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Spanish catheter ablation registry. 23rd official report of the Heart Rhythm Association of the Spanish Society of Cardiology (2023).
No full text20.500.12530/87855We report the results of the 2023 Spanish catheter ablation registry. Procedural data were collected and incorporated into the REDCap platform by all participating centers through a specific form. There were 104 participating centers in 2023 compared with 103 in 2022. In 2023, the total number of ablation procedures was 26 207, indicating a stabilization of the increase observed in 2022 following the pandemic. The increase was mainly due to procedures for atrial fibrillation (AF), with a total of 9942 ablations, representing 38% of all substrates. Notably, pulse-field ablation represented 10.3% of all AF ablation procedures, leading single-shot ablation strategies to outnumber point-by-point AF ablation for the first time in the history of the registry. Cavotricuspid isthmus ablation remained the second most targeted substrate (19% of all substrates, n=5067). The overall acute success rate remained high (97%), with a downward trend in the complication rate (1.6% vs 1.8% in 2022) and mortality rate (0.03%; n=7). Compared with 2022, there was a significant increase in procedures performed using electro-anatomical mapping and zero-fluoroscopy techniques for cavotricuspid isthmus ablation (52% vs 26%), AV node re-entrant tachycardia (48% vs 34%), and accessory pathways (62% vs 22%). We registered 466 ablations in pediatric patients. The data indicate a stabilization in the post-pandemic increase in ablation procedures, with an absolute and relative increase in AF as the predominant substrate. Success rates remained stable with a modest reduction in complication and mortality rates
Effect of the SARS-CoV-2 pandemic on colorectal cancer diagnosis and prognosis.
No full text20.500.12530/87870Our aim was to determine the impact of the SARS-CoV-2 pandemic on the diagnosis and prognosis of colorectal cancer (CRC). This prospective cohort study included individuals diagnosed with CRC between March 13, 2019 and June 20, 2021 across 21 Spanish hospitals. Two time periods were compared: prepandemic (from March 13, 2019 to March 13, 2020) and pandemic (from March 14, 2020 to June 20, 2021, lockdown period and 1 year after lockdown). We observed a 46.9% decrease in the number of CRC diagnoses (95% confidence interval (CI): 45.1%-48.7%) during the lockdown and 29.7% decrease (95% CI: 28.1%-31.4%) in the year after the lockdown. The proportion of patients diagnosed at stage I significantly decreased during the pandemic (21.7% vs. 19.0%; p = 0.025). Centers that applied universal preprocedure SARS-CoV-2 PCR testing experienced a higher reduction in the number of colonoscopies performed during the pandemic post-lockdown (34.0% reduction; 95% CI: 33.6%-34.4% vs. 13.7; 95% CI: 13.4%-13.9%) and in the number of CRCs diagnosed (34.1% reduction; 95% CI: 31.4%-36.8% vs. 26.7%; 95% CI: 24.6%-28.8%). Curative treatment was received by 87.5% of patients diagnosed with rectal cancer prepandemic and 80.7% of patients during the pandemic post-lockdown period (p = 0.002). The COVID-19 pandemic has led to a decrease in the number of diagnosed CRC cases and in the proportion of stage I CRC. The reduction in the number of colonoscopies and CRC diagnoses was higher in centers that applied universal SARS-CoV-2 PCR screening before colonoscopy. In addition, the COVID-19 pandemic has affected curative treatment of rectal cancers
Combination of T cell-redirecting strategies with a bispecific antibody blocking TGF-β and PD-L1 enhances antitumor responses.
No full textT cell-based immunotherapies for solid tumors have not achieved the clinical success observed in hematological malignancies, partially due to the immunosuppressive effect promoted by the tumor microenvironment, where PD-L1 and TGF-β play a pivotal role. However, durable responses to immune checkpoint inhibitors remain limited to a minority of patients, while TGF-β inhibitors have not reached the market yet. Here, we describe a bispecific antibody for dual blockade of PD-L1 and TFG-β, termed AxF (scFv)2, under the premise that combination with T cell redirecting strategies would improve clinical benefit. The AxF (scFv)2 antibody was well expressed in mammalian and yeast cells, bound both targets and inhibited dose-dependently the corresponding signaling pathways in luminescence-based cellular reporter systems. Moreover, combined treatment with trispecific T-cell engagers (TriTE) or CAR-T cells significantly boosted T cell activation status and cytotoxic response in breast, lung and colorectal (CRC) cancer models. Importantly, the combination of an EpCAMxCD3×EGFR TriTE with the AxF (scFv)2 delayed CRC tumor growth in vivo and significantly enhanced survival compared to monotherapy with the trispecific antibody. In summary, we demonstrated the feasibility of concomitant blockade of PD-L1 and TGF-β by a single molecule, as well as its therapeutic potential in combination with different T cell redirecting agents to overcome tumor microenvironment-mediated immunosuppression
Gender-specific capacity of insulin resistance proxies to predict functional decline in older adults.
