Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. (Record no. 3320)

MARC details
000 -LEADER
fixed length control field 04144nam a22004337a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 170411s20162016 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 0195-668X
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 27190101
245 ## - TITLE STATEMENT
Title Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis.
251 ## - Source
Source European Heart Journal. 37(28):2252-62, 2016 Jul 21
252 ## - Abbreviated Source
Abbreviated source Eur Heart J. 37(28):2252-62, 2016 Jul 21
253 ## - Journal Name
Journal name European heart journal
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2016
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2017
266 ## - Date added to catalog
Date added to catalog 2017-05-24
501 ## - WITH NOTE
Local holdings Available online from MWHC library: 1996 - present (after 1 year), Available in print through MWHC library: 1999 - 2006
520 ## - SUMMARY, ETC.
Abstract AIMS: Based on randomized trials using first-generation devices, transcatheter aortic valve replacement (TAVR) is well established in the treatment of high-risk (HR) patients with severe aortic stenosis (AS). To date, there is a paucity of adjudicated, prospective data evaluating outcomes with newer generation devices and in lower risk patients. We report early outcomes of a large, multicentre registry of inoperable, HR, and intermediate-risk (IR) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV).
520 ## - SUMMARY, ETC.
Abstract CONCLUSIONS: The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation.
520 ## - SUMMARY, ETC.
Abstract Copyright Published on behalf of the European Society of Cardiology. All rights reserved. (c) The Author 2016. For permissions please email: [email protected].
520 ## - SUMMARY, ETC.
Abstract METHODS AND RESULTS: Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1078 IR) were enrolled in a multicentre, non-randomized registry at 57 sites in the USA and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1443, 86.9%) and transapical or transaortic (n = 218, 13.1%) access routes. The rate of 30-day all-cause mortality was 2.2% in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7%] and 1.1% in IR patients (mean STS score 5.3%); cardiovascular mortality was 1.4 and 0.9%, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9%, major bleeding 14.0%, major vascular complications 5.1%, and requirement for permanent pacemaker 13.3%. In IR patients, the 30-day rate of major/disabling stroke was 1.0%, major bleeding 10.6%, major vascular complications 6.1%, and requirement for permanent pacemaker 10.1%. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, P < 0.0001) and 54.7 to 74.0 (IR, P < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9% of patients, mild in 40.7%, moderate in 3.4%, and severe in 0.0%. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm(2).
520 ## - SUMMARY, ETC.
Abstract TRIAL REGISTRATION: ClinicalTrials.gov #NCT01314313.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Aortic Valve Stenosis
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Aortic Valve
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Canada
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Cardiac Catheterization
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Echocardiography
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 Prospective Studies
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 Treatment Outcome
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 Weissman, Neil J
790 ## - Authors
All authors Ayele GM, Babaliaros V, Blanke P, Eisenhauer AC, Greason KL, Guerrero M, Hahn RT, Herrmann HC, Kapadia S, Kereiakes DJ, Kodali S, Leipsic J, Leon MB, Lim S, Mack MJ, Makkar RR, Malaisrie SC, Pibarot P, Smith CR, Suri RM, Svensson LG, Szeto WY, Thourani VH, Webb JG, Weissman NJ, Whisenant BK, White J, Williams M
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1093/eurheartj/ehw112">https://dx.doi.org/10.1093/eurheartj/ehw112</a>
Public note https://dx.doi.org/10.1093/eurheartj/ehw112
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 05/24/2017   27190101 27190101 05/24/2017 05/24/2017 Journal Article

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