title: Transcatheter Aortic Valve Replacement Versus Surgery in Women at High Risk for Surgical Aortic Valve Replacement (from the CoreValve US High Risk Pivotal Trial).
abstract: The objective of this study was to compare outcomes in women after surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) using a self-expanding prosthesis in patients with severe aortic stenosis who were at high risk for SAVR. Although registries and meta-analyses have suggested that TAVR is of considerable benefit in women, perhaps even more so than in men, a rigorous evaluation of TAVR with a self-expanding valve versus SAVR in women from a randomized trial has not been performed. Patients with severe aortic stenosis were randomized 1:1 to either TAVR or SAVR. Outcomes at 1 year are reported. Treatment was attempted in a total of 353 women (183 TAVR and 170 SAVR). Baseline characteristics and predicted risk of the 2 groups were comparable, although the frequency of diabetes mellitus was lower in patients undergoing TAVR (33.3% vs 45.3%; p = 0.02). TAVR-treated patients experienced a statistically significant 1-year survival advantage compared with SAVR patients (12.7% vs 21.8%; p = 0.03). The composite all-cause mortality or major stroke rate also favored TAVR (14.9% vs 24.2%; p = 0.04). Quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire summary score, for both the TAVR and SAVR groups increased significantly from baseline to 1 year. In conclusion, female TAVR patients had lower 1-year mortality and lower 1-year all-cause mortality or major stroke compared with women undergoing SAVR, with both cohorts experiencing improved quality of life. Further studies specifically in women are warranted to validate these findings.
authors.affiliation: Department of Cardiology, Geisinger Health System, Danville, Pennsylvania. Electronic address: kaskelding@geisinger.edu.
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Skelding
authors.affiliation: Department of Cardiology, Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Yakubov
authors.affiliation: Department of Cardiology, Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas.
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.affiliation: Department of Cardiothoracic Surgery, Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texase.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
authors.affiliation: Department of Cardiothoracic Surgery, Mount Sinai Medical Center, New York, New York.
authors.forename: David H
authors.initials: DH
authors.lastname: Adams
authors.affiliation: Coronary and Structural Heart Department, Statistics, Medtronic, Mounds View, Minnesota.
authors.forename: Jian
authors.initials: J
authors.lastname: Huang
authors.affiliation: Department of Cardiology, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: John K
authors.initials: JK
authors.lastname: Forrest
authors.affiliation: Department of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D002423:Cause of Death; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods; D006801:Humans; D009026:Mortality; D011183:Postoperative Complications / Q000453:epidemiology*; D012306:Risk; D020521:Stroke / Q000453:epidemiology*; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome