The Balance of Beauty: Pooled Analysis of Adverse Events With a Cohesive Polydensified Matrix-Hyaluronic Acid Filler in Nasolabial Fold Treatments

Background: Recent studies have questioned the efficacy of meniscectomy in older patients with and without evidence of osteoarthritis; however, it continues to be frequently performed. There is limited information about age and other risk factors for adverse events and readmission after the procedure. This knowledge is vital to understand the true risk profile of this common surgery. Purpose: To investigate if age and medical comorbidities were risk factors for postoperative adverse events and readmission after meniscectomy. Study Design: Case-control study; Level of evidence, 3. Methods: Patients who underwent arthroscopic meniscectomy between 2005 and 2012 were identified from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database. Age ≥65 years and medical comorbidities were evaluated as risk factors for any adverse event (AAE), severe adverse events (SAEs), and readmission after meniscectomy using univariate and multivariate analyses. Results: A total of 17,774 patients who underwent meniscectomy were identified. The mean age was 53.0 ± 13.6 years. A total of 3420 patients (19.2%) were ≥65 years. Overall, 208 patients (1.17%) had AAE, 203 patients (1.14%) had an SAE, and 102 patients were readmitted (0.97%). Multivariate logistic regression analyses demonstrated no significant differences between age groups for the occurrence of AAE, SAEs, and readmission. Patients with American Society of Anesthesiologists classification ≥3 had increased odds of AAE (odds ratio [OR], 1.58), SAEs (OR, 1.59), and readmission (OR, 1.99). Patients with diabetes had increased odds of AAE (OR, 1.57) and SAEs (OR, 1.51). Smokers had increased odds of readmission (OR, 1.67). Patients with pulmonary disease had increased odds of AAE (OR, 1.76) and SAEs (OR, 1.70). Conclusion: Meniscectomy is a safe procedure in older patients, as age over 65 years did not increase the odds of any of the adverse events studied. However, regardless of age, patients with an increased comorbidity burden and those with a history of smoking are at increased risk of adverse events and/or readmission after the procedure. Clinical Relevance: Knowledge of these risk factors for adverse events and readmission provides essential information for patient selection and preoperative counseling.

Perioperative tobacco use has been identified as an independent risk factor for adverse events after total hip arthroplasty (THA). It is unknown if perioperative cannabis users share similar levels of risk for adverse events after THA. Patients undergoing THA were identified from the 2010 to 2021 PearlDiver M151 administrative data set. Patient subcohorts were categorized based on presence or absence of cannabis and/or tobacco use, as determined by coding. These subcohorts were equally matched based on patient age, sex, and Elixhauser Comorbidity Index scores to form groups of nonusers, tobacco users, tobacco and cannabis users, as well as cannabis users. The incidences of adverse events within 90 days postoperatively were obtained and compared using univariate and multivariate analyses that controlled for age, sex, and Elixhauser Comorbidity Index. Bonferroni correction was applied. Of 494,431 THA patients, nonusers were 442,000 (89.40%), tobacco users 46,925 (9.50%), tobacco and cannabis users 3,390 (0.69%), and cannabis users 2,116 (0.43%). After matching, there were 1,897 in each group. By multivariate analyses, tobacco-only users were at significantly greater risk of severe adverse events, sepsis, and pneumonia (P < 0.001 for each). Tobacco and cannabis users were at significantly greater risk of severe adverse events, myocardial infarction, pneumonia, and readmission (P < 0.001 for each). Conversely, cannabis-only users were not at significantly greater risk for any of the combined or individual adverse events assessed. This study confirmed that THA patients with tobacco-only use were at greater risk of perioperative adverse events and that these were relatively similar to those with concurrent tobacco and cannabis use. However, cannabis-only users were not at greater risk, a finding that is of clinical interest given the evolving access and increasing use of this agent.

EUS-guided biliary drainage with transluminal stenting after failed ERCP: predictors of adverse events and long-term results

Adverse Events Associated with Cryopreserved and Non-Cryopreserved Hematopoietic Stem Cell Infusion: A Prospective and Multicenter Surveillance Study

