Identification of cavotricuspid isthmus voltage patterns in typical atrial flutter ablation.

Background: Electroanatomical mapping is an essential tool in the ablation of typical AFL. Objectives: To identify the existence of voltage patterns in the CTI voltage maps and their relevance for typical AFL ablation. Methods: A voltage map of the CTI was made prior to ablation, identifying the areas of maximum voltage and their location along the CTI, allowing classification into patterns according to their distribution. A stepwise ablation approach targeting the areas of maximum voltage was conducted. The ablation characteristics were compared based on the pattern obtained. Results: Two voltage patterns were identified, with differences in ablation time to bidirectional CTI block. No complications occurred. Conclusions: Voltage mapping identifies patterns in the CTI with implications for typical AFL ablation.

Real-world experience with secukinumab in the entire axial spondyloarthritis spectrum.

Background: Secukinumab is a biologic disease-modifying antirheumatic drug (bDMARD) that has demonstrated efficacy in the treatment of axial spondyloarthritis (axSpA, i.e., ankylosing spondylitis and non-radiographic axSpA) across various clinical trials. However, data of secukinumab in clinical practice is still limited. Here, we aimed to provide real-world data on secukinumab use, effectiveness, and persistence in axSpA. Patients and methods: Retrospective, multicenter study of patients with a diagnosis of axSpA treated with secukinumab at 12 centers up to June 2021 in the Valencian Community (Spain). Information was gathered on BASDAI measurement, pain, patient and physician global assessment (ptGA, phGA) using a 100-mm visual analog scale (VAS), persistence and other secondary variables by treatment line (first, second, and ≥ third) for up to 24 months. Results: 221 patients were included (69% men; mean age [standard deviation, SD]: 46.7 [12.1] years old). Secukinumab was used as a first-line bDMARD in 38% of patients, as a second-line in 34% and as a ≥ hird-line in 28%. The percentage of patients achieving low disease activity (BASDAI<4) increased from 9% at baseline to 48% at month 6 and was maintained (49%) up to month 24. The greatest improvement in BASDAI was observed in naïve patients (month 6: -2.6; month 24: -3.7), followed by second-line (month 6: -1.9; month 24: -3.1) and ≥ third-line (month 6: -1.3; month 24: -2.3) patients. Reductions in mean pain VAS (-23.3; -31.9), ptGA (-25.1; -31.9) and phGA (-25.1; -31) were also observed at 6 and 24 months. Secukinumab showed an overall 12-months persistence rate of 70% (95% confidence interval [CI]: 63-77%) and a 24-months persistence rate of 58% (95% CI, 51-66%). Patients receiving first-line secukinumab had the highest 24-months persistence rate (p = 0.05). Conclusion: Secukinumab improved disease activity in axSpA patients, especially in naive, and second-line patients, which was accompanied by high persistence rates up to 24 months.

Cardiac magnetic resonance outperforms echocardiography to predict subsequent implantable cardioverter defibrillator therapies in ST-segment elevation myocardial infarction patients.

Background: Implantable cardioverter defibrillators (ICD) are effective as a primary prevention measure of ventricular tachyarrhythmias in patients with ST-segment elevation myocardial infarction (STEMI) and depressed left ventricular ejection fraction (LVEF). The implications of using cardiac magnetic resonance (CMR) instead of echocardiography (Echo) to assess LVEF prior to the indication of ICD in this setting are unknown. Materials and methods: We evaluated 52 STEMI patients (56.6 ± 11 years, 88.5% male) treated with ICD in primary prevention who underwent echocardiography and CMR prior to ICD implantation. ICD implantation was indicated based on the presence of heart failure and depressed LVEF (≤ 35%) by echocardiography, CMR, or both. Prediction of ICD therapies (ICD-T) during follow-up by echocardiography and CMR before ICD implantation was assessed. Results: Compared to echocardiography, LVEF was lower by cardiac CMR (30.2 ± 9% vs. 37.4 ± 7.6%, p < 0.001). LVEF ≤ 35% was detected in 24 patients (46.2%) by Echo and in 42 (80.7%) by CMR. During a mean follow-up of 6.1 ± 4.2 years, 10 patients received appropriate ICD-T (3.16 ICD-T per 100 person-years): 5 direct shocks to treat very fast ventricular tachycardia or ventricular fibrillation, 3 effective antitachycardia pacing (ATP) for treatment of ventricular tachycardia, and 2 ineffective ATP followed by shock to treat ventricular tachycardia. Echo-LVEF ≤ 35% correctly predicted ICD-T in 4/10 (40%) patients and CMR-LVEF ≤ 35% in 10/10 (100%) patients. CMR-LVEF improved on Echo-LVEF for predicting ICD-T (area under the curve: 0.76 vs. 0.48, p = 0.04). Conclusion: In STEMI patients treated with ICD, assessment of LVEF by CMR outperforms Echo-LVEF to predict the subsequent use of appropriate ICD therapies.

Unlocking Bevacizumab's Potential: rCBVmax as a Predictive Biomarker for Enhanced Survival in Glioblastoma IDH-Wildtype Patients.

