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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.

International audience; Background: The aim of this study was to assess the impact of baseline health related quality of life (HRQOL) on the occurrence of postoperative complications and death in patients with resectable esophageal cancer. Methods: Existing data from a prospective, multicenter, open label, randomized, controlled phase III trial comparing hybrid versus open esophagectomy in patients with resectable esophageal cancer from 2009 to 2012 in France were used. A Cox regression model was used to assess the prognostic value of the baseline HRQOL score on the occurrence of major complications (MC), and major pulmonary complications (MPC) at 30 days post-surgery, as well as on 1-year postoperative overall survival (OS). Results: Every 10-point increase in the baseline role functioning score was associated with a 14% reduction in the risk of MC, while every 10-point increase in fatigue or pain score was associated with an 18% increase in the risk of MC. Similarly, higher scores on fatigue and pain were associated with a higher risk of MPC. Compared with the hybrid procedure, patients undergoing open esophagectomy had a significantly higher risk of MC and MPC. Patients diagnosed with esophageal adenocarcinoma were at significantly lower risk of MC or MPC compared to patients with esophageal squamous cell carcinoma. Higher pain (HR = 1.23, p = 0.035) and insomnia (HR = 1.16, P = 0.031) scores were associated with increased 1-year OS. Conclusion: Fatigue, pain, insomnia, and squamous cell pathology were indicators of poor prognosis, and that the presence of these findings might possibly change the management plan towards other forms of treatment and warrant close attention. © 2021

Total thyroidectomy (TT) in patients with Graves’ disease is challenging even for an experienced thyroid surgeon. This study aimed to investigate the accumulation of experience and applying newly developed devices on major complications and voice outcomes after surgery of a single surgeon over 30 years. This study retrospectively reviewed 90 patients with Graves’ disease who received TT. Forty-six patients received surgery during 1990–1999 (Group A), and 44 patients received surgery during 2010–2019 (Group B). Major complications rates were compared between Group A/B, and objective voice parameters were compared between the usage of energy-based devices (EBDs) within Group B. Compared to Group B, Group A patients had higher rates of recurrent laryngeal nerve palsy (13.0%/1.1%, p = 0.001), postoperative hypocalcemia (47.8%/18.2%, p = 0.002), and postoperative hematoma (10.9%/2.3%, p = 0.108). Additionally, Group A had one permanent vocal cord palsy, four permanent hypocalcemia, and one thyroid storm, whereas none of Group B had these complications. Group B patients with EBDs had a significantly better pitch range (p = 0.015) and jitter (p = 0.035) than those without EBDs. To reduce the major complications rate, inexperienced thyroid surgeons should remain vigilant when performing TT for Graves’ disease. Updates on surgical concepts and the effective use of operative adjuncts are necessary to improve patient safety and voice outcome.

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.

Simple Summary Skeletal muscle mass (SMM) depletion is gaining popularity as independent predictor of postoperative complications in many surgical scenarios, even in the field of head and neck oncology. In this study, we demonstrate the value of ultrasound scans of the rectus femoris muscle together with the neck CT/MRI at C3 level in terms of estimation of SMM (through muscle cross sectional area), the identification of sarcopenic patients and as a predictor of major surgical morbidity in a cohort of locally-advanced head and neck cancer patients submitted to surgical treatment. This provides important tools for the on-going re-assessment of patients with regards to any pre-habilitation strategy aimed at reducing postoperative complications. Abstract Skeletal muscle mass (SMM) depletion has been validated in many surgical fields as independent predictor of complications through cross-sectional imaging. We evaluated SMM depletion in a stage III-IV head and neck cancer cohort, comparing the accuracy of CT/MRI at C3 level with ultrasound (US) of rectus femoris muscle (RF) in terms of prediction of major complications. Patients submitted to surgery were recruited from 2016 to 2021. SMM was estimated on CT/MRI by calculating the sum of the cross-sectional area (CSA) of the sternocleidomastoid and paravertebral muscles at C3 level and its height-indexed value (cervical skeletal muscle index, CSMI) and on US by computing the CSA of RF. Specific thresholds were defined for both US and CT/MRI according to ROC curve in terms of best prediction of 30-day major complications to detect sarcopenic subjects (40–53%). Sixty-five patients completed the study. At univariate analysis, major complications were associated to lower RF CSA, lower CSA at C3 level and lower CSMI, together with previous radiotherapy, higher ASA score and higher modified frailty index (mFI). At multivariate analysis RF CSA (OR 7.07, p = 0.004), CSA at C3 level (OR 6.74, p = 0.005) and CSMI (OR 4.02, p = 0.025) were confirmed as independent predictors in three different models including radiotherapy, ASA score and mFI. This analysis proved the value of SMM depletion as predictor of major complications in a head and neck cancer cohort, either defined on cross-sectional imaging at C3 or on US of RF.

