This joint position statement represents the combined efforts of four professional societies (Society of Thoracic Surgeons [STS], American Association for Thoracic Surgery [AATS], American College of Cardiology [ACC], and Society for Cardiovascular Angiography and Interventions [SCAI]), two government agencies (the U.S. Food and Drug Administration [FDA] and the Centers for Medicare and Medicaid Services [CMS]), and numerous industry representatives to assess the foreseeable directions of a class of emerging technologies being developed to enable the percutaneous treatment of cardiac valve dysfunction. Percutaneous heart valve technology (PHVT) is a less invasive means of treating valvular heart disease. The goals of the interdisciplinary group have been to establish cooperation, identify consensus and controversy, and formulate clinical guidelines for the continued development of PHVT.
PROCESS
On April 22, 2004, the STS/AATS Committee/ Workforce for the Assessment of New Technology (Appendix 1) organized a workshop on PHVT. Included were representatives from the STS, the AATS, the ACC, and SCAI. Also in attendance were representatives from the FDA's Division of Cardiovascular Devices, Circulatory Support and Prosthetic Devices Branch, CMS, and industry representatives (Appendix 2). Clinical aspects of PHVT were initially addressed in small groups with representatives from each of the constituencies followed by a summary report and discussion amongst the entire group. All participants of the workshop and writing group members completed a disclosure questionnaire documenting all outside relationships that might be perceived as real or potential conflicts of interest [1]. Current crucial issues addressed were: 1) trial design, 2) control groups, 3) end points for assessment, 4) rate of technological change, 5) institutional and investigator requirements, and 6) safety. Consideration of these issues is undertaken with the acknowledgement that for most patients with heart valve disease, open cardiac surgical procedures provide an established form of treatment.