MARC details
| 000 -LEADER |
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| fixed length control field |
03914nam a22005897a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
140821s20142014 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
0735-1097 |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
24211506 |
| 245 ## - TITLE STATEMENT |
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| Title |
Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve. |
| 251 ## - Source |
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| Source |
Journal of the American College of Cardiology. 63(8):763-8, 2014 Mar 4. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
J Am Coll Cardiol. 63(8):763-8, 2014 Mar 4. |
| 253 ## - Journal Name |
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| Journal name |
Journal of the American College of Cardiology |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2014 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2014 |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2014-08-21 |
| 501 ## - WITH NOTE |
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| Local holdings |
Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
BACKGROUND: The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance prior to permanent implantation. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
CONCLUSIONS: The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients. Copyright 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
METHODS: One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint. There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium (VARC) criteria. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
OBJECTIVES: The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical (DFM) system for the treatment of severe aortic stenosis. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
RESULTS: There was 99% freedom from all cause mortality at 30 days (primary endpoint). VARC criteria defined 30 day combined freedom from patient safety event rate was 91% and overall device success was 93%. The post-implantation echocardiography results demonstrated mild or no aortic regurgitation in 99% (73 of 74) with a mean gradient of 12.6 + 7.1 mm Hg (n = 72) and effective orifice area of 1.50 + 0.56 cm(2) and New York Heart Association functional class was I or II in 92% of cases. |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Aortic Valve Stenosis/su [Surgery] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Cardiac Catheterization/mt [Methods] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Heart Valve Prosthesis |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Heart Valve Prosthesis Implantation/mt [Methods] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Aged |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Aged, 80 and over |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Animals |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Aortic Valve Stenosis/di [Diagnosis] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Aortic Valve/pa [Pathology] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Aortic Valve/su [Surgery] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Cardiac Catheterization/is [Instrumentation] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Cattle |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Cohort Studies |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Female |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Follow-Up Studies |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Heart Valve Prosthesis Implantation/is [Instrumentation] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Male |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Middle Aged |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Prospective Studies |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Heart & Vascular Institute |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Multicenter Study |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Research Support, Non-U.S. Gov't |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Weissman, Neil J |
| 790 ## - Authors |
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| All authors |
Bijuklic K, Bruschi G, Colombo A, Davidson C, DeMarco F, Fajadet J, Friedrich I, Grube E, Hauptmann KE, Klugmann S, Latib A, Lauterbach M, Lefevre T, Low R, Maisano F, Mullen M, Nickenig G, Redwood S, Schmoeckel M, Schofer J, Sinning JM, Tchetche D, Thomas M, Weissman N, Yap J, Young C |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="http://dx.doi.org/10.1016/j.jacc.2013.10.013">http://dx.doi.org/10.1016/j.jacc.2013.10.013</a> |
| Public note |
http://dx.doi.org/10.1016/j.jacc.2013.10.013 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
