title: Pericardial Stentless Valve for Aortic Valve Replacement: Long-Term Results.
abstract: BACKGROUND
  The Freedom Solo (FS) bovine pericardial valve (Sorin Group, Milan, Italy) is a stentless bioprosthesis that was introduced in 2004 and approved by the United States Food and Drug Administration in 2014. No long-term follow-up series are available to date. We report the multicenter experience of 4 European institutions that began implanting FS extensively from its introduction, providing the largest series with long-term follow-up.
  
  
  METHODS
  From 2004 to 2009, 565 patients (242 women [42.8%]; mean age, 74.6 ± 8.3 years) underwent isolated (n = 350) or combined (n = 215) aortic valve replacement with the FS. Mean follow-up, including clinical and strict echocardiographic evaluation, was 6.9 ± 3.7 years (maximum, 11.8 years; cumulative 2,965 patient-years). Primary end point was freedom from structural valve deterioration (SVD), and secondary end points were freedom from reoperation and overall survival.
  
  
  RESULTS
  Mean logistic European System for Cardiac Operative Risk Evaluation I was 10.3% ± 6.7%. Overall 30-day mortality was 3.7%, and no deaths were valve related. There was no severe prostheses-patient mismatch, and moderate prostheses-patient mismatch occurred only in 1 patient (0.17%). Twenty-eight patients (5.2%) underwent reoperation (20 surgical replacements, 8 transcatheter aortic valve-in-valve replacements) due to endocarditis in 9, blunt trauma in 1, and SVD in 18. SVD was reported in 5 other patients alive at time of censoring. Freedom from SVD and reoperation was 90.8% (95% confidence interval, 89.1% to 92.5%) and 87.3% (95% confidence interval, 85.6% to 89.0%), respectively, at 10 years of follow-up, and the overall actuarial survival was 56.4% (95% confidence interval, 53.3% to 59.5%).
  
  
  CONCLUSIONS
  The FS valve provided excellent long-term durability and hemodynamic performance in this large, multicenter European experience. Moreover, the FS, given the low rate of SVD, along with a simple implantability, proved to be a reliable bioprosthesis in the aortic position as a valid alternative to stented bioprostheses.
authors.affiliation: Clinical Department of Cardiac Surgery, University of Brescia, Brescia, Italy. Electronic address: arepossini@yahoo.it.
authors.forename: Alberto
authors.initials: A
authors.lastname: Repossini
authors.affiliation: Department of Cardiac Surgery, Paracelsus Medical University Nuremberg, Nuremberg.
authors.forename: Theodor
authors.initials: T
authors.lastname: Fischlein
authors.affiliation: Department of Cardiac Surgery, Paracelsus Medical University Nuremberg, Nuremberg.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Santarpino
authors.affiliation: Department of Cardiovascular Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Christina
authors.initials: C
authors.lastname: Schäfer
authors.affiliation: Department of Cardiovascular Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Claus
authors.affiliation: Cliniche Humanitas Gavazzeni, Bergamo, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Passaretti
authors.affiliation: Clinical Department of Cardiac Surgery, University of Brescia, Brescia, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Di Bacco
authors.affiliation: Clinical Department of Cardiac Surgery, University of Brescia, Brescia, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Giroletti
authors.affiliation: Clinical Department of Cardiac Surgery, University of Brescia, Brescia, Italy.
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Bisleri
authors.affiliation: Clinical Department of Cardiac Surgery, University of Brescia, Brescia, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Muneretto
authors.affiliation: Department of Cardiovascular Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Herko
authors.initials: H
authors.lastname: Grubitzsch
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001021:Aortic Valve / Q000601:surgery*; D001705:Bioprosthesis / Q000009:adverse effects; D004696:Endocarditis / Q000188:drug therapy / Q000453:epidemiology / Q000601:surgery; D005060:Europe / Q000453:epidemiology; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000379:methods; D006439:Hemodynamics; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000706:statistics & numerical data; D010496:Pericardium; D011183:Postoperative Complications / Q000188:drug therapy / Q000453:epidemiology / Q000601:surgery; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation / Q000706:statistics & numerical data; D065467:Transcatheter Aortic Valve Replacement / Q000706:statistics & numerical data; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents