Eficacia y seguridad de la prótesis valvular pulmonar percutánea para el tratamiento de pacientes pediátricos con antecedente de malformación congénita e historia de cirugía reconstructiva del tracto de salida del ventrículo derecho que presentan regurgitación valvular pulmonar / Efficacy and safety of percutaneous pulmonary valve prosthesis for the treatment of pediatric patients with a history of congenital malformation and history of reconstructive surgery of the right ventricular outflow tract who present pulmonary valve regurgitation

ANTECEDENTES: En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias, aprobada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021, se ha elaborado el presente dictamen, el cual expone la evaluación de la eficacia y seguridad de la prótesis valvular pulmonar percutánea (PVPP) para el tratamiento pacientes pediátricos con antecedente de malformación congénita e historia de cirugía reconstructiva del tracto de salida del ventrículo derecho (TSVD) que presentan regurgitación valvular pulmonar. De este modo, el Dr. Miguel Arboleda Torres, siguiendo la Directiva N° 001-IETSI-ESSALUD-2018, envió al Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) la solicitud de aprobación del dispositivo médico PVPP. ASPECTOS GENERALES: Aproximadamente un 10 % de pacientes con malformaciones cardiacas congénitas poseen alteraciones anatómicas que obstruyen el tracto de salida del ventrículo derecho (TSVD), el cual conecta el ventrículo derecho del corazón y la arteria pulmonar. La malformación congénita más común que afecta al TSVD es la tetralogía de Fallot y se estima que el 90 % de los pacientes con esta patología son sometidos a una cirugía a corazón abierto durante la infancia temprana para reconstruir el TSVD (que se encuentra obstruido o estrecho [estenótice. Por lo general, la reconstrucción se realiza mediante la colocación de un parche, una prótesis o un conducto entre el ventrículo derecho y la arteria pulmonar. No obstante, con el transcurrir de los años, estos pacientes desarrollan anormalidades de la válvula pulmonar, lo que requiere que se sometan a nuevas intervenciones quirúrgicas para reemplazarla por una prótesis valvular (Alkashkari et al., 2018; Gutiérrez-Larraya et al., 2021, p.). METODOLOGÍA: Se llevó a cabo una búsqueda bibliográfica exhaustiva con el objetivo de identificar la mejor evidencia sobre la eficacia y seguridad del reemplazo valvular pulmonar percutáneo empleando el dispositivo PVPP. La búsqueda bibliográfica se realizó en las bases de datos PubMed, The Cochrane Library y LILACS. Asimismo, se realizó una búsqueda manual dentro de las páginas web pertenecientes a grupos que realizan evaluación de tecnologías sanitarias (ETS) y guías de práctica clínica (GPC) incluyendo el National Institute for Health and Care Excellence (NICE), Canadian Agency for Drugs and Technologies in Health (CADTH), Scottish Medicines Consortium (SMC), Scottish Intercollegiate Guidelines Network (SIGN), Institute for Clinical and Economic Review (ICER), El Instituto de Calidad y Eficiencia en la Atención de la Salud (IQWiG, por sus siglas en alemán), la Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA), la OMS, el Ministerio de Salud del Perú (MINSA) y el Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI). Además, se realizó una búsqueda de GPC de las principales sociedades o instituciones especializadas en cardiología y cirugía torácica, tales como: American Heart Association (AHA), American College of Cardiology (ACC), European Society of Cardiology (ESC), European Association for Cardio-Thoracic Surgery (EACTS), y la Sociedad Española de Cardiología. Finalmente, se realizó una búsqueda en ClinicalTrials.govpara identificar ensayos clínicos aleatorizados (ECA) en curso o que no hayan sido publicados aún. RESULTADOS: Luego de la búsqueda bibliográfica hasta noviembre del 2021, no se identificaron ECA que compararan las tecnologías de interés. Además, tampoco se encontraron guías de práctica clínica (GPC), evaluaciones de tecnología sanitaria (ETS), revisiones sistemáticas (RS), ni estudios realizados en población pediátrica exclusivamente. En consecuencia, se consideró la inclusión de evidencia científica con una población mixta (adultos y niños) que respondiera a la pregunta PICO. Así, se incluyeron dos GPC (Baumgartner et al., 2021; National Institute for Health and Care Excellence, 2013), dos revisiones sistemáticas (Ribeiro et al., 2020; Zhou et al., 2019), y dos estudios observacionales comparativos que no se encontraban incluidos en ninguna de las dos RS previas (Hribernik et al., 2021; OuYang et al., 2020). CONCLUSIÓN: Por lo expuesto, el IETSI aprueba el uso de prótesis de válvula pulmonar de inserción percutánea en pacientes pediátricos con antecedente de malformación cardiaca congénita e historia de cirugía reconstructiva del tracto de salida del ventrículo derecho que presenten una regurgitación valvular pulmonar moderada a severa, según lo establecido en el Anexo N° 1. La vigencia del presente dictamen preliminar es de un año a partir de la fecha de publicación y la continuación de dicha aprobación estará sujeta a la evaluación de los resultados obtenidos y de mayor evidencia que pueda surgir en el tiempo.

