Cost-minded Hospitals Give CTO PCI a Second Look

Questions have swirled around the value of percutaneous coronary intervention (PCI) for patients whose quality of life has suffered from chronic total occlusion (CTO). Inevitably, another issue has arisen: which cath labs and operators should be undertaking these difficult and costly procedures?

For many veterans of coronary artery bypass graft (CABG) surgery who continue to experience angina, a trip to their cardiologist often comes with grim news. Beyond medical therapy, they are told, little can be done to help them, that opening their totally occluded arteries would be too risky and the chance of success too uncertain to justify relieving symptoms that are not really life-threatening. No wonder CTO PCI accounts for just 3.8 percent of the total PCI volume for stable coronary artery disease, according to the American College of Cardiology National Cardiovascular Data Registry (NCDR) (JACC Cardiovasc Interv 2015;8[2]:245-53).

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There is little disagreement that CTOs, with their heavy atherosclerotic plaque burden, are among the most challenging lesions to treat in coronary interventional practice, as evidenced by historically low success rates, higher complication rates than standard PCI and weighty demands on institutions that do treat them in terms of equipment, time and resources. For those reasons, many physicians steer their symptomatic CTO patients away from PCI, urging instead a regimen of aggressive medical therapy. Strengthening their argument was the DECISION-CTO trial, which was presented by Seung-Jung Park, MD, PhD, of the Asan Medical Center in Seoul, South Korea, at the American College of Cardiology (ACC) 2017 Scientific Session. Park and colleagues found no therapeutic advantage to CTO PCI vs. optimal medical treatment, though critics quickly fingered design flaws in the randomized study. Meanwhile, institutions are often reluctant to commit to the complex revascularization procedure on grounds it would exact too great an economic toll on both the hospital and the interventionalists.

“It’s one area where there aren’t enough operators willing to tackle them,” says Emmanouil Brilakis, MD, PhD, director of the Center for Advanced Coronary Intervention at Minneapolis Heart Institute, about CTO PCI procedures. “It takes more time to do and to learn than standard PCI, and one in 10 [procedures] will result in failure. There is also a common perception that medical therapy is all you need.”

For all the debate over CTO PCI, studies have shown that the treatment is getting safer thanks to advances in intracoronary imaging, guidewire technology and novel new crossing techniques and devices. While a single-center review from the Mayo Clinic reported a procedural success rate of 51 percent between 1979 and 1989 (Circulation 2011;123[16]:1780-4), DECISION-CTO found a success rate of 91.1 percent in patients undergoing percutaneous treatment of CTO lesions.

What’s more, an expert analysis published on the ACC website in 2015 noted “a growing body of evidence suggesting clinical benefits of CTO PCI,” including improvements in angina symptoms, exercise capacity and left ventricular systolic function.

Large medical centers—the most frequent venue for CTO PCI—cite their obligation to improving patients’ health as reason enough to undertake the demanding treatment. “We’re performing a service for patients who have been told they must continue to try and function with symptoms that limit them,” says Ajay Kirtane, MD, SM, director of the cardiac catheterization laboratories at New York Presbyterian Hospital (NYPH)/Columbia University Medical Center in New York City. “We end up treating them through procedures that are mentally and emotionally taxing and take a long time to do, but they give us the satisfaction of knowing we can make someone who is dysfunctional functional again.”

On the economic front, there is evidence to suggest that CTO PCI may not be the financial albatross that many hospitals reluctant to enter the field have assumed. “It’s certainly been profitable for us,” says Dan Hornberger, RN, BSN, manager of interventional cardiology at Wellspan York Hospital in Pennsylvania, of the roughly 250 CTO PCIs his teaching institution performs annually. “Our contribution margin for the cath lab has increased about 20 percent every year since we started our CTO program, and we’re now looking to add two or three more cath labs.”

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While profitability depends on a range of factors, Wellspan York Hospital’s experience is not inconsistent with a single-center study that found a positive cost margin associated with CTO revascularization and advised that the treatment “should not be considered an economic deterrent.” When Dimitri Karmpaliotis, MD, PhD, director of CTO, Complex and High Risk Angioplasty at NYPH/Columbia University Medical Center in New York City, and colleagues compared 154 CTO procedures with 1,847 non-CTO cases, they found that supply costs attached to a CTO procedure—primarily balloon angioplasty catheters, guidewires and coronary stents—were more than twice those of a less complex PCI and that total cath lab utilization time was two times higher. Despite these higher costs, the researchers concluded that the contribution margin per CTO patient remained positive due to increased total charges for items like equipment and from greater reimbursement compared to regular PCI (Catheter Cardiovasc Interv 2013;82[1]:1-8).

