Left atrial appendage (LAA) occlusion has emerged as an interesting alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). We report the safety, ...efficacy, and durability of concomitant device-enabled epicardial LAA occlusion during open-heart surgery. In addition to long-term follow-up, we evaluate the impact on stroke risk in this selected population.
A total of 291 AtriClip devices were deployed epicardially in patients (mean CHA2DS2-VASc-Score: 3.1 ± 1.5) undergoing open-heart surgery (including isolated coronary artery bypass grafting, valve, or combined procedures) comprising of forty patients from a first-in-man device trial (NCT00567515) and 251 patients from a consecutive institutional registry thereafter. In all patients (n = 291), the LAA was successfully excluded and overall mean follow-up (FU) was 36 ± 23months (range: 1-97 months). No device-related complications were detected throughout the FU period. Long-term imaging work-up (computed tomography) in selected patients ≥5years post-implant (range: 5.1-8.1 years) displayed complete LAA occlusion with no signs of residual reperfusion or significant LAA stumps. Subgroup analysis of patients with discontinued OAC during FU (n = 166) revealed a relative risk reduction of 87.5% with an observed ischaemic stroke-rate of 0.5/100 patient-years compared with what would have been expected in a group of patients with similar CHA2DS2-VASc scores (expected rate of 4.0/100 patient-years). No strokes occurred in the subgroup with OAC.
The long-term results from our first-in-man prospective human trial plus our institutional registry of epicardial LAA occlusion with the AtriClip in patients with AF undergoing cardiac surgery demonstrate the safety and durability of the procedure. In addition, our data are suggestive for the potential efficacy of LAA occlusion in reducing the incidence of stroke. If validated in future large randomized trials, routine LAA occlusion in patients undergoing cardiac surgery (with contraindications to treatment with oral anticoagulants) may represent a reasonable adjunct procedure to reduce the risk of future stroke.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00567515.
This paper deals with the methods of natural healing that were practiced already in the 19th century by Swiss natural healer Arnold Rikli as a part of healing offer in Bled, Slovenia. The paper ...starts with the introduction of Rikli as a natural healer and his healing methods, based on hydrotherapy, heliotherapy, climate therapy and healthy diet. His healing methods were based on strengthening the immune system in a natural way. The paper takes an ethnographic approach based on in-depth analysis of the literature and online resources and fieldwork in Bled using the technique of partially structured interviews with the employees in tourist industry. The paper identifies the potential for the inclusion of Riklis natural healing methods in the modern tourist offer as the basis for creating Covid-adapted programmes and a source of survival for the existing wellness centres and other tourism providers in Bled.
LANGUAGE= "English" Ischemic stroke treatment has been changing in recent years and these procedures have positive effects on patients’ prognosis, morbidity, and mortality. Intravenous Treatment with ...Recombinant Tissue-Type Plasminogen Activator (iv r-tPA) is one of the most efficient approaches in ischemic stroke patients. When administered in the first 4.5 h from symptom onset, it has been proven to be effective in functional improvement. However, physicians may feel hesitant about administering these treatments regarding the possible complications,especially the patients with recurrent stroke. The aim of this article is to contribute to the literature on the efficacy and safety of recur-rent iv r-tPA therapy in patients with recurrent stroke. We present seven patients who underwent thrombolytic treatment more than one time between September 2017 and September 2020 and recorded the patients’ gender, risk factors, age, initial/final National Institutes of Health Stroke Scale (NIHSS), and hemorrhagic transformation rates. Mean interval of iv r-TPA treatment was 244.7 days (minimum 58 days, maximum 1 year 9 months 10 days). Average of NIHSS calculated as 7.57 before the first and 8.26 before the second iv r-tPA treatment; at the time of discharge mean of NIHSS was 1.57 and 2.8 respectively for five patients. Five of the patients have been identified as cardioembolic in aetiology. In two of our