30-day Outcomes Research Articles

Impact of burden and distribution of aortic valve calcification on the hemodynamic performance and procedural outcomes of a self-expanding, intra-annular transcatheter aortic valve system.

Aortic valve calcification (AVC) has been explored as a powerful predictor of procedural complications in patients undergoing transcatheter aortic valve implantation (TAVI). However, little evidence exists on its impact on intra-annular devices' performance. We aimed to investigate the impact of AVC burden and distribution pattern on the occurrence of paravalvular leak (PVL), conduction disturbances requiring permanent pacemaker implantation (PPI) and 30-day clinical outcomes in patients undergoing TAVI with a self-expanding, intra-annular device. According to AVC, 103 patients enrolled in a single medical centre from November 2019 to December 2022 were divided into tertiles. Valve Academic Research Consortium (VARC)-3 definitions were used to classify procedural complications and outcomes. Patients in the highest AVC tertile showed an increased occurrence of mild or more PVL and conduction disorders (p < 0.001 and p = 0.006). AVC tertiles (highest tertile) emerged as an independent predictor of PVL (OR 7.32, 95%CI 3.10-17.28, p < 0.001) and post-TAVI conduction disturbances (OR 3.73, 95%CI 1.31-10.60, p = 0.013) but not of PPI (OR 1.44, 95%CI 0.39-5.35, p = 0.579). Considering calcium distribution, ROC analyses revealed that annular AVC but not left ventricle outflow tract (LVOT) calcium burden significantly indicated the development of PVL (AUC 0.863, 0.77-0.93, p < 0.001) and conduction disorders/PPI (AUC 0.797, 0.70-0.89, p < 0.001 and 0.723, 0.58-0.86, p = 0.018, respectively). After adjustment for age and sex, the highest tertile remained an independent predictor of the 30-day composite outcome (death, myocardial infarction, stroke, major vascular complications, type 3/4 bleedings, acute kidney injury, PPI and ≥ moderate PVL) (OR 3.26; 95%CI 1.26-8.40, p = 0.014). A higher AVC is associated with an increased risk of PVL and conduction disturbances after TAVI with a self-expanding, intra-annular device. However, our findings suggest a minor role for LVOT calcification compared with annular AVC in the performance of this specific prosthesis.

Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Disrupt PAD III Observational Study.

Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified peripheral artery disease (PAD) in large trials and small real-world experiences. Real-world evidence from a larger cohort is lacking, so we aimed to evaluate the real-world acute performance of IVL in the treatment of calcified PAD. The Disrupt PAD III Observational Study (OS) is a prospective, multicenter, single-arm study. Patients with claudication or critical limb-threatening ischemia (CLTI) and at least moderate calcification were eligible. Independent predictors of procedural outcomes were assessed by multivariable analysis. Between November 2017 and June 2021 across 30 global sites, 1373 patients with 1677 lesions (1531, 91.3% core lab evaluable) were enrolled. Diameter stenosis and lesion length was 80.6±17.6% and 93.5±74.3 mm, respectively. Target vessels included femoropopliteal (61%), iliac (15.8%), common femoral (10.7%), and infrapopliteal arteries (12.8%). Lesion characteristics included 31.1% chronic total occlusions (CTOs) and 19.3% long lesions (≥15 cm). At final assessment, residual stenosis was 23.8±11.3%, with 0.9% serious angiographic complications, no abrupt closures, distal embolization, no flow, or thrombotic events. Independent predictors of ≤30% residual stenosis were lesion length ≥15 cm (odds ratio [OR]=0.384), female sex (OR=1.850), age ≤75 years (OR=1.625), IVL balloon to artery ratio ≥1.0 (OR=1.538), and CTO lesions (OR=0.638). Lesion length ≥15 cm (OR=16.076) was an independent predictor of procedural complications. The Disrupt PAD III OS represents the largest assessment of IVL periprocedural outcomes in calcified PAD. It confirmed excellent procedural safety and effectiveness in complex lesions across multiple peripheral vascular beds. This final analysis of the PAD III OS represents the largest report of peripheral IVL utilization in daily clinical practice. The outcomes of this study indicate that previously reported procedural results in clinical trial settings can be translated to a broader patient population. Treatment with peripheral IVL in severely calcified stenotic lower limb lesions demonstrated consistent acute safety and stenosis reduction, even in complex patients across multiple vessel beds. In addition, the importance of proper IVL balloon sizing to achieve excellent acute stenosis reduction was confirmed by multivariate analysis.

