Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database

Cardiovascular Revascularization Medicine - Tập 20 - Trang 507-512 - 2019
Evan Shlofmitz1, Hector M. Garcia-Garcia1, Toby Rogers1,2, Nauman Khalid1, Yuefeng Chen1, Alexandre H. Kajita1, Jaffar M. Khan1,2, Micaela Iantorno1, Robert A. Gallino1, Nelson L. Bernardo1, Hayder Hashim1, Rebecca Torguson1, Ron Waksman1
1Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
2Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD, United States of America

Tài liệu tham khảo

Kuku, 2018, Optical coherence tomography-guided percutaneous coronary intervention compared with other imaging guidance: a meta-analysis, Int J Cardiovasc Imaging, 34, 503, 10.1007/s10554-017-1272-2 Smilowitz, 2018, Impact and trends of intravascular imaging in diagnostic coronary angiography and percutaneous coronary intervention in inpatients in the United States, Catheter Cardiovasc Interv, 92, E410, 10.1002/ccd.27673 Jones, 2018, Angiography alone versus angiography plus optical coherence tomography to guide percutaneous coronary intervention: outcomes from the pan-London PCI cohort, JACC Cardiovasc Interv, 11, 1313, 10.1016/j.jcin.2018.01.274 Barlis, 2009, A multicentre evaluation of the safety of intracoronary optical coherence tomography, EuroIntervention, 5, 90, 10.4244/EIJV5I1A14 Takarada, 2010, Advantage of next-generation frequency-domain optical coherence tomography compared with conventional time-domain system in the assessment of coronary lesion, Catheter Cardiovasc Interv, 75, 202, 10.1002/ccd.22273 Lehtinen, 2013, Feasibility and safety of frequency-domain optical coherence tomography for coronary artery evaluation: a single-center study, Int J Cardiovasc Imaging, 29, 997, 10.1007/s10554-013-0196-8 Manufacturer and User Facility Device Experience (MAUDE) database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm [accessed August 28, 2018]. FDA ILUMIEN OPTIS with DF OPTIS Catheter 510(k) Summary and IFU response. https://www.accessdata.fda.gov/cdrh_docs/pdf14/K141453.pdf [accessed September 4, 2018]. Ensign LG, Cohen KB. A Primer to the Structure, Content and Linkage of the FDA's Manufacturer and User Facility Device Experience (MAUDE) Files. EGEMS (Wash DC). 2017 Jun 14;5(1):12. Khalid, 2019 Chen, 2019, Adverse events associated with the use of guide extension catheters during percutaneous coronary intervention: reports from the manufacturer and user facility device experience (MAUDE) database, Cardiovasc Revasc Med, 10.1016/j.carrev.2019.02.016 Omar, 2016, Review: stent fracture in the drug-eluting stent era, Cardiovasc Revasc Med, 17, 404, 10.1016/j.carrev.2016.06.002 Nebeker, 2006, Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) project, J Am Coll Cardiol, 47, 175, 10.1016/j.jacc.2005.07.071 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141453 [accessed October 1, 2018]. Koyama, 2014, Periprocedural myocardial injury and right bundle branch block during coronary optical coherence tomography in an acute coronary syndrome patient with severe coronary ectasia, Int J Cardiol, 177, 1113, 10.1016/j.ijcard.2014.08.082 Imola, 2010, Safety and feasibility of frequency domain optical coherence tomography to guide decision making in percutaneous coronary intervention, EuroIntervention, 6, 575, 10.4244/EIJV6I5A97 van der Sijde, 2017, Safety of optical coherence tomography in daily practice: a comparison with intravascular ultrasound, Eur Heart J Cardiovasc Imaging, 18, 467 Ulrich, 2017, Safety of optical coherence tomography in pediatric heart transplant patients, Int J Cardiol, 228, 205, 10.1016/j.ijcard.2016.11.109 Ali, 2016, Stone GW; ILUMIEN III: OPTIMIZE PCI investigators. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial, Lancet, 388, 2618, 10.1016/S0140-6736(16)31922-5 Kubo, 2017, Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results, Eur Heart J, 38, 3139, 10.1093/eurheartj/ehx351 Rao, 2008, Postmarket evaluation of breakthrough technologies, Am Heart J, 156, 201, 10.1016/j.ahj.2008.01.036 Al-Lamee, 2018, Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial, Lancet, 391, 31, 10.1016/S0140-6736(17)32714-9 OPTIS™ Software Instructions for Use Version E.4.1 Released Date: 2017.01.18. https://manuals.sjm.com/Search-Form?re=North-America&cc=US&ln=EN&fam=01246feb-5d00-407c-8f4c-f86b3d1ae677&cat=4733416f-6baa-4967-9680-f546d6cacd26&seg=5b42b09e-941f-418b-a8da-621d741b012b&ipp=10 [accessed September 4, 2018]. Fujino, 2018, A new optical coherence tomography-based calcium scoring system to predict stent underexpansion, EuroIntervention, 13, e2182, 10.4244/EIJ-D-17-00962 Shlofmitz, 2018, Algorithmic approach for optical coherence tomography-guided stent implantation during percutaneous coronary intervention, Interv Cardiol Clin, 7, 329 Räber, 2018, Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions, EuroIntervention, 14, 656, 10.4244/EIJY18M06_01 Tearney, 2012, J Am Coll Cardiol, 59, 1058, 10.1016/j.jacc.2011.09.079