Objective Erector spinae plane (ESP) block is an alternative to neuraxial block for post-surgical pain in nephrectomy patients. However, no clinical trial has directly compared ESP block with a control group. Methods In a single-center, double-blind randomized comparative trial, patients undergoing nephrectomy with a subcostal flank incision under general anesthesia were divided into the following two groups: ESP block group (ESP block before anesthesia) and non-ESP (control) group (no intervention). The primary outcome measure was pain score (Numeric Rating Scale [NRS] 0 to 10). Secondary outcomes were postoperative opiate use, anesthetic and surgical complications, length of hospital stay, and patient-reported outcomes. Results Postoperatively (0 to 24 hours), the ESP block group experienced less pain and had lower NRS pain scores 0 to 24 hours postoperatively than the non-ESP group. Opioid consumption and the number of rescue analgesic doses decreased significantly in the ESP group compared with the non-ESP group. Patient-Reported Outcomes Information System (Quality of Recovery-15) scores significantly improved in the ESP group compared with the non-ESP block group. Conclusions Patients receiving an ESP block for intraoperative and postoperative analgesia during radical nephrectomies experienced less postoperative pain 0 to 24 hours compared with the non-ESP group.

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.

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.

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.

BACKGROUND: Textbook outcome (TO) is a multidimensional measure for quality assurance, reflecting the "ideal" surgical outcome.METHODS: Post-hoc analysis of patients who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) for all indications between 2014 and 2017, queried from the nationwide prospective Dutch Pancreatic Cancer Audit. An international survey was conducted among 24 experts from 10 countries to reach consensus on the requirements for TO in pancreatic surgery. Univariable and multivariable logistic regression was performed to identify TO predictors. Between-hospital variation in TO rates was compared using observed-versus-expected rates.RESULTS: Based on the survey (92% response rate), TO was defined by the absence of postoperative pancreatic fistula, bile leak, postpancreatectomy hemorrhage (all ISGPS grade B/C), severe complications (Clavien-Dindo ≥III), readmission, and in-hospital mortality. Overall, 3341 patients were included (2633 (79%) PD and 708 (21%) DP) of whom 60.3% achieved TO; 58.3% for PD and 67.4% for DP. On multivariable analysis, ASA class 3 predicted a worse TO rate after PD (ASA 3 OR 0.59 [0.44-0.80]), whereas a dilated pancreatic duct (>3 mm) and pancreatic ductal adenocarcinoma (PDAC) were associated with a better TO rate (OR 2.22 [2.05-3.57] and OR 1.36 [1.14-1.63], respectively). For DP, female sex and the absence of neoadjuvant therapy predicted better TO rates (OR 1.38 [1.01-1.90] and OR 2.53 [1.20-5.31], respectively). When comparing institutions, the observed-versus-expected rate for achieving TO varied from 0.71 to 1.46 per hospital after casemix-adjustment.CONCLUSIONS: TO is a novel quality measure in pancreatic surgery. TO varies considerably between pancreatic centers, demonstrating the potential benefit of quality assurance programs.

