Real-world evidence demonstrates an appropriate atrial fibrillation population for hybrid convergent approach versus stand-alone cryoballoon ablation: A long-term safety and efficacy study.

INTRODUCTION: A hybrid convergent approach (endocardial and epicardial ablation) demonstrated superior effectiveness in a recent randomized study for long-standing persistent atrial fibrillation (LSPAF). Yet, there is a lack of real-world, long-term evidence as to which patients are best candidates for a hybrid convergent approach compared to standard endocardial cryoballoon pulmonary vein isolation (CB PVI). METHODS AND RESULTS: This single-center, retrospective analysis spanning from 2010 to 2015 compared two distinctly different atrial fibrillation (AF) cohorts; one treated with stand-alone cryoablation and one treated with a hybrid convergent approach. Baseline characteristics described candidates for each approach. The following criteria were utilized to determine CB PVI candidacy: (1) paroxysmal AF (PAF) (stage 3A) with failed class I/III antiarrhythmic drug (AAD) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD unwilling to undergo hybrid procedure. Selection criteria for the hybrid procedure included: (1) PAF refractory to both class I/III AAD and prior CB PVI (stage 3D) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD agreeable to hybrid procedure. Prior sternotomy was excluded. Serial electrocardiograms and continuous monitoring evaluated primary efficacy outcome of time-to-first recurrence of atrial arrhythmia after a 90-day blanking period. Secondary outcomes were procedure-related complications and AAD use (at discharge, 12, and 36 months). Kaplan-Meier methods evaluated arrhythmia recurrence. Of 276 patients, 197 (64.2 ± 10.6 years old; 66.5% male; 74.1% 3A-PAF; 18.3% 3B/3D-persistent AF; 1.0% 3C-LSPAF; 6.6% undetermined) underwent CB PVI and 79 (61.4 ± 8.1 years old; 83.5% male; 41.8% 3D-PAF; 45.5% 3B/3D-persistent AF; 12.7% 3C/3D-LSPAF) underwent hybrid procedure. Arrhythmia freedom through 36 months was 55.2% for CB PVI and 50.4% for hybrid (p = .32). Class I AAD utilization at discharge occurred in 38 (19.3%) patients in the CB PVI group and 5 (6.3%) patients in the hybrid group (p = .01). CB PVI class I AAD utilization at 12 months occurred in 14 (9.0) patients versus 0 patients for hybrid convergent (p = .004). Patients with one or more adverse event were as follows: two (1.0%) in the CB PVI group (both transient phrenic nerve palsy) and three (3.7%) in the hybrid group (two with significant bleeding and one with wound infection) (p = .14). CONCLUSION: This study demonstrated that patients with more complex forms of AF (3D-PAF or 3B/3C/3D-persistent/LSPAF) could be well managed with a convergent approach. In a real-world evaluation, outcomes match safety and efficacy thresholds achieved for patients with earlier, less complex AF etiologies treated by CB PVI alone.

COVID-19? Let me see your hands.

During the first wave of the COVID�19 pandemic, a patient with anti-synthetase syndrome (ASS) was misdiagnosed as having bilateral severe acute respiratory syndrome coronavirus 2 pneumonia on admission. A comprehensive clinical evaluation would have led to the correct diagnosis earlier, as he had some data consistent with ASS on both physical examination and laboratory tests that were initially overlooked. In addition, a malignant lesion in the colon was found on screening for underlying malignancy. In this context, ASS has been considered a low-risk subgroup for cancer among idiopathic inflammatory myopathies. However, this should be interpreted cautiously and should not lead to neglect of adequate cancer screening adjusted for age, sex and other potential risk factors.

Seven Epidemic Waves of COVID-19 in a Hospital in Madrid: Analysis of Severity and Associated Factors.

