@article{3f54c7b7777340288ec58b792c9f74ed,
title = "Part II: Sealing holes in the safety net",
author = "Peterson, {Eric D.} and Hirshfeld, {John W.} and Ferguson, {T. Bruce} and Kramer, {Judith M.} and Califf, {Robert M.} and Kessler, {Larry G.}",
note = "Funding Information: Supported in part by an Agency for Healthcare Research and Quality (AHRQ) Centers for Education and Research on Therapeutics cooperative agreement (Grant # U18HS10548). Funding Information: An alternative method for monitoring device safety is exemplified by the TMR registry, cosponsored by the FDA and Society of Thoracic Surgeons (STS). The TMR registry was efficiently built upon the STS's existing national cardiothoracic database, which had already been collecting detailed patient demographics, risk factors, and data on acute outcomes of many cardiothoracic surgical procedures, including TMR. To that existing data source, sites performing TMR were asked to add a limited amount of TMR device-specific information (such as device type, technical details, and device-specific complications). Given these existing resources, the incremental costs for the registry's initiation and conduct were minimal and were able to be funded by a small grant from the FDA. To date, this registry has revealed important trends in both indicated and off-label uses of TMR as well as the acute risks and risk predictors of TMR. 16 ",
year = "2004",
month = jun,
doi = "10.1016/j.ahj.2004.03.002",
language = "English (US)",
volume = "147",
pages = "985--990",
journal = "American heart journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "6",
}