Differences In Event Rates Research Articles

Helical CT versus intermittent CT fluoroscopic guidance for musculoskeletal needle biopsies: impact on radiation exposure, procedure time, diagnostic yield, and adverse events.

Image-guided percutaneous needle biopsies are essential in the workup of musculoskeletal (MSK) lesions. While helical CT (HCT) is well established, intermittent CT fluoroscopy (iCTF) is an increasingly used alternative. The purpose of this study is to establish whether differences in subject radiation exposure, procedure time, yield, or adverse events exist between HCT and iCTF guidance. This retrospective cohort study included consecutive MSK needle biopsies performed on a single-CT scanner over a 12-month period at a tertiary academic center. Subject demographics, radiation dose, and outcomes were abstracted from the medical record. Comparisons between the two cohorts were performed using Student's t-test for continuous data and using Fisher's exact test for categorical data and a two-tailed p value less than 0.05 was considered significant. Two hundred sixteen adults (115 (53.2%) females) with a mean age of 58.8 ± 18.4years, underwent 216 biopsies (109 (50.5%) HCT guided, 107 (49.5%) iCTF guided) between June 2017 and June 2018. Dose-length product (DLP) and volume CT dose index (CTDIvol) were significantly higher for the HCT cohort (HCT 698.9 ± 400.8 mGycm vs iCTF 312.8 ± 170.8 mGycm; p < 0.005 and HCT 19.1mGy ± 8.8 vs iCTF 6.9mGy ± 1.5, p < 0.001). No significant difference in diagnostic yield, procedure time, or adverse event rate was identified. For CT-guided MSK needle biopsies, iCTF decreases subject radiation dose compared to HCT without negatively affecting outcomes. iCTF should be strongly considered by radiologists performing MSK biopsies given the reduced patient radiation exposure.

Abstract 12498: Incidence Of Non-Sustained Ventricular Tachycardia and Arrhythmic Disease Progression During Follow-Up in Hypertrophic Cardiomyopathy Patients

Introduction: One of the most well-established risk markers for sudden cardiac death is non-sustained ventricular tachycardia (NSVT; 3 ventricular beats with a rate of ≥120 bpm, lasting for &lt;30 seconds). Forty-eight-hours Holter monitoring is recommended to identify NSVT in patients with hypertrophic cardiomyopathy (HCM) . Purpose: The study aims to estimate the 48 hour-incidence of NSVT in HCM patients and to analyze arrhythmic disease progression during follow up. Methods: The study retrospectively evaluated HCM patients enrolled in the Registry for Hereditary Cardiovascular Diseases from 2011 to 2020. A total of 145 patients met the inclusions criteria to be a proband with HCM or a relative with left ventricular hypertrophy ≥13mm. A cross sectional analysis was done in 131 patients with at least one available Holter monitoring. A follow-up Holter monitoring was available in 97 patients. Results: Of 145 patients, the mean age was 54±15 years and 98 (68%) were male. The proportion of patients free of NSVT were 66% after 48 hours of Holter monitoring (n=131) (Kaplan-Meier estimates). Fifteen percent of NSVTs occurred from 36 to 48 hours into the Holter monitoring. The mean follow-up time between first and latest Holter (n=97) was 4.3 (±2.5) years and the median Holter monitoring time was both 48 (IQR, 48-48) hours at the first and 48 (IQR, 47-48) hours at the latest Holter. The proportion of patients free of NSVT in the first 48 hour Holter monitoring was 69% compared to 63% in the latest 48 hour Holter monitoring (p=0.17). Wilcoxon signed rank test showed no difference in number of ventricular cycles or the calculated frequency analyzing the first episode of NSVT in each Holter. Cox regressions analysis showed no significant difference in event rates between first and latest Holter (HR 0.84, 95% CI 0.26-2.70, p=0.77) and no association between age and NSVT (HR 1.03, 95% CI 0.83-1.28, p=0.80). Conclusions: NSVT occurred with an incidence rate of 34% per 48-hours Holter monitoring. An important part of NSVTs was identified in the last 12 hours of monitoring. The was no significant progression in the incidence rate of NSVT nor the characteristics of NSVT during follow up. Age had no effect on the incidence of NSVT.

Usefulness of discharge standards in outpatients undergoing sedative endoscopy: a propensity score-matched study of the modified post-anesthetic discharge scoring system and the modified Aldrete score

BackgroundThis study aimed to evaluate the usefulness of discharge standards in outpatients undergoing sedative endoscopy by comparing the modified post-anesthetic discharge scoring system (MPADSS) and the modified Aldrete score.MethodsWe prospectively enrolled 376 outpatients who underwent gastrointestinal endoscopy under midazolam sedation; 181 outpatients were assessed regarding discharge after sedative endoscopy using the MPADSS (group M), and 195 patients were assessed by the modified Aldrete score (group A). The clinical characteristics, types of endoscopy, endoscopic outcomes, and anesthesia outcomes were evaluated between the two groups. We compared discharge score, recovery time, and adverse events using propensity-score matching.ResultsPropensity-score matching created 120 matched pairs. The proportion of patients who had a recovery time within 60 min after endoscopy was significantly higher in group A than that in group M (42.5% versus 25.0%, respectively; P < 0.01). The proportion of patients who required > 120 min of recovery time after endoscopy was significantly lower in group A than that in group M (0.0% versus 5.0%, respectively; P = 0.03). However, significantly more patients had drowsiness at discharge in group A compared with group M (19.1% versus 5.0%, respectively; P < 0.01). There was no significant difference in the adverse event rate within 24 h of discharge between the groups.ConclusionsPatients assessed by the modified Aldrete score were allowed to discharge earlier than those assessed by the MPADSS. However, a patient’s level of consciousness should be assessed carefully, especially in patients who visit the hospital alone.

