The FReedom from Ischemic Events-New Dimensions for Survival (FRIENDS) registry: design of a prospective cohort study of patients with advanced peripheral artery disease.

BACKGROUND Advanced lower extremity peripheral artery disease (PAD), whether presenting as acute limb ischemia (ALI) or chronic critical limb ischemia (CLI), is associated with high rates of cardiovascular ischemic events, amputation, and death. Past research has focused on strategies of revascularization, but few data are available that prospectively evaluate the impact of key process of care factors (spanning pre-admission, acute hospitalization, and post-discharge) that might contribute to improving short and long-term health outcomes. METHODS/DESIGN The FRIENDS registry is designed to prospectively evaluate a range of patient and health system care delivery factors that might serve as future targets for efforts to improve limb and systemic outcomes for patients with ALI or CLI. This hypothesis-driven registry was designed to evaluate the contributions of: (i) pre-hospital limb ischemia symptom duration, (ii) use of leg revascularization strategies, and (iii) use of risk-reduction pharmacotherapies, as pre-specified factors that may affect amputation-free survival. Sequential patients would be included at an index "vascular specialist-defined" ALI or CLI episode, and patients excluded only for non-vascular etiologies of limb threat. Data including baseline demographics, functional status, co-morbidities, pre-hospital time segments, and use of medical therapies; hospital-based use of revascularization strategies, time segments, and pharmacotherapies; and rates of systemic ischemic events (e.g., myocardial infarction, stroke, hospitalization, and death) and limb ischemic events (e.g., hospitalization for revascularization or amputation) will be recorded during a minimum of one year follow-up. DISCUSSION The FRIENDS registry is designed to evaluate the potential impact of key factors that may contribute to adverse outcomes for patients with ALI or CLI. Definition of new "health system-based" therapeutic targets could then become the focus of future interventional clinical trials for individuals with advanced PAD.

The Underwater Photic Environment of Cape Maclear, Lake Malawi: Comparison Between Rock- and Sand-Bottom Habitats and Implications for Cichlid Fish Vision

Lake Malawi boasts the highest diversity of freshwater fishes in the world. Nearshore sites are categorized according to their bottom substrate, rock or sand, and these habitats host divergent assemblages of cichlid fishes. Sexual selection driven by mate choice in cichlids led to spectacular diversification in male nuptial coloration. This suggests that the spectral radiance contrast of fish, the main determinant of visibility under water, plays a crucial role in cichlid visual communication. This study provides the first detailed description of underwater irradiance, radiance and beam attenuation at selected sites representing two major habitats in Lake Malawi. These quantities are essential for estimating radiance contrast and, thus, the constraints imposed on fish body coloration. Irradiance spectra in the sand habitat were shifted to longer wavelengths compared with those in the rock habitat. Beam attenuation in the sand habitat was higher than in the rock habitat. The effects of water depth, bottom depth and proximity to the lake bottom on radiometric quantities are discussed. The radiance contrast of targets exhibiting diffused and spectrally uniform reflectance depended on habitat type in deep water but not in shallow water. In deep water, radiance contrast of such targets was maximal at long wavelengths in the sand habitat and at short wavelengths in the rock habitat. Thus, to achieve conspicuousness, color patterns of rock-and sand-dwelling cichlids would be restricted to short and long wavelengths, respectively. This study provides a useful platform for the examination of cichlid visual communication.

The effects of resistance training on well-being and memory in eldery volunteers

Objective: to determine the short- and long-term effects of resistance training on muscle strength, psychological well-being, control-beliefs, cognitive speed and memory in normally active elderly people. Methods: 46 elderly people (mean age 73.2 years; 18 women and 28 men), were randomly assigned to training and control groups (n = 23 each). Pre- and post-tests were administered 1 week before and 1 week after the 8-week training intervention. The training sessions, performed once a week, consisted of a 10 min warm-up phase and eight resistance exercises on machines. Results: there was a significant increase in maximum dynamic strength in the training group. This training effect was associated with a significant decrease in self-attentiveness, which is known to enhance psychological well-being. No significant changes could be observed in control-beliefs. Modest effects on cognitive functioning occurred with the training procedure: although there were no changes in cognitive speed, significant pre/post-changes could be shown in free recall and recognition in the experimental group. A post-test comparison between the experimental group and control group showed a weak effect for recognition but no significant differences in free recall. Significant long-term effects were found in the training group for muscular strength and memory performance (free recall) 1 year later. Conclusion: an 8-week programme of resistance training lessens anxiety and self-attentiveness and improves muscle strength.

