Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes

Background Transcatheter aortic valve implantation (TAVI) is a treatment option for high-risk patients with severe aortic stenosis. Previous reports focused on a single device or access site, whereas little is known of the combined use of different devices and access sites as selected by the heart team. The purpose of this study is to investigate clinical outcomes of TAVI using different devices and access sites. Methods A consecutive cohort of 200 patients underwent TAVI with the Medtronic CoreValve Revalving system (Medtronic Core Valve LLC, Irvine, CA; n = 130) or the Edwards SAPIEN valve (Edwards Lifesciences LLC, Irvine, CA; n = 70) implanted by either the transfemoral or transapical access route. Results Device success and procedure success were 99% and 95%, respectively, without differences between devices and access site. All-cause mortality was 7.5% at 30 days, with no differences between valve types or access sites. Using multivariable analysis, low body mass index (<20 kg/m2) (odds ratio [OR] 6.6, 95% CI 1.5-29.5) and previous stroke (OR 4.4, 95% CI 1.2-16.8) were independent risk factors for short-term mortality. The VARC-defined combined safety end point occurred in 18% of patients and was driven by major access site complications (8.0%), life-threatening bleeding (8.5%) or severe renal failure (4.5%). Transapical access emerged as independent predictor of adverse outcome for the Valve Academic Research Consortium–combined safety end point (OR 3.3, 95% CI 1.5-7.1). Conclusion A heart team–based selection of devices and access site among patients undergoing TAVI resulted in high device and procedural success. Low body mass index and history of previous stroke were independent predictors of mortality. Transapical access emerged as a risk factor for the Valve Academic Research Consortium–combined safety end point.

Prosthetic rehabilitation and treatment outcome of partially edentulous patients with severe tooth wear: 3-years results

The purpose of this study was to report on the management and treatment outcomes of partially edentulous elderly patients with severe tooth wear.

[Conventional vs minimally invasive total hip arthroplasty. A prospective study of rehabilitation and complications]

BACKGROUND: In a prospective, nonrandomized study the outcome in terms of rehabilitation and complications of total hip arthroplasty (THA) through a superior capsulotomy exposure (study group) was compared to THA performed through a direct lateral exposure (control group). PATIENTS AND METHODS: The study group (106 THA) and the control group (107 THA) were controlled for complexity and had no significant differences in age, sex, diagnosis, or body mass index. RESULTS: The study group had improved recovery at 6 weeks after surgery which was statistically significant (p<0.001). In addition, the study group had a lower incidence of perioperative complications. CONCLUSION: The current study demonstrates the potential that less-invasive surgical techniques with the philosophy of maximally preserving the abductors, posterior capsule, and short rotators may result in a safer operation with an accelerated recovery.

Level of incongruence during cardiac rehabilitation and prediction of future CVD-related hospitalizations plus all-cause mortality

Independent of traditional risk factors, psychosocial risk factors increase the risk of cardiovascular disease (CVD). Studies in the field of psychotherapy have shown that the construct of incongruence (meaning a discrepancy between desired and achieved goals) affects the outcome of therapy. We prospectively measured the impact of incongruence in patients after undergoing a cardiac rehabilitation program. We examined 198 CVD patients enrolled in a 8–12 week comprehensive cardiac rehabilitation program. Patients completed the German short version of the Incongruence Questionnaire and the SF-36 Health Questionnaire to measure quality of life (QoL) at discharge of rehabilitation. Endpoints at follow-up were CVD-related hospitalizations plus all-cause mortality. During a mean follow-up period of 54.3 months, 29 patients experienced a CVD-related hospitalization and 3 patients died. Incongruence at discharge of rehabilitation was independent of traditional risk factors a significant predictor for CVD-related hospitalizations plus all-cause mortality (HR 2.03, 95% CI 1.29–3.20, p = .002). We also found a significant interaction of incongruence with mental QoL (HR .96, 95% CI .92–.99, p = .027), i.e. incongruence predicted poor prognosis if QoL was low (p = .017), but not if QoL was high (p = .74). Incongruence at discharge predicted future CVD-related hospitalizations plus all-cause mortality and mental QoL moderated this relationship. Therefore, incongruence should be considered for effective treatment planning and outcome measurement.

