MARC details
000 -LEADER |
fixed length control field |
10477nam a22007097a 4500 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
210218s20212021 xxu||||| |||| 00| 0 eng d |
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
International Standard Serial Number |
1522-1946 |
024 ## - OTHER STANDARD IDENTIFIER |
Standard number or code |
10.1002/ccd.29501 [doi] |
040 ## - CATALOGING SOURCE |
Original cataloging agency |
Ovid MEDLINE(R) |
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
PMID |
33539651 |
245 ## - TITLE STATEMENT |
Title |
Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience. |
251 ## - Source |
Source |
Catheterization & Cardiovascular Interventions. 98(3):572-577, 2021 09. |
252 ## - Abbreviated Source |
Abbreviated source |
Catheter Cardiovasc Interv. 98(3):572-577, 2021 09. |
252 ## - Abbreviated Source |
Former abbreviated source |
Catheter Cardiovasc Interv. 2021 Feb 04 |
253 ## - Journal Name |
Journal name |
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Year |
2021 |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Manufacturer |
FY2022 |
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 |
2021-02-18 |
268 ## - Previous citation |
-- |
Catheterization & Cardiovascular Interventions. 2021 Feb 04 |
269 ## - Original dates |
Original fiscal year |
FY2021 |
501 ## - WITH NOTE |
Local holdings |
Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006 |
520 ## - SUMMARY, ETC. |
Abstract |
BACKGROUND: Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited. |
520 ## - SUMMARY, ETC. |
Abstract |
CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices. Copyright (c) 2021 Wiley Periodicals LLC. |
520 ## - SUMMARY, ETC. |
Abstract |
METHODS: Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports. |
520 ## - SUMMARY, ETC. |
Abstract |
OBJECTIVES: We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott). |
520 ## - SUMMARY, ETC. |
Abstract |
RESULTS: Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group. |
546 ## - LANGUAGE NOTE |
Language note |
English |
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 |
Femoral Artery/su [Surgery] |
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 |
Sutures |
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 |
United States Food and Drug Administration |
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 |
Ben-Dor, Itsik |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Bernardo, Nelson L |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Case, Brian Christopher |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Chen, Yuefeng |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Chezar-Azerrad, Chava |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Forrestal, Brian John |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Hashim, Hayder |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Khalid, Nauman |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Khan, Jaffar M |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Musallam, Anees |
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 |
Shlofmitz, Evan |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Waksman, Ron |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Yerasi, Charan Teja Reddy |
790 ## - Authors |
All authors |
Ben-Dor I, Bernardo NL, Case BC, Chen Y, Chezar-Azerrad C, Forrestal BJ, Hashim H, Khalid N, Khan JM, Kumar S, Musallam A, Rogers T, Satler LF, Shlofmitz E, Waksman R, Yerasi C |
856 ## - ELECTRONIC LOCATION AND ACCESS |
DOI |
<a href="https://dx.doi.org/10.1002/ccd.29501">https://dx.doi.org/10.1002/ccd.29501</a> |
Public note |
https://dx.doi.org/10.1002/ccd.29501 |
858 ## - ORCID |
ORCID text |
Khalid, Nauman |
-- |