Copper, ceruloplasmin, and long-term cardiovascular and total mortality (the Ludwigshafen Risk and Cardiovascular Health Study)

BACKGROUND Copper and its main transport protein ceruloplasmin have been suggested to promote the development of atherosclerosis. Most of the data come from experimental and animal model studies. Copper and mortality have not been simultaneously evaluated in patients undergoing coronary angiography. METHODS AND RESULTS We examined whether serum copper and ceruloplasmin concentrations are associated with angiographic coronary artery disease (CAD) and mortality from all causes and cardiovascular causes in 3253 participants of the Ludwigshafen Risk and Cardiovascular Health Study. Age and sex-adjusted hazard ratios (HR) for death from any cause were 2.23 (95% CI, 1.85-2.68) for copper and 2.63 (95% CI, 2.17-3.20) for ceruloplasmin when we compared the highest with the lowest quartiles. Corresponding hazard ratios (HR) for death from cardiovascular causes were 2.58 (95% CI, 2.05-3.25) and 3.02 (95% CI, 2.36-3.86), respectively. Further adjustments for various risk factors and clinical variables considerably attenuated these associations, which, however, were still statistically significant and the results remained consistent across subgroups. CONCLUSIONS The elevated concentrations of both copper and ceruloplasmin are independently associated with increased risk of mortality from all causes and from cardiovascular causes.

A relation between screening masses and real-time rates

Thermal screening masses related to the conserved vector current are determined for the case that the current carries a non-zero Matsubara frequency, both in a weak-coupling approach and through lattice QCD. We point out that such screening masses are sensitive to the same infrared physics as light-cone real-time rates. In particular, on the perturbative side, the inhomogeneous Schrödinger equation determining screening correlators is shown to have the same general form as the equation implementing LPM resummation for the soft-dilepton and photon production rates from a hot QCD plasma. The static potential appearing in the equation is identical to that whose soft part has been determined up to NLO and on the lattice in the context of jet quenching. Numerical results based on this potential suggest that screening masses overshoot the free results (multiples of 2πT) more strongly than at zero Matsubara frequency. Four-dimensional lattice simulations in two-flavour QCD at temperatures of 250 and 340 MeV confirm the non-static screening masses at the 10% level. Overall our results lend support to studies of jet quenching based on the same potential at T ≳ 250 MeV.

Interpolation of hard and soft dilepton rates

Strict next-to-leading order (NLO) results for the dilepton production rate from a QCD plasma at temperatures above a few hundred MeV suffer from a breakdown of the loop expansion in the regime of soft invariant masses M 2 ≪ (πT)2. In this regime an LPM resummation is needed for obtaining the correct leading-order result. We show how to construct an interpolation between the hard NLO and the leading-order LPM expression, which is theoretically consistent in both regimes and free from double counting. The final numerical results are presented in a tabulated form, suitable for insertion into hydrodynamical codes.

Effects of acupuncture on sensory perception: a systematic review and meta-analysis.

BACKGROUND The effect of acupuncture on sensory perception has never been systematically reviewed; although, studies on acupuncture mechanisms are frequently based on the idea that changes in sensory thresholds reflect its effect on the nervous system. METHODS Pubmed, EMBASE and Scopus were screened for studies investigating the effect of acupuncture on thermal or mechanical detection or pain thresholds in humans published in English or German. A meta-analysis of high quality studies was performed. RESULTS Out of 3007 identified articles 85 were included. Sixty five studies showed that acupuncture affects at least one sensory threshold. Most studies assessed the pressure pain threshold of which 80% reported an increase after acupuncture. Significant short- and long-term effects on the pressure pain threshold in pain patients were revealed by two meta-analyses including four and two high quality studies, respectively. In over 60% of studies, acupuncture reduced sensitivity to noxious thermal stimuli, but measuring methods might influence results. Few but consistent data indicate that acupuncture reduces pin-prick like pain but not mechanical detection. Results on thermal detection are heterogeneous. Sensory threshold changes were equally frequent reported after manual acupuncture as after electroacupuncture. Among 48 sham-controlled studies, 25 showed stronger effects on sensory thresholds through verum than through sham acupuncture, but in 9 studies significant threshold changes were also observed after sham acupuncture. Overall, there is a lack of high quality acupuncture studies applying comprehensive assessments of sensory perception. CONCLUSIONS Our findings indicate that acupuncture affects sensory perception. Results are most compelling for the pressure pain threshold, especially in pain conditions associated with tenderness. Sham acupuncture can also cause such effects. Future studies should incorporate comprehensive, standardized assessments of sensory profiles in order to fully characterize its effect on sensory perception and to explore the predictive value of sensory profiles for the effectiveness of acupuncture.

Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial.

BACKGROUND The optimal management of high-risk prostate cancer remains uncertain. In this study we assessed the safety and efficacy of a novel multimodal treatment paradigm for high-risk prostate cancer. METHODS This was a prospective phase II trial including 35 patients with newly diagnosed high-risk localized or locally advanced prostate cancer treated with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel-based chemotherapy and long-term androgen deprivation therapy. Primary endpoint was acute and late toxicity evaluated with the Common Terminology Criteria for Adverse Events version 3.0. Secondary endpoint was biochemical and clinical recurrence-free survival explored with the Kaplan-Meier method. RESULTS Acute gastro-intestinal and genito-urinary toxicity was grade 2 in 23% and 20% of patients, and grade 3 in 9% and 3% of patients, respectively. Acute blood/bone marrow toxicity was grade 2 in 20% of patients. No acute grade ≥ 4 toxicity was observed. Late gastro-intestinal and genito-urinary toxicity was grade 2 in 9% of patients each. No late grade ≥ 3 toxicity was observed. Median follow-up was 63 months (interquartile range 31-79). Actuarial 5-year biochemical and clinical recurrence-free survival rate was 55% (95% confidence interval, 35-75%) and 70% (95% confidence interval, 52-88%), respectively. CONCLUSIONS In our phase II trial testing a novel multimodal treatment paradigm for high-risk prostate cancer, toxicity was acceptably low and mid-term oncological outcome was good. This treatment paradigm, thus, may warrant further evaluation in phase III randomized trials.

Optimal number of oral implants for fixed reconstructions: a review of the literature.

BACKGROUND AND AIM So far there is little evidence from randomised clinical trials (RCT) or systematic reviews on the preferred or best number of implants to be used for the support of a fixed prosthesis in the edentulous maxilla or mandible, and no consensus has been reached. Therefore, we reviewed articles published in the past 30 years that reported on treatment outcomes for implant-supported fixed prostheses, including survival of implants and survival of prostheses after a minimum observation period of 1 year. MATERIAL AND METHODS MEDLINE and EMBASE were searched to identify eligible studies. Short and long-term clinical studies were included with prospective and retrospective study designs to see if relevant information could be obtained on the number of implants related to the prosthetic technique. Articles reporting on implant placement combined with advanced surgical techniques such as sinus floor elevation (SFE) or extensive grafting were excluded. Two reviewers extracted the data independently. RESULTS A primary search was broken down to 222 articles. Out of these, 29 studies comprising 26 datasets fulfilled the inclusion criteria. From all studies, the number of planned and placed implants was available. With two exceptions, no RCTs were found, and these two studies did not compare different numbers of implants per prosthesis. Eight studies were retrospective; all the others were prospective. Fourteen studies calculated cumulative survival rates for 5 and more years. From these data, the average survival rate was between 90% and 100%. The analysis of the selected articles revealed a clear tendency to plan 4 to 6 implants per prosthesis. For supporting a cross-arch fixed prosthesis in the maxilla, the variation is slightly greater. CONCLUSIONS In spite of a dispersion of results, similar outcomes are reported with regard to survival and number of implants per jaw. Since the 1990s, it was proven that there is no need to install as many implants as possible in the available jawbone. The overwhelming majority of articles dealing with standard surgical procedures to rehabilitate edentulous jaws uses 4 to 6 implants.

