title: Sutureless Perceval S aortic valve replacement: a multicenter, prospective pilot trial.
abstract: OBJECTIVE
  A European, multicenter, prospective, non-randomized, clinical pilot trial was designed to evaluate the feasibility of the Perceval S sutureless aortic valve prosthesis. A clinical and echocardiographic follow up was performed at the time of hospital discharge and subsequently after one, three, six, and 12 months.
  
  
  METHODS
  The valve was implanted following sternotomy, extracorporeal circulation (ECC), aortic cross-clamping, cardioplegic arrest, and removal of the native valve. Implantation suturing was not required. Optimal annular sealing was obtained with brief low-pressure balloon dilation. If coronary bypass was indicated, a distal anastomosis was performed first. Between April 2007 and February 2008, 30 patients (mean age: 81 +/- 4 years) underwent aortic valve replacement. The prevalence of pure aortic stenosis was 76.7%, and that of mixed lesion 23.3%. The mean logistic EuroSCORE was 13.18%, and the NYHA class was III and IV in 93.3% and 6.7% of patients, respectively. The implanted valve size was 21 and 23 mm in 37% and 63% of patients, respectively, and 14 (46.7%) underwent coronary artery bypass grafting (11 internal mammary artery, nine vein grafts).
  
  
  RESULTS
  The mean aortic cross-clamp and ECC times were 34 +/- 15 min and 59 +/- 21 min, respectively. There was one in-hospital death (3.3%), and three deaths occurred within 12 months of follow up (one death was valve-related, and two deaths were independent of the valve implantation). A total of 28 patients was assessed at one month post-implantation, and 23 after 12 months. No migration or dislodgement of the valve had occurred, but there were two mild paravalvular leakages and two mild intravalvular insufficiencies.
  
  
  CONCLUSIONS
  The preliminary results of the trial confirmed the safety and efficacy of the Perceval S sutureless aortic valve. In this high-risk subset of patients, shortening the aortic cross-clamp and ECC times may help to reduce mortality and morbidity.
authors.affiliation: Division of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hanover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany. Shrestha.Malakh.Lal@mh-hannover.de
authors.forename: Malakh
authors.initials: M
authors.lastname: Shrestha
authors.forename: Thierry
authors.initials: T
authors.lastname: Folliguet
authors.forename: Bart
authors.initials: B
authors.lastname: Meuris
authors.forename: Alain
authors.initials: A
authors.lastname: Dibie
authors.forename: Christoph
authors.initials: C
authors.lastname: Bara
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Herregods
authors.forename: Nawid
authors.initials: N
authors.lastname: Khaladj
authors.forename: Christian
authors.initials: C
authors.lastname: Hagl
authors.forename: Willem
authors.initials: W
authors.lastname: Flameng
authors.forename: Francois
authors.initials: F
authors.lastname: Laborde
authors.forename: Axel
authors.initials: A
authors.lastname: Haverich
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve; D005112:Extracorporeal Circulation; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D056346:Sternotomy