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Background The known risks and benefits of native kidney biopsies are mainly based on the findings of retrospective studies. The aim of this multicentre prospective study was to evaluate the safety of percutaneous renal biopsies and quantify biopsy-related complication rates in Italy. Methods The study examined the results of native kidney biopsies performed in 54 Italian nephrology centres between 2012 and 2020. The primary outcome was the rate of major complications 1 day after the procedure, or for longer if it was necessary to evaluate the evolution of a complication. Centre and patient risk predictors were analysed using multivariate logistic regression. Results Analysis of 5304 biopsies of patients with a median age of 53.2 years revealed 400 major complication events in 273 patients (5.1%): the most frequent was a ≥2 g/dL decrease in haemoglobin levels (2.2%), followed by macrohaematuria (1.2%), blood transfusion (1.1%), gross haematoma (0.9%), artero-venous fistula (0.7%), invasive intervention (0.5%), pain (0.5%), symptomatic hypotension (0.3%), a rapid increase in serum creatinine levels (0.1%) and death (0.02%). The risk factors for major complications were higher plasma creatinine levels [odds ratio (OR) 1.12 for each mg/dL increase, 95% confidence interval (95% CI) 1.08–1.17], liver disease (OR 2.27, 95% CI 1.21–4.25) and a higher number of needle passes (OR for each pass 1.22, 95% CI 1.07–1.39), whereas higher proteinuria levels (OR for each g/day increase 0.95, 95% CI 0.92–0.99) were protective. Conclusions This is the first multicentre prospective study showing that percutaneous native kidney biopsies are associated with a 5% risk of a major post-biopsy complication. Predictors of increased risk include higher plasma creatinine levels, liver disease and a higher number of needle passes.

Background and Aim Percutaneous endoscopic gastrostomy (PEG) has been used in patients with dysphagia and inadequate food intake via an oral route. Despite being a procedure with a high success rate, complications and death have been reported. The aim was to identify the factors related to major complications and mortality, as well as PEG removal prognostic factors due to improvement of their general condition. Methods Patient characteristics, comorbidities, laboratory data, concomitant medication, sedation, and indication for PEG placement were collected. Major complications, mortality, and PEG removal factors were assessed. Results A total of 388 patients were enrolled. There were 15 (3.9%) cases of major complications, with major bleeding being the most frequent in 6 (1.5%) patients. Corticosteroids were the independent variable associated with major complications (odds ratio [OR] 5.85; 95% confidence interval [CI] 1.71–20; P =, Chronic corticosteroid users potentially a risk factor for major complications after percutaneous endoscopic gastrostomy (PEG) placement. Previous history of aspiration pneumonia was a factor associated with permanent use of PEG. Prophylactic PEG tube feeding in patients with oncological indication was the most benefited in achieving recovery.

Background: There is a paucity of robust clinical data on major postoperative complications following robotic-assisted resection for primary lung cancer. This study assessed the incidence and outcomes of patients who experienced major complications after robotic anatomic pulmonary resection. Methods: This was a multicenter, retrospective review of patients who underwent robotic anatomic pulmonary resection between 2002 and 2018. Major complications were defined as grade III or higher complications according to the Clavien–Dindo classification. Statistical analysis was performed based on patient-, surgeon-, and treatment-related factors. Results: During the study period, 1264 patients underwent robotic anatomic pulmonary resections, and 64 major complications occurred in 54 patients (4.3%). Univariate analysis identified male sex, forced expiratory volume in 1 second, diffusion capacity of the lung for carbon monoxide, neoadjuvant therapy, and extent of resection as associated with increased likelihood of a major postoperative complication. Patient age, performance status, body mass index, reoperation status, and surgeon experience did not have a significant impact on major complications. Patients who experienced at least 1 major complication were at higher risk for an intensive care unit stay of >24 hours (17.0% vs 1.4%; P < .001) and prolonged hospitalization (8.5 days vs 4 days; P < .001). Patients who experienced a major postoperative complication had a 14.8% risk of postoperative death. Conclusions: In this series, the major complication rate during the postoperative period was 4.3%. A number of identified patient- and treatment-related factors were associated with an increased risk of major complications. Major complications had a significant impact on mortality and duration of stay.