(1) Background: COVID-19 has evolved during seven epidemic waves in Spain. Our objective was to describe changes in mortality and severity in our hospitalized patients. (2) Method: This study employed a descriptive, retrospective approach for COVID-19 patients admitted to the Hospital de Fuenlabrada (Madrid, Spain) until 31 December 2022. (3) Results: A total of 5510 admissions for COVID-19 were recorded. The first wave accounted for 1823 (33%) admissions and exhibited the highest proportion of severe patients: 65% with bilateral pneumonia and 83% with oxygen saturation under 94% during admission and elevated levels of CRP, IL-6, and D-dimer. In contrast, the seventh wave had the highest median age (79 years) and comorbidity (Charlson: 2.7), while only 3% of patients had bilateral pneumonia and 3% required intubation. The overall mortality rate was 10.3%. The first wave represented 39% of the total. The variables related to mortality were age (OR: 1.08, 1.07-1.09), cancer (OR: 1.99, 1.53-2.60), dementia (OR: 1.82, 1.20-2.75), the Charlson index (1.38, 1.31-1.47), the need for high-flow oxygen (OR: 6.10, 4.94-7.52), mechanical ventilation (OR: 11.554, 6.996-19.080), and CRP (OR: 1.04, 1.03-1.06). (4) Conclusions: The variables associated with mortality included age, comorbidity, respiratory failure, and inflammation. Differences in the baseline characteristics of admitted patients explained the differences in mortality in each wave. Differences observed between patients admitted in the latest wave and the earlier ones suggest that COVID-19 has evolved into a distinct disease, requiring a distinct approach.

Impact of Diabetes Mellitus on Benefit of ß-Blocker Therapy After Myocardial Infarction.

Beta blockers are uniformly recommended for all patients after myocardial infarction (MI), including those with diabetes mellitus (DM). This study assesses the impact of ß-blocker type and dosing on survival in patients with DM after MI. A cohort of 6,682 patients in the Outcomes of Beta-blocker Therapy After Myocardial INfarction registry were discharged after MI. In this cohort, 2,137 patients had DM (32%). Beta-blocker dose was indexed to the target daily dose used in randomized clinical trials and reported as percentage. Dosage groups were: no ß blocker, >0% to 12.5%, >12.5% to 25%, >25% to 50%, and >50% of the target dose. The overall mean discharge ß-blocker dose in patients with DM was 42.7 ± 34.1% versus 35.9 ± 27.4% in patients without DM (p <0.0001). Patients with DM were prescribed carvedilol at a higher rate than those without DM (27.8% vs 19.6%). The 3-year mortality estimates were 24.4% and 12.8% for patients with DM versus without DM (p <0.0001), respectively, with an unadjusted hazard ratio = 1.820 (confidence interval 1.587 to 2.086, p <0.0001). Patients with DM in the >12.5% to 25% dose category had the highest survival rates, whereas patients in the >50% dose had the lowest survival rate among patients discharged on ß blockers (p <0.0001). In the multivariable analysis among patients with DM after MI, all ß-blocker dose categories demonstrated lower mortality than no therapy; however, only the >12.5% to 25% dose had a statistically significant hazard ratio 0.450 (95% confidence interval 0.224 to 0.907, p = 0.025). In patients with DM, there was no statistically significant difference in 3-year mortality among those treated with metoprolol versus carvedilol. In conclusion, our analysis in patients with DM after MI suggested a survival benefit from ß-blocker therapy, with no apparent advantage to high- versus low-dose ß-blocker therapy; although, physicians tended to prescribe higher doses in patients with DM. There was no survival benefit for carvedilol over metoprolol in patients with DM.

Baricitinib or imatinib in hospitalized COVID-19 patients: Results from COVINIB, an exploratory randomized clinical trial.

Baricitinib and imatinib are considered therapies for coronavirus disease 2019 (COVID-19), but their ultimate clinical impact remains to be elucidated, so our objective is to determine whether these kinase inhibitors provide benefit when added to standard care in hospitalized COVID-19 patients. Phase-2, open-label, randomized trial with a pick-the-winner design conducted from September 2020 to June 2021 in a single Spanish center. Hospitalized adults with COVID-19 pneumonia and a symptom duration ≤10 days were assigned to 3 arms: imatinib (400 mg qd, 7 days) plus standard-care, baricitinib (4 mg qd, 7 days) plus standard-care, or standard-care alone. Primary outcome was time to clinical improvement (discharge alive or a reduction of 2 points in an ordinal scale of clinical status) compared on a day-by-day basis to identify differences ≥15% between the most and least favorable groups. Secondary outcomes included oxygenation and ventilatory support requirements, additional therapies administered, all-cause mortality, and safety. One hundred and sixty-five patients analyzed. Predefined criteria for selection of the most advantageous arm were met for baricitinib, but not for imatinib. However, no statistically significant differences were observed in formal analysis, but a trend toward better results in patients receiving baricitinib was found compared to standard care alone (hazard ratio [HR] for clinical improvement: 1.41, 95% confidence intervals [CI]: 0.96-2.06; HR for discontinuing oxygen: 1.46, 95% CI: 0.94-2.28). No differences were found regarding additional therapies administered or safety. Baricitinib plus standard care showed better results for hospitalized COVID-19 patients, being the most advantageous therapeutic strategy among those proposed in this exploratory clinical trial.

