Prospective Multicenter Study Research Articles

Development and validation of an early diagnosis model for bone metastasis in non-small cell lung cancer based on serological characteristics of the bone metastasis mechanism

Bone metastasis significantly impact the prognosis of non-small cell lung cancer (NSCLC) patients, reducing their quality of life and shortening their survival. Currently, there are no effective tools for the diagnosis and risk assessment of early bone metastasis in NSCLC patients. This study employed machine learning to analyze serum indicators that are closely associated with bone metastasis, aiming to construct a model for the timely detection and prognostic evaluation of bone metastasis in NSCLC patients. The derivation cohort consisted of 664 individuals with stage IV NSCLC, diagnosed between 2015 and 2018. The variables considered in this study included age, sex, and 18 specific serum indicators that have been linked to the occurrence of bone metastasis in NSCLC. Variable selection used multivariate logistic regression analysis and Lasso regression analysis. Six machine learning methods were utilized to develop a bone metastasis diagnostic model, assessed with Area Under the Curve (AUC), Decision Curve Analysis (DCA), sensitivity, specificity, and validation cohorts. External validation used 113 NSCLC patients from the Medical Alliance (2019-2020). Furthermore, a prospective validation study was conducted on a cohort of 316 patients (2019-2020) who were devoid of bone metastasis, and followed-up for at least two years to assess the predictive capabilities of this model. The model's prognostic value was evaluated using Kaplan-Meier survival curves. Through variable selection, 11 serum indictors were identified as independent predictive factors for NSCLC bone metastasis. Six machine learning models were developed using age, sex, and these serum indicators. A random forest (RF) model demonstrated strong performance during the training and internal validation cohorts, achieving an AUC of 0.98 (95% CI 0.95-0.99) for internal validation. External validation further confirmed the RF model's effectiveness, yielding an AUC of 0.97 (95% CI 0.94-0.99). The calibration curves demonstrated a high level of concordance between the anticipated risk and the observed risk of the RF model. Prospective validation revealed that the RF model could predict the occurrence of bone metastasis approximately 10.27±3.58 months in advance, according to the results of the SPECT. An online computing platform (https://bonemetastasis.shinyapps.io/shiny_cls_1model/) for this RF model is publicly available and free-to-use by doctors and patients. This study innovatively employs age, gender, and 11 serological markers closely related to the mechanism of bone metastasis to construct an RF model, providing a reliable tool for the early screening and prognostic assessment of bone metastasis in NSCLC patients. However, as an exploratory study, the findings require further validation through large-scale, multicenter prospective studies. This work is supported by the National Natural Science Foundation of China (NO.81974315); Shanghai Municipal Science and Technology Commission Medical Innovation Research Project (NO.20Y11903300); Shanghai Municipal Health Commission Health Industry Clinical Research Youth Program (NO.20204Y034).

Sepsis epidemiology and prognosis in cancer patients: Preliminary results of a multicenter prospective observational study

Sepsis epidemiology and prognosis in cancer patients: Preliminary results of a multicenter prospective observational study

Health Care Personnel Workdays Lost and Direct Health Care Salary Costs Incurred due to COVID-19 Infection in the Age of Widespread Vaccine Availability.

Vaccination against coronavirus disease 2019 (COVID-19) can mitigate the burden of health care worker (HCW) infection. We investigate the burden of HCW illness and its associated direct health care personnel costs in the setting of widespread vaccine availability and explore factors influencing these outcomes. This multicenter prospective study followed HCWs over an 8-month period from January to August 2023. Data recorded included incident COVID-19 infection, symptom burden, workdays missed, and vaccine history. Workdays lost due to illness were used to calculate direct health care personnel costs due to COVID-19 infection. Univariate analysis and multivariable regression investigated the factors associated with workdays lost and direct health care personnel. In total, 1218 participants were enrolled and followed for 8 months, with 266 incidents of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, 1191 workdays lost, and health care personnel costs of €397 974. Multivariable regression revealed that workdays lost were associated with incomplete primary COVID-19 vaccination course. Being unvaccinated, older age, and male were associated with increased health care personnel costs. Health care workdays lost remain a significant issue and are associated with health care system burden despite vaccine availability. These can be mitigated via targeted implementation of vaccine programs. Seasonal variation in health care workdays lost should inform workforce planning to accommodate surge periods.

