Early real-world implant experience with a helix-fixation ventricular leadless pacemaker.

BACKGROUND: Roughly one in six patients receiving conventional transvenous pacemaker systems experience significant complications within 1 year of implant, mainly due to the transvenous lead and subcutaneous pocket. A new helix-fixation single-chamber ventricular leadless pacemaker (LP) system capable of pre-deployment exploratory electrical mapping is commercially available. Such an LP may mitigate complications while streamlining the implantation. In this study, the initial real-world implant experience of the helix-fixation LP was evaluated following its commercial release. METHODS: In patients indicated for single-chamber right ventricular pacing, helix-fixation Aveir VR LPs (Abbott, Abbott Park, IL) were implanted using the dedicated loading tool, introducer, and delivery catheter. Implant procedural characteristics, electrical parameters, and any 30-day procedure-related adverse events of consecutive implant attempts were retrospectively evaluated. RESULTS: A total of 167 patients with Class I indication for permanent pacing received implants in four North American centers (57% male, 70 years old). Pre-fixation electrical mapping of potential sites allowed repositioning to be avoided in 95.7% of patients. Median [interquartile range] LP procedure and fluoroscopy durations were 25.5 min [20.0, 35.0] and 5.7 min [4.0, 9.2], respectively. Pacing capture threshold, sensed R-wave amplitude, and impedance were 0.8 V [0.5, 1.3], 9.0 mV [6.0, 12.0], and 705 Ω [550, 910], respectively. Implantation was successful in 98.8% of patients, with 98.2% free from acute adverse events. CONCLUSIONS: The initial, real-world experience of the helix-fixation ventricular leadless pacemaker demonstrated safe and efficient implantation with minimal repositioning, viable electrical metrics, and limited acute complications.

Severity of Ischemic Stroke After Left Atrial Appendage Closure vs Nonwarfarin Oral Anticoagulants.

BACKGROUND: Strokes after left atrial appendage closure (LAAC) prophylaxis are generally less severe than those after warfarin prophylaxis-thought to be secondary to more hemorrhagic strokes with warfarin. Hemorrhagic strokes are similarly infrequent with direct oral anticoagulant (DOAC) prophylaxis, so the primary subtype after either LAAC or DOAC prophylaxis is ischemic stroke (IS). OBJECTIVES: The purpose of this study was to compare the severity of IS using the modified Rankin Scale in atrial fibrillation patients receiving prophylaxis with DOACs vs LAAC. METHODS: A retrospective analysis was performed of consecutive patients undergoing LAAC at 8 centers who developed an IS (ISLAAC) compared with contemporaneous consecutive patients who developed IS during treatment with DOACs (ISDOAC). The primary outcome was disabling/fatal stroke (modified Rankin Scale 3-5) at discharge and 3 months later. RESULTS: Compared with ISDOAC patients (n = 322), ISLAAC patients (n = 125) were older (age 77.2 ± 13.4 years vs 73.1 ± 11.9 years; P = 0.002), with higher HAS-BLED scores (3.0 vs 2.0; P = 0.004) and more frequent prior bleeding events (54.4% vs 23.6%; P < 0.001), but similar CHA2DS2-VASc scores (5.0 vs 5.0; P = 0.28). Strokes were less frequently disabling/fatal with ISLAAC than ISDOAC at both hospital discharge (38.3% vs 70.3%; P < 0.001) and 3 months later (33.3% vs 56.2%; P < 0.001). Differences in stroke severity persisted after propensity score matching. By multivariate regression analysis, ISLAAC was independently associated with fewer disabling/fatal strokes at discharge (OR: 0.22; 95% CI: 0.13-0.39; P < 0.001) and 3 months (OR: 0.25; 95% CI: 0.12-0.50; P < 0.001), and fewer deaths at 3 months (OR: 0.28; 95% CI: 0.12-0.64; P < 0.001). CONCLUSIONS: Ischemic strokes in patients with atrial fibrillation are less often disabling or fatal with LAAC than DOAC prophylaxis.

A Systematic Review on the Prevention and Control of Opportunistic Infections in Patients With Chronic Lymphocytic Leukemia Complicated by Richter's Transformation.

