OBJECTIVES: The aim of this study was to provide predictive data on the performance of the Freestyle stentless bioprosthesis that can be used to support and improve the shared decision-making process of prosthetic valve choice for aortic valve replacement. METHODS: Between 1993 and 2014, 604 patients received the Freestyle stentless bioprosthesis (143 subcoronary, 58 root inclusion and 403 full-root replacement). Perioperative data were collected retrospectively, and follow-up data were collected prospectively from 2015. Follow-up was 96% complete (median 4.3 years), with 114 (19%) patients having a follow-up period exceeding 10 years. A competing risks regression model was developed to predict the probability of mortality, structural valve deterioration (SVD) and reoperation for other causes than SVD. RESULTS: The median age of patients was 64 years, 91 (15%) patients had undergone previous aortic valve replacement and 351 (58%) underwent concomitant procedures. The 15-year probability of SVD, reoperation for other causes and death were 16.9%, 8.1% and 47.7%, respectively. Linearized occurrence rates for prosthesis endocarditis, thromboembolic events and bleeding were 0.5%, 0.9% and 0.1% per patient-year, respectively. The constructed predictive model, including age, renal function and implantation technique as significant covariates, had good to fair predictive performance up to 19 years. CONCLUSIONS: The Freestyle stentless bioprosthesis is an efficient prosthesis for aortic valve replacement or root replacement, with low incidences of SVD and valve-related events at long-term follow-up. The predictive model designed in this study can be used to fully inform patients about their expected individual trajectory after implantation of this prosthesis. This improves the shared decision-making process between patients and clinicians.
OBJECTIVES: The aim of this study was to provide predictive data on the performance of the Freestyle stentless bioprosthesis that can be used to support and improve the shared decision-making process of prosthetic valve choice for aortic valve replacement. METHODS: Between 1993 and 2014, 604 patients received the Freestyle stentless bioprosthesis (143 subcoronary, 58 root inclusion and 403 full-root replacement). Perioperative data were collected retrospectively, and follow-up data were collected prospectively from 2015. Follow-up was 96% complete (median 4.3 years), with 114 (19%) patients having a follow-up period exceeding 10 years. A competing risks regression model was developed to predict the probability of mortality, structural valve deterioration (SVD) and reoperation for other causes than SVD. RESULTS: The median age of patients was 64 years, 91 (15%) patients had undergone previous aortic valve replacement and 351 (58%) underwent concomitant procedures. The 15-year probability of SVD, reoperation for other causes and death were 16.9%, 8.1% and 47.7%, respectively. Linearized occurrence rates for prosthesis endocarditis, thromboembolic events and bleeding were 0.5%, 0.9% and 0.1% per patient-year, respectively. The constructed predictive model, including age, renal function and implantation technique as significant covariates, had good to fair predictive performance up to 19 years. CONCLUSIONS: The Freestyle stentless bioprosthesis is an efficient prosthesis for aortic valve replacement or root replacement, with low incidences of SVD and valve-related events at long-term follow-up. The predictive model designed in this study can be used to fully inform patients about their expected individual trajectory after implantation of this prosthesis. This improves the shared decision-making process between patients and clinicians.
Authors: Bo Yang; Aroosa Malik; Linda Farhat; Alexander Makkinejad; Elizabeth L Norton; Mohamed-Ali Sareini; Emma St Pierre; Xiaoting Wu; Jonathan Haft; Matthew Romano; Steven F Bolling; Himanshu J Patel; G Michael Deeb Journal: Ann Thorac Surg Date: 2019-12-23 Impact factor: 4.330
Authors: Adriaan W Schneider; Mark G Hazekamp; Michel I M Versteegh; Arend de Weger; Eduard R Holman; Robert J M Klautz; Eline F Bruggemans; Jerry Braun Journal: Eur J Cardiothorac Surg Date: 2019-12-01 Impact factor: 4.191
Authors: Bart Scheenstra; Anouk M A Princée; Maike S V Imkamp; Bas Kietselaer; Yuri M Ganushchak; Arnoud W J Van't Hof; Jos G Maessen Journal: Eur J Cardiothorac Surg Date: 2021-12-27 Impact factor: 4.191