Comparative Study of Vaccinated and Unvaccinated Hospitalised Patients: A Retrospective Population Study of 500 Hospitalised Patients with SARS-CoV-2 Infection in a Spanish Population of 220,000 Inhabitants.

OBJECTIVES: This study aimed to compare the characteristics of fully and partially vaccinated or unvaccinated coronavirus disease 2019 (COVID-19) patients who were hospitalised in a population of 220,000 habitants. METHODS: Retrospective, observational, and population studies were conducted on patients who were hospitalised due to COVID-19 from March to October 2021. We assessed the impact of vaccination and other risk factors through Cox multivariate analysis. RESULTS: A total of 500 patients were hospitalised, among whom 77 (15.4%) were fully vaccinated, 86 (17.2%) were partially vaccinated, and 337 (67.4%) were unvaccinated. Fully vaccinated (FV) patients were older and had a higher Charlson index than those of partially vaccinated and unvaccinated patients (NFV). Bilateral pneumonia was more frequent among NFV (259/376 (68.9%)) than among FV patients (32/75 (42.7%)). The former had more intensive care unit admissions (63/423) than the latter (4/77); OR: 2.80; CI (1.07-9.47). Increasing age HZ: 1.1 (1.06-1.14)) and haematological disease at admission HZ: 2.99 (1.26-7.11)) were independent risk factors for higher mortality during the first 30 days of hospitalisation. The probability of an earlier discharge in the subgroup of 440 patients who did not die during the first 30 days of hospitalisation was related to age (older to younger: HZ: 0.98 (0.97-0.99)) and vaccination status. CONCLUSIONS: Among the patients hospitalised because of COVID-19, complete vaccination was associated with less severe forms of COVID-19, with an earlier discharge date. Age and haematological disease were related to a higher mortality rate during the first 30 days of hospitalisation.

Sociodemographic and clinical characteristics related to the final condition of patients intoxicated by paraquat in a hospital in southwestern Colombia / Características sociodemográficas y clínicas relacionadas con la condición final de pacientes intoxicados por paraquat en un hospital del suroccidente de Colombia.

Introduction: Paraquat is an agrochemical that constitutes the first cause of death by poisoning in different countries. Objective: To relate sociodemographic and clinical characteristics with the final condition of patients intoxicated by paraquat in a hospital in southwestern Colombia. Materials and methods: This was an observational, descriptive, analytical, crosssectional, and retrospective study. We reviewed the medical records of patients diagnosed with paraquat poisoning at a level III hospital in Pasto, Colombia, from 2013 to 2018. We collected the data regarding their final condition (alive or deceased) and their sociodemographic, clinical, and paraclinical information. We established group comparisons and designed a binary logistic regression model. Results: We reviewed 299 records and, after the exclusion, we analyzed 160 cases. The characteristics related to the final condition of the patients were length of stay (OR = 0.124; 95% CI: 0.03-0.6; p = 0.009), heart rate (OR = 35.65; 95% CI: 1.44-884.78; p = 0.029), and initial creatinine (OR = 1.73; 95% CI: 1.23-2.44; p = 0.002). Conclusion: The proportion of case fatality was higher in patients with short hospital stay times and elevated heart rates and admission creatinine levels. This report may be useful as a rationale for the creation of a severity scale for the early detection of patients with adverse outcomes and their timely treatment.

