title: Early and Mid-term Outcome of the St. Jude Medical Regent 19-mm Aortic Valve Mechanical Prosthesis. Functional and Haemodynamic Evaluation.
abstract: OBJECTIVE
  The aim of the present study is to report the early and mid-term clinical and haemodynamic results of the St Jude Medical Regent 19-mm aortic mechanical prothesis (SJMR-19).
  
  
  METHODS
  Between January 2002 and January 2012, 265 patients with aortic valve disease underwent AVR (Aortic Valve Replacement) with a SJMR-19 (St Jude Medical Regent Nr.19). There were 51 males. Mean age was 67.5±12.72years and mean body surface area (BSA) was 1.67±0.14m2. Thirty-six patients required annulus enlargement. The mean follow-up was 34.5±18.8months (range 6-60 months). All patients underwent echocardiographic examination at discharge and within 1 year after surgery.
  
  
  RESULTS
  There were 14 (5.3%) hospital deaths. Six of the hospital deaths were identified in patients undergoing reoperation, significantly higher than patients undergoing first time operation (p=0.0001). Also the postoperative mortality was significantly higher in patients undergoing annulus enlargement versus patients not requiring annulus enlargement (p=0.02). The mean transprosthesis gradient at discharge was 19±9mmHg. At 6 months follow-up the mean NYHA FC class was 1.6±0.5 significantly lower than preoperatively 2.4±0.75 (p <0.0001). The M-TPG was 15.2±6.5mmHg within 1 year after surgery. Left ventricular mass (LVM) and indexed left ventricular mass (LVMi) were significantly lower than preoperatively The actuarial survival and cumulative freedom from reoperation at 1, 2 and 3 years follow-up were 99.5%, 97.5%, 96.7% and 99.2%, 96.5%, 94.5% respectively. The cumulative actuarial free-events survival at 4 years was 92%. The Cox model identified age (p=0.015), LVEF≤35% (p=0.043), reoperation (p=0.031), combined surgery (p=0.00002), and annulus enlargement (p=0.015) as strong predictors for poor actuarial free-major events survival.
  
  
  CONCLUSIONS
  The SJMR-19 offers excellent postoperative clinical, haemodynamic outcome and LVMireduction in patients with small aortic annulus. These data demonstrate that the modern St Jude small mechanical protheses do not influence the intermediate free-reoperation survival.
authors.affiliation: Division of Cardiac Surgery, University Hospital Center of Tirana, Albania. Electronic address: edvinprifti@hotmail.com.
authors.forename: Edvin
authors.initials: E
authors.lastname: Prifti
authors.affiliation: Department of Cardiovascular Sciences, Policlinico Careggy, University of Florence, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Bonacchi
authors.affiliation: Department of Cardiovascular Sciences, Cardiac Surgery Unit, San Camillo Hospital, Rome, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Minardi
authors.affiliation: Division of Cardiac Surgery, University Hospital Center of Tirana, Albania.
authors.forename: Klodian
authors.initials: K
authors.lastname: Krakulli
authors.affiliation: Division of Cardiac Surgery, University Hospital Center of Tirana, Albania.
authors.forename: Arben
authors.initials: A
authors.lastname: Baboci
authors.affiliation: Division of Cardiac Surgery, Humanitas Gavazzeni, Bergamo, Italy.
authors.forename: Giampiero
authors.initials: G
authors.lastname: Esposito
authors.affiliation: Division of Cardiac Surgery, University Hospital Center of Tirana, Albania.
authors.forename: Aurel
authors.initials: A
authors.lastname: Demiraj
authors.affiliation: Division of Cardiac Surgery, University Hospital Center of Tirana, Albania.
authors.forename: Merita
authors.initials: M
authors.lastname: Zeka
authors.affiliation: Division of Cardiac Surgery, University Hospital Center of Tirana, Albania.
authors.forename: Edlira
authors.initials: E
authors.lastname: Rruci
mesh_terms: D000368:Aged; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D006439:Hemodynamics / Q000502:physiology*; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D013997:Time Factors
keywords: Indexed effective orifice area; Indexed left ventricular mass; St Jude Medical Regent 19-mm mechanical aortic prothesis