title: Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry.
abstract: OBJECTIVE
  Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice.
  
  
  METHODS
  ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA- and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points.
  
  
  RESULTS
  Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P  = 0.46 and 1% vs. 3%, P  = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (≥ moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% ( P  = 0.76), rates of stroke 2% vs. 0% ( P  = 0.24), pacemaker implantation (11% vs. 4%, P  = 0.093), and life-threatening bleeding 4% vs. 3% ( P  = 0.70). Valve safety (both 85%, P  = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups.
  
  
  CONCLUSIONS
  Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation.
  
  
  BACKGROUND
  NCT01991431.
authors.affiliation: Department of Cardiac Surgery, Medical University Innsbruck, Innsbruck, Austria.
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Bonaros
authors.affiliation: Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Kiel, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Petzina
authors.affiliation: Heart Center, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Cocchieri
authors.affiliation: Department of Cardiac and Vascular Surgery, Medical University of Gdansk, Gdansk, Poland.
authors.forename: Dariusz
authors.initials: D
authors.lastname: Jagielak
authors.affiliation: Department of Cardiothoracic Surgery, Foundation IRCCS Policlinico S.Matteo, Pavia, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Aiello
authors.affiliation: Department of Cardivascular Surgery, Hospital Louis Pradel, Lyon, France.
authors.forename: Joel
authors.initials: J
authors.lastname: Lapeze
authors.affiliation: Division of Cardiology, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Mika
authors.initials: M
authors.lastname: Laine
authors.affiliation: Cardiothoracic Surgery, Hospital Jean Minjoz, University Hospital of Besancon, Besancon, France.
authors.forename: Sidney
authors.initials: S
authors.lastname: Chocron
authors.affiliation: Cardiothoracic Division, James Cook Hospital, Middlesbrough, UK.
authors.forename: Douglas
authors.initials: D
authors.lastname: Muir
authors.affiliation: Department of Cardiothoracic Surgery, Klinikum Bogenhausen, Munich, Germany.
authors.forename: Walter
authors.initials: W
authors.lastname: Eichinger
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, University Hospital Essen, Essen, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Thielmann
authors.affiliation: Department of Cardiovascular Surgery, CHU Hospital of Bordeaux, Bordeaux, France.
authors.forename: Louis
authors.initials: L
authors.lastname: Labrousse
authors.affiliation: St. Thomas' Hospital, London, UK.
authors.forename: Vinayak
authors.initials: V
authors.lastname: Bapat
authors.affiliation: Department of Cardiothoracic Surgery, Rikshospital Oslo, Oslo, Norway.
authors.forename: Kjell
authors.initials: K
authors.lastname: Arne Rein
authors.affiliation: Department of Cardiovascular Surgery, CHU Rennes, Rennes, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Verhoye
authors.affiliation: Department of Cardiac Surgery, University of Padova, Padova, Italy.
authors.forename: Gino
authors.initials: G
authors.lastname: Gerosa
authors.affiliation: Department of Cardiovascular Surgery, Robert-Bosch-Krankenhaus Stuttgart, Stuttgart, Germany.
authors.forename: Hardy
authors.initials: H
authors.lastname: Baumbach
authors.affiliation: Department of Cardiac Surgery, Medical University Innsbruck, Innsbruck, Austria.
authors.forename: Markus
authors.initials: M
authors.lastname: Kofler
authors.affiliation: Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
authors.affiliation: Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Deutsch
authors.affiliation: Edwards Lifesciences, Medical Affairs/Professional Education, Nyon, Switzerland.
authors.forename: Martin
authors.initials: M
authors.lastname: Thoenes
authors.affiliation: Department of Internal Medicine III, UKSH, Campus Kiel, Germany.
authors.forename: Derk
authors.initials: D
authors.lastname: Frank
authors.affiliation: Institut Hospitalier Jacques Cartier, Massy, France.
authors.forename: Mauro
authors.initials: M
authors.lastname: Romano
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D011183:Postoperative Complications; D011446:Prospective Studies; D012042:Registries; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000379:methods / Q000401:mortality / Q000706:statistics & numerical data; D016896:Treatment Outcome
keywords: SAPIEN; TAVI; Transaortic; Transapical; Transcatheter Aortic Valve Implantation; Transfemoral