Impact of gender on in-hospital and long-term outcomes after transcatheter aortic valve implantation: an analysis of the Spanish TAVI registry.

INTRODUCTION AND OBJECTIVES: Impact of gender on long-term outcomes after transcatheter aortic valve implantation (TAVI) remains uncertain. We aimed to investigate gender-specific differences in TAVI and its impact on outcomes. METHODS: This analysis used data from the prospective Spanish TAVI registry, which included consecutive TAVI patients treated in 46 Spanish centers from 2009 to 2021. The primary endpoint was all-cause mortality at 12 months. Secondary endpoints included in-hospital and 30-day mortality and TAVI-related complications. Adjusted logistic and Cox regression analyses were performed. RESULTS: The study included 12 253 consecutive TAVI patients with a mean age of 81.2±6.4 years. Women (53.9%) were older, and had a higher STS-PROM score (7.0±7.0 vs 6.2±6.7; P < .001) than men. Overall, the TAVI-related complication rate was similar between women and men, with specific gender-related complications. While women more frequently developed in-hospital vascular complications (13.6% vs 9.8%; P <.001) and cardiac tamponade (1.5% vs 0.6%; P=.009), men showed a higher incidence of permanent pacemaker implantation (14.5% vs 17.4%; P=.009). There was no difference in all-cause mortality either in hospital (3.6% vs 3.6%, adjusted OR, 1.01; 95%CI, 0.83-1.23; P=.902), at 30 days (4.2% vs 4.2%, adjusted OR, 0.90; 95%CI, 0.65-1.25; P=.564) or at 1 year (11% vs 13%, adjusted HR, 0.94; 95%CI, 0.80-1.11; P=.60). CONCLUSIONS: Women treated with TAVI are older and have more comorbidities than men, leading to distinct complications between genders. Nevertheless, all-cause mortality in the short-term and at 1-year was similar between men and women.

The value of sentinel lymph-node biopsy in women with node-positive breast cancer at diagnosis and node-negative tumour after neoadjuvant therapy: a systematic review.

PURPOSE: To conduct a systematic review to analyse the performance of the sentinel lymph-node biopsy (SLNB) in women with node-positive breast cancer at diagnosis and node-negative tumour after neoadjuvant therapy, compared to axillary lymph-node dissection. METHODS: The more relevant databases were searched. Main outcomes were false-negative rate (FNR), sentinel lymph-node identification rate (SLNIR), negative predictive value (NPV), and accuracy. We conducted meta-analyses when appropriate. RESULTS: Twenty studies were included. The pooled FNR was 0.14 (95% CI 0.11-0.17), the pooled SLNIR was 0.89 (95% CI 0.86-0.92), NPV was 0.83 (95% CI 0.79-0.87), and summary accuracy was 0.92 (95% CI 0.90-0.94). SLNB performed better when more than one node was removed and double mapping was used. CONCLUSIONS: SLNB can be performed in women with a node-negative tumour after neoadjuvant therapy. It has a better performance when used with previous marking of the affected node and with double tracer.

The value of sentinel lymph-node biopsy after neoadjuvant therapy: an overview.

PURPOSE: We conducted a systematic review to analyse the performance of the sentinel lymph-node biopsy (SLNB) after the neoadjuvant chemotherapy, compared to axillary lymph-node dissection, in terms of false-negative rate (FNR) and sentinel lymph-node identification rate (SLNIR), sensitivity, negative predictive value (NPV), need for axillary lymph-node dissection (ALND), morbidity, preferences, and costs. METHODS: MEDLINE, Embase, Scopus, and The Cochrane Library were searched. We assessed the quality of the included systematic reviews using AMSTAR2 tool, and estimated the degree of overlapping of the individual studies on the included reviews. RESULTS: Six systematic reviews with variable quality were selected. We observed a very high overlapping degree across the included reviews. The FNR and the SLNIR were quite consistent (FNR 13-14%; SLNIR ~ 90% or higher). In women with initially clinically node-negative breast cancer, the FNR was better (6%), with similar SLNIR (96%). The included reviews did not consider the other prespecified outcomes. CONCLUSIONS: It would be reasonable to suggest performing an SLNB in patients treated with NACT, adjusting the procedure to the previous marking of the affected lymph node, using double tracer, and biopsy of at least three sentinel lymph nodes. More well-designed research is needed. PROSPERO registration number: CRD42020114403.

