title: Midterm stability and hemodynamic performance of a transfemorally implantable nonmetallic, retrievable, and repositionable aortic valve in patients with severe aortic stenosis. Up to 2-year follow-up of the direct-flow medical valve: a pilot study.
abstract: BACKGROUND
  Misplacement during percutaneous aortic valve implantation can be associated with severe complications. The direct flow medical (DFM) valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the valve results in less radial force, which may have an impact on stability and valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM percutaneous aortic valve.
  
  
  RESULTS
  Sixteen symptomatic high-risk for surgery patients with aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM valve over time. Echocardiography revealed a significant decrease of the mean gradient from baseline (50.1±11.3 mm Hg) to 30 days (19.6±5.7 mm Hg, P<0.001), which remained stable over 2 years. The aortic valve area increased from 0.57±0.15 cm(2) at baseline to 1.47±0.35 cm(2) at 30 days (P<0.001) and did not significantly change during 2-year follow-up. Of the patients, 73% had no aortic regurgitation (AR) and 27% had minimal AR.
  
  
  CONCLUSIONS
  In this preliminary series, the 2-year follow-up data of patients, in whom the nonmetallic, repositionable, and retrievable DFM valve was successfully implanted, show stability of the position, shape, and hemodynamic performance, with no AR in most patients.
authors: Medical Care Center Prof Mathey, Prof Schofer, Hamburg University Cardiovascular Center, Hamburg University Heart Center, and Radiologische Allianz, Hamburg, Germany.
authors: Klaudija
authors: K
authors: Bijuklic
authors: Thilo
authors: T
authors: Tuebler
authors: Hermann
authors: H
authors: Reichenspurner
authors: Hendrik
authors: H
authors: Treede
authors: Andreas
authors: A
authors: Wandler
authors: John H
authors: JH
authors: Harreld
authors: Reginald I
authors: RI
authors: Low
authors: Joachim
authors: J
authors: Schofer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000379:methods*; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000502:physiology*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D004452:Echocardiography; D005260:Female; D005268:Femoral Vein; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006439:Hemodynamics / Q000502:physiology*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D061330:Multidetector Computed Tomography; D010865:Pilot Projects; D012039:Regional Blood Flow / Q000502:physiology; D012720:Severity of Illness Index; D016896:Treatment Outcome