Multicenter Retrospective Observational Study Research Articles

Characteristics of Patients Experiencing a Flare of Generalized Pustular Psoriasis: A Multicenter Observational Study.

Generalized pustular psoriasis (GPP) is a rare, severe inflammatory skin disease characterized by recurrent episodes of flares. Characteristics of patients experiencing a flare are hardly described in a real-life setting. The aim of the study is to investigate the clinical characteristics of patients experiencing a flare of GPP. Multicenter retrospective observational study on consecutive patients experiencing a flare of GPP between 2018 and 2022. Disease severity and quality of life were assessed by Generalized Pustular Psoriasis Area, Body Surface Area (BSA), and Severity Index (GPPASI), and Dermatology life quality index (DLQI) questionnaire, respectively. Visual analogue scale (VAS) of itch and pain, triggers, complications, comorbidities, pharmacological therapies, and outcome were collected. A total of 66 patients, 45 (68.2%) females, mean age 58.1 ± 14.9 years, were included. The GPPASI, BSA, and DLQI were 22.9 ± 13.5 (mean ± standard deviation), 47.9 ± 29.1, and 21.0 ± 5.0, respectively. The VAS of itch and pain were 6.2 ± 3.3 and 6.2 ± 3.0, respectively. Fever (>38 °C) and leukocytosis (WBC > 12 × 109/L) were found in 26 (39.4%) and 39 (59.1%) patients, respectively. Precipitating triggers were identified in 24 (36.3%) and included infections (15.9%), drugs (10.6%), stressful life events (7.6%), and corticosteroids withdrawal (3.0%). Fourteen (21.2%) patients were hospitalized because of complications including infections in 9 (13.6%) leading to death in one case and hepatitis in 3 (4.5%). GPP flares can be severe and cause severe pain and itch with significant impact on the quality of life. In about one-third of patients the flare may have a persistent course and, with complications, lead to hospitalization.

Comparison of Clinical Outcomes in Patients Undergoing Common Femoral Thromboendarterectomy With or Without Patch Angioplasty

Surgical thrombo-endarterectomy (TEA) is the standard treatment for an occlusive lesion of the common femoral artery (CFA). However, there is limited knowledge on the need for patch angioplasty in CFA TEA. The objective of this study was to compare the peri-operative and two year results of CFA TEA with or without patch angioplasty. A multicentre retrospective observational study was performed at 34 Japanese centres. Comparisons were made between patients undergoing CFA TEA with or without patch angioplasty after propensity score matching (PSM). The primary endpoints were primary patency and freedom from target lesion revascularisation (TLR) of the TEA lesion. The secondary endpoints were hospital outcomes, limb salvage, and overall survival. Between 2018 and 2020, 428 TEA procedures (237 with patch angioplasty and 191 with primary closure) were performed. PSM extracted 151 pairs with no significant intergroup differences in baseline characteristics. Peri-operative death and complications occurred in 0.7% vs. 1.3% (p = 1.0) and 6.0% vs. 6.6% (p = 1.0), respectively. The follow up rate was 96% in a median follow up period of 14.9 months (interquartile range 8.3, 24.3). Loss of primary patency occurred in 18 patients. The two year primary patency of patch angioplasty cases was statistically significantly higher than that of primary closure cases (97.0% vs. 89.9%; p = .021). TLR was performed in 14 patients. The two year freedom from TLR in patch angioplasty cases was also statistically significantly higher than that in primary closure cases (98.6% vs. 92.9%; p = .003). During follow up, seven limbs required major amputation and 40 patients died. There was no statistically significant difference in limb salvage and survival between the two groups after PSM. This is the first report to show that patch angioplasty may decrease restenosis and target lesion revascularisation of CFA TEA lesions.

Efficacy of carbapenem vs non carbapenem β-lactam therapy as empiric antimicrobial therapy in patients with extended-spectrum β-lactamase-producing Enterobacterales urinary septic shock: a propensity-weighted multicenter cohort study

BackgroundThe rise in antimicrobial resistance is a global threat responsible for about 33,000 deaths in 2015 with a particular concern for extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-E) and has led to a major increase in the use of carbapenems, last-resort antibiotics.MethodsIn this retrospective propensity-weighted multicenter observational study conducted in 11 ICUs, the purpose was to assess the efficacy of non carbapenem regimen (piperacillin–tazobactam (PTZ) + aminoglycosides or 3rd-generation cephalosporin (3GC) + aminoglycosides) as empiric therapy in comparison with carbapenem in extended-spectrum β-lactamase-producing Enterobacterales (ESBL-E) urinary septic shock. The primary outcome was Day-30 mortality.ResultsAmong 156 patients included in this study, 69 received a carbapenem and 87 received non carbapenem antibiotics as empiric treatment. Baseline clinical characteristics were similar between the two groups. Patients who received carbapenem had similar Day-30 mortality (10/69 (15%) vs 6/87 (7%), OR = 1.99 [0.55; 5.34] p = 0.16), illness severity, resolution of septic shock, and ESBL-E infection recurrence rates than patients who received an empiric non carbapenem therapy. The rates of secondary infection with C. difficile were comparable.ConclusionsIn ESBL-E urinary septic shock, empiric treatment with a non carbapenem regimen, including systematically aminoglycosides, was not associated with higher mortality, compared to a carbapenem regimen.

