title: A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis.
abstract: BACKGROUND
  The purpose of this study was to evaluate the safety and performance of the Freedom Solo valve in aortic valve replacement by clinical and hemodynamic outcomes.
  
  
  METHODS
  Six hundred sixteen patients underwent aortic valve replacement in 18 European centers; mean age was 74.5 ± 5.9 years, 54.1% of the patients were male, and concomitant procedures were performed in 43.2% of the patients. The majority (69%) of the implanted sizes were 23 mm and 25 mm.
  
  
  RESULTS
  At 1 year, overall survival was 94.0%, whereas freedom from valve-related death was 98.6%. There were 9 (1.5%) early (≤ 30 days) and 27 (4.4%) late (>30 days) deaths. Early and late valve-related mortality was 0.3% (n = 2) and 1.1% (n = 7), respectively. Freedom from explant was 97.6%; 10 valves were explanted for endocarditis and 4 for paravalvular leak. There were 10 (1.6%) early and 5 (0.8%) late strokes. Atrioventricular block requiring pacemaker implant occurred in 8 (1.3%) and 1 (0.2%) patients in the early and late postoperative period, respectively. Thrombocytopenia was seen in 27 cases (4.4%) in the early postoperative period. Preoperatively, 93.8% of patients were in New York Heart Association functional classes II through IV, whereas at 1 year 96.9% of patients were in New York Heart Association functional classes I and II. At 1-year follow-up, mean and peak pressure gradients were 7.2 and 14.6 mm Hg, respectively. Indexed left ventricular mass decreased by 12% from 138 g/m(2) at discharge to 122 g/m(2) at 1 year.
  
  
  CONCLUSIONS
  At 1-year follow-up after Freedom Solo implantation, we found acceptable clinical results with low mortality and morbidity and good hemodynamic performance, confirming safety and effectiveness in this multicenter experience.
authors.affiliation: Krankenhaus Hietzing, Wien, Austria. Electronic address: thalmann99@hotmail.com.
authors.forename: Markus
authors.initials: M
authors.lastname: Thalmann
authors.affiliation: Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Herko
authors.initials: H
authors.lastname: Grubitzsch
authors.affiliation: Herzzentrum Dresden, Dresden, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Matschke
authors.affiliation: Ospedale Pasquinucci Massa, Carrara, Italy.
authors.forename: Mattia
authors.initials: M
authors.lastname: Glauber
authors.affiliation: Catharina Hospital, Eindhoven, The Netherlands.
authors.forename: Erwin
authors.initials: E
authors.lastname: Tan
authors.affiliation: University Hospital Gent, Gent, Belgium.
authors.forename: Katrien
authors.initials: K
authors.lastname: Francois
authors.affiliation: Hospital S. João, Porto, Portugal.
authors.forename: Mario J
authors.initials: MJ
authors.lastname: Amorim
authors.affiliation: MST-Thoraxcentrum, Enschede, The Netherlands.
authors.forename: Ab G
authors.initials: AG
authors.lastname: Hensens
authors.affiliation: Ospedale Ca Foncello, Treviso, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Cesari
authors.affiliation: Klinik für Herzchirurgie, Erlangen, Germany.
authors.forename: Richard
authors.initials: R
authors.lastname: Feyrer
authors.affiliation: Herz-und Gefäss-Klinik GmbH, Bad Neustadt, Germany.
authors.forename: Anno
authors.initials: A
authors.lastname: Diegeler
authors.affiliation: Krankenhaus Hietzing, Wien, Austria.
authors.forename: Franz
authors.initials: F
authors.lastname: Veit
authors.affiliation: Cardiac Surgery, University of Brescia, Spedali Civili, Brescia, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Repossini
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001705:Bioprosthesis; D004452:Echocardiography; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome