An analysis of implantable cardiac device reliability. The case for improved postmarketing risk assessment and surveillance.

Implantable cardiac devices have become the mainstay of the treatment of patients with heart disease. However, data regarding their reliability and, inferentially, safety have been called into question. We reviewed annual reports submitted to the Food and Drug Administration Office of Device Evaluation by device manufacturers from 2003 to 2007. The annual number of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillator (CRT-D) implants, explants, and returned devices were tabulated along with the cumulative (Cum) number of implants for each device. We derived an annual explantation rate (AER) defined as the ratio of the annual number of explants less the number of normal battery depletions/Cum (×1000). From 2003 to 2007, 256,392 CRT-D and 459,300 ICD devices were implanted in the United States. The overall mean (±SD) AERs for ICD and CRT-D devices were, respectively, 49.5 (15.6) per 1000 ICD devices and 82.6 (35.5) per 1000 CRT-D devices. The AER for each device type significantly decreased over the study period (P for trend <0.001) although the AER for CRT-D devices was 38% higher than that for ICD devices (P < 0.001). On average, 20.3% of CRT-D devices and 22.6% of ICD devices were returned to the manufacturer for analysis after explantation. The rates of explanted CRT-D and ICD devices decreased from 2003 to 2007. Notwithstanding this favorable trend, the AER for CRT-D devices was higher than that for ICD devices. Improved methods for tracking individual device histories are needed for more precise estimates of the risk of device explantation for suspected malfunction. The proportion of devices returned to the manufacturer is suboptimal and needs to be improved to better understand the mechanisms of device malfunction.

Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007.

The quality of clinical data submitted by manufacturers to support Food and Drug Administration cardiovascular device premarket approval (PMA) applications varies widely and formal quality assessment has not been previously performed. This study evaluated all original cardiovascular device PMAs with Food and Drug Administration decisions between January 1, 2000, and December 31, 2007, to assess the quality of clinical investigations submitted by manufacturers. Effectiveness and safety end points were judged high quality if they were clearly defined and associated with a specific time point for analysis. Subject accounting was high quality if 90% or greater of the original cohort was accounted for at study conclusion. In total, 88 cardiovascular device PMAs (77.3% permanent implants), 132 clinical studies, 37,328 study subjects (age 61.0 +/- 14.5 years, 33.9% women, 86.3% white), and 29,408 device recipients were analyzed. All PMAs contained clinical data. Primary effectiveness end points, primary safety end points, and subject accounting were deemed high quality in 81.8%, 60.2%, and 77.3% of pivotal studies, respectively. Key cardiovascular comorbidities (coronary artery disease 51.1%, diabetes 36.6%, hypertension 35.2%, heart failure 37.5%, tobacco use 31.8%) and race (14.8%) were infrequently reported, and studies rarely included patients younger than 18 years of age (10.2% of studies). Poorly defined safety and effectiveness end points, poor patient accounting, and incomplete collection of important patient comorbidities make device safety and effectiveness assessments more challenging. Women, pediatric, and nonwhite populations are underrepresented in premarket cardiovascular clinical trials. Manufacturers, regulators, and the clinical community should collaborate to address these study shortcomings to ensure that patients are treated with reliable, safe, and clinically useful medical devices.

Strengthening the Coordination of Pediatric Mental Health and Medical Care: Piloting a Collaborative Model for Freestanding Practices.

BACKGROUND: Collaborative pediatric mental health and primary care is increasingly recognized as optimal for meeting the needs of children with mental health problems. This paper describes the challenges faced by freestanding specialty mental health clinics and pediatric health practices to provide such coordinated mind-and-body treatment. It describes critical elements of a proactive approach to achieving collaborative pediatric care under real-world circumstances using the patient-centered medical home neighborhood (PCMH-N) model. OBJECTIVE: The current study evaluates the field test of the Practitioner-Informed Model to Facilitate Interdisciplinary Collaboration (PIM-FIC), a systematic approach to improving inter-professional collaboration by building relationships and enhancing communication between pediatric mental health and primary care practices. METHODS: Thirty-nine providers at two mental health and two pediatric primary care practices participated in a pilot project and completed surveys prior to and following their participation. Key informant interviews were also conducted prior to the project. RESULTS: Participating practitioners' survey and interview responses indicate that the quantity and quality of communication between pediatric mental and medical health care providers increased post-project, as did satisfaction with overall collaboration. CONCLUSIONS: Improving relationships and communication are first steps in building the infrastructure to support effective coordinated care. Project results highlight practical and easily implemented strategies that pediatric mental health and primary care practices can take to strengthen their collaboration. Findings also suggest a need for collaborative care policies and competencies for child mental health providers working in freestanding practices within the PCMH-N.

