CardioExchange Archive

The FDA Circulatory Systems Devices Panel has given a strong vote of support in favor of the Sapien Transcatheter Heart Valve (THV) for use in patients with inoperable severe aortic stenosis and with no comorbidities precluding benefit from correction of the stenosis. By large majorities, the panel voted that the procedure was safe (7-3), that the procedure was effective (9-1), and that the benefits of the device outweighed the risks (9-0, 1 abstention).

During the course of the meeting, the FDA and panel members expressed a fair amount of concern that excessive enthusiasm for the device might cause a stampede of early usage. Panel members were concerned that the device might be used in patients who were not ideal candidates and by operators and centers who lacked sufficient experience.

Panel member and CardioExchange interventional cardiology blogger Rick Lange said that the committee strongly recommended that the FDA require all centers that utilize the Sapien THV to participate in a registry that would be jointly managed by the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) and that would include all patients who receive the device.

The committee also expressed anguish over the issue of strokes in the trial, spending much time discussing the various definitions of stroke used in PARTNER B and discrepancies between analyses of the trial from the trial’s sponsor, Edwards, and those from the FDA’s analysts.