Bruno Mario Cesana, Manfredo Rambaldini, Michele De Bonis, Ottavio Alfieri, Gianluigi Bisleri, Claudio Muneretto, Juan Pablo Maureira, Maurizio Tespili, Carlo Savini, Lorenzo Di Bacco, Roberto Di Bartolomeo, François Laborde, Gianluca Folesani, Thierry Folliguet, Alberto Repossini, Muneretto, C, Alfieri, Ottavio, Cesana, Bm, Bisleri, G, DE BONIS, Michele, Di Bartolomeo, R, Savini, C, Folesani, G, Di Bacco, L, Rambaldini, M, Maureira, Jp, Laborde, F, Tespili, M, Repossini, A, and Folliguet, T.
Objective: We sought to investigate the clinical outcomes of patients with isolated severe aortic stenosis and an intermediate-to high-risk profile treated by means of conventional surgery (surgical aortic valve replacement), sutureless valve implantation, or transcatheter aortic valve replacement in a multicenter evaluation. Methods: Among 991 consecutive patients with isolated severe aortic stenosis and an intermediate- to high-risk profile (Society of Thoracic Surgeons score >4 and logistic European System for Cardiac Operative Risk Evaluation I >10), a propensity score analysis was performed on the basis of the therapeutic strategy: surgical aortic valve replacement (n = 204), sutureless valve implantation (n = 204), and transcatheter aortic valve replacement (n = 204). Primary end points were 30-day mortality and overall survival at 24-month follow-up; the secondary end point was survival free from a composite end point of major adverse cardiac events (defined as cardiac-related mortality, myocardial infarction, cerebrovascular accidents, and major hemorrhagic events) and periprosthetic regurgitation greater than 2. Results: Thirty-day mortality was significantly higher in the transcatheter aortic valve replacement group (surgical aortic valve replacement = 3.4% vs sutureless = 5.8% vs transcatheter aortic valve replacement = 9.8%; P = .005). The incidence of postprocedural was 3.9% in asurgical aortic valve replacement vs 9.8% in sutureless vs 14.7% in transcatheter aortic valve replacement (P < .001) and peripheral vascular complications occurred in 0% of surgicalaortic valve replacement vs 0% of sutureless vs 9.8% transcatheter aortic valve replacement (P < .001). At 24-month follow-up, overall survival (surgical aortic valve replacement = 91.3% +/- 2.4% vs sutureless = 94.9% +/- 2.1% vs transcatheter aortic valve replacement = 79.5% +/- 4.3%; P < .001) and survival free from the composite end point of major adverse cardiovascular events and periprosthetic regurgitation were significantly better in patients undergoing surgical aortic valve replacement and sutureless valve implantation than in patients undergoing transcatheter aortic valve replacement (surgical aortic valve replacement = 92.6% +/- 2.3% vs sutureless = 96% +/- 1.8% vs transcatheter aortic valve replacement = 77.1% +/- 4.2%; P < .001). Multivariate Cox regression analysis identified transcatheter aortic valve replacement as an independent risk factor for overall mortality hazard ratio (hazard ratio, 2.5; confidence interval, 1.1-4.2; P = .018). Conclusions: The use of transcatheter aortic valve replacement in patients with an intermediate-to high-risk profile was associated with a significantly higher incidence of peri-operative complications and decreased survival at shortand mid-term when compared with conventional surgery and sutureless valve implantation.