Vagus Nerve Stimulation Paired With Rehabilitation for Upper Limb Motor Impairment and Function After Chronic Ischemic Stroke: Subgroup Analysis of the Randomized, Blinded, Pivotal, VNS-REHAB Device Trial

Background Vagus Nerve Stimulation (VNS) paired with rehabilitation improved upper extremity impairment and function in a recent pivotal, randomized, triple-blind, sham-controlled trial in people with chronic arm weakness after stroke. Objective We aimed to determine whether treatment effects varied across candidate subgroups, such as younger age or less injury. Methods Participants were randomized to receive rehabilitation paired with active VNS or rehabilitation paired with sham stimulation (Control). The primary outcome was the change in impairment measured by the Fugl–Meyer Assessment Upper Extremity (FMA-UE) score on the first day after completion of 6-weeks in-clinic therapy. We explored the effect of VNS treatment by sex, age (≥62 years), time from stroke (>2 years), severity (baseline FMA-UE score >34), paretic side of body, country of enrollment (USA vs UK) and presence of cortical involvement of the index infarction. We assessed whether there was any interaction with treatment. Findings The primary outcome increased by 5.0 points (SD 4.4) in the VNS group and by 2.4 points (SD 3.8) in the Control group (P = .001, between group difference 2.6, 95% CI 1.03-4.2). The between group difference was similar across all subgroups and there were no significant treatment interactions. There was no important difference in rates of adverse events across subgroups. Conclusion The response was similar across subgroups examined. The findings suggest that the effects of paired VNS observed in the VNS-REHAB trial are likely to be consistent in wide range of stroke survivors with moderate to severe upper extremity impairment.

Efficacy and Safety of Polaprezinc-Based Therapy versus the Standard Triple Therapy for Helicobacter pylori Eradication: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Helicobacter pylori (H. pylori) is the most prevalent etiology of gastritis worldwide. H. pylori management depends mainly on antibiotics, especially the triple therapy formed of clarithromycin, amoxicillin, and proton pump inhibitors. Lately, many antibiotic-resistant strains have emerged, leading to a decrease in the eradication rates of H. pylori. Polaprezinc (PZN), a mucosal protective zinc-L-carnosine complex, may be a non-antibiotic agent to treat H. pylori without the risk of resistance. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of a PZN-based regimen for the eradication of H. pylori. This study used a systematic review and meta-analysis synthesizing randomized controlled trials (RCTs) from WOS, SCOPUS, EMBASE, PubMed, and Google Scholar until 25 July 2022. We used the odds ratio (OR) for dichotomous outcomes presented with the corresponding 95% confidence interval (CI). We registered our protocol in PROSPERO with ID: CRD42022349231. We included 3 trials with a total of 396 participants who were randomized to either PZN plus triple therapy (n = 199) or triple therapy alone (control) (n = 197). Pooled OR found a statistical difference favoring the PZN arm in the intention to treat and per protocol H. pylori eradication rates (OR: 2.01 with 95% CI [1.27, 3.21], p = 0.003) and (OR: 2.65 with 95% CI [1.55, 4.54], p = 0.0004), respectively. We found no statistical difference between the two groups regarding the total adverse events (OR: 1.06 with 95% CI [0.55, 2.06], p = 0.85). PZN, when added to the triple therapy, yielded a better effect concerning the eradication rates of H. pylori with no difference in adverse event rates, and thus can be considered a valuable adjuvant for the management of H. pylori. However, the evidence is still scarce, and larger trials are needed to confirm or refute our findings.

Dexamethasone for the treatment of acute respiratory distress syndrome: A systematic review and meta-analysis.

Background:This meta-analysis aimed to evaluate the efficacy and safety of dexamethasone in the treatment of acute respiratory distress syndrome (ARDS).Methods:A systematic search of electronic databases was carried out from inception to May 1, 2022, including PUBMED, EMBASE, Cochrane Library, Wangfang, VIP, and CNKI. Other searches were also checked for dissertations/theses and the reference lists of the included studies. Two team members examined all citations and selected eligible articles. Randomized controlled trials (RCTs) reporting the efficacy and safety of dexamethasone for the treatment of ARDS were included, and the quality of eligible RCTs was assessed using the Cochrane Risk of Bias Tool. If necessary, we conducted data synthesis and meta-analysis. The primary outcome was all-cause mortality. Secondary outcomes were mechanical ventilation duration (day), ventilator-free status at 28 days; intensive care unit (ICU) free (day), ICU mortality, hospital mortality, sequential organ failure assessment (SOFA) as mean and range, SOFA as No. of patients, peak airway pressure (cmH2O), arterial oxygen pressure (mm Hg), days with PaO2 > 10kPa, PaO2, and the occurrence rate of adverse events.Results:Four studies involving 702 patients were included in this analysis. This study showed that dexamethasone could significantly reduce all-cause mortality (odds ratio (OR) = 0.62, 95% confidence interval (CI) [0.44, 0.88], I2 = 30%, P < .001), and decrease ventilator-free status at 28 days (MD = 3.65, 95% CI [1.49, 5.80], I2 = 51%, P < .001). No significant differences in occurrence rates of adverse events were found between dexamethasone and routine or standard care.Conclusions:Evidence from the meta-analysis suggests that dexamethasone is an effective and relatively safe treatment for all-cause mortality and ventilator-free status at 28 days in patients with ARDS. Owning to the small number of eligible RCTs, the conclusions of present study are warranted in the future study.

