One of the challenges hospitals face when buying imaging systems is making sure their equipment can adapt to new twists and developments within the industry for the next decade.

This is especially true when it comes to cath angio systems. Advances in cardiology have made the cath lab an increasingly complex space. To help hospitals anticipate major trends that will shape cath labs of the future, DOTmed Business News spoke with industry experts and cardiologists to get their predictions about where cath labs are going next.

New kids in town
Hybrid procedures like TAVI have already made a huge impact on cath labs, driving the growth of the hybrid OR. But this heart procedure, approved for limited use in the U.S. since late 2011, isn’t an anomaly by any means. Manufacturers are pushing the envelope by developing a whole class of new devices intended for patients who are either ineligible or unresponsive to conventional treatments.

Take hypertension for example. A new balloon catheter device called Vessix sends ablative shocks through tiny electrodes to the renal artery, communicating signals to the brain that tell it to lower blood pressure. Dr. Shing-Chui Wong, director of cardiac catheterization at Perelman Heart Institute at New York-Presbyterian Hospital/Weill Cornell Medical Center, predicts this will be a major tool for treating drug-resistant patients. “It will likely come on the scene and become a mainstay of therapy in three, four, five years from now,” he says.

Another such device is Watchman, a tiny umbrellashaped device designed to catch blood clots in patients at high risk for stroke. The device, developed by Boston Scientific, is intended to be an alternative to blood-thinning medication. It has already gone through multiple long-term trials and Boston Scientific is expected to submit these results for FDA approval soon.

These procedures, which are minimally invasive and require shorter recovery times, coupled with the pressures hospitals are experiencing due to reimbursement cuts, are going to push cath labs toward same-day outpatient procedures.

“We see a growth in what we would call office-spaced or outpatient imaging, and that’s being driven by improvements in devices that can be safely and effectively implanted in a nonhospital setting,” says Greg McIff, global director of cardiovascular strategic marketing, GE Healthcare Surgery.

Echo Chamber
But as the procedures grow increasingly complex, they require more complex imaging tools. “We’re in a particularly exciting era right now when we see the ability to migrate some of these more invasive procedures to image-guided approaches,” says Robert Dewey, senior director of product marketing, cardiology and hybrid OR at Siemens.

3-D echocardiography, for example, has become a mainstay for mitral valve clip implantation procedures. While 2-D echo gives physicians one view of the valve in silhouette, 3-D echo gives them an up-close frontal view of the valve in motion that’s very similar to the view surgeons would get during actual surgery.

And one of the most buzzed-about products to debut at the American College of Cardiology’s annual show and conference this year was Philip’s Echonavigator, a live image guidance device that fuses 3-D echocardiography and fluoroscopy X-ray. This allows cardiologists to see both soft heart tissue and catheters as they perform minimally invasive heart repairs. During a ACC’s Scientific Session, Dr. Neil J. Weissman, professor of medicine at Georgetown University and director of cardiac ultrasound and ultrasound core laboratories at the Cardiovascular Research Institute at Washington Hospital Center, singled this product out during his presentation on devices of the future, but also said manufacturers should step it up a level beyond that. “Superimposing more than two images will become more and more pervasive with the rise of minimally invasive procedures,” he told attendees.

Another emerging technology, MediGuide, acts as a 3-D navigation system that lets physicians evaluate patients using recorded fluoroscopic images instead of images from a live fluoroscopy, allowing physicians to expose patients to less radiation dose — a relevant concern since fluoroscopy uses higher levels of radiation than most modalities.

Miniature sensors embedded in catheters and guidewires specially designed to work with MediGuide technology are magnetically tracked, allowing physicians to see the precise location of the device inside the heart. “The way to look at this is [that it’s similar to] the GPS technology you use in [everyday] life,” says Dr. Dhanunjaya Lakireddy, associate professor at University of Kansas. Doctors like Lakireddy ultimately hope in the future fluoroscopy will only be used to quickly confirm catheter location.

But with great imaging tools comes great responsibility. The use of more modalities and more equipment creates information systems clutter at workstations. Integrated CVIS solutions such as Digisonics’ DigiView and ScImage PicomEnterprise Cardiology, both highly ranked in KLAS research for customer satisfaction, are designed to make data transference and reporting simpler and more efficient for doctors.