Secondary prevention through cardiac rehabilitation: physical activity counselling and exercise training: key components of the position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation

Cardiac patients after an acute event and/or with chronic heart disease deserve special attention to restore their quality of life and to maintain or improve functional capacity. They require counselling to avoid recurrence through a combination of adherence to a medication plan and adoption of a healthy lifestyle. These secondary prevention targets are included in the overall goal of cardiac rehabilitation (CR). Cardiac rehabilitation can be viewed as the clinical application of preventive care by means of a professional multi-disciplinary integrated approach for comprehensive risk reduction and global long-term care of cardiac patients. The CR approach is delivered in tandem with a flexible follow-up strategy and easy access to a specialized team. To promote implementation of cardiac prevention and rehabilitation, the CR Section of the EACPR (European Association of Cardiovascular Prevention and Rehabilitation) has recently completed a Position Paper, entitled 'Secondary prevention through cardiac rehabilitation: A condition-oriented approach'. Components of multidisciplinary CR for seven clinical presentations have been addressed. Components include patient assessment, physical activity counselling, exercise training, diet/nutritional counselling, weight control management, lipid management, blood pressure monitoring, smoking cessation, and psychosocial management. Cardiac rehabilitation services are by definition multi-factorial and comprehensive, with physical activity counselling and exercise training as central components in all rehabilitation and preventive interventions. Many of the risk factor improvements occurring in CR can be mediated through exercise training programmes. This call-for-action paper presents the key components of a CR programme: physical activity counselling and exercise training. It summarizes current evidence-based best practice for the wide range of patient presentations of interest to the general cardiology community.

Prosthetic Rehabilitation, Implant Survival and Quality of Life 2 to 5 Years after Resection of Oral Tumors

Background: After oral tumor resection, structural and functional rehabilitation by means of dental prostheses is complex, and positive treatment outcome is not always predictable. Purpose: The objective of the study was to report on oral rehabilitation and quality of life 2-5 years after resection of malignant oral tumors. Materials and Methods: Data of 46 patients (57 ± 7 years) who underwent oral tumor surgery were available. More than 50% of tumors were classified T3 or T4. Open oro-nasal defects resulted in 12 patients and full mandibulary block resections in 23 patients. Comprehensive planning, implant placement, and prosthetic rehabilitation followed an interdisciplinary protocol. Analysis comprised tumor location, type of prostheses, implant survival, and quality of life. Results: Because of advanced tumor status, resections resulted in marked alteration of the oral anatomy requiring complex treatment procedures. Prosthetic rehabilitation comprised fixed and removable prostheses, with 104 implants placed in 28 patients (60%). Early implant loss was high (13%) and cumulative survival rate of loaded implants was <90% after 5 years. Prosthetic plans had to be modified because of side effects of tumor therapy, complications with implants and tumor recurrence. The majority of patients rated quality of life favorable, but some experienced impaired swallowing, dry mouth, limited mouth opening, appearance, and soreness. Conclusions: Some local effects of tumor therapy could not be significantly improved by prosthetic rehabilitation leading to functional and emotional disability. Many patients had passed away or felt too ill to fill the questionnaires. This case series confirms the complex anatomic alterations after tumor resection and the need for individual treatment approaches especially regarding prosthesis design. In spite of disease-related local and general restrictions, most patients gave a positive assessment of quality of life.

Effect of psychological interventions on depressive symptoms in long-term rehabilitation after an acquired brain injury: a systematic review and meta-analysis

OBJECTIVE To summarize empirical studies on the effectiveness of psychological interventions in long-term rehabilitation after an acquired brain injury (ABI) in reducing depressive symptoms. DATA SOURCES A systematic literature search was conducted on MEDLINE, PsycINFO, Embase, and CINAHL to identify articles published between January 1990 and October 2011. Search terms included the 3 concepts (1) "brain injur*" or "stroke," (2) "psychotherap*" or "therapy" or "intervention" or "rehabilitation," and (3) "depress*." STUDY SELECTION Studies evaluating psychological interventions in patients after ABI were included. Time since injury was on average more than 1 year. Trials reported data on validated depression questionnaires before and after the psychological intervention. DATA EXTRACTION Two independent reviewers extracted information from the sample, the intervention, and the outcome of the included studies and calculated effect sizes (ESs) from depression questionnaires. Thirteen studies were included in a pre-post analysis. Seven studies were eligible for a meta-analysis of ESs in active interventions and control conditions. DATA SYNTHESIS Pre-post ESs were significant in 4 of 13 studies. The overall ES of .69 (95% confidence interval [CI], .29-1.09) suggests a medium effectiveness of psychological interventions on depressive symptoms compared with control conditions. Moderator analysis of the number of sessions and adequate randomization procedure did not show significant ES differences between strata. Studies with adequate randomization did not, however, suggest the effectiveness of psychological interventions on depressive symptoms after ABI. CONCLUSIONS Psychological interventions are a promising treatment option for depressive symptoms in long-term rehabilitation after ABI. Since only a few adequately randomized controlled trials (RCTs) exist, more RCTs are required to confirm this initial finding.

Early 4-Week Cardiac Rehabilitation Exercise Training in Elderly Patients After Heart Surgery

The aim of this study was to assess the effects on exercise performance of supplementing a standard cardiac rehabilitation program with additional exercise programming compared to the standard cardiac rehabilitation program alone in elderly patients after heart surgery.

A Comparison of Psychosocial Risk Factors Between 3 Groups of Cardiovascular Disease Patients Referred for Outpatient Cardiac Rehabilitation

Few studies have examined psychosocial risk factors for cardiovascular disease (CVD) between diagnostic groups of CVD patients. We compared levels of depression, anxiety, hostility, exhaustion, positive affect, and social support, and the prevalence of type D personality between patient groups with a primary diagnosis of coronary heart disease (CHD), chronic heart failure (CHF), or peripheral arterial disease (PAD).

Cognitive functioning, behavior, and quality of life after stroke in childhood

Rationale: To provide a better understanding of cognitive functioning, motor outcome, behavior and quality of life after childhood stroke and to study the relationship between variables expected to influence rehabilitation and outcome (age at stroke, time elapsed since stroke, lateralization, location and size of lesion). Methods: Children who suffered from stroke between birth and their eighteenth year of life underwent an assessment consisting of cognitive tests (WISC-III, WAIS-R, K-ABC, TAP, Rey-Figure, German Version of the CVLT) and questionnaires (Conner's Scales, KIDSCREEN). Results: Twenty-one patients after stroke in childhood (15 males, mean 11;11 years, SD 4;3, range 6;10-21;2) participated in the study. Mean Intelligence Quotients (IQ) were situated within the normal range (mean Full Scale IQ 96.5, range IQ 79-129). However, significantly more patients showed deficits in various cognitive domains than expected from a healthy population (Performance IQ p = .000; Digit Span p = .000, Arithmetic's p = .007, Divided Attention p = .028, Alertness p = .002). Verbal IQ was significantly better than Performance IQ in 13 of 17 patients, independent of the hemispheric side of lesion. Symptoms of ADHD occurred more often in the patients' sample than in a healthy population (learning difficulties/inattention p = .000; impulsivity/hyperactivity p = .006; psychosomatics p = .006). Certain aspects of quality of life were reduced (autonomy p = .003; parents' relation p = .003; social acceptance p = .037). Three patients had a right-sided hemiparesis, mean values of motor functions of the other patients were slightly impaired (sequential finger movements p = .000, hand alternation p = .001, foot tapping p = .043). In patients without hemiparesis, there was no relation between the lateralization of lesion and motor outcome. Lesion that occurred in the midst of childhood (5-10 years) led to better cognitive outcome than lesion in the very early (0-5 years) or late childhood (10-18 years). Other variables such as presence of seizure, elapsed time since stroke and size of lesion had a small to no impact on prognosis. Conclusion: Moderate cognitive and motor deficits, behavioral problems, and impairment in some aspects of quality of life frequently remain after stroke in childhood. Visuospatial functions are more often reduced than verbal functions, independent of the hemispheric side of lesion. This indicates a functional superiority of verbal skills compared to visuospatial skills in the process of recovery after brain injury. Compared to the cognitive outcome following stroke in adults, cognitive sequelae after childhood stroke do indicate neither the lateralization nor the location of the lesion focus. Age at stroke seems to be the only determining factor influencing cognitive outcome.