Comparison of Complications and Cost for Transfemoral Versus Transcarotid Stenting of Carotid Artery Stenosis

Options for endovascular treatment of carotid artery disease have been developed to compliment with carotid endarterectomy, transfemoral carotid artery stenting (TFCAS) and a hybrid approach with transcarotid artery revascularization (TCAR). We sought to capture endpoints outside of stroke, myocardial infarction (MI), and death involved with each procedure at our institution as well as evaluate cost. Carotid stent procedures performed from 2014 to 2020 at our institution underwent comparative analysis based upon access site and type of stent procedure performed, TFCAS versus TCAR. Procedural details and outcomes were captured prospectively and included in the National Cardiovascular Data Peripheral Vascular Intervention Registry (NCDR-PVI). Further retrospective review was performed to evaluate endpoints beyond stroke, MI, and death. Total in-hospital cost, including administrative, capital and utilities (fixed cost), and labor and supplies (variable cost) were also evaluated. One hundred thirty-seven patients were reviewed. Seventy-seven were treated with TFCAS and 60 with TCAR. The mean age was 74years, predominantly male (68%) and Caucasian (90%). Patients undergoing TFCAS were more likely to be symptomatic compared to those receiving TCAR (81.8% vs. 50.0%, P = <0.001). There were no statistically significant differences in event rates, including mortality, recurrent cerebrovascular accident / transient ischemic attack, or bleeding. Complications not captured in the NCDR-PVI database were more frequent in the TCAR group (21.7% vs. 5.2%, P=0.004) and included pneumothorax (n=2), neck hematoma (n=8), and common carotid artery stenosis or injury (n=3). Rates of complications in the TFCAS group (n=4) were lower and limited to groin hematoma (n=2), central retinal artery occlusion causing vision loss and a case of postoperative dysphagia. Geographic miss of initial stent placement was identified in 15.0% of TCAR patients and 2.6% (P=0.008) of TFCAS patients. Restenosis rates on duplex ultrasound were similar between the two groups (14.6% of patients) and were not associated with symptoms. The mean follow-up interval was similar for both groups of 31.8months for TCAR and 30.7months for TFCAS (P=0.797). There was a statistically significant difference in total cost with TCAR being more expensive ($22,315 vs. $11,001) driven by direct costs that included devices, imaging, and extended length of stay in the TCAR group (P<0.001). There was no significant difference between stroke free survival (91.1% vs. 88.6%, P=0.69) and mortality (78.1% vs. 85.2%, P=0.677) at 3years follow-up between TCAR and TFCAS, respectively. Both TFCAS and TCAR provide similar 3-year stroke and mortality risk/benefit and are distinctly different procedures. Both should be evaluated independently with analysis of variables beyond stroke, death, and MI. TFCAS is more cost-effective than TCAR in this single institution study.

Immunogenicity and Safety of COVID-19 Vaccines among People Living with HIV: A Systematic Review and Meta-Analysis.

Background: The immunogenicity and safety of COVID-19 vaccines among people living with human immunodeficiency virus (PLWH) are unclear. We aimed to evaluate the immunogenicity and safety of COVID-19 vaccines among PLWH. Methods: We systematically searched PubMed, EMBASE, and Web of Science from 1 January 2020 to 28 April 2022 and included observational studies, randomized clinical trials, and non-randomized clinical trials reporting extractable data about the immunogenicity and safety of COVID-19 vaccines among PLWH. Results: A total of 34 eligible studies covering 4517 PLWH were included. The pooled seroconversion rates among PLWH after the first and second doses were 67.51% (95% confident interval (CI) 49.09–85.93%) and 96.65% (95%CI 95.56–97.75%), respectively. The seroconversion was similar between PLWH and healthy controls after the first (risk ratio (RR) = 0.89, 95%CI 0.76–1.04) and the second (RR = 0.97, 95%CI 0.93–1.00) dose. Moreover, the geometric mean titer (GMT) showed no significant difference between PLWH and healthy controls after the first dose (standardized mean difference (SMD) = 0.30, 95%CI -1.11, 1.70) and the second dose (SMD = -0.06, 95%CI -0.18, 0.05). Additionally, the pooled incidence rates of total adverse events among PLWH after the first and the second dose were 46.55% (95%CI 28.29–64.82%) and 30.96% (95%CI 13.23–48.70%), respectively. There was no significant difference in risks of total adverse events between PLWH and healthy controls after the first (RR = 0.86, 95%CI 0.67–1.10) and the second (RR = 0.88, 95%CI 0.68–1.14) dose. Conclusions: The available evidence suggested that the immunogenicity and safety of COVID-19 vaccines among PLWH were acceptable. There was no significant difference in the seroconversion rates and incidence rates of adverse events of COVID-19 vaccines between PLWH and healthy controls.

