Early Adverse Events Research Articles

Attachment, suicidal behavior, and self-harm in childhood and adolescence: a study of a cohort of Brazilian schoolchildren

BackgroundAttachment influences the development and the formation of the self and subjectivity and, just as early adverse events, may be related to the occurrence of mental disorders, suicidal behavior, and self-harm throughout life. This study aimed to analyze the effect of mental representation of attachment in children on suicidal behavior and self-harm throughout childhood and adolescence, considering the mediating role of internalizing problems.MethodsBased on a cohort of 500 students (mean age 8 years, SD 1.2) sampled from public schools in a Brazilian southeastern metropolis, 316 children were followed for eight years in three waves (2006, 2008, 2012). The following data from the research baseline (2005) were used: family drawing, maternal and family variables, and sociodemographic data. The mental representation of attachment (independent variable) was measured by the Family Drawing Global Scale, discriminating between secure attachment and non-secure attachment. Suicidal behavior/self-harm (dependent variable) and internalizing problems were evaluated in three research waves through CBCL and YSR (ASEBA). Descriptive analysis, calculation of frequencies and p-values of the variables of interest, as well as modeling of structural equations, were performed.ResultsThe prevalence throughout the study was: 17.1% [CI 13.3–20.8] for suicidal ideation and 8.9% [CI 5.6 – 12.2] for self-harm; there was a recurrence at one time in 16.5% [IC 12.6 – 20.3] and in two or more moments in 4.1% [CI 2.0 – 6.3] of the sample. Female gender (p = 0.035), internalizing disorders (p < 0.01), and non-secure attachment (p = 0.035) were associated with the occurrence of suicidal behavior/self-harm. The modeling indicated that 92,2% of the total effect of attachment (p = 0.069) on suicidal behavior/self-harm was due to direct effect, the other 7,8% of the effect being mediated by internalizing problems, adjusted for the confounding variables sex, skin color/race, and social stratum. The total effect showed a positive value, which indicates an increase in suicidal behavior/self-harm when the non-secure attachment is present. The approximate OR of non-secure attachment on the total effect (direct + indirect) was 1.15, indicating that, when adjusting for confounding variables, there was a 15% increase in suicidal behavior/self-injury from non-secure attachment.ConclusionsThe study supports the hypothesis that there is a relationship between disruptive attachment patterns (non-secure attachment) developed during infancy and suicidal and self-harm behavior during childhood and adolescence. These findings validate the concern about the first thousand days of childhood as a critical period for child growth and development, but also for the mental health of children and adolescents.

NAVIO RATKA shows similar rates of hemoglobin-drop, adverse events, readmission and early revision vs conventional TKA: a single centre retrospective cohort study.

Despite widespread adoption of NAVIO robotic-assisted total knee arthroplasty (NAVIO RATKA) in clinical practice, clinical outcome in terms of adverse events and complications remains unclear. The purpose of this study was to compare adverse events, length of stay, surgical time, hemoglobin drop, early readmission rate and revision rate between conventional TKA (CTKA) and NAVIO RATKA. This single-centre retrospective cohort analysis compared 230 NAVIO RATKA patients to 489 CTKA patients with a minimal follow-up of 12 months. Baseline demographic and comorbidity parameters were collected, as well as length of stay, revision rate and reason for revision, early readmission rate (< 6w) and reason for readmission, post-operative hemoglobin levels, adverse events, surgical time and operating room time. Data were compared using Mann-Whitney U test for continuous data without normal distribution and ordinal data, categorical variables were compared using the Chi-square or Fisher exact test. There were no clinically relevant baseline demographic or comorbidity differences between groups. CTKA had shorter length of stay than NAVIO RATKA (5.0 days vs 5.4 days, p = 0.010) but trended towards a higher reoperation rate (4.1% vs 1.7%, p = .144, n.s). No differences were found in hemoglobin drop, readmission rate or overall incidence of adverse events, but CTKA showed more hematoma formation (1.6% vs 0%, p = .044) and higher incidence of periprosthetic joint infection (PJI) (1% vs 0%, p = n.s.), whilst NAVIO RATKA showed more periprosthetic fractures and persistent wound drainage (0.4% vs 2.2%, p = .038 and 0.6% vs 4.3%, p = .001, respectively). Surgical time remained significantly longer in NAVIO RATKA during all 230 cases (87 min vs 67.6 min) and showed a continuous downward trend. This study further validates the usage of NAVIO RATKA as a safe method to perform TKA, with comparable short term outcomes to CTKA in terms of early revisions and adverse events. Surgeons should be mindful of the differing adverse event profile in NAVIO RATKA and adjust their patient selection accordingly to ensure optimal outcomes. In addition, surgeons using NAVIO RATKA should expect a linear learning curve and a surgical time exceeding that of CTKA. Level III (therapeutic retrospective cohort study).

