Categorisation of complications and validation of the Clavien score for percutaneous nephrolithotomy.

BACKGROUND: Although widely used, the validity and reliability of the Clavien classification of postoperative complications have not been tested in urologic procedures, such as percutaneous nephrolithotomy (PCNL). OBJECTIVE: To validate the Clavien score and categorise complications of PCNL. DESIGN, SETTING, AND PARTICIPANTS: Data for 528 patients with complications after PCNL were used to create a set of 70 unique complication-management combinations. Clinical case summaries for each complication-management combination were compiled in a survey distributed to 98 urologists, who rated each combination using the Clavien classification. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Interrater agreement for Clavien scores was estimated using Fleiss' kappa (κ). The relationship between Clavien score and the duration of postoperative hospital stay was analysed using multivariate nonlinear regression models that adjusted for operating time, preoperative urine microbial culture, presence of staghorn stone, and use of postoperative nephrostomy tube. RESULTS AND LIMITATIONS: Overall interrater agreement in grading postoperative complications was moderate (κ=0.457; p<0.001). Agreement was highest for Clavien score 5 and decreased with lower Clavien scores. Higher agreement was found for Clavien scores 3 and 4 than in subcategories of these scores. Postoperative stay increased with higher Clavien scores and was unaffected by inherent differences between study centres. A standard list of post-PCNL complications and their corresponding Clavien scores was created. CONCLUSIONS: Although the Clavien classification demonstrates high validity, interrater reliability is low for minor complications. To improve the reliability and consistency of reporting adverse outcomes of PCNL, we have assigned Clavien scores to complications of PCN

In-hospital and 6-month outcomes in patients with COVID-19 supported with extracorporeal membrane oxygenation (EuroECMO-COVID): a multicentre, prospective observational study

Background: Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with COVID-19, but uncertainty remains about the determinants of in-hospital mortality and data on post-discharge outcomes are scarce. The aims of this study were to investigate the variables associated with in-hospital outcomes in patients who received ECMO during the first wave of COVID-19 and to describe the status of patients 6 months after ECMO initiation. Methods: EuroECMO-COVID is a prospective, multicentre, observational study developed by the European Extracorporeal Life Support Organization. This study was based on data from patients aged 16 years or older who received ECMO support for refractory COVID-19 during the first wave of the pandemic—from March 1 to Sept 13, 2020—at 133 centres in 21 countries. In-hospital mortality and mortality 6 months after ECMO initiation were the primary outcomes. Mixed-Cox proportional hazards models were used to investigate associations between patient and management-related variables (eg, patient demographics, comorbidities, pre-ECMO status, and ECMO characteristics and complications) and in-hospital deaths. Survival status at 6 months was established through patient contact or institutional charts review. This study is registered with ClinicalTrials.gov, NCT04366921, and is ongoing. Findings: Between March 1 and Sept 13, 2020, 1215 patients (942 [78%] men and 267 [22%] women; median age 53 years [IQR 46–60]) were included in the study. Median ECMO duration was 15 days (IQR 8–27). 602 (50%) of 1215 patients died in hospital, and 852 (74%) patients had at least one complication. Multiorgan failure was the leading cause of death (192 [36%] of 528 patients who died with available data). In mixed-Cox analyses, age of 60 years or older, use of inotropes and vasopressors before ECMO initiation, chronic renal failure, and time from intubation to ECMO initiation of 4 days or more were associated with higher in-hospital mortality. 613 patients did not die in hospital, and 547 (95%) of 577 patients for whom data were available were alive at 6 months. 102 (24%) of 431 patients had returned to full-time work at 6 months, and 57 (13%) of 428 patients had returned to part-time work. At 6 months, respiratory rehabilitation was required in 88 (17%) of 522 patients with available data, and the most common residual symptoms included dyspnoea (185 [35%] of 523 patients) and cardiac (52 [10%] of 514 patients) or neurocognitive (66 [13%] of 512 patients) symptoms. Interpretation: Patient's age, timing of cannulation (<4 days vs ≥4 days from intubation), and use of inotropes and vasopressors are essential factors to consider when analysing the outcomes of patients receiving ECMO for COVID-19. Despite post-discharge survival being favourable, persisting long-term symptoms suggest that dedicated post-ECMO follow-up programmes are required. Funding: None