Chronic lymphocytic leukemia (CLL) is one of the most commonly occurring types of leukemia among the elderly population, contributing to an increased vulnerability to infections that are especially prolific in the immunosuppressed and the risk of rapid progression of the disease into a more aggressive manifestation of large cell lymphoma, a process called Richter's Transformation (RT). CLL alone predisposes patients to develop infections; however, the additional complication of RT decreases survival and makes the prevention and control of infection for the CLL patient even more challenging. However, research that exists on preventing and controlling infection in CLL patients with RT is relatively limited. In most cases, studies have focused on the prevention of infection in CLL patients in general and with no reference to the progression of RT. Considering the dearth of research on infection prevention and control for patients with CLL complicated by RT specifically, the following review examines existing research in addressing the prevention and control of infection in CLL patients with RT and patients in general. The authors explored multiple databases such as PubMed, Google Scholar, and Science Direct. The ultimate focus of this study was to lay a fundamental understanding in preventing and controlling infection in CLL patients. After analyzing several studies, it can be concluded that identifying infections, even if rare, is a crucial aspect of managing CLL patients. A broad range of differential diagnoses should be sought in cases presenting with refractory CLL as well and management of infections before, during, or after CLL treatment should be considered.

Recent Advancements in the Management of Anti-neutrophil Cytoplasmic Antibody-Associated Vasculitis: A Systematic Review.

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis is a rare multisystem autoimmune condition that causes inflammation of small and medium-sized blood vessels and is more commonly seen in the geriatric population. ANCA-associated vasculitis (AAV) is typically characterized as necrotizing vasculitis and includes granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA). The mortality rate remains high, with especially cardiovascular disease, infections, and malignancies being the leading causes of death. Existing treatment options depend heavily on the use of glucocorticoids (GCs), often in combination with cyclophosphamide (CYC); however, as the multitude of adverse effects associated with these agents has increased, numerous studies are being conducted to reduce not only these harmful effects but also improve remission rates. Rituximab, avacopan, corticosteroids, including intravenous pulse methylprednisolone, plasma exchange, and immunological targeting are among the emerging treatments. The purpose of this review is to emphasize the pathogenesis and traditional treatment modalities and give insights into the recent advances in managing this disorder in an attempt to spare the adverse effects of conventional therapies while achieving better remission rates with combination therapies as well. The authors explored multiple databases, employing appropriate keywords, satisfying the quality appraisal, after which a total of 14 reports were included in this review. Upon overall analysis, it can be concluded that rituximab and CYC, when used in combination, provided a safer alternative to GCs while exhibiting equal, if not superior, effectiveness and results, thus, paving the way for additional in-depth research in a larger population of interest.

A Systematic Review on the Management of Transfusion-Related Acute Lung Injury in Transfusion-Dependent Sickle Cell Disease.

The onset of respiratory distress and acute lung injury (ALI) following a blood transfusion is known as transfusion-related acute lung injury (TRALI), although its pathophysiology remains unknown. Even though sickle cell disease (SCD) has been studied for more than a century, few therapeutic and management strategies adequately address the emergence of TRALI. TRALI, an immune-mediated transfusion response that can result in life-threatening consequences, is diagnosed based on clinical signs and symptoms. Early detection and treatment increase the chances of survival and, in most cases, result in a complete recovery. Our objective is to provide a firm grasp of the present status of SCD-related TRALI care and therapy. After exploring multiple databases, this study offers evidence-based guidelines to aid clinicians and other healthcare professionals make decisions concerning transfusion assistance for SCD and the management of transfusion-related complications. Other risk factors for acute lung injury including sepsis aspiration should be ruled out throughout the diagnostic process. Several recent studies have shown that immunotherapy or immunological targets can effectively prevent these complications. Red cell transfusions, red cell antigen matching optimization, and iron chelation can also help reduce negative consequences. It is to be noted that poor clinical outcomes can be avoided by early detection and treatment of hemolytic transfusion reactions. Finally, preventing the onset of TRALI may be the most effective therapeutic strategy for SCD patients who rely on blood transfusions for survival.

Analysis of registered cancer clinical trials in Latin America and the Caribbean, 2007-2013.

