title: Two-in-one aortic valve sizing and valvuloplasty conductance balloon catheter.
abstract: BACKGROUND
  Inaccurate aortic valve sizing and selection is linked to paravalvular leakage in transcatheter aortic valve replacement (TAVR). Here, a novel sizing valvuloplasty conductance balloon (SVCB) catheter is shown to be accurate, reproducible, unbiased, and provides real-time tool for aortic valve sizing that fits within the standard valvuloplasty procedure.
  
  
  RESULTS
  The SVCB catheter is a valvuloplasty device that uses real-time electrical conductance measurements based on Ohm's Law to size the balloon opposed against the aortic valve at any given inflation pressure. Accuracy and repeatability of the SVCB catheter was performed on the bench in phantoms of known dimension and ex vivo in three domestic swine aortic annuli with comparison to computed tomography (CT) and dilator measurements. Procedural workflow and safety was demonstrated in vivo in three additional domestic swine. SVCB catheter measurements had negligible bias or error for bench accuracy considered as the gold standard (Bias: -0.11 ± 0.26 mm; Error: 1.2%), but greater disagreement in ex vivo versus dilators (Bias: -0.3 ± 1.1 mm; Error: 4.5%), and ex vivo versus CT (Bias: -1.0 ± 1.6 mm; Error: 8.7%). The dilator versus CT accuracy showed similar agreement (Bias: -0.9 ± 1.5 mm; Error: 7.3%). Repeatability was excellent on the bench (Bias: 0.02 ± 0.12 mm; Error: 0.5%) and ex vivo (Bias: -0.4 ± 0.9 mm; Error: 4.6%). In animal studies, the device fit well within the procedural workflow with no adverse events or complications.
  
  
  CONCLUSIONS
  Due to the clinical relevance of this accurate, repeatable, unbiased, and real-time sizing measurement, the SVCB catheter may provide a useful tool prior to TAVR. These findings merit a future human study.
authors.affiliation: Department of Biomedical Engineering, Indiana University Purdue University Indianapolis, Indiana.|3DT Holdings LLC, Indianapolis, Indiana.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Svendsen
authors.affiliation: Department of Cardiology, Indiana University Purdue University Indianapolis, Indiana.
authors.forename: Anjan K
authors.initials: AK
authors.lastname: Sinha
authors.affiliation: Department of Biomedical Engineering, Indiana University Purdue University Indianapolis, Indiana.|3DT Holdings LLC, Indianapolis, Indiana.
authors.forename: Zachary C
authors.initials: ZC
authors.lastname: Berwick
authors.affiliation: Department of Biomedical Engineering, Indiana University Purdue University Indianapolis, Indiana.
authors.forename: William
authors.initials: W
authors.lastname: Combs
authors.affiliation: Indiana School of Medicine, Indiana Institute for Biomedical Imaging Sciences, Indianapolis, Indiana.
authors.forename: Shawn D
authors.initials: SD
authors.lastname: Teague
authors.affiliation: Institut Cardiovasculaire Paris Sud, Moassy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefevre
authors.affiliation: Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Vasilis
authors.initials: V
authors.lastname: Babaliaros
authors.affiliation: Department of Biomedical Engineering, Indiana University Purdue University Indianapolis, Indiana.|Department of Surgery, Indiana University Purdue University Indianapolis, Indianapolis, Indiana.|Cellular and Integrative Physiology, Indiana University Purdue University Indianapolis, Indianapolis, Indiana.
authors.forename: Ghassan
authors.initials: G
authors.lastname: Kassab
mesh_terms: D000818:Animals; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D063126:Balloon Valvuloplasty / Q000295:instrumentation*; D004195:Disease Models, Animal; D017548:Echocardiography, Transesophageal; D004867:Equipment Design; D006350:Heart Valve Prosthesis; D011474:Prosthesis Design; D013552:Swine; D014057:Tomography, X-Ray Computed
keywords: CT; Ohm's law; TAVR; annular dimensions; paravalvular leak