The influence of standards and clinical guidelines on prosthetic and orthotic service quality: a scoping review.

OBJECTIVES: Standards and guidelines are an integral part of prosthetic and orthotic service delivery in the developed world underpinned by an assumption that they lead to improved services. Implementing them has a cost, however, and that cost needs to be justified, particularly in resource-limited environments. This scoping review thus asks the question, "What is the evidence of the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics?" MATERIALS AND METHODS: A structured search of three electronic databases (Medline, Scopus and Web of Science) followed by manual searching of title, abstract and full text, yielded 29 articles. RESULTS: Four categories of papers were identified: Descriptions and Commentaries (17 papers), Guideline Development (7), Guideline Testing (2) and Standards implementation (3). No articles were explicitly designed to assess the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics. DISCUSSION AND CONCLUSION: Studies tended to be commentaries on or descriptions of guideline development, testing or implementation of standards. The literature is not sufficiently well developed to warrant the cost and effort of a systematic review. Future primary research should seek to demonstrate whether and how guidelines and standards improve the outcomes for people that require prostheses, orthoses and other assistive devices. Implications for Rehabilitation International Standards and Clinical Guidelines are now an integral part of clinical service provision in prosthetics and orthotics in the developed world. Complying with standards and guidelines has a cost and, particularly in resource-limited environments, it should be possible to justify this in terms of the resulting benefits. This scoping review concludes that there have been no previous studies designed to directly quantify the effects of implementing standards and guidelines on service delivery.

Rapid Globalization of Medical Device Clinical Development Programs in Japan　- The Case of Drug-Eluting Stents.

Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012. The reduction accompanied a shift in clinical development from a succession pattern (initial product development and approval overseas followed by eventual entrance into the Japanese market) to parallel development (employing multiregional clinical trials (MRCTs)). Although resource-intensive in the short-term, MRCTs are proving to be an effective tool in simultaneous global product development. Creative study designs and the absence of significant ethnic differences in Japanese subjects regarding DES safety and efficacy and the pharmacokinetic behavior of their coating drugs propel this process. More general factors such as medical need and industry incentivization also encourage this shift. Physicians' preference for DES over other percutaneous coronary interventions, the expanding global DES market, and streamlined development and approval prospects each motivate industry to continue investing in DES product development. The efforts of various stakeholders were also integral to overcoming practical obstacles, and contributions by 'Harmonization by Doing' and a premarket collaboration initiative between the USA and Japan were particularly effective. Today, USA/Japan regulatory cooperation is routine, and Japan is now integrated into global medical device development. MRCTs including Japanese subjects, sites, and investigators are now commonplace.

Assistive technology in resource-limited environments: a scoping review.

PURPOSE: It is estimated that only 5-15% of people in low and middle income countries (LMICs) who need assistive technologies (AT) have access to them. This scoping review was conducted to provide a comprehensive picture of the current evidence base on AT within LMICs and other resource limited environments. METHOD: The scoping review involved locating evidence, extracting data, and summarizing characteristics of all included research publications. RESULTS: Of the 252 publications included, over 80% focused on types of AT that address mobility (45.2%) and vision (35.5%) needs, with AT types of spectacles and prosthetics comprising over 50% of all publications. Evidence on AT that addresses hearing, communication, and cognition is the most underrepresented within the existing evidence base. The vast majority of study designs are observational (63%). CONCLUSIONS: Evidence on AT in resource-limited environments is limited in quantity and quality, and not evenly distributed across types of AT. To advance this field, we recommend using appropriate evidence review approaches that allow for heterogeneous study designs, and developing a common language by creating a typology of AT research focus areas. Funders and researchers must commit much greater resources to the AT field to ameliorate the paucity of evidence available. Implications for Rehabilitation An increase in the quality and quantity of research is required in resource limited environments, where 80% of the global population of people with disabilities reside. Improved and increased evidence is needed to identify and understand needs, inform policy and practice, and assess progress made in increasing access to and availability of appropriate AT. Over 80% of the existing research publications on assistive technologies in resource limited environments address mobility and vision. More research is needed on AT that address hearing, communication and cognition. The use of a common language would facilitate the advancement of the global AT research field. Specifically there is a need for researchers to use a common definition of AT (i.e., ISO 9999) and typology of AT research focus areas.

Novedades en artroplastia de hombro en 2015 / Update in shoulder surgery 2015: arthroplasty

La indicación en la cirugía de sustitución protésica del hombro ha cambiado de una forma drástica en los últimos años, hemos pasado del tratamiento con prótesis parciales para fracturas agudas al uso de prótesis inversas, la prótesis anatómica ha perdido terreno hasta el punto de que en muchos hospitales la prótesis invertida ha superado con creces a la prótesis anatómica. También podemos decir que las indicaciones de prótesis han variado, así hemos ampliado el uso de la prótesis inversa que fue desarrollada para el tratamiento de las artropatías por manguito rotador. Estos implantes en la actualidad se usan además como recurso para fracturas y recambios. En este artículo intentamos hacer una puesta al día de los problemas más frecuentes de las artroplastias y además se hace una revisión de lo publicado en los últimos años haciendo mayor hincapié en los artículos publicados en el JSES, JBJS y los ICL de la AAOS. De forma resumida se valoran las complicaciones que afectan a las prótesis de hombro

Changes in replacement surgery in the shoulder have happened recently: reverse shoulder prosthesis for acute fractures, and more indications for reverse shoulder arthroplasty than before. In this paper an update of most frequent concepts in shoulder surgery during 2015 is performed

Novedades en cirugía de columna vertebral en 2015 / No disponible

En este artículo de revisión, queremos destacar las principales novedades y curiosidades alrededor de la cirugía de columna que se han publicado el año 2015. Aunque, el año pasado no han sido publicadas grandes novedades en nuestra área de estudio, nosotros queremos hacer hincapié en los aspectos que nos han parecido más relevantes sobre cirugía de columna. Dado que la cirugía de columna representa una importante carga asistencial sanitaria y social. Los estudios aquí reflejados intentan dar respuestas a las múltiples demandas pendientes. Así es como abordaremos temas como la artrodesis cervical vs prótesis cervicales, uso local de vancomicina en polvo, vitamina D, mejoras en las técnicas de cementación vertebral, uso de agentes biológicos, escoliosis idiopática del adolescente y factores de riesgo para la cirugía de columna

In this revision article we want to highlight some news and curiosities around the spine surgery published during 2015. Although last year, they have not been published major innovations in spinal surgery, we want to emphasize some aspects that we consider interesting and useful in our working area. Spinal surgery is a major social and health burden, so the studies reflected here attempt to answer outstanding claims. This is how we address issues such as cervical arthrodesis vs cervical prostheses, use of local powder vancomycin, use of vitamin D, improving vertebral cementation techniques, risk factors for spine surgery, use of biological agents and adolescent idiopathic scoliosis

The orthopaedic experience of Kasr Al Ainy Hospitals in the Egyptian revolution.