Perioperative Morbidity and Mortality of Laparoscopic Sleeve Gastrectomy (LSG) in a Single-Surgeon Experience on 892 Patients Over 11 Years

BackgroundLaparoscopic sleeve gastrectomy (LSG) has been the most frequently performed bariatric procedure since 2014, with continually growing popularity. This study aimed to present our 30-day morbidity and mortality following LSG over a period of 11 years.Patients and methodsThis is a retrospective study that was based on prospectively collected data from patients undergoing LSG by the same surgeon from July 2011 to the end of August 2022. The LSG-associated 30-day morbidity and mortality and the risk factors for 30-day morbidity were assessed.ResultsThis study included 892 patients who underwent LSG over the course of 11 years. Early postoperative adverse events were encountered in 16 patients (1.79%). Overall, twelve patients (1.35%) required blood transfusions, and two patients (0.22%) required ICU admission. The re-operation rate was 0.9% (n = 8) and the mortality rate was 0.22% (n = 2). The patient’s BMI, hypertension, and revisional surgery were marginally significant/significant predictors of early postoperative morbidity. The mean EBWL% was 63.8 ± 15.55 at the 6-month follow-up.ConclusionThis study confirms the previously reported LSG's short-term safety in terms of a low rate of 30-day postoperative morbidity and mortality. Preoperative BMI, hypertension, and revisional surgery are risk factors for 30-day morbidity and mortality.

Effects of Early Adverse Life Events on Depression and Cognitive Performance from the Perspective of the Heart-Brain Axis.

Early adverse life events (EALs) increase susceptibility to depression and impair cognitive performance, but the physiological mechanisms are still unclear. The target of this article is to clarify the impact of adverse childhood experiences on emotional and cognitive performance from the perspective of the heart-brain axis. We used the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) to test cognitive function and the Childhood Trauma Questionnaire (CTQ) to assess adverse childhood experiences. Heart rate variability (HRV) and electroencephalograms (EEG) were acquired at rest. We observed that subjects with depression had experienced more traumatic events during their childhood. Furthermore, they exhibited lower heart rate variability and higher power in the delta, theta, and alpha frequency bands. Moreover, heart rate variability partially mediated the association between childhood trauma exposure and depressive symptoms. Our findings suggested that adverse life events in childhood could influence the development of depression in adulthood, which might be linked to cardiac autonomic dysfunction and altered brain function.

Early long-term low-dosage colchicine and major adverse cardiovascular events in patients with acute myocardial infarction: a systematic review and meta-analysis.

Current evidence on the efficacy and safety of colchicine after acute myocardial infarction (AMI) remains controversial. This study aims to clarify early low-dose long-term colchicine's exact efficacy and safety in AMI patients via more studies. We searched PubMed, Web of Science, Embase, and Cochrane Library databases for randomized controlled trials assessing the efficacy of colchicine on major adverse cardiovascular events (MACE) in recent AMI patients from inception to January 29, 2023, without any restriction. Additionally, we conducted subgroup analyses to assess the impact of early (≤3 days) long-term (≥1 year) low-dosage (0.5 mg/d) colchicine. Summary estimates were computed using Mantel-Haenszel and reported as risk ratios (RRs) or standard mean differences (SMDs), mean differences (MDs) with 95% confidence intervals (CIs). Sensitivity analyses were performed to explore the potential sources of heterogeneity. Review Manager software was used for the meta-analysis. Eight studies identified from 564 screened records were analyzed, with 5,872 patients after AMI. The length of follow-up varied from five days to 22.7 months, and 0.5-1.0 mg colchicine was administered daily. In summary, compared to the control group, colchicine reduced the occurrence of MACE (RR, 0.56; 95% CI, 0.48-0.67) with 2.99-fold gastrointestinal adverse events in patients with recent AMI. Moreover, the relation referred to a gradual decrease in the occurrence of MACE with a longer follow-up duration (≥1 year) and lower dosage (0.5 mg/d) without leading more gastrointestinal adverse events. Colchicine decreased the follow-up levels of C-reactive protein (CRP) (MD -0.66, 95% CI, -0.98- -0.35) and neutrophils (SMD -0.22, 95% CI, -0.39- -0.55) when the follow-up period was 30 days. Early long-term low-dose colchicine decreases the risk of MACE via anti-inflammation without leading more gastrointestinal adverse events in patients with AMI.

