Historical Cohort Of Patients Research Articles

Hybrid resection versus conventional resection for laterally spreading lesions of the papilla

Although conventional hot snare resection (CR) of laterally spreading lesions of the major papilla (LSL-Ps) is effective, it can be associated with delayed bleeding in upward of 25% of cases. Given the excellent safety profile of cold snare polypectomy in the colorectum, we investigated the efficacy and safety of a novel hybrid resection (HR) technique for LSL-P management, consisting of hot snare papillectomy plus cold snare resection of the laterally spreading component. A prospective cohort of patients underwent HR in a tertiary referral center over 60 months until December 2022. This cohort was compared with a historical cohort of patients who underwent CR at the same institution over 120 months until August 2017. The primary outcomes were recurrence and bleeding. Twenty patients underwent HR (14 female; mean age 65.2 ± 12.2 years). Median lesion size was 30mm (interquartile range, 25.0-47.5mm). Recurrent or residual adenoma (RRA) was greater with HR (58.8% [n= 10] vs 29.8% [n= 14]; P= .034). The odds ratio for recurrence was 3.6 times (95% CI, 1.2-11.0) higher with HR (P= .027). RRA was multifocal in 4 (40%) and had a composite RRA volume >10mm in 7 (70%). The median number of procedures required to treat RRA was higher with HR (4 vs 1, P= .002). There was no difference between CR and HR for intraprocedural bleeding (41.1% [n= 23] vs 25% [n= 5]; P= .587) or delayed bleeding (25.0% vs 10.0%, P= .211). There were no perforations. The novel HR technique for LSL-P management is associated with a high rate of RRA that is recalcitrant to treatment, without mitigating the risk of intraprocedural or delayed bleeding. Therefore, CR should remain the mainstay management option for treating patients with an LSL-P. (Clinical trial registration number: NCT02306603.).

Feasibility of articulating laparoscopic instruments in laparoscopic gastrectomy using propensity score matching

Advancements in minimally invasive surgery has led to the development of several surgical instruments, including the ArtiSential®. This new instrument provides a greater range of motion and improved dexterity to laparoscopic procedures, making it an alternative option to traditional straight instruments, and the Da Vinci robot system. The purpose of this study is to compare the postoperative outcomes of a prospective cohort of patients who underwent laparoscopic gastrectomy using articulating instruments with those of a historical cohort of patients who underwent the same procedure using straight instruments. The study was designed as a prospective observational cohort study matched to a retrospective historical cohort using propensity score matching. The primary outcome was the rate of early complications within 90 days of surgery. Other outcomes included the operation time, estimated blood loss, time to first flatus, time to first soft fluid diet, hospital stay, and mortality. After propensity score matching, 41 patients were enrolled in both groups. The mean age was 62.4 ± 12.3 years in the conventional group and 63.5 ± 9.6 years in the artisential group (p = 0.647). Mean operative time was significantly shorter in the artisential group compared to the conventional group (136.1 min vs. 163.9 min, p = 0.032). The time to first soft fluid diet was also significantly shorter in the artisential group (2.2 days vs. 2.8 days, p = 0.030), but there was no significant difference in the time to first flatus and overall hospital stay. The incidence of early complications was lower in the artisential group, but the difference was not significant (24.4% vs 7.3%, p = 0.070). There was no mortality in either group. The use of articulating instruments for laparoscopic gastrectomy did not increase postoperative morbidity compared to straight laparoscopic instruments. The use of articulating instruments may be associated with faster bowel recovery and less early complications.

Propensity Score Matching Analysis Comparing the Efficacy and Steroid Tapering Benefit of Extracorporeal Photopheresis to Best Available Therapy in Third-Line or Beyond Treatment for Chronic GvHD

Graft-versus host disease (GVHD) is one of the major limitations to allogeneic hematopoietic stem cell transplantation (HCT). Although corticosteroids with calcineurin inhibitors are established first line-therapy for chronic graft-versus-host disease (cGVHD), approximately one-half of cGVHD patients are refractory to corticosteroid therapy. The goal of the present study was to compare treatment outcomes of patients treated with extracorporeal photopheresis (ECP) and best available therapy (BAT) as third-line or beyond treatment for cGVHD. Using propensity score matching (PSM), treatment outcomes were compared between ECP-treated patients (n=74) and a historical cohort of cGVHD patients treated with BAT (n=132). By adjusting for unbalanced risk factors between the groups, including GVHD severity at the start of therapy, acute GVHD history, and baseline corticosteroid dose, 62 patients were balanced and selected for PSM. In the PSM cohort, the ECP group showed a 12-month failure-free survival (FFS) rate of 70.1% versus 32.5% in the BAT group (P < .0001; hazard rate [HR], .214), and 93.1% 12 months' overall survival (OS) rate of 93.1% versus 68.1% in the BAT group (P=.0249; HR, .3811); multivariate analysis confirmed ECP's superior FFS and OS compared with BAT. Generalized linear model analysis showed faster tapering of corticosteroids and higher rates of prednisone discontinuation in the ECP versus BAT PSM groups in the first 6 months. The ECP group also had a higher percentage of prednisone discontinuation, by 6% at month 0, by 14.9% at month 3, and by 22.5% at month 6. The current study demonstrates superior FFS, OS, and steroid tapering efficacy for ECP compared with BAT as third-line therapy or beyond in cGVHD patients.