Intraoperative left-sided colorectal anastomotic testing in clinical practice: a multi-treatment machine-learning analysis of the iCral3 prospective cohort.

Current evidence about intraoperative anastomotic testing after left-sided colorectal resections is still controversial. The aim of this study was to analyze the impact of Indocyanine Green fluorescent angiography (ICG-FA) and air-leak test (ALT) over standard assessment on anastomotic leakage (AL) rates according to surgeon's perception of anastomosis perfusion and/or integrity in clinical practice. A database of 2061 patients who underwent left-sided colorectal resections was selected from patients enrolled in a prospective multicenter study. It was retrospectively analyzed through a multi-treatment machine-learning model considering standard visual assessment (NW; No. = 899; 43.6%) as the reference treatment arm, compared to ICG-FA alone (WP; No. = 409; 19.8%), ALT alone (WI; No. = 420; 20.4%) or both (WPI; No. = 333; 16.2%). Twenty-four covariates potentially affecting the outcomes were included and balanced into the model within the subgroups. The primary endpoint was AL, the secondary endpoints were overall morbidity (OM), major morbidity (MM), reoperation for AL, and mortality. All the results were reported as odds ratio (OR) with 95% confidence intervals (95%CI). The WPI subgroup showed significantly higher AL risk (OR 1.91; 95% CI 1.02-3.59; p 0.043), MM risk (OR 2.35; 95% CI 1.39-3.97; p 0.001), and reoperation for AL risk (OR 2.44; 95% CI 1.12-5.31; p 0.025). No other significant differences were recorded. This study showed that the surgeons' perception of both anastomotic perfusion and integrity (WPI subgroup) was associated to a significantly higher risk of AL and related morbidity, notwithstanding the extensive use of both ICG-FA and ALT testing.

Mechanism Matters: Differential benefits of cold-stored whole blood for trauma resuscitation from a prospective multicenter study.

Resuscitation with cold-stored low-titre whole blood (LTOWB) has increased despite the paucity of robust civilian data. Most studies are in predominately blunt trauma and lack analysis of specific subgroups or mechanism of injury. We sought to compare outcomes between patients receiving LTOWB vs. balanced component therapy (BCT) after blunt (BL) and penetrating (PN) trauma. Secondary analysis of a prospective multicenter study of patients receiving either LTWOB-containing or BCT resuscitation was performed. Patients were grouped by mechanism of injury (BL vs PN). A generalized estimated equations model using inverse probability of treatment weighting was employed. Primary outcome was mortality and secondary outcomes were acute kidney injury, venous thromboembolism, pulmonary complications, and bleeding complications. Additional analyses were performed on non-traumatic brain injury (TBI), severe torso injury, and LTOWB-only resuscitation patients. 1617 patients (BL 47% vs PN 54%) were identified; 1175 (73%) of which received LTOWB. PN trauma patients receiving LTOWB demonstrated improved survival compared to BCT (77% vs. 56%; p<0.01). Interval survival was higher at 6 hrs (95% vs. 88%), 12 hrs (93% vs. 80%) and 24 hrs (88% vs. 57%) (all p<0.05). The survival benefit following LTOWB was also seen across PN non-TBI (83% vs. 52%), and severe torso injuries (75% vs. 43%) (all p <0.05). After controlling for age, sex, injury severity, and trauma center, LTWOB was associated with decreased odds of death (OR .31, p<.05) in PN trauma. However, no difference in overall mortality was seen across the BL groups. Both PN and BL patients receiving LTOWB had more frequent AKI compared to BCT (19% vs. 7% and 12% vs 6%, respectively; p<0.05). LTOWB resuscitation was independently associated with decreased mortality following PN trauma, but not BL trauma. Further analysis in BL trauma is required to identify subgroups that may demonstrate survival benefit. Therapeutic/Care Management, III.