Retrospective evaluation of the effect of nutritional status of patients with left ventricular assist device on clinical results in the postoperative period

Abstract Funding Acknowledgements Type of funding sources: None. Objective Malnutrition in patients undergoing left ventricular assist device (LVAD) implantation has negative consequences, such as infection and limited functional capacity. The effects of nutritional status of patients with LVAD on their clinical outcomes were investigated. Methods 116 records of patients with LVAD implantation were retrospectively analysed. For nutritional evaluation, nutrition risk score NRI score was calculated to divide the patients into two groups with and without malnutrition risk. Demographic and clinical data before LVAD, early postoperative adverse events after LVAD, prognostic data, and laboratory findings were analysed. Results 116 patients (6 females, 110 man) had a mean age of 60.5±9,46 years; Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) scores were determined as 1 (n=11), 2 (n=36), 3 (n=65), and 4 (n=4). Forty four patients (44%) (19 mild, 6 moderate, 19 severe) had MR. The MR was higher in patients with preoperative INTERMACS score 1, low level of haemoglobin and albumin The incidence of adverse events was found to be significantly higher in patients with higher preoperative grade NRI (death during the pooperative period, bleeding). Conclusion In the early postoperative period, a MR of 44% was detected in patients who underwent LVAD. Total 72.2 % patients had any adverse events. We found that the presence of MR was effective in predicting postoperative adverse events according to NRI score before LVAD treatment.

The Use of the Off-the-Shelf Inner Branch E-nside Endograft for the Treatment of Elective and Emergent Complex Aortic Aneurysms—A Single-Center Experience

The aim of this single-center study was to evaluate the early results of the off-the-shelf inner branch E-nside endograft in the treatment of complex aortic aneurysms and thoracoabdominal aortic aneurysms. We performed a retrospective analysis of a prospectively maintained database of all patients treated with the E-nside endograft at our institution during the years 2021-2023. Parameters evaluated were technical success, early major adverse events, target vessel patency, and the presence of endoleaks. In total 16 patients underwent treatment with the E-nside endograft. Six additional patients were evaluated for the device but were excluded due to anatomical considerations. Mean age was 71 (range 59-84) and 14 (88%) were males. Mean aneurysm diameter was 66mm(range 54-85). Aneurysms treated included thoracoabdominal in 9 (56%), juxtarenal aneurysms in 5 (31%), postdissection aneurysm in 1 (6%) and a type 1A endoleak after a failed endovascular aneurysm repair in 1 (6%). Five of the treated aneurysms were symptomatic. A total of 58 side branches were placed into target visceral arteries. Mean operative time was 190min (range 150-360). Technical success was achieved in 15/16 of the patients (94%). At 30days, 1 perioperative mortality and 3 major adverse events occurred, 2 of them branch related. The E-nside endograft is a feasible option for the treatment of a broad spectrumof aortic pathologies. As it is an off-the-shelf device, it can be used selectively inelective and emergent settings with acceptable30-day mortality and morbidity. Further follow-up is required to determine the durability of this treatment option and patency of side branches.

A Prospective Open-Label Study for Treatment of Infraorbital Hollows Using a Volumizing Hyaluronic Acid Filler.

This study aimed to prospectively evaluate the effectiveness, patient satisfaction, and early adverse events of using the hyaluronic acid filler VYC-20L for the treatment of infraorbital hollowing. A total of 21 participants underwent injection of VYC-20L. FACE-Q satisfaction surveys before and after treatment along with early adverse events surveys were conducted. Pre- and posttreatment photos were graded, and the Allergan Infraorbital Hollows Scale was used to assess the difference in infraorbital hollowing. The results showed infraorbital hollowing improvement with VYC-20L was significant (p < 0.001). FACE-Q Satisfaction with Eyes scores on average were 27 points higher after treatment (p < 0.001). The mean FACE-Q Satisfaction with Decision score was 74.1%. The most common short-term adverse symptoms were tenderness (67%), swelling (62%), and bruising (52%). This study concludes that VYC-20L is an effective nonsurgical treatment option for infraorbital hollowing with high patient satisfaction.

