MARC details
| 000 -LEADER |
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| fixed length control field |
03558nam a22005177a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
170622s20162016 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
1774-024X |
| 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 |
27934611 |
| 245 ## - TITLE STATEMENT |
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| Title |
A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis. |
| 251 ## - Source |
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| Source |
Eurointervention. 12(11):e1413-e1419, 2016 Dec 10 |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
EuroIntervention. 12(11):e1413-e1419, 2016 Dec 10 |
| 253 ## - Journal Name |
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| Journal name |
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2016 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2017 |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2017-06-22 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
AIMS: Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
CONCLUSIONS: The DFM-TAVS was associated with good short-term outcomes in this real-world registry. The low pacemaker and aortic regurgitation rates confirm the advantages of this next-generation transcatheter heart valve (THV). |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
METHODS AND RESULTS: This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee. The primary endpoint was freedom from all-cause mortality at 30 days post procedure. Secondary endpoints included procedural, early safety and efficacy endpoints at 30 days. Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with the DFM-TAVS were enrolled in 21 European centres. The primary endpoint, freedom from all-cause mortality at 30 days, was met in 98% (245/250) of patients. Device success was 83.8%. Moderate or severe aortic regurgitation was reported in 3% of patients, and none/trace regurgitation in 73% of patients. Post-procedural permanent pacemaker implantation was performed in 30 patients (12.0%). |
| 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 |
*Aortic Valve/su [Surgery] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Transcatheter Aortic Valve Replacement |
| 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 |
Aortic Valve Insufficiency/et [Etiology] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Cardiac Catheterization |
| 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 |
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 |
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 |
Prospective Studies |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Registries |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Risk Factors |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Transcatheter Aortic Valve Replacement/mt [Methods] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Treatment Outcome |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Health Research Institute |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Clinical Trial |
| 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 |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Asch, Federico M |
| 790 ## - Authors |
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| All authors |
Asch F, Baumgartner H, Brueren G, Bruschi G, Butter C, Colombo A, De Marco F, Den Heijer P, Divchev D, Frambach P, Gatto F, Gilard M, Hink U, Ince H, Kische S, Kuck KH, Latib A, Lefevre T, Naber CK, Nickenig G, Pyxaras SA, Schillinger W, Schofer J, Scholtz S, Tchetche D, Van der Heyden J, Wagner D |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.4244/EIJ-D-15-00511">https://dx.doi.org/10.4244/EIJ-D-15-00511</a> |
| Public note |
https://dx.doi.org/10.4244/EIJ-D-15-00511 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
