HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Williams, D. O. Search for Related Content PubMed PubMed Citation Articles by Williams, D. O.

J Thorac Cardiovasc Surg 2005;129:970-976
© 2005 The American Association for Thoracic Surgery

STS/AATS/SCAI Position Statement

The clinical development of percutaneous heart valve technology

A position statement of the Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI)

The first 300 words of the full text of this article appear below.

	Preamble

 
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.

	Background

 
For decades, percutaneous interventional therapy has been . . . [Full Text of this Article]

This article has been cited by other articles:

				R. Zegdi, P. Bruneval, D. Blanchard, and J.-N. Fabiani Evidence of leaflet injury during percutaneous aortic valve deployment Eur J Cardiothorac Surg, July 1, 2011; 40(1): 257 - 260. [Abstract] [Full Text] [PDF]

				T. D. Yan, C. Cao, J. Martens-Nielsen, R. Padang, M. Ng, M. P. Vallely, and P. G. Bannon Transcatheter aortic valve implantation for high-risk patients with severe aortic stenosis: A systematic review J. Thorac. Cardiovasc. Surg., June 1, 2010; 139(6): 1519 - 1528. [Abstract] [Full Text] [PDF]

				R. Zegdi, L. Lecuyer, P. Achouh, B. Didier, A. Lafont, C. Latremouille, and J.-N. Fabiani Increased Radial Force Improves Stent Deployment in Tricuspid but Not in Bicuspid Stenotic Native Aortic Valves Ann. Thorac. Surg., March 1, 2010; 89(3): 768 - 772. [Abstract] [Full Text] [PDF]

				S. R. Kapadia, S. S. Goel, L. Svensson, E. Roselli, R. M. Savage, L. Wallace, S. Sola, P. Schoenhagen, M. H. Shishehbor, R. Christofferson, et al. Characterization and outcome of patients with severe symptomatic aortic stenosis referred for percutaneous aortic valve replacement. J. Thorac. Cardiovasc. Surg., June 1, 2009; 137(6): 1430 - 1435. [Abstract] [Full Text] [PDF]

				M. E. McRae, M. Rodger, and B. A. Bailey Transcatheter and Transapical Aortic Valve Replacement Crit. Care Nurse, February 1, 2009; 29(1): 22 - 36. [Full Text] [PDF]

				P. Lancellotti, T. Marwick, and L. A Pierard How to manage ischaemic mitral regurgitation Heart, November 1, 2008; 94(11): 1497 - 1502. [Full Text] [PDF]

				L. G. Svensson, T. Dewey, S. Kapadia, E. E. Roselli, A. Stewart, M. Williams, W. N. Anderson, D. Brown, M. Leon, B. Lytle, et al. United States Feasibility Study of Transcatheter Insertion of a Stented Aortic Valve by the Left Ventricular Apex Ann. Thorac. Surg., July 1, 2008; 86(1): 46 - 55. [Abstract] [Full Text] [PDF]

				T. K. Rosengart, T. Feldman, M. A. Borger, T. A. Vassiliades Jr, A. M. Gillinov, K. J. Hoercher, A. Vahanian, R. O. Bonow, and W. O'Neill Percutaneous and Minimally Invasive Valve Procedures: A Scientific Statement From the American Heart Association Council on Cardiovascular Surgery and Anesthesia, Council on Clinical Cardiology, Functional Genomics and Translational Biology Interdisciplinary Working Group, and Quality of Care and Outcomes Research Interdisciplinary Working Group Circulation, April 1, 2008; 117(13): 1750 - 1767. [Abstract] [Full Text] [PDF]

				R. F. Padera Jr. and F. J. Schoen Pathology of Cardiac Surgery Card. Surg. Adult, January 1, 2008; 3(2008): 111 - 178. [Full Text]

				D. R. Brinster, D. Unic, M. N. D'Ambra, N. Nathan, and L. H. Cohn Midterm Results of the Edge-to-Edge Technique for Complex Mitral Valve Repair. Ann. Thorac. Surg., May 1, 2006; 81(5): 1612 - 1617. [Abstract] [Full Text] [PDF]

				L. H. Cohn Percutaneous Mitral Valve Repair With the Edge-to-Edge Technique: A Surgeon's Perspective J. Am. Coll. Cardiol., December 6, 2005; 46(11): 2141 - 2142. [Full Text] [PDF]