The impact on cath labs of the increasing use of coronary CT angiography is still being debated. Coronary stent visualized with CTA. (Source: Philips Healthcare)

Recent trial results, multidetector CT and new and more uses for the services and equipment of the traditional cardiac catheterization lab are impacting the bottom line of facilities across the country. These and more factors may have temporarily decreased cath lab procedures, but experts in the field predict recovery—albeit a changing face for the cath lab.

An estimated 4.21 million patient cases were performed at 1,970 cardiac cath lab sites in 2006, according to a report from consulting firm IMV. This represents a 9 percent increase from 2002, which also indicates a slightly slower rate of growth (2 percent a year) than in previous years. The vast majority (89 percent) of procedures are cardiac-related and the remaining 11 percent are non-cardiac applications, such as carotid, iliac, femoral, run-off, renal and extremity studies.

From 2003 to 2006, the average device budget per cath lab increased 18 percent per year to $1.8 million, driven by the adoption of more sophisticated devices such as drug-eluting stents, according to the report. Also, the proportion of sites with capital budgets of over $1.5 million has increased from 14 percent in 2000 to 30 percent in 2006, as hospitals invest in new technology such as flat panel digital detectors.


Growing the business

With that kind of investment, it’s no wonder that many cath labs are growing their business by making it possible for more subspecialists to use the equipment.

To continue to succeed and grow, cath labs have to become multi-imaging destinations, according to Steven Yakubov, MD, an interventional radiologist with OhioHealth. “They have to include CT angiography suites, maybe MRI, and interventional procedures. The cath lab of the future is a multi-imaging destination.”

“We’re certainly using our labs for multiple reasons by multiple users,” says Stephen Green, MD, associate director of the cardiac catheterization lab at North Shore University Hospital in Manhasset, N.Y. His facility was ahead of the curve when it began doing peripheral work in 1996. Newer lab users include vascular surgeons, interventional radiologists and neurointerventional radiologists. Labs have more functionality today so more physicians can use the equipment for endoscopic procedures, clips and coils in the head and more—all in the same lab, he says.

Another benefit of more modern equipment is the capabilities offered by information systems. They’re so good these days, Green says, that they can help with the bottom line by allowing users to track diagnostic volumes and look for various trends and patterns. With these advantages, “business is not going to get smaller.”

The other challenge for individual facilities is keeping their patient population growing. “The economics of the community you’re in is important, plus the level of competition,” says Yakubov. The more labs in your area, the more you have to show that you have superiority in these multidimensional imaging systems. “Your lab’s physicians all need to be experts in their field for that cath lab to stand out in an area where there are multiple labs competing for the same patient base.”

Despite the new and expanded uses for cath lab resources, there are forces at work chipping away at revenue. Recent study results are part of the current “perfect storm” in cardiology that’s forcing reevaluation of cath labs, says Thomas H. Maloney, RT, director of clinical education for Boston Scientific. A series of trials all came in a sequence that has driven stent utilization down from 90 percent to 60 percent and a measured reduction of 10 percent in cath lab procedures between September 2006 and September 2007. Recovery from that decline will be gradual but steady in 2008, he predicts.

Part of that recovery requires savvy about how to increase volumes. Cath labs need to perform new peripheral, neurological and structural heart procedures, Maloney says. “We’re seeing the advent of hybrid labs. We need other, new procedures to replace what we’ve lost.” Most cardiology meetings now focus on carotid stenting, structural heart disease and aortic valve replacement, among other techniques that will help cath labs’ recovery.

There is good reason for the studies and trials that relate to cardiac catheterization labs, says Bonnie Weiner, MD, an internist and interventional cardiologist and the current president of the Society for Cardiovascular Angiography and Interventions (SCAI). “Nobody likes to undergo procedures if they don’t need them. They want to know that the risk-benefit ratio is reasonable and appropriate.”

Weiner says study data, however, must be kept in perspective and allowed to be evaluated critically from a scientific standpoint, but not portrayed in a way that unnecessarily panics patients.

The COURAGE trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation), which looked at percutaneous coronary intervention (PCI) and optimal medical therapy, found that PCI is no better at preventing future events than optimal medical therapy alone in patients with stable coronary disease.

But, the COURAGE trial has a tremendous number of holes, according to Yakubov. Interventional cardiologists didn’t think the study was fair, that it was biased to show medical therapy would be better than angioplasty.

“In selected cases, there is no difference in mortality outcome between balloon angioplasty with stenting and medical therapy. I think every interventional cardiologist would agree with that statement. To say that everybody will do as well is misrepresenting the whole field,” Yakubov said.

According to Weiner, the real message from COURAGE is that patients with stable symptoms and little ischemia will do fine on medications. “That’s a fairly small amount of the patients that we see.” The majority of the COURAGE patients had already had their angiogram and anybody who had high risk or anatomy that really dictated some kind of revascularization were excluded from this study upfront.


