Invasive Treatment Strategy in Adults With Frailty and Non-ST-Segment Elevation Myocardial Infarction: A Secondary Analysis of a Randomized Clinical Trial.

Importance: The MOSCA-FRAIL randomized clinical trial compared invasive and conservative treatment strategies in patients with frailty with non-ST-segment elevation myocardial infarction (NSTEMI). It showed no differences in the number of days alive and out of the hospital at 1 year. Objective: To assess the outcomes of the MOSCA-FRAIL trial during extended follow-up. Design, Setting, and Participants: The MOSCA-FRAIL randomized clinical trial was conducted at 13 hospitals in Spain between July 7, 2017, and January 9, 2021, and included 167 adults (aged ≥70 years) with frailty (Clinical Frailty Scale score ≥4) and NSTEMI. In this preplanned secondary analysis, follow-up was extended to January 31, 2023. Data analysis was performed from April 5 to 29, 2023, using the intention-to-treat principle. Interventions: Patients were randomized to a routine invasive (coronary angiography and revascularization if feasible [n = 84]) or a conservative (medical treatment with coronary angiography only if recurrent ischemia [n = 83]) strategy. Main outcomes and measures: The primary end point was the difference in restricted mean survival time (RMST). Secondary end points included readmissions for any cause, considering recurrent readmissions. Results: Among the 167 patients included in the analysis, the mean (SD) age was 86 (5) years; 79 (47.3%) were men and 88 (52.7%) were women. A total of 93 deaths and 367 readmissions accrued. The RMST for all-cause death over the entire follow-up was 3.13 (95% CI, 2.72-3.60) years in the invasive and 3.06 (95% CI, 2.84-3.32) years in the conservative treatment groups. The RMST analysis showed inconclusive differences in survival time (invasive minus conservative difference, 28 [95% CI, -188 to 230] days). Patients under invasive treatment tended to have shorter survival in the first year (-28 [95% CI, -63 to 7] days), which improved after the first year (192 [95% CI, 90-230] days). Kaplan-Meier mortality curves intersected, displaying higher mortality to 1 year in the invasive group that shifted to a late benefit (landmark analysis hazard ratio, 0.58 [95% CI, 0.33-0.99]; P = .045). Early harm was more evident in the subgroup with a Clinical Frailty Scale score greater than 4. No differences were found for the secondary end points. Conclusions and Relevance: In this extended follow-up of a randomized clinical trial of patients with frailty and NSTEMI, an invasive treatment strategy did not improve outcomes at a median follow-up of 1113 (IQR, 443-1441) days. However, a differential distribution of deaths was observed, with early harm followed by later benefit. The phenomenon of depletion of susceptible patients may be responsible for this behavior. Trial registration: ClinicalTrials.gov Identifier: NCT03208153.

A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries: The REPLICA-EPIC18 Study.

BACKGROUND: Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease. OBJECTIVES: The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setting. METHODS: The REPLICA-EPIC18 study prospectively enrolled consecutive patients treated with IVL in 26 centers in Spain. An independent core laboratory performed the angiographic analysis and event adjudication. The primary effectiveness endpoint assessed procedural success (successful IVL delivery, final diameter stenosis <20%, and absence of in-hospital major adverse cardiovascular events [MACE]). The primary safety endpoint measured freedom from MACE at 30 days. A predefined substudy compared outcomes between acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients. RESULTS: A total of 426 patients (456 lesions) were included, 63% of the patients presenting with ACS. IVL delivery was successful in 99% of cases. Before IVL, 49% of lesions were considered undilatable. The primary effectiveness endpoint was achieved in 66% of patients, with similar rates among CCS patients (68%) and ACS patients (65%). Likewise, there were no significant differences in angiographic success after IVL between CCS and ACS patients. The rate of MACE at 30 days (primary safety endpoint) was 3% (1% in CCS and 5% in ACS patients [P = 0.073]). CONCLUSIONS: Coronary IVL proved to be a feasible and safe procedure in a "real-life" setting, effectively facilitating stent implantation in severely calcified lesions. Patients with ACS on admission showed similar angiographic success rates but showed a trend toward higher 30-day MACE compared with patients with CCS. (REPLICA-EPIC18 study [Registry of Coronary Lithotripsy in Spain]; NCT04298307).