Factors associated with emergency readmissions after acute stroke: A retrospective audit of two hospitals.

Emergency hospital readmissions within 30 days of discharge from hospital are considered a marker for the quality of hospital care, patient experience, the discharge process and integration with community services. This paper describes the frequency and variations in cause of emergency readmissions at 30 and 90 days following discharge after acute stroke from two stroke units. Retrospective data collection of Hospital Episodes Statistics (HES) and Sentinel Stroke National Audit Programme (SSNAP) of consecutive acute stroke hospital discharges over 24 months from 2017 to 2019 from two specialist stroke units in England. HES data were used to calculate the Charlson comorbidity index (CCI). Covariates were analysed for their association with readmission rate, including: age; gender; CCI; length of stay for first stroke admission; living alone; discharge to a care home; discharge receiving stroke specialist early supported discharge (ESD) rehabilitationand stroke severity as determined by National Institute for Health Stroke Scaleon stroke admission. From 2017 to 2019 there were 1999 live discharges with a primary diagnosis of stroke. Both hospitals had a trend of increasing readmission rates with increasing stroke severity and comorbidity. Longer length of stroke admission, especially for patients with increasing stroke severity, and patients receiving ESD rehabilitation after discharge reduced 90-day readmissions. This association was stronger at 90 days than at 30 days. Different readmission event rates were found at 30 and 90 days and when events were compared between the two hospitals. Understanding differences in readmission event rates between hospitals at 30 and 90 days can support local planning of patient needs in the first weeks after stroke discharge and to investigate ways for hospital to reduce the impact of readmission. It is recommended that stroke services use both 30 and 90-day readmissions to inform service evaluation and improvement.

220. An analysis of intraoperative neurophysiological monitoring events during single position minimally invasive spine surgery

<h3>BACKGROUND CONTEXT</h3> The single position minimally invasive (MIS) lateral approach allows access to the anterior and posterior columns with the patient positioned in the lateral decubitus position. The purpose of this approach was to mitigate complications associated with open procedures while achieving circumferential fusion. More recently, an alternative prone-lateral technique has been developed streamlining surgical access with potential advantages. The purpose of this study was to identify differences in intraoperative neurophysiological monitoring (IOM) event rates between single position lateral decubitus and prone-lateral patients during MIS spine surgery. <h3>PURPOSE</h3> To determine if lateral decubitus positioning will correlate with the occurrence of neurophysiological monitoring events during MIS spine surgery. <h3>STUDY DESIGN/SETTING</h3> Retrospective cohort. <h3>PATIENT SAMPLE</h3> A total of 524 MIS patients were included. <h3>OUTCOME MEASURES</h3> Intraoperative neurophysiological monitoring, lateral decubitus, prone lateral. <h3>METHODS</h3> MIS spine surgery patients with available surgical positioning and IOM data were included if they were in a single position. Patients were stratified into 2 groups based on operative positioning: lateral decubitus (Lat) and prone lateral (PL). IOM was performed using somatosensory evoked potentials (SSEPs) and electromyography (EMG) techniques. An abnormal event was defined as any confirmed loss of signal during the operative period in the anatomical distribution of the surgery. Means comparison tests and multivariable logistic regression analysis assessed differences between patient groups. <h3>RESULTS</h3> Of 524 patients eligible, 226 (43.1%) had available positioning and IOM data. Of these, 88 met inclusion criteria (52 Lat and 36 PL). The majority were male (49, 55.7%), mean age of 49.2 yrs and 2.0 levels fused and 18 (20.5%) undergoing an osteotomy. In total, 19 (21.6%) patients had an abnormal IOM event. There was a significant difference in abnormal IOM event rates for patients who were in Lat (31%) and PL (8%) positioning, p=0.012. Multivariable analysis adjusting for surgical invasiveness showed that PL patients were 76.8% less likely to experience an abnormal IOM event than Lat patients (OR .232 [CI .060-.905], p=.035). Of the Lat patients with an abnormal IOM, 6.3% had postoperative sensory loss in the saphenous nerve. <h3>CONCLUSIONS</h3> Lateral decubitus positioning appears to be independently associated with abnormal intraoperative neurophysiological monitoring events when compared to prone lateral positioning during MIS. This has the potential to help with risk stratification in the future when determining patients undergoing a single position procedure. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

P117. An evaluation of preoperative patient weight and body mass index during single-position minimally invasive spine surgery

