Mesh Type With Ventral Hernia Repair: A Systematic Review and Meta-analysis of Randomized Trials.

INTRODUCTION: Synthetic mesh is widely utilized for clean ventral hernia repair; however, it is unclear if synthetic mesh provides the same benefits with high-risk patients or during contaminated cases. Many surgeons use biologic mesh in these settings, but there is little evidence to support this practice. Our objective was to compare the clinical outcomes of utilizing biologic mesh versus synthetic mesh during ventral hernia repair. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines, a review of the literature was conducted using Cochrane library, EMBASE, Clinicaltrials.gov, and PubMed for randomized controlled trials published that compared biologic versus synthetic mesh during ventral hernia repair. The primary outcome was major complications defined as deep or organ space surgical site infection, reoperations, and hernia recurrences. RESULTS: Of 1889 manuscripts screened, four publications were included. The four studies included a total of 758 patients, with 381 receiving biologic mesh and 377 receiving synthetic mesh. Compared to biologic mesh, synthetic mesh had lower rates of major complications (38.6% versus 23.4, risk ratio = 0.55, 95% confidence interval = 0.35 to 0.86, P = 0.009) and hernia recurrence (24.5 % versus 10.3%, risk ratio = 0.44, 95% confidence interval = 0.28 to 0.69, P = 0.004). In addition, there was a lower percentage of surgical site infection and reoperation in the synthetic mesh group. CONCLUSIONS: Contrary to current surgical teaching, placement of permanent synthetic mesh into a contaminated field yielded rates of complications that were comparable or reduced compared to biologic mesh.

Adequate Reporting Among Ventral Hernia Repair Operative Reports: A Cross-Sectional Study of Prevalence of Details and Association With Clinical Outcomes.

Objective: We aimed to evaluate the prevalence of highly detailed ventral hernia repair (VHR) operative reports and associations between operative report detail and postoperative outcomes in a medico-legal dataset. Background: VHR are one of the most common surgical procedures performed in the United States. Previous work has shown that VHR operative reports are poorly detailed, however, the relationship between operative report detail and patient outcomes is unknown. Methods: This is a retrospective cross-sectional observational study. Operative reports describing VHR were obtained from a medical-legal database. Medical records were screened and data was extracted including clinical outcomes, such as surgical site infection (SSI), hernia recurrence, and reoperation and the presence of key details in each report. Highly detailed operative reports were defined as having 70% of recommended details. The primary outcome was the prevalence of highly detailed VHR operative reports. Results: A total of 1011 VHR operative reports dictated by 693 surgeons across 517 facilities in 50 states were included. Median duration of follow-up was 4.6 years after initial surgery. Only 35.7% of operative reports were highly detailed. More recent operative reports, cases with resident involvement, and contaminated procedures were more likely to be highly detailed (all P < 0.05). Compared to poorly detailed operative reports, cases with highly detailed reports had fewer SSIs (13.2% vs 7.5%, P = 0.006), hernia recurrence (65.8% vs 55.4%, P = 0.002), and reoperation (78.9% vs 62.6%, P = 0.001). Conclusions: In this medico-legal dataset, most VHR operative reports are poorly detailed while highly detailed operative reports were associated with lower rates of complications. Future studies should examine a nationally representative dataset to validate our findings.

A Comparison of CT Perfusion Output of RapidAI and Viz.ai Software in the Evaluation of Acute Ischemic Stroke.

BACKGROUND AND PURPOSE: Automated CTP postprocessing packages have been developed for managing acute ischemic stroke. These packages use image processing techniques to identify the ischemic core and penumbra. This study aimed to investigate the agreement of decision-making rules and output derived from RapidAI and Viz.ai software packages in early and late time windows and to identify predictors of inadequate quality CTP studies. MATERIALS AND METHODS: One hundred twenty-nine patients with acute ischemic stroke who had CTP performed on presentation were analyzed by RapidAI and Viz.ai. Volumetric outputs were compared between packages by performing Spearman rank-order correlation and Wilcoxon signed-rank tests with subanalysis performed at early (<6 hours) and extended (>6 hours) time windows. The concordance of selecting patients on the basis of DAWN and DEFUSE 3 eligibility criteria was assessed using the McNemar test. RESULTS: One hundred eight of 129 patients were found to have adequate-quality studies. Spearman rank-order correlation coefficients were calculated on time-to-maximum >6-second volume, time-to-maximum >10-second volume, CBF <30% volume, mismatch volume, and mismatch ratio between both software packages with correlation coefficients of 0.82, 0.65, 0.77, 0.78, 0.59, respectively. The Wilcoxon signed-rank test was also performed on time-to-maximum >6-second volume, time-to-maximum >10-second volume, CBF <30% volume, mismatch volume, and mismatch ratio with P values of .30, .016, <.001, .03, <.001, respectively. In a 1-sided test, CBF <30% was greater in Viz.ai (P < .001). Although this finding resulted in statistically significant differences, it did not cause clinically significant differences when applied to the DAWN and DEFUSE 3 criteria. A lower ejection fraction predicted an inadequate study in both software packages (P = .018; 95% CI, 0.01-0.113) and (P = .024; 95% CI, 0.008-0.109) for RapidAI and Viz.ai, respectively. CONCLUSIONS: Penumbra and infarct core predictions between Rapid and Viz.ai correlated but were statistically different and resulted in equivalent triage using DAWN and DEFUSE3 criteria. Viz.ai predicted higher ischemic core volumes than RapidAI. Viz.ai predicted lower combined core and penumbra values than RapidAI at lower volumes and higher estimates than RapidAI at higher volumes. Clinicians should be cautious when using different software packages for clinical decision-making.

Hernia Prevention Using Biologic Mesh and/or Small Bites: A Multispecialty 2 × 2 Factorial Randomized Controlled Trial.

BACKGROUND: Ventral incisional hernias are the most common complication after abdominal operation. Randomized trials have shown efficacy of prophylactic synthetic mesh and small bites. Adoption of these practices has been limited due to concerns with placement of synthetic mesh in contaminated cases and small bites in an overweight population. We sought to assess the efficacy of prophylactic biologic mesh and small bites to prevent postoperative major complications: ventral incisional hernias, surgical site infection, reoperation, and death. STUDY DESIGN: High-risk patients (overweight/obese, current smoker) undergoing abdominal operation with a midline incision (5 cm or greater) were randomized (2 × 2 factorial trial) to receive either sublay biologic mesh or no mesh and either small bites (0.5 × 0. 5cm) or large bites (1 × 1 cm) fascial closure. The primary outcome measure was major complications at 1 year postoperative. CONSORT guidelines were followed, and this study was registered on clinicaltrials.gov (NCT03148496). Assuming α = 0.05, ß = 0.20, and Δ = 20%, it was estimated that 105 patients were needed. Primary outcome was assessed using Fisher's exact test. RESULTS: A total of 107 patients were randomized: 52 (49%) to mesh, 55 (51%) to no mesh, 55 (51%) to small bites, and 52 (49%) to large bites. Of the patients, 16% were smokers, 31% were overweight, and 55% were obese. At 1 year postoperative, there were no differences in major complications between groups (mesh vs no mesh 21% vs 16%, p = 0.62; small vs large bites 18% vs 19%, p = 1.00). CONCLUSIONS: In this trial, biologic mesh and small bites appear to have no benefit. Further randomized trials are needed among high-risk patients before widespread adoption of prophylactic biologic mesh or small bites.

The Food and Drug Administration's (FDA's) 510(k) Process: A Systematic Review of 1000 Cases.

BACKGROUND: The vast majority of devices cleared by the Food and Drug Administration (FDA) are through the 510(k) process, which allows medical devices to be quickly introduced into the market. The FDA 510(k) process is designed to minimize the burden and expense of bringing new devices to market; however, as a result, the FDA may be limited in its ability to establish the safety of these devices. METHODS: The FDA 510(k) online archives were searched for devices cleared from 2013 to 2014. One thousand devices were randomly selected. PubMed was searched for each device to identify publications about the devices. The primary outcome was the percentage of devices cleared through the 510(k) process with no published research. Secondary outcomes included: conflict of interest (COI) of authors and outcomes of published studies on the devices. RESULTS: A total of 6152 devices were cleared through the 510(k) process in 2013-2014. Of the 1000 randomly selected devices, 17.8% had published research. There were 375 manuscripts, of which 47 (12.5%) were randomized controlled trials. One-fourth (25.1%) of studies had a clearly identifiable COI, while COI was unclear for half (49.9%). CONCLUSION AND RELEVANCE: There is limited evidence examining the safety and effectiveness of devices cleared via the 510(k) process. Thousands of devices are cleared through the FDA's 510(k) process each year with limited or no evidence publicly available. This has led to the market being introduced to potentially costly, nonbeneficial, or harmful devices. Devices, like prescription drugs, should undergo a more rigorous clearance process.

Prevalence and Prognostic Implications of Amyloidosis in Valvular Heart Disease.

