Effectiveness and Safety of the COVID-19 Vaccine in Patients with Rheumatoid Arthritis in a Real-World Setting.

Novel mechanisms of COVID-19 vaccines raised concern about their potential immunogenicity in patients with rheumatoid arthritis (RA) undergoing immunomodulatory treatments. We designed a retrospective single-center study to investigate their effectiveness and safety in this population, analyzing data from the first vaccination program (December 2020-October 2021). Inclusion criteria were availability of post-vaccination serology and a minimum subsequent follow-up of 6 months. Binding antibody units (BAU/mL) ≥ 7.1 defined an adequate serological response. Post-vaccine COVID-19 incidence and its timing since vaccination, adverse events (AEs), and RA flares were recorded. Adjusted logistic and linear multivariate regression analyses were carried out to identify factors associated with vaccine response. We included 118 patients (87.2% women, age 65.4 ± 11.6 years, evolution 12.0 ± 9.6 years), of whom 95.8% had a complete vaccination schedule. Adequate humoral immunogenicity was achieved in 88.1% of patients and was associated with previous COVID-19 and mRNA vaccines, whereas smoking, aCCP, age, and DMARDs exerted a negative impact. Post-vaccine COVID-19 occurred in 18.6% of patients, a median of 6.5 months after vaccination. Vaccine AE (19.5%) and RA flares (1.7%) were mostly mild and inversely associated with age. Our results suggest that COVID-19 vaccines induce adequate humoral immunogenicity, with an acceptable safety profile in RA patients.

Endoscopic treatment (endoscopic balloon dilation/self-expandable metal stent) vs surgical resection for the treatment of de novo stenosis in Crohn's disease (ENDOCIR study): an open-label, multicentre, randomized trial.

BACKGROUND: Stenosis is one of the most common complications in patients with Crohn's disease (CD). Endoscopic balloon dilation (EBD) is the treatment of choice for a short stenosis adjacent to the anastomosis from previous surgery. Self-expandable metal stents (SEMS) may be a suitable treatment option for longer stenoses. To date, however, there is no scientific evidence as to whether endoscopic (EBD/SEMS) or surgical treatment is the best approach for de novo or primary stenoses that are less than 10 cm in length. METHODS/DESIGN: Exploratory study as "proof-of-concept", multicentre, open-label, randomized trial of the treatment of de novo stenosis in the CD; endoscopic treatment (EBD/SEMS) vs surgical resection (SR). The type of endoscopic treatment will initially be with EDB; if a therapeutic failure occurs, then a SEMS will be placed. We estimate 2 years of recruitment and 1 year of follow-up for the assessment of quality of life, costs, complications, and clinical recurrence. After the end of the study, patients will be followed up for 3 years to re-evaluate the variables over the long term. Forty patients with de novo stenosis in CD will be recruited from 15 hospitals in Spain and will be randomly assigned to the endoscopic or surgical treatment groups. The primary aim will be the evaluation of the patient quality of life at 1 year follow-up (% of patients with an increase of 30 points in the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32). The secondary aim will be evaluation of the clinical recurrence rate, complications, and costs of both treatments at 1-year follow-up. DISCUSSION: The ENDOCIR trial has been designed to determine whether an endoscopic or surgical approach is therapeutically superior in the treatment of de novo stenosis in CD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04330846. Registered on 1 April 1 2020. https://clinicaltrials.gov/ct2/home.

EV-associated miRNAs from peritoneal lavage as potential diagnostic biomarkers in colorectal cancer.

BACKGROUND: Colorectal cancer (CRC) is the third leading cause of cancer-related mortality worldwide. Current systematic methods for diagnosing have inherent limitations so development of a minimally-invasive diagnosis, based on the identification of sensitive biomarkers in liquid biopsies could therefore facilitate screening among population at risk. METHODS: In this study, we aim to develop a novel approach to identify highly sensitive and specific biomarkers by investigating the use of extracellular vesicles (EVs) isolated from the peritoneal lavage as a source of potential miRNA diagnostic biomarkers. We isolated EVs by ultracentrifugation from 25 ascitic fluids and 25 peritoneal lavages from non-cancer and CRC patients, respectively. Analysis of the expression of EV-associated miRNAs was performed using Taqman OpenArray technology through which we could detect 371 miRNAs. RESULTS: 210 miRNAs were significantly dysregulated (adjusted p value < 0.05 and abs(logFC) ≥ 1). The top-10 miRNAs, which had the AUC value higher than 0.95, were miRNA-199b-5p, miRNA-150-5p, miRNA-29c-5p, miRNA-218-5p, miRNA-99a-3p, miRNA-383-5p, miRNA-199a-3p, miRNA-193a-5p, miRNA-10b-5p and miRNA-181c-5p. CONCLUSIONS: This finding opens the avenue to the use of EV-associated miRNA of peritoneal lavages as an untapped source of biomarkers for CRC.

Laparoscopic blood-saving liver resection using a new radiofrequency-assisted device: preliminary report of an in vivo study with pig liver.

