Differences In Infectious Complications Research Articles

Frequency of infections during rituximab treatment of autoimmune blistering diseases.

This study investigates the frequency of infections in autoimmune blistering disease (AIBD) patients treated with rituximab and evaluates the difference in infectious complications in patients on concomitant antibiotic and/or antiviral prophylaxis. The study retrospectively reviewed 43 AIBD patients who received rituximab over a five-year interval. The patients were categorized based on prophylaxis type (antibiotic, antiviral, or both) and concomitant immunosuppression status, which we defined as treatment with an immunosuppressive medication during the time frame they were given Rituximab. Our findings suggest that concomitant immunosuppression alongside rituximab did not significantly increase the risk of developing infectious complications compared to rituximab monotherapy. Results revealed that 34.4% of patients with concomitant immunosuppression had a secondary bacterial infection, defined as bacterial complications requiring hospitalization, consistent with prior studies. Moreover, antibiotic prophylaxis did not significantly reduce infection risk in patients on rituximab, with 45.1% of these patients experiencing bacterial complications. There was an absence of pneumocystis pneumonia in the study population. Despite the small sample size and limited timeline, this study suggests that antibiotic prophylaxis may not significantly mitigate the risk of infections in AIBD patients receiving rituximab, and the risk of infection with concomitant immunosuppression with rituximab requires additional investigation for definitive causal risk.

Whole Blood Resuscitation for Injured Patients Requiring Transfusion: A Systematic Review, Meta-Analysis, and Practice Management Guideline from the Eastern Association for the Surgery of Trauma.

Whole blood resuscitation has reemerged as a resuscitation strategy for injured patients. However, the effect of whole blood-based resuscitation on outcomes has not been established. The primary objective of this guideline was to develop evidence-based recommendations on whether whole blood should be considered in civilian trauma patients receiving blood transfusions. An EAST working group performed a systematic review and meta-analysis utilizing the GRADE methodology. One PICO question was developed to analyze the effect of whole blood resuscitation in the acute phase on mortality, transfusion requirements, infectious complications, and ICU length of stay. English language studies including adult civilian trauma patients comparing in-hospital whole blood to component therapy were included. Medline, Embase, Cochrane CENTRAL, CINAHL Plus, and Web of Science were queried. GRADEpro was used to assess quality of evidence and risk of bias. The study was registered on PROSPERO (#CRD42023451143). A total of 21 studies were included. Most patients were severely injured and required blood transfusion, massive transfusion protocol activation, and/or a hemorrhage control procedure in the early phase of resuscitation. Mortality was assessed separately at the following intervals: early (i.e., ED, 3-, or 6-hour), 24-hour, late (i.e., 28- or 30-day), and in-hospital. On meta-analysis, whole blood was not associated with decreased mortality. Whole blood was associated with decreased 4-hour RBC (mean difference -1.82, 95% CI -3.12 to -0.52), 4-hour plasma (mean difference -1.47, 95% CI -2.94 to 0), and 24-hour RBC transfusions (mean difference -1.22, 95% CI -2.24 to -0.19) compared to component therapy. There were no differences in infectious complications or ICU length of stay between groups. We conditionally recommend WB resuscitation in adult civilian trauma patients receiving blood transfusions, recognizing that data are limited for certain populations, including women of childbearing age, and therefore this guideline may not apply to these populations. Level III, Guidelines.

Postoperative Proton Pump Inhibitors are associated with a significantly higher rate of delayed gastric emptying after pancreatoduodenectomy

BackgroundProton pump inhibitors (PPIs) are effective in reducing marginal ulcers after pancreatoduodenectomy. However, their impact on perioperative complications has not been defined. MethodsWe retrospectively analyzed the effect of postoperative PPIs on 90-day perioperative outcomes in all patients who underwent pancreatoduodenectomy at our institution from April 2017 to December 2020. Results284 patients were included; 206 (72.5%) received perioperative PPIs, 78 (27.5%) did not. The two cohorts were similar in demographics and operative variables. Postoperatively, the PPI cohort had significantly higher rates of overall complications (74.3% vs. 53.8%) and delayed gastric emptying (28.6% vs. 11.5%), p < 0.05. However, no differences in infectious complications, postoperative pancreatic fistula, or anastomotic leaks were seen. On multivariate analysis, PPI was independently associated with a higher risk of overall complications (OR 2.46, CI 1.33–4.54) and delayed gastric emptying (OR 2.73, CI 1.26–5.91), p = 0.011. Four patients developed marginal ulcers within 90-days postoperatively; all were in the group who received PPIs. ConclusionPostoperative proton pump inhibitor use was associated with a significantly higher rate of overall complications and delayed gastric emptying after pancreatoduodenectomy.

Systematic Review and Meta-Analysis: Association between Preoperative Ustekinumab and Surgical Complications in Crohn’s Disease Patients

