<BOOK REVIEW>Bashō : The Complete Haiku of Matsuo Bashō, translated, annotated and with an introduction by Andrew Fitzsimons

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2-year outcomes for transcatheter repair in patients with functional mitral regurgitation from the CLASP study

Background: Transcatheter mitral valve repair has emerged as a favourable option in patient care for treating functional mitral regurgitation (FMR) with a need for longer term data. We herein report two-year outcomes from the FMR group of the multicentre, prospective, single arm CLASP study with the PASCAL transcatheter valve repair system. Methods: Patients with symptomatic, clinically significant FMR ≥3+ as evaluated by the core laboratory and deemed candidates for transcatheter repair by the local heart team were eligible for the study. Follow-up was conducted at 30 days, one year, and two years with echocardiographic outcomes evaluated by the core laboratory at all timepoints and major adverse events (MAEs) evaluated by an independent clinical events committee to one year (site-reported thereafter). Results: Eighty-five FMR patients were treated with mean age 72 years, 55% male, 65% in NYHA Class III-IVa, 37% LVEF, and 100% MR grade ≥3+. Successful implantation was achieved in 96% of patients. MAEs included one cardiovascular mortality (1.2%) and one conversion tomitral valve replacement surgery (1.2%) at 30 days, and two reinterventions between 30 days and two years. Kaplan-Meier (KM) estimates for survival were 88% at one year and 72% at two years. Freedom from heart failure (HF) rehospitalization KM estimates were 81% at one year and 78% for two years. The reduction in annualized HF hospitalization rate was 81% at two years (p\u3c0.001). MR ≤1+ was achieved in 73% of patients at 30 days, 75% at one year, and 84% at two years; MR ≤2+ was achieved in 96% of patients at 30 days, 100% at one year, and 95% two years (all p\u3c0.001). Mean LVEDV of 199 mL at baseline decreased by 9 mL at 30 days (p=0.039), 29 mL at one year (p\u3c0.001), and 31 mL at two years (p\u3c0.001). NYHA class I/II was achieved in 87% of patients at 30 days, 86% at one year, and 88% at two years (all p\u3c0.001). Six-minute walk distance (6MWD) improved by 22 m at 30 days (p=0.004) and 40 m at one year (p=0.003). Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved by 16 points at 30 days and one year (all p\u3c0.001). Conclusions: In the CLASP study, the PASCAL transcatheter valve repair system demonstrated sustained favourable outcomes at two years in patients with FMR. Results showed a high survival rate of 72% and freedom from HF rehospitalization of 78% at two years. An 81% reduction in annualized HF hospitalization rate was observed. At two years, sustained MR reduction of MR ≤2+ was achieved in 95% andMR ≤1+ in 84% of patients, with evidence of left ventricular reverse remodelling. Improvements in functional status were significant and sustained at two years. The CLASP IIF randomized pivotal trial is ongoing

Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders.

AIMS Incomplete left atrial appendage occlusion (LAAO) due to peri-device leak (PDL) is a limitation of the therapy. The Amulet IDE trial is the largest randomized head-to-head trial comparing the Amulet and Watchman 2.5 LAAO devices with fundamentally different designs. The predictors and mechanistic factors impacting differences in PDLs within the Amulet IDE trial are assessed in the current analysis. METHODS AND RESULTS An independent core lab analysed all images for the presence or absence of severe PDL (>5 mm). The incidence, mechanistic factors, predictors using propensity score-matched controls, and evolution of severe PDLs through 18 months were assessed. Of the 1878 patients randomized in the trial, the Amulet occluder had significantly fewer severe PDLs than the Watchman device at 45 days (1.1 vs. 3.2%, P < 0.001) and 12 months (0.1 vs. 1.1%, P < 0.001). Off-axis deployment or missed lobes were leading mechanistic PDL factors in each device group. Larger left atrial appendage (LAA) dimensions including orifice diameter, landing zone diameter, and depth predicted severe PDL with the Watchman device, with no significant anatomical limitations noted with the Amulet occluder. Procedural and device implant predictors were found with the Amulet occluder attributed to the learning curve with the device. A majority of Watchman device severe PDLs did not resolve over time through 18 months. CONCLUSION The dual-occlusive Amplatzer Amulet LAA occluder provided improved LAA closure compared with the Watchman 2.5 device. Predictors and temporal observations of severe PDLs were identified in the Amulet IDE trial. CLINICAL TRIAL REGISTRATION https://clinicaltrials.gov Unique identifier NCT02879448

