title: Mechanical aortic valve replacement in young women planning on pregnancy: maternal and fetal outcomes under low oral anticoagulation, a pilot observational study on a comprehensive pre-operative counseling protocol.
abstract: OBJECTIVE
  This pilot prospective observational study aimed to evaluate the maternal and fetal outcomes of pregnancies under low-dose oral anticoagulation therapy after aortic mechanical replacement.
  
  
  BACKGROUND
  Need for valve replacement is still an issue for young women with native valve disease who are planning on future pregnancy. Choice of replacement device is a challenging clinical task.
  
  
  METHODS
  A comprehensive pre-operative counseling protocol to guide choice of replacement device was developed. The pre-operative anticoagulation trial to determine the warfarin daily dosage needed to reach target international normalized ratio (INR) represented the main stem of such protocol. Pregnancies on low-dose anticoagulation therapy (target INR: 1.5 to 2.5) were allowed in a highly selected subset of mechanical aortic valve recipients.
  
  
  RESULTS
  Twenty-two patients of 40 originally referred for native valve disease surgery requiring valve replacement, safely underwent the pre-operative anticoagulation challenge. No maternal or fetal complications were detected in 16 pregnancies under low oral anticoagulation. Patterns of warfarin daily dosage and induced INRs were characterized during pregnancy.
  
  
  CONCLUSIONS
  In this small sample observational study, a pre-operative anticoagulation therapy trial helped young women scheduled for valve replacement to acquire complete information as to the choice of prosthetic device. In selected third-generation mechanical aortic prosthesis recipients, low-dose anticoagulation therapy seems safe and feasible for both mother and fetus. Further studies are needed to validate this approach.
authors.affiliation: Department of Cardiovascular Surgery and Transplant, V Monaldi Hospital, Naples, Italy. luca.desanto@ospedalemonaldi.it
authors.forename: Luca S
authors.initials: LS
authors.lastname: De Santo
authors.forename: Gianpaolo
authors.initials: G
authors.lastname: Romano
authors.forename: Alessandro
authors.initials: A
authors.lastname: Della Corte
authors.forename: Veronica
authors.initials: V
authors.lastname: D'Oria
authors.forename: Gianantonio
authors.initials: G
authors.lastname: Nappi
authors.forename: Salvatore
authors.initials: S
authors.lastname: Giordano
authors.forename: Maurizio
authors.initials: M
authors.lastname: Cotrufo
authors.forename: Marisa
authors.initials: M
authors.lastname: De Feo
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000465:Algorithms; D000925:Anticoagulants / Q000008:administration & dosage*; D001021:Aortic Valve / Q000601:surgery*; D001705:Bioprosthesis / Q000009:adverse effects; D015986:Confounding Factors, Epidemiologic; D003376:Counseling; D004334:Drug Administration Schedule; D005260:Female; D005865:Gestational Age; D006349:Heart Valve Diseases / Q000601:surgery*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage; D006801:Humans; D019934:International Normalized Ratio; D008943:Mitral Valve / Q000601:surgery*; D010865:Pilot Projects; D011247:Pregnancy; D011249:Pregnancy Complications, Cardiovascular / Q000601:surgery*; D011256:Pregnancy Outcome; D011264:Pregnancy Trimesters; D057234:Preoperative Period; D011446:Prospective Studies; D012086:Reoperation; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome; D014859:Warfarin / Q000008:administration & dosage
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D014859:Warfarin