title: One-Year Outcomes of Transcatheter Aortic Valve Implantation Using the Direct Aortic Approach.
abstract: BACKGROUND
  The direct aortic (DA) approach allows for transcatheter aortic valve implantation (TAVI) in patients with difficult peripheral vascular anatomy. The CoreValve ADVANCE Direct Aortic (ADVANCE DA) study was performed to assess the outcomes of DA TAVI with the CoreValve System (Medtronic, Minneapolis, MN) in routine practice.
  
  
  METHODS
  Patients were selected for the DA approach by local cardiac surgical teams, and TAVI was performed with patients under general anesthesia. Safety events were adjudicated according to the Valve Academic Research Consortium-2 definitions by an independent clinical events committee. All imaging data, including that from multislice computed tomography and follow-up echocardiography, were analyzed by an independent core laboratory.
  
  
  RESULTS
  From September 2012 to February 2014, 100 patients were enrolled (52.0% male, age 81.9 ± 5.9 years, The Society of Thoracic Surgeons Score 5.9 ± 3.2%) at 9 centers in Europe. Peripheral vascular disease was present in 51.0% of patients, and 38.0% had diabetes. Of the 100 patients enrolled, 92 underwent TAVI. At 30 days after TAVI, 98.1% were free of moderate or severe paravalvular leak. At 1 year, 16 patients had died (Kaplan-Meier rate 17.9%), 1 (1.1%) patient had had a stroke, classified as nondisabling, and 15 (17.0%) patients had received a permanent pacemaker. Most patients experienced improved quality of life as measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (mean change from baseline to 1 year, 39.6 ± 26.3; p < 0.01).
  
  
  CONCLUSIONS
  The DA approach provides a feasible alternative for patients with challenging anatomic features that may otherwise preclude use of the TAVI procedure.
authors: A. DeGasperis Cardiology and Cardiac Surgery Department, Niguarda Ca' Granda Hospital, Milan, Italy.
authors: Giuseppe
authors: G
authors: Bruschi
authors: Cardiology Department, Cardiocenter Hospital Podlesi, Trinec, Czech Republic.
authors: Marian
authors: M
authors: Branny
authors: Medtronic, Minneapolis, Minnesota.
authors: Molly
authors: M
authors: Schiltgen
authors: Cardiothoracic Department, Spedali Civili di Brescia, Brescia, Italy.
authors: Federica
authors: F
authors: Ettori
authors: Pole Cardiovasculaire et Metabolique, Hôpital de Rangueil, Toulouse, France.
authors: Bertrand
authors: B
authors: Marcheix
authors: Department of Cardiothoracic Surgery, Medisch Centrum Leeuwarden, Leeuwarden, the Netherlands.
authors: Hafid
authors: H
authors: Amrane
authors: Department of Cardiac and Thoracic Surgery, Martin Luther Universität Halle-Wittenberg, Halle, Germany.
authors: Hasan
authors: H
authors: Bushnaq
authors: Department of Cardiothoracic Surgery, Catharina Hospital, Eindhoven, the Netherlands.
authors: M Erwin S H
authors: MESH
authors: Tan
authors: Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom.
authors: Uday
authors: U
authors: Trivedi
authors: Cardiology Department, Cardiocenter Hospital Podlesi, Trinec, Czech Republic.
authors: Piotr
authors: P
authors: Branny
authors: A. DeGasperis Cardiology and Cardiac Surgery Department, Niguarda Ca' Granda Hospital, Milan, Italy.
authors: Silvio
authors: S
authors: Klugmann
authors: Cardiothoracic Department, Spedali Civili di Brescia, Brescia, Italy.
authors: Giuseppe
authors: G
authors: Coletti
authors: Pole Cardiovasculaire et Metabolique, Hôpital de Rangueil, Toulouse, France.
authors: Nicolas
authors: N
authors: Dumonteil
authors: Department of Cardiothoracic Surgery, Medisch Centrum Leeuwarden, Leeuwarden, the Netherlands.
authors: Fabiano
authors: F
authors: Porta
authors: NAMSA, Minneapolis, Minnesota.
authors: Anna
authors: A
authors: Nordell
authors: Cardiovascular BRU, Royal Brompton & Harefield NHS Trust, London, United Kingdom. Electronic address: n.moat@rbht.nhs.uk.
authors: Neil
authors: N
authors: Moat
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000601:surgery*; D001027:Aortography; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D061330:Multidetector Computed Tomography; D011183:Postoperative Complications / Q000209:etiology*; D011446:Prospective Studies; D011474:Prosthesis Design; D011788:Quality of Life; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome