Subanalysis Of Patients Research Articles

Surgical De-Escalation for Re-Excision in Patients with a Margin Less Than 2 mm and a Diagnosis of DCIS.

The current surgical guidelines recommend an optimal margin width of 2 mm for the management of patients diagnosed with ductal carcinoma in situ (DCIS). However, there are still many controversies regarding re-excision when the optimal margin criteria are not met in the first resection. The purpose of this study is to understand the importance of surgical margin width, re-excision, and treatments to avoid additional surgery on locoregional recurrence (LRR). The study is retrospective and analyzed surgical margins, adjuvant treatments, re-excision, and LRR in patients with DCIS who underwent breast-conserving surgery (BCS). A total of 197 patients were enrolled. Re-operation for a close margin rate was 13.5%, and the 3-year recurrence was 7.6%. No difference in the LRR was reported among the patients subjected to BCS regardless of the margin width (p = 0.295). The recurrence rate according to margin status was not significant (p = 0.484). Approximately 36.9% (n: 79) patients had resection margins < 2 mm. A sub-analysis of patients with margins < 2 mm showed no difference in the recurrence between the patients treated with a second surgery and those treated with radiation (p = 0.091). The recurrence rate according to margin status in patients with margins < 2 mm was not significant (p = 0.161). The margin was not a predictive factor of LRR p = 0.999. Surgical re-excision should be avoided in patients with a focally positive margin and no evidence of the disease at post-surgical imaging.

Older age associated with better antidepressant response to H1-coil transcranial magnetic stimulation in female patients

BackgroundTMS is increasingly used to treat depression, but predictors of treatment outcomes remain unclear. We assessed the association between age and TMS response given inconsistent prior reports limited by small sample size, heterogeneity, outdated TMS parameters, lack of assessment of H1-coil TMS, and lack of an a priori hypothesis. We hypothesized that older age would be associated with better treatment response based on trends in recent large exploratory analyses. MethodsWe conducted a naturalistic retrospective analysis of patients (n = 378) ages 18–80 with depression (baseline Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) > 5) who received 29–35 sessions of TMS between 2014 and 2021. Response was assessed using percent reduction of QIDS-SR. The relationship between percent response or remission and age group was assessed using the chi-square test. Results85 % of patients received the standard protocol of H1-coil TMS to the left DLPFC. Percent response and remission rates for the entire study sample increased with age (response: p = .026; remission: p = .0023). This finding was stronger in female patients (response: p = .0033; remission: p = .00098) and was not observed in male patients (response: p = .73; remission: p = .26). This was confirmed in a sub-analysis of patients who only received the standard protocol with the H1-coil for the entire treatment course. LimitationsNaturalistic retrospective analysis from one academic center. ConclusionsOlder age is associated with a better antidepressant response to H1-coil TMS in female patients. This was demonstrated in a hypothesis-driven confirmation of prior exploratory findings in a large sample size with a homogeneous data collection protocol across all participants.

Effects of Concomitant CABG on Outcomes in Veterans Who Require Surgery for Endocarditis.

Infective Endocarditis (IE) is a complicated disease frequently accompanied by coronary artery disease (CAD) though no clear guidelines exist for when concomitant revascularization should be undertaken once valve surgery is indicated. Data on this topic within the United States (US) Veteran population, who have unique healthcare needs when compared to the civilian population, is sparse. We investigated the impact of concomitant coronary artery bypass grafting (CABG) on morbidity and mortality in US Veterans requiring surgical management of IE. We identified 489 patients who underwent surgical management of IE between January 1 2010 and December 31 2020 at any of 43 Veterans Affairs (VA) cardiac surgery centers in the US. Patients were stratified based on who underwent concomitant CABG at the time of operation. Primary outcomes included the occurrence of postoperative myocardial infarction (MI), stroke, or mortality. Continuous variables were compared using independent t-tests or Mann Whitney U tests, and categorical variables were compared using the Chi square test. Cox proportional-hazard models were used to calculate risk for primary outcomes based on group. 61 patients (12.5%) underwent concomitant CABG for CAD. After adjusting for significant covariates, patients who underwent CABG had a higher long-term risk of MI (adjusted hazard ratios (aHR) 2.37, 95% CI: 1.29-4.35, p = 0.005) and higher risk of MI at 30-days (aHR 2.34, 95% CI: 1.06-5.19, p = 0.035). Concomitant CABG was not associated with long-term stroke or death, 30-day stroke or death, or perioperative complications. On sub-analysis of patients with moderate to severe CAD, rates of MI were higher in the CABG group at 30 days (25.9 vs. 3.4%, p = 0.016) and 1 year (33.3 vs. 3.4%, p = 0.004), though not long-term. The mean number of grafts was 1.51 ± 0.76, with only one graft performed in 65.6% (40/61) of patients. Concomitant CABG at the time of operation for IE was associated with increased risk of MI at 30-day and long-term, though most CABGs involved a low number of grafts. It was not associated with 30-day stroke or death, long term stroke or death, or perioperative complications. The optimal treatment of CAD noted during preoperative evaluation for veterans undergoing surgery for IE remains unclear.