Epidemiology and mortality predictors for severe childhood community-acquired pneumonia in ICUs: A retrospective observational study.

To identify the epidemiology and mortality predictors of severe childhood community-acquired pneumonia (CAP) and evaluate the influence of medications on clinical outcomes in the real world. We conducted a multicenter retrospective observational study among children aged ≤5 years with severe CAP, separately comparing the detailed information between those who experienced in-hospital death and those who survived in three different age groups. A multivariate logistic regression model was used to determine mortality predictors. A total of 945 children were recruited: 341 young children aged 2-59 months, 47 infants aged 29 days to 2 months, and 557 neonates aged less than 28 days. A total of 88 deaths occurred (9.3%). There was low adherence to antimicrobial guidelines in the group aged 2-59 months, and carbapenems widely served as initial empirical regimens. However, analysis of all three age groups showed that the efficacy of antibacterial drugs with initial empirical selection grades higher than those recommended by the guidelines was not better than that of antibacterial drugs with grades recommended by the guidelines. In multivariate analyses, very severe pneumonia (odds ratio (OR): 3.48; 95% confidence interval (CI): 1.36-8.93), lower birth weight (OR: 4.64; 95% CI: 1.78-12.20), severe underweight (OR: 6.06; 95% CI: 2.34-15.63), mechanical ventilation (OR: 2.58; 95% CI: 1.00-6.62; OR: 15.63; 95% CI 3.25-76.92), a higher number of comorbidities (OR: 8.40; 95% CI: 1.89-37.04), comorbidities including anemia (OR: 5.24; 95% CI: 2.33-11.76) and gastrointestinal hemorrhage (OR: 3.79; 95% CI: 1.36-10.53), and the use of sedative-hypnotics (OR: 2.60; 95% CI: 1.14-5.95) were independent risk factors for death; infants treated with probiotics had a lower mortality rate (OR: 0.14; 95% CI: 0.06-0.33). Severe CAP remains a primary cause of death in children under 5 years of age. Clinical characteristics, comorbidities and medications are evidently associated with death. Importantly, we should pay particular attention to the identification of mortality predictors and establish prophylactic measures to reduce mortality.

Effect of bevacizumab in advanced low grade serous ovarian cancer: Data from the MITO 22 trial

ObjectiveThe aim of the present analysis was to explore the efficacy of Bevacizumab (Bev) on survival outcome in advanced low grade serous ovarian cancer (LGSOC) both in first line and in recurrent setting. MethodsIn retrospective observational multicenter study, we described the outcome of LGSOC patients enrolled in the MITO 22 study and treated with chemotherapy (CT) with or without Bev. Patients receiving Bev in first-line or in recurrence were considered and compared with patients receiving CT alone (stage III and IV in first line; platinum based-CT in second line). Descriptive and survival analyses were performed for each group. ResultsOut of 128 patients included in MITO 22, 46 LGSOC patients receiving Bev in first line setting or at the time of first recurrence were identified. In first line, 30 patients received Bev + CT and 65 CT alone and the median PFS were 47.86 months (95% CI: 31.48 - NR) and 22.63 months (95% CI 15–39.24) (p-value 0.0392), respectively.In the recurrent setting, 16 patients who received Bev + CT were compared to 33 women treated with platinum-based CT alone. Median PFS were 37.1 months (95% CI: 13.42–40.56) and 11.22 months (95% CI: 8.26–15.63) (p-value 0.013), respectively. ConclusionsOur study suggests that Bev might be effective in LGSOC both at diagnosis and at the time of relapse. These data warrants further studies.

Emergency surgical treatment of colonic acute diverticulitis: a multicenter observational study on behalf of the Italian society of colorectal surgery (SICCR) Lombardy committee.

