Nearly 10 years ago, Dr. Alan Lumsden, a vascular surgeon and pioneer of minimally invasive surgical techniques, was lured from his post at Emory University in Atlanta to the sprawl of Houston, Texas. Lumsden, who now directs the DeBakey Heart and Vascular Center at Methodist Hospital, says part of what drew him to the Lone Star State was that he was offered access to a very early form of a new kind of surgery suite: the hybrid operating room.

Hybrid ORs mean different things to different people, but they’re usually defined as the combination of a catheter lab and an OR; or rather, the installation of a fixed angiography X-ray system in a sterile operating room environment. The rise of minimally invasive procedures that need real-time imaging as well as a working OR as a backup should anything go wrong is leading even smaller hospitals, not just academic medical centers, to look at building these hybrid rooms.

“It’s clearly the wave of the future,” Lumsden tells DOTmed Business News.

While it’s a growing wave, not everyone has an easy time riding it. Analysts have reported training issues for staff trying to get the hang of complex new devices and occasional struggles to fill the rooms with enough volume to justify their multi-million dollar price tags. Hybrid rooms cost, on average, 67 percent more per square foot than a traditional surgery suite. But the push for potentially safer techniques that work best in a hybrid OR means, as Lumsden says, this sector is poised for growth.

Partnering up

While hybrid rooms have existed in some form or another avant la lettre, it wasn’t until 2008 that they really took off, according to Frost & Sullivan analyst Sujith Eramangalath. That was also around the time OR and imaging equipment vendors began to come together. In 2007, Philips spent six months touring the country and setting up formal interviews with OR companies to find a partner for new hybrid OR ventures and learn more about the industry, according to Brian Grant, the project and planning manager with Skytron, an OR equipment maker. After two qualifying interviews, Philips picked Skytron, he says. In the 2008, Philips announced it reached deals with Skytron and Steris, another OR vendor.

“None of these partnerships ever really existed (before then),” Grant tells DOTmed News. “But you had to do that in order to be successful in this new world. I didn’t know about your equipment, and you didn’t know about my equipment.”

Now most of the imaging vendors and OR manufacturers have deals with each other. In addition to Philips, Skytron, for instance, has partnerships with Siemens and Grant says they’re also working on agreements with GE and Toshiba. Siemens says it has deals with, in addition to Skytron and Steris, Trumpf, Stryker and Berchtold.

Room for growth

It’s hard to get a good number on the amount of hybrid ORs out there. According to our conversations with vendors and analysts, about 100 to 200 hybrid ORs are built in the United States every year. Grant estimates that about half of all hybrid ORs were built in the past two years. In Europe, the market grows 15 percent every year, according to Frost and Sullivan’s Eramangalath.

Imaging vendors typically won’t share exact sales numbers, but most of the companies DOTmed News spoke with said they’re all experiencing strong growth, even if the hybrid OR market remains a tiny slice of the total interventional pie. Robert Schapiro, vice president of interventional X-ray for the eastern U.S. with Philips Healthcare, says the total interventional market in the United States is 900 to 1,000 units a year. Of those, 100 to 150 are purchased for a hybrid OR.

Worldwide, Philips estimates it has probably only a few hundred units installed. Its rival Siemens Healthcare says growth for its floor-mounted zeego C-arm, introduced in 2010 and specially designed for hybrids, has far outpaced its ceiling-mounted, non-hybrid-designed siblings. Sudhir Kulkarni, segment director for hybrid OR with Siemens’ angiography business unit, says in the last three years zeego sales have increased at a rate three times higher than that for its ceiling-mounted brethren.

Toshiba also didn’t share hard numbers, but Allan Berthe, the company’s senior cardiology product manger, says he recently surveyed sales specialists, and many of its customers are at least discussing hybrid ORs. “Do they end up with that as a final program today? Well, over 50 percent of larger hospitals show interest and then approximately half of those end up installing at least one hybrid system,” Berthe tells DOTmed News.

Rikki-Tikki TAVI

Why build hybrid ORs? A leading reason is projected growth in minimally invasive cardiovascular procedures, such as percutaenous coronary interventions. These procedures need fluoroscopic guidance, but oftentimes hospitals that do PCIs also need an OR on standby in case, say, a coronary artery is ruptured. Similarly, with abdominal aortic aneurysm repair, if the aorta gets perforated, you need to open the patient right away. A recent Advisory Board study found, in fact, that 80 percent of surveyed sites with hybrid ORs used them for aortic aneurysm repairs.