Antifungal Prophylaxis and Treatment of Breakthrough Invasive Fungal Diseases in High-Risk Hematology Patients: A Prospective Observational Multicenter Study

Antifungal Prophylaxis and Treatment of Breakthrough Invasive Fungal Diseases in High-Risk Hematology Patients: A Prospective Observational Multicenter Study

Hand, foot, and mouth disease: could EPs® 7630 be a treatment option? A prospective randomized open-label multicenter clinical study

PurposeHand, foot and mouth disease (HFMD) is a viral contagious disease of children caused by human enteroviruses (EVs) and coxsackieviruses (CVs). There is no specific treatment option for HFMD. EPs® 7630's anti-infective and immunomodulatory properties have previously been demonstrated in several in vitro and in vivo studies; however, the use of this herbal medicine in children with HFMD has not previously been investigated.MethodsThis prospective randomized multicenter clinical study included 208 children with HFMD. The diagnosis was made by pediatricians. The patients who were within the first 48 h of symptom onset (according to the first onset of fever and skin findings) were enrolled. The study participants were assigned into 2 groups as EPs® 7630 and control groups. All patients were followed up twice more, 48 h after the first admission and on the 5th–7th day. Another phone evaluation was conducted for those with continued complaints from the previous visit.ResultsThe median age was 27 (12–112) months. The male-female ratio was 0.98. One hundred thirty one (63%) of 190 patients had no history of household contact. EPs® 7630 group included 94 and control group included 96 patients. A significant difference was found between the groups in terms of complaint scores at the visits made at the 48th h of the treatment and on days 5–7 (p &amp;lt; 0.001). The mean ± SD disease duration of EPs® 7630 users was significantly shorter 6.07 ± 0.70 days (95% CI: 5.92–6.21)] than the control group [8.58 ± 0.94 days (95% CI: 8.39–8.77)] (p &amp;lt; 0.001). Besides, the hospitalization rate among the EPs® 7630 users were significantly lower (p = 0.019). No side effects were observed, except for unpleasant taste, which was reported in 5 patients (EPs® 7630 group).ConclusionConsidering its efficacy and safety profile EPs® 7630 may represent a feasible herbal-based treatment option for children with HFMD. Clinical Trial RegistrationClinicalTrials.gov, identifier (NCT06353477).

In Reply: Letter to the Editor Regarding Health-related Quality of Life in Idiopathic Toe Walkers: A Multicenter Prospective Cross-sectional Study.

In Reply: Letter to the Editor Regarding Health-related Quality of Life in Idiopathic Toe Walkers: A Multicenter Prospective Cross-sectional Study.

The lung ultrasound in children with SARS-COV-2 infection: a national multicenter prospective study.

Coronavirus disease-19 (COVID-19) caused hospitalizations, severe disease, and deaths in any age, including in the youngest children. The aim of this multicenter national study is to characterize the clinical and the prognostic role of lung ultrasound (LU) in children with COVID-19.We enrolled children between 1 month and 18 years of age with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection who underwent a LU within 6h from the first medical evaluation.A total of 213 children were enrolled, 51.6% were male, median age was 2 years and 5 months (interquartile range (IQR) 4months-11 years and 4 months). One hundred and forty-eight (69.4%) children were admitted in hospital, 9 (6.1%) in pediatric intensive care unit. We found an inverse correlation between the lung ultrasound score (LUS) and the oxygen saturation at the first clinical evaluation (r = -0.16; p = 0.019). Moreover, LUS was significantly higher in patients requiring oxygen supplementation (8 (IQR 3-19) vs 2 (IQR 0-4); p = 0.001).Among LU pathological findings, irregular pleural lines, subpleural consolidations, and pleural effusions were significantly more frequent in patients needing oxygen supplementation (p = 0.007,p = 0.006, and p = 0.001, respectively). Conclusion: This multicenter study showed that LU in children with COVID-19 can highlight pleural line irregularities, vertical artifacts, and subpleural consolidation. Notably, children with higher LUS have a higher risk of hospitalization and need for oxygen supplementation, supporting LU as a valid and safe point-of-care first level tool for the clinical evaluation of children with COVID-19. What is Known: • Few children infected with SARS-CoV-2 develop a severe disease and need oxygen therapy. • Lung ultrasound can easily detect low respiratory tract infection during SARS-CoV-2. What is New: • Children with higher lung ultrasound score have a higher risk of need for oxygen supplementation. • Irregular pleural line, sub-pleural consolidations and pleural effusions were significantly more frequent in patients needing oxygen supplementation.