KONO-S Anastomosis Is Not Superior to Conventional Anastomosis for the Reduction of Postoperative Endoscopic Recurrence in Crohn's Disease.

Surgical resection rates remain high in Crohn's disease (CD). Reducing postoperative recurrence (POR) is challenging. Besides drug therapy, the surgical anastomosis technique may reduce POR. We aimed to compare the endoscopic POR rate after Kono-S vs standard ileocolic anastomosis. The study included all consecutive CD patients operated on for ileocolic resection with a Kono-S anastomosis between February 2020 and March 2022. These patients were prospectively followed, and colonoscopy was performed 6 to 12 months after surgery. Patients were compared with a historical cohort of patients operated on with a conventional anastomosis in the same center. The primary end point was endoscopic POR (Rutgeerts score ≥i2). Factors associated with POR were assessed by univariate and multivariable analyses. A total of 85 patients were included, 30 in the Kono-S group and 55 in the control group. At baseline, there was no significant difference between the 2 groups regarding CD characteristics or known POR risk factors, including previous exposure to biologics. At 6 to 12 months, endoscopic POR rate did not differ significantly between groups (56.7% in the Kono-S group vs 49.1% in the control group; P = .50), nor did endoscopic POR according to the modified Rutgeerts score ≥i2b (46.7% in the Kono-S group vs 40% in the control group; P = .55). Severe endoscopic POR rates were 23.3% and 18.2% in each group, respectively. Clinical recurrence rate was similar in both groups, and no recurrent surgery occurred. By multivariable analysis, the type of anastomosis was not associated with endoscopic POR (OR, 1.229; 95% CI, 0.461-3.274, P = .68); however, postoperative treatment with anti-TNF was (OR, 0.337; 95% CI, 0.131-0.865 P = .02). Kono-S anastomosis was not associated with a reduced rate of endoscopic POR. These results warrant confirmation in prospective, randomized, multicenter studies.

Role of Enhanced Recovery after Surgery (ERAS) Protocol in the Management of Elderly Patients with Glioblastoma.

Among the already difficult management of neuro-oncological patients, the elderly population remains vulnerable. Because of the pathology and the comorbidities, they present a significantly higher rate of medical issues related to surgical management. Despite this, the surgical option, if feasible, remains the gold standard in these patients, and an Enhanced Recovery After Surgery (ERAS) protocol could improve the postoperative safety of the patients. With this purpose, we prepared this study with the aim of defining the postoperative hospital length of stay (LOS), but also of evaluating the postoperative morbidity, perioperative complications, and postoperative pain scores. This was a retrospective, single-cohort study performed at an academic hospital (Department of Neurosurgery, Neurocenter of South Switzerland, Switzerland) on elderly patients who underwent craniotomy for glioblastoma. Patients were enrolled in a novel ERAS protocol from January 2022 to December 2022. Since this is a feasibility study and a direct comparison was not possible, we used a historical cohort of elderly patients who had undergone elective craniotomy surgery for glioblastoma as a control group. A total of 19 patients treated in our center for glioblastoma multiforme (GBM) who were aged over 75 years were included in this study. Among those, seven were newly recruited patients included in the ERAS protocol, while the remaining twelve were part of a historical cohort of previously treated patients. From a statistical point of view, the two cohorts were comparable in terms of baseline demographics. In the follow-up, it was shown that in the ERAS group, there was a reduction in the use of opioids after the surgical procedures that could be seen at 30 days (36.2% vs. 71.7%, p < 0.001), but also at 3 months, after surgery (33.0% vs. 80.0%, p < 0.001). A significant difference has also been documented in terms of mobilization and ambulation: compared to the historical cohort, in the ERAS group, there was a higher rate of mobilization (60.0% vs. 10.0%, p < 0.001), but also of ambulation (36.1% vs. 10.0%, p < 0.001). The ERAS protocol for the management of glioblastoma in elderly patients seems to be an effective option for reducing LOS in the hospital, as well as for reducing the number of days spent in the ICU, improving the general recovery of the patient, and reducing the costs associated with hospitalization.

