Clinical impact of remote heart failure management using the multiparameter ICD HeartLogic alert.

INTRODUCTION AND OBJECTIVES: The multiparametric implantable cardioverter-defibrillator HeartLogic index has proven to be a sensitive and timely predictor of impending heart failure (HF) decompensation. We evaluated the impact of a standardized follow-up protocol implemented by nursing staff and based on remote management of alerts. METHODS: The algorithm was activated in HF patients at 19 Spanish centers. Transmitted data were analyzed remotely, and patients were contacted by telephone if alerts were issued. Clinical actions were implemented remotely or through outpatient visits. The primary endpoint consisted of HF hospitalizations or death. Secondary endpoints were HF outpatient visits. We compared the 12-month periods before and after the adoption of the protocol. RESULTS: We analyzed 392 patients (aged 69±10 years, 76% male, 50% ischemic cardiomyopathy) with implantable cardioverter-defibrillators (20%) or cardiac resynchronization therapy defibrillators (80%). The primary endpoint occurred 151 times in 86 (22%) patients during the 12 months before the adoption of the protocol, and 69 times in 45 (11%) patients (P<.001) during the 12 months after its adoption. The mean number of hospitalizations per patient was 0.39±0.89 pre- and 0.18±0.57 postadoption (P<.001). There were 185 outpatient visits for HF in 96 (24%) patients before adoption and 64 in 48 (12%) patients after adoption (P<.001). The mean number of visits per patient was 0.47±1.11 pre- and 0.16±0.51 postadoption (P<.001). CONCLUSIONS: A standardized follow-up protocol based on remote management of HeartLogic alerts enabled effective remote management of HF patients. After its adoption, we observed a significant reduction in HF hospitalizations and outpatient visits.

Immunosenescence and inflammatory markers in Cuban centenarians: implications for survival.

Centenarians are the best example of successful aging in humans. This work aimed to understand if immune status is associated with survival in Cuban centenarians. In a previous study, our group enrolled 43 centenarians and evaluated their immune status and functional capacity. 41 out of 43 recruited centenarians received follow-up phone calls, during a period of 2 years. Absolute CD4 + T cell count was higher among survivors, while the frequency of CD8 + CCR7-CD45RA + , CD8 + CD45RA + CD28-, and CD4 + CD28- T cells was higher among non-survivors. We also found that higher frequencies of terminally differentiated T cells were related to a higher risk of death, while centenarians with higher frequencies of T cells were more likely to survive. Surprisingly, neither serum inflammatory markers nor frailty/dependency was associated with survival. Our preliminary study suggests that immuno-senescence markers, but not inflammaging or functional capacity, are associated with survival beyond 100 years in a small group of Cuban centenarians.

Alternative Pharmacokinetic Metrics in Single-Dose Studies to Ensure Bioequivalence of Prolonged-Release Products at Steady State-A Case Study.

(1) Background: this article investigates which PK metrics in a single-dose study (concentration at the end of posology interval, Cτ, partial areas under the curve, pAUCs, or half-value duration, HVD) are more sensitive and less variable for predicting the failure of a prolonged-release product at steady-state that was the bioequivalent for Cmax, AUC0-t and AUC0-inf, in the single-dose study; (2) Methods: a cross-over study was performed in 36 subjects receiving desvenlafaxine 100 mg prolonged-release tablets. Conventional (Cmax, AUC0-t and AUC0-inf) and additional (Cτ, pAUCs and HVD) PK metrics were considered after single-dose conditions. Predicted PK metrics at steady state (AUC0-τ, Cmax,ss, and Cτ,ss) were derived using a population PK model approach; (3) Results: the existing differences in the shape of the concentration-time curves precluded to show equivalence for Cτ,ss in the simulated study at steady state. This failure to show equivalence at steady state was predicted by Cτ, pAUCs and HVD in the single-dose study. Cτ was the most sensitive metric for detecting the different shape, with a lower intra-subject variability than HVD; (4) Conclusions: conventional PK metrics for single-dose studies (Cmax, AUC0-t and AUC0-inf) are not enough to guarantee bioequivalence at steady state for prolonged-release products.

Association among Terminally Differentiated T Cells, Frailty, and Dependency in a Group of Cuban Centenarians.