Venous Thromboembolism after Hospital Discharge: Temporal Trends in Baseline Characteristics, Prevention, Treatment, and 90-day Outcomes.

Venous thromboembolism (VTE) after hospital discharge poses a serious health risk. Assessments of patient characteristics, prophylaxis, treatment, outcomes, and over time changes lack consistency. Data on 16,901 hospitalized patients in the Registro Informatizado Enfermedad TromboEmbolica registry (2003-2022) were analyzed to evaluate trends in baseline characteristics, prophylaxis, treatments, and 90-day outcomes among medical (6,218) and surgical (10,683) patient cohorts. Multivariable logistic regression was used to assess the risks of the composite of fatal pulmonary embolism (PE) or recurrent VTE and major bleeding. The proportion of patients who presented with PE increased among medical (from 54 to 72%) and surgical patients (from 55 to 58%). Prophylaxis use increased in medical patients (from 53 to 71%), while decreasing in surgical patients (from 67 to 58%). Notably, the 90-day composite of fatal PE or recurrent VTE decreased in medical (from 3.9 to 1.8%) and surgical patients (from 2.9 to 1.2%; p < 0.001 for both). Conversely, major bleeding increased (3.1 to 4.5%) in medical patients (p = 0.008), with no change in surgical patients (from 2.5 to 2.4%). Risk-adjusted analysis showed a yearly decrease in the risk for the composite outcome (subhazard ratio [sHR]: 0.95; 95% confidence interval [CI]: 0.93-0.98) in medical and surgical patients and an increase in the risk for major bleeding in medical patients only (sHR: 1.04; 95% CI: 1.01-1.07). Results were consistent after excluding coronavirus disease 2019 patients. Over 20 years, the composite of fatal PE or recurrent VTE within 90 days had significantly decreased in VTE patients after hospitalization for medical or surgical care. Medical patients, however, exhibited an increase in major bleeding.

Robotic-Assisted Versus Laparoscopic Approach for Treatment of Acute Cholecystitis in Children.

Introduction: Laparoscopic cholecystectomy (Lap-C) is the standard of care for patients requiring cholecystectomy in the acute setting. Although robotic-assisted cholecystectomy (RA-C) performance has increased, utilization in the acute setting has not been widely reported. We describe the feasibility of RA-C for pediatric patients undergoing acute inpatient cholecystectomy. Methods: A single institutional retrospective review of patients receiving RA-C while admitted for acute cholecystitis and/or choledocholithiasis (June 2017-June 2022) was compared with a matched cohort who underwent traditional multiport Lap-C (June 2021-June 2022). Demographic, perioperative, and postoperative data were analyzed. Results: Fifty patients were included: 25 each in the RA-C and Lap-C groups. Fifty-four percent were female; 66% were non-Hispanic white. Median age (15.7 years [interquartile range, IQR 14.7, 17.3] versus 15.3 years [IQR 14.5, 16.9], P = .91) and preoperative weight (92.6 kg [IQR 60, 105.9] versus 72.3 kg [IQR 61.6, 85.6], P = .15) were similar between the RA-C and Lap-C groups, respectively. No differences were observed in median operating time (89 minutes [IQR 76, 103] versus 88 minutes [IQR 77, 137], P = .70), postoperative length of stay (22.5 hours [21.4, 24.9] versus 20.6 hours [18.0, 25.1], P = .06), or 30-day complications (12% versus 16%, P = .69). Although opioid utilization (.23 milliequivalents/kilogram [MME/kg] [IQR .03, .30] versus .03 MME/kg [0, .09], P = .02) was higher in the RA-C cohort overall, no differences were detected during an analysis of the most recent 2 years (P = .96). Conclusion: RA-C in the acute setting can be performed safely in the pediatric population with comparable procedural times as well as perioperative and 30-day outcomes.

Prognostic impact of intracranial arteriosclerosis subtype after endovascular treatment for acute ischaemic stroke.

The influence of intracranial arteriosclerosis (ICAR) on acute ischaemic stroke (AIS) prognosis is unclear. This study explored its impact, focusing on ICAR subtypes categorized by intracranial carotid artery calcification (ICAC) patterns: intimal or atherosclerotic versus internal elastic lamina calcification or non-atherosclerotic. The aim was to determine their effect on AIS prognosis in patients undergoing endovascular treatment (EVT). This prospective cohort study included consecutive AIS patients with anterior circulation large vessel occlusion undergoing EVT. ICAC, the hallmark of ICAR, was assessed using non-contrast computed tomography to quantify volume and establish the predominant ICAR subtype. The primary outcome was long-term functional outcome, measured by the 90-day modified Rankin Scale score. Secondary outcomes included first-pass effect, revascularization degree, symptomatic intracranial haemorrhage and 24-h infarct volume. Multivariate-adjusted linear and logistic regression models were used to assess the association of ICAC volume and subtype with these outcomes. From January 2021 to February 2022, 181 patients were included, of whom 172 (95%) had ICAC. Internal elastic lamina calcification was the predominant subtype in 103 (57%), intimal in 52 (29%) and mixed in 17 (9%). The intimal or atherosclerotic ICAC pattern was linked to poorer functional outcomes (adjusted odds ratio 2.12, 95% confidence interval [CI] 1.10-4.09), decreased first-pass effect probability (adjusted odds ratio 0.42, 95% CI 0.21-0.84) and higher infarct volume (adjusted β value 22.11, 95% CI 0.55-43.67). A predominant intimal ICAC subtype, linked to underlying atherosclerosis, correlated with larger infarct volume and poorer 90-day functional outcomes in EVT-treated AIS patients. Intracranial atherosclerosis appears to be a relevant factor hampering clinical benefits post-EVT.

Prognostic value of the fat-free mass index-based cachexia index in patients with colorectal cancer

Studies have shown that the cachexia index (CXI) is a useful predictor of cachexia in patients with colorectal cancer. However, the application of the CXI is limited stemming from the intricacy and additional cost of radiographic examinations. This study aimed to develop an easy-to-use and practical CXI based on fat-free mass index (FFMI-CXI) to evaluate the prognostic value of FFMI-CXI in CRC. A total of 656 patients with CRC were enrolled in the Investigation on Nutrition Status and Clinical Outcome of Common Cancers (INSCOC) study. The FFMI-CXI was calculated as [FFMI (kg)/height (m)2 × serum albumin (g/L)]/neutrophil-lymphocyte ratio. The cutoff value for FFMI-CXI was determined through the analysis of ROC curves and Youden’s index for both male and female cohorts. Kaplan–Meier survival curves with log-rank tests were conducted to compare time–event relationships between different groups. Cox proportional hazards regression models incorporating both univariate and multivariate variables were employed to explore the independent prognostic factors associated with OS. Logistic regression analysis was performed to assess the association of the FFMI-CXI with secondary outcomes. The major outcome was 5-year overall survival (OS). Based on the cutoff values, 331 patients had low FFMI-CXI, and 325 patients had high FFMI-CXI. Patients in the low FFMI-CXI subgroup were significantly older and had advanced TNM stage, malnutrition, high systemic inflammation, long hospitalizations, high hospitalization costs, adverse short-term outcomes, and all-cause mortality. Multivariate Cox regression analyses revealed that FFMI-CXI (HR 0.47, 95% CI 0.33–0.66; p < 0.001) and TNM stage (HR 3.38, 95% CI 2.63–4.35; p < 0.001) were independently associated with OS in CRC patients. K-M survival curves revealed that the CRC patients with a high FFMI-CXI had significantly more favorable OS than those with low FFMI-CXI (62.84% vs. 84.31%; log-rank p < 0.001). Furthermore, the FFMI-CXI was valuable for predicting 90-day outcomes, malnutrition, cancer cachexia, length of hospitalization, and hospitalization expenses. This study revealed that the FFMI-CXI can be used as a prognostic indicator in patients with CRC. Patients with low FFMI-CXI should receive more attention.

Heart rhythm at hospital admission: A factor for survival and neurological outcome among ECPR recipients?

BackgroundThe initial rhythm is a known predictor of survival in extracorporeal cardiopulmonary resuscitation (ECPR) patients. However, the effect of the rhythm at hospital admission on outcomes in these patients is less clear. MethodsThis observational, single-center study assessed the influence of the rhythm at hospital admission on 30-day survival and neurological outcomes at discharge in patients who underwent ECPR for out-of-hospital cardiac arrest (OHCA). ResultsBetween January 2012 and December 2023, 1,219 OHCA patients were admitted, and 210 received ECPR. Of these, 196 patients were analyzed. The average age was 52.9 years (±13), with 80.6 % male. The median time to ECPR initiation was 61 min (IQR 54–72). Patients with ventricular fibrillation as both the initial and admission rhythm had the highest 30-day survival rate (52 %: 35/67), while those with asystole in both instances had the lowest (6 %: 1/17, log-rank p < 0.00001). After adjusting for age, sex, initial rhythm, resuscitation time, location, bystander, and witnessed status, asystole at admission was linked to higher 30-day mortality (OR 4.03, 95 % CI 1.49–12.38, p = 0.009) and worse neurological outcomes (Cerebral Performance Category 3–5) at discharge (OR 4.61, 95 % CI 1.49–17.62, p = 0.013). ConclusionsThe rhythm at hospital admission affects ECPR outcomes. Patients presenting with and maintaining ventricular fibrillation have a higher chance of favorable neurological survival, whereas those presenting with or converting to asystole have poor outcomes. The rhythm at hospital admission appears to be a valuable criterion for deciding on ECPR initiation.