Extending multipoint pacing CRT battery longevity by swapping left ventricular pulse configurations.

PURPOSE: Cardiac resynchronization therapy (CRT) with left ventricular (LV) MultiPoint™ pacing (MPP) has been shown to improve CRT response by pacing two LV sites (LV1, LV2). While an additional LV pacing site reduces battery longevity, this cost can be minimized by leveraging an existing device-based capture management algorithm (LVCap™ Confirm). The purpose of this study was to evaluate the MPP battery longevity improvement achieved by configuring LV pacing sites to properly leverage LVCap Confirm. METHODS: Patients previously enrolled in the MORE-CRT MPP trial with existing MPP-enabled CRT-D devices (Abbott Quadra Assura MP™ CD3371-40QC, Quartet™ LV lead) underwent device interrogation. Device electrical characteristics and estimated battery longevities were compared for various MPP settings. RESULTS: At 2.1 ± 1.1 years post-implant, the estimated remaining battery longevity in 65 patients was 70 ± 14 months with MPP Off (LV pacing from minimum capture threshold). Enabling MPP with maximal anatomical separation between LV1 and LV2 cathodes reduced longevity by 15 ± 14%. However, swapping the LV1 and LV2 cathodes, such that the LV1 threshold was the higher of the two, allowed the device to take full advantage of the LVCap™ Confirm capture management algorithm, resulting in significantly lower longevity reduction of 9 ± 11% (p < 0.001). Ultimately, a mean MPP battery longevity improvement of 7.7 ± 10.3% (p < 0.001) was achieved by simply swapping LV1/LV2 configurations. CONCLUSIONS: By properly leveraging device-based capture management features, the impact of MPP on battery longevity can be significantly reduced.

Detection of the sentinel node using a magnetic tracer in thyroid cancer. A technical pilot study. / Detección del ganglio centinela mediante trazador paramagnético en el cáncer de tiroides. Estudio piloto técnico.

INTRODUCTION: There is no standard procedure for the detection of the sentinel node (SN) in thyroid disease. However, the recent detection of the SN using a paramagnetic tracer is proving to be useful in breast cancer and melanoma. The objective was to assess the utility of super paramagnetic iron oxide tracer for the intraoperative detection of the SN in patients with papillary thyroid cancer without nodal involvement in the preoperative study. METHOD: A single center, prospective pilot study of a class IIa medical device (a paramagnetic tracer). The study included thyroid cancers which were T1-T2 tumors in the cytohistological analysis with a negative preoperative nodal assessment, operated on consecutively during scheduled treatment. For the localization of the SN, an interlesional injection of 2mL of super paramagnetic iron oxide was administered. After ten minutes, ferromagnetic activity was detected in the adjacent nodes. Once the node had been detected, we proceeded by extracting it for intraoperative analysis. The effectiveness of the procedure for detecting the SN was assessed, with the main variable being whether it was detected or not. RESULTS: The project was assessed after the first cases had been carried out. The SN was located in all cases, which was done easily in the first four, but in the fifth case the SN detection was complicated by the interference of the reusable neurostimulation electrodes with the ferromagnetic signal. Intraoperative histology revealed the SN was positive in 80% (n=4) of cases (20% [n=1] were macrometastases and 60% [n=3] micrometastases). Total thyroidectomies were carried out, with central lymph node dissection in 4 of the patients and lateral in one due to the result of the detected SN. The histology showed the carcinoma was papillary, a classic type, in 80% (n=4) and a follicular variant in 20% (n=1). Forty percent (n=2) were multifocal, 40% (n=2) had vascular infiltration, and 60% (n=3) had extrathyroidal extension. Staging determined the application of radioactive iodine therapy (150mCi) in 80% of cases (n=4). CONCLUSIONS: A paramagnetic tracer can be useful for detecting the SN and correctly staging papillary carcinoma.

Cryopreserved amniotic membrane in the treatment of diabetic foot ulcers: a case series.