Endoscopic Ultrasound-Guided Tissue Acquisition Versus Fine Needle Aspiration for Diagnosis of Pancreatic Ductal Adenocarcinoma.

Compare the 22Gneedle versus EchoTip ProCore® 20(Cook Medical, Bloomington, IN, USA) on their handling, specimen suitability, amount of tissue obtained, diagnostic performance, the possibility of immunohistochemistry, and rate of adverse events. This is a retrospective, comparative study of consecutively examined patients with pancreatic masses who underwent endosonography-guided fine needle aspiration (FNA) via the 22G needle, and endosonography-guided tissue acquisition (TA) via ProCore 20 (PC20). The operator evaluated needle insertion and subjectively classified the specimen. The pathologist measured the samples, classified the amount of tissue, and determined the influence of bleeding on the interpretation. A total of 129 patients participated in the study, out of whom 52 underwent endosonography-guided FNA with 22G and 77 underwent endosonography-guided TA with a PC20 needle. Malignant lesions were found in 106, and 23 had benign lesions. The duodenal route was used in 62% of patients. The 22G needle was easier to introduce (p=0.0495). However, PC20 obtained a larger amount (p<0.01) with fewer punctures (p<0.001). The PC20 also yielded a larger average microcore diameter (p=0.0032). Microhistology was adequate for 22G and PC20 in 22 (42.2%) and 50 (78.1%) specimens, respectively (p<0.001). Bleeding was not significantly different (p>0.999). Immunohistochemistry was possible in 36 (69.2%) and 40 (51.9%) specimens obtained by 22G and PC20, respectively (p=0.075). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 22G were 93.5%, 100%, 100%, 66.7%, and 94.2%, respectively; and for PC20, it was 95%, 100%, 100%, 85%, and 96.1%, respectively. Mild bleeding was the most common early adverse event, occurring in 2/52 (3.8%) 22G and 4/77 (5.2%) PC20 cases (p>0.05). The PC20 required fewer punctures and reduced the need for immunohistochemistry as it yielded better and larger microcores. Its ease of insertion into the target lesion makes it a good option to obtain satisfactory microcore specimens in difficult positions, such as the transduodenal route.

Catecholamine Vasopressor Exposure Is Associated With Early Poor Allograft Function and Adverse Events in Living Donor Kidney Transplant Recipients

Hypoperfusion leads to allograft injury during kidney transplantation. Catecholamine vasopressors are used to maintain blood pressure in the perioperative period but have demonstrated negative outcomes in the deceased-donor kidney transplant population. Little is known regarding living donor kidney transplants (LDKTs) and vasopressor use. The aim of this study is to describe the incidence of vasopressor use in LDKT and characterize its effects on allograft function and patient outcomes. This retrospective, observational cohort study included adult patients who underwent an isolated LDKT between August 1, 2017, and September 1, 2018. Patients were divided into those who received perioperative vasopressors and those who did not. The primary objective was to compare allograft function between LDKT recipients that received vasopressors and those who did not. Secondary outcomes included safety endpoints and the identification of clinical variables associated with vasopressor use. A total of 67 patients received an LDKT during the study period. Of those, 25 (37%) received perioperative vasopressors, and 42 (62%) did not. Poor graft function, as defined by the development of slow or delayed graft function, occurred more frequently in patients receiving perioperative vasopressors compared with those who did not (6 [24%] vs 1 [2.4%], P=.016). In multivariable regression modeling, only perioperative vasopressors were statistically significantly associated with poor graft function. In addition, patients exposed to vasopressors experienced more postoperative arrhythmias (8 [32%] vs 1 [4.8%], P=.0025). Using perioperative vasopressors was independently associated with worsened early renal allograft function, including delayed graft function and adverse events in the LDKT population.

Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms.

To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. A total of 2603 patients (69% males; mean age 72±10year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.

Total Arterial Revascularization in Diabetic Patients Undergoing Coronary Artery Bypass Graft Surgery: A Systematic Review and Meta-Analysis.

