RESUMO
Cardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real-world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real-world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high-quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real-world practice.
Assuntos
Indicadores de Qualidade em Assistência à Saúde , Sistema de Registros , Procedimentos Cirúrgicos Vasculares , Humanos , Indicadores de Qualidade em Assistência à Saúde/normas , Procedimentos Cirúrgicos Vasculares/normas , Sociedades Médicas/normas , Resultado do Tratamento , Estados Unidos , Confiabilidade dos Dados , Fatores de Risco , Melhoria de Qualidade/normasRESUMO
Restless legs syndrome is a common neurologic movement disorder that affects approximately 10 percent of adults. Of those affected with this condition, approximately one third have symptoms severe enough to require medical therapy. Restless legs syndrome may be a primary condition, or it may be secondary to iron deficiency, renal failure, pregnancy, or the use of certain medications. The diagnosis is clinical, requiring an urge to move the legs usually accompanied by an uncomfortable sensation, occurrence at rest, improvement with activity, and worsening of symptoms in the evening or at night. Restless legs syndrome causes sleep disturbances, is associated with anxiety and depression, and has a negative effect on quality of life. Treatment of secondary causes of restless legs syndrome may result in improvement or resolution of symptoms. Currently, there is little information regarding the effects of lifestyle changes on the symptoms of restless legs syndrome. If medications are needed, dopamine agonists are the primary medications for moderate to severe restless legs syndrome. Other medications that may be effective include gabapentin, carbidopa/levodopa, opioids, and benzodiazepines.