OBJECTIVE: The amniotic membrane (AM) is a tissue with low immunogenity and high therapeutic potential due to its anti-inflammatory, anti-fibrotic and antimicrobial effects. This paper describes the use of cryopreserved amniotic membrane allografts to treat diabetic foot ulcers (DFUs) in patients with diabetes. METHOD: In this case series, AM was processed to obtain a final medicinal product: cryopreserved amniotic membrane. cryopreserved AM was applied every 7-10 days until total epithelialisation of the DFUs. RESULTS: A total of 14 patients with DFUs (median size: 12.30cm, (range: 0.52-42.5cm2) were treated and followed up until complete closure (median time: 20 weeks, range: 7-56 weeks). Patients received 4-40 AM applications. All patients in this study achieved complete epithelialisation of the wound. No adverse events were observed. CONCLUSION: AM is a feasible and safe treatment in complex DFUs. Furthermore, the treatment is successful in achieving epithelialisation of long-evolution, unhealed wounds resistant to conventional therapies.

Mirabegron, a Clinically Approved ß3 Adrenergic Receptor Agonist, Does Not Reduce Infarct Size in a Swine Model of Reperfused Myocardial Infarction.

The administration of the selective ß3 adrenergic receptor (ß3AR) agonist BRL-37344 protects from myocardial ischemia/reperfusion injury (IRI), although the lack of clinical approval limits its translatability. We tested the cardioprotective effect of mirabegron, the first-in-class ß3AR agonist approved for human use. A dose-response study was conducted in 6 pigs to select the highest intravenous dose of mirabegron without significant detrimental hemodynamic effect. Subsequently, closed chest anterior myocardial infarction (45 min ischemia followed by reperfusion) was performed in 26 pigs which randomly received either mirabegron (10 µg/kg) or placebo 5 min before reperfusion. Day-7 cardiac magnetic resonance (CMR) showed no differences in infarct size (35.0 ± 2.0% of left ventricle (LV) vs. 35.9 ± 2.4% in mirabegron and placebo respectively, p = 0.782) or LV ejection fraction (36.3 ± 1.1 vs. 34.6 ± 1.9%, p = 0.430). Consistent results were obtained on day-45 CMR. In conclusion, the intravenous administration of the clinically available selective ß3AR agonist mirabegron does not reduce infarct size in a swine model of IRI.

Plasma Levels of Monocyte Chemoattractant Protein-1, n-Terminal Fragment of Brain Natriuretic Peptide and Calcidiol Are Independently Associated with the Complexity of Coronary Artery Disease.

BACKGROUND AND OBJECTIVES: We investigated the relationship of the Syntax Score (SS) and coronary artery calcification (CAC), with plasma levels of biomarkers related to cardiovascular damage and mineral metabolism, as there is sparse information in this field. METHODS: We studied 270 patients with coronary disease that had an acute coronary syndrome (ACS) six months before. Calcidiol, fibroblast growth factor-23, parathormone, phosphate and monocyte chemoattractant protein-1 [MCP-1], high-sensitivity C-reactive protein, galectin-3, and N-terminal pro-brain natriuretic peptide [NT-proBNP] levels, among other biomarkers, were determined. CAC was assessed by coronary angiogram as low-grade (0-1) and high-grade (2-3) calcification, measured with a semiquantitative scale ranging from 0 (none) to 3 (severe). For the SS study patients were divided in SS<14 and SS≥14. Multivariate linear and logistic regression analyses were performed. RESULTS: MCP-1 predicted independently the SS (RC = 1.73 [95%CI = 0.08-3.39]; p = 0.040), along with NT-proBNP (RC = 0.17 [95%CI = 0.05-0.28]; p = 0.004), male sex (RC = 4.15 [95%CI = 1.47-6.83]; p = 0.003), age (RC = 0.13 [95%CI = 0.02-0.24]; p = 0.020), hypertension (RC = 3.64, [95%CI = 0.77-6.50]; p = 0.013), hyperlipidemia (RC = 2.78, [95%CI = 0.28-5.29]; p = 0.030), and statins (RC = 6.12 [95%CI = 1.28-10.96]; p = 0.013). Low calcidiol predicted high-grade calcification independently (OR = 0.57 [95% CI = 0.36-0.90]; p = 0.013) along with ST-elevation myocardial infarction (OR = 0.38 [95%CI = 0.19-0.78]; p = 0.006), diabetes (OR = 2.35 [95%CI = 1.11-4.98]; p = 0.028) and age (OR = 1.37 [95%CI = 1.18-1.59]; p<0.001). During follow-up (1.79 [0.94-2.86] years), 27 patients developed ACS, stroke, or transient ischemic attack. A combined score using SS and CAC predicted independently the development of the outcome. CONCLUSIONS: MCP-1 and NT-proBNP are independent predictors of SS, while low calcidiol plasma levels are associated with CAC. More studies are needed to confirm these data.