INTRODUCTION: Centenarians are considered a model of successful aging. Cuba exhibits one of the oldest populations in Latin America with more than two thousand centenarians. METHODS: This study aimed to evaluate the immune phenotype of forty-three Cuban centenarians, their clinical characteristics such as comorbidities, frailty, body mass index, and some hemochemical parameters. RESULTS: Centenarians had normal body mass indexes, relatively good health status, and 21.95% of them had no comorbidities; 53.6% were classified as frail, and 7% were classified as robust. In addition, 17% of centenarians were independent, and 41.46% were moderately dependent. The seroprevalence against cytomegalovirus was 100%. Concerning pro-inflammatory markers, the majority of them had very low cytokine levels and serum C-reactive protein around the normal limit. We also found the predominance of memory subsets over naive compartments in CD4+ and CD8+ T cells. Terminally differentiated CD8+CD28- T cells were higher in frail centenarians than in pre-frail, while CD8+CD57+ and CD8+EMRA T cells were higher in moderately and severely dependent individuals than in independent individuals. Severely dependent centenarians had a lower CD4+/CD8+ ratio. CONCLUSION: This study describes for the first time the predominance of memory subsets over naive compartments in CD4+ and CD8+ T cells, as well as its relation to frailty and/or dependency in a group of Cuban centenarians. Further studies are needed to continue understanding the natural biological aging mechanism and the relationship between terminally differentiated lymphocytes and inflammaging in the context of extreme longevity.

Feasibility and safety of zero-fluoroscopy left bundle branch pacing: An initial experience.

INTRODUCTION: Left bundle branch pacing (LBBP) has emerged in recent years as a new pacing modality, providing patients with a narrower paced QRS than conventional pacing and stable pacing parameters. At the same time, there is a growing concern about the use of fluoroscopy in pacemaker implantations, given its harmful effects on both patients and operators. However, there are no prior experiences of zero-fluoroscopy in LBBP procedure. METHODS: We conducted an observational prospective study recruiting consecutive patients that underwent zero-fluoroscopy LBBP pacemaker implantation. A 6-month follow-up visit was programmed for every patient. The main goal of our study was to assess the efficacy, feasibility, and safety of the procedure. RESULTS: From January 2021 to February 2022, we included 10 patients, 8 males. The average age was 63 ± 4 years. The procedure was successful in all patients. We observed a significant reduction in paced QRS width compared with basal QRS width (149 ± 31.9 vs. 116 ± 15.6 ms, p = .02). All device parameters remained stable at 6-month follow-up: no significant differences in mean impedance (700.5 ± 136.4 vs. 494 ± 72.7 Ohm, p = .09), capture threshold (0.67 ± 0.2 vs. 0.83 ± 0.2 V @ 0.4 ms, p = .27) or endocardial V-wave amplitude (10.6 ± 5.2 vs. 13.9 ± 6.3 mV, p = .19). No complications were reported in any case. CONCLUSION: Zero-fluoroscopy LBBP is feasible and safe, and it may be considered in cases where radiation exposure is contraindicated or especially undesirable. Future randomized clinical trials are needed for the widespread use of this new technique.

Local impedance and contact force guidance to predict successful cavotricuspid isthmus ablation with a zero-fluoroscopy approach.

Introduction: A new technology capable of monitoring local impedance (LI) and contact force (CF) has recently been developed. At the same time, there is growing concern regarding catheter ablation performed under fluoroscopy guidance, due to its harmful effects for both patients and practitioners. The aim of this study was to assess the safety and effectiveness of zero-fluoroscopy cavotricuspid isthmus (CTI) ablation monitoring LI drop and CF as well as to elucidate if these parameters can predict successful radiofrequency (RF) applications in CTI ablation. Methods: We conducted a prospective observational study recruiting 50 consecutive patients who underwent CTI ablation. A zero-fluoroscopy approach guided by the combination of LI drop and CF was performed. In each RF application, CF and LI drop were monitored. A 6-month follow-up visit was scheduled to assess recurrences. Results: A total of 767 first-pass RF applications were evaluated in 50 patients. First-pass effective RF applications were associated with greater LI drops: absolute LI drops (30.05 ± 6.23 Ω vs. 25.01 ± 5.95 Ω), p = 0.004) and relative LI drops (-23.3 ± 4.9% vs. -18.3 ± 5.6%, p = 0.0005). RF applications with a CF between 5 and 15 grams achieved a higher LI drop compared to those with a CF below 5 grams (29.4 ± 8.76 Ω vs. 24.8 ± 8.18 Ω, p < 0.0003). However, there were no significant differences in LI drop between RF applications with a CF between 5 and 15 grams and those with a CF beyond 15 grams (29.4 ± 8.76 Ω vs. 31.2 ± 9.81 Ω, p = 0.19). CF by itself, without considering LI drop, did not predict effective RF applications (12.3 ± 7.54 g vs. 11.18 ± 5.18 g, p = 0.545). Successful CTI ablation guided by a zero-fluoroscopy approach was achieved in all patients. Only one patient experienced a recurrence during the 6-month follow-up. Conclusions: LI drop (absolute and relative values) appears to be a good predictor of successful RF applications to achieve CTI conduction block. The optimal CF to achieve a good LI drop is between 5 and 15 g. A zero-fluoroscopy approach guided by LI and CF was feasible, effective, and safe.

