EAES rapid guideline: systematic review, network meta-analysis, CINeMA and GRADE assessment, and European consensus on bariatric surgery-extension 2022.

BACKGROUND: The European Association for Endoscopic Surgery Bariatric Guidelines Group identified a gap in bariatric surgery recommendations with a structured, contextualized consideration of multiple bariatric interventions. OBJECTIVE: To provide evidence-informed, transparent and trustworthy recommendations on the use of sleeve gastrectomy, Roux-en-Y gastric bypass, adjustable gastric banding, gastric plication, biliopancreatic diversion with duodenal switch, one anastomosis gastric bypass, and single anastomosis duodeno-ileal bypass with sleeve gastrectomy in patients with severe obesity and metabolic diseases. Only laparoscopic procedures in adults were considered. METHODS: A European interdisciplinary panel including general surgeons, obesity physicians, anesthetists, a psychologist and a patient representative informed outcome importance and minimal important differences. We conducted a systematic review and frequentist fixed and random-effects network meta-analysis of randomized-controlled trials (RCTs) using the graph theory approach for each outcome. We calculated the odds ratio or the (standardized) mean differences with 95% confidence intervals for binary and continuous outcomes, respectively. We assessed the certainty of evidence using the CINeMA and GRADE methodologies. We considered the risk/benefit outcomes within a GRADE evidence to decision framework to arrive at recommendations, which were validated through an anonymous Delphi process of the panel. RESULTS: We identified 43 records reporting on 24 RCTs. Most network information surrounded sleeve gastrectomy and Roux-en-Y gastric bypass. Under consideration of the certainty of the evidence and evidence to decision parameters, we suggest sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass over adjustable gastric banding, biliopancreatic diversion with duodenal switch and gastric plication for the management of severe obesity and associated metabolic diseases. One anastomosis gastric bypass and single anastomosis duodeno-ileal bypass with sleeve gastrectomy are suggested as alternatives, although evidence on benefits and harms, and specific selection criteria is limited compared to sleeve gastrectomy and Roux-en-Y gastric bypass. The guideline, with recommendations, evidence summaries and decision aids in user friendly formats can also be accessed in MAGICapp:  https://app.magicapp.org/#/guideline/Lpv2kE CONCLUSIONS: This rapid guideline provides evidence-informed, pertinent recommendations on the use of bariatric and metabolic surgery for the management of severe obesity and metabolic diseases. The guideline replaces relevant recommendations published in the EAES Bariatric Guidelines 2020.

Management of cerebral venous thrombosis in Spain: MOTIVATE descriptive study.

INTRODUCTION: Cerebral venous thrombosis (CVT) is an uncommon cause of stroke that mainly affects young adults. Early, accurate diagnosis can reduce the rate and severity of complications. OBJECTIVE: The aim of this study was to analyse the clinical characteristics, management, and treatment of CVT in different centres in Spain. METHODS: We conducted a multicentre, retrospective, descriptive study of patients hospitalised due to CVT between 2008 and 2017 at 10 Spanish centres. RESULTS: We included 256 patients, with a mean age (SD) of 49.8 (18.7) years; 51% of patients were women. The most frequent symptoms were headache (73%), focal deficits (50%), epileptic seizures (33%), and encephalopathy (21%). The most frequent localisations were the superior sagittal sinus (12.5%), the transverse sinus (10.9%), and 2 or more sinuses or veins (66.4%). Thrombophilia was the most frequent known aetiology (24%), and was most commonly associated with the prothrombin G20210A mutation (19%). Forty-six percent of patients were treated with antithrombotics for 3 to 6 months, 21% for one year, and 22.6% required indefinite anticoagulation. Endovascular therapy was performed in 5% of cases, and 33% required neurosurgery. Regarding outcomes, 75% of patients were independent at 3 months (modified Rankin Scale [mRS] score ≤ 2), with papilloedema (P =  .03), focal deficits (P = .001), and encephalopathy (P < .001) showing a statistically significant association with poor prognosis (mRS > 3). The in-hospital mortality rate was 4.3%, with a 3-month mortality rate of 6.3%. CONCLUSION: The diverse risk factors and variable presentation of CVT represent a challenge in the diagnosis and treatment of this condition. To improve prognosis and reduce mortality, it is essential to establish management protocols for this entity.