Khan, Jaffar M |
-- |
Satler, Lowell F |
-- |
Shlofmitz, Evan |
-- |
Waksman, Ron |
Orcid |
<a href="https://orcid.org/0000-0003-4159-555X">https://orcid.org/0000-0003-4159-555X</a> |
-- |
<a href="https://orcid.org/0000-0001-6099-0753">https://orcid.org/0000-0001-6099-0753</a> |
-- |
<a href="https://orcid.org/0000-0001-6446-2683">https://orcid.org/0000-0001-6446-2683</a> |
-- |
<a href="https://orcid.org/0000-0002-0907-5258">https://orcid.org/0000-0002-0907-5258</a> |
-- |
<a href="https://orcid.org/0000-0002-4063-9226">https://orcid.org/0000-0002-4063-9226</a> |
Name |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
858 ## - ORCID |
ORCID text |
Khalid, Nauman |
-- |
Khan, Jaffar M |
-- |
Satler, Lowell F |
-- |
Shlofmitz, Evan |
-- |
Waksman, Ron |
Orcid |
<a href="https://orcid.org/0000-0003-4159-555X">https://orcid.org/0000-0003-4159-555X</a> |
-- |
<a href="https://orcid.org/0000-0001-6099-0753">https://orcid.org/0000-0001-6099-0753</a> |
-- |
<a href="https://orcid.org/0000-0001-6446-2683">https://orcid.org/0000-0001-6446-2683</a> |
-- |
<a href="https://orcid.org/0000-0002-0907-5258">https://orcid.org/0000-0002-0907-5258</a> |
-- |
<a href="https://orcid.org/0000-0002-4063-9226">https://orcid.org/0000-0002-4063-9226</a> |
Name |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
858 ## - ORCID |
ORCID text |
Khalid, Nauman |
-- |
Khan, Jaffar M |
-- |
Satler, Lowell F |
-- |
Shlofmitz, Evan |
-- |
Waksman, Ron |
Orcid |
<a href="https://orcid.org/0000-0003-4159-555X">https://orcid.org/0000-0003-4159-555X</a> |
-- |
<a href="https://orcid.org/0000-0001-6099-0753">https://orcid.org/0000-0001-6099-0753</a> |
-- |
<a href="https://orcid.org/0000-0001-6446-2683">https://orcid.org/0000-0001-6446-2683</a> |
-- |
<a href="https://orcid.org/0000-0002-0907-5258">https://orcid.org/0000-0002-0907-5258</a> |
-- |
<a href="https://orcid.org/0000-0002-4063-9226">https://orcid.org/0000-0002-4063-9226</a> |
Name |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
858 ## - ORCID |
ORCID text |
Khalid, Nauman |
-- |
Khan, Jaffar M |
-- |
Satler, Lowell F |
-- |
Shlofmitz, Evan |
-- |
Waksman, Ron |
Orcid |
<a href="https://orcid.org/0000-0003-4159-555X">https://orcid.org/0000-0003-4159-555X</a> |
-- |
<a href="https://orcid.org/0000-0001-6099-0753">https://orcid.org/0000-0001-6099-0753</a> |
-- |
<a href="https://orcid.org/0000-0001-6446-2683">https://orcid.org/0000-0001-6446-2683</a> |
-- |
<a href="https://orcid.org/0000-0002-0907-5258">https://orcid.org/0000-0002-0907-5258</a> |
-- |
<a href="https://orcid.org/0000-0002-4063-9226">https://orcid.org/0000-0002-4063-9226</a> |
Name |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
858 ## - ORCID |
ORCID text |
Khalid, Nauman |
-- |
Khan, Jaffar M |
-- |
Satler, Lowell F |
-- |
Shlofmitz, Evan |
-- |
Waksman, Ron |
Orcid |
<a href="https://orcid.org/0000-0003-4159-555X">https://orcid.org/0000-0003-4159-555X</a> |
-- |
<a href="https://orcid.org/0000-0001-6099-0753">https://orcid.org/0000-0001-6099-0753</a> |
-- |
<a href="https://orcid.org/0000-0001-6446-2683">https://orcid.org/0000-0001-6446-2683</a> |
-- |
<a href="https://orcid.org/0000-0002-0907-5258">https://orcid.org/0000-0002-0907-5258</a> |
-- |
<a href="https://orcid.org/0000-0002-4063-9226">https://orcid.org/0000-0002-4063-9226</a> |
Name |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
-- |
https://orcid.org/0000-0003-4159-555X |
-- |
https://orcid.org/0000-0001-6099-0753 |
-- |
https://orcid.org/0000-0001-6446-2683 |
-- |
https://orcid.org/0000-0002-0907-5258 |
-- |
https://orcid.org/0000-0002-4063-9226 |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Koha item type |
Journal Article |
Item type description |
Article |