Results of catheter ablation with zero or near zero fluoroscopy in pediatric patients with supraventricular tachyarrhythmias.

INTRODUCTION AND OBJECTIVES: Ionizing radiation exposure in catheter ablation procedures carries health risks, especially in pediatric patients. Our aim was to compare the safety and efficacy of catheter ablation guided by a nonfluoroscopic intracardiac navigation system (NFINS) with those of an exclusively fluoroscopy-guided approach in pediatric patients. METHODS: We analyzed catheter ablation results in pediatric patients with high-risk accessory pathways or supraventricular tachycardia referred to our center during a 6-year period. We compared fluoroscopy-guided procedures (group A) with NFINS guided procedures (group B). RESULTS: We analyzed 120 catheter ablation procedures in 110 pediatric patients (11±3.2 years, 70% male); there were 62 procedures in group A and 58 in group B. We found no significant differences between the 2 groups in procedure success (95% group A vs 93.5% group B; P=.53), complications (1.7% vs 1.6%; P=.23), or recurrences (7.3% vs 6.9%; P = .61). However, fluoroscopy time (median 1.1minutes vs 12minutes; P <.0005) and ablation time (median 96.5seconds vs 133.5seconds; P=.03) were lower in group B. The presence of structural heart disease was independently associated with recurrence (P=.03). CONCLUSIONS: The use of NFINS to guide catheter ablation procedures in pediatric patients reduces radiation exposure time. Its widespread use in pediatric ablations could decrease the risk of ionizing radiation.

His-Bundle Pacing in a Patient With Tricuspid and Mitral Prosthetic Valves Without Suitable Coronary Veins for Lead Placement.

Atrioventricular block in patients with a prosthetic tricuspid valve and a pacemaker with a dysfunctional epicardial lead is not uncommon. In such instances, coronary sinus lead placement is the preferred option, but it has a failure rate of 10%-15%. An atrial transseptal left ventricular lead placement has been proposed as an alternative, but this approach is not feasible in patients with a prosthetic mitral valve. This analysis represents the first reported case of His-bundle pacing from the atria in a patient with prosthetic tricuspid and mitral valves, with no suitable coronary veins for lead placement.

Le bloc auriculo-ventriculaire n'est pas rare chez les patients ayant reçu une valve tricuspide prothétique et porteurs d'un stimulateur cardiaque dont la sonde épicardique est dysfonctionnelle. Dans de tels cas, le positionnement de la sonde sur le sinus coronaire est l'option à privilégier, mais son taux d'échec varie entre 10 et 15 %. L'implantation de la sonde sur le ventricule gauche par la voie transsetale a été proposée à titre de solution de rechange, mais cette approche n'est pas envisageable chez les patients ayant reçu une valve mitrale prothétique. La présente analyse constitue le premier cas de stimulation du faisceau de His à partir des oreillettes chez un patient ayant reçu des valves tricuspides et mitrales prothétiques, en l'absence de veines coronaires se prêtant à l'implantation de la sonde.

[Measurement of insulin in multilayer bags for parenteral nutrition]. / Determinación de insulina en bolsas multicapa de nutrición parenteral.

INTRODUCTION: Introduction: it is common to add rapid-acting insulin to parenteral nutrition (NP) bags for the management of hyperglycemia. However, insulin can be adsorbed in NP bags due to electrostatic interactions. Objective: to determine the influence of the presence of lipids and of insulin concentration in NP bags on the adsorption of insulin in these bags, as well as its stability for 5 days. Method: seven NP bags were prepared with the same volume and with a similar composition except for the presence of lipids and micronutrients, and insulin concentration. Insulin was determined by electrochemiluminescent immunoassay. Samples of 2 mL were taken after preparation and on day 5. Results: on day 1, the mean loss of insulin was 15.26 % (± 7.08) in the bags with lipids and 18.45 % (± 5.67) (p = 0.60) in the bags without lipids. The percentage of insulin lost by day 5 in the PN bags with lipids was 30.13 % (± 4.14), and in the PN bags without lipids it was 44.71 % (± 12.94) (p = 0,052). No correlation was observed between the amount of insulin added to the PN bags and the percentage of insulin lost between day 1 (ρ = -0.407, p = 0.365) or day 5 (ρ = -0.295, p = 0.521). Conclusions: there is an increase in insulin adsorption in NP EVA bags over time. The presence of lipids in the bags decreases adsorption. Further studies are needed to demonstrate the factors associated with insulin adsorption in EVA bags.

INTRODUCCIÓN: Introducción: es habitual adicionar insulina de acción rápida a las bolsas de nutrición parenteral (NP) para el manejo de la hiperglucemia. Sin embargo, la insulina puede adsorberse en las bolsas de NP debido a interacciones electroestáticas. Objetivo: determinar la estabilidad a 5 días y la influencia de la presencia de lípidos y de la concentración de insulina en las NP sobre la adsorción de insulina en las bolsas de NP. Método: se elaboraron 7 NP con el mismo volumen y con una composición semejante exceptuando la presencia de lípidos, los micronutrientes y la concentración de insulina. Se determinó la insulina mediante un inmunoensayo inmunométrico de electroquimioluminiscencia (ECLIA). Se tomaron muestras de 2 mL tras su preparación y en el día 5. Resultados: en el día 1, la pérdida media de insulina fue del 15,26 % (± 7,08) en las bolsas con lípidos y del 18,45 % (± 5,67) (p = 0,60) en las bolsas sin lípidos. El porcentaje de insulina perdido el día 5 en las NP con lípidos fue del 30,13 % (± 4,14) y en las NP sin lípidos del 44,71 % (± 12,94) (p = 0,052). No se observó correlación entre la cantidad de insulina adicionada a las bolsas de NP y el porcentaje perdido de insulina entre el día 1 (ρ = -0,407, p = 0,365), ni el día 5 (ρ = -0,295, p = 0,521). Conclusiones: hay un aumento de la adsorción de insulina en las bolsas de NP de etilenvinilacetato (EVA) con el paso del tiempo. La presencia de lípidos en las bolsas disminuye la adsorción. Son necesarios más estudios para demostrar cuáles son los factores asociados a la adsorción de insulina en las bolsas de EVA.

[Atrial fibrillation predictors in patients with embolic stroke of undetermined source]. / Predictores de fibrilación auricular en pacientes con ictus embólico de origen indeterminado.

BACKGROUND AND OBJECTIVES: Atrial fibrillation (AF) detection in patients with embolic stroke of underdetermined source (ESUS) entails a change of medical treatment and a significant decrease in the incidence of new strokes. It is necessary to determine which patients would benefit more from prolonged electrocardiographic monitoring. Our aim was to find electrocardiographic and echocardiographic AF predictors in patients with ESUS. METHODS: We performed a cohort study that included 95 consecutive patients admitted to the hospital because of an ESUS. An electrocardiogram, each subject in the study underwent a 24-hour Holter-electrocardiogram (Holter-ECG) and an echocardiogram. A 2-year follow up was also conducted, with a 24-hour Holter-ECG every 3months for the first year, and every 6months during the second one. RESULTS: During the follow-up, AF was detected in 11 patients (11.6%), with a detection rate of 3.2% at 6months, 7.4% at 12months, and 11.6% at 18months as well as at 24months. The variables that were independently related to AF detection included moderate or severe left atrium dilation (P=.02), interatrial advanced block (P=.04) and more than 1000 premature atrial beats on 24-hour Holter-ECG (P=.01). CONCLUSIONS: Moderate or severe atrial dilation, interatrial advanced block, and the presence of more than 1000 premature atrial beats on 24-hour Holter-ECG behave as AF predictors in patients with ESUS.