[Influence of the type of thoracic access on postesophagectomy respiratory complications]. / La influencia del tipo de abordaje torácico sobre el desarrollo de complicaciones respiratorias tras la esofagectomía.

INTRODUCTION: A systematic review of the literature was performed with the aim to determine differences in the rate of respiratory complications after esophagectomy for esophageal cancer using minimally invasive access vs traditional thoracic access. METHODS: A literature search was performed using Medline and Cochrane Library, identifying studies that compared the 2 types of thoracic access, regardless of the type of abdominal access (laparotomy/laparoscopy). The studies selected described respiratory complications in absolute numbers and different categories. Studies that considered minithoracotomy as a minimally invasive technique were excluded. Inclusion criteria were: studies decribing the different types of respiratory complications (9 in total), and analysing the most common complications: respiratory infection, respiratory failure and pleural effusion. RESULTS: Nine studies were selected (one prospective randomized trial and 8 case control studies) including 1,190 patients, 1,167 of which were operated on for esophageal cancer: 482 patients by thoracotomy and 708 by thoracoscopy. Three studies included definitions of respiratory complications, and one stratified them. The more frequent complications that allowed a meta-analysis were: respiratory infections, pleural effusion, and respiratory failure. No significant differences were found between the 2 types of access in the global analysis. DISCUSSION: The type of thoracic access (thoracotomy or thoracoscopy) does not seem to influence the development of respiratory complications after esophagectomy for cancer. However, the design of the studies analysed, the absence of clear definitions and stratification of the complications makes this conclusion questionable. A consensus on the definition of complications and further prospective randomized clinical trials are necessary.

Impact of a series of measures for optimisation hospital code stroke care on door-to-needle times.

INTRODUCTION: Time continues to be a fundamental variable in reperfusion treatments for acute ischaemic stroke. Despite the recommendations made in clinical guidelines, only around one-third of these patients receive fibrinolysis within 60minutes. In this study, we describe our experience with the implementation of a specific protocol for patients with acute ischaemic stroke and evaluate its impact on door-to-needle times in our hospital. METHODS: Measures were gradually implemented in late 2015 to shorten stroke management times and optimise the care provided to patients with acute ischaemic stroke; these measures included the creation of a specific on-call neurovascular care team. We compare stroke management times before (2013-2015) and after (2017-2019) the introduction of the protocol. RESULTS: The study includes 182 patients attended before implementation of the protocol and 249 attended after. Once all measures were in effect, the overall median door-to-needle time was 45minutes (vs 74 minutes before, a 39% reduction; P<.001), with 73.5% of patients treated within 60minutes (a 47% increase; P<.001). Median overall time to treatment (onset-to-needle time) was reduced by 20minutes (P<.001). CONCLUSIONS: The measures included in our protocol achieved a significant, sustained reduction in door-to-needle times, although there remains room for improvement. The mechanisms established for monitoring outcomes and for continuous improvement will enable further advances in this regard.

Incidence, outcomes, and associated factors of isolated striatocapsular infarct after mechanical thrombectomy.

OBJECTIVE: To describe baseline and procedural characteristics and clinical outcomes of isolated striatocapsular infarct (iSCI) after mechanical thrombectomy in patients with large-vessel occlusion of the anterior cerebral circulation and its clinical outcome. METHODS: We performed a longitudinal study including all patients treated with mechanical thrombectomy at our centre between 2015 and 2017; patients were divided into 2 groups (iSCI and non-iSCI) according to whether they presented iSCI in a control CT scan at 24 hours. RESULTS: Of the 83 patients identified, 22.9% developed an iSCI. There were no statically significant differences in baseline characteristics or in reperfusion times. Patients presenting iSCI showed better collateral circulation and better reperfusion rates in the bivariate analysis. No significant difference was observed for mortality at discharge or at 3 months, or for functional prognosis at 3 months. CONCLUSIONS: Even if successful reperfusion is achieved, iSCI is a common sequela, independently of reperfusion time, especially in patients with good collateral circulation.