BACKGROUND: Aberrant vascular architecture and angiogenesis are hallmarks of glioblastoma IDH-wildtype, suggesting that these tumors are suitable for antiangiogenic therapy. Bevacizumab was FDA-approved in 2009 following promising results in two clinical trials. However, its use for recurrent glioblastomas remains a subject of debate, as it does not universally improve patient survival. PURPOSES: In this study, we aimed to analyze the influence of tumor vascularity on the benefit provided by BVZ and propose preoperative rCBVmax at the high angiogenic tumor habitat as a predictive biomarker to select patients who can benefit the most. METHODS: Clinical and MRI data from 106 patients with glioblastoma IDH-wildtype have been analyzed. Thirty-nine of them received BVZ, and the remaining sixty-seven did not receive a second-line treatment. The ONCOhabitats method was used to automatically calculate rCBV. RESULTS: We found a median survival from progression of 305 days longer for patients with moderate vascular tumors who received BVZ than those who did not receive any second-line treatment. This contrasts with patients with high-vascular tumors who only presented a median survival of 173 days longer when receiving BVZ. Furthermore, better responses to BVZ were found for the moderate-vascular group with a higher proportion of patients alive at 6, 12, 18, and 24 months after progression. CONCLUSIONS: We propose rCBVmax as a potential biomarker to select patients who can benefit more from BVZ after tumor progression. In addition, we propose a threshold of 7.5 to stratify patients into moderate- and high-vascular groups to select the optimal second-line treatment.

Local detection of microvessels in IDH-wildtype glioblastoma using relative cerebral blood volume: an imaging marker useful for astrocytoma grade 4 classification.

BACKGROUND: The microvessels area (MVA), derived from microvascular proliferation, is a biomarker useful for high-grade glioma classification. Nevertheless, its measurement is costly, labor-intense, and invasive. Finding radiologic correlations with MVA could provide a complementary non-invasive approach without an extra cost and labor intensity and from the first stage. This study aims to correlate imaging markers, such as relative cerebral blood volume (rCBV), and local MVA in IDH-wildtype glioblastoma, and to propose this imaging marker as useful for astrocytoma grade 4 classification. METHODS: Data from 73 tissue blocks belonging to 17 IDH-wildtype glioblastomas and 7 blocks from 2 IDH-mutant astrocytomas were compiled from the Ivy GAP database. MRI processing and rCBV quantification were carried out using ONCOhabitats methodology. Histologic and MRI co-registration was done manually with experts' supervision, achieving an accuracy of 88.8% of overlay. Spearman's correlation was used to analyze the association between rCBV and microvessel area. Mann-Whitney test was used to study differences of rCBV between blocks with presence or absence of microvessels in IDH-wildtype glioblastoma, as well as to find differences with IDH-mutant astrocytoma samples. RESULTS: Significant positive correlations were found between rCBV and microvessel area in the IDH-wildtype blocks (p < 0.001), as well as significant differences in rCBV were found between blocks with microvascular proliferation and blocks without it (p < 0.0001). In addition, significant differences in rCBV were found between IDH-wildtype glioblastoma and IDH-mutant astrocytoma samples, being 2-2.5 times higher rCBV values in IDH-wildtype glioblastoma samples. CONCLUSIONS: The proposed rCBV marker, calculated from diagnostic MRIs, can detect in IDH-wildtype glioblastoma those regions with microvessels from those without it, and it is significantly correlated with local microvessels area. In addition, the proposed rCBV marker can differentiate the IDH mutation status, providing a complementary non-invasive method for high-grade glioma classification.

Validation of multiparametric approaches for the prediction of sudden cardiac death in patients with Brugada syndrome and electrophysiological study.

INTRODUCTION AND OBJECTIVES: Multiparametric scores have been designed for better risk stratification in Brugada syndrome (BrS). We aimed to validate 3 multiparametric approaches (the Delise score, Sieira score and the Shanghai BrS Score) in a cohort with Brugada syndrome and electrophysiological study (EPS). METHODS: We included patients diagnosed with BrS and previous EPS between 1998 and 2019 in 23 hospitals. C-statistic analysis and Cox proportional hazard regression models were used. RESULTS: A total of 831 patients were included (mean age, 42.8±13.1; 623 [75%] men; 386 [46.5%] had a type 1 electrocardiogram (ECG) pattern, 677 [81.5%] were asymptomatic, and 319 [38.4%] had an implantable cardioverter-defibrillator). During a follow-up of 10.2±4.7 years, 47 (5.7%) experienced a cardiovascular event. In the global cohort, a type 1 ECG and syncope were predictive of arrhythmic events. All risk scores were significantly associated with events. The discriminatory abilities of the 3 scores were modest (particularly when these scores were evaluated in asymptomatic patients). Evaluation of the Delise and Sieira scores with different numbers of extra stimuli (1 or 2 vs 3) did not substantially improve the event prediction c-index. CONCLUSIONS: In BrS, classic risk factors such as ECG pattern and previous syncope predict arrhythmic events. The predictive capabilities of the EPS are affected by the number of extra stimuli required to induce ventricular arrhythmias. Scores combining clinical risk factors with EPS help to identify the populations at highest risk, although their predictive abilities remain modest in the general BrS population and in asymptomatic patients.