Trabecular bone score and bone mineral density in patients with long-term controlled acromegaly.

OBJECTIVE: Acromegaly is associated with increased vertebral fracture (VFs) risk not correlated to bone mineral density (BMD). Trabecular bone score (TBS), related to bone microarchitecture, provides information on bone strength. This cross-sectional study considered the usefulness of TBS and BMD to assess bone status in long-term controlled acromegalic patients. DESIGN, PATIENTS, MEASUREMENTS: 26 acromegaly patients (14 female and 12 males) were included in the study. A further 117 subjects were recruited as controls (58 females and 57 males). BMD was measured using dual-energy X-ray absorptiometry (DXA), TBS was obtained applying Medimaps software 2.0. Biochemical parameters were determined by standardized techniques. RESULTS: 73% of patients with acromegaly exhibited normal lumbar spine (LS) BMD. TBS was normal in 38% of acromegalic patients and partially degraded or degraded in 31% of patients, respectively. No differences were found in LS BMD between acromegalic patients and controls. TBS values were significantly lower in patients with acromegaly (1.27 ± 0.13 vs. 1.35 ± 0.17, p = .01). Postsurgical remission was associated with higher TBS values (1.35 ± 0.10 vs. 1.23 ± 0.13, p = .02) and pituitary radiotherapy treatment with lower TBS values (1.18 ± 0.12 vs. 1.31 ± 0.12, p = .004). On multivariate analysis, age, BMI and LS BMD were predictors of TBS changes in patients with acromegaly (p < .05). CONCLUSIONS: Patients with long-term controlled acromegaly can exhibit deterioration of bone microstructure measured with TBS, despite BMD measurement not showing bone loss. Our study suggests that TBS is useful for monitoring the bone status changes in acromegalic patients.

Oncoxin-Viusid® may improve quality of life and survival in patients with hormone-refractory prostate cancer undergoing onco-specific treatments.

The aim of the present study was to identify the efficacy and safety of Oncoxin-Viusid (OV) as a supportive treatment for patients with prostate cancer (PCA). A prospective, non-randomised, open-label phase II clinical trial, including 25 patients with hormone-refractory PCA (HRPC) was conducted at the Hospital Universitario General Calixto García (Havana, Cuba) between June 2017 and March 2018. Each of the patients received chemotherapy (CTX) and/or radiotherapy (RT) and OV treatment. Patients had a mean age of 73 years, clinical stage IV cancer and a high risk of relapse. Six cycles of CTX were completed by 80% of the patients, adverse reactions decreased and no weight loss was observed. Among the 25 patients, 5 were lost to follow-up and 4 died of disease progression. A total of 16 of these patients survived, of which 15 had an improved quality of life and 10 responded to treatment, with a significant reduction in pain and prostate symptoms and ≥50% reduction in baseline PSA. The progression-free survival (PFS) rate was 59% and the overall survival (OS) rate 64% at 1 year after treatment began. The OV nutritional supplement was effective, leading to a significant improvement in the patients' quality of life, good nutritional status and greater treatment tolerance. A clinical and humoral response was observed, with high survival rates and a delayed appearance of signs of disease progression. The present study was registered in ClinicalTrials.gov PRS with ID #NCT03543670.

Efficacy and Safety of Treatment With Ferric Carboxymaltose in Patients With Cirrhosis and Gastrointestinal Bleeding.