There has been less emphasis on the prognostic impact of amyloidosis in patients with valvular heart disease (VHD). We aimed to determine the prevalence of amyloidosis in VHD and its clinical implications in terms of mortality. Patients hospitalized for VHD were identified using National Inpatient Sample 2016-2020 which were divided into 2 cohorts: with and without amyloidosis. Among 5,728,873 patients hospitalized with VHD, 11,715 patients had amyloidosis in which mitral valve disease has the highest prevalence (7.6%) followed by aortic (3.6%), and tricuspid valve disease (1%). Underlying amyloidosis is associated with higher mortality in VHD (OR 1.45, CI 1.2-1.7, P<0.001), mainly mitral valve disease (OR 1.44, CI 1.1-1.9, P<0.01). Patients with amyloidosis have higher adjusted mortality rates (5-6% vs 2.6%, P<0.01), longer mean length of stay (7.1 vs 5.7 days, P<0.001), but they have lower valvular intervention rates. In hospitalized VHD patients, underlying amyloidosis is associated with higher in-hospital mortality.

Fascial Defect Closure During Ventral Hernia Repair: A Systematic Review of Randomized Controlled Trials.

Background: During minimally invasive ventral hernia repair (VHR) it is unknown if a fascial defect closure, as opposed to a bridged repair (current care), is beneficial for patients. We sought to systematically review the published literature on the role of fascial defect closure during minimally invasive VHR. Methods: PubMed, Embase, Scopus, Cochrane, and Clinicaltrials.gov were reviewed for randomized controlled trials (RCTs) that compared fascial defect closure with bridged repair. The primary outcome was major complications defined as deep/organ-space surgical site infections (SSIs), reoperations, hernia recurrences, or deaths. Secondary outcomes included SSI, seroma, eventration, hernia recurrence, post-operative pain, and quality of life (QOL). Pooled risk ratios with 95% confidence intervals were obtained through random effect meta-analyses. Results: Of 579 screened articles, 6 publications of 5 RCTs were included. No significant difference in major complications (10.6% vs 10.4%, RR=1.05, 95% CI=0.51-2.14, P=.90) or recurrences (9.0% vs 10.6%, RR=0.92, 95% CI=0.32-2.61, P=.87) were found between groups. Fascial defect closure decreased the risk of seromas (22.9% vs 34.2%, RR=0.60, 95% CI=0.37-0.97, P=.04) and may decrease the risk of eventrations (6.7% vs 9.0%, RR=0.74, 95% CI=0.37-1.50, P=.41) at the expense of potentially increasing the risk of SSI (3.2% vs 1.4%, RR=1.89, 95% CI=0.60-5.93; P=.28). Reporting of pain and QOL scores was inconsistent. Conclusion: While most individual RCTs demonstrated benefit with fascial defect closure during minimally invasive VHR, our meta-analysis of fascial defect closure demonstrated only a statistically significant difference in seromas compared to bridged repair. Large, multi-center RCTs are needed.

A Case Report on Mycobacterium abscessus: An Emerging Pathogen.

The incidence of infections by rapidly growing mycobacteria has increased in recent decades. nontuberculous mycobacteria(NTM) represent over 190 species and subspecies and can cause both pulmonary and extrapulmonary symptoms. The Mycobacterium abscessus complex (MABC)is among the most drug-resistant mycobacterial species, and prompt diagnosis and effective eradication are burdensome. We present the clinical course of a 55-year-old female who was diagnosed with M. abscessus and explore her clinical diagnosis and possible treatment options. This case report emphasizes the challenges clinicians face in the prompt diagnosis of M. abscessus and discusses the treatment options in light of the recent guidelines.

Cardioembolic-related renal infarction.

Acute renal infarction is a rare condition that can progress to renovascular hypertension, chronic kidney disease, and end-stage kidney disease, depending on the severity. We present a case of a 30-year-old man with no significant past medical history who presented with sudden onset right flank pain. Initially pyelonephritis was suspected but it was later found to be acute renal infarction secondary to cardioemboli from atrial fibrillation.

Mortality and length of stay among HIV patients hospitalized for heart failure: A multicenter retrospective study.

Study objective: The purpose of our study was to determine if CD4+ T-lymphocyte count (CD4 count) was inversely associated with inpatient mortality and length of stay (LOS) among patients with HIV hospitalized for acute heart failure. Design: Retrospective cohort study. Setting: HCA hospitals throughout the United States. Participants: 1704 patients with human immunodeficiency virus (HIV) hospitalized for acute heart failure with a documented, time-updated CD4 count. Interventions: Patients were categorized by CD4 count ranges consisting of >500, 200-499, <200 cells/µL. Main outcome measures: A multivariable negative binomial regression was performed with CD4 count as a predictor of length of stay. Multivariable logistic regression was performed with CD4 count as a predictor of mortality. Results: A CD4 count <200 cells/µL was associated with an increased length of stay compared to a CD4 > 500 cells/µL (IRR 1.24, 95 % CI: 1.11 to 1.39, P ≤ 0.01). A CD4 of 200-499 cells/µL was associated with a shorter LOS compared to a CD4 < 200 cells/µL (IRR 0.82, 95 % CI: 0.75 to 0.89, P ≤ 0.01). A CD4 < 200 cells/µL was associated with an increased mortality compared to a CD4 > 500 cells/µL (OR 3.62, 95 % CI: 1.63 to 8.05, P ≤ 0.01). CD4 count was not independently associated with in-patient mortality after adjusting for viral load. Conclusion: A time-updated CD4 count <200 cells/µL on hospital admission was independently associated with increased length of stay. CD4 cell count and viral load are important markers when considering the morbidity and mortality among patients with HIV hospitalized for acute heart failure.

A Systematic Review and Meta-Analysis on Possible Role of Vitamin C in Sepsis.

Sepsis is a substantial healthcare burden, and its management continues to be a major challenge. Prior studies demonstrate conflicting evidence regarding the utility of vitamin C in sepsis. This systematic review and meta-analysis aim to collect data among critically ill patients (sepsis/septic shock), comparing the efficacy of parenteral vitamin C with standard care. A literature review was conducted using databases including PubMed, Web of Science, Google Scholar, and the Cochrane Library to identify randomized controlled trials (RCTs) and observational studies comparing intravenous vitamin C alone or in combination with thiamine or glucocorticoids to the standard of care. We identified 11 RCTs and seven retrospective cohort studies. The primary outcome was 28-day mortality. Secondary outcomes included intensive care unit (ICU) length of stay, change in Sequential Organ Failure Assessment (SOFA) score, duration of vasopressor use, and duration of mechanical ventilation. A total of 18 studies with 4078 patients were included in our final analysis. Overall, we found no mortality reduction in patients treated with vitamin C compared to standard of care (odds ratio (OR) 0.92; 95% confidence interval (CI) 0.78 to 1.09; p = 0.34). Studies that reported a change in SOFA scores, ICU length of stay, duration of mechanical ventilation, or duration of vasopressor use did not show any significant difference between groups. Subgroup analysis with RCT versus observational studies and vitamin C dosage regimens did not show any difference. Among patients with sepsis or septic shock, treatment with vitamin C was not associated with a reduction in mortality, ICU length of stay, change in SOFA score, duration of vasopressor use, or duration of mechanical ventilation. Further studies are needed to demonstrate the potential role of vitamin C in the management of sepsis.

Anti-spermatogenic activities of Taraxacum officinale whole plant and leaves aqueous extracts.

Taraxacum officinale has been used in Jordan folk medicine to treat male infertility. A recent study has proved a contradictory effect of the whole plant aqueous extract. The aim of the current study was to determine if the leaves of T. officinale have similar anti-fertility activities, and whether this effect is mediated through the regulation of spermatogonial stem cells (SSCs). Fifty adult male rats were divided into five groups. Two groups were gavaged with 1/10 of LD50 of T. officinale whole plant (1.06 g kg(-1) body weight) or leaves (2.30 g kg(-1) body weight) aqueous extract; while two groups were gavaged with 1/20 of LD50 of T. officinale whole plant (2.13 g kg(-1)) or leaves (4.60 g kg(-1)) extract. The control group received distilled water. Oral administration of T. officinale (whole plant and leaves aqueous extract) caused a significant decrease in testis and seminal vesicle weight, a reduction in serum testosterone concentration, impaired sperm parameters, and a decrease in pregnancy parameters. Testicular histology of treated rats showed structural changes such as hypoplasia of germ cells, reduction in the thickness of germinal epithelium, arrest of spermatogenesis at spermatid stage (late maturation arrest) and reduction in the number of Leydig cells. Gene expression levels of two SSCs markers (GFRα1 and CSF1) responsible for self-renewal were relatively counter-balanced. In conclusion, T. officinale whole plant and leaves aqueous extracts changed the gene expression of two SSCs markers leading to the imbalance between spermatogonia self-renewal and differentiation causing late maturation arrest.