Comparing the influence of two immunosuppressants (fingolimod, azathioprine) on wound healing in a rat model of primary and secondary intention wound closure.

In this study, rat models of wound closure by first and second intention were developed to evaluate the influence that two immunosuppressants for treating multiple sclerosis (fingolimod, azathioprine) have on wound healing. Sixty-three Sprague-Dawley rats were daily treated with fingolimod (0.6 mg/kg), azathioprine (2.5 mg/kg), or placebo (saline). Following 6 weeks of treatment, a linear incision (1.5 cm) or a circular excisional defect (diameter 1.5 cm) was made on the dorsal skin. The treatments were uninterrupted and after 7 days (incisional) or 21 days (incisional, excisional), animals were euthanized (n = 7 per group and time-point). Morphometric (wound closure), histological (stainings), and immunofluorescent studies (macrophages) were performed to evaluate the healing process. For both the incisional and excisional defects, animals treated with fingolimod exhibited a healing process equivalent to that of placebo in terms of collagenization, wound closure, and macrophage response. By comparison, groups treated with azathioprine displayed a delay in healing times which was especially evident in the excisional defect, where inflammatory reaction and collagen deposition in the repair tissue remained active by day 21. These results show that immunosuppressants with a selective mechanism of action (fingolimod) can have less impact on wound healing than their classical nonselective counterparts (azathioprine).

Behavior of a new long-chain cyanoacrylate tissue adhesive used for mesh fixation in hernia repair.

BACKGROUND: Synthetic tissue adhesives (TA) are sometimes used in hernia repair surgery. This study compares the use of a new, noncommercial, long-chain cyanoacrylate (n-octyl) TA and Ifabond for mesh fixation. MATERIALS AND METHODS: In two implant models in the rabbit, expanded polytetrafluorethylene meshes were fixed to the parietal peritoneum using a TA or tacks (intraperitoneal model), or polypropylene meshes used to repair partial abdominal wall defects were fixed with a TA or sutures (extraperitoneal model). Animals were euthanized 14 or 90 d postsurgery and implant specimens were processed for microscopy (labeling of macrophages and apoptotic cells), peritoneal fluid and biomechanical strength testing. Interleukin 6 (IL-6) and tumor necrosis factor α (TNF-α) were determinated in peritoneal fluid. RESULTS: Mesothelial cell deposition on the intraperitoneal implants fixed using the new TA and Ifabond was adequate and similar IL-6 and TNF-α levels were detected in these implants. Intraperitoneal meshes fixed with tacks showed IL-6 overexpression. Three months after surgery, macrophage and apoptotic cell rates were higher for the intraperitoneal implants fixed with Ifabond versus the new TA or tacks. In the extraperitoneal model, reduced macrophage and cell damage responses were observed in the meshes fixed with sutures versus both TA. Tensile strengths were greater for the tacks versus TA in the intraperitoneal implants and similar for the sutures and TA in the extraperitoneal implants (90 d). CONCLUSIONS: Both TA showed a good cell response in both models. Their use in an intraperitoneal location resulted in reduced tensile strength compared with the tacks. However, strengths were comparable when extraperitoneal implants were fixed with these adhesives or sutures.

Relationship between volume and in-hospital mortality in digestive oncological surgery.

INTRODUCTION: The results previously obtained in Spain in the study of the relationship between surgical caseload and in-hospital mortality are inconclusive. The aim of this study is to evaluate the volume-outcome association in Spain in the setting of digestive oncological surgery. METHODS: An analytical, cross-sectional study was conducted with data from patients who underwent surgical procedures with curative intent of esophageal, gastric, colorectal and pancreatic neoplasms between 2006-2009 with data from the Spanish MBDS. In-hospital mortality was used as outcome variable. Control variables were patient, health care and hospital characteristics. Exposure variable was the number of interventions for each disease, dividing the hospitals in 3 categories: high volume (HV), mid volume (MV) and low volume (LV) according to the number of procedures. RESULTS: An inverse, statistically significant relationship between procedure volume and in-hospital mortality was observed for both volume categories in both gastric (LV: OR=1,50 [IC 95%: 1,28-1,76]; MV: OR=1,49 (IC 95%: 1,28-1,74)) and colorectal (LV: OR=1,44 [IC 95%: 1,33-1,55]; MV: OR=1,24 [IC 95%: 1,15-1,33]) cancer surgery. In pancreatic procedures, this difference was only statistically significant between LV and HV categories (LV: OR=1,89 [IC 95%: 1,29-2,75]; MV: OR=1,21 [IC 95%: 0,82-1,79]). Esophageal surgery also showed an inverse relationship, which was not statistically significant (LV: OR=1,89 [IC 95%: 0,98-3,64]; MV: OR=1,05 [IC 95%: 0,50-2,21]). CONCLUSIONS: The results of this study suggest the existence in Spain of an inverse relationship between caseload and in-hospital mortality in digestive oncological surgery for the procedures analyzed.