Glioblastoma versus solitary brain metastasis: MRI differentiation using the edema perfusion gradient.

BACKGROUND AND PURPOSE: Differentiation between glioblastoma multiforme (GBM) and solitary brain metastasis (SBM) remains a challenge in neuroradiology with up to 40% of the cases to be incorrectly classified using only conventional MRI. The inclusion of perfusion MRI parameters provides characteristic features that could support the distinction of these pathological entities. On these grounds, we aim to use a perfusion gradient in the peritumoral edema. METHODS: Twenty-four patients with GBM or an SBM underwent conventional and perfusion MR imaging sequences before tumors' surgical resection. After postprocessing of the images, quantification of dynamic susceptibility contrast (DSC) perfusion parameters was made. Three concentric areas around the tumor were defined in each case. The monocompartimental and pharmacokinetics parameters of perfusion MRI were analyzed in both series. RESULTS: DSC perfusion MRI models can provide useful information for the differentiation between GBM and SBM. It can be observed that most of the perfusion MR parameters (relative cerebral blood volume, relative cerebral blood flow, relative Ktrans, and relative volume fraction of the interstitial space) clearly show higher gradient for GBM than SBM. GBM also demonstrates higher heterogeneity in the peritumoral edema and most of the perfusion parameters demonstrate higher gradients in the area closest to the enhancing tumor. CONCLUSION: Our results show that there is a difference in the perfusion parameters of the edema between GBM and SBM demonstrating a vascularization gradient. This could help not only for the diagnosis, but also for planning surgical or radiotherapy treatments delineating the real extension of the tumor.

Immediate Pre-Partum SARS-CoV-2 Status and Immune Profiling of Breastmilk: A Case-Control Study.

Objetive: To address the prevalence of SARS-CoV-2 and the evolutionary profile of immune compounds in breastmilk of positive mothers according to time and disease state. Methods: Forty-five women with term pregnancies with confirmed non-severe SARS-CoV-2 infection (case group), and 96 SARS-CoV-2 negative women in identical conditions (control group) were approached, using consecutive sample. Weekly (1st to 5th week postpartum) reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal swabs (cases) and breastmilk (cases and controls) were obtained. Concentration of cytokines, chemokines, and growth factors in breastmilk (cases and controls) were determined at 1st and 5th week post-partum. Results: Thirty-seven (study group) and 45 (control group) women were enrolled. Symptomatic infection occurred in 56.8% of women in the study group (48% fever, 48% anosmia, 43% cough). SARS-CoV-2 RNA was not found in breastmilk samples. Concentrations of cytokines (IFN-γ, IL-1ra, IL-4, IL-6, IL-9, IL-13, and TNF-α) chemokines (eotaxin, IP-10, MIP-1α, and RANTES) and growth factors (FGF, GM-CSF, IL7, and PDGF-BB) were higher in breastmilk of the study compared with the control group at 1st week postpartum. Immune compounds concentrations decreased on time, particularly in the control group milk samples. Time of nasopharyngeal swab to become negative influenced the immune compound concentration pattern. Severity of disease (symptomatic or asymptomatic infection) did not affect the immunological profile in breast milk. Conclusions: This study confirms no viral RNA and a distinct immunological profile in breastmilk according to mother's SARS-CoV-2 status. Additional studies should address whether these findings indicate efficient reaction against SARS-CoV-2 infection, which might be suitable to protect the recipient child.

Robust estimation of infant feeding indicators by data quality assessment of longitudinal electronic health records from birth up to 18 months of life.

BACKGROUND AND OBJECTIVE: The Baby-Friendly Hospital Initiative (BFHI) is an international strategy aimed at improving breastfeeding practices in health care services. Regular monitoring of indicators is key for BFHI implementation and maintenance. Currently, routine data collected from electronic health records (EHR) is an excellent source for infant feeding monitoring, however data quality (DQ) assessment should be undertaken. The aim of this research is to enable robust estimations of infant feeding indicators through DQ assessment of routine EHR data. MATERIALS AND METHODS: We use the longitudinal series of healthcare contacts belonging to 6427 children born from 2009 to 2018 in the Health Area V of Murcia (Spain). Longitudinal data came from EHR at hospital discharge and community infant health reviews up to 18 months. The data of each healthcare contact contained a 24-h recall of infant feeding. We perform a DQ process in three phases: (1) an assessment of each-single-contact and the definition of their infant feeding status; (2) a longitudinal DQ assessment of completeness and consistency of the series of contacts to obtain meta-information that guides the duration calculus, for each case, of the different types of breastfeeding: exclusive breastfeeding (EBF), full breastfeeding (FBF) and any breastfeeding (ABF); and finally (3) a robust estimation of indicators and description of DQ of each indicator. RESULTS: We found deficiencies of DQ in 30.42% of single contacts for EBF, 19.02% for FBF and 22.50% for ABF that were used to establish the infant feeding status. However, after longitudinal DQ assessment, we obtained valid and reliable data rates for most indicators such as "median duration of breastfeeding" nearly 90%, both for FBF and ABF, not so for EBF. CONCLUSIONS: Despite the DQ deficiencies found in raw data, the DQ assurance approach by indicators proposed in this work, allowed us to obtain a robust estimation of indicators with a significant percentage of subjects with valid information for ABF and FBF monitoring. The estimations were consistent with results previously published. The methodology provided with this study allows a continuous and reliable population monitoring of infant feeding indicators of BFHI from routine EHR data.

