title: Clinical and haemodynamic outcomes in 804 patients receiving the Freedom SOLO stentless aortic valve: results from an international prospective multicentre study.
abstract: OBJECTIVE
  The Freedom SOLO™ valve (Sorin Group, Italy) is a stentless aortic bioprosthesis designed for simplified implantation. The present multicentre study is the largest prospective evaluation of this prosthesis. Herein, we report on outcomes at 3-year follow-up.
  
  
  METHODS
  From March 2009 to February 2013, a total of 804 consecutive patients (mean age 74.9 ± 6.3 years; 45.1% females) underwent aortic valve replacement with the Freedom SOLO™ valve at 33 centres. Concomitant procedures (70.2% coronary artery bypass grafting) were performed in 376 patients. The cumulative follow-up included 1100 patient-years (mean 16.5 ± 10.8 months; range: 0-40.5 months).
  
  
  RESULTS
  Sixty-four patients died (14 early, 50 late); 12 deaths (1 early, 11 late) were valve-related. Operative mortality (30 days) was 1.7%. At 3 years, overall survival was 82.6% [95% confidence interval (CI) 75.5-87.8%] and freedom from valve-related death was 95.5% (95% CI 89.2-98.2%). Linearized late event rates were 0.82%/patient-years for non-structural valve dysfunction, 0.55%/patient-years for structural valve deterioration, 1.55%/patient-years for endocarditis, 3.64%/patient-years for thromboembolism and 3.18%/patient-years for bleeding. In total, there were 22 reinterventions [19 valve explants, 2 refixations, 1 transcatheter aortic valve intervention (TAVI)] for endocarditis (11), non-structural dysfunction (9) and structural valve deterioration (2). Freedom from reintervention was 95.2% (95% CI 91.2-97.4%) at 3 years. There were no instances of valve thrombosis or haemolysis. At 1, 2 and 3 years, 97.0, 95.5 and 91.4% of patients were in NYHA class I or II. Between discharge and 3 years after surgery, mean transvalvular gradients exhibited a non-significant increase (6.5 ± 4.3 vs 8.7 ± 6.5 mmHg), whereas effective orifice area index remained stable (0.9 ± 0.2 vs 0.8 ± 0.3 cm(2)/m(2)). At 3 years, no patient presented with more than mild aortic regurgitation. Left ventricular mass index decreased significantly between discharge and 1 year after surgery (139.4 ± 40.9 vs 122.4 ± 35.3 g/m(2), P < 0.001) and remained unchanged thereafter. Left ventricular size and function did not change over time.
  
  
  CONCLUSIONS
  The Freedom SOLO™ valve is a unique stentless pericardial bioprosthesis whose design favours haemodynamic performance and thus facilitates left ventricular reverse remodelling. In terms of survival, morbidity and functional status, it is associated with beneficial outcomes up to 3 years after surgery. Ongoing follow-up will assess the valve at the long-term course.
authors.affiliation: Department of Cardiovascular Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany herko.grubitzsch@charite.de.
authors.forename: Herko
authors.initials: H
authors.lastname: Grubitzsch
authors.affiliation: Division of Cardiac Surgery, University of Alberta Hospital Edmonton, Edmonton, Canada.
authors.forename: Shaohua
authors.initials: S
authors.lastname: Wang
authors.affiliation: Department of Cardiac Surgery, Herzzentrum Dresden, Dresden, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Matschke
authors.affiliation: Department of Cardiac Surgery, Ospedale del Cuore Fondazione Monasterio, Massa, Italy.
authors.forename: Mattia
authors.initials: M
authors.lastname: Glauber
authors.affiliation: St Vincent Heart Center of Indiana, Indianapolis, USA.
authors.forename: David
authors.initials: D
authors.lastname: Heimansohn
authors.affiliation: Department of Cardiothoracic Surgery, Catharina Hospital Eindhoven, Eindhoven, Netherlands.
authors.forename: Erwin
authors.initials: E
authors.lastname: Tan
authors.affiliation: Department of Cardiac Surgery, University Hospital Gent, Gent, Belgium.
authors.forename: Katrien
authors.initials: K
authors.lastname: Francois
authors.affiliation: Department of Cardiovascular Surgery, Krankenhaus Hietzing, Wien, Austria.
authors.forename: Markus
authors.initials: M
authors.lastname: Thalmann
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D005260:Female; D006349:Heart Valve Diseases / Q000401:mortality / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality*; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009017:Morbidity; D011446:Prospective Studies; D016896:Treatment Outcome
keywords: Aortic valve replacement; Multicentre study; Stentless bioprosthesis