International multicenter randomized double-blind placebo-controlled study assessing the efficacy and safety of sequential therapy with Mexidol and Mexidol FORTE 250 in patients with chronic brain ischemia (MEMO): subanalysis in patients with arterial hypertension

International multicenter randomized double-blind placebo-controlled study assessing the efficacy and safety of sequential therapy with Mexidol and Mexidol FORTE 250 in patients with chronic brain ischemia (MEMO): subanalysis in patients with arterial hypertension

Long-term outcomes after plaque excision grafting for Peyronie's disease and subanalysis of patients who undergo the procedure despite preoperative counseling against it.

Plaque excision and grafting (PEG) has been recommended for patients with Peyronie's disease (PD) with >60° curvature and/or hinge effect and strong preoperative erections, while placement of an inflatable penile prosthesis (IPP) is recommended when rigidity is suboptimal. Nevertheless, many patients counseled to undergo an IPP decline and insist on proceeding with PEG due to personal preference or desire to avoid an implant. We aim to review long-term outcomes in patients who underwent PEG for PD at our institution and investigate whether there is any difference in long-term outcomes in patients who undergo PEG despite a recommendation to undergo IPP. We conducted a retrospective chart review from 2007 to 2021 on PEG surgery performed at a single tertiary care institution in patients ≥18years old who had >3months of follow-up. Postoperative information was gathered from the electronic medical record, including postoperative erectile function, patient satisfaction, and the ability to engage in penetrative sexual intercourse. An overall 251 patients underwent PEG with a median follow-up of 12 months (IQR, 6-54). Among these, 54 (22%) were initially advised to undergo IPP but elected for PEG. Patients who underwent PEG despite counseling to undergo IPP reported lower postoperative ability to engage in intercourse (51% vs 76%). Seven (13%) patients initially advised to undergo IPP eventually received an IPP, relative to 7 (4%) initially advised to undergo PEG. Thorough preoperative assessment of erectile function and penile deformity can guide clinician counseling and manage patient expectations during decision making between PEG surgery and IPP implantation for PD. Limitations of this study include its retrospective nature, high attrition to follow-up, and risk of recall and selection bias. This is a large study with a median follow-up of 12months, with a high-volume single surgeon who treats patients in a specialized population of complex cases. Patients who were initially counseled to undergo IPP due to suboptimal erectile rigidity but elected for PEG had worse postoperative ability to engage in penetrative intercourse, and a higher proportion of these patients eventually received an IPP.

Operative and non-operative management for intestinal emergencies: findings from a single-centre retrospective cohort study.

Patients with an intestinal emergency who do not have surgery are poorly characterised. This study used electronic healthcare records to provide a rapid insight into the number of patients admitted with an intestinal emergency and compare short-term outcomes for non-operative and operative management. A single-centre retrospective cohort study was conducted at a tertiary NHS hospital (from 1 December 2013 to 31 January 2020). Patients were identified using diagnosis codes for intestinal emergencies, based on the inclusion criteria for the National Emergency Laparotomy Audit. Relevant data were extracted from electronic healthcare records (n=3,997). Nearly half of patients admitted with an intestinal emergency received nonoperative management (43.7%). Of those who underwent surgery, 63.7% were started laparoscopically. The non-operative group had a shorter hospital stay (median: 5.4 days vs 8.2 days [started laparoscopically] or 16.8 days [started open]) and fewer unintended intensive care admissions than the surgical group (2.4% vs 8.7% [started laparoscopically] 21.1% [started open]). However, 30-day mortality for non-operative treatment was double that for surgery (22.4% vs 10.1%). The 30-day mortality rate was found to be even higher for non-operative management (50.3%) compared with surgery (19.5%) in a sub-analysis of patients with admission National Early Warning Score ≥4 (n=683). The proportion of patients with intestinal emergencies who do not have surgery is greater than expected, and it appears that many respond well to non-operative treatment. However, 30-day mortality for non-operative management was high, and the low number of admissions to intensive care suggests that major invasive treatment was not appropriate for most in this group.

