MAQUET enrolls first patient in OPTION trial

Sep 23 2010

MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, today announced enrollment of the first patient in the OPTION (Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques) trial which is designed to assess patient outcomes using a standardized, best practices approach in endoscopic vessel harvesting (EVH) for coronary artery bypass graft surgery (CABG) compared with open vein harvesting methods.

The 100-patient OPTION trial is being led by principal investigator, Dr. David Moore of the HEART HOSPITAL Baylor Plano and will be conducted at that center as well as the Medical City Dallas Hospital, which enrolled the first patient (a 65-year-old male, who received four grafts with two arteries and two grafts using saphenous veins harvested using MAQUET's VASOVIEW HEMOPRO 2 EVH system).

"The OPTION study is an important and timely trial because the protocol standardizes harvest procedure, operator experience and medical management. As a result, it will address the shortcomings of previous studies and provide a more contemporary representation of the quality of conduit harvested with the EVH technique," said Dr. Moore.  

"As recently observed with the three-year SYNTAX data, surgery is the best option for close to two-thirds of patients with coronary artery disease," said Dr. Subramanian, M.D., Chairman, Department of Cardiothoracic Surgery, and Director, Department of Surgery at Lenox Hill Hospital in New York. "As more patients are indicated for surgery, it is important to ensure the highest level of conduit vessel quality through the use of next generation technology to further improve the surgeon's experience and patient outcomes."  

The OPTION study will utilize the latest generation VASOVIEW HEMOPRO 2 EVH System, allowing harvesters to achieve zero thermal spread which will further protect conduit quality and improve clinical outcomes and patient quality of life.

Additionally, the study is utilizing experienced harvesters with an appropriate skill level to best preserve and protect the vessel. The study also standardizes a number of pre- and post-harvesting factors, including the use of controlled pressure during conduit preparation with MAQUET's VASOSHIELD Pressure Controlling Syringe.  Vein graft patency will be evaluated at one month and one year following CABG surgery.

"Enrollment of the first patient in the OPTION trial represents an important milestone, as we believe the study will significantly advance EVH practice by validating state-of-the-art EVH instrumentation and best harvest techniques as well as reinforce the benefits of EVH among the cardiovascular community," said Luca Lombardi, M.D., Chief Medical Officer of MAQUET Cardiovascular.  

SOURCE MAQUET Cardiovascular LLC