Contains fulltext : 226022.pdf (Publisher’s version ) (Closed access) BACKGROUND: Textbook outcome (TO) is a multidimensional measure for quality assurance, reflecting the "ideal" surgical outcome. METHODS: Post-hoc analysis of patients who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) for all indications between 2014 and 2017, queried from the nationwide prospective Dutch Pancreatic Cancer Audit. An international survey was conducted among 24 experts from 10 countries to reach consensus on the requirements for TO in pancreatic surgery. Univariable and multivariable logistic regression was performed to identify TO predictors. Between-hospital variation in TO rates was compared using observed-versus-expected rates. RESULTS: Based on the survey (92% response rate), TO was defined by the absence of postoperative pancreatic fistula, bile leak, postpancreatectomy hemorrhage (all ISGPS grade B/C), severe complications (Clavien-Dindo ≥III), readmission, and in-hospital mortality. Overall, 3341 patients were included (2633 (79%) PD and 708 (21%) DP) of whom 60.3% achieved TO; 58.3% for PD and 67.4% for DP. On multivariable analysis, ASA class 3 predicted a worse TO rate after PD (ASA 3 OR 0.59 [0.44-0.80]), whereas a dilated pancreatic duct (>3 mm) and pancreatic ductal adenocarcinoma (PDAC) were associated with a better TO rate (OR 2.22 [2.05-3.57] and OR 1.36 [1.14-1.63], respectively). For DP, female sex and the absence of neoadjuvant therapy predicted better TO rates (OR 1.38 [1.01-1.90] and OR 2.53 [1.20-5.31], respectively). When comparing institutions, the observed-versus-expected rate for achieving TO varied from 0.71 to 1.46 per hospital after casemix-adjustment. CONCLUSIONS: TO is a novel quality measure in pancreatic surgery. TO varies considerably between pancreatic centers, demonstrating the potential benefit of quality assurance programs.

BACKGROUND: Textbook outcome (TO) is a multidimensional measure for quality assurance, reflecting the "ideal" surgical outcome. METHODS: Post-hoc analysis of patients who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) for all indications between 2014 and 2017, queried from the nationwide prospective Dutch Pancreatic Cancer Audit. An international survey was conducted among 24 experts from 10 countries to reach consensus on the requirements for TO in pancreatic surgery. Univariable and multivariable logistic regression was performed to identify TO predictors. Between-hospital variation in TO rates was compared using observed-versus-expected rates. RESULTS: Based on the survey (92% response rate), TO was defined by the absence of postoperative pancreatic fistula, bile leak, postpancreatectomy hemorrhage (all ISGPS grade B/C), severe complications (Clavien-Dindo ≥III), readmission, and in-hospital mortality. Overall, 3341 patients were included (2633 (79%) PD and 708 (21%) DP) of whom 60.3% achieved TO; 58.3% for PD and 67.4% for DP. On multivariable analysis, ASA class 3 predicted a worse TO rate after PD (ASA 3 OR 0.59 [0.44-0.80]), whereas a dilated pancreatic duct (>3 mm) and pancreatic ductal adenocarcinoma (PDAC) were associated with a better TO rate (OR 2.22 [2.05-3.57] and OR 1.36 [1.14-1.63], respectively). For DP, female sex and the absence of neoadjuvant therapy predicted better TO rates (OR 1.38 [1.01-1.90] and OR 2.53 [1.20-5.31], respectively). When comparing institutions, the observed-versus-expected rate for achieving TO varied from 0.71 to 1.46 per hospital after casemix-adjustment. CONCLUSIONS: TO is a novel quality measure in pancreatic surgery. TO varies considerably between pancreatic centers, demonstrating the potential benefit of quality assurance programs.

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.