Comparing the host tissue response and peritoneal behavior of composite meshes used for ventral hernia repair.

BACKGROUND: The use of a prosthetic material is the best treatment option for ventral hernia repair; one of the most frequently performed abdominal surgery procedures. This preclinical study compares the behavior of a new mesh (Parietex composite ventral patch [Ptx]) with that of two existing meshes used for ventral hernia repair. MATERIALS AND METHODS: Fifty-four New Zealand White rabbits (3000 g) were used in an experimental model of umbilical hernia repair (diameter 1.5 cm). The materials tested were: Ventralex ST hernia patch (Vent) (Bard Davol Inc, Warwick, RI) (n = 18); Proceed ventral patch (Ethicon, Somerville, NJ) (PVP) (n = 18) and Ptx (Covidien, Sofradim, Trevoux, France) (n = 18). At 3, 7, 14 d, and 6 wk after implant, peritoneal behavior and adhesion formation were assessed by sequential laparoscopy. Mesh mesothelial cover was determined by scanning electron microscopy. Host tissue ingrowth (collagens I and III) and the macrophage response were assessed by immunohistochemical labeling. Animals were euthanized at 2, 6 wk, and 6 mo after surgery. Data were compared using the Mann-Whitney U test. RESULTS: Adhesion formation from 3 d-6 wk was significantly greater (P < 0.05) for PVP compared with Vent or Ptx. Three encapsulated PVP implants showed "tissue-integrated" adhesions affecting the intestinal loops. All three implant types showed similar patterns of collagen l and III deposition. The PVP mesh elicited the greater macrophage response both at 2 wk and 6 mo. CONCLUSIONS: Ptx and Vent showed excellent mesothelialization, which led to minimum adhesion formation. The appropriate tissue integration of Ptx in the parietal neoperitoneum is likely attributable to its deployment system.

New suture materials for midline laparotomy closure: an experimental study.

BACKGROUND: Midline laparotomy closure carries a significant risk of incisional hernia. This study examines the behavior of two new suture materials, an elastic material, polyurethane (PUe), and a barbed polydioxanone (PDXb) suture thread in a rabbit model of midline incision closure. METHODS: Three 2-cm midline incisions were made in 68 New Zealand White rabbits. The incisions were closed by running suture using four 3/0 threads: polypropylene (PP) (Surgipro®, Covidien), PUe (Assuplus®, Assut Europe), PDX (Assufil®, Assut Europe) or PDXb (Filbloc®, Assut Europe). Animals in each suture group were euthanized 3 weeks and 6 months after surgery. Histological sections of the tissue-embedded sutures were subjected to morphological, collagen expression, macrophage response and uniaxial tensiometry studies. RESULTS: No signs of wound dehiscence or complications were observed. At 3 weeks, all sutures were surrounded by connective tissue composed mainly of collagen III. PUe showed greater collagen I expression than the other sutures. All sutures elicited a macrophage response that diminished from 3 weeks to 6 months (p < 0.001). This response was similar for the non-reabsorbable sutures (PP and PUe) yet PDXb showed a significantly greater response than the other reabsorbable suture (PDX) at 3 weeks (p < 0.01). At this early time point, the tensile strength of PUe was similar to that of control intact tissue (p > 0.05). CONCLUSION: Three weeks after surgery, PUe revealed more collagen I deposition than the remaining materials and this translated to a similar biomechanical behavior to linea alba, that could avoid the appearance of short term dehiscences and thus reduce the incidence of incisional hernia. PDXb provides no additional advantages in their behavior regarding PDX suture.

