MAQUET Cardiovascular initiates study evaluating EVH in CABG compared to open vein harvesting

Jan 27 2010

MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, today announced the initiation of the OPTION (Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques) study. This clinical trial is designed to evaluate the equivalence of Endoscopic Vessel Harvesting (EVH) in Coronary Artery Bypass Graft (CABG) surgery compared with historical data for open vein harvesting.  David Moore, M.D., of THE HEART HOSPITAL Baylor Plano is the principal investigator for the OPTION trial.

"We believe the OPTION study will address the shortcomings of previous studies evaluating EVH in CABG.  The study will emphasize the importance of standardization in harvest procedure, operator experience and medical management, and provide a more contemporary representation of the quality of conduit harvested with the EVH technique," said Michael J. Mack, M.D., Research Director, THE HEART HOSPITAL Baylor Plano.  

OPTION is a 100-patient, single-center study that will evaluate vein graft patency at one month and one year following CABG surgery.  The study standardizes a number of pre- and post-harvesting factors and will utilize the VASOVIEW HEMOPRO technology system, as well as experienced harvesters with the appropriate skill level to best preserve and protect the vessel.  

"The OPTION study underscores MAQUET Cardiovascular's commitment to advancing EVH instrumentation and procedures as well as advancing the dialogue among cardiovascular surgeons about the benefits of EVH," said Luca Lombardi, M.D., Chief Medical Officer of MAQUET Cardiovascular.  "We believe the OPTION study's scientific rigor will validate the safety and efficacy of EVH, without subjecting patients to complications associated with open harvesting techniques that a randomized study would require."