title: Transcatheter, inflatable, and fully repositionable aortic valve: Preliminary results using a modified implantation technique.
abstract: OBJECTIVE
  We present our experience with an inflatable, non-metallic, fully retrievable, and repositionable transcatheter aortic valve [Direct Flow® Medical (DFM)] focusing on technical features adopted during implantation.
  
  
  BACKGROUND
  Implantation techniques of new generation percutaneous aortic valves are still developing and with experience implementations are described.
  
  
  METHODS
  The "low pressure" (initial valve inflation at 4 ATM, lower than the recommended 12 ATM) and the "alternate aortic curve" techniques (initial valve pulling either from the wire running on the side of the inner or from the one on the outer aortic curve) are part of our modified protocol for DFM® implantation.
  
  
  RESULTS
  Forty-two consecutive patients underwent TAVI with DFM. The "low pressure" technique was used in all patients. In 27 (64.3%) patients the bulkiest calcifications were on the inner aortic curve side, and an inner curve technique was used to initiate valve pulling toward the annular hinge point. In the remaining 15 (35.7%) patients, an outer curve technique was used. Neither pull-through nor re-valving was reported. Valve performance showed mean gradient of 8.9 mm Hg. Mild paravalvular leak was reported in seven (16%) patients. No one experienced moderate or severe aortic insufficiency. Thirty-day mortality was 9.5% (4/42).
  
  
  CONCLUSIONS
  The "low pressure technique" and the "alternate curve technique" guarantee an anatomy and patient tailored approach to achieve controlled and finely tuned valve seating.
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain Und Am Urban, Berlin, Germany.|Department of Cardiology, Rostock University Medical Center, Rostock, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Kische
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain Und Am Urban, Berlin, Germany.|Department of Cardiology, 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.|Department of Cardiology, 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.|Department of Cardiology, Rostock University Medical Center, Rostock, Germany.
authors.forename: Hakan
authors.initials: H
authors.lastname: Gürer
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain Und Am Urban, Berlin, Germany.|Department of Cardiology, Rostock University Medical Center, Rostock, Germany.
authors.forename: Jasmin
authors.initials: J
authors.lastname: Ortak
authors.affiliation: Klinikum Oldenburg, Herz-Kreislauf Zentrum, Klinik für Kardiologie, Oldenburg, Germany.
authors.forename: Albrecht
authors.initials: A
authors.lastname: Elsässer
authors.affiliation: Department of Cardiology, Rostock University Medical Center, Rostock, Germany.
authors.forename: Alper
authors.initials: A
authors.lastname: Öner
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain Und Am Urban, Berlin, Germany.|Department of Cardiology, Rostock University Medical Center, Rostock, Germany.
authors.forename: Hüseyin
authors.initials: H
authors.lastname: Ince
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*; D001027:Aortography; D063126:Balloon Valvuloplasty / Q000009:adverse effects / Q000401:mortality; D002114:Calcinosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods* / Q000401:mortality; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods* / Q000401:mortality; D006801:Humans; D008297:Male; D011312:Pressure; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome
keywords: TAVI percutaneous valve; aortic valve disease; percutaneous intervention; structural heart disease intervention