LDR-Brachytherapy monotherapy appears unsuited for NCCN unfavorable intermediate-risk prostate cancer patients

BackgroundTo validate the subdivision of intermediate-risk (IR) prostate cancer (PCa) into favorable intermediate-risk (FIR) and unfavorable intermediate-risk (UIR) PCa in a historical patient cohort and to compare 2 different radiotherapy regimens. MethodsPatients with intermediate-risk (IR) PCa, treated either by 125J-LDR-brachytherapy monotherapy (BT) or by combined-modality radiation therapy (CRT), were retrospectively subclassified into FIR and UIR and reanalyzed with regard to biochemical recurrence-free survival (BRFS), metastasis-free survival (MFS), and prostate cancer-specific survival (CSS). Kaplan-Meier product-limit method and log-rank tests were applied to estimate survival probabilities and compare survival, respectively. Uni- and multivariable analyses were performed using Cox proportional hazard regression. ResultsOf 490 IR patients, 252 had received BT (86.5% FIR, 13.5% UIR), and 238 had received CRT (30% FIR, 70% UIR). Retrospective analysis revealed that BRFS at 10 years was 81% for BT, and 94% for CRT in FIR patients. For UIR patients, BRFS at 10 years was 37% for BT, and 89% for CRT. MFS at 10 years for FIR patients was 87% for BT, and 94% for CRT. For UIR patients MFS at 10 years was 78% for BT, and 95% for CRT. In multivariable analysis treatment (BT vs. CRT) was the single associated factor for biochemical recurrence, and for metastases in the UIR group (BFRS, P < 0.001, HR 16.07 (CI 4.23–61.10); MFS, P = 0.011, HR 8.43 (CI 1.62–43.9). ConclusionsSubclassification of IR prostate cancer into FIR and UIR subcategories appears mandatory. For FIR patients, outcomes after BT monotherapy were acceptable. However, clinical failure after 125J-LDR-BT in UIR patients was notably increased, suggesting that BT monotherapy was less successful in this risk group. In contrast, the outcome in UIR patients after CRT was excellent.

P15.16.A 11C-METHIONIN PET FOR RADIOTHERAPY TREATMENT PLANNING IN PATIENTS WITH RAPID EARLY PROGRESSION AFTER GLIOBLASTOMA SURGERY: PROSPECTIVE PHASE II TRIAL

Abstract BACKGROUND Treatment of glioblastoma, the most aggressive primary brain tumor in adults, is multimodal with radiotherapy (RT) involved in almost of patients after the initial surgery. According to rare retrospective studies, progression is unfortunately seen on planning MR (called Rapid Early Progression, REP), performed usually up to 1 week before RT initiation, in a few tens of percent of patients, with no proven effect of waiting time to RT. REP was proved to be an independent negative prognostic factor. The optimal treatment of patients with REP is unknown and has not yet been studied in detail. The aim of this ongoing prospective phase II clinical trial (Eudra CT number 2020-000640-64) is to evaluate the effect of 11C-Methionin PET scan used for RT planning of glioblastoma patients with REP in order to prolong progression-free survival (PFS, primary outcome). Here we present the initial experience after the enrollment of first 26 patients out of the 67 planned. MATERIAL AND METHODS We included patients with Glioblastoma, IDHwt or Astrocytoma, IDHmt, WHO gr. IV, who developed REP and are fit for concurrent chemoradiotherapy. REP is evaluated by comparison of planning MRI and early postoperative MRI and is defined as 1) increase in postoperative residuum by ≥ 25% in any direction, 2) appearance of a new contras enhancing lesion (T1w MRI), 3) unequivocal progression of the enhancing lesion (e.g., in the case of multifocal glioblastoma where only the main tumor has been removed and the retained satellite has progressed). Patients were treated according to the Stupp or Perry protocol based on their age, and respective overall condition. Treatment response was evaluated using RANO criteria. Target volumes for RT were constructed as follows: Gross tumor volume: tumor cavity + enhancing lesion on T1w MRI + 11C-MET PET with 1.3 tumor-to- BACKGROUND ratio. Clinical target volume: GTV plus modified 2cm. The study is powered to prove increase of PFS from 4.9 months (historical cohort of patients with REP who had median overall survival of 10.7 months) to PFS 8 months. RESULTS A total of 26 patients were evaluated so far, 14 were treated according to Stupp protocol, the rest with an abbreviated course of RT in 15 fractions. The median follow up is 9.7 months. The median volume of GTV-MR was 22.2ccm (range 1.7-110.6ccm), the median volume of GTV-MET was 8.4ccm (range 0.3-46.3ccm). Median PFS was 5.6 months (6months-PFS of 46%) with a difference between those who underwent Perry protocol (8.5 months) and Stupp protocol (4.2 months). Median OS was 14 months (12months OS of 51%). CONCLUSION 11C-MET PET may be valuable in target definitions for RT of glioblastoma patients with REP. Volumetric studies, patterns of failure and quality of life will be important secondary outcomes.Supported by the Ministry of Health of the Czech Republic, grant NU20-03-00148.