Sprinkler irrigation of rice fields reduces grain arsenic but enhances cadmium.

Previous studies have demonstrated that rice cultivated under flooded conditions has higher concentrations of arsenic (As) but lower cadmium (Cd) compared to rice grown in unsaturated soils. To validate such effects over long terms under Mediterranean conditions a field experiment, conducted over 7 successive years was established in SW Spain. The impact of water management on rice production and grain arsenic (As) and cadmium (Cd) was measured, and As speciation was determined to inform toxicity evaluation. Sprinkler irrigation was compared to traditional flooding. Both irrigation techniques resulted in similar grain yields (~3000 kg grain ha(-1)). Successive sprinkler irrigation over 7 years decreased grain total As to one-sixth its initial concentration in the flooded system (0.55 to 0.09 mg As kg(-1)), while one cycle of sprinkler irrigation also reduced grain total As by one-third (0.20 mg kg(-1)). Grain inorganic As concentration increased up to 2 folds under flooded conditions compared to sprinkler irrigated fields while organic As was also lower in sprinkler system treatments, but to a lesser extent. This suggests that methylation is favored under water logging. However, sprinkler irrigation increased Cd transfer to grain by a factor of 10, reaching 0.05 mg Cd kg(-1) in 7 years. Sprinkler systems in paddy fields seem particularly suited for Mediterranean climates and are able to mitigate against excessive As accumulation, but our evidence shows that an increased Cd load in rice grain may result.

[Intra-abdominal hypertension: effects on the splanchnic circulation. Preliminary study in a model of ascites]. / Hipertensión intraabdominal: consecuencias sobre la circulación esplácnica. Estudio preliminar en un modelo de ascitis.

INTRODUCTION: Intra-abdominal hypertension is defined as a rise in intra-abdominal pressure leading to progressive dysfunction of the abdominal organs. OBJECTIVE: To evaluate the effects of intra-abdominal hypertension on the splanchnic circulation in a porcine animal model with a view to determining the diagnostic method of choice. MATERIAL AND METHODS: A total of 10 swine were divided into 2 groups: a control group and a group with an ascites pressure of 20mmHg. Transvesical and transperitoneal intra-abdominal pressures were registered, and the correlation between the measurements obtained was determined. Concentrations of lactic acid, alanine aminotransferase, glucose and gastric mucosal pH were also obtained. We registered the mean arterial and abdominal perfusion pressures, and the correlation of the latter with gastric mucosal pH and lactic acid concentrations. The parameters were registered for a total of 3hours. RESULTS: We observed a high correlation between transvesical and transperitoneal measurements of intra-abdominal pressure (R(2)=0.98). In the 20mmHg pressure group, lactic acid concentrations increased significantly at 180min (p<0.011). Gastric mucosal pH differed significantly between the 2 groups from the beginning of the study (p=0.004) and significantly decreased from 120min onward. Mean arterial and abdominal perfusion pressures gradually decreased during the trial, with early significant changes in the abdominal perfusion pressure (p=0.001), and a good correlation with the remaining study parameters. There were no significant changes in hepatic indicators. CONCLUSIONS: We believe the transvesical approach to be the technique of choice to determine intra-abdominal pressure. Abdominal perfusion pressure is a sensitive marker of intra-abdominal hypertension, and gastric mucosal pH is the first parameter to be affected.

Efficacy of intralesional triamcinolone injection in the treatment of mammillary fistula: a prospective study.

BACKGROUND: Recurring mammillary fistula (MF) is often difficult to manage. PURPOSE: To evaluate the efficacy of intralesional triamcinolone (ILT) injection versus irrigation with saline solution in the management of MF. MATERIAL AND METHODS: A prospective study was conducted including 10 patients with MF. The patients were distributed non-randomly into two groups: saline group (n = 5) and triamcinolone group (n = 5). Ultrasound guidance was used for ILT injection. The injection was repeated in the case of no response or recurrence. RESULTS: No statistically significant differences were observed between the saline and triamcinolone groups for clinical parameters and ultrasonographic characteristics of the MF and for the outcomes of the two methods of treatment. However, a statistically significant difference was observed between the two groups for recurrence of MF (P < 0.046). Success of the treatment with ILT injection was observed in 90% of the patients (9/10), and a failure in one case (10%) after three ILT injections, who was referred for surgery. CONCLUSION: ILT injection is an effective, simple, and safe treatment for the management of MF.