Background: A small tube may facilitate tracheal intubation and improve surgical access. We describe our initial experience with the Tritube (R) that is a novel cuffed endotracheal tube with a 2.4 mm internal diameter.Methods: The Tritube (R) was used in seven adult Ear-Nose-and Throat surgical patients with airway narrowing or whose surgical access was facilitated by this small-bore endotracheal tube. Ventilation through Tritube (R) is performed with the manually operated Ventrain (R)-ventilator that allows active suctioning during expiration, therefore facilitating normoventilation through small diameter airways.Results: The small diameter of Tritube (R) seemed to improve glottis visualisation during intubations and gave excellent working conditions for surgery. Two patients were intubated awake with a flexible scope and a guide wire or with an angulated video laryngoscope. One patient had almost complete glottic occlusion that just allowed for passage of the Tritube (R). Adequate ventilation was achieved in all patients and intratracheal pressure was kept between 5 and 20 cm H2O. The tube was well tolerated after emergence from anaesthesia and kept intratracheally in five awake patients in the post-operative recovery unit, in one case for more than 1 h. Ventilating with Ventrain (R) through Tritube (R) demands meticulous breath by breath measurement and adjustment of the intratracheal pressure.Conclusion: The 2.4 mm internal diameter Tritube (R) seems to facilitate tracheal intubation and to provide unprecedented view of the intubated airway during oral, pharyngeal, laryngeal or tracheal procedures in adults. This technique has the potential to replace temporary tracheostomy, jet-ventilation or extra-corporal membrane oxygenation in selected patients.

Background: A small tube may facilitate tracheal intubation and improve surgical access. We describe our initial experience with the Tritube (R) that is a novel cuffed endotracheal tube with a 2.4 mm internal diameter. Methods: The Tritube (R) was used in seven adult Ear-Nose-and Throat surgical patients with airway narrowing or whose surgical access was facilitated by this small-bore endotracheal tube. Ventilation through Tritube (R) is performed with the manually operated Ventrain (R)-ventilator that allows active suctioning during expiration, therefore facilitating normoventilation through small diameter airways. Results: The small diameter of Tritube (R) seemed to improve glottis visualisation during intubations and gave excellent working conditions for surgery. Two patients were intubated awake with a flexible scope and a guide wire or with an angulated video laryngoscope. One patient had almost complete glottic occlusion that just allowed for passage of the Tritube (R). Adequate ventilation was achieved in all patients and intratracheal pressure was kept between 5 and 20 cm H2O. The tube was well tolerated after emergence from anaesthesia and kept intratracheally in five awake patients in the post-operative recovery unit, in one case for more than 1 h. Ventilating with Ventrain (R) through Tritube (R) demands meticulous breath by breath measurement and adjustment of the intratracheal pressure. Conclusion: The 2.4 mm internal diameter Tritube (R) seems to facilitate tracheal intubation and to provide unprecedented view of the intubated airway during oral, pharyngeal, laryngeal or tracheal procedures in adults. This technique has the potential to replace temporary tracheostomy, jet-ventilation or extra-corporal membrane oxygenation in selected patients.

Introduction: The diagnosis of ankyloglossia, or tongue-tie, and the number of frenotomies performed has increased over 10-fold from 1997 to 2012 in the United States. The sharpest increase has been in neonates. For parents considering frenotomy for their breastfeeding newborn, there is controversy surrounding the evaluation of tongue-tie and the benefit of a frenotomy. Complications from tongue-tie procedures are thought to be low, though it is not well reported nor studied. Objectives: The aim of this study is to describe a case of a sublingual mucocele after laser frenotomy in a neonate with tongue-tie and to investigate major complications reported after tongue-tie release in pediatric patients through a systematic review of the literature. Case report: We present a 6-week-old female who underwent a laser frenotomy procedure performed by a dentist who presented with a new cyst under her tongue. Material and methods: A systematic literature search of articles published from 1965 to April 2020 was conducted in Ovid MEDLINE(R), Ovid EMBASE, and Scopus. Citations were uploaded into a systematic review software program (DistillerSR, Ottawa, ON, Canada), followed by full text screening. Results: 47 major complications were reported in 34 patients, including our patient. Most of the cases were located in the United States and Europe. The most frequent indications for the procedure were breastfeeding problems (n = 18) and speech impediment (n = 4). The procedure was performed by dentists (n = 6), lactation consultants (n = 5), and otolaryngologists (n = 4). The bulk of the major complications after frenotomy included poor feeding (n = 7), hypovolemic shock (n = 4), apnea (n = 4), acute airway obstruction (n = 4), and Ludwig angina (n = 2). Conclusions: Reporting of complications after frenotomy is lacking. Risks to neonates may be different than risks to older children and adults. Practitioners across different specialties should be monitoring and studying this more rigorously to better guide patients and families on the risks and benefits of this procedure.