Objective To characterize cancer clinical trials in Latin America and the Caribbean (LAC), with a focus on registration and enrollment trends. Methods Data were collected from 1 285 active cancer clinical trials registered up until 31 May 2014 in the World Health Organization's International Clinical Trial Registry Platform (ICTRP). The trials were categorized by six characteristics of the continuum of cancer control and care: 1) control and planning, 2) prevention, 3) detection and screening, 4) diagnosis, 5) treatment, and 6) survivorship and palliative care. The search strategy protocol included the use of optimized keywords combined with the names of the 43 countries selected for a descriptive analysis. Results A total of 973 registered and 972 enrolled cancer clinical trials between January 2007 and December 2013 were identified. Trends of growth were observed for both registration and enrollment of cancer treatment clinical trials; for other types of cancer clinical trials, trends for registration and enrollment varied in direction. Conclusions Growth trends in the registration of cancer treatment clinical trials indicate incremental adherence to cancer research reporting and improvements in cancer research transparency. The higher proportion of cancer treatment trials versus other types of cancer clinical trials indicates an imbalance in cancer research in the LAC region and suggests the need for more funding and incentives for other areas of research in order to achieve a more comprehensive approach to gaining knowledge on cancer issues.

Analysis of registered cancer clinical trials in Latin America and the Caribbean, 2007-2013 / Análisis de los ensayos clínicos sobre el cáncer registrados en América Latina y el Caribe del 2007 al 2013

ABSTRACT Objective To characterize cancer clinical trials in Latin America and the Caribbean (LAC), with a focus on registration and enrollment trends. Methods Data were collected from 1 285 active cancer clinical trials registered up until 31 May 2014 in the World Health Organization’s International Clinical Trial Registry Platform (ICTRP). The trials were categorized by six characteristics of the continuum of cancer control and care: 1) control and planning, 2) prevention, 3) detection and screening, 4) diagnosis, 5) treatment, and 6) survivorship and palliative care. The search strategy protocol included the use of optimized keywords combined with the names of the 43 countries selected for a descriptive analysis. Results A total of 973 registered and 972 enrolled cancer clinical trials between January 2007 and December 2013 were identified. Trends of growth were observed for both registration and enrollment of cancer treatment clinical trials; for other types of cancer clinical trials, trends for registration and enrollment varied in direction. Conclusions Growth trends in the registration of cancer treatment clinical trials indicate incremental adherence to cancer research reporting and improvements in cancer research transparency. The higher proportion of cancer treatment trials versus other types of cancer clinical trials indicates an imbalance in cancer research in the LAC region and suggests the need for more funding and incentives for other areas of research in order to achieve a more comprehensive approach to gaining knowledge on cancer issues.

RESUMEN Objetivo Caracterizar los ensayos clínicos sobre el cáncer realizados en América Latina y el Caribe, con especial atención en las tendencias del registro y la incorporación de pacientes. Métodos Se recogieron datos de 1285 ensayos clínicos activos sobre cáncer, registrados del 1° de enero del 2007 al 31 de mayo del 2014 en la Plataforma de Registros Internacionales de Ensayos Clínicos (ICTRP) de la Organización Mundial de la Salud. Los ensayos se clasificaron según seis características del espectro continuo del control y la atención del cáncer, a saber: 1) control y planificación, 2) prevención, 3) detección y tamizaje, 4) diagnóstico, 5) tratamiento y 6) supervivencia y cuidados paliativos. El protocolo de la estrategia de búsqueda incluyó la utilización de palabras clave optimizadas, asociadas con los nombres de los 43 países seleccionados para un análisis descriptivo. Resultados Se encontraron 973 ensayos clínicos registrados y 972 ensayos con pacientes incorporados de enero del 2007 a diciembre del 2013. Se observó una tendencia creciente en el crecimiento del registro y la incorporación de pacientes en los ensayos clínicos de tratamiento; las tendencias del registro y la incorporación en los demás tipos de ensayos clínicos sobre cáncer revelaron direcciones diversas. Conclusiones La tendencia creciente del registro de los ensayos clínicos de tratamiento del cáncer indica un cumplimiento progresivo de la notificación de las investigaciones sobre este tema y un adelanto en materia de transparencia. La mayor proporción de ensayos sobre tratamiento, en comparación con los otros tipos de ensayos clínicos sobre cáncer, pone de manifiesto un desequilibrio de la investigación sobre el cáncer en América Latina y el Caribe y destaca la necesidad de aumentar el financiamiento y mejorar los incentivos en otras esferas de la investigación, a fin de lograr una estrategia más integral que permita ampliar los conocimientos sobre los diferentes aspectos del cáncer.