Utility of time in tight range (TITR) in evaluating metabolic control in pediatric and adult patients with type 1 diabetes in treatment with advanced hybrid closed-loop systems.

PURPOSE: To analyze the time in tight range (TITR), and its relationship with other glucometric parameters in patients with type 1 diabetes (T1D) treated with advanced hybrid closed-loop (AHCL) systems. METHODS: A prospective observational study was conducted on pediatric and adult patients with T1D undergoing treatment with AHCL systems for at least 3 months. Clinical variables and glucometric parameters before and after AHCL initiation were collected. RESULTS: A total of 117 patients were evaluated. Comparison of metabolic control after AHCL initiation showed significant improvements in HbA1c (6.9 ± 0.9 vs. 6.6 ± 0.5%, p < 0.001), time in range (TIR) (68.2 ± 11.5 vs. 82.5 ± 6.9%, p < 0.001), TITR (43.7 ± 10.8 vs. 57.3 ± 9.7%, p < 0.001), glucose management indicator (GMI) (6.9 ± 0.4 vs. 6.6 ± 0.3%, p < 0.001), time below range (TBR) 70-54 mg/dl (4.3 ± 4.5 vs. 2.0 ± 1.4%, p < 0.001), and time above range (TAR) > 180 mg/dl (36.0 ± 7.6 vs. 15.1 ± 6.4%, p < 0.001). Coefficient of variation (CV) also improved (36.3 ± 5.7 vs. 30.6 ± 3.7, p < 0.001), while time between 140-180 mg/dl remained unchanged. In total, 76.3% achieved TITR > 50% (100% pediatric). Correlation analysis between TITR and TIR and GRI showed a strong positive correlation, modified by glycemic variability. CONCLUSIONS: AHCL systems achieve significant improvements in metabolic control (TIR > 70% in 93.9% patients). The increase in TIR was not related to an increase in TIR 140-180 mg/dl. Despite being closely related to TIR, TITR allows for a more adequate discrimination of the achieved control level, especially in a population with good initial metabolic control. The correlation between TIR and TITR is directly influenced by the degree of glycemic variability.

Quality of life, diabetes-related stress and treatment satisfaction are correlated with glycemia risk index (GRI), time in range and hypoglycemia/hyperglycemia components in type 1 diabetes.

INTRODUCTION: To evaluate the relationship between the GRI -component of hypoglycemia (CHypo) and hyperglycemia (CHyper)- with diabetes quality of life (DQoL), diabetes-related stress (DDS), perception of hypoglycemia (Clarke Test), visual analogic scale (VAS) and diabetes-knowledge (DKQ2) in T1D. METHODS: Cross-sectional study in 92 patients with T1D under intensive insulin treatment (21.7% CSII) and flash glucose monitoring (isCGM). Clinical, metabolic and glycometric parameters and quality of life/satisfaction questionnaires were analyzed. RESULTS: 92 patients (54.3% male, BMI 25.4 ± 4.5 kg/m2, HbA1c 7.5 ± 1.0%, TIR 53.9 ± 15.9%) with mean age 36.1 ± 12.6years and 17.8 ± 11.3 T1D duration. The mean GRI was 60.6 ± 22.2 with a CHypo and CHyper of 5.9 ± 4.8 and 27.3 ± 14.4, respectively. 19.1% presented a pathological Clarke's test. Patients with TIR > 70% and GRI < 40 showed better VAS (8.8 ± 1.3 vs 9.3 ± 0.9, p < 0.05) and DDS (46.4 ± 22.1 vs 36.7 ± 16.6, p < 0.05) scores, showing no differences between groups. CHyper > 15 and Chypo > 3.4 were related to worse levels of DQoL (91.1 ± 23.9 vs 76.6 ± 18.6 and 94.6 ± 24.8 vs 79.8 ± 20.1, p < 0.01), DDS(49.8 ± 22.4 vs 35.7 ± 16.5 and 49.8 ± 22.4 vs 35.7 ± 16.5, p < 0.01),and DKQ2 (24.4 ± 4.3 vs 26.8 ± 5.2 and 24.1 ± 4.8 vs 26.0 ± 4.6, p < 0.05), respectively. Worse metabolic control defined by GRI correlated with worse scores in VAS (r = -0.209, p < 0.05), DQoL (r = 0.205, p < 0.05), and DDS (r = 0.205, p < 0.05). No difference was observed in knowledge´s scale. CHyper correlated with worse scores in VAS (r = -0.231, p < 0.05), DQoL (r = 0.422, p < 0.01), and DDS (r = 0.341, p < 0.01) and lower degree of knowledge DKQ2 (r = -0.231, p < 0.05). When analyzing DQoL as a dependent variable in a multiple lineal regression, only age (ß = 0.747; p < 0.001) and CHyper (ß = 0.717; p < 0.001) maintained statistical significance. CONCLUSIONS: Higher GRI was related to worse quality of life, diabetes-related stress and satisfaction with treatment, analogous to the TIR results.CHyper an Chypo were related to a greater decline in quality of life, diabetes-related stress, and lower satisfaction with treatment.However, in a multiple linear regression, only CHyper maintained statistical significance.