OBJECTIVE: The aim of this study was to evaluate correlation between centers' volume and incidence of failure to rescue (FTR) following liver resection for hepatocellular carcinoma (HCC). SUMMARY BACKGROUND DATA: FTR, defined as the probability of postoperative death among patients with major complication, has been proposed to assess quality of care during hospitalization. Perioperative management is challenging in cirrhotic patients and the ability to recognize and treat a complication may be fundamental to rescue patients from the risk of death. METHODS: Patients undergoing liver resection for HCC between 2008 and 2018 in 18 Centers enrolled in the He.Rc.O.Le.S. Italian register. Early results included major complications (Clavien ≥3), 90-day mortality, and FTR and were analyzed according to center's volume. RESULTS: Among 1935 included patients, major complication rate was 9.4% (8.6%, 12.3%, and 7.0% for low-, intermediate- and high-volume centers, respectively, P = 0.001). Ninety-day mortality rate was 2.6% (3.7%, 4.2% and 0.9% for low-, intermediate- and high-volume centers, respectively, P < 0.001). FTR was significantly higher at low- and intermediate-volume centers (28.6% and 26.5%, respectively) than at high-volume centers (6.1%, P = 0.002). Independent predictors for major complications were American Society of Anesthesiologists (ASA) >2, portal hypertension, intraoperative blood transfusions, and center's volume. Independent predictors for 90-day mortality were ASA >2, Child-Pugh score B, BCLC stage B-C, and center's volume. Center's volume and BCLC stage were strongly associated with FTR. CONCLUSIONS: Risk of major complications and mortality was related with comorbidities, cirrhosis severity, and complexity of surgery. These factors were not correlated with FTR. Center's volume was the only independent predictor related with severe complications, mortality, and FTR.

BACKGROUND: Textbook outcome (TO) is a multidimensional measure for quality assurance, reflecting the "ideal" surgical outcome. METHODS: Post-hoc analysis of patients who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) for all indications between 2014 and 2017, queried from the nationwide prospective Dutch Pancreatic Cancer Audit. An international survey was conducted among 24 experts from 10 countries to reach consensus on the requirements for TO in pancreatic surgery. Univariable and multivariable logistic regression was performed to identify TO predictors. Between-hospital variation in TO rates was compared using observed-versus-expected rates. RESULTS: Based on the survey (92% response rate), TO was defined by the absence of postoperative pancreatic fistula, bile leak, postpancreatectomy hemorrhage (all ISGPS grade B/C), severe complications (Clavien-Dindo ≥III), readmission, and in-hospital mortality. Overall, 3341 patients were included (2633 (79%) PD and 708 (21%) DP) of whom 60.3% achieved TO; 58.3% for PD and 67.4% for DP. On multivariable analysis, ASA class 3 predicted a worse TO rate after PD (ASA 3 OR 0.59 [0.44-0.80]), whereas a dilated pancreatic duct (>3 mm) and pancreatic ductal adenocarcinoma (PDAC) were associated with a better TO rate (OR 2.22 [2.05-3.57] and OR 1.36 [1.14-1.63], respectively). For DP, female sex and the absence of neoadjuvant therapy predicted better TO rates (OR 1.38 [1.01-1.90] and OR 2.53 [1.20-5.31], respectively). When comparing institutions, the observed-versus-expected rate for achieving TO varied from 0.71 to 1.46 per hospital after casemix-adjustment. CONCLUSIONS: TO is a novel quality measure in pancreatic surgery. TO varies considerably between pancreatic centers, demonstrating the potential benefit of quality assurance programs.