cases, clinical worsening was observed in the follow-ups after iv r-tPA. Our symptomatic intracranial hemorrhage rates were similar to the literature seen in one patient. Rates of bleeding were directly proportional with calculated HAS-BLED scores in patients who were started anticoagulation. Our complication rates were similar with literature and the prognosis of recurrent r-tPA was discovered to have a good prognosis in the first 3 months.LANGUAGE= "Turkish" İskemik inme konusunda tedavi yöntemleri son yıllarda değişime uğramakta ve bu yöntemler hastaların prognoz ve sağkalımı üzerinde olumlu etki göstermektedir. Rekombinant doku plazminojen aktivatörü alteplazın (r-tPA) kullanıldığı intravenöz trombolitik tedavi bu yaklaşımlardan biridir. Semptom başlangıcından itibaren ilk 4,5 saatte uygulandığında hastaların fonksiyonel sonuçlarının iyileşmesinde etkili olduğu kanıtlanmıştır. Fakat hekimler bazı durumlarda gelişebilecek komplikasyonlar nedeniyle tereddütte kalabilmektedir. Tekrarlayan inme hastalarında bu komplikasyonların gelişme olasılığının yüksek olma düşüncesi, intravenöz r-tPA uygulaması konusunda şüphede bırakmaktadır. Bu yazının amacı, tekrarlayan iskemik inmelerde uygulanan intravenöz trombolitik tedavinin etkinliği ve güvenirliliğine dair literatüre katkı sağlamaktır. Çalışmada, Eylül 2017-Eylül 2020 tarihleri arasında yedi tane birden fazla r-tPA tedavisi uygulanan hasta sunuldu. Hastaların yaş, cinsiyet, inme risk faktörleri, başvuru/final “National Institutes of Health (NIH)” inme skorları ve hemorajik transformasyon oranları değerlendirildi. Trombolitik tedaviler arasında ortalama süre 244,7 gün (en az 58 gün, en fazla 1 yıl 9 ay 10 gün); başvurudaki ortalama NIH inme skoru ilk r-tPA öncesi 7,57, ikincisi öncesi 8,26 idi. Taburculuktaki ortalama NIH inme skoru ilk tPA sonrası 1,57, ikincisi sonrası 2,8 idi. Beş hastada inme etiyolojisinde kardiyoembolik olay saptandı. İki hastamızda klinik kötüleşme izlendi. Semptomatik hemorajik transformasyon oranımız literatüre benzerdi, bir hastada görüldü. Kanama oranları, antikoagülan başlanan hastalarda hesaplanan HAS-BLED ile doğru orantılıydı. Hastalarımızda komplikasyon oranları literatüre benzer görüldü ve ilk üç ayda tekrarlayan trombolitik tedavilerin prognozları iyiydi.
Multiple scores have been proposed to stratify bleeding risk, but their value to guide dual antiplatelet therapy duration has never been appraised. We compared the performance of the CRUSADE (Can ...Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines), ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy), and HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) scores in 1946 patients recruited in the Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) and assessed hemorrhagic and ischemic events in the 24- and 6-month dual antiplatelet therapy groups.
Bleeding score performance was assessed with a Cox regression model and C statistics. Discriminative and reclassification power was assessed with net reclassification improvement and integrated discrimination improvement. The C statistic was similar between the CRUSADE score (area under the curve 0.71) and ACUITY (area under the curve 0.68), and higher than HAS-BLED (area under the curve 0.63). CRUSADE, but not ACUITY, improved reclassification (net reclassification index 0.39, P=0.005) and discrimination (integrated discrimination improvement index 0.0083, P=0.021) of major bleeding compared with HAS-BLED. Major bleeding and transfusions were higher in the 24- versus 6-month dual antiplatelet therapy groups in patients with a CRUSADE score >40 (hazard ratio for bleeding 2.69, P=0.035; hazard ratio for transfusions 4.65, P=0.009) but not in those with CRUSADE score ≤40 (hazard ratio for bleeding 1.50, P=0.25; hazard ratio for transfusions 1.37, P=0.44), with positive interaction (Pint=0.05 and Pint=0.01, respectively). The number of patients with high CRUSADE scores needed to treat for harm for major bleeding and transfusion were 17 and 15, respectively, with 24-month rather than 6-month dual antiplatelet therapy; corresponding figures in the overall population were 67 and 71, respectively.
Our analysis suggests that the CRUSADE score predicts major bleeding similarly to ACUITY and better than HAS BLED in an all-comer population with percutaneous coronary intervention and potentially identifies patients at higher risk of hemorrhagic complications when treated with a long-term dual antiplatelet therapy regimen.
URL: http://clinicaltrials.gov. Unique identifier: NCT00611286.