Please break the silence: Parents' views on communication between pediatric primary care and mental health providers.

INTRODUCTION: The purpose of this study was to gain a better understanding of parents' preferences regarding the sharing of information between their children's primary care and mental health providers. METHOD: Fifty-five parents with a child who was actively engaged in mental health treatment completed an anonymous survey while accompanying their child to either a primary care or mental health clinic appointment. This brief measure elicited parents' experiences with and preferences for treatment coordination across their children's primary care and mental health providers, with a focus on communication practices. RESULTS: Parents consistently described communication among their children's primary care and mental health providers as important, yet frequently reported that such communication was not currently taking place. Further, parents reported that they were often called upon to act as "communication bridges" between professionals caring for their children. DISCUSSION: Implications for the collaborative pediatric and mental health care of children as well as recommendations for improving communication between mental health and pediatric providers are discussed.

The natural and social history of the indigenous lands and protected areas corridor of the Xingu River basin.

The 280,000 km² Xingu indigenous lands and protected areas (ILPAs) corridor, inhabited by 24 indigenous peoples and about 215 riverine (ribeirinho) families, lies across active agriculture frontiers in some of the historically highest-deforestation regions of the Amazon. Much of the Xingu is anthropogenic landscape, densely inhabited and managed by indigenous populations over the past millennium. Indigenous and riverine peoples' historical management and use of these landscapes have enabled their long-term occupation and ultimately their protection. The corridor vividly demonstrates how ILPAs halt deforestation and why they may account for a large part of the 70 per cent reduction in Amazon deforestation below the 1996-2005 average since 2005. However, ongoing and planned dams, road paving, logging and mining, together with increasing demand for agricultural commodities, continued degradation of upper headwaters outside ILPA borders and climate change impacts may render these gains ephemeral. Local peoples will need new, bottom-up, forms of governance to gain recognition for the high social and biological diversity of these territories in development policy and planning, and finance commensurate with the value of their ecosystem services. Indigenous groups' reports of changing fire and rainfall regimes may themselves evidence climate change impacts, a new and serious threat.

State regulations for school nursing practice.

The purpose of this article is to present a state-by-state summary of rules and regulations governing school nursing practice in the United States. Official government and agency sites were reviewed to determine providers of services in schools, criteria for becoming a school nurse, protection of titling, mandates for school nursing, and the requirements for continuing to practice as a school nurse. Trends were identified after verifying regulatory information. The majority of states credential school nurses for practice, with Departments of Education being the most frequent authorizing agency. Almost half (n = 23, 45%) of the states refer to the role of licensed practical nurses in the school setting. Requirements for becoming a school nurse range from licensed practical or vocational nurse (LPN) to registered nurse-bachelor of science degree in nursing with additional education and experience. Limitations related to data collection issues and implications for practice, education, and leadership are discussed.

Effects of selective logging on bat communities in the southeastern Amazon.

Although extensive areas of tropical forest are selectively logged each year, the responses of bat communities to this form of disturbance have rarely been examined. Our objectives were to (1) compare bat abundance, species composition, and feeding guild structure between unlogged and low-intensity selectively logged (1-4 logged stems/ha) sampling grids in the southeastern Amazon and (2) examine correlations between logging-induced changes in bat communities and forest structure. We captured bats in understory and canopy mist nets set in five 1-ha study grids in both logged and unlogged forest. We captured 996 individuals, representing 5 families, 32 genera, and 49 species. Abundances of nectarivorous and frugivorous taxa (Glossophaginae, Lonchophyllinae, Stenodermatinae, and Carolliinae) were higher at logged sites, where canopy openness and understory foliage density were greatest. In contrast, insectivorous and omnivorous species (Emballonuridae, Mormoopidae, Phyllostominae, and Vespertilionidae) were more abundant in unlogged sites, where canopy foliage density and variability in the understory stratum were greatest. Multivariate analyses indicated that understory bat species composition differed strongly between logged and unlogged sites but provided little evidence of logging effects for the canopy fauna. Different responses among feeding guilds and taxonomic groups appeared to be related to foraging and echolocation strategies and to changes in canopy cover and understory foliage densities. Our results suggest that even low-intensity logging modifies habitat structure, leading to changes in bat species composition.

