 peripheral arterial disease, and asymptomatic carotid stenosis revascularization significantly decreased [1484 (16.2%) vs 1014 (14.3%), p=0.0009; 1401 (15.29%) vs 959 (13.52%), p=0.0006; and 1558 (17.01%) vs 934 (13.17%), p<0.0001, respectively]; while revascularization or major amputations for chronic limb-threatening ischemia, and urgent revascularization for symptomatic carotid stenosis significantly increased [1204 (16.98%) vs 1245 (13.59%), p<0.0001; 355 (5.01%) vs 358 (3.91%), p=0.0007; and 153 (2.16%) vs 140 (1.53%), p=0.0009, respectively]. Conclusions: The suspension of elective activities during the COVID-19 pandemic caused a significant reduction in asymptomatic carotid stenosis revascularization, treatment for Rutherford 3 peripheral arterial disease, post-EVAR surveillance. Contestually, we observed a significant increase in urgent revascularization for symptomatic carotid stenosis, and revascularization or major amputations for chronic limb-threatening ischemia.
Background Selective crossectomy and mechanochemical ablation (MOCA) of great saphenous vein (GSV) have been used, for years, individually in the treatment of chronic venous insufficiency. In this paper, we focus on the advantages of a combination of the two techniques, in order to prevent complications and recurrence. Methods A preoperative clinical and instrumental screening phase was conducted for the purpose of dividing patients into three groups: “Saph+Cross” group (51/139 patients) underwent saphenectomy and crossectomy; “MOCA” group (44/139 patients) underwent MOCA of GSV with Flebogrif® device; “MOCA + Cross” group (44/139 patients) subjected to both MOCA and crossectomy procedures. Recurrence rate, defined as total recanalization of GSV and/or onset of neosaphena and/or new varicose veins, was used as a primary outcome. Secondary outcomes were procedural time and intra- and post-procedural complications. Results We conducted a 1-, 6-, and 12-month follow-up with Duplex scan. The recurrence rates were 3.9%, 21.8%, and 4.5% for “Saph+Cross,” “MOCA,” and “MOCA+Cross,” respectively, with a significant difference for the comparison between “MOCA” and “Saph+Cross” (MOCA vs Saph+Cross: OR 5.35, CI95% [0.98; 54.6], p-value .040). The sub-analysis of primary outcome highlighted a lower recanalization rate of GSV when combining the crossectomy with MOCA procedure (2.2% MOCA+Cross vs 15.9% MOCA; 0.12 OR, [0.002; 1.02] CI95%, p-value .029). Among the secondary outcomes, “MOCA” showed a shorter procedural time than the other groups (Saph+Cross: 51.3 ± 11.4; MOCA: 45.1 ± 7.5; MOCA+Cross: 50.4 ± 10; p-value .027). No significant differences were noted in terms of intra- and post-procedural complications. Conclusions The results showed that patients treated with saphenectomy and crossectomy have a lower recurrence rate compared to MOCA alone and MOCA + crossectomy procedures. The association of crossectomy with MOCA significantly reduces the recanalization rate of GSV, and it is also characterized by a higher free survival from recurrence (SSF) than with MOCA alone.
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