Image courtesy of Philips
There are several recent trends in X-ray angiography imaging systems that hospitals should be aware of if they are looking for new or replacement technology.
1. Technology to Lower Radiation Dose
As interventional procedures become more complex, imaging and procedural times naturally increase. To compensate for the higher imaging X-ray doses involved, vendors have developed a new generation of angiography systems that address the need to lower dose for both the operator and the patients. The current-generation systems offered by Canon, GE Healthcare, Philips, Shimadzu and Siemens all offer lower X-ray dose while preserving image quality. This has been accomplished with a combination of new X-ray tubes, more sensitive detectors, new image reconstruction software, image hold technologies, and by using better navigation and multimodality image fusion software to guide procedures.
The most recent example of this was in January 2019, with Philips launching its Azurion 7 with FlexArm system. It is designed to enhance positioning flexibility for image-guided procedures. Due to increasingly complex interventions, clinicians need to quickly and easily visualize critical anatomy and identify changes to the patient during the procedure. This system includes technology to make this easier in both 2-D and 3-D. As the clinician moves the system, the image beam automatically maintains alignment with the patient.
The Azurion with FlexArm’s design provides a high level of flexibility with movement on eight different axes, all controlled with its single controller. Simulation tests with clinicians demonstrated the potential to significantly reduce the repositioning of the patient, staff and equipment to improve access, including radial access. The system has both CE mark and U.S. Food and Drug Administration (FDA) clearance.
2. Hemo Integration
When a hospital installs a new interventional lab, many want a complete package so they do not have to subcontract with multiple vendors. A key element of the labs is integration with a hemodynamic system. All the major angiography vendors now partner with other vendors to offer complete solutions with hemodynamics.
The most recent partnership was Shimadzu Medical Systems USA and Change Healthcare partnering last fall, where Shimadzu will offer Change’s Cardiology Hemo on its Trinias line of angiography systems. Trinias is a single-plane system available in floor or ceiling mounts or as a bi-plane mounted system.
3. Echo Fusion Solutions
Complex procedures, especially in the structural heart space, require visualization of the surrounding soft-tissue anatomy beyond what 2-D angiography can offer. Ultrasound is usually employed for complementary imaging during procedures, usually with transesophageal echo (TEE). A couple vendors have taken TEE a step further by integrating with the live fluoro imaging to co-register the images and display them in one view.
There were two new product introductions in this space in 2018. Philips introduced the Epiq CVxi interventional cardiovascular ultrasound system. Specifically designed for use in the cath lab, the Epiq CVxi with EchoNavigator streamlines communication between the interventional cardiologist and the echocardiographer. Combining live ultrasound and X-ray information into one fused view, it helps interventional cardiologists oversee procedures along with the location of key anatomical structures. The system uses Epiq’s artificial intelligence to automatically identify and extract anatomical structures to speed the image fusion process and show anatomical outlines on live TEE or fluoroscopy.
Siemens introduced its version of a TEE/angiography fusion system with its TrueFusion, released in 2018. It allows fusion of TEE, cardiac computed tomography angiography (CTA) and live fluoro to aid navigation in complex heart procedures.
4. Integration of Augmented Reality
A new technology that is already on the horizon to aid procedural navigation in the cath lab is augmented reality (AR). The technology will enable operators to see true 3-D images of anatomy in a heads-up display while they are looking at the patient or at the main screen in the lab.
Philips Healthcare showed a conceptual work-in-progress of this technology at the Radiological Society of North America (RSNA) meeting in 2017, allowing attendees to put on the headset and manipulate 3-D images with hand movements in the air. NovaRad and TeraRecon have already commercialized similar AR technology to aid in advanced visualization of patient 3-D datasets. Novarad’s FDA-cleared product allows surgeons to fuse a dataset to a patient on a surgical table so they can scroll through the slices to find the exact locations in the underlying tissues.
In February 2018, the National Institutes of Health (NIH) awarded a $2.2 million research grant to the company SentiAR Inc. to advance its work to design AR software to improve visualization in cardiac surgeries and interventional procedures. The grant was awarded following peer review by a panel of cardiologists, engineers and other experts. SentiAR will receive the funding in milestone installments as it advances its platform. It uses the Microsoft heads-up display, allowing physicians to view, measure and manipulate real-time holographic images of the patient’s heart during procedures while still being able to clearly see around the room. It uses real-time navigation data feeds rather than magnetic resonance imaging (MRI) or computed tomography (CT), and displays it as a hologram. SentiAR was hoping to have its technology submitted for FDA review in 2019.