The effect of post-operative adverse events (AEs) on patient outcomes such as length of stay (LOS) and readmissions to hospital is not completely understood. This study examined the severity of AEs from a high-volume thoracic surgery center and its effect on the patient postoperative LOS and readmissions to hospital. This study includes patients who underwent an elective lung resection between September 2018 and January 2020. The AEs were grouped as no AEs, 1 or more minor AEs, and 1 or more major AEs. The effects of the AEs on patient LOS and readmissions were examined using a survival analysis and logistic regression, respectively, while adjusting for the other demographic or clinical variables. Among 488 patients who underwent lung surgery, (Wedge resection [n = 100], Segmentectomy [n = 51], Lobectomy [n = 310], Bilobectomy [n = 10], or Pneumonectomy [n = 17]) for either primary (n = 440) or secondary (n = 48) lung cancers, 179 (36.7%) patients had no AEs, 264 (54.1%) patients had 1 or more minor AEs, and 45 (9.2%) patients had 1 or more major AEs. Overall, the median of LOS was 3 days which varied significantly between AE groups; 2, 4, and 8 days among the no, minor, and major AE groups, respectively. In addition, type of surgery, renal disease (urinary tract infection [UTI], urinary retention, or acute kidney injury), and ASA (American Society of Anesthesiology) score were significant predictors of LOS. Finally, 58 (11.9%) patients were readmitted. Readmission was significantly associated with AE group ( P = 0.016). No other variable could significantly predict patient readmission. Overall, postoperative AEs significantly affect the postoperative LOS and readmission rates.

Study objective The potential of perioperative goal-directed therapy (PGDT) to improve outcome after high-risk abdominal surgery remains subject of debate. In particular, there is a need for large, multicenter trials focusing on relevant patient outcomes to confirm the evidence found in small, single center studies including minor complications in their composite endpoints. The present study therefore aims to investigate the effect of an arterial waveform analysis based PGDT algorithm on the incidence of major complications including mortality after high-risk abdominal surgery. Design Prospective randomized controlled multicenter trial. Setting Operating theatres and Post-Anesthesia/Intensive Care units (PACU/ICU) of four tertiary hospitals in The Netherlands. Patients A total number of 482 patients undergoing elective, abdominal surgery that is considered high-risk due to the extent of the procedure and/or patient comorbidities. Interventions Hemodynamic therapy using an age-specific PGDT algorithm including cardiac index (CI) and stroke volume variation (SVV) measurements during a 24-h perioperative period starting at induction of anesthesia. Measurements The average number of major complications (including mortality) within 30 days after surgery, the number of minor complications, hospital and PACU/ICU length of stay (LOS), amounts of fluids and vasoactive medications used. Complications were graded using the Accordion severity grading system. Results The average number of major complications per patient was 0.79 (PGDT group) versus 0.69 (control group) (p = 0.195). There were no statistically significant differences in the number of minor complications, hospital LOS, PACU/ICU LOS, or grading of complications. Patients in the PGDT group received more fluids intraoperatively, more dobutamine intra- and postoperatively, while patients in the control group received more phenylephrine during the operation. Conclusions PGDT based on a CI and SVV driven algorithm did not result in improved outcomes after high-risk abdominal surgery. Clinical trial registration Netherlands Trial Registry: NTR3380.