Colonic diverticulitis can be treated conservatively, but some cases require surgery. Patients can undergo Hartmann's procedure (H) or resection with primary anastomosis (RA), with or without diverting stoma. This multicenter observational retrospective study aims to evaluate the adherence to current guidelines by assessing the rate of RA and H in Lombardy, Italy, and to analyze differences in patients' features. This study included data collected from nine surgical units performing emergency surgery in Lombardy, in 2019 and 2021. Data for each year were retrospectively collected through a survey among Italian Society of Colorectal Surgery (SICCR) Lombardy members. Additional data were about: Hinchey's classification, laparoscopic (VLS) or converted procedures, procedures with more than two operators, procedures in which the first operator was older than 40years, night or weekend procedures, older-than-80 patients, COVID-19 positivity (just 2021). The total number of operations performed was 254, 115 RA and 130 H (45.3% and 51.2%, diff. 12%, p = 0.73), and 9 (3.5%) other procedures. RAs were more frequent for Hinchey 1 and 2 patients, whereas Hs were more frequent for Hinchey 3 and 4. RAs without ileostomy were significantly less than Hs (66 vs. 130, p = 0.04). Laparoscopy was more used for RA compared to H (57 vs. 21, p = 0.03), whereas no difference was found between RA and H with respect to conversion rate, the presence of more than two operators in the team, the presence of a first operator older than 40years, night or weekend operations, and for older-than-80 patients. This study confirms the adherence to current guidelines for the treatment of acute colonic diverticulitis in Lombardy, Italy. It can be considered as a preliminary survey with interesting results that may open the way to a further prospective observational study to clarify some aspects in the management of this disease.

Clinical outcome and safety profile of metastatic pancreatic cancer patients treated with more than six cycles of nab-paclitaxel plus gemcitabine

The phase III MPACT trial demonstrated the superiority of gemcitabine plus nab-paclitaxel (NABGEM) versus gemcitabine alone in previously untreated patients with metastatic pancreatic cancer (mPC). The aim of this study was to evaluate the responses in terms of efficacy and safety in patients treated with more than 6 cycles of chemotherapy. From January 2015 to December 2018, patients with mPC receiving first-line treatment with NABGEM were included in a multicentre retrospective observational study. Exploratory analyses of efficacy and safety were performed. The cohort included 153 patients with performance status of 1. The median overall survival and progression-free survival were 20 months (hazard ratio [HR] 0.28, 95% confidence interval [CI]: 0.17–0.44) and 10 months (HR 0.24 95% CI: 0.16–0.38) respectively, in patients who received >6 cycles compared to 9 and 5 months in those treated with ≤6 cycles (p < 0.001). The disease control rate was 100% versus 56% in patients receiving >6 and ≤6 cycles, respectively. No progression of disease was recorded in patients who received >6 cycles. Grade 1 neuropathy and grade 3 neutropenia were more frequent in patients treated with >6 cycles compared to patients receiving ≤6 cycles (p = 0.01; p = 0.03, respectively). Dose reduction was necessary for 70.1% and 53.4% of patients treated with >6 or ≤6 cycles, whereas treatment interruption occurred in 37.1% and 21.6%, respectively. Our results confirmed the efficacy and safety of NABGEM in untreated mPC. In particular, we highlighted significant clinical efficacy in patients who received >6 cycles of chemotherapy compared to those who received ≤6 cycles, with manageable toxicity profile.

Prognosis of hospitalised adult patients with respiratory syncytial virus infection: a multicentre retrospective cohort study

ObjectivesRespiratory syncytial virus (RSV) is a common agent of viral respiratory infections with significant morbidity and mortality in adults. The objective of this study was to determine risk factors for mortality and invasive mechanical ventilation and to describe the characteristics of patients who received ribavirin. MethodsA retrospective multicentre observational cohort study was conducted in Great Paris area hospitals, including patients hospitalised between 1 January 2015 and 31 December 2019 for documented RSV infection. Data were extracted from the Assistance Publique-Hôpitaux de Paris Health Data Warehouse. The primary endpoint was in-hospital mortality. ResultsOne thousand one hundred sixty-eight patients were hospitalised for RSV infection, including 288 (24.6%) patients who required intensive care unit (ICU) admission. The median (interquartile range) age of patients was 75 (63–85) years, and 54% (n = 631/1168) of them were women. In-hospital mortality was 6.6% (n = 77/1168) in the whole cohort and 12.8% (n = 37/288) in ICU patients. Factors associated with hospital mortality were age >85 years (adjusted odds ratio [aOR] = 6.29, 95% confidence interval [2.47–15.98]), acute respiratory failure (aOR = 2.83 [1.19–6.72]), non-invasive (aOR = 12.60 [1.41–112.36]), and invasive mechanical ventilation support (aOR = 30.13 [3.17–286.27]) and neutropenia (aOR = 13.19 [3.27–53.27]). Factors associated with invasive mechanical ventilation were chronic heart (aOR = 1.98 [1.20–3.26]) or respiratory failure (aOR = 2.83 [1.67–4.80]), and co-infection (aOR = 2.62 [1.60–4.30]). Patients who were treated with ribavirin were significantly younger than others (62 [55–69] vs. 75 [63–86] years; p < 0.001), more frequently males (n = 34/48 [70.8%] vs. n = 503/1120 [44.9%]; p 0.001), and almost exclusively immunocompromised (n = 46/48 [95.8%] vs. n = 299/1120 [26.7%]; p < 0.001). DiscussionThe mortality rate of patients hospitalised with RSV infections was 6.6%. Twenty-five per cent of the patients required ICU admission.