Predictores e impacto de la adopción de programación basada en la evidencia en la incidencia de terapias del desfibrilador automático implantable / Predictors of adoption and impact of evidence-based programming on the incidence of implantable cardioverter-defibrillator therapies

Introducción y objetivos El estudio ADVANCE III mostró una reducción de terapias del desfibrilador automático implantable (DAI) con el empleo de tiempos de detección de arritmia prolongados. Se describe la adopción y el impacto de dicha estrategia en la incidencia de terapias del DAI. Métodos Estudio observacional retrospectivo de pacientes con implante de DAI Medtronic (2005-2016) en un registro multicéntrico (UMBRELLA-NCT01561144). Se describe la evolución de la adopción de programación ADVANCE en relación con: publicación del estudio, implementación de una campaña de formación y publicación de un consenso de expertos. Se identificaron con regresión logística los predictores de la adopción. Se comparó la incidencia de terapias en pacientes con y sin programación ADVANCE estimando la razón de tasas de incidencia ajustada (RTIa) mediante regresión binomial negativa. Resultados Se incluyó a 3.528 pacientes. Se utilizó la estrategia ADVANCE en el 20% del total y el 44% al final del estudio. La adopción se incrementó tras publicarse el estudio ADVANCE, y en menor grado tras la campaña de formación y consenso de expertos. Predictores de la adopción: DAI con detección nominal 30/40 (ORa=4,4; IC95%, 3,5-5,4), implantador electrofisiólogo (ORa=1,7; IC95%, 1,4-2,2) y prevención secundaria (ORa=3,2; IC95%, 2,6-3,9). El implante de DAI bicameral (ORa=0,6; IC95%, 0,5-0,8) o tricameral (ORa=0,5; IC95%, 0,4-0,7) se asoció con menor adopción. La programación ADVANCE se asoció con reducción de terapias totales (RTIa=0,77; IC95%, 0,69-0,86) y choques inapropiados (RTIa=0,66; IC95%, 0,52-0,85). Conclusiones La adopción de la programación ADVANCE es poco amplia y puede mejorarse mediante una adecuada selección de los parámetros nominales. Emplearla se asocia con una reducción de las terapias del DAI. (AU)

Introduction and objectives The ADVANCE III trial showed that a delayed-detection strategy reduces implantable cardioverter-defibrillator (ICD) therapies. Here, we describe the adherence to and predictors of ADVANCE adoption and compare ICD therapy rates between patients with and without ADVANCE programming. Methods This observational retrospective study analyzed patients implanted with Medtronic ICDs included from 2005 to 2016 in a Spanish national multicenter registry (UMBRELLA database; ClinicalTrials.gov, NCT01561144). Changes in ADVANCE programming adoption were described in relation to a) publication of the ADVANCE trial, b) implementation of an “ADVANCE awareness” campaign, and c) publication of an expert consensus statement. Multivariate logistic regression identified predictors of adoption. Therapy incidence rates were compared between groups by estimating the adjusted incidence rate ratio (aIRR) using negative binomial regression. Results A total of 3528 patients were included. An ADVANCE strategy was used in 20% overall and in 44% at the end of the study. ADVANCE III adoption increased after trial publication, with less growth after an “ADVANCE awareness” campaign and after expert consensus statement publication. Predictors of ADVANCE adoption were as follows: ICD device with a nominal number of intervals to detect 30/40 (aOR, 4.4; 95%CI, 3.5-5.4), implantation by an electrophysiologist (aOR, 1.7; 95%CI, 1.4-2.2), and secondary prevention (aOR, 3.2; 95%CI, 2.6-3.9). Dual-chamber ICDs (aOR, 0.6; 95%CI, 0.5-0.8) and cardiac resynchronization-defibrillators (aOR, 0.5; 95%CI, 0.4-0.7) were associated with lower adoption. ADVANCE programming was associated with reduced total therapy burden (aIRR, 0.77; 95%CI, 0.69-0.86) and fewer inappropriate shocks (aIRR, 0.66; 95%CI, 0.52-0.85). Conclusions ADVANCE adoption remains modest and can be improved through evidence-driven selection of nominal ICD settings. ... (AU)

Differential effect of vascularity between long- and short-term survivors with IDH1/2 wild-type glioblastoma.