Thermal water discharge within the gravity-driven groundwater flow system in the Alps and other similar areas around the world may be hidden in Quaternary deposits which, in these regions, often ...cover the regional aquifer. When thermal water drains into Quaternary deposits, the mixing of the deep thermal component and the cold shallow groundwater forms a thermal plume that extends parallel to the main groundwater flow in shallow system. In the Bled case study in Slovenia, the thermal water discharges from carbonate rocks into Quaternary glaciofluvial sediments, and as the Toplice spring at a rate of 5 l/s at an average temperature of 21.5 °C. Knowing the spatial extent and intensity of thermal outflow is essential to decision making related to the development and protection of this renewable resource. By approximating the thermal water outflow from a discharge zone as a planar source, a planar advective heat transport model can be used to evaluate its geometry and quantify rates. An analytical procedure follows rough assumptions leading to conservative results. Moreover, a numerical model using the FEFLOW code was applied for comparison with the simulations of the analytical model. The heat transport model was based on measured hydraulic parameters (e.g. groundwater levels) and borehole temperatures as well as on-site and international literature (e.g. dispersivity, thermal conductivity). Nine scenarios were applied accounting for different dimensions of the heat source and compared to the results of numerical simulations. Each scenario was verified by calculating the relative error between the analytical models and the measured borehole temperatures. The results confirm that the main outflow of thermal water can be determined using planar geometry, and is 200–300 m wide. The height of the thermal outflow zone is approximately 25 m, corresponding to the expected thickness of the direct contact between the fractured dolomite and the shallower Quaternary aquifer. Using the proposed widths and depths, the hidden natural thermal outflow rates are estimated at 57–86 l/s.
•Analytical model accounting for the planar heat transport and numerical model were applied to evaluate the heat plume dimensions caused by thermal water.•Modelling results were compared with measured temperatures in boreholes.•The thermal water outflow is predominantly bound to a continuous surface, and secondary thermal outflows may occur in some cases.
There is uncertainty whether a focus on modifiable bleeding risk factors offers better prediction of major bleeding than other existing bleeding risk scores.
This study compared a score based on ...numbers of the modifiable bleeding risk factors recommended in the 2016 European guidelines (“European risk score”) versus other published bleeding risk scores that have been derived and validated in atrial fibrillation subjects (HEMORR2HAGES, HAS-BLED, ATRIA, and ORBIT) in a large hospital-based cohort of Chinese inpatients with atrial fibrillation.
The European score had modest predictive ability for major bleeding (c-index 0.63, 95% confidence interval 0.56-0.69) and intracranial hemorrhage (0.72, 0.65-0.79) but nonsignificantly (and poorly) predicted extracranial bleeding (0.55, 0.54-0.56; P = .361). The HAS-BLED score was superior to predict bleeding events compared with the European score, with the differences between c-indexes of 0.10-0.12 (Delong test, all P < .05), net reclassification improvement values of 13.0%-34.5% (all P < .05), and integrated discrimination improvement values of 0.7%-1.4% (all P < .05). The European score had similar predictive value to other bleeding risk schemes (HEMORR2HAGES, ATRIA, and ORBIT) for major bleeding and intracranial hemorrhage (all P > .05). Decision curve analysis clearly shows that HAS-BLED had better net benefit of predicting major bleeding compared with the European score.
Relying on bleeding risk assessment using modifiable bleeding risk factors alone is an inferior strategy for predicting atrial fibrillation patients for major bleeding. Our observations reaffirm the Asian guideline recommendations with HAS-BLED for bleeding risk assessment in patients with atrial fibrillation.
A menudo la evaluación de los riesgos de ictus y hemorragia en la fibrilación auricular (FA) es basal para predecir los resultados años después. Sin embargo, estos riesgos no son estáticos. Se ...investiga si los cambios dinámicos en CHA2DS2-VASc y HAS-BLED a lo largo del tiempo modifican la predicción del riesgo.
Se incluyó a pacientes con FA estables en tratamiento con antagonistas de la vitamina K. Durante 6 años de seguimiento, se registraron todos los ictus isquémicos/accidentes isquémicos transitorios (AIT) y hemorragias mayores. El CHA2DS2-VASc y HAS-BLED se revaluaron cada 2 años y se investigaron los resultados clínicos en periodos de 2 años.
Se incluyó a 1.361 pacientes (medias de CHA2DS2-VASc y HAS-BLED, 4,0±1,7 y 2,9±1,2). Durante el seguimiento, 156 pacientes (11,5%) sufrieron un ictus isquémico/AIT y 269 (19,8%), una hemorragia mayor. En comparación con el valor basal, el CHA2DS2-VASc recalculado a los 2 años presentó mayor capacidad predictiva de ictus isquémico/AIT durante el periodo de 2-4 años. El índice de mejoría de la discriminación (IDI) y el índice de reclasificación neta (NRI) mostraron mejoras en la sensibilidad y mejor reclasificación. El CHA2DS2-VASc recalculado a los 4 años arrojó un mejor rendimiento predictivo que el basal durante el periodo de 4-6 años, con una mejora en el IDI y una mejora de la reclasificación. El HAS-BLED recalculado a los 2 años presentó mayor capacidad predictiva de hemorragia mayor que el basal durante el período de 2-4 años, con mejoras significativas en la sensibilidad y la reclasificación. Se observó un ligero aumento en la sensibilidad del HAS-BLED recalculado a los 4 años respecto al basal.