Treatment of Idiopathic Normal Pressure Hydrocephalus with a Novel Programmable Valve: Prospective Evaluation of Costs, Efficacy, and Safety.

Objective Programmable valves provide an equal or superior neurological outcome when compared with fixed pressure ones, with fewer complications, in treating idiopathic normal pressure hydrocephalus (iNPH) patients. Long-term costs of these treatments have not been properly compared in literature. We sought to compare costs, efficacy, and safety of 1-year treatment of iNPH patients with programmable valve Sphera Pro and a fixed pressure valve. Materials and Methods A prospective cohort of iNPH patients treated with programmable valve was compared with a historical cohort of iNPH patients treated with fixed pressure valve. Our primary outcome was mean direct cost of treating iNPH up to 1 year. Efficacy in treating iNPH and safety were assessed as secondary outcomes. Statistical Analysis Proportions were compared using chi-square or Fisher's exact tests. Normally distributed variables were compared using the Student's t -test or the Mann-Whitney's U test. Differences in the evolution of the variables over time were assessed using generalized estimating equations. All tests were two-sided, with an α of 0.05. Results A total of 19 patients were analyzed in each group (mean age 75 years, the majority male). Comorbidities and clinical presentation were similar between groups. Both fixed pressure and programmable valve patients had neurological improvement over time ( p < 0.001), but no difference was seen between groups ( p = 0.104). The fixed pressure valve group had more complications than the programmable valve group (52.6% vs. 10.5%, respectively, p = 0.013). Annual treatment cost per patient was US$ 3,820 ± 2,231 in the fixed pressure valve group and US$ 3,108 ± 553 in the programmable valve group. Mean difference was US$712 (95% confidence interval, 393-1,805) in favor of the programmable valve group. Conclusion The Sphera Pro valve with gravitational unit had 1 year treatment cost not higher than that of fixed pressure valve, and resulted in similar efficacy and fewer complications.

A symptom-based algorithm for calcium management after thyroid surgery: a prospective multi-center study.

Evidence based treatment guidelines for the management of post-thyroidectomy hypocalcemia are absent. The aim of this study was to evaluate a newly developed symptom-based treatment algorithm including a protocolized attempt to phase out supplementation. In a prospective multicenter study, patients were treated according to the new algorithm and compared to a historical cohort of patients treated with a biochemically-based approach. The primary outcome was the proportion of patients receiving calcium and/or alphacalcidol supplementation. Secondary outcomes were calcium-related complications and predictors for supplementation. 134 patients were included prospectively, and compared to 392 historical patients. The new algorithm significantly reduced the proportion of patients treated with calcium and/or alphacalcidol during the first postoperative year (OR 0.36 [95% CI 0.23 - 0.54], p<0.001), and persistently at 12 months follow-up (OR 0.51 [0.28 - 0.90], p<0.05). No severe calcium-related complications occurred, even though calcium-related visits to the emergency department and readmissions increased (OR 11.5 [4.51 - 29.3], p<0.001) and (OR 3.46 [1.58 - 7.57], p<0.05), respectively. The proportional change in pre- to postoperative parathyroid hormone (PTH) was an independent predictor for supplementation (OR 1.04 [1.02 - 1.07], p<0.05). Symptom-based management of post-thyroidectomy hypocalcemia and a protocolized attempt to phase out supplementation safely reduced the proportion of patients receiving supplementation, although the number of calcium-related hospital visits increased. For the future, we envision a more individualized treatment approach for patients at risk for delayed symptomatic hypocalcemia, including the proportional change in pre- to postoperative PTH.

Effect of interprofessional and intraprofessional clinical collaboration on patient related outcomes in multimorbid older patients – a retrospective cohort study on the Intensive Collaboration Ward

BackgroundThe management and care of older patients with multiple health problems is demanding and complex. Interprofessional and intraprofessional collaboration has the potential to improve both the efficiency and the quality of care for these patients. However, it has proven difficult to demonstrate the efficacy of this approach in terms of objective patient-related outcomes. Recently, a care model with interprofessional and intraprofessional care was started, the Intensive Collaboration Ward (ICW). This ward combines interprofessional care and intraprofessional care for older patients with multiple health problems. The aim of this study was to evaluate the effects of ICW care in older patients with multiple health problems.MethodsThis retrospective cohort study evaluated the effects on patients outcomes. This was done by comparing patients of the new model, the ICW (ICW group), to a historical cohort of comparable patients who would have been eligible for the ICW (control group). Outcomes were medical consultations, allied health professional consultations, radiological procedures, waiting time for radiological procedures, change in primary treating specialty, length of hospital stay, readmission rate, and mortality rate. Linear and logistic regression analyses were performed, adjusted for baseline differences.ResultsThe ICW group required significantly fewer medical consultations than the control group. Calls to specialists from the emergency room decreased significantly, but there was no change in in-person consultations on the ER. 51% of control patients had ≥ 1 in-hospital consultation compared to 21% of ICW patients (p < 0.05). Patients in the ICW group received significantly more consultations with allied health professionals and more often had a change in primary treating specialty.ConclusionsInterprofessional and intraprofessional clinical collaboration on the ICW reduced in-hospital consultations and increased allied health professionals’ consultations. This approach may decrease fragmentation of care and provide more integrated, efficient and patient centered care. This may improve the overall care of older patients with multiple health problems.