INTRODUCTION: IDH1/2 wt glioblastoma (GB) represents the most lethal tumour of the central nervous system. Tumour vascularity is associated with overall survival (OS), and the clinical relevance of vascular markers, such as rCBV, has already been validated. Nevertheless, molecular and clinical factors may have different influences on the beneficial effect of a favourable vascular signature. PURPOSE: To evaluate the association between the rCBV and OS of IDH1/2 wt GB patients for long-term survivors (LTSs) and short-term survivors (STSs). Given that initial high rCBV may affect the patient's OS in follow-up stages, we will assess whether a moderate vascularity is beneficial for OS in both groups of patients. MATERIALS AND METHODS: Ninety-nine IDH1/2 wt GB patients were divided into LTSs (OS ≥ 400 days) and STSs (OS < 400 days). Mann-Whitney and Fisher, uni- and multiparametric Cox, Aalen's additive regression and Kaplan-Meier tests were carried out. Tumour vascularity was represented by the mean rCBV of the high angiogenic tumour (HAT) habitat computed through the haemodynamic tissue signature methodology (available on the ONCOhabitats platform). RESULTS: For LTSs, we found a significant association between a moderate value of rCBVmean and higher OS (uni- and multiparametric Cox and Aalen's regression) (p = 0.0140, HR = 1.19; p = 0.0085, HR = 1.22) and significant stratification capability (p = 0.0343). For the STS group, no association between rCBVmean and survival was observed. Moreover, no significant differences (p > 0.05) in gender, age, resection status, chemoradiation, or MGMT methylation were observed between LTSs and STSs. CONCLUSION: We have found different prognostic and stratification effects of the vascular marker for the LTS and STS groups. We propose the use of rCBVmean at HAT as a vascular marker clinically relevant for LTSs with IDH1/2 wt GB and maybe as a potential target for randomized clinical trials focused on this group of patients.

Safety, efficacy, and reproducibility of cavotricuspid isthmus ablation guided by the ablation index: acute results of the FLAI study.

AIMS: Ablation index (AI) is a marker of lesion quality during catheter ablation that incorporates contact force, time, and power in a weighted formula. This index was originally developed for pulmonary vein isolation as well as other left atrial procedures. The aim of our study is to evaluate the feasibility and efficacy of the AI for the ablation of the cavotricuspid isthmus (CTI) in patients presenting with typical atrial flutter (AFL). METHODS AND RESULTS: This prospective multicentre non-randomized study enrolled 412 consecutive patients with typical AFL undergoing AI-guided cavotricuspid isthmus ablation. The procedure was performed targeting an AI of 500 and an inter-lesion distance measurement of ≤6 mm. The primary endpoints were CTI 'first-pass' block and persistent block after a 20-min waiting time. Secondary endpoints included procedural and radiofrequency duration and fluoroscopic time. A total of 412 consecutive patients were enrolled in 31 centres (mean age 64.9 ± 9.8; 72.1% males and 27.7% with structural heart disease). The CTI bidirectional 'first-pass' block was reached in 355 patients (88.3%), whereas CTI block at the end of the waiting time was achieved in 405 patients (98.3%). Mean procedural, radiofrequency, and fluoroscopic time were 56.5 ± 28.1, 7.8 ± 4.8, and 1.9 ± 4.8 min, respectively. There were no major procedural complications. There was no significant inter-operator variability in the ability to achieve any of the primary endpoints. CONCLUSION: AI-guided ablation with an inter-lesion distance ≤6 mm represents an effective, safe, and highly reproducible strategy to achieve bidirectional block in the treatment of typical AFL.

Predictors of adoption and impact of evidence-based programming on the incidence of implantable cardioverter-defibrillator therapies.

INTRODUCTION AND OBJECTIVES: The ADVANCE III trial showed that a delayed-detection strategy reduces implantable cardioverter-defibrillator (ICD) therapies. Here, we describe the adherence to and predictors of ADVANCE adoption and compare ICD therapy rates between patients with and without ADVANCE programming. METHODS: This observational retrospective study analyzed patients implanted with Medtronic ICDs included from 2005 to 2016 in a Spanish national multicenter registry (UMBRELLA database; ClinicalTrials.gov, NCT01561144). Changes in ADVANCE programming adoption were described in relation to a) publication of the ADVANCE trial, b) implementation of an "ADVANCE awareness" campaign, and c) publication of an expert consensus statement. Multivariate logistic regression identified predictors of adoption. Therapy incidence rates were compared between groups by estimating the adjusted incidence rate ratio (aIRR) using negative binomial regression. RESULTS: A total of 3528 patients were included. An ADVANCE strategy was used in 20% overall and in 44% at the end of the study. ADVANCE III adoption increased after trial publication, with less growth after an "ADVANCE awareness" campaign and after expert consensus statement publication. Predictors of ADVANCE adoption were as follows: ICD device with a nominal number of intervals to detect 30/40 (aOR, 4.4; 95%CI, 3.5-5.4), implantation by an electrophysiologist (aOR, 1.7; 95%CI, 1.4-2.2), and secondary prevention (aOR, 3.2; 95%CI, 2.6-3.9). Dual-chamber ICDs (aOR, 0.6; 95%CI, 0.5-0.8) and cardiac resynchronization-defibrillators (aOR, 0.5; 95%CI, 0.4-0.7) were associated with lower adoption. ADVANCE programming was associated with reduced total therapy burden (aIRR, 0.77; 95%CI, 0.69-0.86) and fewer inappropriate shocks (aIRR, 0.66; 95%CI, 0.52-0.85). CONCLUSIONS: ADVANCE adoption remains modest and can be improved through evidence-driven selection of nominal ICD settings. ADVANCE programming is associated with reduced therapy rates in real-world ICD recipients.

Effect of mountain ultramarathon distance competition on biochemical variables, respiratory and lower-limb fatigue.

The study aimed at assessing the acute physiological effects of running a 65-km vs a 107-km mountain ultramarathon. Nineteen athletes (15 males and 4 females) from the shorter race and forty three athletes (26 males and 17 females) from the longer race were enrolled. Body weight, respiratory and lower limb strength were assessed before and after the race. Blood samples were obtained before, after and 24-h post-race. Body weight loss did not differ between races. A decrease in squat jump height (p<0.01; d = 1.4), forced vital capacity (p<0.01; d = 0.5), forced expiratory volume in 1 s (p<0.01; d = 0.6), peak inspiratory flow (p<0.01; d = 0.6) and maximal inspiratory pressure (p<0.01; d = 0.8) was observed after the longer race; while, after the shorter race only maximal inspiratory pressure declined (p<0.01; d = 0.5). Greater post-race concentrations of creatine kinase (p<0.01; d = 0.9) and C-reactive protein (p<0.01; d = 2.3) were observed following the longer race, while high-sensitivity cardiac troponin was higher after the shorter race (p<0.01; d = 0.3). Sodium decreased post-competition only after the shorter race (p = 0.02; d = 0.6), while creatinine increased only following the longer race (p<0.01; d = 1.5). In both groups, glomerular filtration rate declined at post-race (longer race: p<0.01, d = 2.1; shorter race: p = 0.01, d = 1.4) and returned to baseline values at 24 h post-race. In summary, expiratory and lower-limb fatigue, and muscle damage and inflammatory response were greater following the longer race; while a higher release of cardiac troponins was observed after the shorter race. The alteration and restoration of renal function was similar after either race.

Data-driven discovery of changes in clinical code usage over time: a case-study on changes in cardiovascular disease recording in two English electronic health records databases (2001-2015).

OBJECTIVES: To demonstrate how data-driven variability methods can be used to identify changes in disease recording in two English electronic health records databases between 2001 and 2015. DESIGN: Repeated cross-sectional analysis that applied data-driven temporal variability methods to assess month-by-month changes in routinely collected medical data. A measure of difference between months was calculated based on joint distributions of age, gender, socioeconomic status and recorded cardiovascular diseases. Distances between months were used to identify temporal trends in data recording. SETTING: 400 English primary care practices from the Clinical Practice Research Datalink (CPRD GOLD) and 451 hospital providers from the Hospital Episode Statistics (HES). MAIN OUTCOMES: The proportion of patients (CPRD GOLD) and hospital admissions (HES) with a recorded cardiovascular disease (CPRD GOLD: coronary heart disease, heart failure, peripheral arterial disease, stroke; HES: International Classification of Disease codes I20-I69/G45). RESULTS: Both databases showed gradual changes in cardiovascular disease recording between 2001 and 2008. The recorded prevalence of included cardiovascular diseases in CPRD GOLD increased by 47%-62%, which partially reversed after 2008. For hospital records in HES, there was a relative decrease in angina pectoris (-34.4%) and unspecified stroke (-42.3%) over the same time period, with a concomitant increase in chronic coronary heart disease (+14.3%). Multiple abrupt changes in the use of myocardial infarction codes in hospital were found in March/April 2010, 2012 and 2014, possibly linked to updates of clinical coding guidelines. CONCLUSIONS: Identified temporal variability could be related to potentially non-medical causes such as updated coding guidelines. These artificial changes may introduce temporal correlation among diagnoses inferred from routine data, violating the assumptions of frequently used statistical methods. Temporal variability measures provide an objective and robust technique to identify, and subsequently account for, those changes in electronic health records studies without any prior knowledge of the data collection process.

Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial.

BACKGROUND: The optimal dosage of cryotherapy during cryoballoon ablation of pulmonary veins is still unclear. This trial tested the noninferiority of a novel, individualized, cryotherapy-dosing strategy for each vein. METHODS AND RESULTS: This prospective, randomized, multicenter, noninferiority study included 140 patients with paroxysmal atrial fibrillation, which was refractory to antiarrhythmic drugs. Patients were randomly assigned to a conventional strategy of 180-second cryoballoon applications per vein with a bonus freeze (control group, n=70) or to a shorter-time application protocol, with 1 application that lasted the time required for electric block time to effect plus 60- and a 120-second freeze bonus (study group, n=70). Patients were followed with a long-term monitoring system of 30 days. At 1-year follow-up, no difference was observed in terms of free atrial fibrillation-recurrence rates: 79.4% in control versus 78.3% in study group (Δ=1.15%; 90% confidence interval, -10.33% to 12.63%; P=0.869). Time to effect was detected in 72.1% of veins. The control and study groups had similar mean number of applications per patient (9.6±2 versus 9.9±2.4; P=0.76). Compared with controls, the study group had a significantly shorter cryotherapy time (28.3±7 versus 19.4±4.3 minutes; P<0.001), left atrium time (104±25 versus 92±23 minutes; P<0.01), and total procedure time (135±35 versus 119±31 minutes; P<0.01). No differences were observed in complications or acute reconnections. CONCLUSIONS: The new time-to-effect-based cryotherapy dosage protocol led to shorter cryotherapy and procedure times, with equal safety, and similar acute and 1-year follow-up results, compared with the conventional approach. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT02789358.

Evaluación comparativa de cuatro puntuaciones de riesgo para predecir la mortalidad de pacientes con desfibrilador automático implantable en prevención primaria / Comparative evaluation of four risk scores for predicting mortality in patients with implantable cardioverter-defibrillator for primary prevention

Introducción y objetivos: Se han elaborado varias puntuaciones clínicas del riesgo para identificar a los pacientes con un riesgo de mortalidad por cualquier causa elevado a pesar del implante de un desfibrilador implantable. El objetivo de este trabajo es examinar y comparar la capacidad predictiva de 4 sistemas de puntuación sencillos (MADIT-II, FADES, PACE y SHOCKED) por lo que respecta a la predicción de la mortalidad tras implante de desfibrilador para la prevención primaria de la muerte súbita cardiaca en un país mediterráneo. Métodos: Se llevó a cabo un estudio multicéntrico retrospectivo en 15 hospitales españoles. Se incluyó a los pacientes consecutivos remitidos para implante de desfibrilador entre enero de 2010 y diciembre de 2011. Resultados: Se incluyó a 916 pacientes con cardiopatía isquémica o no isquémica (media de edad, 62 ± 11 años; el 81,4% varones). Durante un periodo de 33,4 ± 12,9 meses, fallecieron 113 pacientes (12,3%), el 9,4% (86 pacientes) por causa cardiovascular. A los 12, 24, 36 y 48 meses, la tasa de mortalidad fue del 4,5, el 7,6, el 10,8 y el 12,3% respectivamente. Todas las puntuaciones de riesgo mostraron un aumento escalonado del riesgo de muerte a lo largo de todo el sistema de puntuación de cada una de ellas y las 4 identificaron a los pacientes en mayor riesgo de mortalidad. Las puntuaciones tuvieron asociación significativa con la mortalidad por cualquier causa en todo el periodo de seguimiento. La puntuación PACE fue la que mostró un valor del índice c más bajo, tanto si la población tenía una cardiopatía de origen isquémico (estadístico c = 0,61) como si era de origen no isquémico (estadístico c = 0,61), mientras que la puntuación MADIT-II (estadístico c = 0,67 y 0,65 en la miocardiopatía isquémica y no isquémica respectivamente), las puntuaciones SHOCKED (estadístico c = 0,68 y 0,66 respectivamente) y FADES (estadístico c = 0,66 y 0,60) mostraron unos valores del estadístico c similares (p ≥ 0,09). Conclusiones: En esta cohorte de pacientes mediterráneos que no formaba parte de un ensayo clínico, las 4 puntuaciones de riesgo evaluadas mostraron un significativo aumento escalonado del riesgo de muerte. De entre las puntuaciones de riesgo existentes, MADIT-II, FADES y SHOCKED aportan un rendimiento ligeramente superior al de la puntuación PACE (AU)

Introduction and objectives: Several clinical risk scores have been developed to identify patients at high risk of all-cause mortality despite implantation of an implantable cardioverter-defibrillator. We aimed to examine and compare the predictive capacity of 4 simple scoring systems (MADIT-II, FADES, PACE and SHOCKED) for predicting mortality after defibrillator implantation for primary prevention of sudden cardiac death in a Mediterranean country. Methods: A multicenter retrospective study was performed in 15 Spanish hospitals. Consecutive patients referred for defibrillator implantation between January 2010 and December 2011 were included. Results: A total of 916 patients with ischemic and nonischemic heart disease were included (mean age, 62 ± 11 years, 81.4% male). Over 33.4 ± 12.9 months, 113 (12.3%) patients died (cardiovascular origin in 86 [9.4%] patients). At 12, 24, 36, and 48 months, mortality rates were 4.5%, 7.6%, 10.8%, and 12.3% respectively. All the risk scores showed a stepwise increase in the risk of death throughout the scoring system of each of the scores and all 4 scores identified patients at greater risk of mortality. The scores were significantly associated with all-cause mortality throughout the follow-up period. PACE displayed the lowest c-index value regardless of whether the population had heart disease of ischemic (c-statistic = 0.61) or nonischemic origin (c-statistic = 0.61), whereas MADIT-II (c-statistic = 0.67 and 0.65 in ischemic and nonischemic cardiomyopathy, respectively), SHOCKED (c-statistic = 0.68 and 0.66, respectively), and FADES (c-statistic = 0.66 and 0.60) provided similar c-statistic values (P ≥ .09). Conclusions: In this nontrial-based cohort of Mediterranean patients, the 4 evaluated risk scores showed a significant stepwise increase in the risk of death. Among the currently available risk scores, MADIT-II, FADES, and SHOCKED provide slightly better performance than PACE (AU)

Comparative Evaluation of Four Risk Scores for Predicting Mortality in Patients With Implantable Cardioverter-defibrillator for Primary Prevention.