Effect of Routine Invasive vs Conservative Strategy in Older Adults With Frailty and Non-ST-Segment Elevation Acute Myocardial Infarction: A Randomized Clinical Trial.

Importance: To our knowledge, no randomized clinical trial has compared the invasive and conservative strategies in frail, older patients with non-ST-segment elevation acute myocardial infarction (NSTEMI). Objective: To compare outcomes of invasive and conservative strategies in frail, older patients with NSTEMI at 1 year. Design, Setting, and Participants: This multicenter randomized clinical trial was conducted at 13 Spanish hospitals between July 7, 2017, and January 9, 2021, and included 167 older adult (≥70 years) patients with frailty (Clinical Frailty Scale score ≥4) and NSTEMI. Data analysis was performed from April 2022 to June 2022. Interventions: Patients were randomized to routine invasive (coronary angiography and revascularization if feasible; n = 84) or conservative (medical treatment with coronary angiography for recurrent ischemia; n = 83) strategy. Main Outcomes and Measures: The primary end point was the number of days alive and out of the hospital (DAOH) from discharge to 1 year. The coprimary end point was the composite of cardiac death, reinfarction, or postdischarge revascularization. Results: The study was prematurely stopped due to the COVID-19 pandemic when 95% of the calculated sample size had been enrolled. Among the 167 patients included, the mean (SD) age was 86 (5) years, and mean (SD) Clinical Frailty Scale score was 5 (1). While not statistically different, DAOH were about 1 month (28 days; 95% CI, -7 to 62) greater for patients managed conservatively (312 days; 95% CI, 289 to 335) vs patients managed invasively (284 days; 95% CI, 255 to 311; P = .12). A sensitivity analysis stratified by sex did not show differences. In addition, we found no differences in all-cause mortality (hazard ratio, 1.45; 95% CI, 0.74-2.85; P = .28). There was a 28-day shorter survival in the invasive vs conservatively managed group (95% CI, -63 to 7 days; restricted mean survival time analysis). Noncardiac reasons accounted for 56% of the readmissions. There were no differences in the number of readmissions or days spent in the hospital after discharge between groups. Neither were there differences in the coprimary end point of ischemic cardiac events (subdistribution hazard ratio, 0.92; 95% CI, 0.54-1.57; P = .78). Conclusions and Relevance: In this randomized clinical trial of NSTEMI in frail older patients, there was no benefit to a routine invasive strategy in DAOH during the first year. Based on these findings, a policy of medical management and watchful observation is recommended for older patients with frailty and NSTEMI. Trial Registration: ClinicalTrials.gov Identifier: NCT03208153.

Antithrombotic strategies in elderly patients with atrial fibrillation revascularized with drug-eluting stents: PACO-PCI (EPIC-15) registry.

BACKGROUND: We sought to investigate the antithrombotic regimens applied and their prognostic effects in patients over 75 years old with atrial fibrillation (AF) after revascularization with drug-eluting stents (DES). METHODS: Retrospective registry in 20 centers including patients over 75 years with AF treated with DES. A primary endpoint of MACCE and a co-primary endpoint of major bleeding by ISTH criteria were considered at 12 months. RESULTS: A total of 1249 patients (81.1 ±â€¯4.2 years, 33.1% women, 66.6% ACS, 30.6% complex PCI) were included. Triple antithrombotic therapy (TAT) was prescribed in 81.7% and dual antithrombotic therapy (DAT) in 18.3%. TAT was based on direct oral anticoagulants (DOAC) in 48.4% and maintained for only 1 month in 52.2%, and DAT included DOAC in 70.6%. Primary endpoint of MACCE was met in 9.6% and primary endpoint of major bleeding in 9.4%. TAT was significantly associated with more bleeding (10.2% vs. 6.1%, p = 0.04) but less MACCE (8.7% vs. 13.6%, p = 0.02) than DAT and the use of DOAC was significantly associated to less bleeding (8% vs. 11.1%, p = 0.03) and similar MACCE (9.8% vs. 9.4%, p = 0.8). TAT over 1 month or with VKA was associated with more major bleeding but comparable MACCE rates. CONCLUSIONS: Despite advanced age TAT prevails, but duration over 1 month or the use of other agent than Apixaban are associated with increased bleeding without additional MACCE prevention. DAT reduces bleeding but with a trade-off in terms of ischemic events. DOAC use was significantly associated to less bleeding and similar MACCE rates.