Low Alanine Aminotransferase, as a Marker of Sarcopenia and Frailty, Is Associated with Shorter Survival Among Prostate Cancer Patients and Survivors. A Retrospective Cohort Analysis of 4064 Patients

BackgroundSarcopenia is characterized by loss of muscle mass and function and is associated with frailty, a syndrome with higher likelihood of falls, fractures, physical disability, and mortality. Both frailty and sarcopenia are known markers of shorter survival in various cancer patient populations. Low alanine aminotransferase (ALT), reflecting loss of muscle mass (sarcopenia), may be associated with greater frailty and shorter survival in multiple cancers. ObjectiveTo assess the potential association between low ALT and shorter survival among prostate cancer (PCa) patients and survivors. Design, setting, and participantsThis was a retrospective analysis of a historical cohort of PCa patients and survivors. Patients were defined as those still actively receiving PCa treatment, while those no longer receiving such treatment were classified as PCa survivors. Outcome measurements and statistical analysisALT data were obtained from results for basic biochemical blood testing carried out for patients on their first hospital admission. Patients were divided into two groups: those with ALT ≥17 IU/l and those with ALT <17 IU/l. Univariate and multivariable analyses were conducted for between-group survival comparisons. Results and limitationsWe identified 9489 PCa records. The final study cohort with ALT data available included 4064 patients with ALT <40 IU/l. Of this cohort, 536 patients were actively receiving medical anticancer therapy for PCa. The mean age for the entire cohort was 74.6 yr (standard deviation 9.6) and the median ALT level was 19.28 IU/l; 1676 patients (41%) had low ALT (<17 IU/l). On univariate analysis, low ALT was associated with a 78% increase in mortality risk (95% confidence interval [CI] 1.62–1.97; p < 0.001). A sensitivity analysis of the 536 patients actively receiving medical anticancer treatment revealed that low ALT was associated with a 48% increase in mortality risk (95% CI 1.19–1.85; p = 0.001). In a multivariable model controlled for age, kidney disease, history of cerebrovascular event/transient ischemic attack, and baseline prostate-specific antigen, low ALT was still associated with a 35% increase in mortality risk (95% CI 1.12–1.63; p = 0.001). Limitations include the single-center, retrospective design. ConclusionsLow ALT, which is indicative of sarcopenia and frailty, is associated with shorter survival among PCa patients and survivors and could potentially be used for treatment personalization. Patient summaryWe compared survival for prostate cancer patients and survivors according to their blood level of the protein alanine aminotransferase (ALT). Low ALT levels in the general population are associated with loss of muscle mass. We found that in our group of prostate cancer patients and survivors, the risk of death from any cause was higher for those with low ALT levels.

Urethral Diverticulum During Pregnancy Managed With Primum Non Nocere Principle: Conservative Treatment During Pregnancy and Diverticulectomy After Child Birth

To report our referral single institution experience of the management of urethral diverticulum (UD) in female during pregnancy (UDp), which is a rare condition, not standardized and sparsely reported in the current literature. The charts of 12 female patients treated for UDp between 2010 and 2020 were screened retrospectively. Baseline demographics, management strategies, delivery complications, and surgical outcomes were specifically analyzed and compared to our historical cohort of UD patients (n=54). Overall, 7/12 (58%) patients were primiparous and 5/12 (42%) had previous pregnancy with no history of UD. Symptoms at diagnosis were respectively urinary tract infections (7/12, 58%), urethral purulent discharge (6/12, 50%), vaginal bulging (4/12, 33%), and dyspareunia (4/12, 33%). Compared to UD outside pregnancy, UDp patients were younger and were more likely to bear asymptomatic UD. Conservative management until delivery was elected in all patients. Vaginal delivery was possible in all but one patient. There was not any reported infectious mother-to-child transmission. Diverticulectomy through vaginal route were performed 3 months after delivery. Low-grade Clavien Dindo complications were reported in up to 25% (3/12) of the cases. No recurrence was reported. Our report showed UDp could be managed conservatively during pregnancy without jeopardizing vaginal delivery and increasing infectious mother-to-child transmission. Surgical diverticulectomy could safely be performed after child birth using similar technique and care pathways generally used for the management of UD outside pregnancy.

A New Clinical Protocol for a Timely Diagnosis and Treatment of Hydrocephalus in Patients with Severe Acquired Brain Injury.