<h3>BACKGROUND CONTEXT</h3> The single position minimally invasive (MIS) approach allows access to the anterior and posterior columns with the ability to mitigate complications associated with open procedures while achieving circumferential fusion. The purpose of this study was to identify if patient weight or body mass index (BMI) leads to differences in intraoperative event rates. <h3>PURPOSE</h3> To determine if patient weight and BMI will correlate with the occurrence of intraoperative events during MIS spine surgery. <h3>STUDY DESIGN/SETTING</h3> Retrospective cohort. <h3>PATIENT SAMPLE</h3> A total of 524 MIS patients. <h3>OUTCOME MEASURES</h3> Weight (kg), BMI (kg/m2), Aborted procedures, estimated blood loss (EBL), operative time (OpTime). <h3>METHODS</h3> Of 524 patients eligible, 226 (43.1%) had available data. Of these, 88 met inclusion criteria (52 Lat and 36 PL). The majority were male (49, 55.7%), mean age of 49.2 yrs and 2.0 levels fused and 18 (20.5%) undergoing an osteotomy. Lat patients with a weight > 130 kg had significantly longer OpTime (p=0.003) and more EBL (p=0.019). There was a significant difference in mean weight for lat patients with (121.8 kg) and without (97.7 kg) an aborted procedure, p=0.021. There was also a significant difference in mean BMI for lat patients with (35.3 kg/m2) and without (29.6 kg/m2) an aborted procedure, p=0.015. Multivariable analysis showed that weight (OR 1.03 [CI 1.01-1.06], p=.020) and BMI (OR 1.15 [CI 1.02-1.30], p=.026) were independent predictors for aborted procedures in lat patients. In an analysis of PL patients, there was one aborted case (weight > 120 kg), but no significant findings for EBL or OpTime. <h3>RESULTS</h3> Of 524 patients eligible, 226 (43.1%) had available data. Of these, 88 met inclusion criteria (52 Lat and 36 PL). The majority were male (49, 55.7%), mean age of 49.2 yrs and 2.0 levels fused and 18 (20.5%) undergoing an osteotomy. Lat patients with a weight > 130 kg had significantly longer OpTime (p=0.003) and more EBL (p=0.019). There was a significant difference in mean weight for lat patients with (121.8 kg) and without (97.7 kg) an aborted procedure, p=0.021. There was also a significant difference in mean BMI for lat patients with (35.3 kg/m2) and without (29.6 kg/m2) an aborted procedure, p=0.015. Multivariable analysis showed that weight (OR 1.03 [CI 1.01-1.06], p=.020) and BMI (OR 1.15 [CI 1.02-1.30], p=.026) were independent predictors for aborted procedures in lat patients. In an analysis of PL patients, there was one aborted case (weight > 120 kg), but no significant findings for EBL or OpTime. <h3>CONCLUSIONS</h3> Weight and BMI appear to be independently associated with aborted procedures for patients in the lateral decubitus position during minimally invasive spine surgery. Patients in the lateral decubitus position who weighed 130 kg or more had on average longer operative times and more estimated blood lost. This study has the potential to help with risk stratification in the future when determining patients undergoing a single position procedure. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Spikes and High Frequency Oscillations in Lateral Neocortical Temporal Lobe Epilepsy: Can They Predict the Success Chance of Hippocampus-Sparing Resections?

PurposeWe investigated the distribution of spikes and HFOs recorded during intraoperative electrocorticography (ioECoG) and tried to elaborate a predictive model for postsurgical outcomes of patients with lateral neocortical temporal lobe epilepsy (TLE) whose mesiotemporal structures are left in situ.MethodsWe selected patients with temporal lateral neocortical epilepsy focus who underwent ioECoG-tailored resections without amygdalo–hippocampectomies. We visually marked spikes, ripples (80–250 Hz), and fast ripples (FRs; 250–500 Hz) on neocortical and mesiotemporal channels before and after resections. We looked for differences in event rates and resection ratios between good (Engel 1A) and poor outcome groups and performed logistic regression analysis to identify outcome predictors.ResultsFourteen out of 24 included patients had a good outcome. The poor-outcome patients showed higher rates of ripples on neocortical channels distant from the resection in pre- and post-ioECoG than people with good outcomes (ppre = 0.04, ppost = 0.05). Post-ioECoG FRs were found only in poor-outcome patients (N = 3). A prediction model based on regression analysis showed low rates of mesiotemporal post-ioECoG ripples (ORmesio = 0.13, pmesio = 0.04) and older age at epilepsy onset (OR = 1.76, p = 0.04) to be predictors of good seizure outcome.ConclusionHFOs in ioECoG may help to inform the neurosurgeon of the hippocampus-sparing resection success chance in patients with lateral neocortical TLE.

A comparison of adverse pregnancy events between ureteral stents and percutaneous nephrostomy tubes in the treatment of nephrolithiasis during pregnancy: A propensity score-matched analysis of a large multi-institutional research network.

To investigate rates of adverse pregnancy events associated with the use of percutaneous nephrostomy tubes (PCN) versus ureteral stents in the treatment of nephrolithiasis during pregnancy. We queried the TriNetX Diamond Network database to evaluate pregnant women (ICD-10 Z34, O09) with a history of nephrolithiasis (N20-23) who underwent a PCN (CPT 50432) or ureteral stent (52332) placement up to 6months before delivery (O80-82). We controlled for the following potentially confounding variables through propensity score matching: age, race, ethnicity, acute pyelonephritis (N10), infections of the genitourinary tract in pregnancy (O23.0), and other sepsis (A41) at the time of stent or PCN placement. We identified 2,999 pregnant women who underwent ureteral stent placement and 321 who underwent PCN. Following propensity score matching, we found there to be no significant difference in the rate of premature labor or delivery (aOR 1.08, 95% CI 0.735-1.588), premature rupture of membranes (0.889, 0.453-1.743), intrauterine infection (0.906, 0.379-2.165), or c-Sect.(0.825, 0.408-1.667). Within 6months of their initial procedure, women with a ureteral stent experienced a significantly decreased rate of subsequent urinary tract infection (UTI) or pyelonephritis (0.52, 0.38-0.71), inpatient hospital stay (0.40, 0.26-0.64), emergency department visit (0.65, 0.48-0.89), and repeat exchange procedure (0.70, 0.51-0.96). In the treatment of nephrolithiasis during pregnancy, PCN versus ureteral stent placement does not confer a significant difference in rates of adverse pregnancy events. However, ureteral stent placement was associated with a lower incidence of hospital admissions, emergency department visits, exchange procedures, and new UTIs or pyelonephritis.

