Siemens 3-D Angiography Imaging Software Cleared by FDA
New processing software simplifies workflow for minimally invasive heart valve implantation
Siemens Healthcare recently received clearance from the U.S. Food and Drug Administration (FDA) for syngo Aortic ValveGuide, an integrated image processing software that helps cardiologists and cardiac surgeons prepare and perform transcatheter aortic valve replacement (TAVR). The syngo Aortic ValveGuide automatically reconstructs a 3D representation of the aortic root from cross-sectional images acquired with the angiography system and provides the best projection angle for the valve replacement. The software selects anatomical landmarks and overlays the 3D image with 2D images acquired during live fluoroscopy, enabling the physician to obtain real-time 3D guidance in the patient’s body while navigating the new valve to its intended location. This groundbreaking software, which is now available to customers, reflects the spirit of Siemens Healthcare’s Agenda 2013 – a recently announced two-year initiative designed in part to strengthen the Healthcare Sector's innovative power and competitiveness.
During the minimally invasive TAVR intervention, an artificial aortic valve is inserted via the femoral artery or through the apex of the heart. syngo Aortic ValveGuide provides the physician with automated 3D guidance by segmenting the aortic root in 3D mode from images created using the angiography system. With the aid of anatomical landmarks in the 3D vessel representation, syngo Aortic ValveGuide calculates the exact perpendicular view on the aortic root. The C-arm adjusts to the corresponding angulations for live fluoroscopy, enabling the physician to precisely position the new valve. Consequently, as soon as the software overlays the 3D image of the aorta with the 2D live fluoroscopy, the cath lab cardiologist – or, respectively, the heart surgeon in the hybrid OR – can begin the intervention. Since syngo Aortic ValveGuide only requires a short fluoroscopy time prior to the procedure, the patient's exposure to radiation and contrast can be reduced considerably.
Prior to syngo Aortic ValveGuide, users had to rely on preprocedural (or intraprocedural) CT, manually co-registering it with live fluoroscopy and overlaying it on a live fluoroscopy image to determine the correct angulation. This process required additional steps and highly skilled personnel. The new syngo Aortic ValveGuide uses syngo DynaCT Cardiac – Siemens software that processes CT-like cardiac images from images acquired using the angiography system.
"syngo DynaCT allows us to evaluate the anatomy of the aortic root and the position of the coronary ostiae. The overlay of the intra-procedural 3D image over live fluoroscopy gives us an additional level of confidence for the valve implantation," says William O'Neill, MD, professor of medicine and cardiology, executive dean for clinical affairs and interim-executive dean for research and research training at the Miller School of Medicine and chief medical officer at University of Miami Health System. "The automated workflow of the syngo Aortic ValveGuide makes the procedure easier – and the indication of a perpendicular view plane helps to make it even safer."
The statement by Siemens customers contained herein is based on results that were achieved in the customer's unique setting. Since there is no "typical" hospital and many variables exist (e.g., hospital size, case mix, level of IT adoption), there can be no guarantee that other customers will achieve the same results.
Launched by Siemens Healthcare Sector in November 2011, Agenda 2013 is a two-year global initiative to further strengthen the Healthcare Sector's innovative power and competitiveness. Specific measures will be implemented in four fields of action: Innovation, Competitiveness, Regional Footprint and People Development.
The Siemens Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 51,000 employees worldwide and operates around the world. In fiscal year 2011 (to September 30), the Sector posted revenue of 12.5 billion euros and profit of around 1.3 billion euros. For further information please visit: http://www.siemens.com/healthcare.