Resource utilization and preparedness within the COVID-19 pandemic in Tunisian medical intensive care units: A nationwide retrospective multicentre observational study

BackgroundThe worldwide SARS-CoV-2 pandemic represents the most recent global healthcare crisis. While all healthcare systems suffered facing the immense burden of critically-ill COVID-19 patients, the levels of preparedness and adaptability differed highly between countries. Aim: to describe resource mobilization throughout the COVID-19 waves in Tunisian University Medical Intensive Care Units (MICUs) and to identify discrepancies in preparedness between the provided and required resource. MethodsThis is a longitudinal retrospective multicentre observational study conducted between March 2020 and May 2022 analyzing data from eight University MICUs. Data were collected at baseline and at each bed expansion period in relation to the nation’s four COVID-19 waves. Data collected included epidemiological, organizational and management trends and outcomes of COVID-19 and non-COVID-19 admissions. ResultsMICU-beds increased from 66 to a maximum of 117 beds. This was possible thanks to equipping pre-existing non-functional MICU beds (n = 20) and creating surge ICU-beds in medical wards (n = 24). MICU nurses increased from 53 to 200 of which 99 non-ICU nurses, by deployment from other departments and temporary recruitment. The nurse-to-MICU-bed ratio increased from 1:1 to around 1·8:1. Only 55% of beds were single rooms, 80% were equipped with ICU ventilators. These MICUs managed to admit a total of 3368 critically-ill patients (15% of hospital admissions). 33·2% of COVID-19-related intra-hospital deaths occurred within the MICUs. ConclusionDespite a substantial increase in resource mobilization during the COVID-19 pandemic, the current study identified significant persisting discrepancies between supplied and required resource, at least partially explaining the poor overall prognosis of critically-ill COVID-19 patients.

Short-Term Effectiveness, Safety, and Potential Predictors of Response of Secukinumab in Patients with Severe Hidradenitis Suppurativa Refractory to Biologic Therapy: A Multicenter Observational Retrospective Study.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease. Biologic drugs have a key role in the long-term anti-inflammatory treatment of moderate to severe patients due to their immunomodulatory properties.The aim of this study is to evaluate the effectiveness and safety of secukinumab in patients with moderate to severe HS after 16weeks of treatment, and to explore potential predictors of clinical response to the drug. Multicenter observational retrospective study. Patients treated with secukinumab 300mg every 2 or 4weeks who had completed at least 16weeks of follow-up from nine hospitals based in southern Spain (Andalusia) were included in this study. Treatment effectiveness was assessed using the Hidradenitis Suppurativa Clinical Response (HiSCR). Information about adverse events was collected, the therapeutic burden of the patients was calculated as the summation of systemic medical treatments and surgical interventions (excluding incision and drainage) experienced until the start of secukinumab treatment. Forty-seven patients with severe HS were included for analysis. At week 16, 48.9% (23/47) of patients achieved HiSCR. Adverse events were present in 6.4% (3/47) of the patients. The multivariate analysis showed that female sex and, to a lesser extent, lower body mass index (BMI) and a lower therapeutic burden were potentially associated with a higher probability of HiSCR achievement. Favorable short-term effectiveness and safety of secukinumab in the treatment of severe HS patients were observed. Female sex, lower BMI and a lower therapeutic burden may be associated with a higher probability of achieving HiSCR.

Severe Infections in Patients Treated with Tocilizumab for Systemic Diseases Other Than Rheumatoid Arthritis: A Retrospective Multicenter Observational Study.