Thermal ablation of colorectal cancer liver metastases with minimum margin > 10 mm offers the best local tumor control. Biliary complications occurred only in patients that received hepatic artery infusion especially in the face of pre-existing biliary dilatation, exposure to bevacizumab, and ablation with minimum margin > 10 mm. For patients at risk, such as those in the hepatic artery infusion group, a margin of 6 to 10 mm offers 76% local tumor control rate and 4% major biliary complications incidence.Introduction: The purpose of this study was to identify risk factors associated with local tumor progression-free survival (LTPFS) and complications after colorectal liver metastases (CLM) thermal ablation (TA). Patients and Methods: This retrospective analysis included 286 patients with 415 CLM undergoing TA (radiofrequency and microwave ablation) in 378 procedures from January 2003 to July 2017. Prior hepatic artery infusion (HAI), bevacizumab, pre-existing biliary dilatation, ablation modality, minimal ablation margin (MM), prior hepatectomy, CLM number, and size were analyzed as factors influencing complications and LTPFS. Statistical analysis included the Kaplan-Meier method, Cox proportional hazards model, competing risk analysis, univariate/multivariate logistic/exact logistic regressions, and the Fisher exact test. Complications were reported according to modified Society of Interventional Radiology guidelines. Results: The median follow-up was 31 months. There was no LTP for MM > 10 mm. Smaller tumor size, increased MM, and prior hepatectomy correlated with longer LTPFS. The major complications occurred following 28 (7%) of 378 procedures. There were no biliary complications in HAI-naive patients, versus 11% in HAI patients (P 10 mm. In HAI patients, ablation with 6 to 10 mm and > 10 mm MM resulted in major biliary complication rates of 4% and 21% (P = .0011), with corresponding LTP rates of 24% and 0% (P = .0033). In HAI-naive patients, the LTP rates for 6 to 10 mm and > 10 mm MM were 27% and 0%, respectively. Conclusions: No LTP was seen for MM > 10 mm. Biliary complications occurred only in HAI patients, especially in those with biliary dilatation, bevacizumab, and MM > 10 mm. In HAI patients, MM of 6 to 10 mm resulted in 76% local tumor control and 4% major biliary complications incidence. (C) 2020 Published by Elsevier Inc.

Background: Variations in atmospheric pressure (AP) are known to affect blood pressure (BP). We assessed the effect of AP on BP, and the major fatal and nonfatal complications thereof (i.e., stroke, myocardial infarction, and pulmonary emboli). Methods: In this observational cohort study, 250 hypertensive patients (aged 65–92 years old) were followed for 3.5–5.4 years in a primary care clinic. Cox proportional hazard regression was performed to define the associations between AP, clinical, demographic and environmental factors, and major complications such as stroke, myocardial infarction, etc. Results: AP fluctuated between 1007 and 1024 millibars (MB). A total of 132 patients (53%) developed various complications, of which 13 (9.8%) were fatal. Among all fatalities, 93 of 119 nonfatal cases and 7 of 13 fatal cases occurred at AP < 1013 MB. A Cox regression analysis showed that low AP (AP < 1013 MB) had a higher hazard ratio (HR) on hypertension (HTN) complications among all demographic, clinical and environmental parameters. Conclusions: Most major complications were associated with very low APs. Low AP was the best predictive risk-factor for major complications of HTN.

The oncological impact of surgical complications has been studied in visceral and pancreatic cancer.To investigate the impact of complications on tumour recurrence after resections for pancreatic neuroendocrine tumours.We have retrospectively analysed 105 consecutive resections performed at the Royal Free London Hospital from 1998 to 2014, and studied the long-term outcome of nil-minor (3) versus major (≥3) Clavien-Dindo complications (CD) on disease-free (DFS) and overall survival (OS).The series accounted for 41 (39%) pancreaticoduodenectomies, two (1.9%) central, 48 (45.7%) distal pancreatectomies, eight (7.6%) enucleations, four (3.8%) total pancreatectomies. Sixteen (15.2%) were extended to adjacent organs, 13 (12.3%) to minor liver resections. Postoperative complications presented in 43 (40.1%) patients; CD grade 1 or 2 in 23 (21.9%), grades ≥3 in 20 (19%). Among 25 (23.8%) pancreatic fistulas, 14 (13.3%) were grades B or C. Thirty-four (32.4%) patients developed exocrine, and 31 (29.5%) endocrine insufficiency. Seven patients died during a median 27 (0-175) months follow up. Thirty-day mortality was 0.9%. OS was 94.1% at 5 years. Thirty tumours recurred within 11.7 (0.8-141.5) months. DFS was 44% at 5 years. At univariate analysis, high-grade complications were not associated with shorter DFS (p = 0.744). At multivariate analysis, no parameter was independent predictor for DFS or OS. The comparison of nil-minor versus major complications showed no DFS difference (p = 0.253).From our series, major complications after P-NETs resection are not associated to different disease recurrence; hence do not require different follow up or adjuvant regimens.