Secondary hydrocephalus is a well-known complication of severe acquired brain injuries (sABIs) often diagnosed during inpatient rehabilitation. Currently, there is no gold standard for its detection. Therefore, we designed a novel clinical diagnostic protocol that integrates clinical, functional, biochemical and neuroradiological assessments to improve the accuracy of its diagnosis in patients with sABIs. This prospective cohort study will be conducted in a tertiary referral rehabilitation center in Italy. A historical cohort of patients will be compared with a prospective cohort undergoing the new clinical diagnostic protocol. The expected results include an increase in the proportion of diagnosed cases, a reduced incidence of clinical complications, an increase in the rehabilitative outcomes at discharge, a significant reduction in the length of hospital stay, and useful information about the diagnostic and prognostic value of the neuroradiological characteristics. We expect that this clinical diagnostic protocol will result in a more appropriate assessment and timely treatment of secondary hydrocephalus in patients with sABIs, with the ultimate goal of improving their prognosis. In addition, it could be adopted by other rehabilitation centers to improve hydrocephalus diagnosis and treatment, thereby reducing the length of hospital stay and accelerating recovery with benefits for both patients and hospitals.

Robotic alignment system Cirq (Brainlab) for navigated brain tumor biopsies in children.

The Cirq robotic alignment system (Brainlab, Munich, Germany) is a manually adjustable electronic arm with a robotic alignment module on its distal end, enabling the neurosurgeon to automatically and accurately align surgical instruments to a preoperatively planned trajectory. In this study, we share our first experiences and results using Cirq for intracranial tumor biopsy in children. From May 2021 until October 2022, all consecutive patients that underwent a brain tumor biopsy using Cirq were included and compared to a historical cohort of patients biopsied with the non-robotic system Varioguide (Brainlab, Munich, Germany). Patient-related data, tumor-related data, and surgery-related data were collected. Registration accuracy was calculated for different patient-to-image registration methods. Pre- and postoperative images were fused, and entry error, target error, and angulation error were calculated. Thirty-seven patients, aged 1-19years, were included (14 with Cirq and 23 with Varioguide). An integrated histopathological and molecular diagnosis was acquired in all cases. Patient-to-image registration was significantly more accurate when based on bone screw fiducials combined with intraoperative CT, as compared to surface matching or skin fiducials. The target error (Euclidian distance) was 5.3mm for Cirq as compared to 8.3mm for Varioguide, but this was not statistically significant. Entry error and angulation error were also not significantly different between both groups. Intracranial biopsy with the Cirq robotic system is feasible and safe, and its accuracy does not differ from the Varioguide system.

Short-course Palliative Hypofractionated Radiotherapy in Patients with Poor-prognosis High-grade Glioma: Survival and Quality of Life Outcomes from a Prospective Phase II Study

AimsTo report longitudinal quality of life (QoL) outcomes and survival in patients with poor-prognosis high-grade glioma (HGG) treated with palliative hypofractionated radiotherapy. Materials and methodsPatients with poor-prognosis HGG were accrued on a prospective study of short-course palliative hypofractionated radiotherapy (35 Gy/10 fractions/2 weeks). The European Organization for Research and Treatment of Cancer QoL core questionnaire (QLQ-C30) and brain cancer module (BN20) were used in English or validated Indian vernacular languages (Hindi and Marathi) for QoL assessment at baseline (before radiotherapy), the conclusion of radiotherapy, 1 month post-radiotherapy and subsequently at 3-monthly intervals until disease progression/death. Baseline QoL scores were compared with corresponding scores from a historical HGG cohort. Summary QoL scores were compared longitudinally over time by related samples Friedman's two-way test. Progression-free survival and overall survival were calculated using the Kaplan–Meier method and reported as 1-year estimates with 95% confidence intervals. ResultsForty-nine (89%) of 55 patients completed the planned course of hypofractionated radiotherapy. Longitudinal QoL data were available in 42 (86%) of 49 patients completing radiotherapy, comprising the present cohort. The median age of included patients, comprised mainly of glioblastoma patients (81%), was 57 years, with an interquartile range (IQR) of 50–66 years and a median baseline Karnofsky score of 60 (IQR = 50–60). Baseline QoL scores were significantly worse for several domains compared with a historical institutional cohort of HGG patients treated previously with conventionally fractionated radiotherapy, indicating negative selection bias. QoL scores remained stable for most domains after palliative hypofractionated radiotherapy, with statistically significant improvements in fatigue (P = 0.032), dyspnoea (P = 0.042) and motor dysfunction (P = 0.036) over time. At a median follow-up of 8 months, Kaplan–Meier estimates of 1-year progression-free survival and overall survival were 33.3% (95% confidence interval 21.7–51.1%) and 38.1% (95% confidence interval 25.9–56%), respectively. ConclusionShort-course palliative hypofractionated radiotherapy in patients with poor-prognosis HGG is associated with stable and/or improved QoL scores in several domains, making it a viable resource-sparing regimen.