Total arterial revascularization (TAR) has gradually become accepted and recognized, but its effect and safety in diabetic patients are not clear. We performed a systematic review and meta-analysis to summarize the safety and efficacy of TAR and additionally evaluated the clinical outcomes of arterial revascularization using different arterial deployments in patients with diabetes. PubMed, Embase, and the Cochrane Library databases from inception to July 2022 for studies that studied the effect of arterial revascularization in diabetic patients undergoing isolated coronary artery bypass graft (CABG) were searched. The primary outcome was long-term ( 12 months of follow-up) death by any cause. The secondary efficacy endpoints were long-term ( 12 months) cardiovascular death, early sternal wound infection (SWI) and death ( 30 days or in hospital). Risk ratios (RRs), hazard ratios (HRs), and their corresponding 95% confidence intervals (CIs) were calculated to describe short-term results and long-term survival outcomes. Two different ways were used to analyze the effect of TAR and the impact of diabetes on the clinical outcomes of TAR. Thirty-five studies were included in the study, covering 178,274 diabetic patients. Compared to conventional surgery with saphenous veins, TAR was not associated with increased early mortality (RR 0.77, 95% CI 0.48-1.23) and risk of SWI (RR 0.77, 95% CI 0.46-1.28). The overall Kaplan-Meier survival curves based on reconstructed patient data indicated a significant association between TAR and reduced late mortality (HR 0.52, 95% CI 0.48-0.67) and the curves based on the propensity-score matched (PSM) analyses suggested a similar result (HR 0.74, 95% CI 0.66-0.85). TAR could also effectively decrease the risk of cardiovascular death (HR 0.42, 95% CI 0.24-0.75). Through comparing the effect of TAR in patients with and without diabetes, we found that the presence of diabetes did not elevate the risk of early adverse events (death: RR 1.50, 95% CI 0.64-3.49; SWI: RR 2.52, 95% CI 0.91-7.00). Although diabetes increased long-term mortality (HR 1.06; 95% CI 1.35-2.03), the cardiovascular death rate was similar in patients with diabetes and patients without diabetes (HR 1.09; 95% CI 0.49-2.45). Regarding the selection of arterial conduits, grafting via the bilateral internal mammary artery (BIMA) decreased the risk of overall death (HR 0.67, 95% CI 0.52-0.85) and cardiovascular death (HR 0.55, 95% CI 0.35-0.87) without resulting in a significantly elevated rate of early death (RR 0.95, 95% CI 0.82-1.11). However, the evidence from PSM studies indicated no difference between the long-term mortality of the BIMA group and that of the single internal mammary arteries (SIMA) groups (HR 0.76, 95% CI 0.52-1.11), and the risk of SWI was significantly increased by BIMA in diabetes (RR 1.65, 95% CI 1.42-1.91). The sub-analysis indicated the consistent benefit of the radial artery (RA) application in diabetic patients (HR 0.71, 95% CI 0.63-0.79) compared to saphenous vein graft. In two propensity-score-matched studies, the evidence showed that the survival outcomes of the BIMA group were similar to that of the SIMA plus RA group but that grafting via the RA reduced the risk of sternal wound infection. Compared with conventional surgery using SVG, TAR was associated with an enhanced survival benefit in diabetes and this long-term gain did not increase the risk of early mortality or SWI. Given the increased infection risk and controversial long-term survival gains of grafting via the BIMA in diabetes, its wide use for grafting in this cohort should be seriously considered. Compared to using the right internal mammary artery (RIMA), RA might be a similarly effective but safer option for patients with diabetes.

Association Between Preoperative Sarcopenia and Early Postoperative Outcomes in Pediatric Patients Undergoing Total Correction of Tetralogy of Fallot: A Retrospective Cohort Study

To identify the association between preoperative low muscle mass and early postoperative outcomes in pediatric patients undergoing total correction of tetralogy of Fallot (TOF). A retrospective cohort study. A single university hospital in Seoul, South Korea. Pediatric patients (≤3 years) who underwent total correction of TOF between May 2008 and February 2018. None. Cross-sectional areas of the pectoralis and erector spinae muscles were measured using preoperative chest computed tomography (CT) scans, and adjusted to body surface area to define muscle mass index. The patients were divided into sarcopenia, presarcopenia, and no sarcopenia groups based on cutoff values determined using the mean and SD of the muscle mass index in the third z-weight quintile. Of a total of 330 patients included in the final analysis, 13 were associated with the sarcopenia group, 57 in the presarcopenia group, and 260 in the no sarcopenia group. The sarcopenia group exhibited a higher incidence of major adverse events than the presarcopenia and no sarcopenia groups, respectively (38% v 25% v 18%; p=0.033). Logistic regression analyses revealed that only younger age at the time of surgery was significantly associated with major adverse events (odds ratio 0.82; 95% CI 0.72-0.94, p=0.003). The incidence of sarcopenia, as assessed by preoperative chest CT, was low in pediatric patients undergoing total correction of TOF, and preoperative sarcopenia did not predict early postoperative major adverse events.