International audience; Aims: We aimed at describing outcomes and predictors of cardiac avulsion or tear (CA/T) with tamponade and vascular avulsion or tear (VA/T) after transvenous lead extraction (TLE) in the ESC-EHRA European Lead Extraction ConTRolled (ELECTRa) registry.Methods and results: A total of 3555 consecutive patients of whom 3510 underwent TLE at 73 centres in 19 European countries were enrolled. Among 58 patients (1.7%) with procedure-related major complications, 49 (84.5%) patients (30 CA/T and 19 VA/T) presented cardiovascular complications requiring pericardiocentesis, chest tube positioning and/or surgical repair. The mortality was 20% in patients with tamponade due to CA/T and 31.6% in patients with VA/T. Pericardiocentesis as first manoeuvre followed by rescue surgical repair was highly effective in case of CA/T (93.8%). At multivariate analysis, CA/T with tamponade was more common in RIATA lead extraction, female patients, leads with a mean dwelling time more than 10 years, and when ≥3 leads were extracted or multiple sheaths required. Occlusion or critical stenosis of superior venous access and the leads mean dwelling time more than 10 years were independent predictors for VA/T, while mechanical dilatation was an independent predictor of a lower incidence of this complication as compared to the use of powered sheaths.Conclusions: In the ELECTRa registry, RIATA lead extraction and superior venous access occlusion/thrombosis are two new independent predictors for cardiac tamponade and major vascular complications, respectively. The use of mechanical sheaths seems to be associated with a lower incidence of VA/T. A strategy of pericardiocentesis followed by a rescue surgical approach seems to be reasonable in order to treat a CA/T with tamponade.

Introduction: The Revised Trauma Score (RTS) accurately identifies trauma patients at high risk of adverse events or death. Less is known about its usefulness in the general population and non-trauma recipients of Helicopter Emergency Medical Service (HEMS). The RTS is a simple tool and omits a lot of other data obtained during clinical evaluation. The aim was to assess the role of the RTS to identify patients at risk of major complications (death, cardiopulmonary resuscitation, defibrillation, intubation) in the general population of HEMS patients. Clinical factors beyond the RTS were analyzed to identify additional prognostic factors for predicting major complications. Material and methods: A retrospective analysis of medical records of adult patients routinely collected during HEMS missions in the years 2011-2014 was performed. Results: The analysis included 19 554 HEMS missions. Patients were 55 ±20 years old and 68% were male. The most common indication for HEMS was diseases of the circulatory system - 41%. Major complications occurred in 2072 (10.6%) cases. In the general population of HEMS patients, the RTS accurately identified individuals at risk of major complications at a cut-off value of 10.5 and area under the curve (AUC) of 93.5%. In multivariate analysis, additional clinical data derived from clinical examination (ECG; skin, pupil and breathing examination) significantly but marginally improved the accuracy of RTS assessment: AUC 95.6% (p < 0.001 for the difference). Conclusions: The Revised Trauma Score accurately identifies individuals at risk of major complications during HEMS missions regardless of the indication. Additional clinical data significantly but marginally improved the accuracy of RTS in the general population of HEMS patients

The purpose of this study was to determine whether the Intubation Difficulty Scale is meaningful when used with indirect laryngoscopes. Data were analysed from previously published clinical trials from our group that compared the indirect laryngoscopes with the Macintosh laryngoscope. For each laryngoscope type, the Intubation Difficulty Scale score obtained for each tracheal intubation was correlated with data for duration of the intubation attempt and with the user rated difficulty of the intubation attempt. The strengths of the correlations between these indices were then compared for tracheas intubated with the Macintosh vs the indirect laryngoscopes. The Intubation Difficulty Scale performed well when compared with data for duration and user rated difficulty of the intubation attempts for the both direct and indirect laryngoscopy. However, the correlation between the Intubation Difficulty Scale score and both user rated difficulty (p = 0.001) and the duration of tracheal intubation (p = 0.003) were significantly stronger for the Macintosh laryngoscope compared with the indirect laryngoscopes. In contrast, the correlation between user rated difficulty scores and the data for duration of tracheal intubation was not different between the device types. The Intubation Difficulty Scale performs less well with indirect laryngoscopes than with the Macintosh laryngoscope. These findings suggest the need for caution with the use of this score with indirect laryngoscopes.