Background and purpose: 12–18% of patients encounter adverse events after distal radius fracture (DRF) surgery with volar locking plates (VLPs). Risk factors for which preventive measures could be administered are currently scarce. We aimed to examine the incidence of postoperative adverse events and assess the causes and risk factors for the adverse events after VLP fixation of DRFs.Methods: We performed a single-center retrospective cohort study evaluating all adult DRF patients treated with VLP fixation between 2009 and 2019 at Helsinki University Hospital. Patients with previous disabilities or ulnar fractures, other than styloid process fractures, in the affected extremity were excluded. We examined each patient’s treatment using the electronic medical records system and identified postoperative adverse events defined as any deviation from the ordinary postoperative course, showcasing clinical symptoms. We used multivariable binary logistic regression to assess the risk for adverse events.Results: 2,790 cases of DRF were included. The incidence of adverse events was 16%. Hardware complications (8.3%), predominantly intra-articular screws (4.9%), were the most commonly encountered adverse events. Other frequent adverse events included carpal tunnel syndrome (2.8%), tendon complications (2.8%), and surgical site infections (1.5%). In the multivariable analysis, smoking, higher body mass index (BMI), alcohol abuse, C-type fractures, residual intra-articular displacement, and dorsal tilt were found as risk factors for adverse events.Conclusion: The incidence of adverse events was 16% after VLP fixation of DRFs. We identified several new risk factors for adverse events, which included residual dorsal tilt, intra-articular dislocation, insufficiently corrected inclination, smoking, alcohol abuse, and higher BMI.

BackgroundIn order to evaluate the safety of acupuncture in China objectively, we investigated the adverse events associated with acupuncture based on three multicentre randomized controlled trials (RCTs) to assess the safety of acupuncture, identifying the common types of acupuncture adverse events, and analysing the related risk factors for their occurrence.MethodsThis observational study included patients who received acupuncture from three multicentre RCTs respectively for migraine, functional dyspepsia and Bell's palsy. The 1968 patients and their acupuncturists documented adverse events associated with acupuncture after treatment. We collected data about adverse events due to acupuncture treatment from their case report forms. We analysed the incidence and details of the adverse effects, and studied the risk factors for acupuncture adverse events with non-conditional logistic regression analysis.ResultsAmong the 1968 patients, 74 patients (3.76%) suffered at least one adverse event throughout the treatment period. We did not observe the occurrence of serious adverse events. 73 patients with adverse events recovered within 2 weeks through effective treatment such as physiotherapy or self-treatment. A total of 3 patients withdrew because of adverse events. There were 9 types of adverse events related to acupuncture, including subcutaneous haematoma, bleeding, skin bruising and needle site pain. Subcutaneous haematoma and haemorrhage in the needling points were the most common adverse events. Age and gender were related to the occurrence of acupuncture adverse events. The older the patients were, the higher the risk of adverse events was. In addition, male patients had slightly higher risk of an adverse event than female patients.ConclusionsAcupuncture is a safe therapy with low risk of adverse events in clinical practice. The risk factors for adverse events (AEs) were related to the patients' gender and age and the local anatomical structure of the acupoints. AEs could be reduced and mitigated by improving the medical environment, ensuring a high technical level of the acupuncture practitioners and establishing a good relationship of mutual trust between doctor and patient.Trial RegistrationClinicalTrials.gov: NCT00599586, NCT00599677, NCT00608660

Studies have documented the importance of procedure type and hemodynamic variables on the incidence of procedure related adverse events (AE) after cardiac catheterization. However, little is known about the impact of low weight on the incidence and severity of AE. Data were prospectively collected using a multicenter registry (C3PO). Infants <1 year were divided into four weight categories: <2 kg, 2-3 kg, 3-5 kg, ≥5 kg. AE severity was classified as level 1-5 (none, minor, moderate, major, death). Eight centers submitted details on 3,679 cases (34% diagnostic) performed in infants <1 year from 2/07 to 6/10: <2 kg: 57 (1.5%), 2-3 kg: 403 (11%), 3-5 kg: 1,527 (41.5%), ≥5 kg: 1,692 (46%). AE occurred in 20% of cases (<2 kg: 28%, 2-3 kg: 25%, 3-5 kg: 23%, ≥5 kg: 16%) with 41% of all AE being level 3-5 AE. Death occurred more frequently in the <2 kg group (12%), 71% of which were interventional cases. The case-related mortality in all other weight groups was <1%. By multivariable analysis, weight <2 kg, 2-3 kg, and 3-5 kg were independent risk factors for high severity (level 3-5) AE (<2 kg: OR 2, 95%CI 1.1-3.6; 2-3 kg: OR 1.4, 95%CI 1-1.8; 3-5 kg: OR 1.3, 95%CI 1.1-1.5), with similar findings for all AE. Blood transfusions were more common in lower weight categories (<2 kg: 42%, 2-3 kg: 29%, 3-5 kg: 25%, ≥5 kg: 15%, p<0.001). The risk of AE during cardiac catheterization of infants increases with lower weight. Infants who weigh less than 2 kg have a significantly higher risk of adverse events (most notably death) even after correcting for hemodynamic vulnerability and procedure type risk group.