This study aimed to describe severe infections in patients treated with tocilizumab for systemic diseases other than rheumatoid arthritis. Data from patients receiving at least 2 doses of tocilizumab for systemic diseases other than rheumatoid arthritis between January 1, 2012, and July 1, 2020, in the region Poitou-Charentes (France) were retrospectively collected from medical records. Psoriatic arthritis and systemic juvenile idiopathic arthritis were also excluded as usually treated with similar modalities to rheumatoid arthritis. Of 37 patients, mainly suffering from giant cell arteritis, 25 patients (68%) had at least 1 infectious event and 15 severe infections occurred in 6 patients (3.2/100 patient-years), mainly bacterial. Lower respiratory tract and skin were the main sites. Severe bacterial infections were associated with a marked biological inflammatory syndrome, even under a cycle of administration of tocilizumab. Two severe zonas and 1 severe diverticulitis occurred. No tuberculosis or viral hepatitis reactivation was observed. The incidence rate of severe infections was 3.2/100 patient-years and seems lower than that reported in rheumatoid arthritis. C-reactive protein dosage could be helpful for the diagnosis of bacterial infectious adverse events in patients on tocilizumab. Further larger studies are needed to confirm these results to assess potential risk factors for severe infections.

The clinical features, management and outcomes of lymphoma in pregnancy: A multicentre study by the Australasian Lymphoma Alliance.

Lymphoma in pregnancy (LIP) presents unique clinical, social and ethical challenges; however, the evidence regarding this clinical scenario is limited. We conducted a multicentre retrospective observational study reporting on the features, management, and outcomes of LIP in patients diagnosed between January 2009 and December 2020 at 16 sites in Australia and New Zealand for the first time. We included diagnoses occurring either during pregnancy or within the first 12 months following delivery. A total of 73 patients were included, 41 diagnosed antenatally (AN cohort) and 32 postnatally (PN cohort). The most common diagnoses were Hodgkin lymphoma (HL; 40 patients), diffuse large B-cell lymphoma (DLBCL; 11) and primary mediastinal B-cell lymphoma (PMBCL; six). At a median follow up of 2.37 years, the 2- and 5-year overall survival (OS) for patients with HL were 91% and 82%. For the combined DLBCL and PMBCL group, the 2-year OS was 92%. Standard curative chemotherapy regimens were successfully delivered to 64% of women in the AN cohort; however, counselling regarding future fertility and termination of pregnancy were suboptimal, and a standardised approach to staging lacking. Neonatal outcomes were generally favourable. We present a large multicentre cohort of LIP reflecting contemporary practice and identify areas in need of ongoing research.

The impact of COVID-19 pandemic on breast surgery in Italy: a multi-centric retrospective observational study

COVID-19 pandemic had an impact on surgical activities. The aim of this multi-centric, retrospective study was to evaluate the impact of the COVID-19 pandemic on breast surgery. The patients who operated during the pre-pandemic year 2019 were compared to those operated in 2020. Fourteen Breast Care Units provided data on breast surgical procedures performed in 2020 and 2019: total number of breast-conserving surgery (BCS), number of 1st level oncoplastic breast surgery (OBS), number of 2nd level OBS; total number of mastectomies, mastectomies without reconstruction, mastectomies with a tissue expander, mastectomies with direct to implant (DTI) reconstruction, mastectomies with immediate flap reconstruction; total number of delayed reconstructions, number of expanders to implant reconstructions, number of delayed flap reconstructions. Overall 20.684 patients were included: 10.850 (52.5%) operated during 2019, and 9.834 (47.5%) during 2020. The overall number of breast oncologic surgical procedures in all centers in 2020 was 8.509, compared to 9.383 in 2019 (− 9%). BCS decreased by 744 cases (− 13%), the overall number of mastectomies decreased by 130 cases (− 3.5%); mastectomy-BCS ratio was 39–61% in 2019, and 42–58% in 2020. Regarding immediate reconstructive procedures mastectomies with DTI reconstruction increased by 166 cases (+ 15%) and mastectomies with immediate expander reconstruction decreased by 297 cases (− 20%). Breast-delayed reconstructive procedures in all centers in 2020 were 142 less than in 2019 (− 10%). The outburst of the COVID-19 pandemic in 2020 determined an implemented number of mastectomies compared to BCS, an implemented number of immediate breast reconstructions, mainly DTI, and a reduction of expander reconstruction.

Sex, age, role and geographic differences in traumatic spinal fractures caused by motor vehicle collisions: a multicentre retrospective study

To investigate the sex, age, role and geographic differences in traumatic spinal fractures (TSFs) caused by motor vehicle collisions (MVCs) in adults (≥ 18 years old). This was a multicentre retrospective observational study. In total, 798 patients with TSFs caused by MVCs admitted to our hospitals from January 2013 to December 2019 were enrolled. The patterns were summarized with respect to different sexes (male and female), age group (18–60 and ≥ 60), role (driver, passenger and pedestrian) and geographic location (Chongqing and Shenyang). Significant differences in distribution related to district (p = 0.018), role (p < 0.01), motorcycle (p = 0.011), battery electric vehicle (p = 0.045), bicycle (p = 0.027), coma after injury (p = 0.002), pelvic fracture (p = 0.021), craniocerebral injury (p = 0.008) and fracture location (p < 0.01) were observed between the male and female groups. Significant differences in distribution related to district (p < 0.01), role (p < 0.01), car (p = 0.013), coma after injury (p = 0.003), lower limb fracture (p = 0.016), fracture location (p = 0.001) and spinal cord injury (p < 0.01) were observed between the young adult and elderly groups. Significant differences in distribution related to sex ratio (p < 0.01), age (p < 0.01), district (p < 0.01), most vehicles involved (P < 0.01), lower limb fracture (p < 0.01), pelvic fracture (p < 0.01), fracture location (p < 0.01), complications (p < 0.01), and spinal cord injury (p < 0.01) were observed between the three different groups of pedestrian, passenger, and driver. Significant differences in distribution related to sex ratio (p = 0.018), age (p < 0.01), role (p < 0.01), most vehicles involved (p < 0.01), coma after injury (p = 0.030), LLF (P = 0.002), pelvic fracture (p < 0.01), craniocerebral injury (p = 0.011), intrathoracic injury (p < 0.01), intra-abdominal injury (p < 0.01), complications (p = 0.033) and spinal cord injury (p < 0.01) were observed between the Chongqing and Shenyang groups. This study demonstrates the age-, gender-, role- and geographic-specific clinical characteristics of TSFs resulting from MVCs and reveals a significant relationship between different ages, sexes, roles, geographic locations and associated injuries, complications and spinal cord injuries.

Minimal is not minor also in patients with mild traumatic brain injury on oral direct anticoagulant therapy.

Currently, all patients, regardless of the type of head injury, should undergo a head computerized tomography (CT) if on oral anticoagulant therapy. The aim of the study was to assess the different incidences of intracranial hemorrhage (ICH) between patients with minor head injury (mHI) and patients with mild traumatic brain injury (MTBI) and whether there were differences in the risk of death at 30days as a result of trauma or neurosurgery. A retrospective multicenter observational study was conducted from January 1, 2016, to February 1, 2020. All patients on DOACs therapy who suffered head trauma and underwent a head CT were extracted from the computerized databases. Patients were divided into two groups MTBI vs mHI all in DOACs treatment. Whether a difference in the incidence of post-traumatic ICH was present was investigated, and pre- and post-traumatic risk factors were compared between the two groups to assess the possible association with ICH risk by propensity score matching. 1425 with an MTBI in DOACs were enrolled. Of these, 80.1% (1141/1425) had an mHI and 19.9% (284/1425) had an MTBI. Of these, 16.5% (47/284) patients with MTBI and 3.3% (38/1141) with mHI reported post-traumatic ICH. After propensity score matching, ICH was consistently found to be more associated with patients with MTBI than with mHI (12.5% vs 5.4%, p = 0.027). Risk factors associated with immediate ICH in mHI patients were high energy impact, previous neurosurgery, trauma above the clavicles, post-traumatic vomiting and headache. Patients on MTBI (5.4%) were found to be more associated with ICH than those with mHI (0.0%, p = 0.002). also when the need for neurosurgery or death within 30days were considered. Patients on DOACs with mHI have a lower risk of presenting with post-traumatic ICH than patients with MTBI. Furthermore, patients with mHI have a lower risk of death or neurosurgery than patients with MTBI, despite the presence of ICH.

The international experience of in-situ recovery of the DCD heart: a multicentre retrospective observational study

Heart transplantation is an effective treatment offering the best recovery in both quality and quantity of life in those affected by refractory, severe heart failure. However, transplantation is limited by donor organ availability. The reintroduction of heart donation after the circulatory determination of death (DCD) in 2014 offered an uplift in transplant activity by 30%. Thoraco-abdominal normothermic regional perfusion (taNRP) enables in-situ reperfusion of the DCD heart. The objective of this paper is to assess the clinical outcomes of DCD donor hearts recovered and transplanted from donors undergoing taNRP. This was a multicentre retrospective observational study. Outcomes included functional warm ischaemic time, use of mechanical support immediately following transplantation, perioperative and long-term actuarial survival and incidence of acute rejection requiring treatment. 157 taNRP DCD heart transplants, performed between February 2, 2015, and July 29, 2022, have been included from 15 major transplant centres worldwide including the UK, Spain, the USA and Belgium. 673 donations after the neurological determination of death (DBD) heart transplantations from the same centres were used as a comparison group for survival. taNRP resulted in a 23% increase in heart transplantation activity. Survival was similar in the taNRP group when compared to DBD. 30-day survival was 96.8% ([92.5%-98.6%] 95% CI, n=156), 1-year survival was 93.2% ([87.7%-96.3%] 95% CI, n=72) and 5-year survival was 84.3% ([69.6%-92.2%] 95% CI, n=13). Our study suggests that taNRP provides a significant boost to heart transplantation activity. The survival rates of taNRP are comparable to those obtained for DBD transplantation in this study. The similar survival may in part be related to a short warm ischaemic time or through a possible selection bias of younger donors, this being an uncontrolled observational study. Therefore, our study suggests that taNRP offers an effective method of organ preservation and procurement. This early success of the technique warrants further investigation and use. None of the authors have a financial relationship with a commercial entity that has an interest in the subject.