Management of cerebral venous thrombosis in Spain: MOTIVATE descriptive study. / Manejo de la trombosis venosa cerebral en España: estudio descriptivo MOTIVATE.

INTRODUCTION: Cerebral venous thrombosis (CVT) is an uncommon cause of stroke that mainly affects young adults. Early, accurate diagnosis can reduce the rate and severity of complications. OBJECTIVE: The aim of this study was to analyse the clinical characteristics, management, and treatment of CVT in different centres in Spain. METHODS: We conducted a multicentre, retrospective, descriptive study of patients hospitalised due to CVT between 2008 and 2017 at 11 Spanish centres. RESULTS: We included 256 patients, with a mean age (SD) of 49.8 (18.7) years; 51% of patients were women. The most frequent symptoms were headache (73%), focal deficits (50%), epileptic seizures (33%), and encephalopathy (21%). The most frequent localisations were the superior sagittal sinus (12.5%), the transverse sinus (10.9%), and 2 or more sinuses or veins (66.4%). Thrombophilia was the most frequent known aetiology (24%), and was most commonly associated with the prothrombin G20210A mutation (19%). Forty-six percent of patients were treated with antithrombotics for 3-6 months, 21% for one year, and 22.6% required indefinite anticoagulation. Endovascular therapy was performed in 5% of cases, and 33% required neurosurgery. Regarding outcomes, 75% of patients were independent at 3 months (modified Rankin Scale [mRS] score ≤ 2), with papilloedema (P=.03), focal deficits (P=.001), and encephalopathy (P <.001) showing a statistically significant association with poor prognosis (mRS> 3). The in-hospital mortality rate was 4.3%, with a 3-month mortality rate of 6.3%. CONCLUSION: The diverse risk factors and variable presentation of CVT represent a challenge in the diagnosis and treatment of this condition. To improve prognosis and reduce mortality, it is essential to establish management protocols for this entity.

Dose-finding study and pharmacogenomic analysis of fixed-rate infusion of gemcitabine, irinotecan and bevacizumab in pretreated metastatic colorectal cancer patients.

BACKGROUND: To determine the dose-limiting toxicity (DLT), maximum tolerated dose, recommended dose (RD) and preliminary evidence of activity of escalating doses of irinotecan (CPT-11) fixed-dose-rate infusional gemcitabine (FDR-GMB) and bevacizumab in pretreated metastatic colorectal cancer (mCRC) patients. Pharmacogenomic analysis was performed to investigate the association between VEGF single-nucleotide polymorphisms and clinical outcome. PATIENTS AND METHODS: A total of 89 mCRC patients were recruited in a two-step study design; 28 were included in the dose-finding study and 59 in the pharmacogenomic analysis. The FDR-GMB of 1000 mg m⁻², bevacizumab 5 mg kg⁻¹ and CPT-11 doses ranging from 100 to 160 mg m⁻² were explored. The VEGF protein serum levels were quantified by EIA. Allelic discrimination was performed to genotype polymorphisms in the VEGF gene. RESULTS: CPT-11 RD was 150 mg m⁻². Diarrhoea and neutropenia were the DLT. After a median follow-up of 42 months, the median time to progression (TTP) and overall survival were 5.2 and 19.9 months, respectively. VEGF levels were significantly correlated with VEGF-2578AA and VEGF-460CC genotypes, and a trend was observed with VEGF+405GG genotype. The presence of any of these genotypes correlated with a longer median TTP (8.8 vs 4.5 months, P=0.04). CONCLUSION: The triplet combination tested in this study is effective and well tolerated. A possible predictive role for VEGF gene polymorphisms and baseline VEGF circulating levels is suggested.