A Nasal Swab Classifier to Evaluate the Probability of Lung Cancer in Patients With Pulmonary Nodules

Accurate assessment of the probability of lung cancer (pCA) is critical in patients with pulmonary nodules (PNs) to help guide decision-making. We sought to validate a clinical-genomic classifier developed using whole-transcriptome sequencing of nasal epithelial cells from patients with a PN≤ 30mm who smoke or have previously smoked. Can the pCA in individuals with a PN and a history of smoking be predicted by a classifier that uses clinical factors and genomic data from nasal epithelial cells obtained by cytologic brushing? Machine learning was used to train a classifier using genomic and clinical features on 1,120 patients with PNs labeled as benign or malignant established by a final diagnosis or a minimum of 12months of radiographic surveillance. The classifier was designed to yield low-, intermediate-, and high-risk categories. The classifier was validated in an independent set of 312 patients, including 63 patients with a prior history of cancer (other than lung cancer), comparing the classifier prediction with the known clinical outcome. In the primary validation set, sensitivity and specificity for low-risk classification were 96%and 42%, whereas sensitivity and specificity for high-risk classification was 58%and 90%, respectively. Sensitivity was similar across stages of non-small cell lung cancer, independent of subtype. Performance compared favorably with clinical-only risk models. Analysis of 63 patients with prior cancer showed similar performance as did subanalyses of patients with light vsheavy smoking burden and those eligible for lung cancer screening vsthose who were not. The nasal classifier provides an accurate assessment of pCA in individuals with a PN≤ 30mm who smoke or have previously smoked. Classifier-guided decision-making could lead to fewer diagnostic procedures in patients without cancer and more timely treatment in patients with lung cancer.

Effect of ICD on patients with improved EF in idiopathic dilated cardiomyopathy

Abstract Background The efficacy of implantable cardioverter defibrillator (ICD) therapy in patients who had heart failure with improved ejection fraction (HFimpEF) above guidelines indication for ICD (&amp;gt;35%) during generator change is still controversial. This meta-analysis assesses the impact of ICD therapy in patients with HFimpEF with EF &amp;gt;35% and patient with NICM. Methods Databases were searched for studies reporting the association between ICD in patients with NICM and HFimpEF and ventricular arrhythmias (VA) and sudden cardiac death (SCD); including Ovid MEDLINE, EMBASE, Web of Science, and Google Scholar. The search was not restricted to time or publication status. The minimal follow up duration was one year. Results A total of 38 studies and 13,538 patients (5,829 with improved EF vs 7,709 with EF &amp;lt;35% during follow up) were included; mean follow up was 43 months (ranging between 12 to 74 months). Mean age was 63.5 and 75% were males. Patients with HFimpEF with ICD, wither alone or as part of CRT therapy, was associated with lower risk of VA and SCD (OR 0.39, 95% CI 0.32-0.47; P&amp;lt;0.01; annual rate 4.1 vs. 8%). Sub-analysis for patients with ICD for patient with NICM was associated with lower risk of VA and SCD (OR 0.25, 95% CI 0.1-0.62; P&amp;lt;0.01; annual rate 2.9 vs. 10.2%). (Figure) Conclusion Improved EF is associated with reduced VA but with still elevated risk in HFimpEF especially in NICM.

Abstract 18037: Left Bundle Branch Area versus Biventricular Pacing in Cardiac Resynchronization Therapy: A Systematic Review and Meta-Analysis

Introduction: Cardiac resynchronization therapy (CRT) through biventricular pacing (BVP) is the standard treatment for heart failure with reduced ejection fraction (HFrEF) and left bundle-branch block (LBBB). Left bundle-branch area pacing (LBBAP) has emerged as a potentially more effective approach. However, its superiority over BVP remains unclear. Hypothesis: Is LBBAP more effective and safer than BVP for CRT in patients with HFrEF? Methods: We systematically searched PubMed, Embase, and Cochrane for randomized controlled trials (RCTs) or observational studies that reported adjusted effect estimates (i.e propensity score-matched populations or multivariate analysis), comparing the efficacy and safety of LBBAP versus BVP. We applied the random-effects model to calculate adjusted hazard ratio (aHR) and mean difference (aMD), with the corresponding 95% confidence interval. Heterogeneity was assessed using I 2 statistics. Statistical analysis was performed using R version 4.2.1. Results: Our analysis included 7 studies, yielding 2,743 patients, of whom 1,164 (42.4%) were assigned to LBBAP group. Compared with BVP, LBBAP was associated with a significant reduction of the composite of overall mortality and heart failure hospitalizations (aHR 0.67; 95% CI 0.56-0.80; I 2 =0%; p&lt;0.001; Figure 1A). Additionally, LBBAP demonstrated a significant increase in LVEF (aMD 5.77%; 95% CI 2.94-8.60; I 2 =68%; p&lt;0.001; Figure 1B) and shortening of QRS duration (aMD -25.71 ms; 95% CI -35.87 to -15.55; I 2 =0%; p&lt;0.001; Figure 2A) compared with BVP. Sub-analysis of patients with LBBB also demonstrated a significant reduction of the composite of overall mortality and heart failure hospitalizations (aHR 0.64; 95% CI 0.49 to 0.85; I 2 =0%; p&lt;0.001; Figure 2B) in LBBAP. Conclusions: This meta-analysis of RCTs and multivariable adjusted studies suggests that LBBAP is superior to BVP in patients with HFrEF undergoing CRT for both electrophysiological and clinical outcomes.