PURPOSE: Neoadjuvant chemotherapy (NAC) improves survival in muscle invasive bladder cancer (MIBC). Rate of adverse events (AE) have been reported only in randomized clinical trials (RCT). Purpose was to evaluate incidence, type, and risk factors of AEs during NAC treatment in a population-based setting. MATERIAL AND METHODS: The Finnish national cystectomy database covering years 2008–2014 was utilized. NAC associated AEs were reported by Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. AEs during NAC in five-tier severity scale was the outcome measure. Spearman correlation between AEs and 22 clinical variables were calculated. P-values were corrected for multiple testing by controlling false discovery rate (FDR) with Benjamini-Hochberg method. RESULTS: Thirty-one percent of MIBC patients were assigned to NAC. Final analysis included 229 NAC patients representing 30% of radical cystectomy (RC) population. Majority (88%) received cisplatin-gemcitabine. 105 patients (46%) had no AEs. 124 patients (54%) had 168 AEs in total. Severe events (CTCAE grade 3–5) were documented in 31% of patients and one (0.4%) died. In five patients (2.1%) RC was not performed due to the AE. Of the severe AEs, hematological were most common, followed with cardiac, vascular and urinary tract as most commonly affected organ systems. The number of chemotherapy cycles was the only variable significantly associated with AEs. Severe AEs occurred already during or after the first cycle of NAC leading to early termination. CONCLUSION: NAC is generally well tolerated, but poses a considerable risk for adverse events. This is the first study to evaluate AEs caused by NAC in real life scenario on population level.

Most studies of ketamine administered to children for procedural sedation are limited to emergency department use. The objective of this study was to describe the practice of ketamine procedural sedation outside of the operating room and identify risk factors for adverse events. Observational cohort review of data prospectively collected from 2007 to 2015 from the multicenter Pediatric Sedation Research Consortium. Sedation services from academic, community, free-standing children's hospitals and pediatric wards within general hospitals. Children from birth to 21 years old or younger. None. Describe patient characteristics, procedure type, and location of administration of ketamine procedural sedation. Analyze sedation-related adverse events and severe adverse events. Identify risk factors for adverse events using multivariable logistic regression. A total of 22,645 sedations performed using ketamine were analyzed. Median age was 60 months (range, < 1 mo to < 22 yr); 72.0% were American Society of Anesthesiologists-Physical Status less than III. The majority of sedations were performed in dedicated sedation or radiology units (64.6%). Anticholinergics, benzodiazepines, or propofol were coadministered in 19.8%, 57.9%, and 35.4%, respectively. The overall adverse event occurrence rate was 7.26% (95% CI, 6.92-7.60%), and the frequency of severe adverse events was 1.77% (95% CI, 1.60-1.94%). Procedures were not completed in 39 of 19,747 patients (0.2%). Three patients experienced cardiac arrest without death, all associated with laryngospasm. This is a description of a large prospectively collected dataset of pediatric ketamine administration predominantly outside of the operating room. The overall incidence of severe adverse events was low. Risk factors associated with increased odds of adverse events were as follows: cardiac and gastrointestinal disease, lower respiratory tract infection, and the coadministration of propofol and anticholinergics.

e14036 Background: Proper assessment of harms of cancer treatment is essential to make risk-benefit trade off decisions in oncology clinic. CONSORT guidelines require the authors of RCTs to provide exact data for adverse events (AEs) grade 3 or higher (severe AEs), serious AEs (SAEs) and fatal AEs (FAEs) and avoid using general terms (such as well-tolerated) that downplay the harms. We aimed to assess the incidence and risks of severe AEs, SAEs and FAEs in such RCTs of cancer drugs that downplayed the harms. Methods: We extracted all the phase 2 and 3 RCTs of cancer drugs from the five major journals (NEJM, Lancet, Lancet Oncology, JAMA, JCO) from 2016 January to 2016 December. The abstracts/full texts of the papers were studied to assess if the harms of the experimental arm were downplayed. Use of any of the following terms while describing toxicities or AEs or safety was assumed to downplay the harms: acceptable, feasible, tolerable (or well-tolerated) , favorable, safe, manageable. Data on severe AEs, SAEs and FAEs for both the experimental and control cohorts were extracted from these RCTs and pooled using random-effects model to determine the overall incidence and risk. Results: Of 122 phase 2/3 RCTs of cancer drugs identified, 53 (43.4%) reports used terms downplaying the toxicities of the experimental arm and were included in this analysis. The overall incidence of severe AEs, SAEs and FAEs with these cancer drugs were 50.6% (95% CI: 41.5%-59.7%), 21.9% (95% CI: 16.3%-28.7%) and 1.6% (95% CI: 1.2%-2.2%) respectively. Compared with control, the risk of severe AEs and SAEs were significantly increased with the use of these cancer drugs: severe AEs (RR 1.15, 95% CI: 1.04-1.27, p = 0.005) and SAEs ( RR 1.49, 95% CI: 1.26-1.77, p &lt; 0.001) . However, the risk of FAEs was similar across the experimental and control arms ( RR 0.89, 95% CI: 0.72-1.11, p = 0.306) Conclusions: Our analysis shows that considerable proportions of patients suffer severe AEs, SAEs and FAEs and significantly increased risk of severe AEs and SAEs in the trials that downplay the toxicities of cancer drugs. Terms that falsely downplay the toxicities of cancer drugs should be avoided in the reporting of RCTs to encourage accurate risk-benefit assessment.