BACKGROUND: 25 January 2011 marks the onset of the Egyptian revolution. Causalities were estimated to be at least 846 moralities and 6000 injuries. The purpose of this study is to document the orthopaedic injuries coming to the tertiary center of Cairo University Hospitals (Kasr Al Ainy) during the climax of the Egyptian revolution and the lessons learnt. MATERIAL AND METHODS: We retrospectively reviewed all hospital admissions in the period of 28 January 2011 till 4th February 2011 due to injuries related to the revolution. Total number of patients examined by the orthopaedic residents and staff members in the emergency room during that period was 553 patients. A total of 110 patients were admitted to the orthopaedic department. RESULTS: Various injuries were encountered. The most common were gun shot injuries (45 cases), followed by falls (28 cases), road traffic accidents (26) and trauma by blunt objects (11 cases). Overall 121 operative procedures were conducted in the operative theater by our residents and staff members. Fractures of the femur were the most common fractures (27 cases) followed by forearm fractures (13 cases). Limitations were the availability of a limited variety of orthopaedic implants. CONCLUSION: We believe that tertiary centers should be prepared for mass causalities. A variety of orthopaedic implants should be within reach and that personnel should be trained to work under stressful environments with a well laid disaster management plan.

El desarrollo de la cardiología pediátrica española y su impacto en el manejo de las cardiopatías congénitas / The development of Spanish paediatric cardiology and its impact on congenital heart disease management

No disponible

Resultados coste-efectividad del implante de dexametasona en edema macular / A cost-effectiveness study of dexamethasone implants in macular edema

OBJETIVO: Analizar el beneficio coste-efectividad del implante intravítreo de dexametasona (Ozurdex®, Allergan, Irvine, CA, EE. UU.) en sus aplicaciones clínicamente relevantes. MATERIAL Y MÉTODOS: Un total de 88 ojos de 86 pacientes con edema macular de > 300 μm medido mediante tomografía de coherencia óptica (Zeiss Cirrus, Dublín, CA, EE. UU.) fueron incluidos en este trabajo retrospectivo de 2 años, con un seguimiento mínimo de 6 meses. Se incluyeron 3 grupos de pacientes: el grupo 1 con edema macular en oclusión venosa retiniana, el grupo 2 con uveítis posterior no infecciosa y el grupo 3 con edema macular diabético, estando este fuera de indicación pero avalado por la literatura médica. Antes del implante y los días 1, 30, 60, 90 y 180 se evaluó la agudeza visual corregida (Snellen), espesor retiniano central, presión intraocular y biomicroscopia. Los análisis de coste-beneficio se tabularon por línea de visión ganada, comparando las principales alternativas terapéuticas, y se valoró el perfil de seguridad del implante intravítreo de dexametasona (Ozurdex®; Allergan, Irvine, CA, EE. UU.). RESULTADOS: Los resultados de este estudio no difirieron de los publicados por otros, en términos de mejoría de la agudeza visual en el 63,3% y del espesor macular central en el 97%. En los casos de recidiva, se produjo a los 120 días de media; la necesidad de retratamiento fue del 40,9%. Entre los efectos secundarios, el incremento de presión intraocular > 23 mm Hg se produjo en el 29,54%, controlándose con tratamiento tópico, excepto un 1,13% de los casos que requirieron tratamiento quirúrgico. El desarrollo de catarata fue del 44,7%, requiriendo cirugía un 10,6%. Los resultados del tratamiento mostraron una menor necesidad en la frecuencia del uso de Ozurdex® frente a otros tratamientos para el control de la enfermedad, convirtiéndose en una opción que permite el ahorro de costes. DISCUSIÓN: Los análisis coste-efectividad son clínicamente relevantes cuando se aplican estrategias terapéuticas en pacientes con edema macular. El implante de dexametasona intravítrea es una opción terapéutica segura y eficiente

OBJECTIVE: To analyze the cost-effectiveness and benefits of a dexamethasone intravitreal implant (Ozurdex®, Allergan, Irvine, CA, USA.) in its clinically relevant applications. MATERIAL AND METHODS: A total of 88 eyes of 86 patients with macular edema of > 300 μm measured by optical coherence tomography (Cirrus Zeiss, Dublin, CA, USA) were included in this two-year retrospective study, with a minimum of 6 months follow-up. The patients were divide into 3 groups: group 1 with macular edema in retinal vein occlusion, group 2 with non-infectious posterior uveitis, and group 3 with diabetic macular edema. The treatment was off-label but supported by the literature. Before implantation, and on days 1, 30, 60, 90 and 180, corrected visual acuity (Snellen), central retinal thickness, intraocular pressure and biomicroscopy were evaluated. The cost-benefit analysis was tabulated by line of visual acuity gained, comparing the main therapeutic alternatives and assessment of the safety profile of the dexamethasone intravitreal implant (Ozurdex®, Allergan, Irvine, CA, USA). RESULTS: The results of this study did not differ from the published studies, in terms of visual acuity improvement in 63.3% of cases, and with central macular thickness improvement in 97% of cases. There were relapses, which occurred after 120 days on average, and the need for retreatment was 40.9%. Increased intraocular pressure >23 mm Hg was among the side effects in 29.54%, and was controlled with topical treatment, except in 1.13% requiring surgical treatment. The development of cataract was 44.7%, and 10.6% required surgery. Treatment results showed less frequent use of Ozurdex® than other treatments for disease control, being a cost saving option. DISCUSSION: Cost-effectiveness analyses are clinically relevant when applying treatment strategies in patients with macular edema. Dexamethasone intravitreal implant appears to be a safe and efficient therapy