Effectiveness of High-Protein Energy-Dense Oral Supplements on Patients with Malnutrition Using Morphofunctional Assessment with AI-Assisted Muscle Ultrasonography: A Real-World One-Arm Study.

Background: User-friendly tools for assessing nutrition status and interventions in malnourished patients are crucial. This study evaluated the effectiveness of a personalised nutrition intervention using a novel oral nutritional supplement and AI-supported morphofunctional assessment to monitor clinical outcomes in patients with disease-related malnutrition (DRM). Methods: This prospective observational study involved patients receiving concentrated high-protein, high-calorie ONS (cHPHC-ONS), per usual clinical practice. Comprehensive assessments were performed at baseline (B0) and three months (M3) post-intervention. Results: 65 patients participated in the study. Significant decreases were observed in the percentage weight loss from B0 (-6.75 ± 7.5%) to M3 (0.5 ± 3.48%) (p < 0.01), in the prevalence of malnutrition (B0: 93.4%; M3: 78.9%; p < 0.01), severe malnutrition (B0: 60.7%; M3: 40.3%; p < 0.01), and sarcopenia (B0: 19.4%; M3: 15.5%; p < 0.04). Muscle area increased (p = 0.03), and there were changes in the echogenicity of the rectus femoris muscle (p = 0.03) from B0 to M3. In patients aged ≥60, an increase in muscle thickness (p = 0.04), pennation angle (p = 0.02), and handgrip strength (p = 0.04) was observed. There was a significant reduction in the prevalence of malnutrition (B0: 93.4%; M3: 78.9%; p < 0.01) and severe malnutrition (B0: 60.7%; M3: 40.3%; p < 0.01). Conclusions: In patients with DRM, a personalised intervention with cHPHC-ONS significantly reduces the prevalence of malnutrition, severe malnutrition, and sarcopenia and improves muscle mass and function.

Clinical Evaluation of an Artificial Intelligence-Based Decision Support System for the Diagnosis and American College of Radiology Thyroid Imaging Reporting and Data System Classification of Thyroid Nodules.