OTAC: Optimization of Antibiotic Therapy in Critically ill Patients. Using beta-lactam antibiotics by continuous infusion

ObjectiveTo determine the percentage of patients given standard doses of piperacillin/tazobactam or meropenem by continuous infusion who achieved the target pharmacokinetic/pharmacodynamic (PK/PD) index, which was defined as free concentrations four times more than the minimum inhibitory concentration (CMI) for 100% of the dosing interval (100% fT ≥ 4 x MIC). MethodPreliminary data from a larger prospective clinical study analysing the PK/PD behaviour of β-lactams antibiotics continuous infusion (CI) in critical patients. The study was conducted in the intensive care units of a tertiary university hospital for adults (June 2015-May 2017). Inclusion criteria: normal renal function (glomerular renal function (GFR) CKD-EPI formula ≥ 60 mL/min/1.73 m2) and treatment with standard dose β-lactams CI. Concentrations at steady state (Css) conditions were determined using UHPLC-MS/MS. We selected the highest susceptible MIC for all likely organisms according to European Commitee on Antimicrobial Susceptibility Testing's (i.e. piperacillin/tazobactam: 8 mg/L for enterobacteriaceae and 16 mg/L for Pseudomonas aeruginosa; meropenem: 2 mg/L for any microorganism). In addition, a subanalysis of patients was conducted using actual MIC values. Results61 patients were enrolled (25 to meropenem and 36 to piperacillin/tazobactam). Average age was 59 (15) years and median GFR rate was 95 mL/min/1.73 m2 (83-115). Median meropenem and piperacillin free concentrations were 16 mg/L (11-29) and 40 mg/L (21-51), respectively.88% of patients treated with meropenem reached the PK/PD target, without differences between both microorganisms. For piperacillin/tazobactam, 61% and 11% of patients reached the target, with enterobacteriaceae and Pseudomonas as suspected microorganisms, respectively. The pathogen was isolated in 35 (57%) patients: 94% reached the target PK/PD, without differences between both antibiotic therapies. ConclusionsStandard doses of meropenem CI are sufficient to achieve a PK/PD target of 100% fT ≥ 4 x MIC in suspected infections with high MICs (Pseudomonas aeruginosa or enterobacteriaceae). However, higher doses of piperacillin/tazobactam could be considered to achieve this goal. In patients with isolated microorganisms, a standard dose of both antibiotic therapies would be sufficient to achieve the target. Therapeutic drug monitoring is highly recommended for therapeutic optimization.

Extraintestinal Manifestations of Inflammatory Bowel Disease Are Associated With Increased Biologic Cycling.

Extraintestinal manifestations (EIMs) of inflammatory bowel disease (IBD) are a common, frequently debilitating complication of the disease. Biologics are indicated and often required in patients with EIMs to control disease; however, little is known about whether patients with EIMs cycle through more therapies than their counterparts without EIMs. To address this question, we performed a retrospective analysis of patients enrolled in the Study of Prospective Adult Research Cohort with IBD registry seen at our University Medical Center, on data from December 2016 to January 2021. Four hundred fifty-six participants with information on EIMs and biologic use available were included, and demographic and clinical characteristics were analyzed. Three hundred thirty-eight and 118 participants without and with EIMs were identified, respectively. Those with EIMs were likelier to have biologic exposure, and cycle through more biologics, both in univariate and multivariate analyses controlling for age, disease duration, sex, corticosteroid use, and IBD type (P-value = .006). In a subanalysis of patients with Crohn's disease (CD), EIMs were associated with increased biologic cycling in ileocolonic disease (P-value = .050). To our knowledge, this is the first study assessing biologic cycling in patients with EIMs. Our findings that patients with EIMs are likelier to cycle through biologics, particularly CD patients with ileocolonic disease, highlights the need for more research on which biologics may be most effective for specific subsets of IBD patients, including those with concurrent EIMs. The presence of EIMs is a marker of harder-to-treat IBD and may indicate earlier initiation of advanced therapies.

Delayed time to radiation and overall survival in Merkel cell carcinoma.

