Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the Edwards SAPIEN™ Transcatheter Heart Valve

The Panel commended the Sponsor for conducting a welldesigned study to evaluate the Edwards SAPIEN™ THV. The majority of Panel members agreed that that the discussed device and procedure is effective in lowering mortality in the specific population studied. The Panel recommended tight monitoring of this technology in a post-approval period. Stroke emerged as a major issue even though the reduction in mortality outweighed it. Hence, it is critical that elderly patients be made aware of the tradeoff. Some patients may decide that living with a stroke and its sequelae is worse than a shortened lifespan. The available QOL data were insufficient for shedding light on what metrics are important for elderly patients. It is essential to conduct vigorous research to assess QOL in unblinded percutaneous heart valve trials. Statements made by the professional societies in support of the device, and adherence to indications, were very important. It seems critical that physicians respect this technology so that once approved there is not another "DES stent thrombosis scare" with limited data to figure out what has happened. Based on the Panel recommendation, it is anticipated that the device will be approved by the FDA. © 2011 American Heart Association, Inc.