Sea surface temperature and sea ice variability in the subpolar North Atlantic from explosive volcanism of the late thirteenth century

In this study, we use IP and alkenone biomarker proxies to document the subdecadal variations of sea ice and sea surface temperature in the subpolar North Atlantic induced by the decadally paced explosive tropical volcanic eruptions of the second half of the thirteenth century. The short- and long-term evolutions of both variables were investigated by cross analysis with a simulation of the IPSL-CM5A LR model. Our results show short-term ocean cooling and sea ice expansion in response to each volcanic eruption. They also highlight that the long response time of the ocean leads to cumulative surface cooling and subsurface heat buildup due to sea ice capping. As volcanic forcing relaxes, the surface ocean rapidly warms, likely amplified by subsurface heat, and remains almost ice free for several decades

Exercise capacity, physical activity patterns and outcomes six years after cardiac rehabilitation in patients with heart failure.

OBJECTIVE To determine the short- and long-term effects of an intensive, concentrated rehabilitation programme in patients with chronic heart failure. DESIGN Randomized controlled trial, with one-month and six-year evaluations. SETTING Residential rehabilitation centre in Switzerland. SUBJECTS Fifty patients with chronic heart failure, randomized to exercise or control groups. INTERVENTIONS A rehabilitation programme lasting one month, including educational sessions, a low-fat diet, and 2 hours of individually prescribed exercise daily. MAIN MEASURES Exercise test responses, health outcomes and physical activity patterns. RESULTS Peak Vo(2) increased 21.4% in the exercise group during the rehabilitation programme (P<0.05), whereas peak Vo(2) did not change among controls. After the six-year follow-up period, peak Vo(2) was only slightly higher than that at baseline in the trained group (7%, NS), while peak Vo(2) among controls was unchanged. During long-term follow-up, 9 and 12 patients died in the exercise and control groups, respectively (P = 0.63). At six years, physical activity patterns tended to be higher in the exercise group; the mean energy expenditure values over the last year were 2,704 +/- 1,970 and 2,085 +/- 1,522 kcal/week during recreational activities for the exercise and control groups, respectively. However, both groups were more active compared to energy expenditure prior to their cardiac event (P<0.001). CONCLUSIONS Six years after participation in a residential rehabilitation programme, patients with chronic heart failure had slightly better outcomes than control subjects, maintained exercise capacity and engaged in activities that exceed the minimal amount recommended by guidelines for cardiovascular health.

The Freedom SOLO bovine pericardial stentless valve: Single-center experience, outcome and long-term durability

Abstract Objectives We report our institutional experience and long-term results with the Sorin Freedom SOLO bovine pericardial stentless bioprosthesis. Methods Between January 2005 and November 2009, 149 patients (mean age 73.6±8.7 years, 68 [45.6%] female) underwent isolated (n=75) or combined (n=74) aortic valve replacement (AVR) using the SOLO in our institution. Follow-up was 100% complete with an average follow-up time of 5.9±2.6 years (maximum 9.6 years) and a total of 885.3 patient years. Results Operative (30-day) mortality was 2.7% (1.3% for isolated AVR [n=1] and 4.0% for combined procedures [n=3]). All causes of death were not valve-related. Preoperative peak (mean) gradients of 74.2±23.0 mmHg (48.6 ± 16.3 mmHg) decreased to 15.6±5.4 (8.8±3.0) after AVR, and remained low for up to 9 years. The postoperative effective orifice area (EOA) was 1.6 ±0.57 cm2, 1.90±0.45 cm2, 2.12±0.48 cm2 and 2.20±0.66 cm2 for the valve sizes 21, 23, 25 and 27, respectively; with absence of severe prosthesis-patient-mismatch (PPM) and 0.7% (n=1) moderate PPM. During follow-up, Twenty-six patients experienced structural valve deterioration (SVD) and 14 patients underwent explantation. Kaplan-Meier estimates for freedom from death, explantation and SVD at 9 years averaged 0.57 [0.47‒0.66], 0.82 [0.69‒0.90] and 0.70 [0.57‒0.79], respectively. Conclusions The Freedom SOLO stentless aortic valve is safe to implant and shows excellent early and mid-term hemodynamic performance. However, SVD was observed in a substantial number of patients after only 5 ̶ 6 years and the need for explantation increased markedly, suggesting low durability.