Two-in-one aortic valve sizing and valvuloplasty conductance balloon catheter

Mark C. Svendsen, Anjan Sinha, Zachary C. Berwick, William Combs, Shawn D. Teague, Thierry Lefevre, Vasilis Babaliaros, Ghassan Kassab

Research output: Contribution to journalArticle

1 Citation (Scopus)

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. Methods and 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.

Original languageEnglish
Pages (from-to)136-143
Number of pages8
JournalCatheterization and Cardiovascular Interventions
Volume86
Issue number1
DOIs
StatePublished - Jul 1 2015

Fingerprint

Balloon Valvuloplasty
Aortic Valve
Catheters
Workflow
Tomography
Swine
Equipment and Supplies
Economic Inflation
Safety
Pressure

Keywords

  • annular dimensions
  • CT
  • Ohm's law
  • paravalvular leak
  • TAVR

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

Cite this

Svendsen, M. C., Sinha, A., Berwick, Z. C., Combs, W., Teague, S. D., Lefevre, T., ... Kassab, G. (2015). Two-in-one aortic valve sizing and valvuloplasty conductance balloon catheter. Catheterization and Cardiovascular Interventions, 86(1), 136-143. https://doi.org/10.1002/ccd.25774

Two-in-one aortic valve sizing and valvuloplasty conductance balloon catheter. / Svendsen, Mark C.; Sinha, Anjan; Berwick, Zachary C.; Combs, William; Teague, Shawn D.; Lefevre, Thierry; Babaliaros, Vasilis; Kassab, Ghassan.

In: Catheterization and Cardiovascular Interventions, Vol. 86, No. 1, 01.07.2015, p. 136-143.

Research output: Contribution to journalArticle

Svendsen, MC, Sinha, A, Berwick, ZC, Combs, W, Teague, SD, Lefevre, T, Babaliaros, V & Kassab, G 2015, 'Two-in-one aortic valve sizing and valvuloplasty conductance balloon catheter', Catheterization and Cardiovascular Interventions, vol. 86, no. 1, pp. 136-143. https://doi.org/10.1002/ccd.25774
Svendsen, Mark C. ; Sinha, Anjan ; Berwick, Zachary C. ; Combs, William ; Teague, Shawn D. ; Lefevre, Thierry ; Babaliaros, Vasilis ; Kassab, Ghassan. / Two-in-one aortic valve sizing and valvuloplasty conductance balloon catheter. In: Catheterization and Cardiovascular Interventions. 2015 ; Vol. 86, No. 1. pp. 136-143.
@article{19dd9d85d61d4e6684e91e06a8b57bc1,
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. Methods and 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.",
keywords = "annular dimensions, CT, Ohm's law, paravalvular leak, TAVR",
author = "Svendsen, {Mark C.} and Anjan Sinha and Berwick, {Zachary C.} and William Combs and Teague, {Shawn D.} and Thierry Lefevre and Vasilis Babaliaros and Ghassan Kassab",
year = "2015",
month = "7",
day = "1",
doi = "10.1002/ccd.25774",
language = "English",
volume = "86",
pages = "136--143",
journal = "Catheterization and Cardiovascular Interventions",
issn = "1522-1946",
publisher = "Wiley-Liss Inc.",
number = "1",

}

TY - JOUR

T1 - Two-in-one aortic valve sizing and valvuloplasty conductance balloon catheter

AU - Svendsen, Mark C.

AU - Sinha, Anjan

AU - Berwick, Zachary C.

AU - Combs, William

AU - Teague, Shawn D.

AU - Lefevre, Thierry

AU - Babaliaros, Vasilis

AU - Kassab, Ghassan

PY - 2015/7/1

Y1 - 2015/7/1

N2 - 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. Methods and 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.

AB - 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. Methods and 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.

KW - annular dimensions

KW - CT

KW - Ohm's law

KW - paravalvular leak

KW - TAVR

UR - http://www.scopus.com/inward/record.url?scp=84931834801&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84931834801&partnerID=8YFLogxK

U2 - 10.1002/ccd.25774

DO - 10.1002/ccd.25774

M3 - Article

C2 - 25510238

AN - SCOPUS:84931834801

VL - 86

SP - 136

EP - 143

JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

SN - 1522-1946

IS - 1

ER -