“You don’t have time to move the patient elsewhere,” Siemens’ Kulkarni says.

Arguably one of the biggest pushes has been from transcatheter aortic valve replacement, or TAVR (also known as transcatheter aortic valve implantation, or TAVI). In this, an aortic valve with severe stenosis is replaced with a prosthetic valve that’s threaded up the body through a catheter, instead of during open surgery. The procedure has been available in Europe for nearly six years, but it’s new in the United States. The Food and Drug Administration approved Edwards Lifesciences’ Sapien valve only in the fall of 2011. Initially, the indication was limited to patients ruled totally ineligible for open surgery, but last year it was expanded to include simply high-risk patients.

It’ still quite a niche market – the Advisory Board said of surveyed hybrid OR sites, only 32 percent used it for TAVR – but it’s on the upswing. A MD&DI article from last summer said the market size (for the devices) could be as high as $2.5 billion.

“We’re seeing large institutions doing it, but small institutions are looking ahead even if they don’t have a program today,” Toshiba’s Berthe says. “The (hybrid) rooms are built for probably a 10-year lifespan.”

Importantly perhaps for the future of hybrid ORs, the Centers for Medicare and Medicaid Services says having one is one way to meet the (many) conditions for reimbursement for TAVR procedures.

In its guidelines, in fact, the CMS specifies having a fixed angiography system with flat-panel fluoroscopy for coverage. The problem with mobile C-arms is that they are not powerful enough to visualize key vascular features, and they can’t do continuous fluoroscopy for a long enough time because they risk overheating, and shutting down, Kulkarni says. “They sometimes put ice bags on tubes [to cool them], but you can’t do this if you’re doing a procedure which could potentially be life-threatening.”

The OR is also the biggest revenue generator in a hospital, and in Europe at least, adding hybrid capacities could make the rooms more efficient. While 42 percent of a European hospital’s revenues come from the OR, they’re generally only running at 68-70 percent capacity, Frost & Sullivan’s Eramangalath says. Hybrid ORs could help boost those volumes through multidisciplinary sharing.

But the hybrid OR is not, of course, the answer for all procedures.

“Honestly, the way we think about it is the right case in the right room,” says Dr. Lumsden, who incidentally was invited to give a talk on hybrid OR planning at the Transcatheter Valve Therapies conference 2013 in Vancouver in June. He says diagnostic and basic angiograms are potentially better suited for the cath lab, and the hybrid OR should be reserved for a mix of open and endovascular procedures.

His own hybrid OR runs at 80 to 90 percent capacity, but it takes a lot of planning and smart scheduling to do that, especially as TAVR procedures take up a little more than one day a week.

“TAVR has given us a challenge,” he says, because of the rising caseloads in their hybrid OR. “We’re looking at building another one.”

If his hospital does, it should expect to shell out a pretty penny.


“The cost equation”

Minimally invasive techniques might be driving demand for hybrid ORs, but hospitals mulling over designing one of these rooms face several hurdles. A major one is cost. A typical hybrid suite runs between $3 million and $9 million, according to Frost and Sullivan’s Eramangalath, and installation costs for greenfield suites start at $4 million. Hybrid ORs are also bigger than their traditional counterparts. It varies from country to country, but a typical OR is between 700 and 900 square feet, Eramangalath says, while a hybrid OR usually requires as much as 1,000 to 1,200 square feet.

“The cost is really dependent on the use of an existing room versus a buildout, location of the OR and the rest of the procedural focus,” Robert Popilock, senior market development manager with Steris, tells DOTmed News. “Most commonly in the OR, we’re seeing dedicated C-arms (monoplanes or biplanes) but some of these more sophisticated ORs are using MRI or CT or even have robotics, which will also change the cost equation.”

Hybrid ORs, at least compared to cath labs, have another pricey element: lighting. Typically they need two to three sets of lights above the table because of the different entry points on the body that need to be illuminated. This means lighting up an OR is an order of magnitude more expensive than outfitting a cath lab. Standard cath lab lighting could run you $10,000 to $25,000, while OR lighting could be as much as $100,000, Philips’ Schapiro says.

