Joe Shrawder, GE Healthcare Surgery’s CEO
Reaz Rasul, General Manager of Interventional Cardiology
One of the world’s largest annual gatherings of interventional cardiologists, cardiovascular surgeons, nurses and technicians — EuroPCR 2011 — opens this week in Paris. Among the trending topics at this year’s conference is the hybrid operating room, which allows both open surgery and catheter-based imaging therapies to take place in the same operating room. The Hybrid OR provides the appropriate environment whether a patient needs both open and catheter-based procedures or for multiple patients needing a variety of procedures and therapies.
Two types of doctors are interested in the hybrid OR: interventionalists (cardiologists and radiologists), who perform catheter-based interventions to look at blood vessels, and may perform angioplasty or leave a small metal stent when a blockage is more severe; and surgeons (cardiac and vascular), who repair cardiac and vascular abnormalities via open surgery such as coronary bypasses, valve replacement and aneurysm repair.
While both types of specialists focus on the cardiovascular system, they have traditionally worked in completely separate clinical environments. The two worlds are merging in many ways today with interventionalists increasingly requiring an environment where there is sterility, anesthesia, heart-lung machines and other devices of an operating room and surgeons increasingly requiring the use of high-end imaging capabilities typically found in the cath lab.
We spoke with GE Healthcare Surgery’s CEO, Joe Shrawder, and General Manager of Interventional Cardiology, Reaz Rasul, to further explain this trend and GE Healthcare’s history in the hybrid OR space.
Why is the hybrid OR getting so much attention, currently?
Rasul: ‘Hybrid OR’ is a relatively new term developed by the industry — not GE — that describes the transition of high-end imaging from a cath lab and radiology lab area to the operating room. We see the new hybrid OR as merging capabilities and expanding opportunities for the clinicians who use them.
There are three recent procedures that are further contributing to a shift from open surgery to catheter-based procedures. Two of these deal with aneurysms or dissections of the abdominal and thoracic aorta. In an Endovascular Aneurysm Repair (EVAR) or Thoracic EndoVascular Aortic Repair (TEVAR), an endoluminal stent graft is fed through the vasculature via a catheter and deployed in the aorta’s problem area. These procedurescan combine with an open operation to minimize overall invasiveness
The third procedure, known as transcatheter aortic valve implantation(TAVI), is approved in Europe but not yet in the United States While not the sudden killer that aortic dissection or ruptured aneurysm is, severe aortic stenosisnegatively impacts the function and health of the heart. Many patients with severe aortic stenosis are not candidates for surgical replacement of their aortic valve due to coexisting conditions. A recent clinical trial showed that this less invasive alternative, TAVI, represents a life-saving therapeutic option for these patients.
Many of these techniques and devices are still new, and the technologies used for treatment are not yet widespread. However, as cardiovascular disease has become more prevalent, and the development of minimally invasive therapies to treat cardiac and vascular abnormalities continues, more and more hospitals are aiming to provide this kind of care to patients.
Shrawder:Another driver is that patients — particularly in developed economies — are very well informed about their healthcare options. This puts hospitals in a position to compete with each other to have the best-equipped facilities. All of these trends are driving interest and equipment sales for the hybrid OR.
What are the components of a hybrid OR?
Rasul: First, you begin with a room that has surgical capability, meaning it is a sterile room. It should have Laminar flow ventilation, where all air in the room is exchanged every minute or so.
Second is a high-end imaging system that is able to perform digital subtraction angiography, roadmapping, and fluoroscopy — these are the key features for vascular imaging. Also, because many procedures are complex and lengthy, they require an imaging system that has extended thermal capacity. The ability to perform good quality 3D angio CT is also very important, both for planning the intervention and also to help navigate catheters during the procedure.
Third is a surgical-capable table you can image through — usually made of carbon fiber. It must have the ability to move the patient in a lateral plane as well as the ability to tilt, and it needs a means of attaching surgical instruments to the sides of the table. Then of course you need anesthesia, monitoring, lights, ultrasound, access to your PACS system, all of the other components of a modern operating room, and a full complement of endovascular devices and tools.
Is GE Healthcare a latecomer to the hybrid OR offering?
Shrawder: The genesis of the hybrid OR was in the 1990s. OEC, now part of GE Healthcare, partnered with leading vascular surgeons in the very early days of aortic aneurysm therapy — and worked with these early pioneers in developing imaging techniques in the operating room for vascular procedures. The company developed its vascular imaging systems with these innovative surgeons for the therapies they were developing.
The FDA approved the transluminal stent graft treatment of abdominalaortic aneurysms in the late 1990s, shortly after major research and academic centers began to build fixed rooms within the operating room setting. Fixed C-arms allow some incremental functionality. However, OEC has shown over the last 15 years that cardiac and vascular procedures requiring advanced imaging can effectively be done on mobile imaging units.
What sets a GE Healthcare hybrid OR apart from other companies’ products?
Shrawder: It’s worth noting that we offer a robust portfolio of products—from mobile to fixedimaging systems—to help healthcare providers create the hybrid OR they need.
When it comes to products, our mobile C-arms have features that others don’t. For example, the OEC Elite 9900MD has a tableside control panel with a joystick that allows the surgeon to control the imaging angle of a motorized C-arm, to get the image he’s looking for. And its unique X-ray tube and cooling system allows for full-resolution imaging for relatively long periods of time. This is critical for the lengthy catheter-based procedures.
Rasul: As procedures grow in complexity and length, image quality must be high but exposure to radiation is a growing concern. Our family ofInnova* fixed imaging systems provides industry-leading Detective Quantum Efficiency (DQE). High DQE enables better quality images at the same dose, or the same quality image at a lower dose. Also, Innova’s advanced 3D controls are incredibly helpful during structural heart and EVAR procedures. And Innova is available with a combo detector allowing both PCI and other cardiac or peripheral endovascular procedures.
Without going down the list of all our unique product features, the key point is that we have a long history and deep experience in OR imaging, and we offer a truly comprehensive package of hybrid OR technologies. Not only that, our Performance Solutions group offers consulting to help a hospital build a custom solution that meets their specific needs. Only GE Healthcare has this range of high quality products and a dedicated support group to help any facility expand its OR capabilities.
Martin B. Leon, et al, New England Journal of Medicine, October, 2010, Vol. 363, No. 17
GE Healthcare's fixed imaging systems include the Innova 2100-IQ, 3100-IQ and 4100-IQ with the Innova-IQ table in OR configuration. The Innova OR is not CE marked yet, not commercially available in the EU and other medical device regulated countries restricting advertising, promotion and commercial release. Those devices in OR configuration cannot be marketed outside EU countries (including advertising and promotions).