Identifying and reducing complications of outpatient medications.

Objective The study was designed to analyze the risk factors for perioperative adverse events in Ebstein's anomaly(EA) after cone construction. Methods A retrospective analysis was performed on EA cases undergoing cone construction in pediatric heart center of Beijing Anzhen Hospita from January 2010 to January 2017. Patients were divided into group A(no adverse events occurred) and group B(adverse events occurred) according to the presence or not of perioperative adverse events. Univariate and multivariate logistic regression analysis was performed with 9 preoperative and intraoperative variables as the predicted risk factors. Results The incidence of adverse events was 13.1%. Univariate logistic regression analysis showed that preoperative percutaneous oxygen saturation(SpO2)≤ 0.90(P=0.001, OR=10.578) and extracorporeal circulation time(P=0.034, OR=1.021) were risk factors for perioperative adverse events. Results of multivariate logistic regression analysis: preoperative SpO2≤ 0.90 was an independent risk factor for perioperative adverse events(P=0.002, OR=9.108). In 64 cases(64.6%) with atrial septum defect, there was no significant correlation between preoperative SpO2 and preoperative tricuspid regurgitation(P=0.838, r=0.026). Conclusion Preoperative SpO2≤0.90 is an independent risk factor for adverse events in the perioperative period of cone reconstruction. It is a simple and efficient method to evaluate the operation difficulty and determine the prognosis by SpO2. Key words: Cone reconstruction; Preoperative; Percutaneous oxygen saturation

Risk factors for adverse events after clavicle fracture open reduction and internal fixation: A NSQIP study

Background: This study compared the adverse events (AEs) of the second and third doses of BNT162b2, as well as investigated the impact of vaccine recipients’ background and vaccination interval on the AEs of the third dose. Methods: We conducted a questionnaire survey of AEs among health care workers at Osaka University Dental Hospital. Chi-square tests were performed to compare AEs to the administration of second and third vaccine doses. Logistic regression analyses were conducted to identify factors influencing the presence of AEs using age, sex, comorbidities, and the vaccination interval. Spearman’s rank correlation coefficient was calculated to investigate the correlation between age, vaccination interval, and severity of each AE. Results: The third dose of BNT162b2 was associated with significantly more frequent or milder AEs than the second dose. Logistic regression analyses detected significant differences in six items of AEs by age, three by sex, two by comorbidities, and zero by vaccination interval. Consistently, the risk of AEs was greater among younger persons, females, and those without comorbidities. Significant negative correlations were detected between age and vaccination interval, and between age and the severity of most AEs. Conclusions: Young, female, and having no comorbidities are risk factors for AEs after the third dose of BNT162b2, while vaccination interval is not.

Cohesive polydensified matrix (CPM®) hyaluronic acid fillers are now available with or without lidocaine. The aim of this study was to investigate the safety and performance of CPM® fillers with lidocaine in the clinical setting. In an open-label, prospective, postmarketing study, 108 patients from seven sites in Germany and Denmark were treated with one or more lidocaine-containing CPM® fillers. Performance was assessed using the Merz Aesthetics Scales® (MAS). Pain was rated on an 11-point visual analog scale. Patients’ and physicians’ satisfaction as well as adverse events were recorded. Improvements of ≥1-point on MAS immediately after and 17 days posttreatment were observed in ~90% of patients compared with baseline. All investigators assessed ejection force, product positioning, and performance as similar or superior to the respective nonlidocaine products. Overall, 94% of investigators were satisfied with the esthetic outcomes and were willing to continue using the products. All patients except one were satisfied with the results, and all were willing to repeat the treatment. Mean pain scores were low during (<3.0) and after injection (<0.6). Except for one case of bruising, all adverse events were mild to moderate. CPM® fillers with lidocaine are safe and effective for a wide range of esthetic facial indications.