Since the clinical benefits of fractional flow reserve (FFR) were confirmed with the release of the FAME study in January 2009, the technology has gained wider adoption. To assess its impact on contemporary cath labs, five interventionalists came together from across the U.S. to discuss the economic considerations.
Clinical benefits + cost savings
FFR is a physiological index that determines the severity of blood flow blockages in the coronary arteries, measured by pressure wire technology. This helps physicians identify lesions that may or may not cause ischemia.
The FAME study found a statistically significant 30 percent difference in major adverse cardiac events (MACE) such as death, MI and repeat revascularization with FFR-guided strategy, compared with angiographic-guided strategy for stent placement. The FFR arm received significantly fewer stents—roughly two stents versus three per patient in the angio-guided arm—leading to significantly less contrast agent use, lower procedure costs (from about $6,000 to $5,000) and a trend toward shorter hospital stays.
William Fearon, MD, co-principal investigator for FAME and an interventional cardiologist at Stanford University in Stanford, Calif., notes that at two years, the MACE curves remain separated with about a 4.5 percent difference—with MI and death rates significantly lower in the FFR-guided group.
Fearon also cites the one-year economic evaluation from FAME, which found that the overall costs associated with the FFR-guided arm were $16,521, compared with $19,362 in the angio-guided arm.
Salman A. Arain, MD, an interventional cardiologist at Tulane University in New Orleans, says he evaluates 40 to 50 percent of his patients with FFR in the outpatient setting. He speaks to the value of employing FFR in the distinct New Orleans patient population, which has “a mixture of private sector, insured patients, as well as a fair number of indigent patients who often don’t have insurance. Arain notes that the use of FFR has risen in both populations, but more so in the indigent population.
“One of the things that changed for us is the economics of the hospital,” Arain says. “We started to watch patients who were coming back to the hospital and realized that we may have been using too many stents, and then FAME was published. Now, the balance has shifted in favor of using the pressure wire.”
Adoption barriers: Past and present
Peter N. Ver Lee, MD, an interventional cardiologist at Northeast Cardiology Associates in Bangor, Maine, started using FFR in 2000 and now uses a pressure wire in about 35 percent of his cases. An early adopter, he says the initial barriers were the skepticism about a new technology, “particularly from administration and surgeons. After about two years, everyone was on board.”
Of course, how to use FFR varies across clinical practices. Ashequl Islam, MD, an interventional cardiologist from Baystate Medical Center in Springfield, Mass., notes they have 12 operators—five in the academic group—who opt for IVUS for left main disease. “However, when we question IVUS, we might use FFR—that’s how much we trust the technology,” he says.
The provider setting also impacts the economics of employing FFR. “In private practice, you can bill for performing an FFR procedure, even if you don’t implant a stent,” says Ver Lee, adding that hospital-employed interventionalists are impacted differently.
“Part of the reason why some physicians have been slow to adopt the technology is due to the perception—and maybe a reality—that in most settings, you would perform fewer PCI procedures,” responds David J. Cohen, MD, director of cardiovascular research at St. Luke’s Mid America Heart Institute in Kansas City, Mo. “If you evaluate what happens [when FFR is not used], there are many lesions that get treated with a stent that shouldn’t. As a result, there has always been some pushback from interventional communities, particularly those who get paid by the number of procedures performed.
“Hospital administrators aren’t always thrilled about the adoption of FFR because most hospitals view stenting as a profitable procedure, especially with relatively simple lesions, and they may lose some of that business,” explains Cohen. “However, based on the results of FAME, FFR will save the hospital a lot of money by eliminating unnecessary stent implantations.”
The full benefits of FFR include fewer downstream costs, which the U.S. reimbursement system doesn’t reward for, says Cohen, adding that such perverse incentives may change with healthcare reform as there is a greater focus on long-term outcomes.
Fearon concurs, noting that “guidelines now recommend FFR in a broader population. This swing will hopefully affect the major healthcare insurers, including Kaiser Permanente and Medicare.”
Decision makers = Peace of mind
While Arain says FFR has become the gold standard, the economic benefits of FFR cannot be properly evaluated in one or two cases, instead, they have to be based on a large number of cases and include downstream costs.
He exemplifies a hypothetical patient who presents with suggestive symptoms, but hasn’t had a functional study. Typically, the patient would be taken off the cath lab table, sent for a nuclear study and returned to either the inpatient or outpatient setting.
“In this case,” Arain explains, “the hospital incurs the cost of a second angiogram that may or may not be fully reimbursed. Additionally, the quality of the nuclear study may be questionable, and the patient receives a second dose of radiation. FFR can shorten everything down to one procedure, providing better care in a cost-effective manner.” He adds that FFR can decrease hospital turnover times.
To support Arain’s example, Fearon references a 2003 JACC study, conducted by Leesar et al, which assessed the cost effectiveness of FFR at the time of the original cath versus taking the patient off the table to perform a nuclear stress test. The researchers found that FFR “markedly reduced” the duration and cost of hospitalization compared with stress perfusion scintigraphy (11 hours vs. 49 hours; and $1,329 vs. $2,113).
Ver Lee adds that the coronary physiology data gained through FFR give decision makers confidence in their treatment strategy. “If that patient comes back in the next two to four weeks with pain, unless he or she has not filled the Plavix prescription, the physician has the confidence to know it is not coronary ischemia.”
Observing the varied nature of the practices, Cohen points out that Ver Lee and Islam are “pretty geographically isolated,” and as a result, have a unique opportunity to see every patient that comes back. “In major cities, patients may have many different provider options, and you can’t guarantee the absolute continuity of care.”
Yet, Arain notes FFR has the ability to standardize care. “Other institutions are familiar with the nature of FFR, so they will trust our report,” he says. “In contrast, one physician may consider an angiogram 70 percent, while it may be 80 or 90 percent in my opinion. Yet if my patient gets admitted to another facility, those physicians will confidently accept our reports because of our use of FFR.
“The true value of FFR comes into full bloom when you start saving money and you don’t see it in the first week or the first three months, but instead, a year or two ahead,” Arain concludes.