Strange bedfellows
Hybrid ORs live up to their name in several ways. They’re built for procedures that require multidisciplinary teams which may include radiologists, cardiologists and anesthesiologists, among others.

But they also require more collaboration and crosspollination between different technologies and OEMs. As their jobs become more difficult, cardiologists expect seamless integration between different systems and companies.

The medical device industry is notoriously resistant to standardization, but it will have to get past that very quickly as cath labs continue to require more complex technology, experts warn.

“They’ll have to develop common languages so that if I’m using a Siemens X-ray machine or a Philips ultrasound machine I’ll be able to pull both data into a kind of common workstation, fuse it, and co-register it,” says Dr. Gary Gershony, director of cardiovascular research, education & technology at John Muir Health and Cardiovascular Institute.“Whoever’s able to do that best and soonest will become the market leader.”

Indeed, the industry is moving quickly to develop partnerships and acquisitions that will help it branch out into intravascular and endovascular (read: minimally invasive) imaging. Intravascular imaging and ultrasound company Volcano Corporation has already developed partnerships with Siemens and other major manufacturers. And in November 2012 Volcano bought Sync-Rx Ltd, an Israeli company that develops advanced software for transcatheter cardiovascular interventions.

But OEMs aren’t the only ones having to make room for new players. While the rooms are theoretically meant to be shared among specialists, this is often not the case in practice. Cardiologists tend to monopolize the room, but this is not a sustainable trend, say experts. “In order for the hybrid OR concept to work, it has to be a universal operating room. It’s simply not cost effective otherwise,” says GE Healthcare’s McIff.

Other specialties such as interventional oncology are also developing less invasive surgical techniques that must be performed in a hybrid OR. “There’s a trend towards procedures that can deliver treatment to specific region in the body instead of targeting the entire body through chemo or other methods,” says Richard Fabian, vice president of imaging systems marketing at Philips Healthcare.

In the future, cardiologists can expect to share their hybrid rooms with interventional oncologists, neurologists and even gastroenterologists. But these specialists aren’t just going to share space. They must have input on how the hybrid room is designed and laid out, what equipment to buy, and how the room’s resources will be allocated. By necessity, the room cannot look like a cardiologist’s lab — it must be a space that serves multiple, sometimes radically different disciplines.


Moveable feats
Mobility and space are at a premium in hybrid rooms increasingly crowded with equipment. GE’s new Discovery IGS 730 angiography system is a direct answer to this problem. It eliminates the need for a ceiling- or floor-mounted gantry, instead using a wheeled base and a precision laser guidance system. The end result? It offers the same imaging and features of a fixed gantry system but has the mobility of a mobile C-arm.

“That’s why I really think vascular surgeons are very excited about this new concept—you still have the mobile application but you also have imaging applications that are not available in mobile C-arms,” says Dr. Stéphan Haulon, head of Vascular Surgery Department, University Hospital of Lille, France, who helped design the Discovery.

Other advanced tools may help free up surgeons’ mobility as well. “If we can combine advanced imaging systems with robots, then we would probably be able to be faster and more accurate and even less invasive,” says Haulon.

The Corindus CorPath 200 and the Hansen Magellan, robotic-assisted systems which doctors can manipulate with joysticks, take them out of the radiation field. This frees them from wearing cumbersome lead aprons and allows them to navigate arteries with more precision.

Georgetown University’s Weissman also thinks robot-assisted surgery ranks among the top device trends that will revolutionize the special procedure labs of the future. In fact, he predicts that one day robots will be able to perform surgical feats in the same way cars are now able to parallel park without a driver. “Using pattern recognition technology, the robots will automatically identify different anatomies of the body in relation to each other to help the surgeon operate,” he says.

Names in boldface are Premium Listings.
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DOTmed Registered DMBN April 2013 - Special Procedure Cath/Angio Companies

Elie Semaan, Rayon-x Engineering, LLC, CA
Chris Sharrock, Block Imaging International, Inc., MI
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