title: Retrograde transarterial implantation of a nonmetallic aortic valve prosthesis in high-surgical-risk patients with severe aortic stenosis: a first-in-man feasibility and safety study.
abstract: BACKGROUND
  To assess the feasibility and safety of retrograde transarterial implantation of a novel nonmetallic aortic valve prosthesis (Direct Flow Medical Inc, Santa Rosa, Calif), a prospective single-center study was performed in patients with severe aortic stenosis at high risk for open-heart surgery.
  
  
  RESULTS
  Fifteen patients (intention-to-treat cohort) with an aortic valve area < or = 0.8 cm(2), a > or = 35-mm Hg mean transvalvular pressure gradient, and a logistic EuroSCORE > or = 20% were enrolled. Percutaneous aortic valve replacement was performed with the patient under general anesthesia. Hemodynamic parameters were assessed before and after implantation by transesophageal echocardiography. Clinical follow-up and transthoracic echocardiographic assessment were obtained at 30 days. Procedural success was achieved in 12 patients (80%). Surgical conversion became necessary at day 2 in 1 patient; 11 patients (73%) were discharged with a permanent implant. In these patients, implantation resulted acutely in a significant increase in aortic valve area (median, 1.64 [interquartile range, 1.27 to 1.74] versus 0.60 [0.46 to 0.69] cm(2); P = 0.0033) and a concomitant reduction in the mean pressure gradient (14.0 [13.2 to 16.5] versus 54.0 [43.2 to 59.8] mm Hg; P = 0.0033). At 30 days, 1 cardiac death (6.7%; 95% CI, 0.2% to 32.0%) and 1 major stroke were observed. The 10 surviving patients with a permanent implant showed marked hemodynamic and clinical improvement at this time point.
  
  
  CONCLUSIONS
  In this small series of patients, percutaneous implantation of the Direct Flow Medical aortic valve prosthesis in high-surgical-risk patients was feasible and associated with a reasonably low safety profile.
authors.affiliation: Medical Care Center Prof Mathey, Prof Schofer and Hamburg University Cardiovascular Center, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.forename: Michael
authors.initials: M
authors.lastname: Schlüter
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.forename: Olaf W
authors.initials: OW
authors.lastname: Franzen
authors.forename: Thilo
authors.initials: T
authors.lastname: Tübler
authors.forename: Andrea
authors.initials: A
authors.lastname: Pascotto
authors.forename: Reginald I
authors.initials: RI
authors.lastname: Low
authors.forename: Steven F
authors.initials: SF
authors.lastname: Bolling
authors.forename: Thomas
authors.initials: T
authors.lastname: Meinertz
authors.forename: Hermann
authors.initials: H
authors.lastname: Reichenspurner
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000473:pathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000503:physiopathology / Q000628:therapy*; D002404:Catheterization / Q000009:adverse effects* / Q000379:methods / Q000401:mortality; D018450:Disease Progression; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000379:methods / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D008297:Male; D012307:Risk Factors; D016019:Survival Analysis; D016896:Treatment Outcome