title: Transcatheter Aortic Valve Implantation Compared With Surgical Aortic Valve Replacement in Low-Risk Patients.
abstract: BACKGROUND
  The proven efficacy of transcatheter aortic valve implantation (TAVI) in high-risk patients is leading to the expansion of its indications toward lower-risk patients. However, this shift is not supported by meaningful evidence of its benefit over surgical aortic valve replacement (SAVR). This analysis aims to describe outcomes of TAVI versus SAVR in low-risk patients.
  
  
  RESULTS
  We compared the outcome after TAVI and SAVR of low-risk patients (European System for Cardiac Operative Risk Evaluation II [EuroSCORE II] <4%) included in the Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment (OBSERVANT) study. The primary outcome was 3-year survival. Secondary outcomes were early events and major adverse cardiac and cerebrovascular events at 3 years. Propensity score matching resulted in 355 pairs of patients with similar baseline characteristics. Thirty-day survival was 97.1% after SAVR and 97.4% after TAVI (P=0.82). Cardiac tamponade, permanent pacemaker implantation, major vascular damage, and moderate-to-severe paravalvular regurgitation were significantly more frequent after TAVI compared with SAVR. Stroke rates were equal in the study groups. SAVR was associated with higher risk of cardiogenic shock, severe bleeding, and acute kidney injury. At 3 years, survival was 83.4% after SAVR and 72.0% after TAVI (P=0.0015), whereas freedom from major adverse cardiac and cerebrovascular events was 80.9% after SAVR and 67.3% after TAVI (P<0.001).
  
  
  CONCLUSIONS
  In patients with low operative risk, significantly better 3-year survival and freedom from major adverse cardiac and cerebrovascular events were observed after SAVR compared with TAVI. Further studies on new-generation valve prostheses are necessary before expanding indications of TAVI toward lower-risk patients.
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
authors.forename: Stefano
authors.initials: S
authors.lastname: Rosato
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
authors.forename: Francesco
authors.initials: F
authors.lastname: Santini
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
authors.forename: Marco
authors.initials: M
authors.lastname: Barbanti
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
authors.forename: Fausto
authors.initials: F
authors.lastname: Biancari
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.). paola.derrigo@iss.it.
authors.forename: Paola
authors.initials: P
authors.lastname: D'Errigo
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
authors.forename: Francesco
authors.initials: F
authors.lastname: Onorati
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
authors.forename: Marco
authors.initials: M
authors.lastname: Ranucci
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
authors.forename: Remo Daniel
authors.initials: RD
authors.lastname: Covello
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
authors.forename: Gennaro
authors.initials: G
authors.lastname: Santoro
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
authors.forename: Claudio
authors.initials: C
authors.lastname: Grossi
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
authors.forename: Martina
authors.initials: M
authors.lastname: Ventura
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
authors.forename: Danilo
authors.initials: D
authors.lastname: Fusco
authors.affiliation: From the National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy (S.R., P.D., F. Seccareccia); Division of Cardiac Surgery, IRCCS S Martino, University Hospital, Genova, Italy (F. Santini); Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., C.T.); Department of Surgery, Oulu University Hospital, Oulu, Finland (F.B.); Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy (F.O.); Department of Cardiothoracic and Vascular Anesthesia and ICU-IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (M.R.); Department of Anesthesia and Intensive Care, Ospedale di Busto Arsizio, Varese, Italy (R.D.C.); Division of Cardiology, Careggi Hospital, Florence, Italy (G.S.); Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy (C.G.); and Department of Epidemiology of Lazio Regional Health Service, Rome, Italy (M.V., D.F.).
authors.forename: Fulvia
authors.initials: F
authors.lastname: Seccareccia
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000628:therapy*; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D012306:Risk; D018570:Risk Assessment; D012307:Risk Factors; D016019:Survival Analysis; D065467:Transcatheter Aortic Valve Replacement; D016896:Treatment Outcome
keywords: EuroSCORE II; TAVI; TAVR; aortic valve replacement; aortic valve stenosis; low-risk; surgical