Clinically localized Merkel cell carcinoma (MCC) is commonly treated with surgical excision and radiotherapy. The relationship between time to adjuvant radiotherapy and overall survival (OS) remains understudied. This retrospective study used data from the National Cancer Database (2006-2019). Patients with clinically localized MCC who received surgical excision and adjuvant radiotherapy were included. Multivariate regressions were used to account for various patient and tumor factors. The primary outcome was 5-year OS, and the secondary outcome was time from diagnosis to adjuvant radiation (TTR). Of the 1965 patients included, most were male (n = 1242, 63.2%) and white (n = 1915, 97.5%), and the median age was 74 years (interquartile range [IQR]: 66-81). The median TTR was 83 days (IQR: 65-106). A total of 83.6% of patients received radiotherapy to the primary site, 21.3% to the draining nodal basin, 17.1% to both, and 12.2% whose target location of radiotherapy was not recorded in the data. TTR of ≥79 days (the 45th percentile) was associated with worse OS on both univariate and multivariate analyses (log-rank p = 0.0014; hazard ratio [HR]: 1.258, 95% confidence interval [CI]: 1.055-1.500, p = 0.010). This persisted on sub-analyses of patients <80 years old (n = 1407; HR: 1.380, 95% CI: 1.080-1.764, p = 0.010) and of patients with Charlson comorbidity index (CCI) of 0 (n = 1411; HR: 1.284, 95% CI: 1.034-1.595, p = 0.024). Factors associated with delayed TTR included greater age (p = 0.039), male sex (p = 0.04), CCI > 1 (p = 0.036), academic facility (p < 0.001), rural county (p = 0.034), AJCC T2 stage (p = 0.010), negative margins (p = 0.017), 2+ pathologically positive regional nodes (p = 0.011), and margin size >2 cm (p = 0.015). Delayed radiotherapy (≥79 days) was associated with worse OS of MCC patients. Further study in controlled cohorts is needed to ascertain this relationship.

Planning vascular access creation: The promising role of the kidney failure risk equation.

Planning for vascular access (VA) creation is essential in pre-dialysis patients although optimal timing for VA referral and placement is debatable. Guidelines suggest referral when eGFR is 15-20 mL/min/1.73 m2. This study aimed to validate the use of kidney failure risk equation (KFRE) in VA planning. Retrospective analysis of all adult patients with CKD who were referred for first VA placement, namely AVF or AVG, at a tertiary center, between January 2018 and December 2019. The four-variable KFRE was calculated. Start of KRT, mortality, and VA placement were assessed in a 2-year follow-up. We used Cox regression to predict KRT start and calculated the ROC curve. 256 patients were included and 64.5% were male, mean age was 70.4 ± 12.9 years and mean eGFR was 16.09 ± 10.43 mL/min/1.73 m2. One hundred fifty-nine patients required KRT (62.1%) and 72 (28.1%) died in the 2-year follow-up. The KFRE accurately predicted KRT start within 2-years (38.3 ± 23.8% vs 17.6 ± 20.9%, p < 0.001; HR 1.05 95% CI (1.06-1.12), p < 0.001), with an auROC of 0.788 (p < 0.001, 95% CI (0.733-0.837)). The optimal KFRE cut-off was >20%, with a HR of 9.2 (95% CI (5.06-16.60), p < 0.001). Patients with KFRE ⩾ 20% had a significant lower mean time from VA consult to KRT initiation (10.8 ± 9.4 vs 15.6 ± 10.3 months, p < 0.001). On a sub-analysis of patients with an eGFR < 20 mL/min/1.73 m2, a KFRE ⩾ 20% was also a significant predictor of 2-year start of KRT, with an HR of 6.61 (95% CI (3.49-12.52), p < 0.001). KFRE accurately predicted 2-year KRT start in this cohort of patients. A KFRE ⩾ 20% can help to establish higher priority patients for VA placement. The authors suggest referral for VA creation when eGFR < 20 mL/min/1.73 m2 and KFRE ⩾ 20%.

Emergency Department Shock Index Outperforms Prehospital and Delta Shock Indices in Predicting Outcomes of Trauma Patients

IntroductionMultiple shock indices (SIs), including prehospital, emergency department (ED), and delta (ED SI - Prehospital SI) have been developed to predict outcomes among trauma patients. This study aims to compare the predictive abilities of these SIs for outcomes of polytrauma patients on a national level. MethodsThis was a retrospective analysis of the American College of Surgeons Trauma Quality Improvement Program (2017-2018). We included adult (≥18 y) trauma patients and excluded patients who were transferred, had missing vital signs, and those with severe head injuries (Head-Abbreviated Injury Scale>3). Outcome measures were 24-h and in-hospital mortality, 24-h packed red blood cells transfusions, and intensive care unit and hospital length of stay. Predictive performances of these SIs were evaluated by the Area Under the Receiver Operating Characteristics for the entire study cohort and across all injury severities. ResultsA total of 750,407 patients were identified. Meanstandard deviation age and lowest systolic blood pressure were 53 ± 21 y, and 81 ± 32 mmHg, respectively. Overall, 24-h and in-hospital mortality were 1.2% and 2.5%, respectively. On multivariable analysis, all three SIs were independently associated with higher rates of 24-h and in-hospital mortality, blood product requirements, intensive care unit and hospital length of stay (P < 0.001). ED SI was superior to prehospital and delta SIs (P < 0.001) for all outcomes. On subanalysis of patients with moderate injuries, severe injuries, and positive delta SI, the results remained the same. ConclusionsED SI outperformed both prehospital and delta SIs across all injury severities. Trauma triage guidelines should prioritize ED SI in the risk stratification of trauma patients who may benefit from earlier and more intense trauma activations.