Long-term and large-scale multispecies dataset tracking population changes of common European breeding birds.

Around fifteen thousand fieldworkers annually count breeding birds using standardized protocols in 28 European countries. The observations are collected by using country-specific and standardized protocols, validated, summarized and finally used for the production of continent-wide annual and long-term indices of population size changes of 170 species. Here, we present the database and provide a detailed summary of the methodology used for fieldwork and calculation of the relative population size change estimates. We also provide a brief overview of how the data are used in research, conservation and policy. We believe this unique database, based on decades of bird monitoring alongside the comprehensive summary of its methodology, will facilitate and encourage further use of the Pan-European Common Bird Monitoring Scheme results.

Impact of Anemia on the Risk of Bleeding Following Percutaneous Coronary Interventions in Patients ≥75 Years of Age.

Bleeding risk stratification is an unresolved issue in older adults. Anemia may reflect subclinical blood losses that can be exacerbated after percutaneous coronary intervention . We sought to prospectively determine the contribution of anemia to the risk of bleeding in 448 consecutive patients aged 75 or more years, treated by percutaneous coronary interventions without concomitant indication for oral anticoagulation. We evaluated the effect of WHO-defined anemia on the incidence of 1-year nonaccess site-related major bleeding. The prevalence of anemia was 39%, and 13.1% of anemic and 5.2% of nonanemic patients suffered a bleeding event (hazard ratio 2.75, 95% confidence interval 1.37 to 5.54, p = 0.004). Neither PRECISE-DAPT nor CRUSADE scores were superior to hemoglobin for the prediction of bleeding. In conclusion, anemia is a powerful predictor of bleeding with potential utility for simplifying tailoring therapies.

Análisis retrospectivo multicéntrico de las incidencias asociadas a las prótesis de aposición luminal tipo Axios(TM) / A retrospective, multicenter analysis of incidents associated with Axios(TM) lumen-apposing stents

Introducción: existe controversia respecto a los riesgos asociados a las prótesis de aposición luminal (PAL), con importantes variaciones entre los trabajos disponibles. Objetivos: describir el tipo y la proporción de complicaciones durante la permanencia y retirada de PAL tipo Axios(TM). Describir la relación entre tiempo de permeabilidad, diana terapéutica y presencia de complicaciones. Métodos: serie de casos retrospectiva y multicéntrica que incluyó todos los pacientes consecutivos a los que se les colocó una PAL para acceder a estructuras extraluminales durante el año 2017. Se registraron únicamente aquellos casos que alcanzaron éxito técnico. Resultados: se incluyeron 179 pacientes de siete centros (rango 4-68 casos/centro) con edad media de 64,3 años (DE: 15,8, rango 24,6-98,8 años), 122 (68,2%) de ellos varones. Las indicaciones más frecuentes fueron las necrosis encapsuladas (58, 32,4%), seguidas de pseudoquistes (31, 17,3%) y drenajes vesiculares (26, 14,5%). Durante la permanencia de la PAL se documentaron complicaciones en 19 pacientes (10,9%), siendo las más frecuentes las obstrucciones de la luz protésica o del marco gastroduodenal en ocho (4,5%) casos y las hemorragias en siete (3,9%) pacientes. Las PAL no se retiraron en 86 pacientes (48%) por los siguientes motivos: intención permanente de la PAL en 46 (53,5%), pérdida del seguimiento en 18 (20,9%), fallecimiento del paciente en 16 (18,6%) y migración en seis (7%). Durante la retirada se observaron cinco complicaciones (5,4%), tres casos de hemorragia y dos perforaciones. No observamos una asociación entre el tiempo de permanencia y las complicaciones (p = 0,67). Conclusión: la aparición de complicaciones secundarias a la inserción de PAL es poco frecuente, aunque pueden ser graves. En este estudio no se ha observado una asociación entre la aparición de complicaciones y el tiempo de permanencia de la prótesis

