@article{bab25ec4ce594e038187cd82c27d3af4,
title = "Multisociety (AATS, ACCF, SCAI, and STS) expert consensus statement: Operator and institutional requirements for transcatheter valve repair and replacement",
author = "Tommaso, \{Carl L.\} and Bolman, \{R. Morton\} and Ted Feldman and Joseph Bavaria and Acker, \{Michael A.\} and Gabriel Aldea and Cameron, \{Duke E.\} and Dean, \{Larry S.\} and Dave Fullerton and Hijazi, \{Ziyad M.\} and Eric Horlick and Miller, \{D. Craig\} and Moon, \{Marc R.\} and Richard Ringel and Ruiz, \{Carlos E.\} and Alfredo Trento and Weiner, \{Bonnie H.\} and Zahn, \{Evan M.\}",
note = "Funding Information: The potential negative impact of a valve prosthesis recall, in regards to the increased risk associated with reoperative surgery for a permanent implant, far outweighs that associated with the removal of a pharmacologic agent from the market ( 34 ). Thus, the allocation of adequate funding to allow complete follow-up studies is essential, including financial support from industry, the FDA, National Institutes of Health, CMS, and professional societies, with scientific oversight distanced from industry and potential conflicts of interest. Postmarket surveillance governed solely by industry self-regulation can be of dubious value. In a 2005 editorial, Eugene Blackstone cautioned, “Industry has not developed a viable mechanism for dealing with {\textquoteleft}bad news,' the disclosure of which often leads to the demise of the company” ( 35 ). The Interagency Registry for Mechanically Assisted Circulatory Support exemplifies a potentially efficient model that could be emulated by professional societies for monitoring transcatheter inventions during the next decade, during which durability data will be generated ( 36 ). ",
year = "2012",
month = may,
day = "29",
doi = "10.1016/j.jacc.2012.02.016",
language = "English (US)",
volume = "59",
pages = "2028--2042",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier Inc.",
number = "22",
}