Recanalization of CTos with soundBite™ active Wire

Marianne Brodmann, Eric ThÉRasse, Andrew Benko, Louis Philippe Riel, Steven Dion, Philippe Genereux, Martin Brouillette

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: The aim of this study was to examine the safety and effcacy of the SoundBite™ Crossing System for the recanalization of infrainguinal chronic total occlusion (CTo) lesions. CTos are frequent among patients with severe claudication or critical limb ischemia. failure to recanalize CTos remains common and is associated with poor prognosis. The soundBite™ Crossing system (soundBite Medical solutions inc., Montreal, QC, Canada) is a newly developed device that uses a 0.018-inch wire (soundBite™ active Wire) to deliver acoustic shock waves to the distal tip of a steerable guidewire to facilitate directed penetration of the proximal cap and crossing of the occlusion. MeThods: symptomatic patients with de novo infrainguinal CTos from 3 centers were enrolled in a prospective, single-arm feasibility study. The primary endpoint was 30-day device success defned as composite of technical success, defned as penetration and progression within the CTo with the soundBite™ active Wire followed by complete recanalization, and freedom from device-related major adverse events including death, urgent amputation, clinically-driven target vessel revascularization, perforation, type =C dissection, or distal embolization requiring intervention. resulTs: Thirty-seven patients including 41 CTo lesions were enrolled in this study. CTo length ranged from 10 mm to 270 mm (mean 97.9±77.4 mm), and moderate-to-severe calcifcation was present in 24 (58.5%) of the treated lesions. CTOs were successfully crossed in 34 (91.9%) patients. No device-related adverse events occurred, resulting in a 30-day device success rate of 91.9%. Compared with baseline, 30-day ankle brachial index (0.66±0.24 versus 0.89±0.20; P<0.001) and rutherford class (3 [2, 4] versus 0 [0, 1], P<0.001) signifcantly improved. CONCLUSIONS: The SoundBite™ Active Wire Crossing System feasibility study demonstrates a favorable safety and effcacy profle for the soundBite™ active Wire in infrainguinal CTos.

Original languageEnglish (US)
Pages (from-to)529-537
Number of pages9
JournalJournal of Cardiovascular Surgery
Volume59
Issue number4
DOIs
StatePublished - Aug 1 2018
Externally publishedYes

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Equipment and Supplies
Feasibility Studies
Safety
Ankle Brachial Index
Amputation
Canada
Dissection
Ischemia
Extremities

All Science Journal Classification (ASJC) codes

  • Surgery
  • Cardiology and Cardiovascular Medicine

Cite this

Brodmann, M., ThÉRasse, E., Benko, A., Riel, L. P., Dion, S., Genereux, P., & Brouillette, M. (2018). Recanalization of CTos with soundBite™ active Wire. Journal of Cardiovascular Surgery, 59(4), 529-537. https://doi.org/10.23736/s0021-9509.18.10587-8
Brodmann, Marianne ; ThÉRasse, Eric ; Benko, Andrew ; Riel, Louis Philippe ; Dion, Steven ; Genereux, Philippe ; Brouillette, Martin. / Recanalization of CTos with soundBite™ active Wire. In: Journal of Cardiovascular Surgery. 2018 ; Vol. 59, No. 4. pp. 529-537.
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title = "Recanalization of CTos with soundBite™ active Wire",
abstract = "Background: The aim of this study was to examine the safety and effcacy of the SoundBite™ Crossing System for the recanalization of infrainguinal chronic total occlusion (CTo) lesions. CTos are frequent among patients with severe claudication or critical limb ischemia. failure to recanalize CTos remains common and is associated with poor prognosis. The soundBite™ Crossing system (soundBite Medical solutions inc., Montreal, QC, Canada) is a newly developed device that uses a 0.018-inch wire (soundBite™ active Wire) to deliver acoustic shock waves to the distal tip of a steerable guidewire to facilitate directed penetration of the proximal cap and crossing of the occlusion. MeThods: symptomatic patients with de novo infrainguinal CTos from 3 centers were enrolled in a prospective, single-arm feasibility study. The primary endpoint was 30-day device success defned as composite of technical success, defned as penetration and progression within the CTo with the soundBite™ active Wire followed by complete recanalization, and freedom from device-related major adverse events including death, urgent amputation, clinically-driven target vessel revascularization, perforation, type =C dissection, or distal embolization requiring intervention. resulTs: Thirty-seven patients including 41 CTo lesions were enrolled in this study. CTo length ranged from 10 mm to 270 mm (mean 97.9±77.4 mm), and moderate-to-severe calcifcation was present in 24 (58.5{\%}) of the treated lesions. CTOs were successfully crossed in 34 (91.9{\%}) patients. No device-related adverse events occurred, resulting in a 30-day device success rate of 91.9{\%}. Compared with baseline, 30-day ankle brachial index (0.66±0.24 versus 0.89±0.20; P<0.001) and rutherford class (3 [2, 4] versus 0 [0, 1], P<0.001) signifcantly improved. CONCLUSIONS: The SoundBite™ Active Wire Crossing System feasibility study demonstrates a favorable safety and effcacy profle for the soundBite™ active Wire in infrainguinal CTos.",
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Brodmann, M, ThÉRasse, E, Benko, A, Riel, LP, Dion, S, Genereux, P & Brouillette, M 2018, 'Recanalization of CTos with soundBite™ active Wire', Journal of Cardiovascular Surgery, vol. 59, no. 4, pp. 529-537. https://doi.org/10.23736/s0021-9509.18.10587-8