Impact of Signet-Ring Cell Histology in the Management of Patients with Non-Metastatic Gastric Cancer: Results from a Retrospective Multicenter Analysis Comparing FLOT Perioperative Chemotherapy vs. Surgery Followed by Adjuvant Chemotherapy.

FLOT perioperative chemotherapy represents the standard of care in non-metastatic gastric cancer patients. Signet-ring cell positivity is associated with a worse prognosis in patients with gastric cancer treated with chemotherapy. Comparison between FLOT perioperative chemotherapy vs. surgery followed by adjuvant chemotherapy based on signet-ring cell positivity is lacking. The aim of the analysis was to compare perioperative FLOT with adjuvant chemotherapy in gastric cancer patients stratified by signet-ring cell positivity. We conducted a retrospective multicenter analysis based on disease-free survival (DFS) and overall survival (OS) in patients with gastric cancer who received perioperative chemotherapy with a FLOT regimen and compared their survival with a historical cohort of patients treated with adjuvant chemotherapy, matched by cT and cN stage and by tumor histological features. Seventy-six patients were enrolled and 24 (32%) were signet-ring cell positive. At a median follow-up time of 39 months, the median DFS was 26.3 months and the median OS was 37.3 months. Signet-ring cell positivity was associated with a shorter OS (median OS: 20.4 vs. 46.9 months, HR: 3.30, 95%CI: 1.56-6.99, p = 0.0018) and DFS (mDFS: 15.2 vs. 38.6 months, HR: 3.18, 95%CI: 1.55-6.54, p = 0.0016). This was confirmed by multivariate analysis for DFS (Exp(B): 2.55) and OS (Exp(B): 2.68). After propensity score matching, statistically significant shorter DFS (HR: 3.30, 95%CI: 1.50-7.35, p = 0.003) and OS (HR: 5.25, 95%CI: 2.18-12-68, p = 0.0002) were observed for patients with signet-ring cell positivity who received perioperative treatment vs. those who received surgery followed by adjuvant chemotherapy. Signet-ring positivity was associated with shorter DFS and OS in patients who received perioperative treatment with FLOT compared with surgery followed by adjuvant therapy. These data suggest that for patients with signet-ring cell histology, FLOT perioperative treatment might not always be the best choice of treatment, and further research should be focused on this group of patients.

Impact of a pulmonary embolism response team initiative on hospital mortality of patients with bilateral pulmonary embolism

IntroductionPulmonary embolism (PE) response teams (PERT) for the management of high-risk PE (HR-PE) and intermediate-high risk PE (IHR-PE) are encouraged in PE guidelines. We aimed to assess the impact of a PERT initiative on mortality in these groups of patients, compared with standard care. MethodsWe conducted a prospective, single-center registry, including consecutive patients with HR-PE and IHR-PE with PERT activation from February-2018 to December-2020 (PERT group, n=78 patients) and compared it with an historic cohort of patients admitted to our hospital in a previous 2-year period (2014–2016), managed with standard of care (SC-group, n=108 patients). ResultsPatients in the PERT group were younger and less comorbid. The risk profile at admission and the percentage of HR-PE was similar in both cohorts (13% in SC-group and 14% in PERT-group, p=0.82). Reperfusion therapy was more frequently indicated in PERT-group (24.4% vs 10.2%, p=0.01), with no differences in fibrinolysis treatment, while catheter-directed therapy (CDT) was more frequent in PERT group (16.7% vs 1.9%, p<0.001). Reperfusion and CDT were associated with lower in-hospital mortality (2.9% vs 15.1%, p=0.001 for reperfusion and 1.5% vs 16.5%, p=0.001 for CDT). The primary outcome, 12-month mortality, was lower in the PERT-group (9% vs 22.2%, p=0.02), There were no differences in 30-day readmissions. In multivariate analysis PERT activation was associated with lower mortality at 12 months (HR 0.25, 95% confidence interval 0.09–0.7, p=0.008). ConclusionA PERT initiative in patients with HR-PE and IHR-PE was associated with a significant reduction in 12-month mortality compared with standard of care, and also with an increase in the use of reperfusion, especially catheter-directed therapies.