An experimental test of density- and distant-dependent recruitment of mahogany (Swietenia macrophylla) in southeastern Amazonia.

According to the Janzen-Connell model, high mortality of seeds and seedlings in proximity to conspecific adults can help maintain species diversity in tropical forests. Using a natural population of big-leaf mahogany (Swietenia macrophylla King), we tested the model's mechanism by examining seed predation and juvenile recruitment in the forest understory and in treefall gaps in the vicinity of both isolated and clumped adults. We used tethered seeds placed in three types of exclosure plots: (1) complete access to seeds, (2) semi-access (access by small-sized seed predators) and (3) no access (all mammals excluded). Exclosure treatments were applied within the understory (both near and far from adults) and in gaps at eight fruiting adults in the late dry season (2001) and scored ten months later. Significantly more seeds were removed in canopy gaps near clumped adults than at isolated adults; otherwise, none of the treatment factors significantly influenced seed predation. In contrast, understory juvenile recruitment was significantly enhanced by distance from adults and was twice as high at isolated than clumped adults, providing novel support for the Janzen-Connell mechanism. No-access exclosures protected significantly more seeds than semi- and full-access exclosures, implicating small mammals in seed losses. Across the eight trees, juvenile recruitment in the no-access exclosures decreased significantly with conspecific adult densities, implicating non-mammalian density-responsive factor(s) in mortality following germination; likely a known specialist invertebrate herbivore. When all treatments were combined, conspecific adult basal area and total DBH explained 72 and 90% of variation in overall juvenile recruitment, respectively. Collectively, these results indicate that Janzen-Connell effects can operate in S. macrophylla, especially during the seed-to-seedling transition, and will likely reduce recruitment in areas of high conspecific densities. They also suggest that further research into the causes of density-dependence in tropical trees should investigate mortality agents following germination.

Vocalizations of primary forest frog species in the Central Amazon

The calls of 18 species of Amazonian forest frogs were recorded in 3 localities: the Tapajos National Park near Itaituba, the Reserva Ducke near Manaus, and the INPA-WWF reserves near Manaus. Structural and time parameters and sonographs of these calls including previously undescribed vocalization by 10 species are presented. Unlike open habitat species, several forest frong species characteriscally demonstrated one on more of the following temporal parameters: very low call rates, sporadic intervals, infrequent nights of calling and synchronized chorusing. It is hypothesized that predation has influenced the evolution of vocal behaviour in Amazonian forest frogs.

As vocalizações de 18 espécies de anuros da floresta amazônica foram gravadas em 3 locais: O Parque Nacional de Tapajós, perto de Itaituba, a Reserva Ducke, perto de Manaus, e as reservas do INPA-WWF, perto de Manaus. Parâmetros estruturais e temporais e sonografias dessas vocalizações são apresentadas, incluindo vocalizações não descritas previamente de Phyllobates femoralis, Centrolenella oyampiensis, Osteocephalous taurinus, Osteocephalous sp., Phrynohyas resinifictrix, Phyllomedusa bicolor; P. tarsius, P. tomopterna, Eleutherodactylus fenestratus e Synapturanus salseri. Ao contrário das espécies de habitat aberto, várias espécies de anuros florestais caracteristicomente demonstram um ou mais dos seguintes parâmetros temporais; baixa taxa de vocalizações, intervalos esporadicos de vocalizações, noites infrequentes de vocalizações e côros sincronizados. Também, a densidade, de vocalizações de anuros é muito mais baixa na floresta do que no habitat aberto. Hipotetizamos que a predação tem influenciado a evolução do comportamento vocal nos anuros amazônicos. Côros de vocalizações sincronizadas entre indivíduos de espécies florestais acredita-se que seja uma forma acústica da hipótese da " manada egoística " de Hamilton. Desta maneira, se um anuro vocalizasse o mais perto possível dos seus vizinhos, suas chances de ser escolhido por um predador que se orienta acusticamente tendem a ser reduzidas em comparação com indivíduos que vocalizam isoladamente. Phyllomedusa bicolor e P. tomopternausam vocalizações compostas. É desconhecida a função de cada nota nessas vocalizações de notas duplas. Foram gravadas vocalizações complexas de Hyla geographica, Eleutherodactylus fenestratus , e. Phrynohyas resinifictrix. Até hoje não se sabe qual é a função dessa vocalização não estereotipada.