Comparative effects of off-pump and multiple cardiopulmonary bypass strategies in coronary artery bypass grafting surgery: protocol for a systematic review and network meta-analysis

IntroductionMultiple revascularisation strategies with or without cardiac arrest have been developed to minimise the negative effects of cardiopulmonary bypass interventions during coronary artery bypass grafting (CABG) surgery. Several observational and...

Incidence of Early Adverse Events After Tibial Tubercle Osteotomy.

Tibial tubercle osteotomy (TTO) is a commonly utilized surgical procedure for the treatment of patellofemoral instability. Although midterm and long-term outcomes are known, perioperative complications have not been consistently reported. To identify the incidence and predictors of adverse events in the first 90-day perioperative period after TTO. Case series; Level of evidence, 4. Patients undergoing primary TTO between January 1, 2010, and December 31, 2019, were included. Readmissions in the first 90 days after surgery were collected, and data were collected for the following variables: age, sex, smoking status, body mass index, laterality, preoperative diagnosis, presence of trochlear dysplasia, tourniquet use, TTO procedure, tibial tubercle distalization, trochleoplasty, chondral procedure, number of screws, and use of an epidural catheter. Predictors of readmission for any reason were identified using multivariable logistic regression analysis. A total of 345 TTO procedures were included in the final analysis. The incidence of readmissions for any reason was 20.6% (71/345). The most common reason for readmission was postoperative pain (26/345 [7.5%]), followed by wound complications (19/345 [5.5%]) and epidural catheter-related complications (overall: 16/345 [4.6%]; specific: 16/167 [9.6%]. The incidence of major complications was 2.0% (7/345). The number of patients with each major complication was as follows: 1 for deep vein thrombosis, 2 for pulmonary embolism, 1 for septic arthritis, 1 for tibial tubercle fracture, and 2 for loss of fixation. Female sex and smoking were associated with readmission for pain. The incidence of major complications after TTO was very low (2.0%), but 20.6% of cases required readmission, primarily for an indwelling epidural catheter (3.5%) and postoperative pain (7.5%). Concomitant soft tissue procedures and the number of screws were associated with readmission after TTO. Utilizing individualized postoperative pain management and preoperative discussions about expected pain may help to avoid readmission for pain after TTO.

High quality colonoscopy: using textbook process as a composite quality measure.

BACKGROUND : High quality colonoscopy is fundamental to good patient outcomes. "Textbook outcome" has proven to be a feasible multidimensional measure for quality assurance between surgical centers. In this study, we sought to establish the "textbook process" (TP) as a new composite measure for the optimal colonoscopy process and assessed how frequently TP was attained in clinical practice and the variation in TP between endoscopists. METHODS : To reach consensus on the definition of TP, international expert endoscopists completed a modified Delphi consensus process. The achievement of TP was then applied to clinical practice. Prospectively collected data in two endoscopy services were retrospectively evaluated. Data on colonoscopies performed for symptoms or surveillance between 1 January 2018 and 1 August 2021 were analyzed. RESULTS : The Delphi consensus process was completed by 20 of 27 invited experts (74.1 %). TP was defined as a colonoscopy fulfilling the following items: explicit colonoscopy indication; successful cecal intubation; adequate bowel preparation; adequate withdrawal time; acceptable patient comfort score; provision of post-polypectomy surveillance recommendations in line with guidelines; and the absence of the use of reversal agents, early adverse events, readmission, and mortality. In the two endoscopy services studied, TP was achieved in 5962/8227 colonoscopies (72.5 %). Of 48 endoscopists performing colonoscopy, attainment of TP varied significantly, ranging per endoscopist from 41.0 % to 89.1 %. CONCLUSION : This study proposes a new composite measure for colonoscopy, namely "textbook process." TP gives a comprehensive summary of performance and demonstrates significant variation between endoscopists, illustrating the potential benefit of TP as a measure in future quality assessment programs.

