WHAT THIS PAPER ADDS This is the largest systematic review and meta-analysis detailing the presentation, management, and procedural complications following carotid body tumour (CBT) surgery. Although relatively rare, complications associated with CBT are not inconsiderable, especially in the more challenging Shamblin III CBTs where procedural stroke rates were about 4%, while cranial nerve injury rates approached 20%. The increasing morbidity associated with Shamblin III tumours must be considered during the consent process.Objectives: The aim was to determine the mode of presentation and 30 day procedural risks in 4418 patients with 4743 carotid body tumours (CBTs) undergoing surgical excision. Methods: This is a systematic review and meta-analysis of 104 observational studies. Results: Overall, 4418 patients with 4743 CBTs were identified. The mean age was 47 years, with the majority being female (65%). The commonest presentation was a neck mass (75%), of which 85% were painless. Dysphagia, cranial nerve injury (CNI), and headache were present in 3%, while virtually no one presented with a transient ischaemic attack (0.26%) or stroke (0.09%). The majority (97%) underwent excision, but only 21% underwent pre-operative embolisation. Overall, 27% were Shamblin I CBTs; 44% were Shamblin II; and 29% were Shamblin III. The mean 30 day mortality was 2.29% (95% CI 1.79e2.93). The mean 30 day stroke rate was 3.53% (95% CI 2.91e4.29), while the mean 30 day CNI rate was 25.4% (95% CI 24.5e31.22). The prevalence of persisting CNI at 30 days was 11.15% (95% CI 8.42e14.64). Twelve series (544 patients) correlated 30 day stroke with Shamblin status. Shamblin I CBTs were associated with a 1.89% stroke rate (95% CI 0.92e3.82), increasing to 2.71% (95% CI 1.43e5.07) for Shamblin II CBTs and 3.99% (95% CI 2.34e 6.74) for Shamblin III tumours. Twenty-six series (1075 patients) correlated CNI rates with Shamblin status: 3.76% (95% CI 2.62e5.35) for Shamblin I CBTs, 14.14% (95% CI 11.94e16.68) for Shamblin II, and 17.10% (95% CI 14.82e19.65) for Shamblin III tumours. The prevalence of neck haematoma requiring re-exploration was 5.24% (95% CI 3.45e7.91). The proportion of patients with a neck haematoma requiring re-exploration was not reduced by pre-operative embolisation (5.92%; 95% CI 2.56e13.08) vs. no embolisation (5.82%; 95% CI 2.76e11.88). Pre-operative embolisation did not reduce drainage losses (639 mL vs. 653 mL). Conclusions: This is the largest meta-analysis of outcomes after CBT excision. Procedural risks associated with tumour excision were considerable, especially with Shamblin III tumours where 4% suffered a peri-operative stroke and 17% suffered a CNI.
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).
Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality among patients with end-stage renal disease (ESRD). Clustering of traditional atherosclerotic and non-traditional risk factors drive the excess rates of coronary and non-coronary CVD in patients with ESRD. Coronary artery disease (CAD) is a key disease process, present in ∼50% of the haemodialysis population ≥65 years of age. Patients with ESRD are more likely to be asymptomatic, posing a challenge to the correct identification of CAD, which is essential for appropriate risk stratification and management. Given the lack of randomized clinical trial evidence in this population, current practice is informed by observational data with a significant potential for bias. For this reason, the most appropriate approach to the investigation of CAD is the subject of considerable discussion, with practice patterns largely varying between different centres. Traditional imaging modalities are limited in their diagnostic accuracy and prognostic value for cardiac events and survival in patients with ESRD, demonstrated by the large number of adverse cardiac outcomes among patients with negative test results. This review focuses on the current understanding of CAD screening in the ESRD population, discussing the available evidence for the use of various imaging techniques to refine risk prediction, with an emphasis on their strengths and limitations.
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