The impact of delayed gastric emptying as measured by gastric emptying scintigraphy on the outcome of magnetic sphincter augmentation.

The impact of delayed gastric emptying (DGE) on the outcome of anti-reflux surgery (ARS) is controversial. There is concern that poor gastric emptying diminishes outcomes. Magnetic sphincter augmentation (MSA) may have a comparatively mild impact on gastric physiology, but the relationship between DGE and MSA outcomes is unknown. This study aims to evaluate the relationship between objective DGE and MSA outcomes over time. Patients who completed gastric emptying scintigraphy (GES) prior to MSA between 2013 and 2021 were included. DGE was defined as a 4 h retention > 10% or half emptying time > 90min on GES. Outcomes were compared between DGE and normal gastric emptying (NGE) groups at 6 months, 1 and 2 years. Sub-analysis of patients with severe (> 35%) DGE and correlation analysis between 4-h retention and symptom and acid-normalization were performed. The study population consisted of 26 (19.8%) patients with DGE and 105 with NGE. DGE was associated with more 90-days readmissions (18.5 vs 2.9%, p = 0.009). At 6 months patients with DGE had higher median (IQR) GERD-HRQL total [17.0(10-29) vs 5.5(3-16), p = 0.0013], heartburn [1(1-3) vs 0(0-1), p = 0.0010) and gas-bloat [4(2-5) vs 2(1-3), p = 0.033] scores. Outcomes at 1 and 2 years follow-up were comparable (p > 0.05). From 6months to 1-year the gas-bloat score decreased from 4(2-5) to 3(1-3), p = 0.041. Total and heartburn scores decreased, but not significantly. Severe DGE (n = 4) patients had lower antiacid medication freedom at 6months (75 vs 87%, p = 0.014) and 1-year (50 vs 92%, p = 0.046). There were non-significant trends for higher GERD-HRQL scores, dissatisfaction, and removal rates in severe DGE at 6months and 1-year. There was a weak correlation between 4-h retention and 6-month GERD-HRQL total score [R = 0.253, 95%CI (0.09-0.41), p = 0.039], but not acid-normalization (p > 0.05). Outcomes after MSA are diminished early on in patients with mild-to-moderate DGE, but comparable by 1 year and durable at 2 years. Severe DGE outcomes may be suboptimal.

#4913 ANALYSIS OF THE LIPID PROFILE IN THE RENAL PATIENT AND SUB-ANALYSIS OF THE POPULATION WITH POLYCYSTIC KIDNEY DISEASE

Abstract Background and Aims Dyslipidemia is frequent in patients with chronic kidney disease (CKD), it constitutes a factor of progression of both cardiovascular risk (CVR) and CKD itself. It has its own characteristics, which are modified with the ERC stadium. The subgroup of patients with Polycystic Kidney Disease (PKD) presents its own characteristics. The aim of the study was to analyze the lipid profile in the renal population and the differences in the PKD group. Method Retrospective observational study, includes population under follow-up in nephrology consultations in a health area, during 2018–2021. We analyzed lipid profile, renal function and whether they received statins. IBM SPSS Statistics V24 was used. Results 3301 prevalent patients with kidney disease were collected, excluding those on renal replacement therapy (RRT), with glomerular filtration rate (GFR), glomerular filtration rate (GFR) &amp;lt;10ml/min/1.73m² and proteinuria greater than 1.5g. Of these, 112 (3.4%) patients had PKD. 51% of the total CKD patients were under treatment with statins. The average number of Total Cholesterol (TC) was 170.4+/-43mg/dl, LDL 92.3+/-37mg/dl, HDL 50.3+/-15mg/dl and triglycerides (TG) 147.3+/-92mg/dl. In 37% of CKD patients, LDL was &amp;gt;100mg/dl and only 35% had LDL&amp;lt;75mg/dl. In the CKD group with a GFR &amp;lt;60ml/min/1.73m² (N = 2337; 71%), there was a high prevalence of patients with LDL values &amp;gt;100mg/dl (N = 784; 33.5%). In the case of GFR &amp;lt;30ml/min/1.73m² (N = 981; 29.7%), the presence of LDL&amp;gt;100mg/dl 30% (N = 297) was also frequent. In the subanalysis of patients with PKD, the mean TC was 182+/-40mg/dl, LDL 101.2+/-33mg/dl, HDL 56.4+/-17mg/dl, and TG 123.7+/-59mg/dl. 76% of the PKD had GFR &amp;lt;60ml/min/1.73m² (N = 73), of which 43% presented LDL&amp;gt;100mg/dl (N = 32). In PKD patients with GFR &amp;gt; 60ml/min/1.73m² (N = 39), half (N = 22; 56.4%) also had LDL &amp;gt;100mg/dl. In addition, 51% were taking a statin, despite this they had a mean TC 183mg/dl+/-46, LDL 102.7+/-39, HDL 53+/-15, and TG 142+/-69mg/dl. Conclusion The presence of elevated LDL was frequent in CKD, especially in the group with GFR &amp;lt; 60ml/min/1.73m² without statin and in a quarter of patients with the same GFR with statin. It is notable in the PKD group, probably due to less awareness of strict CVR control.