The Prediction of Cardiac Events Using Contemporary Risk Prediction Models after Radiation Therapy for Head and Neck Cancer.

Simple SummaryRadiation therapy is associated with an increased risk for atherosclerotic cardiovascular disease (ASCVD). Contemporary risk prediction models accurately predict ASCVD in general populations. Whether these models adequately capture ASCVD risk after radiation therapy (RT) is unknown. Our data show that these standard risk scores do not reliably differentiate between those who will and those who will not have an ASCVD event after RT and underestimate the risk for ASCVD among patients receiving RT for HNCA.This study aims to evaluate the efficacy of the Pooled Cohort Equation (PCE), U.S. Preventative Services Task Force (USPSTF), and Framingham Risk Score (FRS) models in predicting ASCVD events among patients receiving radiation therapy (RT) for head and neck cancer (HNCA). From a large cohort of HNCA patients treated with RT, ASCVD events were adjudicated. Observed vs. predicted ASCVD events were compared. We compared rates by statin eligibility status. Regression models and survival analysis were used to identify the relationship between predicted risk and post-RT outcomes. Among the 723 identified patients, 274 (38%) were statin-eligible based on USPSTF criteria, 359 (49%) based on PCE, and 234 (32%) based on FRS. During follow-up, 17% developed an ASCVD, with an event rate of 27 per 1000 person-years, 68% higher than predicted (RR 1.68 (95% CI: 1.02, 2.12), p < 0.001). In multivariable regression, there was no difference in event rates by statin eligibility status (p > 0.05). Post-RT, the observed event rate was higher than the predicted ASCVD risk across all grades of predicted risk (p < 0.05) and the observed risk of an ASCVD event was high even among patients predicted to have a low risk of ASCVD. In conclusion, current ASCVD risk calculators significantly underestimate the risk for ASCVD among patients receiving RT for HNCA.

Enhanced nuclear localization of phosphorylated MLKL predicts adverse events in patients with dilated cardiomyopathy.

The role of necroptosis in dilated cardiomyopathy (DCM) remains unclear. Here, we examined whether phosphorylation of mixed lineage kinase domain-like protein (MLKL), an indispensable event for execution of necroptosis, is associated with the progression of DCM. Patients with DCM (n=56, 56±15years of age; 68% male) were enrolled for immunohistochemical analyses of biopsies. Adverse events were defined as a composite of death or admission for heart failure or ventricular arrhythmia. Compared with the normal myocardium, increased signals of MLKL phosphorylation were detected in the nuclei, cytoplasm, and intercalated discs of cardiomyocytes in biopsy samples from DCM patients. The phosphorylated MLKL (p-MLKL) signal was increased in enlarged nuclei or nuclei with bizarre shapes in hypertrophied cardiomyocytes. Nuclear p-MLKL level was correlated negatively with septal peak myocardial velocity during early diastole (r=-0.327, P=0.019) and was correlated positively with tricuspid regurgitation pressure gradient (r=0.339, P=0.023), while p-MLKL level in intercalated discs was negatively correlated with mean left ventricular wall thickness (r=-0.360, P=0.014). During a median follow-up period of 3.5years, 10 patients (18%) had adverse events. To examine the difference in event rates according to p-MLKL expression levels, patients were divided into two groups by using the median value of nuclear p-MLKL or intercalated disc p-MLKL. A group with high nuclear p-MLKL level (H-nucMLKL group) had a higher adverse event rate than did a group with low nuclear p-MLKL level (L-nucMLKL group) (32% vs. 4%, P=0.012), and Kaplan-Meier survival curves showed that the adverse event-free survival rate was lower in the H-nucMLKL group than in the L-nucMLKL group (P=0.019 by the log-rank test). Such differences were not detected between groups divided by a median value of intercalated disc p-MLKL. In δ-sarcoglycan-deficient (Sgcd-/- ) mice, a model of DCM, total p-MLKL and nuclear p-MLKL levels were higher than in wild-type mice. The results suggest that increased localization of nuclear p-MLKL in cardiomyocytes is associated with left ventricular diastolic dysfunction and future adverse events in DCM.

Gastric variceal bleeding treated through endoscopic ultrasound-guided coiling and N-butyl-2-cyanoacrylate application.

To evaluate efficacy and safety between dual angiotherapy (endocoil plus N-butyl-cyanoacrylate) guided by endoscopic ultrasound) versus N-butyl-cyanoacrylate in the secondary prophylaxis of gastroesophageal varices (GOV). Prospective non-inferiority study comparing two gastric variceal eradication techniques. We evaluated technical and clinical success, GOV occlusion and eradication, rebleeding, reoperation, GOV-free period, complications, and mortality. Chi square for categorical variables and Student's t for numerical variables with a significance level of 0.05. There were 68 patients (average age 55.5 ± 10 years, women 44 (64.7%) and average body mass index 25.7 ± 3.5 kg/m2). The most frequent cause was alcoholic steatohepatitis (58%). Dual therapy had greater technical (100% vs. 94.3%) and clinical (100% vs. 85%) success. Obliteration was faster (100 vs. 79.2%). This group only required one session. The GOV size was 24 ± 14 mm and 1-2 endocoils were placed. The median follow-up was 221 days. The reoperation-free rate was high (100% vs. 94%; p = 0.9). Dual angiotherapy guided by endoscopic ultrasound and cyanoacrylate injection are effective for the eradication of GOV without differences in adverse event rates.