A scoping literature review of the provision of orthoses and prostheses in resource-limited environments 2000-2010. Part two: research and outcomes.

BACKGROUND: Despite the activities of many orthotic and prosthetic provision organizations in resource-limited environments, there is still a great need and there are several areas for improvement, as identified in Part One of this series. OBJECTIVES: Our goal was to examine outcomes and conclusions of research studies to produce an evidence base for determining factors that may lead to successful provision of orthoses and prostheses in resource-limited environments. STUDY DESIGN: Literature review. METHODS: We conducted a scoping literature review of all information related to orthotic and prosthetic provision in resource-limited environments published from 2000 to 2010. We extracted measured outcomes reported in all types of articles and analyzed conclusions from research studies. RESULTS: Reported outcomes included durability, cost, satisfaction, use/nonuse of device, amount of utilization, walking speed, discomfort, pain, fit, misalignment, capacity for service provision, number of devices produced or delivered, and number of graduates from training programs. CONCLUSIONS: There are many gaps in the evidence base, notably in measuring inclusion, participation, and quality of life for orthosis and prosthesis users in resource-limited environments. There is a paucity of reported outcomes for orthotics. Valid, reliable, and standard methods of data collection and reporting are needed to advance the field and enhance the evidence base.

Experiences of providing prosthetic and orthotic services in Sierra Leone--the local staff's perspective.

UNLABELLED: In Sierra Leone, West Africa, there are many people with disabilities in need of rehabilitation services after a long civil war. PURPOSE: The aim of this qualitative study was to explore the experiences of prosthetic and orthotic service delivery in Sierra Leone from the local staff's perspective. METHOD: Fifteen prosthetic and orthotic technicians working at all the rehabilitation centres providing prosthetic and orthotic services in Sierra Leone were interviewed. The interviews were transcribed and subjected to latent content analysis. RESULTS: One main theme emerged: sense of inability to deliver high-quality prosthetic and orthotic services. This main theme was generated from eight sub-themes: Desire for professional development; appraisals of work satisfaction and norms; patients neglected by family; limited access to the prosthetic and orthotic services available; problems with materials and machines; low public awareness concerning disabilities; marginalisation in society and low priority on the part of government. CONCLUSIONS: The findings illustrated traditional beliefs about the causes of disability and that the public's attitude needs to change to include and value people with disabilities. Support from international organisations was considered necessary as well as educating more prosthetic and orthotic staff to a higher level.

Orchestrating cell/material interactions for tissue engineering of surgical implants.

Research groups are currently recognising a critical clinical need for innovative approaches to organ failure and agenesis. Allografting, autologous reconstruction and prosthetics are hampered with severe limitations. Pertinently, readily available 'laboratory-grown' organs and implants are becoming a reality. Tissue engineering constructs vary in their design complexity depending on the specific structural and functional demands. Expeditious methods on integrating autologous stem cells onto nanoarchitectured 3D nanocomposites, are being transferred from lab to patients with a number of successful first-in-man experiences. Despite the need for a complete understanding of cell/material interactions tissue engineering is offering a plethora of exciting possibilities in regenerative medicine.

Experiences in the provision, fitting and supply of external breast prostheses: findings from a national survey.