Introduction: The impact of ustekinumab (UST) therapy on surgical complications in patients with Crohn’s disease (CD) remains controversial. The aim of this meta-analysis is to explore the link between these two. Methods: Databases (PubMed, Web of Science, Cochrane, and Springer Link) were searched until April 2022. Studies of CD patients who received UST and no UST prior to surgery (including no biological therapy, anti-tumor necrosis factor-α [anti-TNF-α] agent, and vedolizumab [VDZ]) were included. Primary outcomes included overall complications, infectious complications, and noninfectious complications. Results: Nine studies totaling 3,225 CD patients were enrolled; 332 patients received UST treatment. There was no evidence of difference in the overall complications (odds ratio [OR] = 0.84, p = 0.37, 95% confidence interval [CI] = [0.57–1.23], I² = 40%) between CD patients who had UST treatment preoperatively and those who had no UST treatment. There was no evidence of a difference in infectious complications (OR = 1.15, p = 0.35, 95% CI = [0.86–1.53], I² = 2%). Additionally, there was no significant evidence of difference between these groups in terms of noninfectious complications and death. Specifically, there was no evidence of difference in overall complications, infection complications (including wound complications, sepsis, abscess, and anastomotic leakage), and noninfection complications (ileus, readmission, and return to operation), compared with no biological therapy and anti-TNF-α agents. At the same time, no significant evidence of difference was discovered in the comparison of preoperative UST and VDZ therapy in terms of overall complications, infectious complications (sepsis and abscess), and noninfectious complications (intestinal obstruction, readmission, and recovery surgery). Conclusion: In general, compared with other biological agents, preoperative use of UST in the treatment of CD patients is usually safe and does not increase surgical complications.

Corporotomy localization in inflatable penile implant surgery: learning curve and comparing different surgical approaches in high volume surgeons

Inflatable penile prostheses (IPP) is a viable solution for patients with erectile dysfunction unresponsive to or with contraindications for conservative treatment. In contrast to rapporting of IPP design and material modifications, no data exist regarding the effect of different surgical approaches during IPP implantation on the corporotomy site. The purpose of the present multi-center study was to investigate different IPP implantation surgical approaches and their influence the corporotomy site, while the effect of learning curve on the corporotomy site was also evaluated. Data was collected from 6 high-volume IPP surgeons. Surgical notes were searched for incision site, proximal and distal corporal length measurement, total length measurement, total cylinder length, length of rear tip extenders (RTE), surgery time, type of implant and reservoir placement while postoperative complications were also reported. The association between proximal/distal corporal length, the recorded covariates and infectious complications were examined. 1757 patients with virgin 3-piece IPP implantation were included in the analysis. The proximal/distal ratio averaged at 0.829 (SD ±0.293) in penoscrotal incisions (N=782), 0.687 (SD± 0.245) in infrapubic (N=1664) and 0.724 (SD± 0.179) in subcoronary (N=972) incisions. No significant differences where observed in the three highest volume surgeons. Correcting for significant covariates (diabetes mellitus, RTE, age) did not change this outcome. In the three highest volume surgeons, a more proximal incision resulted in significantly less RTE use. There was no difference in infectious complications with different surgical techniques (p = 0.280). Focusing on the data of the principal center, we found a decrease in the proximal/distal ratio of 8.41% per additional year of experience. We were unable to draw a firm conclusion about the difference in corporotomy site between different surgical approaches as such, but we found no significant difference between the highest volume surgeons using different techniques. Nevertheless, a significant effect of experience on the proximalization of the corporotomy was reported. none

Incidence, Risk Factors and Outcomes of Pancytopenia Following Chimeric Antigen Receptor (CAR)-T Cell Therapy in Relapsed Refractory Diffuse Large B Cell Lymphoma

Introduction: CD19 directed CAR-T cell therapy has changed treatment paradigm of relapse refractory diffuse large B cell lymphoma (DLBCL). It is associated with certain unique toxicities including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), B-cell aplasia and hypogammaglobulinemia. However, the information on hematologic toxicity including neutropenia, thrombocytopenia and anemia is limited.Methods: We retrospectively evaluated patients who received CAR-T cell therapy for relapsed refractory DLBCL to estimate incidence, risk factors and outcomes of hematological toxicity especially pancytopenia. We also evaluated the impact of prophylactic G-CSF administration on incidence and duration of neutropenia, and infectious complications.Results: Between April 2018 and December 2020, 30 adult patients received CAR-T cell therapy (AxiCel=22, TisaCel=8). Median age of the population was 57 years (range, 23-81). Median time from diagnosis to CAR-T cell therapy was 674 days. Four patients each had double expressor and double hit subtypes. Seventy percent patients had extra-nodal disease, 60% of patients received three or more lines of therapy, 27% of patients received prior autologous stem cell transplant (autoSCT), and 23% patients received bridging therapy. All patients received Fludarabine and Cyclophosphamide (Flu/Cy) as a lymphodepleting therapy. CRS and ICANS were noted in 83% and 37% patients, respectively. One-year progression-free and overall survival were 49.76% and 85.91%, respectively.After CAR-T cell therapy, 93% (28/30) patients developed neutropenia with 17 (57%) experiencing absolute neutrophil count (ANC) <100/mm3, 9 (30%) developing ANC 100-500/mm3, and two (7%) with ANC 500-1000/mm3. Median ANC nadir was zero (range, 0-2800/mm3). The median time to ANC <1500/mm3, ANC <1000/mm3, ANC <500/mm3 and ANC <100/mm3 was 1 day, 2 days, 4 days, and 7 days post-CAR-T cell therapy, respectively. At day+30, the cumulative incidences of ANC <1500/mm3, ANC <500/mm3, ANC <100/mm3 were 93.3%, 90%, and 56.7%, respectively. The median duration of ANC <1500/mm3, ANC <500/mm3, and ANC <100/mm3 was 24 days, 6 days, and 3 days, respectively. At day +30, 3.7% of patients had persistent neutropenia with ANC <500/mm3, whereas 23.21% of patients experienced mild neutropenia (ANC <1500/mm3) at day +80 following CAR-T cell therapy. Nineteen patients received prophylactic G-CSF and 11 patients did not. No difference in infectious complications, and ICU admission was noted between both groups.Following CAR-T cell therapy, 86% (26/30) patients developed thrombocytopenia with two (7%) experiencing platelets <10,000/µL, 12 (40%) developing platelets 10,000-50,000/µL, and 12 (40%) with platelets 50,000-150,000/µL. Median platelet nadir was 57,000/µL (range, 2000-194,000). The median time to platelets <150,000/µL, <50,000/µL, and <10,000/µL was 1 day, 6 days, and 20 days post-CAR-T cell therapy, respectively. At day+30, the cumulative incidences of platelets <150,000/µL, platelets <50,000/µL, and platelets <10,000/µL were 83.3%, 40%, and 6.67%, respectively. The median duration of platelets <50,000/µL was 28.5 days and <150,000/µL was 192 days. At day +30, 50% of patients had persistent thrombocytopenia with platelets <50,000/µL, and 80.77% of patients had thrombocytopenia with platelets <150,000/µL. Sixty-one percent patients still experienced platelets <150,000/µL at day +80 following CAR-T cell therapy.Univariable analyses revealed that high dose of CAR-T cell was associated with decreased incidence of neutropenia (HR, 0.63; p=0.02), while absence of extra-nodal disease was associated with increased incidence of neutropenia (HR, 3.19; p=0.02). Moreover, patients with prior autoSCT had a lower likelihood of resolution of neutropenia (HR, 0.33; p=0.03), and those with multiple prior therapies had a lower likelihood of resolution of thrombocytopenia (HR, 0.36; p=0.002).Conclusion: Our study shows that a proportion of patients experienced prolonged hematological toxicity, and prior autoSCT and multiple lines of therapy were identified as risk factors. Prophylactic G-CSF did not appear to have any benefit on the prevention of neutropenia or infectious complications. [Display omitted] DisclosuresDeol: Kite, a Gilead Company: Consultancy. Modi: Genentech: Research Funding; Seagen: Membership on an entity's Board of Directors or advisory committees; MorphoSys: Membership on an entity's Board of Directors or advisory committees.