Implementation of lung ultrasonography by general practitioners for lower respiratory tract infections: a feasibility study

Objective To evaluate the feasibility of lung ultrasonography (LUS) performed by novice users’ general practitioners (GPs) in diagnosing lower respiratory tract infections (LRTIs) in primary health care settings. Design A prospective interventional multicenter study (December 2019–March 2020). Settings and subjects Patients aged >3 months, suspected of having LRTI consulting in three different general practices (GPs) (rural, semirural and urban) in France. Main outcome measures Feasibility of LUS by GPs was assessed by (1) the proportion of patients where LUS was not performed, (2) technical breakdowns, (3) interpretability of images by GPs, (4) examination duration and (5) patient perception and acceptability. Results A total of 151 patients were recruited, and GPs performed LUS for 111 (73.5%) patients (LUS group). In 99.1% (n = 110) of cases, GPs indicated that they were able to interpret images. The median [IQR] exam duration was 4 [3–5] minutes. LRTI was diagnosed in 70.3% and 60% of patients in the LUS and no-LUS groups, respectively (p = .43). After LUS, GPs changed their diagnosis from ‘other’ to ‘LRTI’ in six cases (+5.4%, p < .001), prescribed antibiotics for five patients (+4.5%, p = .164) and complementary chest imaging for 10 patients (+9%, p < .001). Patient stress was reported in 1.8% of cases, 81.7% of patients declared that they better understood the diagnosis, and 82% of patients thought that the GP diagnosis was more reliable after LUS. Conclusions LUS by GPs using handheld devices is a feasible diagnostic tool in primary health care for LRTI symptoms, demonstrating both effectiveness and positive patient reception. Trial Registration Number Clinicaltrial.gov: NCT04602234, 20/10/2020.

Antibiotic adherence in dermatologic surgery: a Multicenter prospective cohort study.

Understanding patient non-adherence to prescribed antibiotics can inform clinical practices, patient counseling, and antibiotic efficacy study design in dermatology. The primary objective was to determine the rate of and reasons for antibiotic non-adherence in the dermatologic surgery setting. The secondary objective was to test the applicability of previously studied survey questions for antibiotic non-adherence screening in the dermatologic surgery setting. Five academic outpatient dermatologic surgery centers across the United States conducted one multicenter prospective cohort study. Dermatologic surgery patients ≥ 18 years of age who were prescribed an antibiotic were included as part of this study. 15.2% (42/276) of patients did not adhere to their antibiotic regimen after dermatologic surgery. Most common reasons for incomplete antibiotic courses included forgotten antibiotics (42.9%,18/42) and side effects (28.6%, 12/42). Previously evaluated questions to identify and predict non-adherence had modest performance in the dermatologic surgery setting (Area under the curve of 0.669 [95% CI (0.583-0.754)]). Antibiotic non-adherence after skin surgery is prevalent and commonly due to reasons that physicians can address with patients.

Real-life Achievements of MiniMed™ 780G Advanced Closed Loop System in Youth With Type 1 Diabetes: AWeSoMe Study Group Multi-Center Prospective Trial.

We assessed real-life glycemic outcomes and predictors of composite measures of optimal glycemic control in children and adolescents with type 1 diabetes (T1D) during their initial 12 months of the MiniMed™ 780G use. This prospective observational multicenter study collected demographic, clinical, and two-week 780G system data at five timepoints. Optimal glycemic control was defined as a composite glycemic control (CGC) score requiring the attainment of four recommended continuous glucose monitoring (CGM) targets, as well as the glycemia risk index (GRI) of hypoglycemia and hyperglycemia and composite CGM index (COGI). Outcome measures included longitudinal changes in multiple glycemic parameters and CGC, GRI, and COGI scores, as well as predictors of these optimal measures. The cohort included 93 children, 43% girls, with a median age of 15.1 years [IQR 12.9,17.0]. A longitudinal analysis adjusted for age and socioeconomic index yielded a significant improvement in glycemic control for the entire cohort (ptime<0.001) after the transition to 780G. The mean HbA1c (SE) was 8.65%(0.12) at baseline and dropped by more than 1% after one year to 7.54%(0.14) (ptime<0.001). Optimal glycemic control measures improved at 12 months post 780G; CGC improved by 5.6-fold (p<0.001) and was attained by 24% of the participants, the GRI score improved by 10-fold (p=0.009) and was achieved by 10% of them, and the COGI improved by 7.6-fold (p<0.001) and was attained by 20% of them. Lower baseline HbA1c levels and increased adherence to AHCL usage were predictors of achieving optimal glycemic control. The AHCL 780G system enhances glycemic control in children and adolescents with T1D, demonstrating improvements in HbA1c and CGM metrics, albeit most participants did not achieve optimal glycemic control. This highlights yet ongoing challenges in diabetes management, emphasizing the need for continued proactive efforts on the part of healthcare professionals, youth, and caregivers.

Investigating incidence of and factors associated with SARS-CoV-2 infection over a nine-month period in a highly-vaccinated healthcare worker cohort.

Healthcare workers (HCWs) are at increased risk of SARS-CoV-2 infection. This risk persists despite the implementation of mitigating factors, including vaccination. The ongoing impact of incident SARS-CoV-2 infection and symptomatic COVID-19 disease in vaccinated healthcare workers is poorly understood. We aimed to describe the epidemiology of incident SARS-CoV-2 infections, as well as investigating the serological, clinical and demographic factors associated with developing infection. This was a multi-centre prospective longitudinal study followed a HCW cohort over a nine-month period. Spike and nucleocapsid SARS-CoV-2 antibodies were measured at enrolment. Vaccination status, demographics, and medical history were collated. Incident infection over the study period was recorded. Multivariable regression models investigated factors associated with nucleocapsid antibody status, incident infection, and symptomatic infection. 1,260 participants took part, of whom n = 1,006 were anti-nucleocapsid antibody positive. Negative anti-nucleocapsid antibody was associated with older age and having a known SARS-CoV-2 acquisition risk. There were n = 274 (22%) incident infections, with n = 225 (87%) diagnosed using antigen tests. Incident infections were associated with lower anti-nucleocapsid titres, increased time since previous SARS-CoV-2 infection, and having a known acquisition risk, but were not associated with vaccination status. This study demonstrates a high rate of incident SARS-CoV-2 infection amongst healthcare workers, despite broad vaccine coverage. There is a shift in diagnostics, from PCR to antigen testing. We identify at-risk groups for incident infection, and these should continue be targeted as part of risk reduction campaigns. Vaccination status and prior infection status alone are not surrogates for protection.

Use of Immune Profiling Panel to assess the immune response of septic patients for prediction of worsening as a composite endpoint

Sepsis induces intense, dynamic and heterogeneous host response modulations. Despite improvement of patient management, the risk of mortality and healthcare-associated infections remains high. Treatments to counterbalance immune response are under evaluation, but effective biomarkers are still lacking to perform patient stratification. The design of the present study was defined to alleviate the limitations of existing literature: we selected patients who survived the initial hyperinflammatory response and are still hospitalized at day 5–7 after ICU admission. Using the Immune Profiling Panel (IPP), a fully automated RT-qPCR multiplex prototype, we optimized a machine learning model combining the IPP gene expression levels for the identification of patients at high risk of worsening, a composite endpoint defined as death or secondary infection, within one week after sampling. This was done on 332 sepsis patients selected from two retrospective studies. The IPP model identified a high-risk group comprising 30% of patients, with a significant increased proportion of worsening events at day 28 compared to the low-risk group (49% vs. 28%, respectively). These preliminary results underline the potential clinical application of IPP for sepsis patient stratification in a personalized medicine perspective, that will be confirmed in a larger prospective multicenter study.

Inflammation and endothelial function relevant genetic polymorphisms, carotid atherosclerosis, and vascular events in high-risk stroke population

AimTo identify the associations of 19 single nucleotide polymorphisms (SNPs) in genes involved in inflammation and endothelial function and carotid atherosclerosis with subsequent ischemic stroke and other vascular events in the high-risk stroke population.MethodsThis was a multicenter community-based sectional survey and prospective cohort study in Sichuan, southwestern China. Eight communities were randomly selected, and the residents in each community were surveyed using a structured face-to-face questionnaire. Carotid ultrasonography and DNA information were obtained from 2,377 out of 2,893 individuals belonging to a high-risk stroke population. Genotypes of the 19 SNPs in genes involved in inflammation and endothelial function were measured. All the 2,377 subjects were followed up for 4.7 years after the face-to-face survey. The primary outcome was ischemic stroke, and the secondary outcome was a composite of vascular events.ResultsAmong the 2,377 subjects, 2,205 (92.8%) completed a 4.7-year follow-up, 947 (42.9%) had carotid atherosclerosis [372 (16.9%) carotid vulnerable plaque, 405 (18.4%) mean IMT &amp;gt; 0.9 mm, 285 (12.0%) carotid stenosis ≥15%]. Outcomes occurred in 158 (7.2%) subjects [92 (4.2%) ischemic stroke, 17 (0.8%) hemorrhagic stroke, 48 (2.2%) myocardial infarction, and 26 (1.2%) death] during follow-up. There was a significant gene–gene interaction among ITGA2 rs1991013, IL1A rs1609682, and HABP2 rs7923349 in the 19 SNPs. The multivariate logistic regression model revealed that carotid atherosclerosis and the high-risk interactive genotypes among the three SNPs were independent with a higher risk for ischemic stroke (OR = 2.67, 95% CI: 1.52–6.78, p = 0.004; and OR = 3.11, 95% CI: 2.12–9.27, p &amp;lt; 0.001, respectively) and composite vascular events (OR = 3.04, 95% CI: 1.46–6.35, p &amp;lt; 0.001; and OR = 3.23, 95% CI: 1.97–8.52, p &amp;lt; 0.001, respectively).ConclusionThe prevalence of carotid atherosclerosis was shown to be very high in the high-risk stroke population. Specific SNPs, interactions among them, and carotid atherosclerosis were independently associated with a higher risk of ischemic stroke and other vascular events.

