This report originally appeared in the February 2009 issue of DOTmed Business News

Every day at hospitals across the country, life-saving tests and interventions play out in the cath/angio lab. In addition to diagnosing heart disease, an important measure of hospital quality is also assessed in this suite. It's a widely reported stopwatch on the effectiveness of health care delivery known as "door-to-balloon" time. If you can reduce that time, you've got the edge when you report to regulators and disclose performance data to the public.

"The 'door-to-balloon' is the time from somebody coming into the hospital with chest pain to the time they are diagnosed, brought into a cath suite and have angioplasty and a stent placed in their coronary artery," explained Richard Fabian, VP and Business Manager for CV and General X-ray, Philips Healthcare. "Door-to-balloon is becoming a more important metric because every minute that providers can shave off that time means they are saving lives." (The Brigham and Women's Hospital D2B record is 14 minutes.)

The total U.S. market for cath and angio capital equipment is roughly one billion dollars with about two-thirds devoted to cardiac applications and one-third to vascular. Within cardiac, electrophysiology components are a relatively small but growing slice of the pie chart, between $100 and $150 million. Angioplasty and stent placement predominate cath lab work, but vascular procedures are increasingly driving workflow.

DOTmed industry experts candidly report that the overall market for cardiac cath lab equipment is as flat as a panel detector at the moment. But encouragingly, capital investment persists due to the urgency to address the number one health problem of Americans - heart disease.

"We are seeing a continued investment in cardiovascular services by hospitals across the US. It still is a very profitable segment of the hospital, it still is an investment strategy for hospitals nationwide and we continue to see a focus there," said Erin Lange, General Manager, Americas Interventional Marketing, GE Healthcare.




"We saw an increased investment last year in electrophysiology (EP) which we do expect to continue this year. So it is one of the growth areas where hospitals are investing in their cardiovascular service line." She noted EP drivers including new technologies and procedures such as intracardiac echo (ICE) and new indications for pacemakers.

On the angio side, the interventional radiology market was down slightly last year. However, interesting growth areas include a focus on interventional oncology, Lange said. "We are seeing new procedure codes [for reimbursement] coming out for that equipment."

Innovations such as improved diagnostics, image fusion of MR and CT, the growing use of CTA images, an increasing focus on vascular disease, the development of hybrid OR/interventional suites, and even moving the physical location of the cath lab closer to the ER are all trends that may help grow these equipment markets.

Aftermarket Options and Issues

With the choked capital markets today, some health care providers are turning to independent service organizations, pre-owned equipment, or field upgrades to save costs. New equipment in a fixed site hospital setting will run about one million dollars for either a single-plane cath lab or new angio suite. A refurbished suite costs in the $175,000 to $400,000 range installed with a warranty. Systems as recently manufactured as 2002-2006 are often available. With hospitals facing funding losses in the stock market and increasing pressures to serve the uninsured, used systems may become more attractive.

"Pre-owned systems are a very good way to save money in today's marketplace. Many systems that utilize flat panel technology are now available in the secondary market, so end users can get recent technology at affordable prices," said Bill Adkins, President, National X-Ray Corporation.

"When a facility is not financed, it will opt for a pre-owned unit instead of a new one," said Leon A. Gugel, Metropolis International LLC. He noted the significant technical expertise required of third-party providers but said that special procedures suites can be upgraded in the field by qualified companies.

"In a field refurbishment of installed equipment you go in and change the imaging system, do software upgrades, make sure the systems are working as designed," said Dan Wheeler, President, Transtate Equipment Company. "If there is degradation through usage or non-maintenance, we go in and reawaken the equipment and its capabilities."

The most effective upgrades involve changing out and upgrading the front end of the imaging chain and updating the software on the digital acquisition, with OEM support. These upgrades pertain to PACS/DICOM capabilities and remote import and retrieval of cases in a filmless environment. Some hospitals still hold on to their image intensifiers and upgrade those with a CCD camera and digital package as interim steps before equipping a fully digital room, sources tell DOTmed. (See our January 2009 report on X-ray tubes and image intensifiers, online at www.dotmed.com/magazine/archive.)

Pre-owned special procedure suites can also be completely de- and reinstalled. For this to take place, boards need to be changed, subcomponents tested and calibrated and software and firmware upgraded and reloaded. X-ray tube glassware, an expensive component, may need to be replaced.

Used Equipment Shortage?

Of course, the economy affects every aspect of the industry. If hospitals are sluggish in buying new equipment, the aftermarket is also impacted.

"Money is not moving, so equipment is not moving. That puts us in a squeeze because the secondary market doesn't have a lot of business," Adkins reported. He said that he expected the service-side of the industry to prosper since hospitals are hanging on to equipment. "I'm glad we never forgot how to use our toolbox."

He also observed that some de-installations that would previously have been shipped to Latin America are now remaining stateside to provide upgrades to domestic hospitals. For example a cath lab was recently deinstalled and shipped from the east to west coast of the U.S.

Another note on deinstalls: "Deinstallation in some ways can be more important than the install. If you don't save cables; if you handle the equipment roughly, it may never work again," said James E. Bowman, Jr., President, U.S. Medical Resources Corp. "Another rule is that the guy who is deinstalling is the same guy who is installing it... accountability."