Negative laparotomy rates and outcomes following blunt traumatic injury in the United States

IntroductionExploratory laparotomy remains the mainstay of treatment following blunt abdominal trauma. However, the decision to operate can be difficult in hemodynamically stable patients with unreliable physical exams or equivocal imaging findings. The risk of a negative laparotomy and the subsequent complications must be weighed against the potential morbidity and mortality of a missed abdominal injury. Our study aims to evaluate trends and the effect of negative laparotomies on morbidity and mortality in adults with blunt traumatic injuries in the United States. MethodsWe reviewed the National Trauma Data Bank (2007–2019) for adults with blunt traumatic injuries who underwent an exploratory laparotomy. Positive or negative laparotomy of abdominal injury was compared. We performed bivariate analysis and a modified Poisson regression to estimate the effect of negative laparotomy on mortality. A sub-analysis of patients who underwent computed tomography (CT) of the abdomen and pelvis was performed. Results92,800 patients met the inclusion criteria of the primary analysis. Negative laparotomy rates were 12.0% in this population, down-trending throughout the study. Negative laparotomy patients had a significantly higher crude mortality (31.1% vs. 20.5%, p < 0.001), despite lower injury severity scores (20 (10–29) vs. 25 (16–35), p < 0.001) than positive laparotomy patients. Patients that underwent negative laparotomy had a 33% higher risk for mortality (RR1.33, 95% CI 1.28–1.37, P < 0.001) than positive laparotomy patients after adjusting for pertinent covariates. Patients that underwent CT abdomen/pelvis imaging (n = 45,654) had a lower rate of negative laparotomy (11.1%) and decreased difference in crude mortality (22.6% vs. 14.1%, p < 0.001) compared to positive laparotomy patients. However, the relative risk for mortality remained high at 37% (RR 1.37, 95% CI 1.29 – 1.46, p < 0.001) for this sub-cohort. ConclusionNegative laparotomy rates in adults with blunt traumatic injuries are trending down in the United States but remains substantial and may show improvement with increased use of diagnostic imaging. Negative laparotomy has a relative risk for mortality of 33% despite lower injury severity. Thus, surgical exploration in this population should be thoughtfully undertaken with appropriate evaluation via physical exam and diagnostic imaging to prevent unnecessary morbidity and mortality.

Voxel-Based Dosimetry Predicts Hepatotoxicity in Hepatocellular Carcinoma Patients Undergoing Radioembolization with 90Y Glass Microspheres.

