Document Detail

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.
MedLine Citation:
PMID:  15976802     Owner:  NLM     Status:  MEDLINE    
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.
Joseph P Carrozza; Christophe Caussin; Gregory Braden; Peter Braun; Forde Hansell; Robin Fatzinger; Greg Walters; William Kussmaul; Jeffrey Breall;
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  American heart journal     Volume:  149     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2005 Jun 
Date Detail:
Created Date:  2005-06-24     Completed Date:  2005-11-28     Revised Date:  2006-02-27    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1136     Citation Subset:  AIM; IM    
Section of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.
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MeSH Terms
Aged, 80 and over
Analysis of Variance
Atherosclerosis / complications,  therapy*
Balloon Occlusion*
Embolism / etiology,  prevention & control*
Equipment Design
Intraoperative Care
Middle Aged
Pilot Projects
Saphenous Vein / transplantation*
United States

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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