Background: This study aimed to evaluate the clinical impact of an artificial intelligence (AI)-based decision support system (DSS), Koios DS, on the analysis of ultrasound imaging and suspicious characteristics for thyroid nodule risk stratification. Methods: A retrospective ultrasound study was conducted on all thyroid nodules with histological findings from June 2021 to December 2022 in a thyroid nodule clinic. The diagnostic performance of ultrasound imaging was evaluated by six readers on the American College of Radiology Thyroid Imaging Reporting and Data System (ACR TI-RADS) before and after the use of the AI-based DSS and by AI itself. Results: A total of 172 patients (83.1% women) with a mean age of 52.3 ± 15.3 years were evaluated. The mean maximum nodular diameter was 2.9 ± 1.2 cm, with 11.0% being differentiated thyroid carcinomas. Among the nodules initially classified as ACR TI-RADS 3 and 4, AI reclassified 81.4% and 24.5% into lower risk categories, respectively. Receiver operating characteristic (ROC) curve analysis was performed to evaluate the diagnostic performance of the readers and the AI-based DSS versus histological diagnosis. There was an increase in the area under the ROC curve (AUROC) after the use of AI (0.776 vs. 0.817, p < 0.001). The AI-based DSS improved the mean sensitivity (Sens) (82.3% vs. 86.5%) and specificity (Spe) (38.3% vs. 54.8%), produced a high negative predictive value (94.5% vs. 96.4%), and increased the positive predictive value (PPV) (14.0% vs. 16.1%) and diagnostic precision (43.0% vs. 49.3%). Based on the ACR TI-RADS score, there was significant improvement in interobserver agreement after the use of AI (r = 0.741 for ultrasound imaging alone vs. 0.981 for ultrasound imaging and the AI-based DSS, p < 0.001). Conclusions: The use of an AI-based DSS was associated with overall improvement in the diagnostic efficacy of ultrasound imaging, based on the AUROC, as well as an increase in Sens, Spe, negative and PPVs, and diagnostic accuracy. There was also a reduction in interobserver variability and an increase in the degree of concordance with the use of AI. AI reclassified more than half of the nodules with intermediate ACR TI-RADS scores into lower risk categories.

Clinical, glycometric features and treatment in a family with monogenic diabetes due to a new mutation in the insulin gene.

Monogenic diabetes caused by changes in the gene that encodes insulin (INS) is a very rare form of monogenic diabetes (<1%). The aim of this work is to describe the clinical and glycaemic control characteristics over time from four members of a family diagnosed with monogenic diabetes with the novel mutation: c.206del,p.(Gly69Aalfs*62) located in exon 3 of the gene INS. 75% are females, with debut in adolescence and negative autoimmunity. In all cases, C-peptide is detectable decades after diagnosis (>0.6ng/ml). Currently, patients are being treated either with insulin in a bolus-basal regimen, oral antidiabetics or hybrid closed loop system. Monogenic diabetes due to mutation in the INS is an entity with heterogeneous presentation, whose diagnosis requires high suspicion and presents an important clinical impact. Given the lack of standards in this regard, therapy must be individualized, although insulin therapy could help preserve beta cell functionality in these subjects.

Impact of glucose variability on the assessment of the glycemia risk index (GRI) and classic glycemic metrics.

OBJECTIVE: To evaluate the impact of glucose variability on the relationship between the GRI and other glycemic metrics in a cohort of pediatric and adult patients with type 1 diabetes (T1D) using intermittent scanning continuous glucose monitoring (isCGM). METHODS: We performed a cross-sectional study of 202 patients with T1D under intensive insulin treatment (25.2% CSII) using isCGM. Clinical, metabolic, and glycemic metrics were collected, and the GRI was calculated with its hypoglycemia (CHypo) and hyperglycemia (CHyper) components. The correlation between the GRI and other classical glycometrics in relation to the coefficient of variation (CV) was evaluated. RESULTS: A total of 202 patients were included (53% male; 67.8% adults) with a mean age of 28.6 ± 15.7 years and 12.5 ± 10.9 years of T1D evolution (TIR 59.0 ± 17.0%; CV 39.8 ± 8.0%; GMI 7.3 ± 1.1%). The mean GRI was 54.0 ± 23.3 with a CHypo and CHyper component of 5.7 ± 4.8 and 23.4 ± 14.3, respectively. A strong negative correlation was observed between the GRI and TIR (R = -0.917; R2 = 0.840; p < 0.001), showing differences when dividing patients with low glycemic variability (CV < 36%) (R = -0.974; R2 = 0.948; p < 0.001) compared to those with greater CV instability (≥36%) (R = -0.885; R2 = 0.784; p < 0.001). The relationship of GRI with its two components was strongly positive with CHyper (R = 0.801; R2 = 0.641; p < 0.001) and moderately positive with CHypo (R = 0.398; R2 = 0.158; p < 0.001). When the GRI was evaluated with the rest of the classic glycemic metrics, a strong positive correlation was observed with HbA1c (R = 0.617; R2 = 0.380; p < 0.001), mean glucose (R = 0.677; R2 = 0.458; p < 0.001), glucose standard deviation (R = 0.778; R2 = 0.605; p < 0.001), TAR > 250 (R = 0.801; R2 = 0.641; p < 0.001), and TBR < 54 (R = 0.481; R2 = 0.231; p < 0.001). CONCLUSIONS: The GRI correlated significantly with all the glycemic metrics analyzed, especially with the TIR. Glycemic variability (GV) significantly affected the correlation of the GRI with other parameters and should be taken into consideration.