Recanalization of CTos with soundBite™ active Wire. / Brodmann, Marianne; ThÉRasse, Eric; Benko, Andrew; Riel, Louis Philippe; Dion, Steven; Genereux, Philippe; Brouillette, Martin.

In: Journal of Cardiovascular Surgery, Vol. 59, No. 4, 01.08.2018, p. 529-537.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Recanalization of CTos with soundBite™ active Wire

AU - Brodmann, Marianne

AU - ThÉRasse, Eric

AU - Benko, Andrew

AU - Riel, Louis Philippe

AU - Dion, Steven

AU - Genereux, Philippe

AU - Brouillette, Martin

PY - 2018/8/1

Y1 - 2018/8/1

N2 - Background: The aim of this study was to examine the safety and effcacy of the SoundBite™ Crossing System for the recanalization of infrainguinal chronic total occlusion (CTo) lesions. CTos are frequent among patients with severe claudication or critical limb ischemia. failure to recanalize CTos remains common and is associated with poor prognosis. The soundBite™ Crossing system (soundBite Medical solutions inc., Montreal, QC, Canada) is a newly developed device that uses a 0.018-inch wire (soundBite™ active Wire) to deliver acoustic shock waves to the distal tip of a steerable guidewire to facilitate directed penetration of the proximal cap and crossing of the occlusion. MeThods: symptomatic patients with de novo infrainguinal CTos from 3 centers were enrolled in a prospective, single-arm feasibility study. The primary endpoint was 30-day device success defned as composite of technical success, defned as penetration and progression within the CTo with the soundBite™ active Wire followed by complete recanalization, and freedom from device-related major adverse events including death, urgent amputation, clinically-driven target vessel revascularization, perforation, type =C dissection, or distal embolization requiring intervention. resulTs: Thirty-seven patients including 41 CTo lesions were enrolled in this study. CTo length ranged from 10 mm to 270 mm (mean 97.9±77.4 mm), and moderate-to-severe calcifcation was present in 24 (58.5%) of the treated lesions. CTOs were successfully crossed in 34 (91.9%) patients. No device-related adverse events occurred, resulting in a 30-day device success rate of 91.9%. Compared with baseline, 30-day ankle brachial index (0.66±0.24 versus 0.89±0.20; P<0.001) and rutherford class (3 [2, 4] versus 0 [0, 1], P<0.001) signifcantly improved. CONCLUSIONS: The SoundBite™ Active Wire Crossing System feasibility study demonstrates a favorable safety and effcacy profle for the soundBite™ active Wire in infrainguinal CTos.

AB - Background: The aim of this study was to examine the safety and effcacy of the SoundBite™ Crossing System for the recanalization of infrainguinal chronic total occlusion (CTo) lesions. CTos are frequent among patients with severe claudication or critical limb ischemia. failure to recanalize CTos remains common and is associated with poor prognosis. The soundBite™ Crossing system (soundBite Medical solutions inc., Montreal, QC, Canada) is a newly developed device that uses a 0.018-inch wire (soundBite™ active Wire) to deliver acoustic shock waves to the distal tip of a steerable guidewire to facilitate directed penetration of the proximal cap and crossing of the occlusion. MeThods: symptomatic patients with de novo infrainguinal CTos from 3 centers were enrolled in a prospective, single-arm feasibility study. The primary endpoint was 30-day device success defned as composite of technical success, defned as penetration and progression within the CTo with the soundBite™ active Wire followed by complete recanalization, and freedom from device-related major adverse events including death, urgent amputation, clinically-driven target vessel revascularization, perforation, type =C dissection, or distal embolization requiring intervention. resulTs: Thirty-seven patients including 41 CTo lesions were enrolled in this study. CTo length ranged from 10 mm to 270 mm (mean 97.9±77.4 mm), and moderate-to-severe calcifcation was present in 24 (58.5%) of the treated lesions. CTOs were successfully crossed in 34 (91.9%) patients. No device-related adverse events occurred, resulting in a 30-day device success rate of 91.9%. Compared with baseline, 30-day ankle brachial index (0.66±0.24 versus 0.89±0.20; P<0.001) and rutherford class (3 [2, 4] versus 0 [0, 1], P<0.001) signifcantly improved. CONCLUSIONS: The SoundBite™ Active Wire Crossing System feasibility study demonstrates a favorable safety and effcacy profle for the soundBite™ active Wire in infrainguinal CTos.

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