title: Experimental Study and Early Clinical Application Of a Sutureless Aortic Bioprosthesis.
abstract: BACKGROUND
  The conventional aortic valve replacement is the treatment of choice for symptomatic severe aortic stenosis. Transcatheter technique is a viable alternative with promising results for inoperable patients. Sutureless bioprostheses have shown benefits in high-risk patients, such as reduction of aortic clamping and cardiopulmonary bypass, decreasing risks and adverse effects.
  
  
  OBJECTIVE
  The objective of this study was to experimentally evaluate the implantation of a novel balloon-expandable aortic valve with sutureless bioprosthesis in sheep and report the early clinical application.
  
  
  METHODS
  The bioprosthesis is made of a metal frame and bovine pericardium leaflets, encapsulated in a catheter. The animals underwent left thoracotomy and the cardiopulmonary bypass was established. The sutureless bioprosthesis was deployed to the aortic valve, with 1/3 of the structure on the left ventricular face. Cardiopulmonary bypass, aortic clamping and deployment times were recorded. Echocardiograms were performed before, during and after the surgery. The bioprosthesis was initially implanted in an 85 year-old patient with aortic stenosis and high risk for conventional surgery, EuroSCORE 40 and multiple comorbidities.
  
  
  RESULTS
  The sutureless bioprosthesis was rapidly deployed (50-170 seconds; average=95 seconds). The aortic clamping time ranged from 6-10 minutes, average of 7 minutes; the mean cardiopulmonary bypass time was 71 minutes. Bioprostheses were properly positioned without perivalvar leak. In the first operated patient the aortic clamp time was 39 minutes and the patient had good postoperative course.
  
  
  CONCLUSIONS
  The deployment of the sutureless bioprosthesis was safe and effective, thereby representing a new alternative to conventional surgery or transcatheter in moderate- to high-risk patients with severe aortic stenosis.
authors.affiliation: Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.
authors.forename: Walter J
authors.initials: WJ
authors.lastname: Gomes
authors.affiliation: Sociedade Portuguesa de Beneficência de São José do Rio Preto, SP, Brazil.
authors.forename: João Carlos
authors.initials: JC
authors.lastname: Leal
authors.affiliation: Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.
authors.forename: Fabio Biscegli
authors.initials: FB
authors.lastname: Jatene
authors.affiliation: Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.
authors.forename: Nelson A
authors.initials: NA
authors.lastname: Hossne
authors.affiliation: Braile Biomédica, São José do Rio Preto, SP, Brazil.
authors.forename: Renata
authors.initials: R
authors.lastname: Gabaldi
authors.affiliation: Braile Biomédica, São José do Rio Preto, SP, Brazil.
authors.forename: Glaucia Basso
authors.initials: GB
authors.lastname: Frazzato
authors.affiliation: Braile Biomédica, São José do Rio Preto, SP, Brazil.
authors.forename: Guilherme
authors.initials: G
authors.lastname: Agreli
authors.affiliation: Faculdade de Medicina de São José do Rio Preto, São José do Rio Preto, SP, Brazil.
authors.forename: Domingo M
authors.initials: DM
authors.lastname: Braile
mesh_terms: D000369:Aged, 80 and over; D000818:Animals; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis; D002417:Cattle; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D020007:Implants, Experimental; D061646:Operative Time; D011474:Prosthesis Design; D012756:Sheep; D016896:Treatment Outcome