INTRODUCTION AND OBJECTIVES: Several clinical risk scores have been developed to identify patients at high risk of all-cause mortality despite implantation of an implantable cardioverter-defibrillator. We aimed to examine and compare the predictive capacity of 4 simple scoring systems (MADIT-II, FADES, PACE and SHOCKED) for predicting mortality after defibrillator implantation for primary prevention of sudden cardiac death in a Mediterranean country. METHODS: A multicenter retrospective study was performed in 15 Spanish hospitals. Consecutive patients referred for defibrillator implantation between January 2010 and December 2011 were included. RESULTS: A total of 916 patients with ischemic and nonischemic heart disease were included (mean age, 62 ± 11 years, 81.4% male). Over 33.4 ± 12.9 months, 113 (12.3%) patients died (cardiovascular origin in 86 [9.4%] patients). At 12, 24, 36, and 48 months, mortality rates were 4.5%, 7.6%, 10.8%, and 12.3% respectively. All the risk scores showed a stepwise increase in the risk of death throughout the scoring system of each of the scores and all 4 scores identified patients at greater risk of mortality. The scores were significantly associated with all-cause mortality throughout the follow-up period. PACE displayed the lowest c-index value regardless of whether the population had heart disease of ischemic (c-statistic = 0.61) or nonischemic origin (c-statistic = 0.61), whereas MADIT-II (c-statistic = 0.67 and 0.65 in ischemic and nonischemic cardiomyopathy, respectively), SHOCKED (c-statistic = 0.68 and 0.66, respectively), and FADES (c-statistic = 0.66 and 0.60) provided similar c-statistic values (P ≥ .09). CONCLUSIONS: In this nontrial-based cohort of Mediterranean patients, the 4 evaluated risk scores showed a significant stepwise increase in the risk of death. Among the currently available risk scores, MADIT-II, FADES, and SHOCKED provide slightly better performance than PACE.

Diagnóstico microbiológico de la infección bacteriana asociada al parto y puerperio / Microbiological diagnosis of bacterial infection associated with delivery and postpartum

La infección en el recién nacido puede adquirirse a través del canal del parto por colonización materna, como la infección neonatal precoz por Streptococcus agalactiae, o por adquisición a través de la placenta, líquido amniótico o productos del parto. Tras el parto, el recién nacido que precisa ingreso hospitalario puede adquirir infecciones nosocomiales durante su estancia y de forma excepcional, a través de la lactancia, por mastitis infecciosa o por incorrecta manipulación de la leche materna propia o donada de bancos de leche, lo que no obliga a suspender la lactancia en la mayoría de las ocasiones pero sí a establecer un tratamiento. Por los motivos expuestos es necesario establecer un correcto diagnóstico microbiológico de las infecciones perinatales, especialmente relevantes en el recién nacido pretérmino de bajo o muy bajo peso con una elevada mortalidad

The newborn may acquire infections during delivery due to maternal colonization of the birth canal, by microorganisms such as Streptococcus agalactiae that caused early neonatal infection, or acquisition through the placenta, amniotic fluid or birth products. After birth, the newborn that needs hospitalization can develop nosocomial infections during their care and exceptionally through lactation by infectious mastitis or incorrect handling of human milk, which does not require to stop breastfeeding in most cases. It is important and necessary to perform microbiological diagnosis for the correct treatment of perinatal infections, especially relevant in preterm infants with low or very low weight with high mortality rates

Prevención primaria con cardiodesfibrilador implantable y terapia de resincronización cardíaca en pacientes ancianos: resultados de un estudio multicéntrico español

Propósito: a la fecha sigue sin haber pruebas en cuanto a los resultados del uso de dispositivos para arritmias ventriculares en pacientes añosos, y menos aun para indicaciones de prevención primaria. La finalidad del estudio fue describir la evolución en términos de la eficacia y seguridad de la terapia con cardiodesfibriladores implantables (CDI) en una gran cohorte de pacientes añosos. Métodos y resultados: estudio multicéntrico retrospectivo realizado en 15 hospitales españoles. Se incluyeron pacientes consecutivos referidos para implante de CDI antes de 2011. Se consideró que 162 de los 1.174 pacientes (13,8%) con 75 años o más eran “añosos”. Comparado con aquellos pacientes <75 años, este subgrupo presentaba más comorbilidades como hipertensión, enfermedad pulmonar obstructiva crónica y falla renal, y más internaciones previas debido a insuficiencia cardíaca (IC). A lo largo de una media de seguimiento de 104,4 ± 3,3 meses, fallecieron 162 pacientes (14%), 120 de los más jóvenes (12,4%) y 42 (24,4%) de los añosos. El análisis de Kaplan-Meier mostró un aumento de la probabilidad de morir con el aumento de la edad (17, 24, 28, y 69% a los 12, 24, 48, y 60 meses de seguimiento en el grupo de pacientes añosos). No hubo diferencias entre la tasa de intervenciones con CDI apropiadas o inapropiadas. Conclusión: en el mundo real, los pacientes añosos constituyen ~15% de los implantes de CDI para prevención primaria de la muerte súbita cardíaca (MSC). Si bien la tasa de terapias apropiadas es similar en los diferentes grupos, el beneficio de CDI se ve atenuado por un mayor aumento del riesgo de mortalidad entre los pacientes que son mayores de 75 años al momento del implante.