Early supplemental parenteral nutrition is associated with reduced mortality in critically ill surgical patients with high nutritional risk

Adequate nutritional provision is important for critically ill patients to improve clinical outcomes. Starting enteral nutrition (EN) as early as possible is recommended and preferred to parenteral nutrition (PN). However, patients who undergo emergency abdominal operations may have alterations in their intra-abdominal environment and gastrointestinal motility leading to limitation in starting an enteral diet. Therefore, our study was designed to evaluate the benefit of early supplemental PN to achieve adequate calorie and protein supply in critically ill patients undergoing surgery who are not eligible for early EN. We reviewed the medical records of 317 patients who underwent emergency abdominal surgery for complicated intra-abdominal infection (cIAI) between January 2013 and December 2018. The nutritional data of the patients were collected for 7 days in maximum, starting on the day of intensive care unit (ICU) admission. The patients were divided by low or high malnutrition risk using the modified Nutrition Risk in Critically ill (mNUTRIC) score and body mass index. The low- and high-risk groups were subdivided into the following two categories: those who received PN within 48h ("early") and those who did not ("usual"). Data regarding the baseline characteristics, initial severity of illness, morbidity, and mortality rates were also obtained. The average calorie and protein supply per day were calculated in these groups. Patients in all groups showed no significant differences in baseline characteristics, initial status, and infectious complications. In terms of outcomes, patients with low malnutrition risk had no significant difference in mortality. However, among patients with high malnutrition risk, the "Early" group had lower rates of 30-day mortality (7.6% vs. 26.7%, p=0.006) and in-hospital mortality (13.6% vs. 28.9%, p=0.048) than those of the "Usual" group. Kaplan-Meier survival curves for 30-day mortality in these groups also showed a statistically significant difference (p=0.001). The caloric adequacy of the "Early" group and the "Usual" group were 0.88±0.34 and 0.6±0.29, respectively. Amounts of protein received were 0.94±0.39g/kg in the "Early" group and 0.47±0.34g/kg in the "Usual" group, respectively. There was no significant difference in infectious complications between both groups. Mortality in patients with high malnutrition risk who received early PN supply within 48h after emergency surgery for cIAI was lower than those who did not receive PN earlier. PN may be necessary to fulfill the caloric and protein requirements for critically ill patients who cannot achieve their nutritional requirements to the fullest with EN alone.

Preventing Prostate Biopsy Complications: to Augment or to Swab?

ObjectiveTo use data from a large, prospectively- acquired regional collaborative database to compare the risk of infectious complications associated with three American Urologic Association- recommended antibiotic prophylaxis pathways, including culture-directed or augmented antibiotics, following prostate biopsy. MethodsData on prostate biopsies and outcomes were collected from the Pennsylvania Urologic Regional Collaborative, a regional quality collaborative working to improve the diagnosis and treatment of prostate cancer. Patients were categorized as receiving one of three prophylaxis pathways: culture-directed, augmented, or provider-discretion. Infectious complications included fever, urinary tract infections or sepsis within one month of biopsy. Odds ratios of infectious complication by pathway were determined, and univariate and multivariate analyses of patient and biopsy characteristics were performed. Results11,940 biopsies were included, 120 of which resulted in infectious outcomes. Of the total biopsies, 3246 used “culture-directed”, 1446 used “augmented” and 7207 used “provider-discretion” prophylaxis. Compared to provider-discretion, the culture-directed pathway had 84% less chance of any infectious outcome (OR= 0.159, 95% CI = [0.074, 0.344], P < 0.001). There was no difference in infectious complications between augmented and provider-discretion pathways. ConclusionsThe culture-directed pathway for transrectal prostate biopsy resulted in significantly fewer infectious complications compared to other prophylaxis strategies. Tailoring antibiotics addresses antibiotic-resistant bacteria and reduces future risk of resistance. These findings make a strong case for incorporating culture-directed antibiotic prophylaxis into clinical practice guidelines to reduce infection following prostate biopsies.

