title: Three-Year Outcomes of Transcatheter Aortic Valve Implantation in Patients With Varying Levels of Surgical Risk (from the CoreValve ADVANCE Study).
abstract: This study compared 3-year clinical outcomes of patients who underwent transcatheter aortic valve implantation with the Society of Thoracic Surgeons (STS) score ≤7% to those of patients with a score >7%. Data were drawn from the ADVANCE study, a multinational post-market clinical trial that enrolled real-world patients with severe aortic stenosis treated with the CoreValve bioprosthesis. Events were independently adjudicated using Valve Academic Research Consortium-1 definitions. A total of 996 patients were implanted: STS ≤7% (n = 697, median STS 4.3%, interquartile range 3.1% to 5.4%) and STS >7% (n = 298, median STS 9.7%, interquartile range 8.0% to 12.4%). At 3 years, the STS ≤7% group had lower rates of all-cause mortality (28.6 vs 45.9, p <0.01) and cardiovascular mortality (19.0 vs 30.2, p <0.01) than the STS >7% group. No differences were observed in cerebrovascular accidents, vascular complications, bleeding, or myocardial infarction. In patients with STS ≤7%, mortality at 3 years was higher in those with moderate or severe aortic regurgitation (AR) at discharge than in those with mild or less AR (39.9% vs 22.9%; hazard ratio 1.98; 95% confidence interval 1.37 to 2.86; p <0.01). Conversely, the severity of AR at discharge did not affect 3-year mortality in patients with STS >7% (42.9% vs 44.6%, moderate/severe vs mild/less; hazard ratio 1.04; 95% confidence interval, 0.62 to 1.75; p = 0.861; p for interaction = 0.047). In conclusion, patients with STS ≤7% had lower rates of all-cause and cardiovascular mortality at 3 years after transcatheter aortic valve implantation. Complication rates were low and stable in both groups, demonstrating the safety of this procedure for patients at various levels of surgical risk.
authors.affiliation: Department of Cardiology, Ferrarotto Hospital, University of Catania, Italy. Electronic address: mbarbanti83@gmail.com.
authors.forename: Marco
authors.initials: M
authors.lastname: Barbanti
authors.affiliation: Department of Structural Heart Clinical Operations, Medtronic, Mounds View, Minnesota.
authors.forename: Molly
authors.initials: M
authors.lastname: Schiltgen
authors.affiliation: Department of Biostatistics, North American Sciences Associates, Inc., Minneapolis.
authors.forename: Sarah
authors.initials: S
authors.lastname: Verdoliva
authors.affiliation: Department of Cardiology, University Hospital Antwerp, Antwerp, Belgium.
authors.forename: Johan
authors.initials: J
authors.lastname: Bosmans
authors.affiliation: Department of Cardiovascular Surgery, German Heart Center, Technical University Munich, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Bleiziffer
authors.affiliation: Department of Cardiology, Gemeinschaftskrankenhaus, Bonn, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Gerckens
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Wenaweser
authors.affiliation: Department of Cardiology, St. George's Hospital, London, United Kingdom.
authors.forename: Stephen
authors.initials: S
authors.lastname: Brecker
authors.affiliation: Department of Cardiology, Ferrarotto Hospital, University of Catania, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Gulino
authors.affiliation: Department of Cardiology, Ferrarotto Hospital, University of Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.affiliation: Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery*; D001705:Bioprosthesis; D005260:Female; D005500:Follow-Up Studies; D014943:Global Health; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods* / Q000401:mortality; D016896:Treatment Outcome