title: Early and late (one year) outcomes following transcatheter aortic valve implantation in patients with severe aortic stenosis (from the United States REVIVAL trial).
abstract: Transcatheter aortic valve implantation (TAVI) with the Cribier-Edwards prosthesis may provide an alternative to conventional aortic valve replacement in high-risk patients with aortic stenosis. Previous studies have indicated that TAVI is feasible in this patient population. Transcatheter implantation of a Cribier-Edwards prosthesis was attempted in 55 patients in a United States Food and Drug Administration-approved prospective observational study. Clinical and echocardiographic outcomes were assessed in hospital and at 30 days, 6 months, and 12 months. Fifty-five patients (55% women, mean age 83 years) with a mean aortic valve area of 0.57 ± 0.14 cm(2) and a mean logistic European System for Cardiac Operative Risk Evaluation score of 33.5 ± 17.0% were enrolled. Transcatheter heart valves were implanted successfully in 48 patients (87%). Mean echocardiographic aortic valve area improved from 0.56 ± 0.14 to 1.6 ± 0.48 cm(2) after the procedure (p <0.0001). Thirty-day all-cause mortality and major adverse cardiac and cerebrovascular events were 7.3% and 20%, respectively. There were also 7 major procedural vascular complications (12.7%). Mortality and major adverse cardiac and cerebrovascular events increased to 23.6% and 32.7%, respectively, at 1 year, with most late events related to underlying co-morbidities. Mean New York Heart Association functional class improved from 3.22 ± 0.66 at baseline to 1.50 ± 0.85 at 1 year follow-up (p <0.001). In conclusion, TAVI in high-risk patients with aortic stenosis was feasible, with sustained clinical benefit at 12 months. Procedural complications and late major adverse cardiac and cerebrovascular events, however, overshadowed the overall clinical benefit of TAVI in this high-risk patient population.
authors.affiliation: Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York, USA. skodali@columbia.edu
authors.forename: Susheel K
authors.initials: SK
authors.lastname: Kodali
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.forename: Mathew
authors.initials: M
authors.lastname: Williams
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.forename: Murat
authors.initials: M
authors.lastname: Tuzcu
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.forename: Samir
authors.initials: S
authors.lastname: Kapadia
authors.forename: George
authors.initials: G
authors.lastname: Hanzel
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000401:mortality; D002423:Cause of Death; D004452:Echocardiography; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000401:mortality; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000000981:diagnostic imaging; D011183:Postoperative Complications / Q000000981:diagnostic imaging; D011446:Prospective Studies; D011474:Prosthesis Design