Robotic-Assisted Inguinal Hernia Repair with The Dexter System™: A Prospective Multicentre Clinical Investigation

Abstract Background Robot-assisted transabdominal preperitoneal inguinal hernia repair (rTAPP) is established as safe and feasible with various robotic platforms. The Dexter robotic system is an open platform with a sterile surgeon’s console, two robotic instrument arms, and one robotic endoscope arm. Aims We conducted a prospective multicentre study (ClinicalTrials.gov NCT05873582) to assess the safety and performance of this new robotic platform. Methods Three centres in France, Germany, and Switzerland participated. The primary objectives of the study were to document the successful completion of the rTAPP procedures and to collect data on the occurrence of adverse events and device-related events perioperatively and up to 30 days post-surgery. The procedures were performed by three surgeons with varying levels of experience in robotic systems, including novice, intermediate and expert. Results Fifty patients were operated for inguinal hernia repair (33 unilateral, 17 bilateral). The mean age and BMI of the patients were 60 years (±15) and 25.7 kg/cm2 (±3.3), respectively. All surgeries were successfully completed as planned using three standard laparoscopy trocars sized 10/12mm. Each procedure was performed with robotic assistance, and there were no conversions to open surgery. No intra-operative complications, device deficiency, or adverse events of Clavien-Dindo Grade III to V occurred. The mean skin-to-skin operative time was 55 min (±14) for unilateral hernia repair and 95 min (±22) for bilateral hernia repair. The mean robotic console time was 34 min (±12) for unilateral hernia and 68 min (±21) for bilateral hernia repairs. The patients were discharged within 1day (± 1 day) after surgery. Conclusion Our rTAPP experience with the Dexter system confirms feasibility, safety, and comparable operative times to other robotic platforms. This study demonstrates the practicality and safety of the robotic techniques, positioning the Dexter system as a valuable tool in hernia repair.

Variables that predict hospital stay and the outcome of Fournier gangrene at King Abdulaziz University Hospital: a retrospective study

BackgroundThe aggressive nature of Fournier gangrene and the associated health issues can result in a more complex clinical course and potentially a longer hospital stay. This study aimed to assess factors that affect the length of hospital stay (LHS) and its relation to the outcome of Fournier gangrene patients.MethodsA retrospective study was performed at King Abdulaziz University Hospital (KAUH), Saudi Arabia, on patients diagnosed with Fournier gangrene between 2017 and 2023. Data about length of hospital stay (LHS), age, BMI, clinical and surgical data and outcome was obtained.ResultsThe mean age of the studied patients was 59.23 ± 11.19 years, the mean body mass index (BMI) was 26.69 ± 7.99 kg/m2, and the mean duration of symptoms was 10.27 ± 9.16 days. The most common presenting symptoms were swelling or induration (64%), 88% had comorbidities with diabetes mellitus (DM) (84%), and 76% had uncontrolled DM. of patients, 24% had a poly-microbial infection, with E. coli being the most common (52%). The mean length of hospital stay (LHS) was 54.56 ± 54.57 days, and 24% of patients had an LHS of more than 50 days. Longer LHS (> 50 days) was associated with patients who did not receive a compatible initial antibiotic, whereas shorter LHS was associated with patients who received Impenem or a combination of vancomycin and meropenem as alternative antibiotics following incompatibility. Reconstruction patients had significantly longer LHS and a higher mean temperature. However, none of the studied variables were found to be predictors of long LHS in the multivariate regression analysis.ConclusionKnowledge of the values that predict LHS allows for patient-centered treatment and may be useful in predicting more radical treatments or the need for additional treatment in high-risk patients. Future multicenter prospective studies with larger sample sizes are needed to assess the needed variables and predictors of long LHS.

