title: The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis.
abstract: OBJECTIVE
  Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis (AS) at high surgical risk. The JenaValve™ is a second-generation, self-expanding transcatheter heart valve (THV), implanted through transapical access (TA). During stent deployment, a specific 'clipping-mechanism' engages native aortic valve cusps for fixation. We present 1-year outcomes of the JUPITER registry, a post-market registry of the JenaValve for TA-TAVR.
  
  
  METHODS
  The JUPITER registry is a prospective, multicentre, uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV. A total of 180 patients with AS were enrolled between 2012 and 2014. End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions.
  
  
  RESULTS
  The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7%. The procedure was successful in 95.0% (171/180), implantation of a second THV (valve-in-valve) was performed in 2.2% (4/180) and conversion to surgical aortic valve replacement (SAVR) was necessary in 2.8% (5/180). No annular rupture or coronary ostia obstruction occurred. Two patients required SAVR after the day of index procedure (1.1%). All-cause mortality at 30 days was 11.1% (20/180), being cardiovascular in 7.2% (13/180). A major stroke occurred in 1.1% (2/180) at 30 days, no additional major strokes were observed during 1 year. All-cause mortality after 30 days was 13.1% (21/160) and combined efficacy at 1 year was 80.8% (122/151). At 1-year follow-up, no patient presented with more than moderate paravalvular leakage, while 2 patients (3.2%) showed moderate, 12 (19.0%) mild and 49 (82.4%) trace/none paravalvular regurgitation.
  
  
  CONCLUSIONS
  In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia obstruction, annular rupture or with limited aortic valve calcification, the JenaValve might be preferable for implantation due to its clipping-mechanism engaging native aortic valve cusps for fixation with reduced radial forces of the self-expanding stent.
authors.affiliation: Department of Cardiothoracic Surgery, King's College Hospital London, London, UK.
authors.forename: Miriam
authors.initials: M
authors.lastname: Silaschi
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.affiliation: Department of Cardiac Surgery, Center of Cardiovascular Diseases Rotenburg a. d. Fulda, Rotenburg, Germany.
authors.forename: Ardawan J
authors.initials: AJ
authors.lastname: Rastan
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 Cardiovascular Surgery Freiburg, University Heart Center Freiburg-Bad Krozingen, Freiburg, Germany.
authors.forename: Friedhelm
authors.initials: F
authors.lastname: Beyersdorf
authors.affiliation: Department of Cardiac Surgery, University Heart Center Dresden, Dresden, Germany.
authors.forename: Utz
authors.initials: U
authors.lastname: Kappert
authors.affiliation: Department of Cardiovascular Surgery, Klinikum Bogenhausen, Munich, Germany.
authors.forename: Walter
authors.initials: W
authors.lastname: Eichinger
authors.affiliation: Department of Cardiac Surgery, University Hospital Basel, Basel, Switzerland.
authors.forename: Florian
authors.initials: F
authors.lastname: Rüter
authors.affiliation: Department of Cardiothoracic Surgery, St. Antonius Hospital, Nieuwegein, Netherlands.
authors.forename: Thomas L
authors.initials: TL
authors.lastname: de Kroon
authors.affiliation: Department of Cardiovascular Surgery, German Heart Center Munich at Technische Universität München, Munich, Germany.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Lange
authors.affiliation: Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Ensminger
authors.affiliation: Department of Cardiothoracic Surgery, King's College Hospital London, London, UK olaf.wendler@nhs.net.
authors.forename: Olaf
authors.initials: O
authors.lastname: Wendler
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000401:mortality / Q000503:physiopathology / Q000534:rehabilitation / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000503:physiopathology / Q000534:rehabilitation / Q000601:surgery*; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D011788:Quality of Life; D012042:Registries; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation / Q000379:methods* / Q000534:rehabilitation; D016896:Treatment Outcome
keywords: Aortic stenosis; TAVI; TAVR; Transcatheter heart valves