title: Transcatheter Aortic Valve Replacement in Women Versus Men (from the US CoreValve Trials).
abstract: Treatment for severe symptomatic aortic stenosis has changed significantly in recent years due to advances in transcatheter aortic valve replacement (TAVR). Recent studies with the CoreValve prosthesis have demonstrated superior results compared with surgical aortic valve replacement in patients at increased risk for surgery, but there are limited data on gender-related differences in patient characteristics and outcomes with this device. We compared baseline characteristics and clinical outcomes in women and men undergoing TAVR with the CoreValve prosthesis. A total of 3,687 patients (1,708 women and 1,979 men) were included. At baseline, women tended to be slightly older and to have increased frailty, but they had fewer cardiac co-morbidities, higher left ventricular systolic function, less coronary artery disease, and fewer previous strokes. All-cause mortality was 5.9% for women and 5.8% for men at 30 days (p = 0.87) and 24.1% and 21.3%, respectively, at 1 year (p = 0.08). The incidence of stroke was 5.7% in women and 4.0% in men at 30 days (p = 0.02) and 9.3% and 7.7%, respectively, at 1 year (p = 0.05). Women had a higher incidence of bleeding, including more life-threatening bleeds, and a greater incidence of major vascular complications than men at 30 days. Device success was achieved in 86.9% of women and 86.1% of men (p = 0.50). In conclusion, although there were significant baseline differences and procedure-related complications between women and men undergoing TAVR with the CoreValve prosthesis, this analysis found no significant difference in 30-day or 1-year mortality.
authors.affiliation: Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut. Electronic address: john.k.forrest@yale.edu.
authors.forename: John K
authors.initials: JK
authors.lastname: Forrest
authors.affiliation: Department of Cardiovascular Surgery, Mount Sinai Health System, New York, New York.
authors.forename: David H
authors.initials: DH
authors.lastname: Adams
authors.affiliation: Cardiovascular Division, Department of Internal Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.affiliation: Department of Cardiac Surgery, Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
authors.affiliation: Department of Surgery, University of Michigan Medical Center, Ann Arbor, Michigan.
authors.forename: G Michael
authors.initials: GM
authors.lastname: Deeb
authors.affiliation: Department of Cardiology, Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Yakubov
authors.affiliation: Department of Cardiovascular Disease, St. Vincent Medical Center, Indianapolis, Indiana.
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.affiliation: Department of Statistical Services, Medtronic, Mounds View, Minnesota.
authors.forename: Jian
authors.initials: J
authors.lastname: Huang
authors.affiliation: Department of Cardiology, Geisinger Medical Center, Danville, Pennsylvania.
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Skelding
authors.affiliation: Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Lansky
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000453:epidemiology / Q000601:surgery*; D002423:Cause of Death; D015897:Comorbidity; D005260:Female; D016330:Frail Elderly; D006801:Humans; D015994:Incidence; D008297:Male; D009026:Mortality; D011183:Postoperative Complications / Q000453:epidemiology*; D019106:Postoperative Hemorrhage / Q000453:epidemiology; D012720:Severity of Illness Index; D012737:Sex Factors; D020521:Stroke / Q000453:epidemiology*; D065467:Transcatheter Aortic Valve Replacement; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000453:epidemiology