000			05100nam a22006137a 4500
008			190621s20192019 xxu||||| |||| 00| 0 eng d
022			_a0098-7484
024			_a10.1001/jama.2019.7108 [doi]
024			_a2735503 [pii]
040			_aOvid MEDLINE(R)
099			_a31184741
245			_aAssociation Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke.
251			_aJAMA. 321(22):2193-2202, 2019 06 11.
252			_aJAMA. 321(22):2193-2202, 2019 06 11.
253			_aJAMA
260			_c2019
260			_fFY2019
265			_sppublish
266			_d2019-06-21
501			_aAvailable online from MWHC library: 1998 - present, Available in print through MWHC library: 1999 - present
520			_aConclusions and Relevance: In this preliminary, registry-based study of propensity-matched patients who had undergone transcatheter aortic valve replacement for aortic stenosis, patients with bicuspid vs tricuspid aortic stenosis had no significant difference in 30-day or 1-year mortality but had increased 30-day risk for stroke. Because of the potential for selection bias and the absence of a control group treated surgically for bicuspid stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis.
520			_aDesign, Setting, and Participants: Registry-based prospective cohort study of patients undergoing TAVR at 552 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies Registry from June 2015 to November 2018.
520			_aExposures: TAVR for bicuspid vs tricuspid aortic stenosis.
520			_aImportance: Transcatheter aortic valve replacement (TAVR) indications are expanding, leading to an increasing number of patients with bicuspid aortic stenosis undergoing TAVR. Pivotal randomized trials conducted to obtain US Food and Drug Administration approval excluded bicuspid anatomy.
520			_aMain Outcomes and Measures: Primary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications, valve hemodynamics, and quality of life assessment.
520			_aObjective: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis.
520			_aResults: Of 81822 consecutive patients with aortic stenosis (2726 bicuspid; 79096 tricuspid), 2691 propensity-score matched pairs of bicuspid and tricuspid aortic stenosis were analyzed (median age, 74 years [interquartile range {IQR}, 66-81 years]; 39.1%, women; mean [SD] STS-predicted risk of mortality, 4.9% [4.0%] and 5.1% [4.2%], respectively). All-cause mortality was not significantly different between patients with bicuspid and tricuspid aortic stenosis at 30 days (2.6% vs 2.5%; hazard ratio [HR], 1.04, [95% CI, 0.74-1.47]) and 1 year (10.5% vs 12.0%; HR, 0.90 [95% CI, 0.73-1.10]). The 30-day stroke rate was significantly higher for bicuspid vs tricuspid aortic stenosis (2.5% vs 1.6%; HR, 1.57 [95% CI, 1.06-2.33]). The risk of procedural complications requiring open heart surgery was significantly higher in the bicuspid vs tricuspid cohort (0.9% vs 0.4%, respectively; absolute risk difference [RD], 0.5% [95% CI, 0%-0.9%]). There were no significant differences in valve hemodynamics. There were no significant differences in moderate or severe paravalvular leak at 30 days (2.0% vs 2.4%; absolute RD, 0.3% [95% CI, -1.3% to 0.7%]) and 1 year (3.2% vs 2.5%; absolute RD, 0.7% [95% CI, -1.3% to 2.7%]). At 1 year there was no significant difference in improvement in quality of life between the groups (difference in improvement in the Kansas City Cardiomyopathy Questionnaire overall summary score, -2.4 [95% CI, -5.1 to 0.3]; P = .08).
546			_aEnglish
650			_a*Aortic Valve Stenosis/su [Surgery]
650			_a*Aortic Valve/ab [Abnormalities]
650			_a*Stroke/et [Etiology]
650			_a*Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
650			_a*Transcatheter Aortic Valve Replacement/mo [Mortality]
650			_aAged
650			_aAged, 80 and over
650			_aAortic Valve/su [Surgery]
650			_aFemale
650			_aHumans
650			_aKaplan-Meier Estimate
650			_aMale
650			_aMiddle Aged
650			_aPostoperative Complications/mo [Mortality]
650			_aPropensity Score
650			_aProspective Studies
650			_aRegistries
650			_aRisk
651			_aMedStar Heart & Vascular Institute
657			_aJournal Article
657			_aResearch Support, Non-U.S. Gov't
700			_aThourani, Vinod H
790			_aBabaliaros V, Chakravarty T, Cheng W, Kaneko T, Kapadia SR, Kodali S, Leon MB, Mack MJ, Makkar RR, Rinaldi M, Shah PB, Skipper ER, Tang GHL, Thourani VH, Trento A, Vemulapalli S, Yoon SH
856			_uhttps://dx.doi.org/10.1001/jama.2019.7108 _zhttps://dx.doi.org/10.1001/jama.2019.7108
942			_cART _dArticle
999			_c4411 _d4411