DOTmed users offer some caveats in choosing secondary market equipment and vendors. "The word 'refurbished' is a term that is widely used but has many definitions. Acquire full disclosure on the refurbishment process and a way of verification that all steps were completed," suggests Edward Rawley, Classic Diagnostic Imaging LLC.

"A buyer should look for an experienced team with a credible track record. They will want someone who will be delivering the refurbished system with the capability to deliver after-sale service and support. Look for a company willing to provide a turnkey solution and a two-year full warranty as part of the package," said Bowman, who specializes in international work. He cautioned against basing purchase decisions on price alone since support is so important. "This is not a commodity. The cost of the equipment is the smallest part of [a reinstallation] project. The relocation/installation of a special procedures system is a very complicated process (he noted 14 distinct steps). It is a 'skilled people' business and without high quality, ethical people behind the project you have little hope of success."

"We classify and label the equipment according to the level of service provided for it," said Wheeler. "For refurbished equipment, we completely disassemble the equipment, put it in a staging bay, test it, replace worn parts, make sure it has all the current updates and feature enhancements so that they're the latest that the platform can support; then install and warranty the equipment for parts and labor for a period of a up to a year or more."

Driving Trends for the Future

Stent placement remains the bread and butter of the cath lab along with diagnostic imaging/angiography that supports those procedures.

"What we see as growth areas are cardiologists who are treating peripheral [artery disease] in addition to coronary," said Philips' Fabian. "Where we see a huge growth in cardiology is what we call large field-of-view labs. The bigger detectors are able to image not only the coronary disease on the table but the entire patient...all the way up from their carotids down to their feet. Often you'll see cardiologists working on the blood flow in the vascular structure such as the legs or other parts of the body."




Another advancement becoming more common is the application of detailed CT and other modalities in this specialty to complement traditional X-ray fluoroscopy. CT angiography (CTA or CCTA) almost lost its Medicare reimbursement but for the outcry from the medical community in 2008. (See https://www.dotmed.com/news/story/5613.) Despite that fortunate reversal, cardiac CT imaging is not yet reimbursed by Medicare.

"Hospitals are not putting patients through a non-reimbursable procedure and they are still diagnosing in the cath lab," Fabian said. "If reimbursement changes, you will see more diagnostics going to CT, which will allow more patients to be screened because it's less invasive than a cath lab. As you are able to screen earlier you will be able to treat more patients in a cath lab."

Advancements can be seen in the shift toward hybrid cath/OR suites in which the less invasive catheter procedures can be accomplished, yet, if needed, open heart surgery can take place also. The hybrid approach is also a trend in vascular surgery.

"What we are seeing is endovascular surgeons, interventional radiologists, and interventional cardiologists investing in a piece of equipment in a surgery or OR environment to handle interventional procedures in a different part of the hospital," GE's Lange said. "So putting a fixed piece of X-ray equipment-a fixed lab-in an OR, whereas traditionally there was a mobile C-ARM there."

An example of a procedure performed in a hybrid suite is the experimental placement of a heart valve using a catheter-style procedure. (Read about the Edwards Lifesciences PARTNER trial at www.dotmed.com/news/story/7862.)

"A driver is that more procedures are being performed in a less invasive way. If you think of the original one-the conditions addressed by CABG procedures are now in effect being done with a stent," Fabian said.

Finally, in the goal of reducing door-to-balloon times, some hospitals are simply moving the cath lab closer to ER. That presents a perfect time to upgrade the suite. If only reimbursement issues were sped-up as much as the door-to-balloon times, this segment would expand in no time!

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DOTmed Registered Special Procedures Angio/Cath Lab Sales & Service Companies
Names in boldface are Premium Listings.

Domestic
David Denholtz, Integrity Medical Systems, Inc., FL
DOTmed Certified/100
Dennis Giuzio, Mobile Radiology, Inc., FL
Robert Serros, Jr., Amber Diagnostics, FL
Bill Adkins, National X-ray Corporation, FL
DOTmed Certified/100
John Froemke, MMI, IL
Craig Whelan, Medical Imaging International, KY
DOTmed Certified
Jeff Rogers, Medical Imaging Resources, INC., MI
DOTmed Certified
Joe Zaremba, Advanco Medical Systems, MO
DOTmed 100
Dan Wheeler, Transtate Equipment Co., NC
Leon Gugel, Metropolis International, NY
DOtmed Certified/100
John Kollegger, Bay Shore Medical, LLC, NY
DOTmed 100
James E Bowman, Jr., US Medical Resources Corp., OH
Edward Rawley, Classic Diagnostic Imaging LCC, OH
Michael Ruthemeyer, ApronCheck.com, TX
Robert Smith, Inter-Components, TX
Matthew Smith, Emerge Medical Imaging, TX
Ron de Ru, NorthWest Supply, WA
DOTmed Certified/100

International
Weber Gomes, Eletronmedic, Brazil
David Lapenat, ANDA Medical, Inc., Canada
Pantelis Papathanasiou, Intrahealth, Greece

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