ATLANTA – Building on the umbrella emphasis on cardiac imaging at this year's scientific meeting of the American College of Cardiology (ACC; Bethesda, Maryland),GE Healthcare (Waukesha, Wisconsin) unveiled plans for the first in a series of multicenter, multipatient trials to further validate the clinical efficacy of 64-slice computed tomography (CT) as a method for the diagnosis and treatment planning of cardiovascular disease.
This multicenter trial will use the company's LightSpeed VCT system, with enhanced ergonomic features, to demonstrate its efforts in providing faster, more accurate diagnostic capabilities and avoiding downstream invasive procedures.
Cardiac catheterization, the current gold standard for diagnosing CAD, is an invasive and costly procedure that can impose unnecessary stress to patients.
About 30% of those who undergo this cath lab procedure do not need, since they are found to present with no significant coronary artery disease (CAD) and this can be managed with therapeutics and lifestyle changes, according to Bob Davis, general manager for GE Healthcare's Americas cardiology sales and marketing.
The trial will involve 20 centers, with the results of Lightspeed scanning compared to cath lab diagnosis, Davis told Medical Device Daily, which he called, thus far, the “gold standard“ in this area.
He said that most previous studies have been single-arm efforts that have generally demonstrated the benefits of the 64-slice scanning system and that the GE-sponsored trial will be the first longitudinal study using a control group.
He said that the study intent is really twofold.
“Payers need this kind of data,“ he said, to be convinced that there is a cost savings in the use of the CT scanning as an alternative to the more expensive, more invasive cath lab procedure.
But the study will also be focused on patient management of “lower to moderate risk“ patients and perhaps provide guidance in developing changes in the management of such patients. Thus, the study will be designed to highlight the decision-making processes that cardiologists use in the protocols they use for handling such patients.
Overall, he emphasized that the LightSpeed VCT offers one piece of the company's “early health“ model of patient care, focused on earlier, less-invasive diagnostic modality.
Dr. Matthew Budoff, MD, associate professor of medicine, Harbor-UCLA Medical Center , and the chair of the ACC CT working group, has written ACC-approved guidelines for utilization and patient selection for diagnostic CT. An early adopter of cardiac CT technology, Budoff also is a member of the advisory panel that assisted GE in designing the multicenter trial protocols.
“It is extremely important to validate the efficacy of new cardiac imaging technologies such as multislice CT so that the industry, and in particular medical associations like the American College of Cardiology, will have the necessary data to recommend appropriate changes in CAD diagnosis and potentially in cardiac patient management,“ Budoff said.
According to Dr. James Min, MD, assistant professor of medicine, division of cardiology at Weill Cornell Medical College and New York Presbyterian Hospital , and one of the investigators in GE's cardiac CT multicenter clinical trial, “Based on my initial findings using the VCT, I strongly believe that cardiac CT angiography has the potential to dramatically change the way we practice clinical cardiology.“
Patient enrollment in this trial is now beginning, GE said, predicting the publication of clinical results some time in 2007.
Also at the ACC meeting, GE bannered the official launch of its collaboration with Volcano (Rancho Cordova, California) in developing a digital cardiovascular imaging system with integrated intravascular ultrasound imaging (IVUS) capabilities. The proposed agreement was initially unveiled and described in November (MDD, Nov. 3, 2005).
The agreement focus on integrating GE's Innova all-digital X-ray cath lab system with Volcano's PC-based IVUS platform for providing a precise view of coronary and peripheral vessel morphology for the interventional cardiologist. The goal is to assist in determining the extent of cardiovascular disease to guide therapeutic procedures, such as stent placement, by determining the exact lesion length and stent length.
Volcano's S5 device was introduced at last year's Transcatheter Cardiovascular Therapeutics meeting.
The imaging device produced will be co-developed by Volcano's team in Rancho Cordova and GE Healthcare's cardiovascular X-ray team in Buc, France.
The companies have said that the combination of Volcano's IVUS system and GE's Innova family of interventional suits will the “the first of its kind“ for facilitating stent deployment.