BACKGROUND: The aim of any device designed for liver resection is to allow blood saving and quick resections. This may be optimized using a minimally invasive approach. A radiofrequency-assisted device is described that combines a cooled blunt-tip electrode with a sharp blade on one side in an in vivo preliminary study using hand-assisted laparoscopy to perform partial hepatectomies. METHODS: Eight partial hepatectomies were performed on pigs with hand-assisted laparoscopy using the radiofrequency-assisted device as the only method for transection and hemostasis. The main outcome measures were transection time, blood loss, transection area, transection speed, blood loss per transection area, and tissue coagulation depth. The risk for biliary leak also was assessed using the methylene blue test. RESULTS: The transection time was 13 +/- 7 min for a mean transected area of 34 +/- 11 cm(2). The mean total blood loss was 26 +/- 34 ml. The mean transection speed was 3 +/- 1 cm(2)/min, and the blood loss per transection area was 1 +/- 1 ml/cm(2). Abdominal examination showed no complications in nearby organs. One biliary leak was identified in one case using the methylene blue test. The transection surface was 34 +/- 11 cm(2), and the mean tissue coagulation depth was 9 +/- 2 mm. The inviability of the coagulated surface was assessed by adenine dinucleotide (NADH) staining. CONCLUSIONS: The radiofrequency-assisted device has shown with a laparoscopic approach that it can perform liver resections faster and with less blood loss using a single device in a minimally invasive manner without vascular control than other commercial devices. The results show no significant differences with the same device used in an open procedure.

[Minimally invasive breast surgery. Breast reconstruction using pure muscular latissimus dorsi flap]. / Cirugía mamaria mínimamente invasiva: reconstrucción mamaria mediante colgajo muscular puro del gran dorsal.

INTRODUCTION: Minimally invasive surgical techniques have extended to all the fields of surgery. Breast surgery can also benefit from these concepts because of their special characteristics, reduction of aggressiveness, avoiding or hiding scars. The aim of our work is to introduce a new surgical approach for the resection of a large volume of breast parenchyma, including complete subcutaneous mastectomy and reconstruction using a pure muscular latissimus dorsi flap, with or without prosthetic material, through a minimal cutaneous incision. PATIENTS AND METHOD: Retrospective analysis of our series of 5 cases using our surgical technique which allows us to establish proper indications. We analyse the technical details, complications and results. RESULTS: Five patients were operated using this technique (1 giant hamartoma, 1 multicentred in situ carcinoma with Paget's disease, 1 multicentred infiltrating carcinoma and 2 malignant tumours arising in the external part of the breast). We performed oncological resections (2 partial resections and 3 complete subcutaneous mastectomies) including sentinel lymph node biopsy or total axillary lymphadenectomy. After a mean follow-up of 10 months no local relapses were found and the cosmetic results were excellent. CONCLUSIONS: Minimally invasive surgical techniques through a posterior axillary line vertical incision enable total or partial subcutaneous mastectomy and a breast reconstruction, using muscular flaps or prosthetic material, to be performed.

Cirugía mamaria mínimamente invasiva: reconstrucción mamaria mediante colgajo muscular puro del gran dorsal / Minimally invasive breast surgery. Breast reconstruction using pure muscular latissimus dorsi flap

Introducción. Las técnicas mínimamente invasivas se han extendido a todos los campos de la cirugía, la cirugía mamaria es quizá la cirugía que más se debería beneficiar de estos conceptos, por sus características especiales, reduce la agresión quirúrgica y elimina u oculta cicatrices. El propósito de nuestro trabajo es presentar una nueva técnica quirúrgica para la resección de grandes volúmenes de tejido mamario, incluida la mastectomía subcutánea completa, y reconstrucción mediante un colgajo del músculo gran dorsal con o sin material protésico, a través de una mínima incisión cutánea. Pacientes y metodo. Análisis retrospectivo de nuestra serie de 5 casos clínicos intervenidos con esta técnica, que nos ha permitido ponerla a punto y establecer las indicaciones. Analizamos los detalles técnicos, las complicaciones y los resultados. Resultados. Hemos intervenido a 5 pacientes mediante esta técnica quirúrgica (1 con hamartoma gigante, 1 con carcinoma in situ multicéntrico con enfermedad de Paget, 1 con tumor mamario maligno multicéntrico y 2 con tumoraciones malignas únicas de cuadrantes externos) practicando resecciones oncológicas suficientes (2 resecciones parciales mamarias y 3 mastectomías subcutáneas) e incluían biopsia de ganglio centinela o linfadenectomía axilar completa. Tras un período de seguimiento medio de 10 meses no ha habido recidivas locales y el resultado estético es excelente. Conclusiones. La técnica mínimamente invasiva, a través de una incisión vertical en línea axilar posterior, permite realizar una resección mamaria parcial o completa, así como una reconstrucción inmediata mediante tejido autólogo o material protésico (AU)

Introduction. Minimally invasive surgical techniques have extended to all the fields of surgery. Breast surgery can also benefit from these concepts because of their special characteristics, reduction of aggressiveness, avoiding or hiding scars. The aim of our work is to introduce a new surgical approach for the resection of a large volume of breast parenchyma, including complete subcutaneous mastectomy and reconstruction using a pure muscular latissimus dorsi flap, with or without prosthetic material, through a minimal cutaneous incision. Patients and method. Retrospective analysis of our series of 5 cases using our surgical technique which allows us to establish proper indications. We analyse the technical details, complications and results. Results. Five patients were operated using this technique (1 giant hamartoma, 1 multicentred in situ carcinoma with Paget's disease, 1 multicentred infiltrating carcinoma and 2 malignant tumours arising in the external part of the breast). We performed oncological resections (2 partial resections and 3 complete subcutaneous mastectomies) including sentinel lymph node biopsy or total axillary lymphadenectomy. After a mean follow-up of 10 months no local relapses were found and the cosmetic results were excellent. Conclusions. Minimally invasive surgical techniques through a posterior axillary line vertical incision enable total or partial subcutaneous mastectomy and a breast reconstruction, using muscular flaps or prosthetic material, to be performed (AU)