title: Transfemoral Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation.
abstract: OBJECTIVE
  This study sought to evaluate the use of the Direct Flow Medical (DFM) transcatheter heart valve (Direct Flow Medical, Santa Rosa, California) for the treatment of noncalcific pure aortic regurgitation (AR).
  
  
  BACKGROUND
  The treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak.
  
  
  METHODS
  The study population consisted of patients treated for severe noncalcific pure AR with transfemoral implantation of a DFM transcatheter heart valve at 6 European centers. The primary endpoint was the composite endpoint of device success and the secondary endpoint was the composite early safety endpoint (according to the VARC-2 criteria).
  
  
  RESULTS
  Eleven high-risk (STS score 8.84 ± 8.9, Logistic EuroSCORE 19.9 ± 7.1) patients (mean age 74.7 ± 12.9 years) were included. Device success was achieved in all patients. In 1 patient, the initial valve prosthesis was retrieved after pull-through, and a second valve was successfully deployed. The early safety endpoint was reached in 91% of the patients, with 1 patient requiring surgical aortic valve replacement secondary to downward dislocation of the prosthesis that was successfully managed with surgical aortic valve replacement. DFM implantation resulted in excellent hemodynamics with none or trivial paravalvular regurgitation in 9 patients and a transprosthetic gradient of 7.7 ± 5.1 mm Hg at 30-day follow up. All patients derived symptomatic benefit following the procedure, with 72% in New York Heart Association functional class I or II.
  
  
  CONCLUSIONS
  This study reports the feasibility of treating severe noncalcific AR with the Direct Flow prosthesis via the transfemoral route.
authors.affiliation: Albertinen Heart Center, Hamburg, Germany; Medical Care Center Prof. Mathey Prof. Schofer, Hamburg, Germany. Electronic address: Schofer@herz-hh.de.
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.affiliation: University Heart Center, Cardiology and Cardiovascular Surgery, University Hospital Zürich, Zurich, Switzerland.
authors.forename: Fabian
authors.initials: F
authors.lastname: Nietlispach
authors.affiliation: Medical Care Center Prof. Mathey Prof. Schofer, Hamburg, Germany.
authors.forename: Klaudija
authors.initials: K
authors.lastname: Bijuklic
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute & EMO-GVM Centro Cuore Colombus, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Herz-Zentrum Saar, SHG-Kliniken Völklingen, Völklingen, Germany.
authors.forename: Fernando
authors.initials: F
authors.lastname: Gatto
authors.affiliation: Cardiology and Cardiac Surgery Department, Niguarda Ca' Granda Hospital, Milan, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: De Marco
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute & EMO-GVM Centro Cuore Colombus, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Mangieri
authors.affiliation: Albertinen Heart Center, Hamburg, Germany.
authors.forename: Lorenz
authors.initials: L
authors.lastname: Hansen
authors.affiliation: Cardiology and Cardiac Surgery Department, Niguarda Ca' Granda Hospital, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Bruschi
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute & EMO-GVM Centro Cuore Colombus, Milan, Italy.
authors.forename: Neil
authors.initials: N
authors.lastname: Ruparelia
authors.affiliation: Albertinen Heart Center, Hamburg, Germany.
authors.forename: Friedrich-Christian
authors.initials: FC
authors.lastname: Rieß
authors.affiliation: University Heart Center, Cardiology and Cardiovascular Surgery, University Hospital Zürich, Zurich, Switzerland.
authors.forename: Franscesco
authors.initials: F
authors.lastname: Maisano
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute & EMO-GVM Centro Cuore Colombus, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D002406:Catheterization, Peripheral / Q000379:methods*; D005060:Europe / Q000453:epidemiology; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology*; D011474:Prosthesis Design; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome
keywords: Direct Flow Medical; pure aortic regurgitation; transfemoral aortic valve replacement