Impact of a series of measures for optimisation hospital code stroke care on door-to-needle times. / Impacto en los tiempos puerta-aguja de un conjunto de medidas para optimizar la atención hospitalaria del código ictus.

INTRODUCTION: Time continues to be a fundamental variable in reperfusion treatments for acute ischaemic stroke. Despite the recommendations made in clinical guidelines, only around one-third of these patients receive fibrinolysis within 60minutes. In this study, we describe our experience with the implementation of a specific protocol for patients with acute ischaemic stroke and evaluate its impact on door-to-needle times in our hospital. METHODS: Measures were gradually implemented in late 2015 to shorten stroke management times and optimise the care provided to patients with acute ischaemic stroke; these measures included the creation of a specific on-call neurovascular care team. We compare stroke management times before (2013-2015) and after (2017-2019) the introduction of the protocol. RESULTS: The study includes 182 patients attended before implementation of the protocol and 249 attended after. Once all measures were in effect, the overall median door-to-needle time was 45minutes (vs 74 minutes before, a 39% reduction; P<.001), with 73.5% of patients treated within 60minutes (a 47% increase; P<.001). Median overall time to treatment (onset-to-needle time) was reduced by 20minutes (P<.001). CONCLUSIONS: The measures included in our protocol achieved a significant, sustained reduction in door-to-needle times, although there remains room for improvement. The mechanisms established for monitoring outcomes and for continuous improvement will enable further advances in this regard.

Incidence, outcomes, and associated factors of isolated striatocapsular infarct after mechanical thrombectomy. / Incidencia, pronóstico y factores asociados al infarto estriatocapsular aislado tras trombectomía mecánica.

OBJECTIVES: To describe baseline and procedural characteristics and clinical outcomes of isolated striatocapsular infarct (iSCI) after mechanical thrombectomy in patients with large-vessel occlusion of the anterior cerebral circulation andits clinical outcome. METHODS: We performed a longitudinal study including all patients treated with mechanical thrombectomy at our centre between 2015 and 2017; patients were divided into 2 groups (iSCI and non-iSCI) according to whether they presented iSCI in a control CT scan at 24h. RESULTS: Of the 83 patients identified, 22.9% developed an iSCI. There were no statically significant differences in baseline characteristics or in reperfusion times. Patients presenting iSCI showed better collateral circulation and better reperfusion rates in the bivariate analysis. No significant difference was observed for mortality at discharge or at 3 months, or for functional prognosis at 3 months. CONCLUSIONS: Even if successful reperfusion is achieved, iSCI is a common sequela, independently of reperfusion time, especially in patients with good collateral circulation.

[Influence of mechanical thrombectomy on the incidence of isolated striatocapsular infarction and a description of its clinical characteristics]. / Influencia de la trombectomia mecanica en la incidencia de infarto estriatocapsular aislado y descripcion de sus caracteristicas clinicas.

INTRODUCTION: The great vulnerability of the striatocapsular region to ischaemia means that mechanical thrombectomy has its limitations in occlusions of large-calibre vessels when it comes to preventing the striatocapsular region from undergoing infarction. AIMS: To analyse the effect of endovascular treatment on the incidence of isolated striatocapsular infarction (iSCI) and to describe its clinical characteristics. PATIENTS AND METHODS: We conducted a retrospective study to analyse the incidence of iSCI following treatment of cerebral reperfusion. The baseline and clinical characteristics of the patients identified with iSCI and the incidence of iSCI is compared between two groups according to the availability of mechanical thrombectomy: one (pre-thrombectomy group) that received intravenous fibrinolysis as the only treatment for cerebral reperfusion available in that moment; and another (post-thrombectomy group) that received a mechanical thrombectomy with or without intravenous fibrinolysis. RESULTS: Of the 390 patients who received reperfusion, 8.2% had iSCI. Of the 135 patients treated with intravenous fibrinolysis, 4.4% (n = 6) developed iSCI (pre-thrombectomy group), and of the 255 patients treated in the post-thrombectomy group, iSCI was observed in 10.2%. The statistical analysis of the incidence of iSCI between the two groups showed significant differences (p = 0.034). A sensory-motor clinical picture was the most frequent among the patients with iSCI (63.33%), with a frequency of cortical symptoms of 55.17%. CONCLUSIONS: According to the data, there has been an increase in the incidence of iSCI in our setting following the establishment of mechanical thrombectomy.

