GE Discovery IGS 730
As catheter-based, minimally invasive procedures expand rapidly beyond treatment of the coronary arteries into all areas of the human anatomy, angiography X-ray imaging systems have moved beyond their original purpose of simple vascular imaging. Today, in addition to interventional cardiology, cath labs are frequently shared by numerous specialists, including interventional radiology, interventional oncology, electrophysiology (EP), vascular surgeons and neurology.
For this reason, GE and other vendors are now tailoring technology packages for each user. These include specific technologies for EP, interventional radiology, vascular surgery, cardiology and neurology. This change in the market led GE this past fall to use a new concept name for its angiography systems, now called Innova Image Guided Systems (IGS). It introduced the IGS name during the 2011 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
According to the market research firm IMV Medical Information Division’s December 2011 report on angiography system market trends,1 there were about 1,710 cath labs in the United States, which performed an estimated 4.9 million procedures in 2010. At least 50 percent of the total cath lab volume consisted of noncoronary angiography procedures, IMV found. In addition to interventional cardiologists and radiologists, IMV found vascular surgeons are the second most likely physician type to be using cath labs, performing procedures in more than 60 percent of the cath lab sites.
All vendors say the complexity of interventional procedures has increased, raising interest in more advanced visualization and 3-D guidance tools. More complexity also means longer imaging times, so users are more concerned about monitoring dose.
A New Class of Angiography Systems
GE Healthcare launched two recently U.S. Food and Drug Administration (FDA)-cleared angiography systems offering the high image quality and features of a fixed system, but with the versatility of a mobile C-arm. The systems were shown for the first time at the Radiological Society of North America (RSNA) show in December 2011 and formally released to the market in March at the American College of Cardiology (ACC) 2012 meeting.
The Discovery IGS 730 system was designed to address the challenge departments historically have had in needing to switch between ceiling-, floor-mounted and mobile C-arm systems. It uses a wireless, laser-guided, motorized, wheeled, mobile gantry, allowing it to be moved anywhere in a room. It is ideal for hybrid operating rooms (ORs) because it can be parked away from the patient table, allowing open access for patient transport or open surgical procedures.
GE also introduced the Innova IGS 520/530 with the OR option. This system uses a specifically designed table and accessories to enable both transcatheter and open surgical procedures in one room.
New Software Tools
With the approval of the Edwards Sapien Valve in November 2011, several vendors have created transcatheter aortic valve replacement (TAVR) software to help screen patients, plan procedures and guide the procedures in the cath lab or hybrid OR. GE Healthcare’s ValveAssist and Siemens’ syngo Aortic ValveGuide software were demonstrated at ACC.
Other new software includes:
• Siemens’ syngo Neuro PBV IR (parenchymal blood volume interventional radiology) provides visual assistance in the diagnosis and treatment of vessel malformations. In neuroradiology, this feature assists physicians in the treatment of stroke patients by displaying a color-coded qualitative map of cerebral tissue.
• GE’s AngioViz yields additional information from digital subtraction angiography (DSA), utilizing parametric imaging, which examines each pixel and determines the peak opacification caused by the contrast and the time it takes for that pixel to reach that peak.
• Toshiba introduced Volume Navigation 3-D roadmapping for the Infinix-i product line, allowing real-time procedural guidance. It links the movements of system components with the fusion 3-D and fluoroscopic display, so despite changes in table and C-arm position, the 3-D overlay is automatically aligned.
• GE began offering Veran’s ig4 fusion imaging angiography electromagnetic navigation system using 4-D registration to precisely target cancerous lesions. The system helps deliver instruments to small targets in hard-to-access regions of the human body.
Concern Over Dose
In 2011, the Society for Cardiovascular Angiography and Interventions (SCAI) published guiding principles and best practices for the development of radiation safety programs in cardiac cath labs.2 It focused on the need for safe practice and continuing education for all facilities that perform angiographic interventions. The document summarizes program development criteria, including procedural guidelines, training, dose management and monitoring, equipment considerations and potential safety concerns.
In 2011, Toshiba introduced a DICOM radiation dose structured report on all new Infinix-i systems to automatically record dose information from every X-ray event. The data is transferred into a standard format suitable for storage, making it easier to document, manage and evaluate overall dose usage.
1. “2011 Interventional Angiography Lab Market Summary Report.” IMV Medical Information Division. December 2011. www.imvinfo.com
2. Charles E. Chambers, et al. “Radiation Safety Program for the Cardiac Catheterization Laboratory.” Catheterization and Cardiovascular Interventions (CCI), January 2011, vol. 77, issue 4, pages 546-556. http://onlinelibrary.wiley.com/doi/10.1002/ccd.22867/pdf.