Genetic engineering and the world trade system

While the WTO agreements do not regulate the use of biotechnology per se, their rules can have a profound impact on the use of the technology for both commercial and non-commercial purposes. This book seeks to identify the challenges to international trade regulation that arise from biotechnology. The contributions examine whether existing international obligations of WTO Members are appropriate to deal with the issues arising for the use of biotechnology and whether there is a need for new international legal instruments, including a potential WTO Agreement on Biotechnology. They combine various perspectives on and topics relating to genetic engineering and trade, including human rights and gender; intellectual property rights; traditional knowledge and access and benefit sharing; food security, trade and agricultural production and food safety; and medical research, cloning and international trade.

Transformation of local medicinal knowledge in the Andean Highlands: Case studies from Peru and Bolivia

In the Andean highlands, indigenous environmental knowledge is currently undergoing major changes as a result of various external and internal factors. As in other parts of the world, an overall process of erosion of local knowledge can be observed. In response to this trend, some initiatives that adopt a biocultural approach aim at actively strengthening local identities and revalorizing indigenous environmental knowledge and practices, assuming that such practices can contribute to more sustainable management of biodiversity. However, these initiatives usually lack a sound research basis, as few studies have focused on the dynamics of indigenous environmental knowledge in the Andes and on its links with biodiversity management. Against this background, the general objective of this research project was to contribute to the understanding of the dynamics of indigenous environmental knowledge in the Andean highlands of Peru and Bolivia by investigating how local medicinal knowledge is socially differentiated within rural communities, how it is transformed, and which external and internal factors influence these transformation processes. The project adopted an actor-oriented perspective and emphasized the concept of knowledge dialogue by analyzing the integration of traditional and formal medicinal systems within family therapeutic strategies. It also aimed at grasping some of the links between the dynamics of medicinal knowledge and the types of land use systems and biodiversity management. Research was conducted in two case study areas of the Andes, both Quechua-speaking and situated in comparable agro-ecological production belts - Pitumarca District, Department of Cusco (Southern Peruvian Highlands) and the Tunari National Park, Department of Cochabamba (Bolivian inner-Andean valleys). In each case study area, the land use systems and strategies of 18 families from two rural communities, their environmental knowledge related to medicine and to the local therapeutic flora, and an appreciation of the dynamics of this knowledge were assessed. Data were collected through a combination of disciplinary and participatory action-research methods. It was mostly analyzed using qualitative methods, though some quantitative ethnobotanical methods were also used. In both case studies, traditional medicine still constitutes the preferred option for the families interviewed, independently of their age, education level, economic status, religion, or migration status. Surprisingly and contrary to general assertions among local NGOs and researchers, results show that there is a revival of Andean medicine within the younger generation, who have greater knowledge of medicinal plants than the previous one, value this knowledge as an important element of their way of life and relationship with “Mother Earth” (Pachamama), and, at least in the Bolivian case, prefer to consult the traditional healer rather than go to the health post. Migration to the urban centres and the Amazon lowlands, commonly thought to be an important factor of local medicinal knowledge loss, only affects people’s knowledge in the case of families who migrate over half of the year or permanently. Migration does not influence the knowledge of medicinal plants or the therapeutic strategies of families who migrate temporarily for shorter periods of time. Finally, economic status influences neither the status of people’s medicinal knowledge, nor families’ therapeutic strategies, even though the financial factor is often mentioned by practitioners and local people as the main reason for not using the formal health system. The influence of the formal health system on traditional medicinal knowledge varies in each case study area. In the Bolivian case, where it was only introduced in the 1990s and access to it is still very limited, the main impact was to give local communities access to contraceptive methods and to vaccination. In the Peruvian case, the formal system had a much greater impact on families’ health practices, due to local and national policies that, for instance, practically prohibit some traditional practices such as home birth. But in both cases, biomedicine is not considered capable of responding to cultural illnesses such as “fear” (susto), “bad air” (malviento), or “anger” (colerina). As a consequence, Andean farmers integrate the traditional medicinal system and the formal one within their multiple therapeutic strategies, reflecting an inter-ontological dialogue between different conceptions of health and illness. These findings reflect a more general trend in the Andes, where indigenous communities are currently actively revalorizing their knowledge and taking up traditional practices, thus strengthening their indigenous collective identities in a process of cultural resistance.