Effects of Different Running Intensity on Serum Levels of IL-6 and TNF-α in Patients with Early Knee Osteoarthritis.

To investigate the effects of different running intensities on interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) in patients with early knee osteoarthritis (KOA). Clinical comparative study. Department of Orthopedics, Longyan First Affiliated Hospital of Fujian Medical University, Fujian, China, from January 2019 to January 2021. A total of 131 patients with early KOA admitted to Longyan First Hospital Affiliated to Fujian Medical University from January 2019 to January 2021 were selected and randomly divided into four groups using the random number table method: Group A (static control group, 34 cases), Group B (walking group, 32 cases), Group C (brisk walking group, 32 cases), and Group D (jogging group, 33 cases), and the training duration of the four groups was 6 months. Moreover, the levels of IL-6 and TNF-α, the activity of daily living (ADL), Fugl-Meyer assessment scale (FMA) scores, and adverse events before and after training were compared between the four groups. No statistical significance was observed in the differences of TNF-α, IL-6, ADL-advanced ability, ADL-basic ability, FMA-upper limb, and FMA-lower limb among the four groups before training (p>0.05). After training, the levels of TNF-α and IL-6 of the four groups were decreased, while the scores of FMA and ADL were increased. Group C had the highest FMA-upper limb and FMA-lower limb scores, ADL- advanced ability and ADL-basic ability after training, which were higher than those in groups A, B, and D (p<0.05). No statistical significance could be observed in the difference in the adverse event rate among the four groups during training (X2=3.339, p>0.05). Exercise training of different intensities, such as slow walking, brisk walking, and jogging, is touted to enhance the overall recovery of patients with early KOA. The exercise intensity of brisk walking training is moderate, and the activity of daily living and exercise ability of patients are significantly improved after training, while the levels of TNF-α and IL-6 are obviously decreased. Knee osteoarthritis, Interleukin-6, Exercise training, Exercise intensity, Tumor necrosis factor α.

Clinical and Quality-of-Life Outcomes Following Invasive vs Conservative Treatment of Patients With Chronic Coronary Disease Across the Spectrum of Kidney Function

Prior trials of invasive vs conservative management of chronic coronary disease (CCD) have not enrolled patients with severe chronic kidney disease (CKD). As such, outcomes across kidney function are not well characterized. To evaluate clinical and quality-of-life (QoL) outcomes across the spectrum of CKD following conservative and invasive treatment strategies. Participants from the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) and ISCHEMIA-Chronic Kidney Disease (CKD) trials were categorized by CKD stage: stage 1 (estimated glomerular filtration rate [eGFR] 90 mL/min/1.73m2 or greater), stage 2 (eGFR 60-89 mL/min/1.73m2), stage 3 (eGFR 30-59 mL/min/1.73m2), stage 4 (eGFR 15-29 mL/min/1.73m2), or stage 5 (eGFR less than 15 mL/min/1.73m2 or receiving dialysis). Enrollment took place from July 26, 2012, through January 31, 2018, with a median follow-up of 3.1 years. Data were analyzed from January 2020 to May 2021. Initial invasive management of coronary angiography and revascularization with guideline-directed medical therapy (GDMT) vs initial conservative management of GDMT alone. The primary clinical outcome was a composite of death or nonfatal myocardial infarction (MI). The primary QoL outcome was the Seattle Angina Questionnaire (SAQ) summary score. Among the 5956 participants included in this analysis (mean [SD] age, 64 [10] years; 1410 [24%] female and 4546 [76%] male), 1889 (32%), 2551 (43%), 738 (12%), 311 (5%), and 467 (8%) were in CKD stages 1, 2, 3, 4, and 5, respectively. By self-report, 18 participants (<1%) were American Indian or Alaska Native; 1676 (29%), Asian; 267 (5%), Black; 861 (16%), Hispanic or Latino; 18 (<1%), Native Hawaiian or Other Pacific Islander; 3884 (66%), White; and 13 (<1%), multiple races or ethnicities. There was a monotonic increase in risk of the primary composite end point (3-year rates, 9.52%, 10.72%, 18.42%, 34.21%, and 38.01% respectively), death, cardiovascular death, MI, and stroke in individuals with higher CKD stages. Invasive management was associated with an increase in stroke (3-year event rate difference, 1%; 95% CI, 0.3 to 1.7) and procedural MI (1.6%; 95% CI, 0.9 to 2.3) and a decrease in spontaneous MI (-2.5%; 95% CI, -3.9 to -1.1) with no difference in other outcomes; the effect was similar across CKD stages. There was heterogeneity of treatment effect for QoL outcomes such that invasive management was associated with an improvement in angina-related QoL in individuals with CKD stages 1 to 3 and not in those with CKD stages 4 to 5. Among participants with CCD, event rates were inversely proportional to kidney function. Invasive management was associated with an increase in stroke and procedural MI and a reduced risk in spontaneous MI, and the effect was similar across CKD stages with no difference in other outcomes, including death. The benefit for QoL with invasive management was not observed in individuals with poorer kidney function.