Introducción. El herbicida paraquat constituye la primera causa de decesos por intoxicaciones en distintos países. Objetivo. Relacionar las características sociodemográficas y clínicas con la condición final de pacientes intoxicados por paraquat atendidos en un hospital del suroccidente de Colombia. Materiales y métodos. En este estudio observacional, descriptivo, analítico, transversal y retrospectivo, se revisaron las historias clínicas de pacientes atendidos por intoxicación con paraquat en una institución de tercer nivel de complejidad en Pasto (Colombia) entre el 2013 y el 2018. Se recolectó la información sobre la condición final (vivo o fallecido) de cada paciente, así como los datos sociodemográficos, clínicos y de los exámenes paraclínicos. Se establecieron comparaciones por grupos y se diseñó un modelo de regresión logística binaria. Resultados. Se filtró la información de 299 registros y se analizaron finalmente 160 casos. Las características relacionadas con la condición final de los pacientes fueron el tiempo de estancia (OR=0,124; IC95% 0,03-0,6; p=0,009), la frecuencia cardiaca (OR=35,65; IC95% 1,44-884,78; p=0,029) y la creatinina inicial (OR=1,73; IC95% 1,23-2,44; p=0,002). Conclusiones. La proporción de la letalidad fue mayor entre los pacientes con estancia hospitalaria corta, taquicardia y elevación de la concentración sérica de creatinina al ingreso. Este reporte puede ser útil como fundamento de una escala de gravedad para detectar a los pacientes con resultados adversos en la fase temprana para que puedan recibir una intervención oportuna.

Características sociodemográficas y clínicas relacionadas con la condición final de pacientes intoxicados por paraquat en un hospital del suroccidente de Colombia / Sociodemographic and clinical characteristics related to the final condition of patients intoxicated by paraquat in a hospital in southwestern Colombia

Introducción. El herbicida paraquat constituye la primera causa de decesos por intoxicaciones en distintos países. Objetivo. Relacionar las características sociodemográficas y clínicas con la condición final de pacientes intoxicados por paraquat atendidos en un hospital del suroccidente de Colombia. Materiales y métodos. En este estudio observacional, descriptivo, analítico, transversal y retrospectivo, se revisaron las historias clínicas de pacientes atendidos por intoxicación con paraquat en una institución de tercer nivel de complejidad en Pasto (Colombia) entre el 2013 y el 2018. Se recolectó la información sobre la condición final (vivo o fallecido) de cada paciente, así como los datos sociodemográficos, clínicos y de los exámenes paraclínicos. Se establecieron comparaciones por grupos y se diseñó un modelo de regresión logística binaria. Resultados. Se filtró la información de 299 registros y se analizaron finalmente 160 casos. Las características relacionadas con la condición final de los pacientes fueron el tiempo de estancia (OR=0,124; IC95% 0,03-0,6; p=0,009), la frecuencia cardiaca (OR=35,65; IC95% 1,44-884,78; p=0,029) y la creatinina inicial (OR=1,73; IC95% 1,23-2,44; p=0,002). Conclusiones. La proporción de la letalidad fue mayor entre los pacientes con estancia hospitalaria corta, taquicardia y elevación de la concentración sérica de creatinina al ingreso. Este reporte puede ser útil como fundamento de una escala de gravedad para detectar a los pacientes con resultados adversos en la fase temprana para que puedan recibir una intervención oportuna.

Introduction: Paraquat is an agrochemical that constitutes the first cause of death by poisoning in different countries. Objective: To relate sociodemographic and clinical characteristics with the final condition of patients intoxicated by paraquat in a hospital in southwestern Colombia. Materials and methods: This was an observational, descriptive, analytical, crosssectional, and retrospective study. We reviewed the medical records of patients diagnosed with paraquat poisoning at a level III hospital in Pasto, Colombia, from 2013 to 2018. We collected the data regarding their final condition (alive or deceased) and their sociodemographic, clinical, and paraclinical information. We established group comparisons and designed a binary logistic regression model. Results: We reviewed 299 records and, after the exclusion, we analyzed 160 cases. The characteristics related to the final condition of the patients were length of stay (OR = 0.124; 95% CI: 0.03-0.6; p = 0.009), heart rate (OR = 35.65; 95% CI: 1.44-884.78; p = 0.029), and initial creatinine (OR = 1.73; 95% CI: 1.23-2.44; p = 0.002). Conclusion: The proportion of case fatality was higher in patients with short hospital stay times and elevated heart rates and admission creatinine levels. This report may be useful as a rationale for the creation of a severity scale for the early detection of patients with adverse outcomes and their timely treatment.

