TY - JOUR
T1 - Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study
AU - Fischlein, Theodor
AU - Meuris, Bart
AU - Folliguet, Thierry
AU - Hakim-Meibodi, Kavous
AU - Misfeld, Martin
AU - Carrel, Thierry
AU - Zembala, Marian
AU - Cerutti, Elisa
AU - Asch, Federico M.
AU - Haverich, Axel
AU - CAVALIER Trial Investigators
AU - Zannis, Kostantinos
AU - Pfeiffer, Steffen
AU - Santarpino, Giuseppe
AU - Shrestha, Malakh
AU - Sarikouch, Samir
AU - Gummert, Jan F.
AU - Mohr, Friedrich W.
AU - Dohmen, Pascal
AU - Stalder, Mario
AU - Roost, Eva
AU - Filipiak, Krzysztof
AU - Niklewski, Tomasz
AU - Madonna, Francesco
AU - Roques, Xavier
AU - Flameng, Willem J.
AU - Laczkovics, Axel M. M.
AU - Bechtel, Matthias
AU - Prat, Alain G.
AU - Banfi, Carlo
AU - Dapunt, Otto E.
AU - Eichstaedt, Harald C.
AU - Harringer, Wolfgang
AU - Carstens-Fitz, Ulrike
AU - Spyt, Tom J.
AU - Wimmer-Greinecker, Jan Gerhard
AU - Machner, Matthias
AU - Tan, Erwin S. H.
AU - Casselman, Filip P. A.
AU - Yilmaz, Alaaddin
AU - Sonker, Uday
AU - Bleiziffer, Sabine
AU - Oberwalder, Peter J.
AU - Kocher, Alfred A.
AU - Seitelberger, Rainald
AU - Treede, Hendrik
AU - Conradi, Leonard
AU - Cocchieri, Riccardo
AU - de Mol, Bas
AU - Roussel, Jean-Christian
AU - Despins, Philippe
N1 - Funding Information: This work was supported by LivaNova . LivaNova funded all trial-related activities and participated in site selection, data monitoring, trial management, and statistical analysis. Publisher Copyright: © 2021 The American Association for Thoracic Surgery
PY - 2022
Y1 - 2022
N2 - Objective: The objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve. Methods: Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years. Results: The mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years. Conclusions: This series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance.
AB - Objective: The objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve. Methods: Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years. Results: The mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years. Conclusions: This series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance.
KW - clinical and hemodynamic outcomes
KW - multicenter study
KW - sutureless aortic valve
UR - http://www.scopus.com/inward/record.url?scp=85099650871&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.jtcvs.2020.12.109
DO - https://doi.org/10.1016/j.jtcvs.2020.12.109
M3 - Article
C2 - 33597099
SN - 0022-5223
VL - 164
SP - 1772-1780.e11
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 6
ER -