Systematic Review and Meta-Analysis: Preoperative Vedolizumab and Postoperative Complications in Patients with IBD.

The effect of vedolizumab on postoperative outcomes in patients with inflammatory bowel disease (IBD) remains unclear. We aimed to determine the relation between preoperative vedolizumab and early postoperative complications in patients with IBD undergoing abdominal surgery. A search of databases and abstracts from gastroenterology conferences was performed. Primary outcomes included overall and infectious postoperative complication rates as well as surgical site infections. Studies that compared Crohn disease, ulcerative colitis, or patients with IBD-undefined with preoperative vedolizumab treatment undergoing abdominal surgery with controls with preoperative antitumor necrosis factor-α (anti-TNF-α) treatment or no preoperative biologic treatment were included. A meta-analysis was completed using the Mantel-Haenszel and DerSimonian and Laird models. Six studies totaling 1201 patients were included; 281 patients were treated preoperatively with vedolizumab, 327 patients were treated preoperatively with anti-TNF-α agents, and 593 patients were not treated preoperatively with any biologics. There was no significant difference in overall complications (odds ratio [OR] 1.04, 95% confidence interval [CI] 0.48-2.24, P = 0.92, I2 =77%) between the vedolizumab and no-biologic groups. There also was no significant difference in infectious complications (OR 1.00, 95% CI 0.37-2.69, P = 1.00, I2 = 78%), which persisted after sensitivity analysis (OR 0.71, 95% CI 0.31-1.60, P = 0.41, I2 = 46%). Furthermore, there was no significant difference in overall complications (OR 0.77, 95% CI 0.24-2.46, P = 0.66, I2 = 85%) and infectious complications (OR 0.89, 95% CI 0.20-3.94, P = 0.87, I2 = 86%) between the vedolizumab and anti-TNF-α groups. After sensitivity analysis, differences in overall and infectious complications remained insignificant (OR 0.54 and 0.50, 95% CI 0.24-1.17 and 0.22-1.15, P = 0.12 and 0.10, I2 = 39% and 18%, respectively). Vedolizumab was also not associated with a significant increase in surgical site infections compared with the no-biologic (OR 1.45, 95% CI 0.33-6.32, P = 0.62, I2 = 75%) and anti-TNF (OR 1.30, 95% CI 0.22-7.60, P = 0.77, I2 = 81%) groups. Preoperative treatment with vedolizumab in patients with IBD undergoing abdominal surgery is not associated with increases in overall or infectious postoperative complications compared with preoperative anti-TNF-α treatment and no preoperative biologic treatment. Large, prospective studies are needed to further assess the impact of preoperative vedolizumab treatment on postoperative complications, particularly with respect to IBD subtype.

Orca-T, a Precision Treg-Engineered Donor Product, Prevents Acute Gvhd with Less Immunosuppression in an Early Multicenter Experience with Myeloablative HLA-Matched Transplants

Orca-T, a Precision Treg-Engineered Donor Product, Prevents Acute Gvhd with Less Immunosuppression in an Early Multicenter Experience with Myeloablative HLA-Matched Transplants

A prospective comparative study of the MNA-SF and GNRI nutritional screening tools in predicting infectious complications among elderly patients over 70years undergoing posterior lumbar arthrodesis.

Malnutrition is a risk factor for postoperative infectious complications of elderly patients undergoing posterior lumbar arthrodesis. At present, there is no gold standard for nutrition screening tools. We analyzed the value of predicting infectious complications among elderly patients over 70years undergoing posterior lumbar arthrodesis by comparing the MNA-SF and GNRI. Demographic data, anthropometric measurements, serum albumin, surgical data and the occurrence of infectious complications and LOS were collected. Mini Nutritional Assessment short form (MNA-SF), Geriatric Nutritional Risk Index (GNRI) were performed within 24h before surgery. Multivariable logistic regression analyses were used to identify predictors of infectious complications. The discriminatory performances of GNRI and MNA-SF scores for the occurrence of infectious complications were determined by receiver operating characteristic curves (ROC) analyses and the area under the curve (AUC). The study included 252 patients with a median age of 76.82 ± 6.41years (range 70-84years), and 142 patients (56.3%) were female. There were no significant differences in infectious complications (p = 0.236) and LOS (p = 0.580) among different GNRI categories. 27.3% malnourished patients evaluated by the MNA-SF suffered from infectious complications and 10.1% patients at risk of malnourished had infectious complications. Those patients had statistically significant higher prevalence of infectious complications (p = 0.002) and longer LOS (p = 0.023) than well-nourished patients. Multivariable analysis revealed that preoperative malnutrition and at risk of malnourished by the MNA-SF was significantly associated with infections. The area under the curve (AUC) of MNA-SF was 0.754, which was significantly high than AUC of GNRI (0.623) (Delong's test, p = 0.033). This study demonstrated that MNA-SF is a simple and effective tool for predicting the risk of infectious complications in elderly patients undergoing posterior lumbar arthrodesis.