Background: Patients with liver cirrhosis and gastrointestinal bleeding (GIB) often develop anemia. Ferric carboxymaltose (FCM) is an intravenous (i.v.) iron formulation approved for use in patients with iron deficiency with inadequate response to oral iron therapy or when oral iron cannot be used. Here we analyzed the efficacy and safety of FCM treatment in cirrhotic patients with anemia and GIB. Methods: Retrospective observational study of patients with cirrhosis and acute or chronic GIB treated with 1,000 mg FCM at the University Hospital Arnau de Vilanova (Lleida, Spain) that follows a restrictive-transfusion strategy. All data were obtained from the patients' medical records. We used the Wilcoxon test to evaluate statistical significance. Results: Patients with cirrhosis and GIB (n = 34) were treated with 1,000 mg FCM. Portal hypertension were present in 88.2% of the patients. For hospitalized patients (n = 21), median serum hemoglobin (s-Hb) levels increased by 3.0 g/dL (p < 0.02) and 3.9 g/dL (p < 0.07) for patients treated with FCM who had or had not received also a transfusion, respectively, compared to levels recorded upon admission. For outpatients (n = 13) the mean s-Hb levels was 9.8 ± 1.6 g/dL before FCM treatment and 11.3 ± 2.1 g/dL after treatment, demonstrating a mean increase of 1.5 g/dL (p < 0.001). No serious adverse reactions to FCM were observed. Conclusion: FCM administration achieved optimal s-Hb levels in most cirrhotic patients with acute or chronic GIB, suggesting that early FCM infusion improves and maintains optimal s-Hb levels in these patients and may be an appropriate first-line therapy to treat their anemia.

Syncope and bifascicular block in the absence of structural heart disease.

The treatment of patients with bifascicular block (BFB) and syncope in the absence of structural heart disease (SHD) is not well defined. The objective of our study is to compare pacemaker empirical implantation with the use of electrophysiological studies (EPS). This is a prospective cohort study that included 77 patients with unexplained cardiogenic syncope and BFB without structural heart disease between 1997 and 2012. Two groups: 36 patients received empirical pacemakers (Group A) and 41 underwent EPS (Group B) to guide their treatment. The incidence of syncope recurrence and atrioventricular block was lower in group A. Mortality and complication rates were similar between both groups. Multivariate analysis demonstrated a higher number of events (combined endpoint) in group B. Our study shows that treatment according to EPS does not improve the results of a treatment strategy based on empirical pacemaker.

Prognostic impact of misdiagnosis of cardiac channelopathies as epilepsy.

INTRODUCTION: Cardiac channelopathies are a frequent cause of sudden cardiac death (SCD) and often manifest with convulsive syncope, leading to a misdiagnosis of epilepsy. We aim to evaluate the clinical impact of epilepsy misdiagnosis in a cohort of patients with cardiac channelopathies. METHODS: Fifty probands/families with a cardiac channelopathy were included. We retrospectively collected information from medical records to identify all patients who presented with convulsive syncope and were diagnosed with epilepsy after neurological evaluation. Clinical data and outcome were compared with those of patients without a previous epilepsy diagnosis. RESULTS: Eight patients had a previous diagnosis of epilepsy. At first episode, 3 of them presented a positive family history of SCD and 5 showed a pathological electrocardiogram; half presented with sudden cardiac arrest (SCA) and the rest with recurrent syncope despite treatment with 1 or more anti-epileptic drugs. Five patients had long QT syndrome, 2 had catecholaminergic polymorphic ventricular tachycardia, and 1 had Brugada syndrome. Epilepsy misdiagnosis was associated with an increased risk of SCA/SCD (OR 6.92, P = .04), a delay of 12 years (P = .047) in correct diagnosis, and a delay from first symptom to channelopathy diagnosis of 18.45 years (P < .0001). CONCLUSION: Cardiac channelopathy patients can be misdiagnosed with epilepsy. This involves a delayed diagnosis, a delay from the first symptom to a correct diagnosis, and an increased risk of SCA/SCD.

Trabecular Bone Score, Bone Mineral Density and Bone Markers in Patients with Primary Hyperparathyroidism 2 Years After Parathyroidectomy.

Following a parathyroidectomy there is a bone mineral density (BMD) improvement in patients with primary hyperparathyroidism. However, data of bone microarchitecture are scarce. Trabecular bone score (TBS) estimates bone microarchitecture and could provide valuable information in those patients. The aim of this study is to assess TBS changes 2 years after successful surgery in a group of patients with primary hyperparathyroidism and correlate these results with changes in BMD and bone turnover markers. This is a prospective study including 32 patients. In all participants BMD and TBS were measured, before and 24 months after surgery. Biochemical data: serum calcium, PTH, 25-OH-vitamin D, beta-crosslaps, bone alkaline phosphatase, and osteocalcin. 25 female and 7 male patients, mean age 64.6±12.4 years, were included in the study. At baseline, BMD was low at: lumbar spine (T-score -2.19±1.31), total hip (-1.33±1.12), femoral neck (-1.75±0.84), and distal one-third radius (-2.74±1.68). Baseline TBS showed partially degraded microarchitecture (1.180±0.130). After parathyroidectomy lumbar spine BMD increased significantly (5.3±13.0%, p<0.05), as well as total hip (3.8±8.8%, p<0.05). There was an increase in TBS, but this was not significant. There was a correlation between TBS and BAP at baseline (rs=0.73; p<0.01) and TBS and BAP 2 years after surgery (rs=0.57, p<0.05). Although bone density improves 2 years after surgery in patients with primary hyperparathyroidism and there is a restoration of bone turnover markers, TBS is not completely restored. These results remark the necessity of longer periods of study, to confirm if bone microarchitecture could be completely restored after surgery.

A randomized multicenter study comparing seawater washes and carmellose artificial tears eyedrops in the treatment of dry eye syndrome.

PURPOSE: To investigate the safety and efficacy of sterile isotonic seawater washes vs standard treatment with carmellose artificial tears in dry eye syndrome (DES). PATIENTS AND METHODS: This is a randomized multicenter prospective study with 12 weeks of follow-up. A group of patients with DES (N=60) were treated with seawater spray (Quinton®) five times daily, and another similar group (N=60) were treated with carmellose artificial tears eyedrops (Viscofresh® 0.5%) five times a day. The parameters studied and measured were as follows: Ocular Surface Disease Index questionnaire score, Schirmer I test (without anesthesia) score, tear osmolarity (TearLab®), tear breakup time, tear meniscus height (meniscography OCT), fluorescein corneal staining score (National Eye Institute scale), lissamine green conjunctival staining score, and levels of IL-1 beta and IL-6 in tears (Luminex® 200). RESULTS: In the group treated with seawater, symptoms decreased by 68%, and the decrease was 26% statistically superior to the group treated with carmellose artificial tears eyedrops (P<.001). Levels of IL-1 beta and IL-6 in tears significantly decreased in the seawater group compared to the carmellose artificial tears group (19%/17% vs 52%/51%) (P<0.001). There were no statistically significant differences in the other measured parameters. There were no cases of poor tolerance or side effects. CONCLUSION: Administration of seawater is more effective than treatment with carmellose artificial tears in reducing symptoms and pro-inflammatory molecules (IL-1 beta and IL-6) in tears of patients with DES.

Clinical experience with ferric carboxymaltose in the management of anemia in acute gastrointestinal bleeding.

OBJECTIVE: The aim of this study was to assess the efficacy and safety of intravenous ferric carboxymaltose (FCM) following hospitalization for acute gastrointestinal bleeding (AGIB) in the context of a restrictive transfusion strategy. PATIENTS AND METHODS: A retrospective single-center study analyzed patients with AGIB (excluding AGIB secondary to portal hypertension) administered a single FCM dose with or without blood transfusion. RESULTS: Eighty-six episodes in 84 patients were analyzed. Seventy-nine patients had upper AGIB. Nineteen episodes were associated with hemodynamic instability. FCM was administered during hospitalization as a single dose of 1000 mg iron in 84/86 episodes and as a single dose of 500 mg iron in two episodes, with blood transfusion in 60/86 (69.8%) episodes. The mean hemoglobin (Hb) was 9.0 g/dl at admission, 7.6 g/dl at the lowest in-hospital value, 9.4 g/dl at discharge, and 12.7 g/dl at follow-up (mean: 55 days postdischarge) (P<0.001 for follow-up vs. all other timepoints). The lowest mean in-hospital Hb value was 7.2 and 8.8 g/dl, respectively, in patients with transfusion+FCM versus FCM alone; the mean Hb was 12.4 versus 13.7 g/dl at follow-up. In patients administered FCM alone, the mean Hb at follow-up in the subpopulations aged older than or equal to 75 years (n=33), Charlson comorbidity index of at least 3 (n=48), and Hb of up to 10 g/dl at admission (n=47) were 12.6, 13.1, and 13.3 g/dl, respectively. No adverse effects were detected. CONCLUSION: Treatment with FCM for AGIB is associated with a good erythropoietic response and anemia correction after hospitalization, even in severe episodes or when transfusion is needed. FCM is safe and well tolerated, and may support a restrictive transfusion policy.