Prognostic Significance of Enlarged Lymph Nodes in Stage II Colorectal Cancer.

Many studies have reported a correlation between lymph node metastasis and prognosis in patients with colorectal cancer. However, the clinical significance of enlarged lymph nodes for prognosis has scarcely been explored. This study aimed to assess the clinical significance of enlarged lymph nodes in stage II colorectal cancer. This is a multicenter retrospective observational study with a median follow-up period of 66.8 months. Patients' medical records were retrospectively collected from the Japanese Study Group for Postoperative Follow-up of Colorectal Cancer database. This study included 2212 patients with stage II colorectal cancer who underwent surgical resection between January 2009 and December 2012. Patients were classified into the enlarged lymph node and nonenlarged lymph node groups and their data were compared. Clinicopathological characteristics and prognoses of the 2 groups were compared. The main outcomes measured were recurrence-free survival and overall survival. The enlarged lymph node group showed significantly better overall survival and recurrence-free survival in pT4b cases but not in pT3 or pT4a cases. In pT4b cases, an enlarged lymph node (HR, 0.53; 95% CI, 0.29-0.98) was an independent prognostic factor for longer recurrence-free survival, whereas a rectal lesion (HR, 3.46; 95% CI, 1.90-6.29) was an independent prognostic factor for shorter recurrence-free survival. An enlarged lymph node was associated with a lower distant recurrence rate (HR, 0.49; 95% CI, 0.26-0.92) and a tendency to correlate with better overall survival (HR, 0.50; 95% CI, 0.22-1.14). The retrospective design may have increased the risk of selection bias. Inadequate information regarding enlarged lymph nodes is another study limitation. This study showed that enlarged lymph nodes are associated with a favorable prognosis in patients with pT4b stage II colorectal cancer. See Video Abstract at http://links.lww.com/DCR/C246 . ANTECEDENTES:Muchos estudios han informado una correlación entre la metástasis en los ganglios linfáticos y el pronóstico en pacientes con cáncer colorrectal. Sin embargo, apenas se ha explorado la importancia clínica de los ganglios linfáticos agrandados para el pronóstico.OBJETIVO:El objetivo fue evaluar la importancia clínica de los ganglios linfáticos agrandados en el cáncer colorrectal en estadio II.DISEÑO:Este es un estudio observacional retrospectivo multicéntrico con una mediana de seguimiento de 66,8 meses.CONFIGURACIÓN:Los registros médicos de los pacientes se recopilaron retrospectivamente de la base de datos del Grupo de estudio japonés para el seguimiento posoperatorio del cáncer colorrectal.PACIENTES:Incluimos 2212 pacientes con cáncer colorrectal en estadio II que se sometieron a resección quirúrgica entre enero de 2009 y diciembre de 2012. Los pacientes se clasificaron en grupos de ganglios linfáticos agrandados y no agrandados y se compararon sus datos.PRINCIPALES MEDIDAS DE RESULTADO:Se compararon las características clinicopatológicas y los pronósticos de los dos grupos. Los principales resultados medidos fueron la supervivencia sin recurrencia y la supervivencia general.RESULTADOS:El grupo de ganglios linfáticos agrandados mostró una supervivencia general significativamente mejor y una supervivencia libre de recurrencia en los casos pT4b, pero no en los casos pT3 ni pT4a. En los casos de pT4b, el agrandamiento de los ganglios linfáticos (CRI, 0,53; IC 95 %, 0,29-0,98) fue un factor pronóstico independiente para una supervivencia sin recidiva más prolongada, mientras que la lesión rectal (CRI, 3,46; IC 95%, 1,90-6,29) fue un factor pronóstico independiente para RFS más cortos. Los ganglios linfáticos agrandados se relacionaron con una tasa más baja de recurrencia a distancia (CRI, 0,49; IC 95%, 0,26-0,92) y una tendencia a correlacionarse con una mejor supervivencia general (CRI, 0,50; IC 95%, 0,22-1,14).LIMITACIONES:El diseño retrospectivo puede haber aumentado el riesgo de sesgo de selección. La información inadecuada sobre el agrandamiento de los ganglios linfáticos es otra limitación del estudio.CONCLUSIONES:Este estudio mostró que los ganglios linfáticos agrandados están asociados con un pronóstico favorable en pacientes con cáncer colorrectal pT4b en estadio II. Consulte Video Resumen en http://links.lww.com/DCR/C246 . ( Traducción - Dr. Mauricio Santamaria ).