Omega-3 fatty acids, subclinical atherosclerosis, and cardiovascular events: Implications for primary prevention

Background and aimsHigh-dose eicosapentaenoic acid (EPA) therapy was beneficial in high-risk patients without clinical cardiovascular disease (CVD). Whether higher plasma levels of EPA and docosahexaenoic acid (DHA) have similar benefits in those without subclinical CVD is unclear. We aim to evaluate the interplay between plasma omega-3 fatty acids and coronary artery calcium (CAC) in relation to CVD events. MethodsWe examined 6568 participants from the Multi-Ethnic Study of Atherosclerosis (MESA) with plasma EPA and DHA levels and CAC measured at baseline. The primary outcome was incident CVD events (myocardial infarction, angina, cardiac arrest, stroke, CVD death). Hazard ratios for the primary outcome were adjusted for potential confounder using Cox regression. ResultsMean ± SD age was 62.1 ± 10.2 years and 52.9% were females. The median follow-up time was 15.6 years. Higher loge(EPA) (adjusted hazard ratio, aHR = 0.83; 95% CI, 0.74–0.94) and loge(DHA) (aHR = 0.79; 95% CI, 0.66–0.96) were independently associated with fewer CVD events. The difference in absolute CVD event rates between lowest vs. highest EPA tertile increased at higher CAC levels. The adjusted HR for highest vs. lowest EPA tertile within CAC = 0 was 1.02 (95% CI, 0.72–1.46), CAC = 1–99 was 0.71 (95% CI, 0.51–0.99), and CAC≥100 was 0.67 (95% CI, 0.52–0.84). A similar association was seen in tertiles of DHA by CAC category. ConclusionsIn an ethnically diverse population free of clinical CVD, higher plasma omega-3 fatty acid levels were associated with fewer long-term CVD events. The absolute decrease in CVD events with higher omega-3 fatty acid levels was more apparent at higher CAC scores.

Effect of Oral Methylprednisolone on Decline in Kidney Function or Kidney Failure in Patients With IgA Nephropathy

The effect of glucocorticoids on major kidney outcomes and adverse events in IgA nephropathy has been uncertain. To evaluate the efficacy and adverse effects of methylprednisolone in patients with IgA nephropathy at high risk of kidney function decline. An international, multicenter, double-blind, randomized clinical trial that enrolled 503 participants with IgA nephropathy, proteinuria greater than or equal to 1 g per day, and estimated glomerular filtration rate (eGFR) of 20 to 120 mL/min/1.73 m2 after at least 3 months of optimized background care from 67 centers in Australia, Canada, China, India, and Malaysia between May 2012 and November 2019, with follow-up until June 2021. Participants were randomized in a 1:1 ratio to receive oral methylprednisolone (initially 0.6-0.8 mg/kg/d, maximum 48 mg/d, weaning by 8 mg/d/mo; n = 136) or placebo (n = 126). After 262 participants were randomized, an excess of serious infections was identified, leading to dose reduction (0.4 mg/kg/d, maximum 32 mg/d, weaning by 4 mg/d/mo) and addition of antibiotic prophylaxis for pneumocystis pneumonia for subsequent participants (121 in the oral methylprednisolone group and 120 in the placebo group). The primary end point was a composite of 40% decline in eGFR, kidney failure (dialysis, transplant), or death due to kidney disease. There were 11 secondary outcomes, including kidney failure. Among 503 randomized patients (mean age, 38 years; 198 [39%] women; mean eGFR, 61.5 mL/min/1.73 m2; mean proteinuria, 2.46 g/d), 493 (98%) completed the trial. Over a mean of 4.2 years of follow-up, the primary outcome occurred in 74 participants (28.8%) in the methylprednisolone group compared with 106 (43.1%) in the placebo group (hazard ratio [HR], 0.53 [95% CI, 0.39-0.72]; P < .001; absolute annual event rate difference, -4.8% per year [95% CI, -8.0% to -1.6%]). The effect on the primary outcome was seen across each dose compared with the relevant participants in the placebo group recruited to each regimen (P for heterogeneity = .11): full-dose HR, 0.58 (95% CI, 0.41-0.81); reduced-dose HR, 0.27 (95% CI, 0.11-0.65). Of the 11 prespecified secondary end points, 9 showed significant differences in favor of the intervention, including kidney failure (50 [19.5%] vs 67 [27.2%]; HR, 0.59 [95% CI, 0.40-0.87]; P = .008; annual event rate difference, -2.9% per year [95% CI, -5.4% to -0.3%]). Serious adverse events were more frequent with methylprednisolone vs placebo (28 [10.9%] vs 7 [2.8%] patients with serious adverse events), primarily with full-dose therapy compared with its matching placebo (22 [16.2%] vs 4 [3.2%]). Among patients with IgA nephropathy at high risk of progression, treatment with oral methylprednisolone for 6 to 9 months, compared with placebo, significantly reduced the risk of the composite outcome of kidney function decline, kidney failure, or death due to kidney disease. However, the incidence of serious adverse events was increased with oral methylprednisolone, mainly with high-dose therapy. ClinicalTrials.gov Identifier: NCT01560052.