title: Balloon expandable transcatheter aortic valve implantation via the transfemoral route with or without pre-dilation of the aortic valve - rationale and design of a multicentre registry (EASE-IT TF).
abstract: Transcatheter aortic valve implantation via the transfemoral route (TF-TAVI) is commonly performed as a treatment for severe aortic stenosis (AS) in patients at high surgical risk. Pre-deployment balloon aortic valvuloplasty (BAV) has generally been considered an essential step for preparing the valve landing zone for receipt of the prosthesis. However, there is little evidence supporting the clinical value of BAV, while several associated complications have been documented. This has provoked several groups to evaluate the feasibility and safety of omitting BAV form the TF-TAVI procedure (direct TF-TAVI), with encouraging results. However, studies comparing the clinical outcomes of direct TF-TAVI to standard TF-TAVI are lacking.
  
  
  
  EASE-IT TF is a prospective, observational, two-armed, multicentre registry designed to gather data on procedural aspects, adverse events and survival rates associated with direct TF-TAVI using the Edwards SAPIEN 3 balloon-expandable prosthesis.
  
  
  
  EASE-IT-TF data will be analysed firstly to determine the risks and benefits associated with direct TF-TAVI vs. standard TF-TAVI, and secondly to identify associations between patient variables and specific outcomes. This may assist identification of patients who stand to benefit from direct TF-TAVI, therefore contributing to clinical reductions in TF-TAVI-associated morbidity and mortality rates in high-risk AS patients.
  
  
  
  Clinictrials.gov: NCT02760771.
authors.affiliation: Department of Cardiology, Immanuel Clinic Bernau, Heart Center Brandenburg, Ladeburger Straße 17, 16321, Bernau, Germany. c.butter@immanuel.de.
authors.forename: Christian
authors.initials: C
authors.lastname: Butter
authors.affiliation: Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
authors.affiliation: Herzzentrum, Universitätsklinikum Köln, Cologne, Germany.
authors.forename: Tanja
authors.initials: T
authors.lastname: Rudolph
authors.affiliation: Herzzentrum, Universitätsklinikum Göttingen, Göttingen, Germany.
authors.forename: Claudius
authors.initials: C
authors.lastname: Jacobshagen
authors.affiliation: Division of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Rothe
authors.affiliation: Universitätsklinik und Poliklinik für Herzchirurgie, Universitätsklinikum Halle, Halle, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.affiliation: Herz- und Gefäß-Klinik, Bad Neustadt, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Kerber
authors.affiliation: ZHK (German Centre for Cardiovascular Research), Partner Site Kiel/Hamburg/Lübeck, Hamburg, Germany.|Department of Internal Medicine III (Cardiology and Angiology), University Hospital Schleswig-Holstein, Campus Kiel, Germany.
authors.forename: Derk
authors.initials: D
authors.lastname: Frank
authors.affiliation: Edwards Lifesciences, Prague, Czech Republic.
authors.forename: Lenka
authors.initials: L
authors.lastname: Seilerova
authors.affiliation: Medical Clinic IV, Department of Cardiology, Municipal Hospital, Karlsruhe, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schymik
mesh_terms: D000368:Aged; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D006328:Cardiac Catheterization / Q000379:methods*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D005471:Fluoroscopy; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D012720:Severity of Illness Index; D025321:Surgery, Computer-Assisted / Q000379:methods*; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*; D016896:Treatment Outcome
keywords: Balloon aortic valvuloplasty (BAV); Direct TAVI; EASE-IT; Edwards SAPIEN; Transcatheter aortic valve implantation; Transfemoral