No full text20.500.12530/87857Insulin resistance determined by Homeostasis Model of Insulin Resistance (HOMA-IR) has been associated with functional decline in non-diabetic older subjects. However, insulin is not routinely assessed. The study evaluated the predictive value of non-insulin-dependent IR surrogates on functional decline in non-diabetic older men and women. Prospective cohort study over 5 years. The study included 615 older participants from the Toledo Study of Healthy Aging. Frailty was assessed by the Frailty Trait Scale-5 (FTS-5) at baseline and after 5 years follow-up. 193 subjects experienced functional decline (2.5-point reduction in the FTS-5 score). Multivariate regression models analysed the effect of five described IR surrogates on functional decline considering potential confounders. Among evaluated IR proxies, triglyceride glucose-body mass index (TyG-BMI) and HOMA-IR were significantly associated with an increased risk of functional decline (odd ratio (95% confidence interval) TyG-BMI: 1.16 (1.05, 1.28), p = 0.0035 and HOMA-IR: 1.59 (1.15, 2.21), p = 0.0056) among all participants. When stratified by gender, HOMA-IR was related to functional decline in men [2.02 (1.13, 3.59), p = 0.0173] and TyG-BMI in women [1.19 (1.05, 1.35), p = 0.0057]. Only TyG-BMI index mimics the predictive capacity of insulin-based IR marker. The predictive ability of IR indexes is gender-specific, being TyG-BMI the only index able to predict functional decline in women and HOMA-IR in men
Machine learning based detection of T-wave alternans in real ambulatory conditions.
No full text20.500.12530/87908T-wave alternans (TWA) is a fluctuation in the repolarization morphology of the ECG. It is associated with cardiac instability and sudden cardiac death risk. Diverse methods have been proposed for TWA analysis. However, TWA detection in ambulatory settings remains a challenge due to the absence of standardized evaluation metrics and detection thresholds. In this work we use traditional TWA analysis signal processing-based methods for feature extraction, and two machine learning (ML) methods, namely, K-nearest-neighbor (KNN) and random forest (RF), for TWA detection, addressing hyper-parameter tuning and feature selection. The final goal is the detection in ambulatory recordings of short, non-sustained and sparse TWA events. We train ML methods to detect a wide variety of alternant voltage from 20 to 100 μV, i.e., ranging from non-visible micro-alternans to TWA of higher amplitudes, to recognize a wide range in concordance to risk stratification. In classification, RF outperforms significantly the recall in comparison with the signal processing methods, at the expense of a small lost in precision. Despite ambulatory detection stands for an imbalanced category context, the trained ML systems always outperform signal processing methods. We propose a comprehensive integration of multiple variables inspired by TWA signal processing methods to fed learning-based methods. ML models consistently outperform the best signal processing methods, yielding superior recall scores
Beyond effectiveness in eHealth trials: Process evaluation of a stepped-care programme to support healthcare workers with psychological distress (RESPOND-HCWs).
No full text20.500.12530/87913This study presents the process evaluation of an effective stepped-care programme of eHealth interventions (Doing What Matters in Times of Stress [DWM] and Problem Management Plus [PM+]) for healthcare workers (HCWs) with psychological distress (RESPOND-HCWs trial) conducted in Spain. The aim is to analyse the context in which the programme was delivered, assess key implementation outcomes and explore mechanisms of action. We used mixed methods. Quantitative data came from routine randomised control trial monitoring and structured observation, and qualitative data were collected using semi-structured, in-depth interviews with trial participants (n = 12) and decision-makers (n = 7) and a focus group discussion with intervention providers (n = 7). We conducted a descriptive analysis of quantitative data using R software and a thematic analysis of qualitative data using NVivo. Context analysis revealed implementation barriers, including unrealistic expectations of participants about the programme and mental health-related stigma. The flexibility of interventions and the opportunity for mental health actions were enabling factors. Implementation outcomes showed that the trial was feasible, appropriate and timely, and that the intervention was delivered with minimal protocol deviations and good acceptance among participants. Mechanisms of action included confidence in the positive effect of the intervention, a good therapeutic relationship and specific intervention components. These results supplement the outcome evaluation and can help inform large-scale implementation in similar settings. Specific recommendations include increasing mental health awareness and reducing stigma in the implementation setting, including a short orientation session and ensuring flexibility in schedules and peer support. NCT04980326
A virtual community of practice to empower patients with recent ischemic heart disease: A randomized controlled trial.
