title: North American trial results at 1 year with the Sorin Freedom SOLO pericardial aortic valve.
abstract: OBJECTIVE
  A North American prospective, 15-centre Food and Drug Administration (FDA) valve trial was designed to assess the safety and effectiveness of the Freedom SOLO stentless pericardial aortic valve in the treatment of surgical aortic valve disease.
  
  
  METHODS
  Beginning in 2010, 251 patients (mean: 74.7 ± 7.5 years), were recruited in the Freedom SOLO aortic valve trial. One hundred eighty-nine patients have been followed for at least 1 year and are the basis for this review. Preoperatively, 54% of patients had NYHA functional class III or IV symptoms, and the majority of patients had a normal ejection fraction (EF) (median EF = 61%). Concomitant procedures were performed in 61.9% of patients, with coronary artery bypass grafting (CABG) (48.7%) being the most common followed by a MAZE procedure (13.7%). Reoperations were performed in 8.5% of patients in the study.
  
  
  RESULTS
  The entire cohort of 251 patients enrolled had 7 deaths prior to 30 days, 2 of which were valve-related (aspiration pneumonia and sudden death) and 5 were not valve-related. There were 11 deaths after 30 days, 1 valve-related (unknown cardiac death) and 10 not valve-related. Five valves were explanted, 3 early (endocarditis, acute insufficiency and possible root dissection) and 2 late (endocarditis). Thirty-day adverse events include arrhythmias requiring permanent pacemaker (4.2%), thromboembolic events (3.7%) and thrombocytopenia (7.4%). One-year follow-up of all 189 patients demonstrated mean gradients for valve sizes 19, 21, 23, 25 and 27 mm of 11.7, 7.8, 6.3, 4.6 and 5.0 mmHg, respectively. Effective orifice areas for the same valve sizes were 1.2, 1.3, 1.6, 1.8 and 1.9 cm(2), respectively. Ninety-six percent of patients (181/189) were in NYHA class I or II at the 1-year follow-up.
  
  
  CONCLUSIONS
  The Freedom SOLO stentless pericardial aortic valve demonstrated excellent haemodynamics and a good safety profile out to the 1 year of follow-up.
authors.affiliation: Department of Cardiothoracic Surgery, St Vincent Heart Center, Indianapolis, IN, USA heimansohn@mac.com.
authors.forename: David
authors.initials: D
authors.lastname: Heimansohn
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Eric E
authors.initials: EE
authors.lastname: Roselli
authors.affiliation: Division of Cardiothoracic Surgery, Emory University, Atlanta, GA, USA.
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.affiliation: Department of Cardiothoracic Surgery, University of Alberta, Edmonton, AB, USA.
authors.forename: Shaohua
authors.initials: S
authors.lastname: Wang
authors.affiliation: Division of Cardiac Surgery, Hospital Laval, QC, Canada.
authors.forename: Pierre
authors.initials: P
authors.lastname: Voisine
authors.affiliation: St. Paul's Hospital, Vancouver, BC, Canada.
authors.forename: Jian
authors.initials: J
authors.lastname: Ye
authors.affiliation: Great Lakes Cardiovascular and Thoracic Surgeons, Dearborn, MI, USA.
authors.forename: Reza
authors.initials: R
authors.lastname: Dabir
authors.affiliation: Mazankowski Alberta Heart Institute, Edmonton, AB, Canada.
authors.forename: Michael
authors.initials: M
authors.lastname: Moon
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000209:etiology / Q000401:mortality; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality / Q000503:physiopathology; D011446:Prospective Studies; D012086:Reoperation; D016896:Treatment Outcome
keywords: Aortic valve replacement; Multicentre trial; Stentless bioprosthesis