000			04144nam a22004337a 4500
008			170411s20162016 xxu||||| |||| 00| 0 eng d
022			_a0195-668X
040			_aOvid MEDLINE(R)
099			_a27190101
245			_aEarly clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis.
251			_aEuropean Heart Journal. 37(28):2252-62, 2016 Jul 21
252			_aEur Heart J. 37(28):2252-62, 2016 Jul 21
253			_aEuropean heart journal
260			_c2016
260			_fFY2017
266			_d2017-05-24
501			_aAvailable online from MWHC library: 1996 - present (after 1 year), Available in print through MWHC library: 1999 - 2006
520			_aAIMS: 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			_aCONCLUSIONS: 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			_aCopyright Published on behalf of the European Society of Cardiology. All rights reserved. (c) The Author 2016. For permissions please email: [email protected].
520			_aMETHODS 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			_aTRIAL REGISTRATION: ClinicalTrials.gov #NCT01314313.
546			_aEnglish
650			_a*Aortic Valve Stenosis
650			_aAortic Valve
650			_aCanada
650			_aCardiac Catheterization
650			_aEchocardiography
650			_aHumans
650			_aProspective Studies
650			_aTranscatheter Aortic Valve Replacement
650			_aTreatment Outcome
651			_aMedStar Heart & Vascular Institute
657			_aJournal Article
700			_aWeissman, Neil J
790			_aAyele 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			_uhttps://dx.doi.org/10.1093/eurheartj/ehw112 _zhttps://dx.doi.org/10.1093/eurheartj/ehw112
942			_cART _dArticle
999			_c3320 _d3320