The Grand SANS FLUORO (SAy No Series to FLUOROsopy) Study: Examining Fluoroscopy Use in More than 1,000 Ablation Procedures.

The majority of electrophysiologists routinely use fluoroscopy (FLUORO) during ablation procedures for common arrhythmias despite the known complications of radiation exposure and protective lead use. This study assessed the safety of catheter ablation (CA) with FLUORO versus without FLUORO (SANS FLUORO) in patients with the following common arrhythmias: atrial fibrillation (AF), atrial flutter, supraventricular tachycardia, and ventricular tachycardia. A total of 1,258 CA procedures were performed in 816 consecutive patients over a 53-month period (SANS FLUORO CA: 609 patients; FLUORO CA: 209 patients).

Community-Engaged Neighborhood Revitalization and Empowerment: Busy Streets Theory in Action.

Busy streets theory predicts that engaging residents in physical revitalization of neighborhoods will facilitate community empowerment through the development of sense of community, social cohesion, collective efficacy, social capital, and behavioral action. Establishing safe environments fosters positive street activity, which reinforces neighborhood social relationships. A community-engaged approach to crime prevention through environmental design (CE-CPTED) is one promising approach to creating busy streets because it engages residents in collaborative interactions to promote safer environments.

Fetal heterotaxy with tricuspid atresia, pulmonary atresia, and isomerism of the right atrial appendages at 22 weeks.

We report the accurate prenatal diagnosis at 22 weeks gestation of right atrial isomerism in association with tricuspid atresia. Several distinctive sonographic features of isomerism of the right atrial appendages were present in this fetus: complex cardiac abnormality, ventriculoarterial discordance, juxtaposition of the aorta and the inferior vena cava to the right side, pulmonary atresia, and anomalous pulmonary venous return to the morphological right atrium. Tricuspid atresia, which is an extremely rare lesion within heterotaxy spectrum disorders, was present.

Fractures in women treated with raloxifene or alendronate: a retrospective database analysis.

Background: Raloxifene and alendronate are anti-resorptive therapies approved for the prevention and treatment of postmenopausal osteoporosis. Raloxifene is also indicated to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk of invasive breast cancer. A definitive study comparing the fracture effectiveness and rate of breast cancer for raloxifene and alendronate has not been published.

Arzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women.

Arzoxifene is a selective estrogen receptor modulator (SERM) that has been shown to be more potent in preclinical testing than currently available agents. Its effects on clinical outcomes are not known. In a randomized, blinded trial, women aged 60 to 85 years with osteoporosis, defined as a femoral neck or lumbar spine bone mineral density T-score of -2.

Effect of Raloxifene on all-cause mortality.

Objective: Raloxifene, a selective estrogen receptor modulator, reduces osteoporosis and invasive breast cancer risk but increases risk for venous thromboembolism and fatal stroke in women with or at high risk for coronary heart disease. To assess the risk/benefit of raloxifene as a preventative treatment, we analyzed treatment effects on overall and cause-specific mortality.

Methods: A pooled analysis of mortality data was performed from large clinical trials of raloxifene (60 mg/day) versus placebo, including the Multiple Outcomes of Raloxifene Evaluation/Continuing Outcomes Relevant to Evista studies (7705 postmenopausal osteoporotic women followed for 4 years and a subset of 4011 participants followed for an additional 4 years; 110 deaths) and the Raloxifene Use for the Heart trial (10,101 postmenopausal women with coronary disease or multiple risk factors for coronary disease followed for 5.

Effects of raloxifene on fracture risk in postmenopausal women: the Raloxifene Use for the Heart Trial.

Unlabelled: Using data from a randomized placebo-controlled trial of 10,101 postmenopausal women not selected on the basis of osteoporosis, we examined whether the effect of raloxifene treatment on fractures was consistent across categories of fracture risk. Treatment with raloxifene for 5 yr reduced the risk of clinical vertebral fractures, but not nonvertebral fractures, irrespective of the presence or absence of risk factors for fracture.

Introduction: In The Raloxifene Use for The Heart (RUTH) trial, women assigned to raloxifene had a lower risk of clinical vertebral fractures but not nonvertebral fractures.

Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass.

Unlabelled: The double-blind, randomized raloxifene alendronate comparison trial was the first study designed to compare two osteoporosis therapies head-to-head for fracture risk reduction. The original protocol planned to treat 3000 postmenopausal women with alendronate 10 mg/day (ALN) or raloxifene 60 mg/day (RLX) for 5 years, and to recruit women (50-80 years old) with a femoral neck bone mineral density (BMD) T-score between -2.5 and -4.

The effect of raloxifene therapy on the risk of new clinical vertebral fractures at three and six months: a secondary analysis of the MORE trial.

Objective: Raloxifene treatment (60 mg/day) significantly decreases the risk of new clinical vertebral fractures by 68% at 1 year compared with placebo. The objective of the present analysis is to evaluate the effects of raloxifene on the incidence of new clinical vertebral fractures at 3 and 6 months after initiation of treatment.

Research Design And Methods: A double-blind, randomized, placebo-controlled, 4-year Multiple Outcomes of Raloxifene Evaluation (MORE) trial was conducted in 180 study centers.