Experience in the perioperative management of patients with hip fracture in southwestern Colombia. Retrospective cohort study

Introduction: Hip fracture is one of the main causes of morbidity and mortality among the elderly population. In Colombia there is a shortage of scientific literature on the perioperative management of this population of patients.&#x0D; Objective: To describe the perioperative management of hip fracture patients at a tertiary university hospital in Cali, Colombia.&#x0D; Methods: An observational study was conducted with relational scope of a historical cohort of patients with hip fracture who underwent surgical management between January 2018 and June 2022. A non-probability sampling method was used and contingency tables were designed aimed at describing the relationship between the patients’ characteristics and the postoperative outcomes.&#x0D; Results: 235 patients were included, of which 57 % were males. The mean age was 79 years and 49.8 % were classified as ASA III or higher. Spinal anesthesia was the most commonly used technique in 63.4 % of the cases. The most frequent outcomes were delirium in 17.9 %, and acute kidney failure in 6.8 %. 83.4 % of the patients underwent surgery within 48 hours of admission to the emergency department and intra-hospital mortality was 2.6 %.&#x0D; Conclusion: The results of this study provide relevant information to identify opportunities for improvement and their implementation, such as the reduction in the time elapsed until surgical management and the development of care protocols in the region.

Intestinal microbiome characterization in immune checkpoint inhibition (ICI) resistant disease.

2515 Background: The gut microbiome modifies response to ICI treatment. Despite durable response rates seen with ICI, most pts do not benefit from treatment (primary resistance) or have only a period of disease control (acquired resistance). The Immune Resistance Interrogation Study (IRIS, NCT03702309) is a prospective pan-cancer study that aims at characterizing ICI-resistant disease through multiomic and gut microbial composition profiling. Herein we compare the gut microbial diversity of pts with PR vs AR to PD-1/PD-L1 based treatment as part of the wider IRIS framework. Methods: Patients who progressed after anti-PD1/PD-L1-based ICI were classified into 2 groups. Acquired resistance (AR): complete response (CR), partial response (PR) or stable disease (SD) for ≥6 months (m) with subsequent (PD) or PD after ≥3m from last dose of adjuvant ICI; or primary resistance (PR): PD at first imaging, SD but progressed ≤6m or progression ≤3m from last dose of adjuvant ICI. Stool samples were collected at time of PD and underwent DNA extraction and metagenomic sequencing. Species-level Shannon diversity indices were calculated and compared using unpaired Wilcoxon test. Principal component analysis (PCA) of Bray-Curtis dissimilarity indices was performed to assess differences in taxonomic composition. Results: Stool samples from 62 pts (PR n=38; AR n=24) were evaluated. Tumor types were melanoma n=37 (60%), head and neck n=17/62 (27%), gastrointestinal n=3/62 (5%), gynaecological n=2/62 (3%) and other n=3/61 (5%). Most pts n=59/62 (95%) were treated with palliative intent, and n= 3/62 (5%) with adjuvant therapy. Anti-PD-1/PD-L1 monotherapy was received by 32/62 (52%) pts and n=30/62 (48%) received combination anti-PD-1/PD-L1 with either anti-CTLA-4 inhibition, experimental immunotherapy, chemotherapy, or targeted treatment. The median Shannon diversity index was similar between pts with PR (median: 3.5; range: 2.5 - 4.3) vs AR (median: 3.4; range: 0.9 – 3.9; p = 0.7). There were no differences in composition by group by PCA of Bray-Curtis dissimilarity indices. Abundance testing did not reveal any differentially abundant species between pts with AR vs PR while controlling for antibiotic use within 1m of sampling and type of treatment. No taxa were significantly different between AR and PR; top taxa per group are shown. Conclusions: Primary analysis showed no significant differences in gut microbial composition between primary vs acquired resistance to ICI. Comparative analysis between ICI-resistance samples and ICI-naïve samples from historical patient cohorts is underway. These results will be collated with other analyses from IRIS to create a multi-modal characterisation of ICI resistance. Clinical trial information: NCT03702309 . [Table: see text]

P.098 Antibacterial envelopes prevent post-operative infections in neuromodulation surgery

Background: Neuromodulation unit placement can provide efficacious control of many neurological conditions. They are high risk for infection with a historic infection rate as high as 10%. Treatment of infection requires surgical removal and a long course of systemic antibiotics. &lt;font size=”1”&gt; &lt;/font&gt;At our center, one surgeon uses antibacterial envelopes with all implanted neuromodulation devices. Methods: We conducted a retrospective cohort study of consecutive implantable pulse generator (IPG) and intrathecal pump unit implantation with an antibacterial envelope at our center. This cohort was then compared to a historical cohort of consecutive patients undergoing IPG or pump placement or revision prior to the use of the envelopes. Results: IPG: There were 18 (11.9%) class I infections in the pre-envelope cohort compared with 5 (2.1%) in the post-envelope cohort. The absolute risk reduction (ARR) with the use of antibacterial envelopes was 9.85% (95% confidence interval (CI) 4.3-15.4%, p&lt;0.01).Pump: There were 6 (14.6%) class I infections in the pre-envelope cohort compared with 1 (1.7%) in the post-envelope cohort. The ARR with the use of antibacterial envelopes was 12.9% (95% confidence interval 1.6-24.3, p&lt;0.05). Conclusions: Based on our results, we recommend usage of antibacterial envelopes to reduce infection rates in neuromodulation surgery. Further study is needed.