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Circ Cardiovasc Interv. 2016 May;9(5):e003326. doi: 10.1161/CIRCINTERVENTIONS.115.003326.

Transcatheter Aortic Valve Implantation Compared With Surgical Aortic Valve Replacement in Low-Risk Patients.

Author information

1
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.).
2
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.

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.

METHODS AND 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.

KEYWORDS:

EuroSCORE II; TAVI; TAVR; aortic valve replacement; aortic valve stenosis; low-risk; surgical

[Indexed for MEDLINE]

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