No full textTo evaluate the effectiveness of a virtual community of practice (vCoP) in improving the activation of individuals with ischemic heart disease (IHD). We conducted a randomized controlled trial. A total of 282 patients with IHD from Madrid, Catalonia, and the Canary Islands were randomly allocated to an intervention or a control group. Patients were anonymized and the statistician was blinded to group allocation. The intervention was a multicomponent-tailored vCoP built on the Web 2.0 concept and focused on skills toward patient empowerment. The primary outcome was the Patient Activation Measure score. Secondary outcomes were self-efficacy to manage the disease, adherence to the Mediterranean diet, level of physical activity, depression, anxiety, medication adherence, and health-related quality of life. A linear regression model of mixed effects was carried out to estimate the effect of participating in the vCoP. Significant differences in adherence to the Mediterranean diet were found favoring the intervention at 6, 12, and 18 months, B = 0.86, 95% confidence interval (CI) [0.36, 1.35]. No significant changes among data collection points were found for the other variables. Our results suggest that vCoPs can be helpful for improving adherence to the Mediterranean diet in individuals with IHD, but not for improving their activation or quality of life. However, considerable uncertainty remains due to participants' high dropout rate. Further research is needed to identify the behavioral change mechanisms of such an intervention. (PsycInfo Database Record (c) 2025 APA, all rights reserved)
Bezlotoxumab during the first episode of Clostridioides difficile infection in patients at high risk of recurrence.
No full text20.500.12530/87855To describe a cohort with a high risk of recurrence who received bezlotoxumab during the first episode of Clostridioides difficile infection (CDI) and to compare this cohort with patients with similar characteristics who did not receive the monoclonal antibody. A prospective and multicentre study of patients with a high risk of recurrence (expected recurrence rate>35%) who were treated with bezlotoxumab during their first episode of CDI was conducted. A propensity score-matched model 1:2 was used to compare both cohorts that were weighed according to basal characteristics (hospital-acquisition, creatinine value, and fidaxomicin as a CDI treatment). Sixty patients (mean age:72 years) were prospectively treated with bezlotoxumab plus anti-Clostridioides antibiotic therapy. Vancomycin (48 patients) and fidaxomicin (12 patients) were prescribed for CDI treatment, and bezlotoxumab was administered at a mean of 4.2 (SD:2.1) days from the beginning of therapy. Recurrence occurred in nine out of 54 (16.7%) evaluable patients at 8 weeks. Forty bezlotoxumab-treated patients were matched with 69 non-bezlotoxumab-treated patients. Recurrence rates at 12 weeks were 15.0% (6/40) in bezlotoxumab-treated patients vs. 23.2% (16/69) in non-bezlotoxumab-treated patients (OR:0.58 [0.20-1.65]). No adverse effects were observed related to bezlotoxumab infusion. Only one of 9 patients with previous heart failure developed heart failure. We observed that patients treated with bezlotoxumab in a real-world setting during a first episode of CDI having high risk of recurrence, presented low rate of recurrence. However, a significant difference in recurrence could not be proved in comparison to the controls. We did not detect any other safety concerns
Current role of midazolam in sedation of the ventilated critically ill patient: in favour
No full text20.500.12530/8790
Exploring candidate biomarkers for rheumatoid arthritis through cardiovascular and cardiometabolic serum proteome profiling.
No full text20.500.12530/87913RA patients are at higher risk of cardiovascular disease, influenced by therapies. Studying their cardiovascular and cardiometabolic proteome can unveil biomarkers and insights into related biological pathways. This study included two cohorts of RA patients: newly diagnosed individuals (n=25) and those with established RA (disease duration >25 years, n=25). Both cohorts were age and sex-matched with a control group (n=25). Additionally, a longitudinal investigation was conducted on a cohort of 25 RA patients treated with methotrexate and another cohort of 25 RA patients treated with tofacitinib for 6 months. Clinical and analytical variables were recorded, and serum profiling of 184 proteins was performed using the Olink technology platform. RA patients exhibited elevated levels of 75 proteins that might be associated with cardiovascular disease. In addition, 24 proteins were increased in RA patients with established disease. Twenty proteins were commonly altered in both cohorts of RA patients. Among these, elevated levels of CTSL1, SORT1, SAA4, TNFRSF10A, ST6GAL1 and CCL18 discriminated RA patients and HDs with high specificity and sensitivity. Methotrexate treatment significantly reduced the levels of 13 proteins, while tofacitinib therapy modulated the expression of 10 proteins. These reductions were associated with a decrease in DAS28. Baseline levels of SAA4 and high levels of BNP were associated to the non-response to methotrexate. Changes in IL6 levels were specifically linked to the response to methotrexate. Regarding tofacitinib, differences in baseline levels of LOX1 and CNDP1 were noted between non-responder and responder RA patients. In addition, response to tofacitinib correlated with changes in SAA4 and TIMD4 levels. In summary, this study pinpoints molecular changes linked to cardiovascular disease in RA and proposes candidate protein biomarkers for distinguishing RA patients from healthy individuals. It also highlights how methotrexate and tofacitinib impact these proteins, with distinct alterations corresponding to each drug's response, identifying potential candidates, as SAA4, for the response to these therapies