Free Anterolateral Thigh Versus Vastus Lateralis Muscle Flaps for Coverage of Lower Extremity Defects in Chronic Wounds

The thigh has been called the reconstructive warehouse. The anterolateral thigh (ALT) and vastus lateralis (VL) flaps are popular options for free tissue transfer in lower extremity reconstruction. We sought to review the largest experience of these flaps in the chronic wound population. We retrospectively reviewed patients who underwent lower extremity reconstruction using ALT or VL flaps by a single surgeon between 2012 and 2018. Fifty ALT and 34 VL flaps were identified. Comorbidities were similar between groups with the exception of body mass index (ALT, 26.8; VL, 30.1; P = 0.0121). There was also a significant difference rate of independent ambulation preoperatively (ALT, 98.0%; VL, 85.3%; P = 0.0375). An adjunct was needed for recipient site coverage in 31.5% (19/50) of ALT patients and 100% (34/34) of VL patients. Of the patients who received skin grafts, delayed placement was more frequent in the ALT (53.3%) versus VL cohort (18.2%) (P = 0.0192). Median graft take and the rate of skin graft revision were not statistically different. Flap success rates were similar: ALT, 92.0%; and VL, 94.1%. Overall complication rates were not significantly different: ALT, 26.0%; and VL, 38.2%. Infectious complications were also comparable. Subsequent debulking procedures were performed on 8.0% of ALT flaps and 11.8% VL flaps (P = 0.7092). Limb salvage rates were similar between both cohorts (ALT, 82.0%; VL, 88.2%). Ambulation rate was significantly higher for the ALT cohort at 92.0% compared with 73.5% for the VL cohort (P = 0.0216). Median follow-up was similar for both groups. We present the largest comparison study of ALT and VL flaps in lower extremity salvage. Complication rates, flap success, and limb salvage were similar between the 2 cohorts. Despite a high prevalence of osteomyelitis in both cohorts, there was no difference in infectious complications. Although the need for skin grafting remains an inherent disadvantage of the VL flap, a significant proportion of ALT recipients also needed an adjunct for recipient site coverage. Ambulation rate was significantly greater in the ALT group. However, flap type was no longer significant for ambulation when controlling for preoperative ambulatory status.

O19 OUTCOMES OF IVOR LEWIS VERSUS MCKEOWN OESOPHAGECTOMY FOR CANCER: A PROPENSITY SCORE MATCHED ANALYSIS OF THE NETHERLANDS CANCER REGISTRY

Abstract Aim The aim this study was to investigate possible differences in outcomes between Ivor-Lewis (IL) versus McKeown esophagectomy (MK) in a population based cohort. Background It is unknown whether IL or MK should be preferred in patients with potentially curable locoregionally oesophageal or gastro-oesophageal junction (GEJ) cancer. Methods Oesophageal and GEJ cancer patients without distant metastases who underwent a transthoracic oesophagectomy between 2015 and 2017 were selected from the Netherlands Cancer Registry. Patient and tumour characteristics, and treatment outcomes were analysed and compared between IL and MK after propensity score matching (PSM). Patients were matched based on sex, age, tumour morphology and topography, comorbidities, neoadjuvant treatment, cT and cN stage, ASA-score and hospital volume. Postoperative complications and survival were compared between both groups using Chi-Square and multivariable Cox regression analyses. In the multivariable Cox regression analyses we corrected for infectious complications (wound complications and pneumonia) and anastomotic leakage to investigate its effect on survival. Results Off all 1764 included patients (1201 IL patients and 563 MK patients), 948 patients remained after matching. Significantly more lymph nodes were yielded after IL compared to MK (P=0.02). Surgical radicality did not differ between both groups (P=0.25). The complication rate was significantly lower in the IL group regarding anastomotic leakage (17% vs. 28%, P&lt;0.0007) and recurrent laryngeal nerve palsy (2% vs. 6%, P&lt;0.001). Cardiac complications were seen more frequently in patients who underwent IL (17% vs. 11%, P&lt;0.02). No differences were observed in 30 day and 90 day mortality. Kaplan-Meier showed a better survival for IL (63%) compared to MK (58%) (log-rank p=0.07). When correcting for anastomotic leakage and infectious complications the difference in survival remained (HR=0.84, 95% CI 0.69 – 1.03). Similar results regarding postoperative complications and survival were observed in the unmatched cohort. Conclusion Patients who underwent an IL have better outcomes in terms of anastomotic leakage and recurrent laryngeal nerve palsy rate and overall survival compared to MK. The difference in survival appears not to be related to the differences in infectious complications. Based on these results, IL appears to be the treatment of choice in patients in whom both oncological resections are appropriate.

Comparison of Early Versus Delayed Filgrastim (G-CSF) Administration Following Autologous Stem Cell Transplantation in Patients with Multiple Myeloma - Real-World Data from a Single-Center Institution