Introduction: there is controversy with regard to the risks associated with lumen-apposing metal stents (LAMSs), with significant variations between available reports. Objectives: to describe the types and proportions of complications that arise during the permanence time and removal of Axios(TM) LAMS. Furthermore, the relationship between patency time, therapeutic target and the presence of complications was also described. Methods: a retrospective, multicenter case series study was performed of all patients with an implanted LAMS to access extra-luminal structures during 2017. Only technically successful cases were recorded. Results: a total of 179 patients from seven sites (range, 4-68 cases/site) were included in the study, with a mean age of 64.3 years (SD: 15.8; range: 24.6-98.8 years) and 122 (68.2%) were male. Most common indications included encapsulated necrosis (58, 32.4%), pseudocysts (31, 17.3%) and gallbladder drains (26, 14.5%). Complications during LAMS stay were reported in 19 patients (10.9%); stent lumen or gastroduodenal obstruction (8, 4.5%) and bleeding (7, 3.9%) were the most common. LAMS were not removed in 86 (48%) patients due to the following reasons: a permanent stent was used (46, 53.5%), loss to follow-up (18, 20.9%), patient demise (16, 18.6%) and stent migration (6, 7%). Five (5.4%) complications were reported during stent removal, which were three bleeds and two perforations. No association was found between stent duration and complications (p = 0.67). Conclusion: complications secondary to LAMS insertion are uncommon but may be serious. This study found no association between complications and stent duration

A retrospective, multicenter analysis of incidents associated with Axios™ lumen-apposing stents.

INTRODUCTION: there is controversy with regard to the risks associated with lumen-apposing metal stents (LAMSs), with significant variations between available reports. OBJECTIVES: to describe the types and proportions of complications that arise during the permanence time and removal of Axios™ LAMS. Furthermore, the relationship between patency time, therapeutic target and the presence of complications was also described. METHODS: a retrospective, multicenter case series study was performed of all patients with an implanted LAMS to access extra-luminal structures during 2017. Only technically successful cases were recorded. RESULTS: a total of 179 patients from seven sites (range, 4-68 cases/site) were included in the study, with a mean age of 64.3 years (SD: 15.8; range: 24.6-98.8 years) and 122 (68.2%) were male. Most common indications included encapsulated necrosis (58, 32.4%), pseudocysts (31, 17.3%) and gallbladder drains (26, 14.5%). Complications during LAMS stay were reported in 19 patients (10.9%); stent lumen or gastroduodenal obstruction (8, 4.5%) and bleeding (7, 3.9%) were the most common. LAMS were not removed in 86 (48%) patients due to the following reasons: a permanent stent was used (46, 53.5%), loss to follow-up (18, 20.9%), patient demise (16, 18.6%) and stent migration (6, 7%). Five (5.4%) complications were reported during stent removal, which were three bleeds and two perforations. No association was found between stent duration and complications (p = 0.67). CONCLUSION: complications secondary to LAMS insertion are uncommon but may be serious. This study found no association between complications and stent duration.

Obstrucción coronaria tardía tras válvulas autoexpandibles: características clínicas y angiográficas de una complicación inesperada / Late coronary obstruction after implantation of self-expandable valves. clinical and angiographic features of an unexpected complication

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Extracting Work from Quantum Measurement in Maxwell's Demon Engines.

The essence of both classical and quantum engines is to extract useful energy (work) from stochastic energy sources, e.g., thermal baths. In Maxwell's demon engines, work extraction is assisted by a feedback control based on measurements performed by a demon, whose memory is erased at some nonzero energy cost. Here we propose a new type of quantum Maxwell's demon engine where work is directly extracted from the measurement channel, such that no heat bath is required. We show that in the Zeno regime of frequent measurements, memory erasure costs eventually vanish. Our findings provide a new paradigm to analyze quantum heat engines and work extraction in the quantum world.

Coloduodenal and enterocutaneous fistula in twins with Crohn´s disease.

We present the case of a pair of 45-year-old monozygotic twins (A and B) diagnosed with Crohn's disease (CD) at age 20 (A) and 22 (B) with similar presenting symptoms: diarrhea, fever and weight loss. Both of them had duodenal and ileocolonic disease (A2, L3+L4 according to Montreal classification); twin B also presented jejunal involvement and perianal disease (B1p). They received treatment with antibiotics, corticosteroids, 5-ASA, azathioprine and anti-TNF with a poor control of activity. They both developed a coloduodenal fistula that required surgery. Twin A developed the fistula 12 years after the first presentation; fistula closure with duodenorraphy and ileocolonic resection with gastrojejunostomy was performed. Twin B developed the fistula 22 years after the first presentation, and right colectomy, partial duodenectomy and duodenorraphy was carried out. Both developed an enterocutaneous fistula during the postoperative period. With intensive medical treatment, both twins remain asymptomatic.