Glycemia Risk Index Assessment in a Pediatric and Adult Patient Cohort With Type 1 Diabetes Mellitus.

BACKGROUND: To evaluate the glycemia risk index (GRI) as a new glucometry in pediatric and adult populations with type 1 diabetes (T1D) in clinical practice. METHODS: A cross-sectional study of 202 patients with T1D receiving intensive treatment with insulin (25.2% continuous subcutaneous insulin infusion [CSII]) and intermittent scanning (flash) glucose monitoring (isCGM). Clinical and glucometric isCGM data were collected, as well as the component of hypoglycemia (CHypo) and component of hyperglycemia (CHyper) of the GRI. RESULTS: A total of 202 patients (53% males and 67.8% adults) with a mean age of 28.6 ± 15.7 years and 12.5 ± 10.9 years of T1D evolution were evaluated.Adult patients (>19 years) presented higher glycated hemoglobin (HbA1c) (7.4 ± 1.1 vs 6.7 ± 0.6%; P < .01) and lower time in range (TIR) (55.4 ± 17.5 vs 66.5 ± 13.1%; P < .01) values than the pediatric population, with lower coefficient of variation (CV) (38.6 ± 7.2 vs 42.4 ± 8.9%; P < .05). The GRI was significantly lower in pediatric patients (48.0 ± 22.2 vs 56.8 ± 23.4; P < .05) associated with higher CHypo (7.1 ± 5.1 vs 5.0 ± 4.5; P < .01) and lower CHyper (16.8 ± 9.8 vs 26.5 ± 15.1; P < .01) than in adults.When analyzing treatment with CSII compared with multiple doses of insulin (MDI), a nonsignificant trend to a lower GRI was observed in CSII (51.0 ± 15.3 vs 55.0 ± 25.4; P= .162), with higher levels of CHypo (6.5 ± 4.1 vs 5.4 ± 5.0; P < .01) and lower CHyper (19.6 ± 10.6 vs 24.6 ± 15.2; P < .05) compared with MDI. CONCLUSIONS: In pediatric patients and in those with CSII treatment, despite a better control by classical and GRI parameters, higher overall CHypo was observed than in adults and MDI, respectively. The present study supports the usefulness of the GRI as a new glucometric parameter to evaluate the global risk of hypoglycemia-hyperglycemia in both pediatric and adult patients with T1D.

Nutritional Ultrasonography, a Method to Evaluate Muscle Mass and Quality in Morphofunctional Assessment of Disease Related Malnutrition.

Nutritional ultrasonography is an emerging technique for measuring muscle mass and quality. The study aimed to evaluate the relationship between the parameters of body mass and quality of ultrasonography with other parameters of morphofunctional assessment in patients with disease-related malnutrition (DRM). METHODS: A cross-sectional study was developed on 144 patients diagnosed with DRM according to the Global Leadership Initiative on Malnutrition (GLIM) criteria. Morphofunctional evaluation was assessed with anthropometric variables, handgrip strength and bioelectrical impedanciometry (BIA). Nutritional ultrasonography of quadriceps rectus femoris (QRF) was made (muscle mass (Muscle Area of Rectus Femoris index (MARFI)), Y axis and muscle quality (X-Y index and echogenicity). RESULTS: The mean age of patients was 61.4 (17.34) years. The prevalence of sarcopenia in the sample was 33.3%. Patients with sarcopenia (S) had lower values of MARFI [(S: 1.09 (0.39) cm2/m2; NoS: 1.27 (0.45); p = 0.02), Y axis (S: 0.88 (0.27); NoS: 1.19 (0.60); p < 0.01) and X-Y index (S: 1.52 (0.61); NoS: 1.30 (0.53); p < 0.01)]. There was a correlation between BIA parameters (phase angle) and muscle mass ultrasonographic variables (MARFI) (r = 0.35; p < 0.01); there was an inverse correlation between muscle quality ultrasonographic variables (echogenicity) and handgrip strength (r = -0.36; p < 0.01). In the multivariate analysis adjusted by age, the highest quartile of the X-Y index had more risk of death OR: 4.54 CI95% (1.11-18.47). CONCLUSIONS: In patients with DRM and sarcopenia, standardized muscle mass and muscle quality parameters determined by ultrasonography of QRF are worse than in patients without sarcopenia. Muscle quality parameters had an inverse correlation with electric parameters from BIA and muscle strength. The highest quartile of the X-Y index determined by ultrasonography was associated with increased mortality risk.

Predictive value and dynamic risk stratification of high sensitive basal or stimulated thyroglobulin assay in a long-term thyroid carcinoma cohort.

PURPOSE: To evaluate the predictive value of the rhTSH thyroglobulin stimulation test (rhTSH-Tg) compared to basal high-sensitive thyroglobulin (hs-Tg) under TSH suppressive therapy at 12 months after the completion of initial treatment to predict the long-term response and Dynamic Risk Stratification (DRS) at the last follow-up visit in a long-term DTC cohort. METHODS: Prospective study in 114 DTC patients (77.2% women, mean age 46.4 ± 14.1 years old, median/IQR evolution 6.7[3.1-8.0] years) from 2013 to 2020 undergoing total thyroidectomy and radioiodine ablation in whom hs-Tg and rhTSH-Tg was performed 12 months after completing initial treatment. Pearson correlation, receiving operating characteristics (ROC) and DRS at initial and last follow-up visit were analyzed. RESULTS: hs-Tg and rhTSH-Tg show a strong positive linear correlation (r = 0.864, p < 0.001). The diagnostic performance of initial hs-Tg and rhTSH-Tg levels were evaluated via ROC-AUC as a predictor of excellent response (ER) in the last follow-up visit. Hs-Tg showed a better AUC (0.969, 95%CI = 0.941-0.997) than rhTSH-Tg (0.944, 95%IC = 0.905-0.984; p < 0.001). The hs-Tg and rhTSH-Tg cutoff point of highest sensitivity (S) and specificity (E) was 0.110 and 0.815 ng/dl, respectively. Hs-Tg showed a higher diagnostic accuracy than rhTSH-Tg (S = 100% vs 96.8%, E = 84.3% vs 84.3%, NPV = 100% vs 98.6%, PPV = 70.5% vs 69.7%; p < 0.05). The DRS based on initial hs-Tg showed better ability to predict ER (93.3% vs 86.7%) and biochemical incomplete response (53.3%vs13.3%) in the last follow-up visit compared to rhTSH-Tg. CONCLUSIONS: Both initial hs-Th and rhTSH-Tg were good predictors of long-term ER. In patients with hs-Tg, the rhTSH-test did not provide relevant prognosis information. An ER after initial treatment was associated with a very high NPV at subsequent follow-up.

* The New Zealand White Rabbit as a Model for Preclinical Studies Addressing Tissue Repair at the Level of the Abdominal Wall.

In this report, we review the use of the New Zealand White rabbit as the experimental animal for several models of abdominal wall repair. For the repair of an abdominal wall defect, such as a hernia in clinical practice, multiple types of prosthetic material exist. Before their marketing, each of these biomaterials needs to be tested in a preclinical setting to confirm its biocompatibility and appropriate behavior at the different tissue interfaces. For preclinical trials, we have always used the New Zealand White rabbit as the model owing to its ease of handling and suitable size. This size allows for laparoscopic studies designed to follow the behavior in real time of a biomaterial implanted at the peritoneal interface, a delicate interface that often gives rise to complications in human practice. The size of the rabbit also offers a sufficiently large number of implant samples to be harvested for a complete battery of tests at several time points postimplant. In this review, we first describe the models established and then provide the results obtained so far using these models to test the different types of biomaterial. We end our review with a discussion of the clinical implications of these results.

