Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure: A bench study

Janarthanan Sathananthan; Mark Hensey; Stephanie Sellers; Aaron M Barlow; Adnan K Chhatriwalla; Keith B Allen; Anson Cheung; Lars Søndergaard; Philipp Blanke; Jian Ye; Jonathan Leipsic; David Wood; John Webb

doi:10.1002/ccd.28503

Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure: A bench study

Janarthanan Sathananthan, Mark Hensey, Stephanie Sellers, Aaron M Barlow, Adnan K Chhatriwalla, Keith B Allen, Anson Cheung, Lars Søndergaard, Philipp Blanke, Jian Ye, Jonathan Leipsic, David Wood, John Webb

Department of Cardiology

5 Citations (Scopus)

Abstract

OBJECTIVES: We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP).

BACKGROUND: The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations.

METHODS: A 20, 22, 24, 26, and 28 mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z-MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator.

RESULTS: The mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon at nominal pressure (3 atm) was 20.02 ± 0.09, 21.77 ± 0.07, 23.9 ± 0.06, 25.82 ± 0.08, and 27.62 ± 0.08 mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon was 20.39 ± 0.03 mm (15 atm), 22.35 ± 0.03 mm (15 atm), 24.55 ± 0.02 mm (15 atm), 26.48 ± 0.02 mm (12 atm), and 28.39 ± 0.03 mm (12 atm), respectively. The 20/22/24 and 26/28 mm balloon failed when inflated beyond 15 atm and 12 atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z-MED balloons.

CONCLUSION: The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12 atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.

Original language	English
Journal	Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Volume	96
Issue number	2
Pages (from-to)	E187-E195
ISSN	1522-1946
DOIs	https://doi.org/10.1002/ccd.28503
Publication status	Published - Aug 2020

Keywords

aortic stenosis
balloon valvuloplasty
degenerative valve
other
valve restenosis

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10.1002/ccd.28503

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Sathananthan, J., Hensey, M., Sellers, S., Barlow, A. M., Chhatriwalla, A. K., Allen, K. B., Cheung, A., Søndergaard, L., Blanke, P., Ye, J., Leipsic, J., Wood, D., & Webb, J. (2020). Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure: A bench study. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 96(2), E187-E195. https://doi.org/10.1002/ccd.28503

Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure : A bench study. / Sathananthan, Janarthanan; Hensey, Mark; Sellers, Stephanie et al.

In: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, Vol. 96, No. 2, 08.2020, p. E187-E195.

Research output: Contribution to journal › Journal article › Research › peer-review

Sathananthan, J, Hensey, M, Sellers, S, Barlow, AM, Chhatriwalla, AK, Allen, KB, Cheung, A, Søndergaard, L, Blanke, P, Ye, J, Leipsic, J, Wood, D & Webb, J 2020, 'Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure: A bench study', Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, vol. 96, no. 2, pp. E187-E195. https://doi.org/10.1002/ccd.28503

Sathananthan J, Hensey M, Sellers S, Barlow AM, Chhatriwalla AK, Allen KB et al. Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure: A bench study. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2020 Aug;96(2):E187-E195. https://doi.org/10.1002/ccd.28503

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abstract = "OBJECTIVES: We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP).BACKGROUND: The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations.METHODS: A 20, 22, 24, 26, and 28 mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z-MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator.RESULTS: The mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon at nominal pressure (3 atm) was 20.02 ± 0.09, 21.77 ± 0.07, 23.9 ± 0.06, 25.82 ± 0.08, and 27.62 ± 0.08 mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon was 20.39 ± 0.03 mm (15 atm), 22.35 ± 0.03 mm (15 atm), 24.55 ± 0.02 mm (15 atm), 26.48 ± 0.02 mm (12 atm), and 28.39 ± 0.03 mm (12 atm), respectively. The 20/22/24 and 26/28 mm balloon failed when inflated beyond 15 atm and 12 atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z-MED balloons.CONCLUSION: The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12 atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.",

keywords = "aortic stenosis, balloon valvuloplasty, degenerative valve, other, valve restenosis",

author = "Janarthanan Sathananthan and Mark Hensey and Stephanie Sellers and Barlow, {Aaron M} and Chhatriwalla, {Adnan K} and Allen, {Keith B} and Anson Cheung and Lars S{\o}ndergaard and Philipp Blanke and Jian Ye and Jonathan Leipsic and David Wood and John Webb",

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issn = "1522-1946",

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T1 - Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure

T2 - A bench study

AU - Sathananthan, Janarthanan

AU - Hensey, Mark

AU - Sellers, Stephanie

AU - Barlow, Aaron M

AU - Chhatriwalla, Adnan K

AU - Allen, Keith B

AU - Cheung, Anson

AU - Søndergaard, Lars

AU - Blanke, Philipp

AU - Ye, Jian

AU - Leipsic, Jonathan

AU - Wood, David

AU - Webb, John

PY - 2020/8

Y1 - 2020/8

N2 - OBJECTIVES: We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP).BACKGROUND: The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations.METHODS: A 20, 22, 24, 26, and 28 mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z-MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator.RESULTS: The mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon at nominal pressure (3 atm) was 20.02 ± 0.09, 21.77 ± 0.07, 23.9 ± 0.06, 25.82 ± 0.08, and 27.62 ± 0.08 mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon was 20.39 ± 0.03 mm (15 atm), 22.35 ± 0.03 mm (15 atm), 24.55 ± 0.02 mm (15 atm), 26.48 ± 0.02 mm (12 atm), and 28.39 ± 0.03 mm (12 atm), respectively. The 20/22/24 and 26/28 mm balloon failed when inflated beyond 15 atm and 12 atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z-MED balloons.CONCLUSION: The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12 atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.

AB - OBJECTIVES: We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP).BACKGROUND: The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations.METHODS: A 20, 22, 24, 26, and 28 mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z-MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator.RESULTS: The mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon at nominal pressure (3 atm) was 20.02 ± 0.09, 21.77 ± 0.07, 23.9 ± 0.06, 25.82 ± 0.08, and 27.62 ± 0.08 mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon was 20.39 ± 0.03 mm (15 atm), 22.35 ± 0.03 mm (15 atm), 24.55 ± 0.02 mm (15 atm), 26.48 ± 0.02 mm (12 atm), and 28.39 ± 0.03 mm (12 atm), respectively. The 20/22/24 and 26/28 mm balloon failed when inflated beyond 15 atm and 12 atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z-MED balloons.CONCLUSION: The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12 atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.

KW - aortic stenosis

KW - balloon valvuloplasty

KW - degenerative valve

KW - other

KW - valve restenosis

U2 - 10.1002/ccd.28503

DO - 10.1002/ccd.28503

M3 - Journal article

C2 - 31566873

VL - 96

SP - E187-E195

JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

SN - 1522-1946

IS - 2

ER -

Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure: A bench study

Abstract

Keywords

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