MARC details
000 -LEADER |
fixed length control field |
05305nam a22008417a 4500 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
191105s20192019 xxu||||| |||| 00| 0 eng d |
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
International Standard Serial Number |
1936-8798 |
024 ## - OTHER STANDARD IDENTIFIER |
Standard number or code |
10.1016/j.jcin.2019.05.053 [doi] |
024 ## - OTHER STANDARD IDENTIFIER |
Standard number or code |
S1936-8798(19)31295-6 [pii] |
040 ## - CATALOGING SOURCE |
Original cataloging agency |
Ovid MEDLINE(R) |
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
PMID |
31629746 |
245 ## - TITLE STATEMENT |
Title |
Dedicated Closure Device for Transcaval Access Closure: From Concept to First-in-Human Testing. |
251 ## - Source |
Source |
Jacc: Cardiovascular Interventions. 12(21):2198-2206, 2019 11 11. |
252 ## - Abbreviated Source |
Abbreviated source |
JACC Cardiovasc Interv. 12(21):2198-2206, 2019 11 11. |
252 ## - Abbreviated Source |
Former abbreviated source |
JACC Cardiovasc Interv. 2019 Oct 11 |
253 ## - Journal Name |
Journal name |
JACC. Cardiovascular interventions |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Year |
2019 |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Manufacturer |
FY2020 |
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
Publication status |
aheadofprint |
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
Publication status |
ppublish |
266 ## - Date added to catalog |
Date added to catalog |
2019-11-05 |
268 ## - Previous citation |
-- |
Jacc: Cardiovascular Interventions. 2019 Oct 11 |
501 ## - WITH NOTE |
Local holdings |
Available online through MWHC library: 2008 - present |
520 ## - SUMMARY, ETC. |
Abstract |
BACKGROUND: Transcaval access enables delivery of large-caliber devices to the aorta in patients ineligible for transfemoral arterial access. Closure of aortocaval fistulae using off-label nitinol cardiac occluders has been shown to be safe, but persistent aortocaval fistulae at exit from the catheterization lab and bleeding complications were common in a prospective study. |
520 ## - SUMMARY, ETC. |
Abstract |
CONCLUSIONS: The TCD achieved complete closure of the transcaval access tract in most subjects at exit from the catheterization lab and essentially eliminated transcaval-related bleeding. Dedicated devices for transcaval access and closure could enable more widespread adoption of transcaval techniques without fear of bleeding complications. (Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement; NCT03432494). Copyright Published by Elsevier Inc. |
520 ## - SUMMARY, ETC. |
Abstract |
METHODS: Preclinical testing of the TCD was performed in 24 Yorkshire swine, including 10 under good laboratory practice conditions. Subsequently, subjects undergoing transcatheter aortic valve replacement for symptomatic severe aortic stenosis, ineligible for transfemoral arterial access, were enrolled in a U.S. Food and Drug Administration-approved early feasibility study of the TCD (Transmural Systems, Andover, Massachusetts). Independently adjudicated endpoints included technical, device, and procedural success, incorporating in-hospital and 30-day clinical and imaging follow-up. |
520 ## - SUMMARY, ETC. |
Abstract |
OBJECTIVES: The study sought to test safety and exploratory effectiveness of a dedicated transcaval closure device (TCD). |
520 ## - SUMMARY, ETC. |
Abstract |
RESULTS: Transcaval access and closure in swine confirmed that at 30 days, TCDs were almost entirely endothelialized. Subsequently, 12 subjects were enrolled in the early feasibility study. Transcaval access, transcatheter aortic valve replacement, and aortocaval fistula closure was successful in all 12 subjects. The primary endpoint of technical success was met in 100% of subjects. Complete closure of the transcaval access tract was achieved in 75% of subjects at exit from the catheterization lab and in 100% of subjects at 30 days. There were zero modified Valve Academic Research Consortium-2 major vascular complications and zero Valve Academic Research Consortium-2 life-threatening or major bleeding complications related to transcaval access or the TCD. |
546 ## - LANGUAGE NOTE |
Language note |
English |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Aortic Valve Stenosis/su [Surgery] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Catheterization, Peripheral |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Femoral Artery |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Hemorrhage/pc [Prevention & Control] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Hemostatic Techniques/is [Instrumentation] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Transcatheter Aortic Valve Replacement |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Vascular Closure Devices |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Venae Cavae |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Aged |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Aged, 80 and over |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Animals |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Aortic Valve Stenosis/dg [Diagnostic Imaging] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Catheterization, Peripheral/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Catheterization, Peripheral/is [Instrumentation] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Equipment Design |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Feasibility Studies |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Female |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Femoral Artery/dg [Diagnostic Imaging] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Hemorrhage/et [Etiology] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Hemostatic Techniques/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Humans |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Male |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Models, Animal |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Prospective Studies |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Punctures |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Risk Factors |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Sus scrofa |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Time Factors |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Transcatheter Aortic Valve Replacement/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Transcatheter Aortic Valve Replacement/is [Instrumentation] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Treatment Outcome |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
United States |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Venae Cavae/dg [Diagnostic Imaging] |
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
Institution |
MedStar Heart & Vascular Institute |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Journal Article |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Babaliaros, Vasilis C |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Khan, Jaffar M |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Rogers, Toby |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Satler, Lowell F |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Waksman, Ron |
790 ## - Authors |
All authors |
Babaliaros VC, Chen MY, Eng MH, Greenbaum AB, Khan JM, Lederman RJ, Leshnower BG, Paone G, Rogers T, Satler LF, Schenke WH, Stine AM, Waksman R |
856 ## - ELECTRONIC LOCATION AND ACCESS |
DOI |
<a href="https://dx.doi.org/10.1016/j.jcin.2019.05.053">https://dx.doi.org/10.1016/j.jcin.2019.05.053</a> |
Public note |
https://dx.doi.org/10.1016/j.jcin.2019.05.053 |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Koha item type |
Journal Article |
Item type description |
Article |