Personalized dosimetry holds promise to improve radioembolization treatment outcomes in hepatocellular carcinoma (HCC) patients. To this end, tolerance absorbed doses for nontumor liver tissue are assessed by calculating the mean absorbed dose to the whole nontumor liver tissue (AD-WNTLT), which may be limited by its neglect of nonuniform dose distribution. Thus, we analyzed whether voxel-based dosimetry could be more accurate in predicting hepatotoxicity in HCC patients undergoing radioembolization. Methods: In total, 176 HCC patients were available for this retrospective analysis; of these, 78 underwent partial- and 98 whole-liver treatment. Posttherapeutic changes in bilirubin were graded using the Common Terminology Criteria for Adverse Events. We performed voxel-based and multicompartment dosimetry using pretherapeutic 99mTc-labeled human serum albumin SPECT and contrast-enhanced CT/MRI and defined the following dosimetry parameters: AD-WNTLT; the nontumor liver tissue volume exposed to at least 20 Gy (V20), at least 30 Gy (V30), and at least 40 Gy (V40); and the threshold absorbed dose to the 20% (AD-20) and 30% (AD-30) of nontumor liver tissue with the lowest absorbed dose. Their impact on hepatotoxicity after 6 mo was analyzed using the area under the receiver-operating-characteristic curve; thresholds were identified using the Youden index. Results: The area under the curve for prediction of posttherapeutic grade 3+ increases in bilirubin was acceptable for V20 (0.77), V30 (0.78), and V40 (0.79), whereas it was low for AD-WNTLT (0.67). The predictive value could further be increased in the subanalysis of patients with whole-liver treatment, where a good discriminatory power was found for V20 (0.80), V30 (0.82), V40 (0.84), AD-20 (0.80), and AD-30 (0.82) and an acceptable discriminatory power was found for AD-WNTLT (0.63). The accuracies of V20 (P = 0.03), V30 (P = 0.009), V40 (P = 0.004), AD-20 (P = 0.04), and AD-30 (P = 0.02) were superior to that of AD-WNTLT but did not differ significantly from each other. The respective thresholds were 78% (V30), 72% (V40), and 43 Gy (AD-30). Statistical significance was not reached for partial-liver treatment. Conclusion: Voxel-based dosimetry may more accurately predict hepatotoxicity than multicompartment dosimetry in HCC patients undergoing radioembolization, which could enable dose escalation or deescalation with the intent to optimize treatment response. Our results indicate that a V40 of 72% may be particularly useful in whole-liver treatment. However, further research is warranted to validate these results.

Clinical Outcomes of Offset Stem Couplers with or without Cone Augmentation in Revision Total Knee Arthroplasty.

Intramedullary stems are often required in patients undergoing revision total knee arthroplasty (rTKA) to achieve stable fixation. Significant bone loss may require the addition of a metal cone to maximize fixation and osteointegration. The purpose of this study was to investigate clinical outcomes in rTKA using different fixation techniques. We conducted a single-institution retrospective review of all patients who received a tibial and femoral stem during rTKA between August 2011 and July 2021. Patients were separated into three cohorts based on fixation construct: press-fit stem with an offset coupler (OS), fully cemented straight (CS) stem, and press-fit straight (PFS) stem. A subanalysis of patients who received tibial cone augmentation was also conducted. A total of 358 patients who underwent rTKA were included in this study, of which 102 (28.5%) had a minimum 2-year follow-up and 25 (7.0%) had a minimum 5-year follow-up. In the primary analysis, 194 patients were included in the OS cohort, 72 in the CS cohort, and 92 in the PFS cohort. When stem type alone was considered, there was no significant difference in rerevision rate (p = 0.431) between cohorts. Subanalysis of patients who received augmentation with a tibial cone demonstrated that OS implants led to significantly higher rates of rerevision compared with the other two stem types (OS: 18.2% vs. CS: 2.1% vs. PFS: 11.1%; p = 0.037). The findings of the present analysis demonstrate that CS and cones in rTKA may provide more reliable long-term outcomes compared with press-fit stems with OS. LEVEL III EVIDENCE: Retrospective Cohort Study.

The dynamics of hypertension and renal function in CKD and non-CKD patients affected with COVID-19 – final results of BIRCOV trial

Introduction and aim. There is evidence in the literature about a change in the effectiveness of inhibitors of the renin-angiotensin system (iRAS) in people with COVID-19. Considering different mechanisms of pressure reduction by different iRAS groups, one can expect differences in people with COVID-19 receiving these drugs. The aim of angiotensin-converting enzyme inhibitors (ACEi), angiotensin II receptor blockers (ARB) and direct renin inhibitors (DRi) usage in COVID-19 (BIRCOV study) was to pinpoint clinical and laboratory differences in people with hypertension who received iRAS and suffered coronavirus infection. Material and methods. An open prospective trial of 108 patients was performed in subjects suffering from COVID-19 who have been receiving iRAS: ACEi, ARB or DRi as basic antihypertensive therapy. The disease follow-up was 12 and 24 weeks. A blood pressure (BP) measurement was performed the week before COVID-19 and up to 24 weeks from the disease onset. Subanalysis in patients with chronic kidney disease (CKD) was performed. Results. In patients with COVID-19, a change in the effectiveness of antihypertensive therapy depending on the type of drug in the iRAS group has been documented in the first 4 weeks from the onset of the disease. The use of ACEi had significantly increased the risk of severe hypotension, unlike ARBs that do not cause hypotension. The synchronous decline of estimated glomerular filtration rate (eGFR) and systolic BP was more pronounced in CKD patients followed by albuminuria incidence. The greatest decrease in eGFR was in people taking ACEi. Conclusion. People with grade 1-2 hypertension who are constantly receiving RAS inhibitors suffering from COVID-19 may develop hypotension with ACEi. COVID-19 leads to transient albuminuria and decreased glomerular filtration rate, which is especially dangerous for people with CKD 4-5.