VALIDATION OF QUANTITATIVE FLOW RATIO DERIVED VIRTUAL ANGIOPLASTY WITH POST–ANGIOPLASTY FRACTIONAL FLOW RESERVE. THE QIMERA–I STUDY

Abstract Backgroud Quantitative flow ratio (QFR) virtual angioplasty with pre–PCI residual QFR showed better results compared with angiographic approach to assess post–PCI functional results. However correlation with pre–PCI residual QFR and post–PCI fractional flow reserve (FFR) is lacking. Methods Multicenter prospective study including consecutive patientswith angiographically 50–90% coronary lesions and positive QFR result. All patients were evaluated with QFR, hyperemic and non–hyperemic pressure ratios (NHPR) before and after the index PCI. Pre–PCI residual QFR (virtual angioplasty) was calculated and compared with post–PCI fractional flow reserve (FFR), QFR and NHPR. Results A total of 84 patients with 92 treated coronary lesions were included, with a mean age of 65.5±10.9 years and 59% of single vessel lesion being the left anterior descending artery in 69%. The mean vessel diameter was 2.82±0.41 mm. Procedural success was achieved in all cases, with a mean number of implanted stents of 1.17±0.46. Baseline QFR value was 0.69 ± 0.12 and baseline FFR and NHPR were 0.73 + 0.08 and 0.82 + 0.11, respectively. Mean post–PCI FFR increased to 0.87 ±0.05 whereas residual QFR had been estimated as 0.95 ± 0.05 showing poor correlation with post–PCI FFR (0.163; 95%CI:0.078–0.386) and a low diagnostic accuracy (30.9%, 95%CI:20–43%). Conclusions In this analysis, the results of QFR–based virtual angioplasty did not seem to accurately correlate with post–PCI FFR.

Which Surgical Technique for Liver Resection is Favourable in Patients with Colorectal Liver Metastases?

Abstract Background The liver is the most common metastatic site after curative treatment for colorectal cancer (CRC). Around 50% of all patients with CRC will develop colorectal liver metastases (CRLM). Liver resection (LR) represents a curative treatment option. Benefits of anatomic (ALR) versus non-anatomic liver resection (NALR) show a lack of consistent evidence. While ALR seems to be associated with a higher postoperative complication rate, NALR could lead to more recurrences. Aims We investigated complication and survival rates of patients with CRLM after both resection types. Methods This is a multicentre cohort study using retrospectively and prospectively collected data. All patients undergoing LR for CRLM between 2009 and 2020 from 3 specialised centres in Switzerland and Germany were included. Complication and survival rates after ALR versus NALR were analysed using uni- and multivariate Cox regression models. Results 624 patients were included. Median follow-up time was 25.49 months. In 292/624 patients (47%) ALR was performed, while 53% underwent NALR. Complications according to the Clavien-Dindo classification have been observed significantly more often in the ALR group (p=0.001). Especially severe complications grade III and IV have been more present after ALR (36/292 vs. 26/332 and 13/292 vs. 11/332, respectively). Both, length of ICU and postoperative hospital stay have been significantly longer in the ALR group (p&amp;lt;0.001 each). The uni- and multivariate models have shown no significant differences in overall survival (OS) and recurrence free survival rates (RFS) between both groups (for OS adjusted HR of 0.84 (95% CI 0.59 - 1.21; p=0.35) and for RFS adjusted HR 0.92 (95% CI 0.69 - 1.22, p=0.56)). Conclusion This multicentre prospective study investigating ALR versus NALR for CRLM has shown no significant differences in OS and RFS. However, postoperative complications have been reported significantly more often after ALR. NALR seems to be the better choice for patients with CRLM undergoing LR.

5-Aminolaevulinic acid-based photodynamic therapy for actinic keratosis in Chinese patients: A prospective multicenter study.

5-Aminolaevulinic acid-based photodynamic therapy for actinic keratosis in Chinese patients: A prospective multicenter study.