title: Transcatheter aortic valve implantation with the direct flow medical prosthesis: Impact of native aortic valve calcification degree on outcomes.
abstract: OBJECTIVE
  We present our single center experience with the direct flow medical (DFM) prosthesis addressing the impact of native aortic valve (AV) calcification degree on outcomes.
  
  
  BACKGROUND
  The DFM® has been introduced for transcatheter aortic valve implantation (TAVI). The valve has a nonmetallic and inflatable support structure.
  
  
  METHODS
  Patients were divided in two groups according to preoperative cardiac computed tomography (CT): group I moderate calcification and group II heavy calcification of the total AV area. We evaluated 118 patients: 53 (45%) group I and 65 (55%) group II.
  
  
  RESULTS
  Preoperative trans-AV gradient and calcification extension across the aortic unit were significantly higher in group II (P = 0.008 and P < 0.0001). CT perimeter derived annular diameter (group I 24.7 ± 2.1 mm vs. group II 24.8 ± 1.9; P = 0.6) and implanted prosthesis size (group I 26.1 ± 1.5 mm vs. group II 25.7 ± 1.5; P = 0.1) were similar. Hemodynamics were similar: mean gradient 16.1 ± 5.9 mm Hg (group I) vs. 17.3 ± 6.5 mm Hg (group II) (P = 0.3). Total aortic regurgitation (AR) was mild in 5.7% in group I and 20% in group II (P = 0.03). None developed moderate/severe AR. Heavy AV calcification was the sole independent determinant for mild regurgitation (P = 0.02; OR = 7; 95% CI: 1.2-37.6). Follow-up (289 days; 40-760 days) estimated survival was 88.1% (group I) and 93.8% (group II) (P = 0.3).
  
  
  CONCLUSIONS
  Independent of AV calcification degree, adequate sizing and implantation can be achieved with the DFM®. Although higher burden of calcification increases the rate of mild AR, no patient developed moderate and severe AR. Short-term estimated survival was not influenced by calcification degree. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain und Am Urban, Berlin, Germany.|Heart Center, Rostock University Medical Center, Rostock, Germany.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: D'Ancona
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain und Am Urban, Berlin, Germany.|Heart Center, Rostock University Medical Center, Rostock, Germany.
authors.forename: Hüseyin U
authors.initials: HU
authors.lastname: Agma
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain und Am Urban, Berlin, Germany.|Heart Center, Rostock University Medical Center, Rostock, Germany.
authors.forename: Hüseyin
authors.initials: H
authors.lastname: Ince
authors.affiliation: Department of Cardiology, Vivantes Humboldt-Klinikum, Berlin, Germany.
authors.forename: Gihan
authors.initials: G
authors.lastname: El-Achkar
authors.affiliation: Department of Cardiology, Vivantes Humboldt-Klinikum, Berlin, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Dißmann
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain und Am Urban, Berlin, Germany.|Heart Center, Rostock University Medical Center, Rostock, Germany.
authors.forename: Jasmin
authors.initials: J
authors.lastname: Ortak
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain und Am Urban, Berlin, Germany.|Heart Center, Rostock University Medical Center, Rostock, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Kische
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000473:pathology* / Q000503:physiopathology; D001022:Aortic Valve Insufficiency / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D001705:Bioprosthesis; D002114:Calcinosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016009:Chi-Square Distribution; D004452:Echocardiography; D005260:Female; D005858:Germany; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D011474:Prosthesis Design; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
keywords: aortic valve calcifications; percutaneous; trans-catheter aortic valve implantation