Long-term patient reported outcomes after robotic, laparoscopic, and open ventral hernia repair.

Current evidence demonstrates questionable incremental benefit of robotic abdominal wall (ventral) hernia repair when compared to other approaches. However, data are mainly limited to 30-day outcomes and do not capture long-term patient reported outcomes (PROs) where the robotic may provide distinct advantages. We analyzed patients who underwent ventral hernia repair from January 2020-September 30, 2022 in the Michigan Surgical Quality Collaborative Core Optimization Hernia Registry (MSQC-COHR). Validated PROs included the Ventral Hernia Recurrence Inventory (VHRI), PROMIS Pain Intensity 3a (Pain 3a), and HerQLes quality of life measures. Survey weighting was employed to reduce non-response bias and balance respondents with the overall COHR population. Logistic regression was used to assess the relationship of operative approach with answering "Yes" to the 3 VHRI questions, reporting a worse than average Pain 3a score, and reporting a below median HerQLes score. Models accounted for patient, hernia, and operative characteristics. Our sample included 1583 patients undergoing hernia repair, of which 507 (32.0%) were robotic, 202 (12.8%) were laparoscopic, and 874 (55.2%) were open. Median follow up time was 1.3years (IQR 1.2-1.5). Patient characteristics were similar across approaches. Robotic repairs were more often performed electively, on larger hernias, and with mesh. After controlling for covariates, a robotic approach was associated with a lower predicted probability of reporting a bulge [19.5% (95% CI 15.7-23.2%)] than a laparoscopic approach [26.8% (95% CI 20.4-33.2%)], but was no different than an open approach [18.8% (95% CI 16.1-21.6%)]. No other differences in PROs were found by approach. We found a lower likelihood of reporting a bulge after robotic ventral hernia repair when compared with a laparoscopic approach, but no difference when compared with an open approach. No other differences in long-term PROs were found when comparing robotic to laparoscopic or open approaches.

Thirty-day outcome of patients who present with chest pain to the emergency department of a tertiary care hospital of Sri Lanka

Background: Patients present with chest pain causes significant burden to the workload in an emergency department (ED). Quick but thorough attention is needed for life threatening emergencies and to minimize unnecessary admissions. We assess the burden of chest pain and 30-day outcome of patients who present with chest pain to the ED. Methodology: Prospective observational study of all adult patients presented to ED over one month with the primary complain of chest pain were evaluated and followed for 30 days. Results: A total of 661 (20.3% of total admissions) patients (mean age 56.7±1 4.9 years, 51% males) were studied. Common causes for the chest pain included gastroesophageal reflux disease (GORD) (29%) and acute coronary syndrome (ACS) (25%). ACS patients included ST-elevation myocardial infarction (STEMI) (10%), Non-ST-elevation myocardial infarction (6.7%) and unstable angina (8.3%). Fifty patients (75% of the STEMI patients) were thrombolysed. Primary angioplasty facility was not available in the hospital during the study period. Five patients (3% of the ACS patients) had coronary revascularization during the follow-up period – 2 patients had angioplasty and 3 patients had coronary bypass surgery. In-hospital mortality was 2.7%. Thirty-day mortality was 3.2%. Thirty three percent of them continued to have recurrent chest pain despite thorough investigation and treatment. Conclusions: Chest pain carries a significant burden to the workload of a busy ED. The commonest causes for chest pain were ACS and GORD. A considerable number of patients continued to experienced chest pain despite investigations and treatment.

Long-term comparative outcomes in patients undergoing transcatheter aortic valve implantation with self-expanding valves versus balloon-expandable valves

ABSTRACT Background This study aimed to compare long-term clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) with self-expanding (SEV) valve versus balloon-expandable valve (BEV), with a minimum follow-up period of five years. Materials and Methods Utilizing a prospectively maintained database, this observational study identified patients who underwent TAVI using either SEV or BEV for severe aortic stenosis and were followed for at least five years. Clinical outcomes encompassed both 30-day post-TAVI outcomes and long-term outcomes, including all-cause mortality, cardiovascular mortality, structural valve deterioration (SVD), heart failure related hospitalization, bioprosthetic valve failure, and valve related hospitalization and complications. Results A total of 74 patients were included in this study, with 64 patients in the SEV group and 10 patients in the BEV group. The median follow-up duration was 6.8 years, ranging from 5.0 to 10.2 years. Throughout the post-TAVI period, the SEV group consistently demonstrated a lower mean pressure gradient than the BEV group. No significant differences were observed between the two groups in terms of short-term or long-term outcomes. Within the study, four patients encountered moderate or severe SVD and one experienced thrombosis, and no cases of bioprosthetic valve failure or endocarditis were observed. Conclusions This study revealed that SEV and BEV demonstrated comparable long-term outcomes in patients undergoing TAVI, including all-cause and cardiovascular mortality, as well as the risk of SVD.

Burden and mortality of congenital gastrointestinal anomalies: insights from a nationwide cohort study.

Improved perioperative care has enhanced survival in children with congenital gastrointestinal conditions and abdominal wall defects (AWD). However, epidemiological and surgical outcomes in developing nations are still scarce. Our aim was to assess the burden and mortality of common congenital gastrointestinal anomalies and AWD in Malaysia, and their influencing factors. Using the Global PaedSurg study protocol with permission, we performed a prospective cohort study on children presenting for the first time between October 2021 and April 2022 with these conditions: Esophageal atresia (EA), congenital diaphragmatic hernia (CDH), intestinal atresia, gastroschisis, exomphalos, anorectal malformation (ARM) and Hirschsprung's disease. We compared mortality and 30-day outcome data across different geographical regions in Malaysia. There were 228 patients with 242 study conditions (EA n = 28, CDH n = 36, intestinal atresia n = 49, gastroschisis n = 12, exomphalos n = 8, ARM n = 77, Hirschsprung's disease n = 32). Our mortality rate was 8.8%; 60% of these were CDH patients. Factors significantly associated with mortality were CDH diagnosis, central venous access requirement, higher American Society of Anesthesiologists (ASA) score, blood transfusion and ventilation requirement. Diagnosis of CDH is the most important predictor for sepsis on arrival and mortality, therefore measures should be taken for early recognition and aggressive management.

Pre-Operative Gastroesophageal Reflux Does Not Affect 30-Day Outcomes in Patients Undergoing Revisional Bariatric Surgery to Single Anastomosis Duodeno-Ileal Bypass (SADI): An Analysis of 933 Metabolic and Bariatric Accreditation and Quality Improvement Program Patients.

Background: The use of a single anastomosis duodeno-ileal bypass (SADI) as a revisional procedure in patients with pre-operative GERD is not well understood. Thirty-day outcomes in patients with pre-existing GERD undergoing revision with an SADI have not been previously reported. Methods: The Metabolic and Bariatric Accreditation and Quality Improvement Program registry was consulted to identify patients undergoing revisional bariatric surgery with an SADI between 2020 and 2021. Our analysis sought to determine if preoperative GERD had significant impact on thirty-day outcomes. Bivariate and multivariable logistic regression analyses were used to identify independent predictors of 30-day morbidity. Results: Preoperative GERD was seen in 342 patients (36.7%). Preoperative GERD was not associated with anastomotic leak (2.5% non-GERD cohort vs. 1.2% GERD cohort; p = 0.2) nor bleeding (1% non-GERD cohort vs. 1.8% GERD cohort; p = 0.33). There was no difference in thirty-day readmission (5.6% vs. 5.9%, p = 0.9), reintervention (2.4% vs. 1.2%, p = 0.2), or reoperation (3.6% vs. 2.05%; p = 0.19) rates. The multivariable regression analysis revealed that a history of myocardial infarction was associated with a significantly elevated risk of serious complication (OR 12.2; 95% CI 2.79-53.23; p = 0.001), as was dyslipidemia (OR 2.2; 95% CI 1.04-4.56; p = 0.04). Conclusions: Pre-operative GERD does not have any association with anastomotic leak, bleeding, thirty-day readmission, reintervention, or reoperation in patients undergoing revisional bariatric surgery to SADI. A history of myocardial infarction and dyslipidemia are independent predictors of post-operative thirty-day morbidity, irrespective of the presence of preoperative GERD.

Evaluating Racial Disparities in 30-day Outcomes for African Americans Following Colectomy for Volvulus.

