RESUMO
BACKGROUND: The aim of this systematic review was to update scientific knowledge concerning the safety of neuromuscular electrical stimulation (NMES) to increase exercise capacity and prevent cardiac cachexia in patients with implantable cardioverter defibrillators (ICDs). METHODS: A systematic review including the electronic databases PubMed, MEDLINE, and SCOPUS was conducted for the time period from 1966 to March 31, 2016. RESULTS: Only four articles fulfilled the inclusion criteria (three original articles/safety studies and one case report). The three (safety) studies used NMES to increase muscle strength and/or endurance capacity of the thighs. NMES did not show electromagnetic interference (EMI) with ICD function. EMI was described in a case report of 2 patients with subpectoral ICDs and application of NMES on abdominal muscles. CONCLUSION: This review indicates that NMES may be applied in cardiac ICD patients if 1) individual risks (e. g., pacing dependency, acute heart failure, unstable angina, ventricular arrhythmic episode in the last 3 months) are excluded by performing a safety check before starting NMES treatment and 2) "passive" exercise using NMES is performed only for thighs and gluteal muscles in 3) compliant ICD patients (especially for home-based NMES) and 4) the treatment is regularly supervised by a physician and the device is examined after the first use of NMES to exclude EMI. Nevertheless, further studies including larger sample sizes are necessary to exclude any risk when NMES is used in this patient group.
Assuntos
Caquexia/epidemiologia , Caquexia/reabilitação , Desfibriladores Implantáveis/estatística & dados numéricos , Terapia por Estimulação Elétrica/estatística & dados numéricos , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/prevenção & controle , Contraindicações , Traumatismos por Eletricidade/epidemiologia , Falha de Equipamento/estatística & dados numéricos , Segurança de Equipamentos/estatística & dados numéricos , Feminino , Humanos , Masculino , Prevalência , Coxa da Perna/inervaçãoRESUMO
BACKGROUND: EOS is a biplane X-ray imaging system manufactured by EOS Imaging (formerly Biospace Med, Paris, France). It uses slot-scanning technology to produce a high-quality image with less irradiation than standard imaging techniques. OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of EOS two-dimensional (2D)/three-dimensional (3D) X-ray imaging system for the evaluation and monitoring of scoliosis and other relevant orthopaedic conditions. DATA SOURCES: For the systematic review of EOS, electronic databases (MEDLINE, Allied and Complementary Medicine Database, BIOSIS Previews, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library, EMBASE, Health Management Information Consortium, Inspec, ISI Science Citation Index and PASCAL), clinical trials registries and the manufacturer's website were searched from 1993 to November 2010. REVIEW METHODS: A systematic review of studies comparing EOS with standard X-ray [film, computed radiography (CR) or digital radiography] in any orthopaedic condition was performed. A narrative synthesis was undertaken. A decision-analytic model was developed to assess the cost-effectiveness of EOS in the relevant indications compared with standard X-ray and incorporated the clinical effectiveness of EOS and the adverse effects of radiation. The model incorporated a lifetime horizon to estimate outcomes in terms of quality-adjusted life-years (QALYs) and costs from the perspective of the NHS. RESULTS: Three studies met the inclusion criteria for the review. Two studies compared EOS with film X-ray and one study compared EOS with CR. The three included studies were small and of limited quality. One study used an earlier version of the technology, the Charpak system. Both studies comparing EOS with film X-ray found image quality to be comparable or better with EOS overall. Radiation dose was considerably lower with EOS: ratio of means for posteroanterior spine was 5.2 (13.1 for the study using the Charpak system); ratio of means for the lateral spine was 6.2 (15.1 for the study using the Charpak system). The study comparing EOS with CR found image quality to be comparable or better with EOS. Radiation dose was considerably lower with EOS than CR; ratio of means for the centre of the back was 5.9 and for the proximal lateral point 8.8. The lowest ratio of means was at the nape of the neck, which was 2.9. No other outcomes were assessed in the included studies, such as implications for patient management from the nature and quality of the image. Patient throughput is the major determinant of the cost-effectiveness of EOS. The average cost per procedure of EOS decreases with utilisation. Using estimates of patient throughput at national level from Hospital Episode Statistics data suggests that EOS is not cost-effective for the indications considered. Throughput in the region of 15,100 to 26,500 (corresponding to a workload of 60 to 106 patient appointments per working day) for EOS compared with a throughput of only 7530 for CR (30 patient appointments per working day) is needed to achieve an incremental cost-effectiveness ratio of £30,000 per QALY. EOS can be shown to be cost-effective only when compared with CR if the utilisation for EOS is about double the utilisation of CR. LIMITATIONS: The main limitation of the systematic review of the clinical effectiveness of EOS was the limited number and quality of the data available. In particular, there were no studies assessing the potential health benefits arising from the quality and nature of the image, over and above those associated with reduced radiation exposure. Uncertainty in the model inputs was not fully explored owing to a lack of reporting of standard deviations or confidence intervals in the published literature for most of the parameters. As a result, uncertainty in the cost-effectiveness results was not presented. CONCLUSIONS: Radiation dose is considerably lower with EOS than standard X-ray, whereas image quality remains comparable or better with EOS. However, the long-term health benefits from reduced radiation exposure with EOS are very small and there was a lack of data on other potential patient health benefits. The implications of any changes in the quality and nature of the EOS image compared with standard X-ray, for patient health outcomes, needs to be assessed. Given the higher cost of an EOS machine, utilisation is the major determinant of cost-effectiveness. Estimates of patient throughput at national level suggest that EOS is not cost-effective. FUNDING: The National Institute for Health Research Health Technology Assessment programme.