Prognostic factors and combined use of tocilizumab and corticosteroids in a Spanish cohort of elderly COVID-19 patients.

Coronavirus disease 2019 (COVID-19) infection in elderly patients is more aggressive and treatments have shown limited efficacy. Our objective is to describe the clinical course and to analyze the prognostic factors associated with a higher risk of mortality of a cohort of patients older than 80 years. In addition, we assess the efficacy of immunosuppressive treatments in this population. We analyzed the data from 163 patients older than 80 years admitted to our institution for COVID-19, during March and April 2020. A Lasso regression model and subsequent multivariate Cox regression were performed to select variables predictive of death. We evaluated the efficacy of immunomodulatory therapy in three cohorts using adjusted survival analysis. The mortality rate was 43%. The mean age was 85.2 years. The disease was considered severe in 76.1% of the cases. Lasso regression and multivariate Cox regression indicated that factors correlated with hospital mortality were: age (hazard ratio [HR] 1.12, 95% confidence interval [CI]: 1.03-1.22), alcohol consumption (HR 3.15, 95% CI: 1.27-7.84), CRP > 10 mg/dL (HR 2.67, 95% CI: 1.36-5.24), and oxygen support with Venturi Mask (HR 6.37, 95% CI: 2.18-18.62) or reservoir (HR 7.87, 95% CI: 3.37-18.38). Previous treatment with antiplatelets was the only protective factor (HR 0.47, 95% CI: 0.23-0.96). In the adjusted treatment efficacy analysis, we found benefit in the combined use of tocilizumab (TCZ) and corticosteroids (CS) (HR 0.09, 95% CI: 0.01-0.74) compared to standard treatment, with no benefit of CS alone (HR 0.95, 95% CI: 0.53-1.71). Hospitalized elderly patients suffer from a severe and often fatal form of COVID-19 disease. In this regard, several parameters might identify high-risk patients upon admission. Combined use of TCZ and CS could improve survival.

Sinus node sparing novel hybrid approach for treatment of inappropriate sinus tachycardia/postural sinus tachycardia: multicenter experience.

BACKGROUND: The ideal treatment of inappropriate sinus tachycardia (IST) and postural orthostatic tachycardia syndrome (POTS) still needs to be defined. Medical treatments yield suboptimal results. Endocardial catheter ablation of the sinus node (SN) may risk phrenic nerve damage and open-heart surgery may be accompanied by unjustified invasive risks. METHODS: We describe our first multicenter experience of 255 consecutive patients (235 females, 25.94 ± 3.84 years) having undergone a novel SN sparing hybrid thoracoscopic ablation for drug-resistant IST (n = 204, 80%) or POTS (n = 51, 20%). As previously described, the SN was identified with 3D mapping. Surgery was performed through three 5-mm ports from the right side. A minimally invasive approach with a bipolar radiofrequency clamp was used to ablate targeted areas while sparing the SN region. The targeted areas included isolation of the superior and the inferior caval veins, and a crista terminalis line was made. All lines were interconnected. RESULTS: Normal sinus rhythm (SR) was restored in all patients at the end of the procedure. All patients discontinued medication during the follow-up. After a blanking period of 6 months, all patients presented stable SR. At a mean of 4.07 ± 1.8 years, normal SN reduction and chronotropic response to exercise were present. In the 51 patients initially diagnosed with POTS, no syncope occurred. During follow-up, pericarditis was the most common complication (121 patients: 47%), with complete resolution in all cases. Pneumothorax was observed in 5 patients (1.9%), only 3 (1.1%) required surgical drainage. Five patients (1.9%) required a dual-chamber pacemaker due to sinus arrest > 5 s. CONCLUSIONS: Preliminary results of this multicenter experience with a novel SN sparing hybrid ablation of IST/POTS, using surgical thoracoscopic video-assisted epicardial ablation combined with simultaneous endocardial 3D mapping may prove to be an efficient and safe therapeutic option in patients with symptomatic drug-resistant IST and POTS. Importantly, in our study, all patients had a complete resolution of the symptoms and restored normal SN activity.