Background Renal biopsies are essential in nephrology but they are invasive and complications can occur. The aim of this study was to explore clinical parameters that can be used as predictors for biopsy complications. Methods Clinical parameters such as demographics, biopsy indications, serology, comorbidities and clinical chemistry were retrieved from a regional biopsy registry between 2006 and 2015 and from a nationwide registry between 2015 and 2017. Clinical data before biopsy were compared with data on major biopsy complications. Fisher’s exact and χ2 tests were used and odds ratios (ORs) with 95% confidence intervals (CIs) were presented. Univariate and multiple binary logistic regression analyses were performed with complications as outcome. A two-sided P-value Results In total, 2835 consecutive native kidney biopsies were analysed (39% women and 61% men, median age 57 years). No death and nephrectomy due to biopsy complications were registered. The frequency of major biopsy complications was 5.65%. In the multiple logistic regression, the risk for complications increased in women [OR 1.51 (95% CI 1.08–2.11)] and decreased with age: 45–64 years age group [OR 0.66 (95% CI 0.44–0.99)] and >74 years age group [OR 0.51 (95% CI 0.27–0.96)]. Among comorbidities, patients with diabetes mellitus type 2 [OR 2.07 (95% CI 1.15–3.72)] and non-ischaemic heart disease [OR 3.20 (95% CI 1.64–6.25)] had a higher risk for major biopsy complications. Conclusions Female gender, younger age (≤44 years), diabetes mellitus type 2 and non-ischaemic heart disease were found as risk factors for major biopsy complications.

To review outcomes following microwave ablation (MWA) of colorectal cancer pulmonary metastases and assess predictors of oncologic outcomes.Technical success, primary and secondary technique efficacy rates were evaluated for 50 patients with 90 colorectal cancer pulmonary metastases at immediate, 4-8 weeks post-MWA and subsequent follow-up CT and/or F-18-FDG PET/CT. Local tumor progression (LTP) rate, LTP-free survival (LTPFS), cancer-specific and overall survivals were assessed. Complications were recorded according to SIR classification.Median follow-up was 25.6 months. Median tumor size was 1 cm (0.3-3.2 cm). Technical success, primary and secondary technique efficacy rates were 99, 90 and 92%, respectively. LTP rate was 10%. One-, 2- and 3-year LTPFS were: 93, 86 and 86%, respectively, with median LTPFS not reached. Median overall survival was 58.6 months, and median cancer-specific survival (CSS) was not reached. One-, 2- and 3-year overall and CSS were 94% and 98, 82 and 90%, 61 and 70%, respectively. On univariate analysis, minimal ablation margin (p = 5 mm and/or tumor size 10 ng/ml (p = 0.046) and >= 3 prior chemotherapy lines predicted decreased CSS (p = 0.02). There was no 90-day death. Major complications rate was 13%.MWA with minimal ablation margin >= 5 mm is essential for local control of colorectal cancer pulmonary metastases. Pleural-based metastases and larger tumor size were associated with higher risk of LTP. CEA level and pre-MWA chemotherapy impacted CSS.

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

Background & Objective: Ureteroscopic lithotripsy is a prevalent and minimally invasive modality for the management of ureteral calculi. This study was done evaluate to the incidence and management of major complications in 3900 cases of ureteroscopic lithotripsy. Materials & Methods: This descriptive – cross sectional study was done on 3900 cases of ureteroscopic lithotripsy in Isfahan – Iran, during 1994-2006. All complications and treatment of patients recorded. Results: Major complications occurred in 29 cases either intraoperatively or postoperatively (1 to 30 days), including ureteral perforation in 16 cases, ureteral avulsion in 7, urinoma in 4 and perinephric abcess in 2. Two cases of uretral avulsion at the ureterovesical junction underwent ureteroneocystostomy. The other 5 cases were managed by psoas hitch together with Boari flap, transureteroureterostomy, open placement of double J stent with omental wrap, and ureteroscopic placement of double J stent and ileal substitution. Urinomas were managed by percutaneous drainage of the urinoma and placement of double J stent (3 cases) and open surgery (1case). Two cases of perinephric abscess were managed by open surgical procedure and double J placement. Fourteen cases of ureteral perforation were managed by ureteroscopic double J placement and in 2 cases by open surgery. Conclusion: Ureteroscopic lithotripsy is an excellent and minimally invasive modality for the management of ureteral calculi. Major complications may occur, emphasizing the need for constant vigilance and precautionary measures.

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.