Skeletal effects of raloxifene after 8 years: results from the continuing outcomes relevant to Evista (CORE) study.

Unlabelled: In the CORE breast cancer trial of 4011 women continuing from MORE, the incidence of nonvertebral fractures at 8 years was similar between placebo and raloxifene 60 mg/day. CORE had limitations for assessing fracture risk. In a subset of 386 women, 7 years of raloxifene treatment significantly increased lumbar spine and femoral neck BMD compared from the baseline of MORE.

Similar proportions of women lose bone mineral density with raloxifene or alendronate treatment.

The ISCD recommends that bone mineral density (BMD) be monitored in patients undergoing antiresorptive therapy to identify patients with a significant BMD loss. This analysis compares the proportions of postmenopausal women treated with raloxifene 60 mg/d (n=82) or alendronate 10 mg/d (n=83) who had significant BMD loss in a randomized, double-blind, placebo-controlled trial that assessed changes in lumbar spine and femoral neck BMD from baseline to 1 yr, measured using dual-energy X-ray absorptiometry. According to ISCD criteria, significant BMD loss was defined as greater than the least significant change, calculated as precision multiplied by 2.

Raloxifene reduces risk of vertebral fractures [corrected] in postmenopausal women regardless of prior hormone therapy.

Objective: We examined whether past use of hormone therapy influences the effects of raloxifene on the risk of new vertebral fracture, cardiovascular events, or breast cancer.

Study Design: The Multiple Outcomes of Raloxifene Evaluation (MORE) trial examined vertebral fracture incidence as the primary endpoint, breast cancer incidence as a secondary endpoint. Cardiovascular events were collected as secondary safety endpoints.

Comparison of fracture, cardiovascular event, and breast cancer rates at 3 years in postmenopausal women with osteoporosis.

Objectives: To compare event rates for osteoporotic fractures, cardiovascular events, and breast cancer in postmenopausal women with osteoporosis.

Design: A prospective, observational study of the placebo group in the double-blind, randomized Multiple Outcomes of Raloxifene Evaluation trial.

Setting: One hundred eighty clinical research centers in 25 countries.

Antiresorptive treatment of postmenopausal osteoporosis: review of randomized clinical studies and rationale for the Evista alendronate comparison (EVA) trial.

Standard pharmacological antiresorptive therapy for the prevention and/or treatment of postmenopausal osteoporosis now consists of four categories of drugs: estrogens, a selective estrogen receptor modulator (SERM), bisphosponates, and calcitonin. All of these drugs have been studied in randomized controlled trials, but meaningful comparisons of the efficacy of drugs have been difficult due to differences in baseline risks for fracture and differences in study design, including calcium and vitamin D supplementation, definition of fracture, and discontinuation rates. The current paper reviews results from pivotal studies of antiresorptive therapies with fracture as a primary endpoint, as well as head-to-head trials comparing these therapies using surrogate markers of fracture risk, and introduces the first head-to-head trial with fracture as a primary endpoint.

A national random survey of bone mineral density reporting in the United States.

The rapidly evolving technology of bone mineral density (BMD) testing has revolutionized the clinical care of osteoporosis; however, at present, there are no guidelines for BMD reporting. A survey was mailed to a random sample of bone densitometry centers in the United States registered in the National Osteoporosis Foundation database in order to evaluate the practice of BMD reporting in the United States. Of the 1200 questionnaires mailed, 22.

Antiresorptive treatment of postmenopausal osteoporosis: comparison of study designs and outcomes in large clinical trials with fracture as an endpoint.

Antiresorptive treatments for postmenopausal osteoporosis have been studied extensively, but due to the volume of published data and lack of head-to-head trials, it is difficult to evaluate and compare their fracture reduction efficacy. The objective of this review is to summarize the results from clinical trials that have fracture as an endpoint and to discuss the factors in study design and populations that can affect the interpretation of the results. Although there are numerous observational studies suggesting that estrogen and hormone replacement therapies may reduce the risk of vertebral and nonvertebral fractures, there is no large, prospective, randomized, placebo-controlled, double-blind clinical trial demonstrating fracture efficacy.

Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy.

Although low absolute values of bone mineral density (BMD) predict increased fracture risk in osteoporosis, it is not certain how well increases in BMD with antiresorptive therapy predict observed reductions in fracture risk. This work examines the relationships between changes in BMD after 1 year or 3 years of raloxifene or placebo therapy and the risk for new vertebral fractures at 3 years. In the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, 7705 postmenopausal women with osteoporosis were randomized to placebo or raloxifene 60 mg/day or 120 mg/day.

Urinary cyclic AMP excretion is increased in Macaca fascicularis and Macaca mulatta compared to humans.

Changes in parathyroid hormone and its second messenger cyclic AMP have been implicated in the pathogenesis of osteoporosis. Nonhuman primate models have been useful in the study of osteoporosis, but the physiology of mineral metabolism in certain species is different than in humans. We investigated parameters of mineral metabolism in 15 normal adult female cynomolgus and 14 normal adult female rhesus monkeys.