Surgery is the definitive treatment for colonic volvulus despite initial decompression therapy. In general surgery, African Americans were found to have higher risks of mortality and morbidities. However, racial disparity in colectomy outcomes for volvulus among African Americans had not been explored. This study examined the 30-day outcomes for African Americans following colectomy for volvulus. The National Surgical Quality Improvement Program (NSQIP) targeted colectomy database from 2012 to 2022 was used. Only patients with volvulus as the primary indication for colectomy were selected. A 1:1 propensity score matching was applied to African Americans and Caucasians to match sex, age, baseline characteristics, preoperative preparation, indication for surgery (if emergent), and operative approaches. Thirty-day postoperative outcomes were examined. There were 1027 and 7451 African Americans and Caucasians who underwent colectomy for volvulus, respectively. All African Americans were 1:1 propensity-score matched to their Caucasian counterparts. African Americans and Caucasians had a comparable mortality rate (7.21% vs 7.89%, P = 0.62). While African Americans had a higher risk of pulmonary complications (16.85% vs 13.53%, P = 0.04), other surgical complications were all comparable between African Americans and Caucasians. However, African Americans had a longer time from admission to operation (2.70 ± 3.99 vs 2.17 ± 3.36days, P < 0.01) and a longer length of stay (LOS; 12.81 ± 10.28 vs 10.50 ± 7.72days, P < 0.01). African Americans were found to have higher risks of pulmonary complications, delayed operation, and extended LOS. These disparities raise concerns and warrant further investigation into their underlying causes. Effective targeted interventions may be necessary to address these issues.

Three-month outcomes and cost-effectiveness of interferon gamma-1b in critically ill patients: a secondary analysis of the PREV-HAP trial

BackgroundInterferon gamma‑1b has been proposed to treat critical illness-induced immunosuppression. We aimed to determine the effects on 90-day outcomes and the cost-effectiveness of interferon gamma‑1b compared to placebo in mechanically ventilated critically ill patients.MethodsA cost-effectiveness analysis (CEA) was embedded in the “PREV-HAP trial”, a multicenter, placebo‑controlled, randomized trial, which randomly assigned critically ill adults under mechanical ventilation to receive interferon gamma or placebo. The CEA compared interferon-gamma with placebo using a collective perspective at a 90-day time horizon. The primary outcome was the incremental cost-effectiveness ratio (ICER) expressed in terms of adjusted cost per adjusted Quality-Adjusted Life-Years (QALYs) gained. QALYs were estimated from the responses of patients and proxy respondents to the health-related quality of life questionnaire EQ-5D-3L.ResultsThe 109 patients in the PREV-HAP trial were included in the CEA. At day 90, all-cause mortality rates were 23.6% in the interferon group and 25% in the placebo group (Odds Ratio (OR) = 0.88 (0.40 –1.93) p = 0.67). The difference in the mean adjusted costs per patient at 90 days was €-1.638 (95%CI €-17.534 to €11.968) in favor of interferon gamma-1b. The mean difference in adjusted QALYs between interferon gamma-1b and the placebo group was + 0.019 (95%CI -0.005 to 0.043). The probability that interferon gamma-1b was cost-effective ranged from 0.60 to 0.71 for a willingness to pay a QALY between €20k and €150k for the base case analysis.ConclusionEarly administration of interferon gamma might be cost-effective in critically ill patients supporting the realization of other studies on this treatment. However, the generalization of the findings should be considered cautiously, given the small sample size due to the premature end of PREV-HAP.Trial registration ClinicalTrials.gov Identifier: NCT04793568, Registration date: 2021–02-24.

Machine learning for predicting device-associated infection and 30-day survival outcomes after invasive device procedure in intensive care unit patients

This study aimed to preliminarily develop machine learning (ML) models capable of predicting the risk of device-associated infection and 30-day outcomes following invasive device procedures in intensive care unit (ICU) patients. The study utilized data from 8574 ICU patients who underwent invasive procedures, sourced from the Medical Information Mart for Intensive Care (MIMIC)-IV version 2.2 database. Patients were allocated into training and validation datasets in a 7:3 ratio. Seven ML models were employed for predicting device-associated infections, while five models were used for predicting 30-day survival outcomes. Model performance was primarily evaluated using the receiver operating characteristic (ROC) curve for infection prediction and the survival model’s concordance index (C-index). Top-performing models progressively reduced the number of variables based on their importance, thereby optimizing practical utility. The inclusion of all variables demonstrated that extreme gradient boosting (XGBoost) and extra survival trees (EST) models yielded superior discriminatory performance. Notably, when restricted to the top 10 variables, both models maintained performance levels comparable to when all variables were included. In the validation cohort, the XGBoost model, with the top 10 variables, achieved an area under the curve (AUC) of 0.810 (95% CI 0.808–0.812), an area under the precision-recall curve (AUPRC) of 0.226 (95% CI 0.222–0.230), and a Brier score (BS) of 0.053 (95% CI 0.053–0.054). The EST model, with the top 10 variables, reported a C-index of 0.756 (95% CI 0.754–0.757), a time-dependent AUC of 0.759 (95% CI 0.763–0.775), and an integrated Brier score (IBS) of 0.087 (95% CI 0.087–0.087). Both models are accessible via a web application. The internally evaluated XGBoost and EST models demonstrated exceptional predictive accuracy for device-associated infection risks and 30-day survival outcomes post-invasive procedures in ICU patients. Further validation is required to confirm the clinical utility of these two models in future studies.