Multislice mayhem

Multidetector CT scanners also are impacting cath lab business. If smaller institutions get a high-end scanner, they can get a better handle on their patient population rather than referring them and their business on to larger facilities, says U. Joseph Schoepf, MD, an associate professor of radiology and director of CT research and development at the Medical University of South Carolina in Charleston.

Maloney agrees with Schoepf. He points out that before MDCT, younger patients would have been referred to the cath lab for angina. Now, CT, as a triage tool for low- to intermediate-risk patients can keep them out of the cath lab when tests are negative. “Multislice CT is definitely going to take off,” he says, which will help balance the field between smaller facilities and larger, academic medical centers that have invested in state-of-the-art cath labs.
 

While cath labs experienced a 9 percent increase in the number of cases from 2002 to 2006, it actually represents a slower rate of growth (2 percent) than in previous years. (Source: IMV)
From 2003 to 2006, the average device budget per cath lab increased 18 percent per year as more sophisticated devices such as drug-eluting stents were adopted. (Source: IMV)

Another financial aspect of MDCT is its ability to prevent rather than cure, says Furqan H. Tejani, MD, director of advanced cardiovascular imaging at Long Island College Hospital in Brooklyn, N.Y. “If you can prevent a sentinel event, even one, the cost containment is large enough that one MI prevented is enough to pay for 10 patients’ CT angiography.” That’s crucial right now as the Centers for Medicare & Medicaid Services continues to scrutinize the evidence supporting CT angiography.

While CMS at this point has chosen to allow local Medicare carriers to pay for CT angiography, it can still decide in the future to restrict payment. If the agency restricts reimbursement for CT angiography, the technique could go the way of MR, says Tejani. CMS has taken a very long time to adequately reimburse for cardiac MR. “When you take the financial incentive out of certain technologies, adoption becomes very slow.”

Physicians are seeing more gatekeeping from insurance companies, says North Shore University’s Green. Insurers are refusing nuclear stress tests on patients who would have been routinely triaged to that test two years ago. Mild symptoms or no symptoms means all testing stops and this patient population doesn’t make it to the cath lab for intervention.

About $300 billion of annual healthcare expenditures in the United States pays for the assessment and care of ischemic heart disease. Medicare and other payers are increasing their scrutiny of these expenditures, which makes MDCT ideal for the cardiac community, says Schoepf. “A CT scanner is an ideal tool to keep growth in healthcare spending in check. It allows you to end up with the same diagnostic information from diagnostic catheterization at a fraction of the cost.”

There is some debate as to what is the best gatekeeper test for cardiac patients: stress test, CT angiography or cardiac catheterization. The initial thought was that CT angiography would decrease stress testing but Tejani says the opposite is happening. “We see plaques or lesions and want to assess whether they are hemodynamically significant.” Patients with a moderate risk of coronary artery disease, moderate stenosis and positive stress test results end up in the cath lab. “CT angiography has taken away some of the negative caths but it hasn’t actually reduced the number of caths being done.”

The majority of coronary caths—60 percent—are for diagnostic purposes and unconnected to any type of intervention. Typically, reimbursement for diagnostic cath without therapy is a wash, says Schoepf. “By utilizing CT to rule out significant stenosis and, therefore, eliminating an unnecessary cath procedure and intervention, cath labs can make better use of cath suite time, which typically results in a better reimbursement scheme.”

Tejani says that a real-world registry would help the medical community get enough information to accurately establish a gatekeeper test. A central repository would help determine whether the current clinical hypothesis requires little or substantial change. “If sensitivity and specificity precipitately drop, then CT angiography is not a good test for the emergency department, where the majority of cardiac admissions originate.”

The only way to determine exactly where this test fits in is by doing extensive registry of these patients, he says. Meanwhile, physicians are performing the study on a few patients and trying to come up with their own consensus statement, but, “clinical anecdotes have no value in clinical medicine,” Tejani says.

It may be inevitable that CT becomes a part of the evolving role of interventional cardiologists: to what degree, remains to be seen. In the short-term, it’s clear that leaders in cardiology departments are responding to the changing healthcare market by initiating several steps: opening up cath labs to other specialists; incorporating multi-imaging modalities into their labs; and reaching out to physicians and consumers alike to educate and inform them about the new possibilities in interventional cardiology.  
 

Studies and issued guidelines and their media coverage drove a 10 percent decline in coronary interventional procedures. These drivers include the European Society of Cardiology’s release of the first European Guidelines on Percutaneous Coronary Interventions (PCI); the FDA’s drug-eluting stents advisory panel recommending that the agency change the labels of the two approved coronary devices to warn that off-label use may increase the risk of thrombosis, myocardial infarction, and death; and results of the COURAGE trial. (Source: Boston Scientific)