Multicenter validation of two nomograms to predict non-sentinel node involvement in breast cancer.

INTRODUCTION: Nomograms are used to predict the involvement of non-sentinel nodes (nSN) in breast cancer. This study attempts to externally validate two of the more commonly used nomograms (MSKCC and Stanford University). MATERIALS AND METHODS: Five hundred and one cases of positive SNB with posterior axillary lymphadenectomy from 11 Spanish hospitals with widespread experience of the technique were studied. In all cases, an estimate of the probability of nSN involvement was made using the MSKCC and the Stanford University nomograms. Discrimination was assessed by calculating the area under the receiver operating characteristic curve. To assess the calibration of the nomogram, observed probability was plotted against the nomogram-calculated predicted probability. RESULTS: The overall predictive accuracy of the MSKCC nomogram was 0.684 (95 % confidence interval, 0.635-0.732), while in the case of that from Stanford the predictive accuracy was 0.658 (95 % confidence interval 0.607-0.709). The mean predicted probability of nSN metastases in each group of patients was correlated with the observed probability with an acceptable concordance (r = 0.820; p < 0.004 in MSKCC nomogram and r = 0.888; p < 0.001 in Stanford nomogram). CONCLUSION: These nomograms can be useful tools in the evaluation of patients with breast cancer and positive sentinel nodes but other factors, including a comprehensive clinical assessment, must be used to decide the most appropriate surgical approach for an individual patient, especially with regard to avoiding unnecessary lymphadenectomy.

Management of infected pancreatic necrosis using retroperitoneal necrosectomy with flexible endoscope: 10 years of experience.

BACKGROUND: This study was designed to provide our experience in the management of infected and drained pancreatic necrosis using the retroperitoneal approach. METHODS: This was a prospective observational study in a tertiary care university hospital. Thirty-two patients with confirmed infected pancreatic necrosis were studied. Superficial necrosectomy was performed with lavage and aspiration of debris. This was achieved though a retroperitoneal approach of the pancreatic area and under the direct vision of a flexible endoscope. The follow-up procedure using retroperitoneal endoscopy did not require taking the patient to the operating room. The main outcome measures were infection control, morbidity, and mortality related to technique, reintervention, and long-term follow-up. RESULTS: No significant morbidity or mortality related to the technique was observed in all of the patients with infected pancreatic necrosis treated with this retroperitoneal approach compared with published data using other approaches. Reinterventions were not required and patients are currently asymptomatic. CONCLUSIONS: Retroperitoneal access of the pancreatic area is a good approach for drainage and debridement of infected pancreatic necrosis. Translumbar retroperitoneal endoscopy allows exploration under direct visual guidance avoiding open transabdominal reintervention and the risk of contamination of the abdominal cavity. This technique does not increase morbidity and mortality, can be performed at the patients' bedside as many times as necessary, and has advantages over other retroperitoneal approaches.

Ileal Vanek's tumor mimicking cecal carcinoma.

Inflammatory fibroid polyps or Vanek's tumors are rare benign pseudotumoral lesions with morphological characteristics similar to those of submucosal mesenchymal tumors. They have been described in the gastrointestinal tract, most frequently in the gastric antrum. We present a case of ileal Vanek's tumor associated with a raised carcinoembryonic antigen level and with radiological and endoscopic features mimicking cecal carcinoma.

Sonographically guided percutaneous intralesional triamcinolone injection: a new treatment for mammillary fistulas: preliminary results.

We describe a new procedure, sonographically guided intralesional triamcinolone injection, for the treatment of mammillary fistulas. Six patients with mammillary fistulas were enrolled in this prospective study. Clinical improvement was rapid after the first triamcinolone injection. The initial response to treatment was assessed as complete in 4 cases, and the remaining 2 cases resolved successfully with additional injections. On the basis of the excellent results obtained in this study, it is thought that intralesional triamcinolone injection may be a good alternative to surgery.