Safety and efficacy of endoscopic ultrasound-guided radiofrequency ablation for pancreatic insulinoma: A single-center experience

Background/objectivesInsulinomas are rare, functioning pancreatic neuroendocrine neoplasms (pNEN), whose gold standard therapy is surgical resection. Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) is a recent technique that has emerged as a minimally invasive therapeutic option for patients with pancreatic lesions not eligible for surgery. In this study, we aimed to describe a series of patients with unresectable pancreatic insulinoma treated with EUS-RFA. MethodsThis is a single-center, retrospective study including all consecutive patients with functioning pancreatic insulinoma undergoing EUS-RFA for surgical unfitness or surgery refusal, between March 2017 and September 2021. Technical success (i.e., complete mass ablation), adverse event rate and severity, clinical and radiologic outcomes (i.e., symptom remission with a normal concentration of blood glucose, and the presence of intralesional necrosis), and post-procedural follow-up were assessed. ResultsA total of 10 patients (mean age: 67.1 ± 10.1years; F:M 7:3) were included. The mean size of insulinoma was 11.9 ± 3.3 mm. Technical success and clinical remission were achieved in 100% of patients. Only one (10%) patient was successfully treated with two RFA sessions. Two procedure-related early adverse events occurred, including two (20%) cases of mild abdominal pain. No major complications were observed. The complete radiologic response within 3 months after EUS-RFA was observed in all patients (100%). After a median follow-up of 19.5 (range12–59) months, symptom remission and persistent euglycemia were assessed in all the patients. ConclusionsData from this case series suggest that EUS-RFA is a feasible and safe therapeutic approach for pancreatic insulinomas in patients unwilling or unable to undergo surgery with medium-term efficacy.

Novel anti-reflux biliary metal stent with a distal tapered end for distal malignant biliary obstruction: a feasibility study.

Background and study aims We developed a self-expandable metallic stent (SEMS) with a distal tapered end to reproduce the physiological bile flow with a pressure gradient due to the difference in the diameter. We aimed to evaluate the safety and efficacy of the newly developed distal tapered covered metal stent (TMS) for distal malignant biliary obstruction (DMBO). Patients and methods This single-center, prospective, single-arm study was conducted in patients with DMBO. The primary endpoint was time to recurrent biliary obstruction (TRBO), and the secondary endpoints were the survival time and incidence of adverse events (AEs). Results Thirty-five patients (15 men, 20 women; median age, 81 years [range: 53-92]) were enrolled between December 2017 and December 2019. The primary diseases were pancreatic head cancer in 25 cases, bile duct cancer in eight cases, and ampullary cancer in two cases. TMS was successfully placed in all cases. Acute cholecystitis occurred as an early AE (within 30 days) in two cases (5.7 %). The median TRBO was 503 days, median survival time was 239 days. RBO was observed in 10 cases (28.6 %), and the causes were distal migration in six cases, proximal migration in two cases, biliary sludge in one case, and tumor overgrowth in one case. Conclusions Endoscopic placement of the newly developed TMS in patients with DMBO is technically feasible and safe, and the TRBO was remarkably long. The anti-reflux mechanism based on the difference in diameter may be effective, and a randomized controlled trial with a conventional SEMS is required.

Predictors of three-month mortality and severe chemotherapy-related adverse events in patients aged 70 years and older with metastatic non-small-cell lung cancer: A secondary analysis of ESOGIA-GFPC-GECP 08–02 study

