Inside Cardiology's PCI Problem

"If you have to get a flat tire, don't get one in front of that hospital; it's a real heart mill," I used to hear physicians say as they rolled their eyes. "If their cardiologists spot you, you're sure to get cathed."

The doctors were only partly joking. The adage was that interventionalists at that facility set extremely low thresholds to determine if an otherwise healthy, non-emergent passer-by needed angioplasty.

A report in the July 6 issue of the Journal of the American Medical Association gives credence to that "heart mill" phenomenon. Looking at some 144,737 non-acute percutaneous coronary intervention (PCI) procedures for elective patients performed at 1,100 hospitals, the authors deemed only 50% of the procedures appropriate, 12% downright unnecessary and for another 38%, the need was unclear.

And, within that undetermined 38%, a significant number might be categorized as inappropriate if more information had been provided.

By my calculation, if only one-third of the 38% were truly inappropriate, it would mean 24% of PCIs, roughly one in four, should not have been performed.

The researchers drilled their data down to individual hospitals' catheterization labs. There, they found, "substantial hospital-level variation in the proportion of inappropriate procedures in non-acute settings, ranging from 0% to 55%. Collectively, these findings suggest an important opportunity to examine and improve the selection of patients undergoing PCI in the non-acute setting."

The finding suggests a far greater "likelihood of patients with identical clinical characteristics receiving an inappropriate PCI at one randomly selected hospital as compared with another," wrote the authors, Paul Chan, MD, cardiologist with Saint Luke's Mid America Heart and Vascular Institute in Kansas City and colleagues from 11 other hospital systems.

"The most important point of our paper, the biggest take home message...is the substantial variability between hospitals in these elective cases in terms of the degree of inappropriateness," Ralph Brindis, MD, past president of the American College of Cardiology and an author of that JAMA report, told me in an interview last week.

"Feeding back this data will help hospitals and clinicians re-examine their practice patterns, so we can try to eliminate angioplasty where there is no value," he said.

Other evidence that PCIs are being inappropriately performed comes in a gaggle of recent highly publicized state and federal complaints that specific doctors bilked federal and private payers millions of dollars for unnecessary stent and other angiography procedures.

In just the last few months at least seven doctors in Tennessee, Maryland, Pennsylvania, Texas, and Louisiana faced penalties and accusations for performing unnecessary cardiovascular procedures in hundreds of patients.

For example, one patient received 32 stents and another 25, far above the average rate of a mere 1.6 per patient.  A few hospitals now being targeted, may have known about such schemes but failed to stop them.

Last week Peninsula Medical Center of Salisbury, MD, agreed to pay the federal government $1.8 million to settle claims that hospital officials knew about, but failed to act on, unnecessary cardiac stent procedures performed by a cardiologist.

Brindis acknowledged that the issue of inappropriate angioplasty "has gotten everyone's attention, particularly in Washington and particularly with payers, and the reason is a good one: 43% of Medicare expenses are in the cardiovascular arena."

Now the ACC, with its National Cardiovascular Data Registry CathPCI, is addressing the problem in a big way, with the first of many coming reports like this one, he said.

Present in more than 80% of the nation's hospitals, the registry is giving cardiology experts a way to evaluate and measure these procedures, "not just in terms of clinical outcomes, safety and effectiveness and mortality, but now we're actually assessing the appropriateness" not just of the angioplasty itself, but of the imaging and other tests performed on patients who didn't need them, he explained.

"We're trying to avoid unnecessary tests on patients who didn't need them, to help physicians and payers use these technologies more judiciously," Brindis said.

"As Peter Drucker said, ‘if you don't measure it, you can't manage it,' " Brindis said.

Brindis, an invasive cardiologist with Kaiser Permanente in Northern California who also is on the faculty of the UCSF Philip R. Lee Institute for Health Policy Studies, says the success of this introspection could not have occurred without an auditing process to vet the veracity of the data hospitals supplied.

When that happened several years ago, he said, "all of a sudden payers, regulators and the U.S. Food and Drug Administration became very interested in using the registry."

This new auditing strategy will give feedback, based on benchmarks, data and quarterly reports, to each hospital where those procedures take place so each hospital will know how many PCIs under its roof were inappropriate, and why, in hope of eventually reducing that 38% "undetermined" to a much smaller number, Brindis said.

Even the use of stress testing and imaging is under the spotlight, so that patients don't undergo tests with higher rates of false positives.

"These are the patients who give us opportunities to be better stewards of our healthcare dollar, in terms of doing angioplasty in people who may not necessarily benefit from it," said Brindis. "This is a changing landscape."

Several other factors are at work to measure appropriateness, including recent endorsement of PCI guidelines by the National Quality Forum six years ago. There's active review of standards for cardiovascular disease severity to determine when the narrowing of an artery is significant enough to merit intervention.

Another issue is the increased recognition that PCIs, largely thought of as a benign intervention, are not harm-free. As the authors of the JAMA article wrote, "patients who undergo PCI are exposed to risks of periprocedural complications and longer-term bleeding and stent thrombosis. Moreover, recent trials in stable patients without acute coronary syndromes have shown that PCI, compared with medical therapy, may provide only a modest population average improvement in symptom relief."

The national need to bend the cost curve is of course another reason for the spotlight, and here's where hospitals need to pay close attention.

Angiography and stenting is enormous business, with an estimated 700,000 or so PCIs performed this year at a cost of $12 billion, half of them acute – which were determined at a 99% rate to be necessary.

But if those among the rest that are injudicious are stopped, hospitals may suffer huge financial losses, especially if they weighted their balance sheets with that revenue.

Hospital leaders and interventional departments should realize that the days of the heart mill will soon be over, if they aren't already, and they should examine any operators whose volume may be in question. 

Even though the findings from the NCDR Cath PCI Registry, down to the hospital level, won't be released to the public, presumably peer pressure, as well as increasing accusations against publicly named cardiologists, should be persuasive enough to do the right thing.