Relación entre volumen de casos y mortalidad intrahospitalaria en la cirugía del cáncer digestivo / Relationship between volume and in-hospital mortality in digestive oncological surgery

INTRODUCCIÓN: Los resultados de estudios realizados en España sobre la relación inversa entre el número de intervenciones quirúrgicas y la mortalidad intrahospitalaria no han sido concluyentes. El objetivo de este trabajo ha sido analizar la relación entre número de intervenciones quirúrgicas y mortalidad en la cirugía del cáncer digestivo en España. MÉTODOS: Estudio analítico, transversal con datos procedentes del CMBD, de los pacientes tratados con cirugía con intención curativa de neoplasias esofágicas, gástricas, colorrectales y pancreáticas entre 2006 y 2009. Se utilizó la mortalidad intrahospitalaria como variable de resultados. Las variables de control fueron características de los pacientes, la asistencia sanitaria y los hospitales. La variable de exposición fue el número de intervenciones para cada enfermedad, dividiendo los hospitales en 3 categorías: volumen alto (VA), volumen medio (VM) y volumen bajo (VB) en función del número de intervenciones quirúrgicas realizadas. RESULTADOS: Se observó una relación inversa, estadísticamente significativa en ambas categorías, de volumen tanto en cirugía gástrica (VB: OR = 1,50 [IC 95%: 1,28-1,76]; VM: OR = 1,49 [IC 95%: 1,28-1,74]) como en cirugía colorrectal (VB: OR = 1,44 [IC 95%: 1,33-1,55]; VM: OR = 1,24 [(IC 95%: 1,15-1,33]). En cirugía pancreática, la diferencia solo fue estadísticamente significativa entre las categorías de menor y mayor volumen (VB: OR = 1,89 [IC 95%: 1,29-2,75]; VM: OR = 1,21 [IC 95%: 0,82-1,79]). La cirugía de esófago también mostró una relación inversa entre el volumen de intervenciones quirúrgicas y la mortalidad, pero no fue estadísticamente significativa (VB: OR = 1,89 [IC 95%: 0,98-3,64]; VM: OR = 1,05 [IC 95%: 0,50-2,21]). CONCLUSIONES: Estos resultados indican que en España existe una relación inversa entre número de intervenciones quirúrgicas y mortalidad intrahospitalaria en la cirugía del cáncer digestivo

INTRODUCTION: The results previously obtained in Spain in the study of the relationship between surgical caseload and in-hospital mortality are inconclusive. The aim of this study is to evaluate the volume-outcome association in Spain in the setting of digestive oncological surgery. METHODS: An analytical, cross-sectional study was conducted with data from patients who underwent surgical procedures with curative intent of esophageal, gastric, colorectal and pancreatic neoplasms between 2006-2009 with data from the Spanish MBDS. In-hospital mortality was used as outcome variable. Control variables were patient, health care and hospital characteristics. Exposure variable was the number of interventions for each disease, dividing the hospitals in 3 categories: high volume (HV), mid volume (MV) and low volume (LV) according to the number of procedures. RESULTS: An inverse, statistically significant relationship between procedure volume and in-hospital mortality was observed for both volume categories in both gastric (LV: OR = 1,50 [IC 95%: 1,28-1,76]; MV: OR = 1,49 (IC 95%: 1,28-1,74)) and colorectal (LV: OR = 1,44 [IC 95%: 1,33-1,55]; MV: OR = 1,24 [IC 95%: 1,15-1,33]) cancer surgery. In pancreatic procedures, this difference was only statistically significant between LV and HV categories (LV: OR = 1,89 [IC 95%: 1,29-2,75]; MV: OR = 1,21 [IC 95%: 0,82-1,79]). Esophageal surgery also showed an inverse relationship, which was not statistically significant (LV: OR = 1,89 [IC 95%: 0,98-3,64]; MV: OR = 1,05 [IC 95%: 0,50-2,21]). CONCLUSIONS: The results of this study suggest the existence in Spain of an inverse relationship between caseload and in-hospital mortality in digestive oncological surgery for the procedures analyze