En pacientes con FA, los riesgos de ictus y hemorragia son dinámicos y cambian con el tiempo. Las escalas CHA2DS2-VASc y HAS-BLED deben revaluarse con regularidad, especialmente para una precisa predicción del riesgo de ictus.
Stroke and bleeding risks in atrial fibrillation (AF) are often assessed at baseline to predict outcomes years later. We investigated whether dynamic changes in CHA2DS2-VASc and HAS-BLED scores over time modify risk prediction.
We included patients with AF who were stable while taking vitamin K antagonists. During a 6-year follow-up, all ischemic strokes/transient ischemic attacks (TIAs) and major bleeding events were recorded. CHA2DS2-VASc and HAS-BLED were recalculated every 2-years and tested for clinical outcomes at 2-year periods.
We included 1361 patients (mean CHA2DS2-VASc and HAS-BLED 4.0±1.7 and 2.9±1.2). During the follow-up, 156 (11.5%) patients had an ischemic stroke/TIA and 269 (19.8%) had a major bleeding event. Compared with the baseline CHA2DS2-VASc, the CHA2DS2-VASc recalculated at 2 years had higher predictive ability for ischemic stroke/TIA during the period from 2 to 4 years. Integrated discrimination improvement (IDI) and net reclassification improvement (NRI) showed improvements in sensitivity and better reclassification. The CHA2DS2-VASc recalculated at 4 years had better predictive performance than the baseline CHA2DS2-VASc during the period from 4 to 6 years, with an improvement in IDI and an enhancement of the reclassification. The recalculated HAS-BLED at 2-years had higher predictive ability than the baseline score for major bleeding during the period from 2 to 4 years, with significant improvements in sensitivity and reclassification. A slight enhancement in sensitivity was observed with the HAS-BLED score recalculated at 4 years compared with the baseline score.
In AF patients, stroke and bleeding risks are dynamic and change over time. The CHA2DS2-VASc and HAS-BLED scores should be regularly reassessed, particularly for accurate stroke risk prediction.
Various bleeding risk prediction schemes, such as the Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized Ratio, Elderly, ...Drugs/alcohol (HAS-BLED), Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA), and Outcomes Registry for Better Informed Treatment (ORBIT) scores, have been proposed in patients with atrial fibrillation. We compared the relative predictive values of these bleeding risk scores for clinically relevant bleeding and the relationship of ATRIA and ORBIT scores to the quality of anticoagulation control on warfarin, as reflected by time in therapeutic range.
We conducted a post hoc ancillary analysis of clinically relevant bleeding and major bleeding events among 2293 patients receiving warfarin therapy in the AMADEUS trial.
Only HAS-BLED was significantly predictive for clinically relevant bleeding, and all 3 risk scores were predictive for major bleeding. The predictive performance of HAS-BLED was modest, as reflected by c-indexes of 0.59 (P < .001) and 0.65 (P < .002) for clinically relevant bleeding and major bleeding, respectively. The HAS-BLED score performed better than the ATRIA (P = .002) or ORBIT (P = .001) score in predicting any clinically relevant bleeding. Only the HAS-BLED score was significantly associated with the risk for both bleeding outcomes on Cox regression analysis (any clinically relevant bleeding: hazard ratio, 1.85; 95% confidence interval, 1.43-2.40, P < .001; major bleeding: hazard ratio, 2.40; 95% confidence interval, 1.28-4.52; P = .007). There were strong inverse correlations of ATRIA and ORBIT scores to time in therapeutic range as a continuous variable (low risk ATRIA, r = −0.96; P = .003; ORBIT, r = −0.96; P = .003). Improvement in the predictive performance for both ATRIA and ORBIT scores for any clinically relevant bleeding was achieved by adding time in therapeutic range to both scores, with significant differences in c-indexes (P = .001 and P = .002, respectively), net reclassification improvement, and integrated discriminant improvement (both P < .001).
All 3 bleeding risk prediction scores demonstrated modest predictive ability for bleeding outcomes, although the HAS-BLED score performed better than the ATRIA or ORBIT score. Significant improvements in both ATRIA and ORBIT score prediction performances were achieved by adding time in therapeutic range to both scores.
PDF