TITLE: Influencia de la trombectomia mecanica en la incidencia de infarto estriatocapsular aislado y descripcion de sus caracteristicas clinicas.Introduccion. La gran vulnerabilidad a la isquemia de la region estriatocapsular hace que la trombectomia mecanica tenga sus limitaciones en las oclusiones de vaso de gran calibre a la hora de evitar que la region estriatocapsular se infarte. Objetivos. Analizar el efecto del tratamiento endovascular en la incidencia de infarto estriatocapsular aislado (IECa) y describir sus caracteristicas clinicas. Pacientes y metodos. Estudio retrospectivo en el que se analiza la incidencia de IECa tras el tratamiento de reperfusion cerebral. Se describen las caracteristicas basales y clinicas de los pacientes identificados con IECa y se compara la incidencia del IECa entre dos grupos segun la disponibilidad de trombectomia mecanica: uno (grupo pretrombectomia) que recibio fibrinolisis intravenosa como unico tratamiento de reperfusion cerebral disponible en ese momento, y otro (grupo postrombectomia) que recibio trombectomia mecanica con o sin fibrinolisis intravenosa. Resultados. Del total de 390 pacientes reperfundidos, un 8,2% tuvo un IECa. De 135 pacientes tratados con fibrinolisis intravenosa, un 4,4% (n = 6) desarrollo un IECa (grupo pretrombectomia), y de 255 pacientes tratados en el grupo postrombectomia, se visualizo IECa en un 10,2%. El analisis estadistico de la incidencia de IECa entre ambos grupos mostro diferencias significativas (p = 0,034). La clinica sensomotora fue la mas frecuente entre los pacientes con IECa (63,33%), con una frecuencia de sintomas corticales de un 55,17%. Conclusiones. Segun los datos, hemos presenciado un aumento en la incidencia de IECa en nuestro medio tras la instauracion de la trombectomia mecanica.

Preliminary results of the combination of bevacizumab and weekly Paclitaxel in advanced melanoma.

BACKGROUND: Pretreated advanced melanoma is a poor prognosis scenario with few, if any, active therapeutic options. The antibody against vascular endothelial growth factor, bevacizumab, has demonstrated increased activity in combination with chemotherapy in many tumors. We intended to evaluate the activity of the combination of weekly paclitaxel and bevacizumab in previously treated metastatic melanoma. PATIENTS AND METHODS: Patients with previously treated metastatic melanoma received paclitaxel 70 mg/m(2) weekly and bevacizumab 10 mg/kg biweekly for 5 consecutive weeks every 6 weeks. RESULTS: Twelve patients were treated. Two patients (16.6%) achieved a partial response and 7 patients (58.3%) stable disease. Responses were seen in soft tissue, lung and brain metastases. Median disease-free and overall survival times were 3.7 and 7.8 months, respectively. Treatment was well tolerated. Main toxicities were grade 3 asymptomatic lymphopenia in 6 patients, grade 3 leucopenia in 2 patients, and grade 3 thrombocytopenia in 1 patient. CONCLUSIONS: Our preliminary results suggest that the combination of bevacizumab and weekly paclitaxel is active and safe in patients with metastatic melanoma, warranting further investigation.

Response of resistant melanoma to a combination of weekly paclitaxel and bevacizumab.

We report here a taxol-bevacizumab-responsive metastatic melanoma case. Although the patient had been heavily pretreated for two years, she did not show any stabilisation or objective response of her disease. After treatment with taxol and bevacizumab combination an impressive response was obtained.