Contribución del enfoque de extensión en proyectos de desarrollo, al mejoramiento de la eficiencia productiva de cooperativas ganaderas

The contribution of a development project approach for livestock extension was assessed at a number of cooperatives from the dairy production center “Triñangulo Tres” in Camagüey province. Goods, equipment, accessories, and other resources were bought to this purpose. Producer teams from different cooperatives gathered in working sessions. The strategy to carry out this project, based on technology investments and cattlemen working groups, was discussed. The project centered itself in solving a number of limitations within three aspects: 1 Technology application, 2. /I+D/ activities, and 3. Working groups discussion towards a lower cost for technology disemination. Technology application and extension development were linked to changes in grazing methods with a higher number of cowsheds which allowed the grazing ground restoration, a milk production and birth rate increase, and a investment cost decrease concerning food needs. Another aspect was weed control favoring dairy cattle production and dairy farms environmental conditions. Gross gains per dairy farm increased from 38 465 pesos (national currency) during the first year to 46 915 pesos in the third year. The project approach favorable effect on livestock extension and development was proved on the ground.Se evaluó la contribución del enfoque de proyecto en las actividades de extensión ganadera, en cooperativas de la empresa Triangulo Tres de Camagüey, Cuba. Se compraron insumos, equipos, implementos y otros recursos para las actividades de extensión. Se realizaron sesiones de trabajo con un equipo de productores de varias cooperativas. Se discutió la estrategia para ejecutar el proyecto, basada en la inversión de recursos en tecnologías y en la formación de grupos de discusión entre ganaderos. El proyecto se focalizó en la solución de las limitaciones señaladas en tres vertientes, a saber: 1. La intervención tecnológica; 2. Las acciones de I+D y 3. El trabajo de los grupos de discusión; este último ayudó a la difusión tecnológica con menor costo. Las intervenciones tecnológicas y de extensión estuvieron ligadas, entre otras, a los cambios en los métodos de pastoreo con mayor número de cuartones que permitió mayor reposo del pastizal, produjo incrementos de la producción de leche y la natalidad, además de reducir los costos de las operaciones por la menor necesidad de alimentos. Otro componente fue el control de malezas que favoreció la producción ganadera y la situación ambiental de las vaquerías. Los ingresos brutos por finca se incrementaron, de 38 465 pesos (moneda nacional) en el primer año, a 46 915 pesos en el tercero. Se comprobó en la práctica el favorable efecto del enfoque de proyecto para las acciones de extensión y desarrollo rural

Mitral Valve Transcatheter Edge-to-Edge Repair:1-Year Outcomes From the MiCLASP Study

Background: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established. Objectives: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study. Methods: Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee–adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory–assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Results: A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P &lt; 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P &lt; 0.001 vs baseline). Conclusions: One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life.</p

A Review of the Rationale for Additional Therapeutic Interventions to Attain Lower LDL-C When Statin Therapy Is Not Enough

Statins alone are not always adequate therapy to achieve low-density lipoprotein (LDL) goals in many patients. Many options are available either alone or in combination with statins that makes it possible to reach recommended goals in a safe and tolerable fashion for most patients. Ezetimibe and bile acid sequestrants reduce cholesterol transport to the liver and can be used in combination. Niacin is very effective at lowering LDL, beyond its ability to raise high-density lipoprotein and shift LDL particle size to a less atherogenic type. When statins cannot be tolerated at all, red yeast rice can be used if proper formulations of the product are obtained. Nutrients can also be added to the diet, including plant stanols and sterols, soy protein, almonds, and fiber, either individually or all together as a portfolio diet. A clear understanding of how each of these strategies works is essential for effective results