Se realizaron ecografías tridimensionales en tiempo real y cartografías electroanatómicas de todos los pacientes, antes y después de dicha terapia, así como una resonancia magnética para evaluar la cicatriz miocárdica. Se estudió a 6 pacientes con función ventricular izquierda normal y 12 pacientes con disfunción del ventrículo izquierdo y bloqueo de rama izquierda tratados con terapia de resincronización cardiaca. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and Interagency Registry of Mechanically Assisted Circulatory Support.ĭebido a la controversia existente al determinar si la terapia de resincronización cardiaca corrige asincronía eléctrica o mecánica, el objetivo del estudio es determinar si hay correlación entre las secuencias eléctricas y mecánicas y si la cicatriz miocárdica tiene un impacto relevante. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Interagency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. Maintaining a regulatory environment to foster efficient introduction of safe and effective technologies is critical to the success of ventricular assist device therapy and the health of patients with advanced heart failure. The regulatory oversight of these new technologies has been difficult owing to the complexities of these devices, associated adverse event profile, and severity of illness of the intended patient population. Mechanical circulatory support has evolved to become an important therapy for patients who have advanced heart failure with the advent of more durable, implantable ventricular assist devices. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US Food and Drug Administration.