Outcomes of Pregnancy in Egyptian Women with Multiple Sclerosis in the New Treatment Era: A Multi-Center Retrospective Observational Study.

Outcomes of Pregnancy in Egyptian Women with Multiple Sclerosis in the New Treatment Era: A Multi-Center Retrospective Observational Study.

Aspects of vertebral column resection in patients with rigid kyphotic and kyphoscoliotic deformities of different genesis of the thoracolumbar spine: multicenter retrospective observational cohort study

BACKGROUND: Vertebral column resection (VCR) as a type of spinal osteotomy is characterized by maximum possibilities of three-dimensional correction of various etiologies: congenital, post-tuberculous, iatrogenic (after other interventions on the spine), degenerative, and vertebral spondyloptosis caused by Kmmels disease, and primary, and metastatic tumor lesions of the spine. Nowadays, the use of single-level VCR is far beyond its initial purpose.&#x0D; OBJECTIVE: The study aimed to compare features of VCR for rigid deformities of various etiologies and management of erythrocyte blood products in the perioperative period.&#x0D; MATERIALS AND METHODS: A multicenter retrospective observational cohort study analyzed data from 53 adult (aged 18 years) patients with kyphotic and kyphoscoliotic deformities of the thoracic and lumbar spine, distributed into four comparison groups according to the deformity genesis, namely, impaired spinal development, traumatic genesis, degenerative or idiopathic, and neoplasms of the vertebral bodies. The characteristics of VCR in these patients were compared.&#x0D; RESULTS: The surgery duration was longer in VCR for spinal neoplasms (p 0.05) than for high-energy burst compression fractures of vertebral bodies and scoliotic deformities (grade IV). On average, this group also had the most cranial osteotomy level among the study groups. VCR for idiopathic scoliotic deformities is characterized by a larger intraoperative blood loss volume than other nosologies, and the differences were statistically significant. In male patients of this group, the hemoglobin level on day 1 after surgery was statistically significantly lower than in those who underwent VCR for compression fractures of the vertebral bodies or impaired vertebral development. During resection of the vertebral column for burst compression fractures of the vertebral bodies, the fixation length was less (p 0.05), with a similar intervention for developmental anomalies, deformities of postoperative genesis, and grade IV idiopathic scoliosis. VCR for grade IV idiopathic scoliosis requires a larger (p 0.05) volume of the reinfused autologous blood than for intervention for acute traumatic pathologies (burst compression fractures of the vertebral bodies).&#x0D; CONCLUSION: The versatility of clinical tasks for which resection of the spinal column can be performed using the VCR technique also determines the significant heterogeneity of the patients who undergo such treatment. Knowledge of the interventions in various nosologies is very useful in vertebrological practice.

Benralizumab Efficacy in Late Non-Responders to Mepolizumab and Variables Associated with Occurrence of Switching: A Real-Word Perspective.

Overlapping eligibility to different biologics for severe asthma is still challenging, especially when addressing the same target. We aimed to characterize severe eosinophilic asthma patients according to their maintained or reduced response to mepolizumab over time and to explore baseline variables significantly associated with the occurrence of switching to benralizumab. We performed a multicentre retrospective observational study evaluating OCS reduction, exacerbation rate, lung function, exhaled nitric oxide levels (FeNO), Asthma control test (ACT), and blood eosinophil concentrations at baseline and before and after switching occurrence among 43 female and 25 male patients with severe asthma aged 23 to 84 years. Younger age, higher OCS daily dose and lower blood eosinophils at baseline were associated with a significantly higher risk (odds) for switching occurrence. All the patients showed an optimal response to mepolizumab, up to six months. The need for switching, according to the above-mentioned criterion, occurred for 30 out of 68 patients after a median time of 21 months (Q1-Q3: 12-24) from mepolizumab initiation. At the follow-up time-point after the switch (median time: 31 months, Q-Q3: 22-35), all the outcomes substantially improved and no cases of poor clinical response to benralizumab were detected. Although the small sample size and the retrospective design represent major limitations, to our knowledge, our study provides the first real-word focus on clinical variables potentially predicting a better response to anti IL-5r in patients fully eligible for both mepolizumab and benralizumab and suggests that in late non responder patients to mepolizumab, more robustly targeting the IL-5 axis may be effective.