Embolic protection during saphenous vein graft intervention using a second-generation balloon protection device: Results from the combined US and European pilot study of the TriActiv Balloon Protected Flush Extraction System

Joseph P. Carrozza, Christophe Caussin, Gregory Braden, Peter Braun, Forde Hansell, Robin Fatzinger, Greg Walters, William Kussmaul, Jeffrey Breall

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Stent placement in saphenous vein bypass grafts is associated with a high incidence of myonecrosis usually resulting from embolization of thrombus and friable atheroma. Embolic protection devices reduce the incidence of adverse events after vein graft stenting. However, first-generation balloon occlusion systems are still associated with a 10% incidence of periprocedural adverse events. We report the first experience with a new second-generation balloon occlusion embolic protection device, the TriActiv Balloon Protected Flush Extraction System. Methods: Ninety-six lesions in 78 saphenous vein grafts were treated in 74 patients. The primary end point was major adverse cardiovascular events at 30 days. Results: Device success was achieved in 92% of patients, and atheromatous debris was recovered in 69% of analyzed aspirates. By 30 days, major adverse cardiovascular events, which were limited to non-Q-wave myocardial infarctions, occurred in 16.2%. Per protocol analysis in patients with device success revealed a rate of adverse events of only 5.7%. Conclusions: The initial experience with the TriActiv Balloon Protected Flush Extraction System demonstrated a high success rate and recovery of embolic debris with an acceptable rate of adverse events. A large randomized trial will compare this device to other embolic protection systems.

Original languageEnglish
JournalAmerican Heart Journal
Volume149
Issue number6
DOIs
StatePublished - Jun 2005

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Saphenous Vein
Embolic Protection Devices
Balloon Occlusion
Transplants
Equipment and Supplies
Incidence
Atherosclerotic Plaques
Stents
Veins
Thrombosis
Myocardial Infarction

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Embolic protection during saphenous vein graft intervention using a second-generation balloon protection device : Results from the combined US and European pilot study of the TriActiv Balloon Protected Flush Extraction System. / Carrozza, Joseph P.; Caussin, Christophe; Braden, Gregory; Braun, Peter; Hansell, Forde; Fatzinger, Robin; Walters, Greg; Kussmaul, William; Breall, Jeffrey.

In: American Heart Journal, Vol. 149, No. 6, 06.2005.

Research output: Contribution to journalArticle

Carrozza, Joseph P. ; Caussin, Christophe ; Braden, Gregory ; Braun, Peter ; Hansell, Forde ; Fatzinger, Robin ; Walters, Greg ; Kussmaul, William ; Breall, Jeffrey. / Embolic protection during saphenous vein graft intervention using a second-generation balloon protection device : Results from the combined US and European pilot study of the TriActiv Balloon Protected Flush Extraction System. In: American Heart Journal. 2005 ; Vol. 149, No. 6.
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abstract = "Background: Stent placement in saphenous vein bypass grafts is associated with a high incidence of myonecrosis usually resulting from embolization of thrombus and friable atheroma. Embolic protection devices reduce the incidence of adverse events after vein graft stenting. However, first-generation balloon occlusion systems are still associated with a 10{\%} incidence of periprocedural adverse events. We report the first experience with a new second-generation balloon occlusion embolic protection device, the TriActiv Balloon Protected Flush Extraction System. Methods: Ninety-six lesions in 78 saphenous vein grafts were treated in 74 patients. The primary end point was major adverse cardiovascular events at 30 days. Results: Device success was achieved in 92{\%} of patients, and atheromatous debris was recovered in 69{\%} of analyzed aspirates. By 30 days, major adverse cardiovascular events, which were limited to non-Q-wave myocardial infarctions, occurred in 16.2{\%}. Per protocol analysis in patients with device success revealed a rate of adverse events of only 5.7{\%}. Conclusions: The initial experience with the TriActiv Balloon Protected Flush Extraction System demonstrated a high success rate and recovery of embolic debris with an acceptable rate of adverse events. A large randomized trial will compare this device to other embolic protection systems.",
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AU - Caussin, Christophe

AU - Braden, Gregory

AU - Braun, Peter

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AU - Walters, Greg

AU - Kussmaul, William

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