Impact of advanced trauma life support training on 30-day mortality in severely injured patients at a Kenyan tertiary center: a retrospective matched case-control study

IntroductionTrauma is a leading cause of mortality worldwide, particularly in low and middle-income countries (LMICs) like Kenya. This study evaluates the impact of Advanced Trauma Life Support (ATLS) training on 30-day mortality outcomes in severely injured patients at a tertiary care center in Kenya.MethodsA retrospective matched case-control study was conducted at Aga Khan University Hospital, Nairobi. The study included adult patients (≥ 18 years) with polytrauma (Injury Severity Score [ISS] > 15) from 2011 to 2022. Propensity score matching was used to pair 81 post-ATLS cases with 81 pre-ATLS controls based on age and ISS. Data analysis was performed using R Statistical language (version 4.3.0).ResultsThe 30-day mortality rate decreased significantly from 17% (95% CI: 9.4–27.4%) pre-ATLS to 6% (95% CI: 2.0-13.5%) post-ATLS (p = 0.028). No significant differences were found in baseline characteristics between the two groups. Road traffic accidents were the primary cause of trauma in both groups (72% pre-ATLS vs. 78% post-ATLS).ConclusionATLS training significantly reduced 30-day mortality in severely injured patients, demonstrating its effectiveness even in resource-limited settings. Further prospective randomized studies are recommended to confirm these findings and evaluate long-term outcomes.

ProGlide-AngioSeal versus ProGlide-FemoSeal for vascular access hemostasis posttranscatheter aortic valve implantation.

The hybrid strategy combining plug-based and suture-based vascular closure devices (VCD) was introduced as a promising technique for vascular access hemostasis after transcatheter aortic valve implantation (TAVI) with satisfactory outcomes. However, data comparing two plug-based VCDs each in the combination with a suture-based VCD, namely ProGlide/AngioSeal (P/AS) with ProGlide/FemoSeal (P/FS) VCDs, is still lacking. To compare the 30-day outcome of the hybrid strategy using P/AS versus P/FS for vascular access site closure after TAVI. A retrospective single-center observational study included 608 patients recruited from a prospective TAVI registry between 2016 and 2022. The composite endpoint was defined as any VCD-related major vascular complications and/or bleeding more than type 1 according to Valve Academic Research Consortium criteria. The current study reported a significantly higher rate of composite endpoint in P/AS group, which was driven by a higher rate of major bleeding (5.4% vs. 1.4%, p = 0.036). We also found a higher rate of VCD-related minor bleeding in P/AS group (16.3% vs. 8.1%, p = 0.013). Successful access site hemostasis was achieved in 71.7% of P/AS group versus 83.1% in P/FS group (p = 0.006). The presence of anterior wall calcification at the access site was significantly associated with the composite endpoint (adj odds ratio 2.49; 95% confidence interval (1.08-5.75), p = 0.032). The hybrid strategy for large bore vascular access closure using P/FS showed a potentially better 30-day outcomes compared with P/AS. The presence of anterior calcification at the access site carries a significant risk of VCD-related complications.

Expression of microRNA-21 in acute ischemic stroke: relationship with inflammatory cytokines, clinical severity, and clinical outcome