Background: Autologous stem cell transplantation (ASCT) performed early in the disease course or at first relapse leads to improved progression-free and overall survival in transplant-eligible patients with multiple myeloma (MM). Filgrastim, a recombinant granulocyte colony-stimulating factor (G-CSF), when used after ASCT has been shown to accelerate time to neutrophil engraftment (TNE), and in some studies, it has been associated with reduced length of hospitalization, infectious complications, and antibiotic use. Strategies that reserve G-CSF administration to when neutrophil recovery is delayed, have attempted to show that there is no difference in infectious complications, length of hospitalization or TNE when compared to early administration of G-CSF on the day after stem cell infusion (DOT). However, the optimal timing for administering G-CSF has not yet been determined in patients with MM undergoing ASCT. Methods: This is a retrospective, single-center analysis of patients with MM undergoing ASCT from mobilized peripheral blood stem cells. Patients enrolled in a clinical trial of high-dose lenalidomide and melphalan as conditioning therapy which mandated the administration of filgrastim from day +1 after DOT (Lenalidomide Plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma, NCT01054196) were assigned to the early strategy group (ES). Patients receiving filgrastim as per our institutional guideline (starting on day +12 if ANC &lt; 1000 cells/uL, or at the physician's discretion) were included in the delayed strategy group (DS). Patients were excluded from the analysis if their conditioning regimen included a different agent other than melphalan or lenalidomide. DOT was defined as the day of stem cell infusion. Date of neutrophil engraftment was defined as the first of three consecutive days with an ANC ≥ 500 cells/uL. TNE was calculated as the time from DOT to the date neutrophil engraftment. Total duration of neutropenia was defined as the time from onset of neutropenia (ANC &lt; 500 cells/uL) to date of neutrophil engraftment. Length of hospitalization was defined as the time from DOT to the day of discharge. Results: We identified 59 patients in the ES group and 39 patients in the DS group from 08-16-2010 to 05-22-2019, for a total of 98 included in this analysis. Median age was 60 and 65 years in the ES and DS groups, respectively. Patients received a comparable dose of CD34+ cells, 5.05x106/kg in the ES group vs 4.66x106/kg in the DS group (p = 0.48). The ES group started filgrastim administration earlier (day +1 vs +9, p &lt; 0.001) and received a greater median number of doses (10 vs 4, p &lt; 0.001) as compared to patients in the DS group. Median time to neutrophil engraftment was shorter in the ES group compared to the DS group (10 vs 12 days, p &lt; 0.001), as was the total duration of neutropenia (5 vs 6 days, p &lt; 0.001). Documented infections were just as likely in both groups, 37% in the ES group and 39% in the DS group (p = 1). Length of hospitalization was shorter in the ES group as compared to the DS group (15 vs 17 days, p = 0.01). Discussion: Filgrastim use guided by an ES decreased the time to neutrophil engraftment, the duration of neutropenia and the length of hospitalization compared to a DS. Further analyses to identify predictive factors associated with a reduction in infectious complications and length of stay are underway, with the aim of developing a risk-adapted strategy for the use of filgrastim in patients with MM undergoing ASCT. Disclosures Van Besien: Miltenyi Biotec: Research Funding. Coleman:Kite Pharmaceuticals: Equity Ownership; Merck: Research Funding; Pharmacyclics: Speakers Bureau; Gilead, Bayer, Celgene: Consultancy, Research Funding, Speakers Bureau. Rosenbaum:Janssen: Research Funding; Honoraria Akcea: Other: Accordant Health. Rossi:Janssen, Celgene, Amgen: Consultancy; BMS: Research Funding. Niesvizky:Takeda, Amgen, BMS, Janssen, Celgene: Consultancy, Research Funding.

Trasplante hepático en un centro de Colomba: comparación de dos periodos

Objetivo: el trasplante hepático es el tratamiento de elección para la falla hepática aguda y crónica. Los resultados en el trasplante hepático han mejorado en los últimos años, así que el objetivo de nuestro trabajo es comparar la experiencia de un centro en Colombia en dos períodos de tiempo diferentes.&#x0D; Pacientes y métodos: estudio descriptivo retrospectivo donde se analizaron pacientes adultos con primer trasplante hepático en dos períodos; serie 1, entre 2004-2010 (241 pacientes); y serie 2, entre 2011-2016 (142 pacientes).&#x0D; Resultados: la edad promedio fue de 54 años, el 57 % eran hombres y con un puntaje Model for End-stage Liver Disease (MELD) promedio de 20, sin cambios significativos en las características del donante y del receptor en los dos períodos. Las principales indicaciones de trasplante hepático fueron cirrosis por alcohol, cirrosis criptogénica y cirrosis por hepatitis autoinmune, con una disminución de los casos de hepatitis B y C en la serie 2. El 30 % de los pacientes tenía hepatocarcinoma. La supervivencia de los pacientes a 1 año fue de 81 % frente a 91 % y a 5 años fue de 71 % frente a 80 %, respectivamente. Las principales causas de muerte fueron: cáncer, enfermedad cardiovascular y sepsis. Existió un incremento significativo en las complicaciones biliares, sin diferencias en las complicaciones infecciosas, vasculares y el rechazo celular entre los dos períodos.&#x0D; Conclusión: el trasplante hepático en este centro en Colombia se relaciona con excelentes resultados a corto y mediano plazo, con una mejoría significativa en la supervivencia de los pacientes en los últimos años y con resultados similares a los reportados en otros centros del mundo.

Infectious complications of laparoscopic and robotic hysterectomy: a systematic literature review and meta-analysis.

We performed a systematic review of the literature and meta-analysis of the infectious complications of hysterectomy, comparing robotic-assisted hysterectomy to conventional laparoscopic-assisted hysterectomy. We searched PubMed, CINAHL, CDSR, and EMBASE through July 2018 for studies evaluating robotic-assisted hysterectomy, laparoscopic-assisted hysterectomy, and infectious complications. We employed random-effect models to obtain pooled OR estimates. Heterogeneity was evaluated with I2 estimation and the Cochran Q statistic. Pooled ORs were calculated separately based on the reason for hysterectomy (eg, benign uterine diseases, endometrial cancer, and cervical cancer). Fifty studies were included in the final review for the meta-analysis with 176 016 patients undergoing hysterectomy. There was no statistically significant difference in the number of infectious complication events between robotic-assisted hysterectomy and laparoscopic-assisted hysterectomy (pooled OR 0.97; 95 % CI 0.74 to 1.28). When we performed a stratified analysis, similar results were found with no statistically significant difference in infectious complications comparing robotic-assisted hysterectomy to laparoscopic-assisted hysterectomy among patients with benign uterine disease (pooled OR 1.10; 95 % CI 0.70 to 1.73), endometrial cancer (pooled OR 0.97; 95 % CI 0.55 to 1.73), or cervical cancer (pooled OR 1.09; 95 % CI 0.60 to 1.97). In our meta-analysis the rate of infectious complications associated with robotic-assisted hysterectomy was no different than that associated with conventional laparoscopic-assisted hysterectomy.