Valorization of agrobiodiversity products and strengthening of local identities in the Peruvian Andes: Experiences from the BioAndes Programme

In the Peruvian Andes, a long history of interaction between the local populations and their natural environment has led to extraordinary levels of agrobiodiversity. However, in sharp contrast with this biological wealth, Andean indigenous populations live under most precarious conditions. Moreover, natural resources are undergoing severe degradation processes and local knowledge about biodiversity management is under serious pressure. Against this background, the BioAndes Programme is developing initiatives based on a biocultural approach that aim at fostering biodiversity through the enhancement of cultural processes. On the basis of intercultural dialogue, joint learning and capacity development, and transdisciplinary action-research, indigenous communities, development practitioners, and researchers strive for the creation of innovative ways to contribute to more sustainable economic, socio-cultural, and political valorization of Andean biodiversity. Project activities are diverse and range from the cultivation, transformation, and commercialization of organic Andean fruits in San Marcos, Cajamarca Department, to the recuperation of natural dying techniques for alpaca wool and traditional weaving in Pitumarca, Cusco Department, and the promotion of responsible ecotourism in both regions. Based on the projects’ first two-years of experience, the following lessons learnt will be presented and discussed: 1. The economic valorization and commercialization of local products can be a powerful tool for the revival and innovation of eroded know-how; at the same time it contributes to the strengthening of local identities, in parallel with the empowerment of marginalized groups such as smallholders and women. 2. Such initiatives are only successful when they are embedded within activities that go beyond the focus on local products and seek the valorization of the entire natural and cultural landscape (e.g. through the promotion of agrotourism and local gastronomy, more sustainable management of local resources including the restoration of ecosystems, and the realization of inventories of local agrobiodiversity and the knowledge related to it). 3. The sustainability of these initiatives, which are often externally induced, is conditioned by the ability of local actors to acquire ownership of projects and access to the knowledge required to carry them out, which also means developing the personal and institutional capacities for handling the whole chain from production to commercialization. 4. The confrontation of different economic rationalities and their underlying worldviews that occur when local or indigenous people integrate into the market economy implies the need for a dialogical co-production of knowledge and collective action by local people, experts from NGOs, and political authorities in order to better control the conditions relating to the market economy. The valorization of local agrobiodiversity shows much potential for enhancing natural and cultural diversity in Southern countries, but only when local communities can participate in the shaping of the conditions under which this happens. Such activities should be designed in the mid- to long-term as part of social learning processes that are carefully embedded in the local context. Supporting institutions play a crucial role in these processes, but should see themselves only as facilitators, while ensuring that control and ownership remain with the local actors.