Background When the brain is deprived of oxygen and nutrients due to stenosis or arterial rupture, neurons in the affected area suffer irreversible damage and cellular death. MicroRNA has been shown to regulate target genes implicated in arterial hypertension, atherosclerosis, and diabetes mellitus, all of which influence the risk of ischemic stroke through inflammation, oxidative stress, cell proliferation, and apoptosis. The study aims to determine the changes in miRNA expression, namely miRNA-21, between acute ischemic stroke patients and controls and their relationship to proinflammatory cytokines, clinical severity, and outcome. Methods Serum samples from tertiary hospitals and controls were used to evaluate miRNA-21 expression as well as cytokines TNF-α, IL-10, ICAM-1, and CCL5 levels within 7 days of stroke onset. The 30-day clinical severity and outcome were assessed using the National Institute of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS), respectively. Result A total of 64 acute ischemic stroke patients and 22 age-matched controls were recruited, with median ages of 56 and 55.5 years old, respectively. There were more male subjects than females (35 to 29). A statistically significant difference was observed in miRNA-21 expression between patients and controls (p&lt;0.001). This finding implies that miRNA-21 expression may have a contribution in acute stroke patients. This was followed by an increase in proinflammatory markers TNF-α, IL-10, ICAM-1, and CCL5. However, no association was found between miRNA-21 and any pro-inflammatory cytokine. There was no significant correlation between miRNA-21 or cytokines markers with clinical severity or prognosis. Conclusion Our study demonstrated increased miRNA-21 expression and proinflammatory cytokine expression in acute ischemic stroke patients relative to controls. However, this was not related to clinical severity or clinical outcomes.

Outcomes of Patients Undergoing Elective Cancer Surgery After SARS-CoV-2 Infection: An Observational Cohort Study.

We evaluated the impact of preoperative SARS-CoV-2 infections on postoperative outcomes among patients undergoing elective cancer surgery. This ambidirectional (retrospective and prospective) study was conducted among patients undergoing elective cancer surgery between December 2022 and March 2023. Patients with different time intervals between SARS-CoV-2 infection and surgery (0-6 weeks and ≥7 weeks) were compared with those without SARS-CoV-2 infection. The primary outcome was 30-day postoperative pulmonary complications (PPCs). Secondary outcomes included 30-day postoperative mortality, major adverse cardiovascular events (MACE), and other postoperative adverse outcomes. Of the 830 patients analyzed, 239 (28.8%) had SARS-CoV-2 infection 0-6 weeks before cancer surgery, and they had a higher incidence of PPCs (4.6% in no SARS-CoV-2 infection, 12.1% in 0-6 weeks, and 5.1% in ≥7 weeks, p = 0.001). The logistic regression model revealed that, compared with patients without SARS-CoV-2 infection, surgery performed 0-6 weeks after SARSCoV-2 infection was associated with a higher risk of PPCs (adjusted odds ratio [aOR] 2.83; 95% confidence interval [CI] 1.34-5.98), and surgery performed ≥7 weeks after SARSCoV-2 infection was associated with a similar risk of PPCs (aOR 1.19; 95% CI 0.54-2.64). However, preoperative SARS-CoV-2 infection was not associated with a risk of 30-day postoperative mortality, MACE, or other adverse postoperative outcomes. In patients with preoperative Omicron variant infection, nonemergency cancer surgery can be scheduled ≥7 weeks after the infection to decrease the risk of PPCs, but it can be advanced if the risk of delay exceeds the risk of proceeding with the surgery.

Outcomes and Cost-Effectiveness of Hospital Outpatient Versus Ambulatory Surgery Center Lumbar Decompression Surgery.

Retrospective Chart Review. Outpatient spinal surgeries in Ambulatory Surgery Centers (ASCs) have gained traction due to their potential cost efficiencies and improved perioperative processes. This study aims to compare the cost-effectiveness and patient outcomes of lumbar laminectomies performed in hospital settings vs ASCs. A retrospective analysis was conducted on 771 patients who underwent 1 or 2-level outpatient laminectomy between 2019 and 2023. Patient demographics, 90-day and one-year clinical and patient-reported outcomes (PROs), and one-year episode of care costs were evaluated. A one-year cost-effectiveness analysis was performed using the EQ-5D to measure quality-adjusted life years (QALYs). ASC patients demonstrated lower body mass index and American Society of Anesthesiologists (ASA) scores, with a higher prevalence of 1-level laminectomies compared to hospital patients. ASC-based laminectomy was associated with lower initial surgery cost and one-year episode of care costs ($5662 ± 4748 vs $10229 ± 9202, P < 0.001), with similar rates of complications and postoperative resource utilization. These trends remained after controlling for patient demographics, comorbidities, and number of levels treated. In patients completing baseline and 1-year EQ-5D scores, ASC-based laminectomy was over twice as cost-effective as hospital procedures ($64873/QALY gained vs $152630). The findings support the safety and one-year cost effectiveness of ASCs for appropriately selected patient populations undergoing lumbar laminectomy. Additional studies are needed to replicate these findings across institutions, and to assess the cost effectiveness of ASC-based laminectomy beyond one-year postoperatively.