Disease severity and treatment requirements in familial inflammatory bowel disease.

PURPOSE: Several studies demonstrate an increased prevalence and concordance of inflammatory bowel disease among the relatives of patients. Other studies suggest that genetic influence is over-estimated. The aims of this study are to evaluate the phenotypic expression and the treatment requirements in familial inflammatory bowel disease, to study the relationship between number of relatives and degree of kinship with disease severity and to quantify the impact of family aggregation compared to other environmental factors. METHODS: Observational analytical study of 1211 patients followed in our unit. We analyzed, according to the existence of familial association, number and degree of consanguinity, the phenotypic expression, complications, extraintestinal manifestations, treatment requirements, and mortality. A multivariable analysis considering smoking habits and non-steroidal-anti-inflammatory drugs was performed. RESULTS: 14.2% of patients had relatives affected. Median age at diagnosis tended to be lower in the familial group, 32 vs 29, p = 0.07. In familial ulcerative colitis, there was a higher proportion of extraintestinal manifestations: peripheral arthropathy (OR = 2.3, p = 0.015) and erythema nodosum (OR = 7.6, p = 0.001). In familial Crohn's disease, there were higher treatment requirements: immunomodulators (OR = 1.8, p = 0.029); biologics (OR = 1.9, p = 0.011); and surgery (OR = 1.7, p = 0.044). The abdominal abscess increased with the number of relatives affected: 5.1% (sporadic), 7.0% (one), and 14.3% (two or more), p=0.039. These associations were maintained in the multivariate analysis. CONCLUSIONS: Familial aggregation is considered a risk factor for more aggressive disease and higher treatment requirements, a tendency for earlier onset, more abdominal abscess, and extraintestinal manifestations, remaining a risk factor analyzing the influence of some environmental factors.

Coloduodenal and enterocutaneous fistula in twins with Crohn’s disease

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Usefulness of Urinoculture to Patients With Dementia and Femoral Neck Fracture at Admission to Hospital: Preliminary Results.

INTRODUCTION: While preoperative urinary tract infection (UTI) has the potential to cause bacteremia and postsurgical acute prosthetic joint infections (APJIs), the influence of asymptomatic bacteriuria (AB) in these infections remains unclear. So the majority of guidelines not recommend the treatment of AB prior to the surgery. However, as patients with dementia usually cannot explain the symptoms of dysuria, the differential diagnosis between AB and UTI may be very difficult in this group of patients. The principal aim of the study was to compare the rate of positive urine culture at admission in patients with femoral neck fracture with and without dementia and secondarily try to assess the connection of positive urinoculture and postoperative acute gram-negative PJI. METHODS: All patients with a femoral neck fracture underwent a urine culture on hospital admission and were prospectively recorded. Variables such as sex, age, institutionalization, dementia and other comorbidities, PJI rate, and in-hospital death were collected. The results of cultures were retrospectively revised. Patients who received postoperative antibiotics or had been diagnosed with UTI during hospital stay were excluded. Statistical comparisons between patients with and without dementia were performed using SPSS software version 17. RESULTS: A total of 148 patients were included (52 with dementia). The rate of positive urine culture was 32% (n = 16) in patients with dementia and 11.5% in patients without dementia (P = .003). Of these 16 patients with dementia and positive urine culture, 2 (12.5%) developed an acute gram-negative PJI, whereas there were no cases in the group without dementia (P = .011). DISCUSSION: The only difference between UTI and AB is the expression of symptoms by the patient. However, as patients with dementia have difficulties to explain UTI symptoms, some UTI may be underdiagnosed. CONCLUSION: Patients with dementia have a statistically higher rate of presurgical positive urine culture compared with patients without dementia.

Neoatherosclerosis causing occlusive in-stent restenosis: Impact of intracoronary imaging in the intensity of lipid-lowering therapy.

The unique physical properties of optical coherence tomography (OCT) make it a useful technique in the study of restenosis mechanisms. In fact, OCT is able to differentiate between neointimal proliferation and neoatherosclerosis within the stent. We report a rare case of occlusive neoatherosclerosis presenting beyond one year after a successful drug-eluting stent implantation. The impact of OCT findings in the clinical decision making process is emphasized.