Infectious Complications of Conventional Laparoscopic vs Robotic Laparoscopic Prostatectomy: A Systematic Literature Review and Meta-Analysis.

Recent studies have shown that using minimally invasive surgical techniques (conventional laparoscopy or robotic) for prostatectomy is associated with lower perioperative complication rates compared with open radical retropubic prostatectomy. However, differences in infectious complications between these minimally invasive approaches are not well characterized. To study this further, we performed a systematic review of the literature and meta-analysis of the infectious complications of prostatectomy, comparing robotic prostatectomy (RP) with conventional laparoscopic prostatectomy (LP). We searched PubMed, CINAHL, CDSR, and EMBASE through September 2018 for studies evaluating minimally invasive prostatectomy and infectious complications. We employed random-effect models to obtain pooled odds ratio (pOR) estimates. Heterogeneity was evaluated with I2 estimation and the Cochran Q statistic. pORs were calculated separately based on the indication for prostatectomy. Fifteen studies were included in the final review for the meta-analysis with 14,121 patients undergoing minimally invasive prostatectomy. There was no statistically significant difference in the number of infectious complication events between RP and LP (pOR 0.94; 95% CI 0.50, 1.76). When we performed a stratified analysis, similar results were found with no statistically significant difference in infectious complications comparing RP with LP among patients with prostate cancer (pOR 0.73; 95% CI 0.43, 1.24). We observed that infectious complications were nearly threefold higher with the robotic approach in earlier studies (published between 2007 and 2012, pOR 2.81; 95% CI 1.07, 7.39), but no significant difference was found in later studies (between 2013 and 2018, pOR 0.80, 95% CI 0.40, 1.57). The rate of infectious complications associated with RP was no different than that associated with conventional LP.

Post-Transplantation Cyclophosphamide Versus Low Doses ATG Fresenius As Part of Two Immunosuppression Regimens for Graft Versus Host Disease Prophylaxis: Low Severe Graft Versus Host Disease (GVHD) Incidence and y Similar Gvhd-Free and Relapse-Free Survival (GRFS)

BACKGROUND AND OBJECTIVES.Post transplantation High dose Cyclophosphamide (PTCY) used in haploidentical hematopoietic transplantations, has a high effectivity in acute Graft versus Host Disease (aGVHD), and chronic Graft versus Host Disease prophylaxis (cGVHD), however it is associated with high relapse rates. On the other hand, Anti-T-Lymphocyte Globulin (ATG-Fresenius ®) is also effective as immunosuppressive (IS) drug, but its benefit on Overall Survival (OS) and Relapse Free Survival (RFS) is unclear.The aim of this study was to compare the effectiveness of two GVHD prophylaxis regimes used in high risk transplantation: PTCY used in Haploidentical transplantation and ATG used for peripheral blood, non-related, related and mismatched donors.The primary endpoint was to evaluate the incidence of aGVHD and cGVHD, and its severity in both groups. As secondary endpoints we analyse the OS, RFS and GRFS (recorded adverse events include grade 3-4 aGVHD, systemic therapy-requiring cGVHD, relapse or death during median follow-up). We also consider transplantation related mortality (TRM) and post-transplantation complications.PATIENTS AND METHODS.We retrospectively analyse 111 allo-transplantations performed at our institution between 2012 and 2017. We analyse two cohorts: 49 haploidentical transplantation with PTCY (50 mg/kg, on day +3, +4) followed by Tacrolimus and Mycophenolate; and 62 peripheral blood related, non-related and mismatched with low dose ATG Fresenius (7mgr/Kg on days -3, -2, -1) associated with Tacrolimus/Cyclosporine starting on day -1 with a short course Methotrexate (on day +1, +3, +6) or Mycophenolate. Mycophenolate was stopped on day +28 and Cyclosporine or Tacrolimus were tapered on day +50.RESULTS.There were no differences in patients' age (49 vs 51), sex or pre-transplantation HCTI-score ≥ 3 (30 vs 26) between PTCY and ATG groups. We found differences between diagnosis (lymphoproliferative disorders (16 vs 4, p= 0.003), high DRI-score (18 vs 11, p = 0.04), number of previous transplantations (12 vs 5, p= 0.02), reduced intensity conditioning regimen (36 vs 20, p < 0.001) and bone marrow as stem cells source (38 vs 9, p < 0.001) between PTCY and ATG groups.The median time to neutrophil engraftment (>500/uL) was similar: 17 days [13-34] for PTCY and 16 days [9-33] for ATG. Median time to platelet recovery was higher in PTCY cohort (33 vs 18 days, p= 0.016). There were 3 secondary graft failures in PTCY group vs 4 graft failures in ATG (3 primary, 1 secondary).The were no differences in grade 2 - 4 aGVHD incidence between groups (PTCY:30.6% vs ATG:36.4%), but we found differences in grades 3 - 4 aGVHD (PTCY:4.1% vs ATG: 9%, p=ns).The global incidence of any NIH grade cGVHD was 56.1% in PTCY vs 66% in ATG group. Mild, moderate and severe cGVHD incidence were 31.7%, 19.5% and 4.8% for PTCY vs 28%, 26% and 12% in ATG (p=ns).The median duration of IS in alive patients with cGVHD was 6.5 months [3-19] in PTCY patients and 10 [3-34] in ATG group. Among moderate and severe forms, the median IS duration was 10 and 5 months in PTCY group vs 13 and 12 months in ATG respectively.PTCY cohort developed more non-infectious complications, especially, cardiac, lung, digestive and neurologic complications, (p=0.086), however there were not differences in infectious complications (Table 1).TRM was similar between groups, 18.4% for PTCY vs 22.5% for ATG, (p=0.250). We didn´t find differences in early toxic mortality (<100 days): 16.3% for PTCY and 14.5% for ATG (p=0,421).With a median follow-up of 27 months in alive patients (28 months for PTCY and 22 months for ATG) we report an 67.8 % and 61% OS at 12 and 24 months for PTCY and 68.8% and 59.9% for ATG (Log Rank=0.971). Relapse free survival at 12 and 24 months was 61% and 57.9% for PTCY and 69% and 54% for ATG (Log Rank=0.839).GRFS at 12 and 24 months was 46.5% and 42.9% for PTCY patients and 40.7% and 33% for ATG patients, (Log Rank = 0.433).CONCLUSIONS.Regardless the different scenarios between transplantation cohorts, the use of PTCY and low dose ATG are equally effective in the prophylaxis of severe forms of aGVHD and cGVHD, offering similar GRFS. PTCY shows higher early toxicity but a similar rate of infectious events. In order to validate these results, it would be necessary to carry out a randomized controlled trial. DisclosuresNo relevant conflicts of interest to declare.