Cost is important to get a handle on, as hospitals have to plan for what sort of volume they’ll see. Schapiro says many hospitals could only expect 75-150 TAVR cases a year, which isn’t enough to sustain the room. That’s one of the reasons, he says, Philips has partnered with Maquet to offer a configurable OR table for surgeries, called the Magnus, which can be swapped with their Philips-made radiolucent table for image-guided procedures. The OR table is for customers that, say, aren’t big academic medical centers, and who might need to do orthopaedic or other procedures in the hybrid OR to get the most out of the space. Toshiba has had a similar deal with Maquet since 2008, and Siemens inked one last spring.

“If you’re only doing a few TAVI procedures a week, what else do you use the room for? The vascular surgeon can pick up some time. But if they doesn’t have the volume, the Maquet table comes in,” Berthe says. “You don’t want the OR sitting idle.”

For its part, Maquet tells DOTmed News in an e-mail that it has outfitted more than 175 hybrid rooms with either its Magnus table or its complete hybrid solution, including lights, booms OR integration and cardiac disposables.

Up or down?

When designing a hybrid OR, a key issue is space. These rooms get crowded, and access to patients can be a challenge. For TAVR procedures, as many as 15 people could be jostling around monitoring equipment, working on the patient or simply on standby. “At a moment’s notice they could need access to the patient and the C-arms have to move quickly out of the way,” says Toshiba’s Berthe.

That’s why one of the most important decisions centers on the C-arm. In short, where do you put it, on the floor or the ceiling? There’s no industry consensus, and there are tradeoffs to each. On the one hand, the ceiling is crowded with booms and, for the sake of hygiene, laminar airflow in an operating room has to be protected. On the other hand, the floor is occupied by moving bodies, and tables and carts could present a collision risk to expensive imaging equipment.

Vendors often offer both ceiling- and floor-mounted systems, though by and large they’ve made different bets. Siemens’ zeego, one of the first C-arms designed specifically for the hybrid OR, is a floor-mounted system.

“I think the optimum is floor-mounted if you can get the flexibility right,” Kirk Ising, an analyst with KLAS who wrote a report on the interventional X-ray and hybrid OR markets last year, tells DOTmed News. “But there’s a lot of flexibility with the ceiling mount, which is why people have gone that route.”

Ceiling systems are, indeed, very common. Manufacturers have also tried to address some of the problems ceiling-mounted systems face in hybrid ORs. Philips, for instance, developed the FlexMove ceiling-mounted option for its Allura Xper FD. The company says it originally designed a prototype two and a half years ago in Germany, to appeal to customers performing TAVR procedures. The device, which lets the C-arm move laterally and longitudinally on ceiling rails, was cleared by the Food and Drug Administration for sale in the United States last year.

“In those TAVI procedures, people would have to adjust their positioning based on the equipment they had,” Philips’ Schapiro says. “What we saw with the FlexMove mounted on the ceiling, the system was flexible enough to move around the procedure.”

GE also is courting hybrid OR customers with its new, laser-guided Discovery IGS 730. Toshiba, which sells both floor- and ceiling-mounted Infinix-I C-arms, pushes as the “key differentiating feature” in the hybrid space its Work Rite technology and Access Halo. The feature, included on all Infinix-I systems, allows users to configure the C-arms to give 180-degree, unobstructed head-end access to the patient.

Training days

Cost isn’t the only concern for hospitals building hybrids. Many customers have reported some issues with getting staff up to snuff on new equipment, according to a KLAS report on hybrid ORs that came out in June.

The report, which surveys customers on how they like their equipment and vendor service, mentions that Siemens customers who use its Artis zee fluoroscopy system in the hybrid OR, as opposed to in a pure interventional suite, give it a lower overall performance score, partly because of training issues.

“There are two major challenges,” Ising, the report author, says. “The vendor’s new at it, and the providers are new at it.”

Overall, Toshiba placed first in performance scores for interventional X-ray in the report, partly because of its popular service, followed by Philips, GE and Siemens. However, KLAS says Siemens was seen as the “hybrid OR leader,” with the most hybrid OR installs and some of the most “cutting-edge” innovations. In its survey of 172 providers, KLAS validated 13 Siemens hybrid ORs for the zee and zeego, two each for Philips’ FD20 and Toshiba’s Infinix-I, and none for GE’s Innova 3100. GE’s brand-new hybrid OR-focused IGS 730 was at “too few sites” to be included, although the OEM did garner praise for the steady improvement in its scores over the past five years.

