Citation: Journal of the American College of Cardiology. 2018 Sep 17.Journal: Journal of the American College of Cardiology.Published: ; 2018ISSN: 0735-1097.Full author list: Sondergaard L; Rodes-Cabau J; Hans-Peter Linke A; Fichtlscherer S; Schafer U; Kuck KH; Kempfert J; Arzamendi D; Bedogni F; Asch FM; Worthley S; Maisano F.UI/PMID: 30261238.Subject(s): IN PROCESS -- NOT YET INDEXEDInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access onlineDigital Object Identifier: https://dx.doi.org/10.1016/j.jacc.2018.09.014 (Click here)Abbreviated citation: J Am Coll Cardiol. 2018 Sep 17.Local Holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007.Abstract: BACKGROUND: The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk.Abstract: OBJECTIVES: To report 1-year outcomes of transcatheter aortic valve replacement (TAVR) with new THV system.Abstract: METHODS: This ongoing, international, multicenter study evaluated patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access and follow-up at 30 days, 1 year and annually through 5 years. The primary endpoint is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated.Abstract: RESULTS: A total of 941 patients (82.4 +/- 5.9 years, 65.7% female, STS score: 5.8%) were enrolled and underwent an implant at 61 sites in Europe, Australia and Canada. At 1 year, Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates and myocardial infarction are 12.1%, 6.6%, 2.2% and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66mmHg and 1.75cm<sup>2</sup> respectively. Paravalvular leakage was moderate or higher in 2.6% of patients with no severe leakage. New pacemaker rates were 18.7% and 21.3% for pacemaker naive patients at 30 days and 1 year, respectively. Functional class, exercise capacity and quality of life improved significantly from baseline to 1 year.Abstract: CONCLUSION: Transcatheter aortic valve replacement with the new THV in patients at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant PVL.Abstract: Copyright (c) 2018. Published by Elsevier Inc.