Safety of Anti-TNF-Alpha Therapy During Pregnancy on Long-term Outcome of Exposed Children: A Controlled, Multicenter Observation.

Evidence of the impact of in utero exposure to anti-tumor necrosis factor (TNF)-alpha on long-term childhood development is limited. The aim was to assess the impact of in utero exposure to anti-TNF-alpha due to mothers' inflammatory bowel disease (IBD) on long-term postnatal development of exposed children. We included consecutive children (≥12 months of age) born to mothers with IBD (2007-2016) treated with anti-TNF-alpha during pregnancy in 3 centers in the Czech Republic. A control group was comprised of unexposed children of non-IBD mothers undergoing mandatory check-ups at general pediatricians' offices. Data on perinatal period, psychomotor development, vaccination, infections, antibiotics, and allergy were collected by treating pediatricians using a predefined questionnaire. Seventy-two exposed and 69 unexposed children were included (median age, 35 and 50 months, respectively). Exposed children had growth and psychomotor development similar to controls. There was no significant difference in infectious complications within the first year of life (23.9% vs 17.4%; P = 0.36) or during the whole follow-up between exposed infants and controls (P = 0.32). Concomitant immunosuppressants during pregnancy and anti-TNF-alpha levels in cord blood were not associated with elevated infection rate within the first year of life (P > 0.05). Over 95% of exposed children had adequate serologic response to vaccination, except for haemophilus and mumps vaccines. Clinically manifested allergy was similar between the groups (P = 0.98). Anti-TNF-alpha exposure in utero does not seem to have a negative impact on postnatal development of children with regard to infectious complications, allergy, growth, or psychomotor development when compared with unexposed children of non-IBD women.

Young Investigator: Corticosteroid Use Is Not Associated With Decreased Length of Stay in Patients Hospitalized With Crohnʼs Associated Small Bowel Obstruction

BACKGROUND: Nearly one-half of Crohn's disease patients require bowel resection within the first 10 years of disease (1). Small bowel obstruction (SBO) is the most common indication for surgery in Crohn's patients, followed by abscess and presence of fistulizing disease (2). There are little data regarding pharmacologic treatment of Crohn's-associated SBO with corticosteroids. In particular, the safety and efficacy of corticosteroids in treating inflammation in the setting of acute Crohn's SBO remains unclear. METHODS: Our group performed a retrospective chart review of patients admitted with Crohn's-disease associated SBO to our institution. Key variables examined included use of corticosteroids, length of stay, infectious complications, and short-term requirement for surgery. Inclusion criteria included adults (>18 years) who were not pregnant and carried a known diagnosis of Crohn's disease. Using the i2b2 search engine, patients admitted with the ICD10 diagnoses for Crohn's disease and a primary diagnosis of SBO were included. Analysis of outcomes was performed comparing patients who received steroids versus those who did not using t-statistics and chi-square analysis. RESULTS: Between 2015 and 2017, fifty-seven patients met inclusion criteria. The majority (n=32, 56%) received no corticosteroids for the preceding three months nor during the admission for SBO, while the minority (n=25, 44%) did receive steroids. The mean age of patients (45±19 years vs 46±18 years, P=0.92), and duration of Crohn's disease (14±13 years vs 14±12 years, P=0.93) did not differ between groups. C-reactive peptide (CRP) on admission did not differ between groups (23.9±17 vs 46.6±78, P=0.49). Eleven patients (19%) required surgery related to Crohn's disease during or within the three months following admission. There was no difference in requirement for surgery between groups. In multivariable logistic regression, the only factor associated with requirement for surgery was duration of Crohn's disease (P<0.05). There was no difference in duration of nasogastric tube placement, time to PO challenge, or length of hospital stay. There were no mortalities in either group and no difference in infectious complications after discharge. CONCLUSION(S): These results suggest that corticosteroids are not associated with improved outcomes in patients with Crohn's associated SBO. Length of stay is not decreased due to use of corticosteroids. The study is limited by its retrospective design and small sample size. However, future case-control or randomized clinical trials can examine the use of corticosteroids during acute Crohn's-associated SBO.