Siemens’ Kulkarni says a problem they found is that surgeons or staff sometimes don’t take the time to train on the new devices before scheduling their first cases, often because the hospital is eager to start seeing revenue from the new room. But he says his company – like many others – is working to make hybrid OR equipment training more robust.

“What we did after we got those KLAS reports, we’ve increased the amount of training that we give to each hospital,” he says. The company now offers more than 120 hours of training. Also, it asks customers to slot a brief pre-procedure training period.

“We also request, and we can only request time and again, not to schedule cases the first week, so that the surgeon can spend some time, and the staff can spend some time learning how the system works,” Kulkarni says.

For staff, training can be quite involved. Toshiba offers a one-week training course at its facility in Irvine, Calif., where customers can practice on two fully functioning systems and some workstations. Typically, customers send two people, often techs but also doctors, per system purchased. After the training on campus, Toshiba then sends people to the hospital and gives them in-location training for another week. Then about a month or so later, after they’ve had a time to test out the system, Toshiba comes back for a follow-up session. “They’re not doing their regular job, they’re focused on learning,” Berthe says.

There are other staff issues, too. For many hospitals, staff rotates from operating room to operating room. The problem is that a staff might only work in the hybrid OR once every month or two, making it hard to get familiar with the equipment, which is why Kulkarni recommends a dedicated staff for hybrid ORs.

“It’s so damned complicated that you really need to have a dedicated staff,” Dr. Michael Friebe, a professor at Munich Technical University who used to work in the imaging equipment industry, tells DOTmed News. “Two or three people who really know everything perfectly, otherwise the whole OR is not usable.”

Even so, everyone has to be on board. Dr. Lumsden says it’s important to “cross-train.” as the rooms typically run 24 hours a day, every day of the year. Even if you have a dedicated staff, they might not be on the night shift when you have a case coming in.

“You’re going to be dealing with whoever happens to be in the nursing team and the imaging team who are available at that time,” he says. “It’s nice to have a dedicated team, but they have to (cross-train the) nursing pool.”


The universal room

For all their challenges, KLAS’ Ising is bullish on hybrid ORs. “I would anticipate most hospitals having one in a few years,” he says. “It’s just growing pains. It’s very new and different from what they’ve been doing.” He says KLAS is doing more research in the next six or seven months to see how the market’s changing.

Professor Friebe also thinks that, in time, the training difficulties will be solved as a new generation of doctors comes up that’s familiar with these rooms. In Germany, for instance, where Friebe teaches, of the 34 university clinics that train new doctors, each has a hybrid OR. “I see it increasing,” he says. “(Doctors) will be much more adapted to this technology in the future.”

Vendors will possibly change, too.

“Vendors have to step up and be a best-practice adviser as opposed to just [saying], ‘Customer’s always right,’” Ising says. “[Customers] want the vendors to be better advisers. If the vendor can help steer them to the most optimal way to manage the room, that’s going to be the most well received.”

The appeal of a hybrid OR will spread to other specialties, too. Neurosurgery, orthopedics, thoracic lung surgery, liver re-sections, trauma – all look to benefit from image-guided, less invasive procedures in the future, Siemens’ Kulkarni says. That’s why he thinks instead of calling it a hybrid OR, it might soon be called a “universal room.” And that, he thinks, could be awfully appealing to health care administrators.

“You have one room which can do anything and everything,” he envisions. “What would you as a hospital CFO or CEO prefer, a workhorse that can be turned into anything in a jiffy, or everything separate?”

“It’s something to think about,” he adds.

DOTmed Registered DMBN March 2013 - OR Suite Companies

Names in boldface are Premium Listings.
Domestic
Tom Kimmes, Alpha Medical Equipment, Inc., AR
Veronica Villanueva, Comerlat Enterprises LLC, CA
Jeovanni Rivas, Comprehensive Equipment Management Corporation, FL
Moshe Alkalay, Hi Tech Int'l Group, FL
DOTmed Certified
Alda Clemmey, Saffire Medical, MA
DOTmed Certified
DOTmed 100
Michael Koda, Minnesota Medical Redistributors, MN
DOTmed Certified
Bob Adair, MedSource CES, Inc., OK
Philip Mothena, Simple Solutions, Inc., VA

International
Vladimer Chipashvili, Medical Innovations Company, Ltd, Georgia
Deepak Raj Onta, Himalaya Intermed, Nepal
Dan Kongsted, Cervius Medical, Denmark
Ashish Bhavsar, Wave Visions, India