IntroductionPredictors for mortality and toxicity in older patients with cancer are mainly studied in cohorts with various cancers at different stages. This study aims to identify predictive geriatric factors (PGFs) for early death and severe chemotherapy related adverse events (CRAEs) in patients aged ≥70 years with metastatic non-small-cell lung cancer (mNSCLC). Material and MethodsThis is a secondary analysis of the multicenter, randomized, phase 3 ESOGIA trial that compared, for patients ≥70 years with mNSCLC, a treatment algorithm based on performance status and age to another algorithm based on geriatric assessment. To identify PGFs of three-month mortality and grade 3, 4, or 5 CRAEs, multivariate Cox models and logistic models, adjusted for treatment group and center, and stratified by randomization arm, were constructed. ResultsAmong 494 included patients, 145 (29.4%) had died at three months and 344 (69.6%) had severe chemotherapy toxicity. For three-month mortality, multivariate analyses retained mobility (Test Get up and Go), instrumental activity of daily living (IADL) dependence and weight loss as PGFs. The combined effect of IADL ≤2/4 and weight loss ≥3 kg was strongly associated with three-month mortality (adjusted hazard ratio: 5.71 [95% confidence interval [CI]: 2.64–12.32]). For chemotherapy toxicity, Charlson Comorbidity Index ≥2 was independently associated with grade3, 4, or 5 CRAEs (adjusted odds ratio [95% CI]: 1.94 [1.06–3.56]). DiscussionMobility, IADL dependence, and weight loss were predictive of three-month mortality in a population aged ≥70 years treated for mNSCLC, while comorbidities were independently associated with severe chemotherapy toxicity.

Early Adverse Event Derived Biomarkers in Predicting Clinical Outcomes in Patients with Advanced Non-Small Cell Lung Cancer Treated with Immunotherapy.

Adverse events (AEs) have been shown to have clinical associations, in addition to patient safety assessments of drugs of interest. However, due to their complex content and associated data structure, AE evaluation has been restricted to descriptive statistics and small AE subset for efficacy analysis, limiting the opportunity for global discovery. This study takes a unique approach to utilize AE-associated parameters to derive a set of innovative AE metrics. Comprehensive analysis of the AE-derived biomarkers enhances the chance of discovering new predictive AE biomarkers of clinical outcomes. We utilized a set of AE-associated parameters (grade, treatment relatedness, occurrence, frequency, and duration) to derive 24 AE biomarkers. We further innovatively defined early AE biomarkers by landmark analysis at an early time point to assess the predictive value. Statistical methods included the Cox proportional hazards model for progression-free survival (PFS) and overall survival (OS), two-sample t-test for mean difference of AE frequency and duration between disease control (DC: complete response (CR) + partial response (PR) + stable disease (SD)) versus progressive disease (PD), and Pearson correlation analysis for relationship of AE frequency and duration versus treatment duration. Two study cohorts (Cohort A: vorinostat + pembrolizumab, and B: Taminadenant) from two immunotherapy trials in late-stage non-small cell lung cancer were used to test the potential predictiveness of AE-derived biomarkers. Data from over 800 AEs were collected per standard operating procedure in a clinical trial using the Common Terminology Criteria for Adverse Events v5 (CTCAE). Clinical outcomes for statistical analysis included PFS, OS, and DC. An early AE was defined as event occurrence at or prior to day 30 from initial treatment date. The early AEs were then used to calculate the 24 early AE biomarkers to assess overall AE, each toxicity category, and each individual AE. These early AE-derived biomarkers were evaluated for global discovery of clinical association. Both cohorts showed that early AE biomarkers were associated with clinical outcomes. Patients previously experienced with low-grade AEs (including treatment related AEs (TrAE)) had improved PFS, OS, and were associated with DC. The significant early AEs included low-grade TrAE in overall AE, endocrine disorders, hypothyroidism (pembrolizumab's immune-related adverse event (irAE)), and platelet count decreased (vorinostat related TrAE) for Cohort A and low-grade AE in overall AE, gastrointestinal disorders, and nausea for Cohort B. In contrast, patients with early development of high-grade AEs tended to have poorer PFS, OS, and correlated with PD. The associated early AEs included high-grade TrAE in overall AE, gastrointestinal disorders with two members, diarrhea and vomiting, for Cohort A and high-grade AE in overall AE, three toxicity categories, and five related individual AEs for Cohort B. One low-grade TrAE, alanine aminotransferase increased (vorinostat + pembrolizumab related), was an irAE and correlated with worse OS in Cohort A. The study demonstrated the potential clinical utility of early AE-derived biomarkers in predicting positive and negative clinical outcomes. It could be TrAEs or combination of TrAEs and nonTrAEs from overall AEs, toxicity category AEs, to individual AEs with low-grade event leaning to encouraging effect and high-grade event to undesirable impact. Moreover, the methodology of the AE-derived biomarkers could change current AE analysis practice from a descriptive summary into modern informative statistics. It modernizes AE data analysis by helping clinicians discover novel AE biomarkers to predict clinical outcomes and facilitate the generation of vast clinically meaningful research hypotheses in a new AE content to fulfill the demands of precision medicine.