A good-quality external breast prosthesis and prosthesis-fitting service is integral to recovery post-mastectomy. However, this area of care has minimal information or research available. The aim of this study was to investigate women's experience of the provision, fitting, supply and use of breast prostheses in Ireland. Three national surveys were undertaken with women (n = 527), breast care nurses (BCNs) (n = 32) and retail prosthesis fitters (n = 12). The findings identified the importance of the prosthesis for shape, appearance to self, appearance to others, sense of well-being, self-confidence and femininity. Dissatisfaction with weight, comfort and movement of the prosthesis was identified. Cost and travel distance were found to influence the replacement of the prosthesis. Dissatisfaction emerged with the display and choice of products, and brochure availability at the prosthesis fitting. Women preferred to be fitted for the first silicone prosthesis by a BCN in a hospital setting whereas for the replacement prosthesis they preferred a trained fitter at a specialized prosthesis supplier. BCNs and retail fitters identified the need for service guidelines and increased availability of professional development opportunities in prosthesis-fitting. These findings contributed to the development of standards of care for breast prosthesis-fitting services to benefit women and to provide guidelines for those providing the service.

Implicaciones de los nuevos diseños protésicos de baja densidad en la mejora de la reparación de defectos herniarios / Role of the new lightweight prostheses in improving hernia repair

El empleo de materiales protésicos para tratar enfermedades de la pared abdominal y/o torácica ha resuelto, en gran medida, el problema creado por el defecto tisular y las complicaciones de recidiva. Clásicamente, el más empleado ha sido el polipropileno en forma de prótesis reticular. Este material, con una biocompatibilidad óptima, está sufriendo modificaciones, encaminadas a conseguir la mejor adaptación posible al tejido receptor y mantener las mejores propiedades funcionales en el lugar del implante. De esta forma, las prótesis clásicas denominadas de alta densidad están siendo sustituidas por otras más ligeras (de baja densidad), con una configuración espacial sencilla y un poro más amplio. Las prótesis de baja densidad mantienen su elasticidad, lo que genera menos fibrosis y rigidez tras el implante. De cualquier forma, son necesarios estudios que consigan una densidad de material y un tamaño de poro ideales, dos parámetros que condicionan el comportamiento de dichos biomateriales (AU)

The use of a prosthetic material to treat abdominal and/or thoracic disease has, to a great extent, resolved the problem created by the tissue defect itself and complications of recurrence. The most commonly used of these materials has been polypropylene in the form of a reticular mesh. This biomaterial, which boasts optimal biocompatibility, has been the object of constant modification aimed at better adapting it to the functional needs of the host tissue. Hence, the classic prostheses, nowadays known as heavyweights, are being gradually replaced by lighter materials with a simple spatial configuration and, more importantly, with a larger pore size (lightweight prostheses). Lightweight meshes are able to preserve abdominal wall compliance by generating less post-implant fibrosis and rigidity. However, further studies are still needed to achieve the ideal balance between material density and pore size. These two factors will determine the behaviour of these new prosthetic designs (AU)

Treating natural disaster victims is dealing with shortages: an orthopaedics perspective.

During natural disasters such as earthquakes or tsunamis, most of the casualties are known to suffer from musculoskeletal injuries. This leads to an enormous need of orthopaedic (surgical) implants such as osteosynthesis plates, which are difficult to provide in developing countries that rely on imported ones. One of the alternatives is utilization of local resources, but only after they have been proven safe to use, and meet the international standards set. Through this paper we would like to urge the international community to include locally produced biomedical products, like osteosynthesis plates in their scientific evaluations and communications. When the quality of local products is proven, the reluctance to use local products also by surgeons from developing countries will disappear and larger scale production can be initiated. This in its turn solves many problems that come after natural disasters and stimulates the national economy in an efficient and effective way.

Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel meeting on patent foramen ovale closure devices.

Patent foramen ovales (PFOs) are common congenital cardiac defects that are more prevalent among patients experiencing cryptogenic stroke than among those with strokes of known origin. Medical treatment for these processes is often considered inadequate, and mechanical closure of the PFO is an attractive, albeit controversial, alternative. Although it is plausible that percutaneous PFO closure will reduce the rate of recurrent stroke in these patients, randomized trials examining the efficacy of devices in this setting have not been completed. In 2007, the Food and Drug Administration convened a meeting of the Circulatory System Devices Panel to discuss the necessity of randomized trials, as well as obstacles to trial enrollment and completion.