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A possible hierarchy of hospitals

Reimbursement aside, experts agree that not every hospital and not every interventionalist should be performing CTO PCI. “One reason so few of these procedures get done is because they’re hard to do and most operators in this country don’t have the technical capabilities to successfully and reliably offer CTO PCI, particularly to the more complex patients,” says Robert Yeh, MD, director of the Total Chronic Occlusion PCI Program at Beth Israel Deaconess Medical Center in Boston. “But I don’t think we need a thousand CTO PCI centers in the country. It should be a limited number, where we can concentrate expertise to really optimize patient outcomes.”

While large medical centers with multiple cath labs, considerable resources and large patient volumes are best suited to meet the rigorous demands of CTO PCI, smaller hospitals should not rule out entering the field, according to Karmpaliotis. “If they have an interest, I would encourage smaller hospitals to develop CTO programs, as long as they’re very careful about patient selection and they collaborate with major tertiary centers,” says Karmpaliotis, who spends 80 percent of his time performing CTO PCI. He believes that each state should have, depending on its population, two or three “centers of excellence” for the most complex CTO cases and a network of smaller satellite centers for lower-level procedures that can readily get advice or on-site assistance from their tertiary partners when it’s needed.

Karmpaliotis notes similarities between CTO PCI and TAVR programs. Both, he contends, require a strong infrastructure with dedicated operators who have the latitude to develop their skills and learn new techniques; cath labs that can commit the resources and procedural time to these complex treatments; and support teams consisting of nurses, intensive care space and post-procedural care. For those same reasons, many cath labs have determined they can ill afford to make the investment. In 2011, Pinak B. Shah, MD, director of the interventional cardiology training program at Brigham and Women’s Hospital and an assistant professor of medicine at Harvard Medical School, wrote that CTO PCI procedures can “lead to inefficient use of catheterization laboratory personnel and physician time, which can reduce patient flow through the laboratory,” requiring resource use that “may be difficult to justify for a procedure that has reduced success rates” (Circulation 2011;123[16]:1780-4).

On the other hand, a CTO PCI program can provide payback in ways apart from the bottom line. Because of its “halo effect”—conferring an aura of cutting-edge competence and achievement on an institution—the procedure can “create positive feedback and recommendations so that you get referrals for other procedures,” Brilakis points out. At Wellspan York Hospital, establishing a CTO program has resulted in a growing referral base of CTO patients from the area and other states. What’s more, it has given the hospital a technological platform for treating other complex cardiovascular conditions. According to cath lab manager Hornberger, much of the equipment and technology that’s employed for CTO PCI is transferrable to multivessel disease, left main disease and bifurcation lesions, and has given the 580-bed community teaching hospital an entry point for research projects.

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Operator experience leads to efficiencies

To achieve profitability with CTO PCI, programs need to gain experience and translate what they’ve learned into efficiencies. CTO revascularization “becomes more cost-effective from an institutional standpoint as procedure times are reduced, as equipment usage goes down because people are choosing the right equipment at the outset and as teams generally become more efficient,” Yeh says.

CTO operators are a critical part of the equation. The most experienced are able to ensure the best patient outcomes and parlay that reputational asset into a growing caseload from the community and beyond. A study aimed at understanding the operator learning curve found that high-volume CTO PCI operators achieved a 75.2 percent success rate, outpacing their low-volume counterparts by over 16 percent. Findings like this support the view, held by many, that CTO cases should be reserved for one or two dedicated operators in each lab. (In the largest tertiary centers, that might mean hundreds of cases annually per operator.) Because they have considerably more staffing and resource flexibility than smaller hospitals, tertiary centers may be able to allow less experienced CTO PCI operators to partner with more seasoned counterparts. At NYPH/Columbia, they “usually scrub two attendings for the most difficult cases,” says Kirtane. “That way the patient gets the best outcomes.”

An increasing number of CTO PCI fellowships and training programs are being offered across the U.S., reportedly drawing a good deal of interest from professionals in the field. While many early CTO operators were self-taught, current learning resources include websites, CTO-specific meetings and proctorships. “Even if people don’t want to become expert operators in complex CTO, learning about the techniques, equipment and technology required to perform a successful CTO PCI makes them better operators overall,” stresses Karmpaliotis. “In any hospital with a CTO PCI center, the overall quality and level of PCI has improved dramatically.”

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Total programmatic approach

Experienced operators, however, are only part of a total programmatic approach that experts say is essential for a successful CTO enterprise. Nurses, technologists and quality specialists tasked with measuring outcomes need to be on board, as must cath lab and hospital administrators to champion the program and commit to considerable requirements for lab time, space and equipment. At Beth Israel Deaconess Medical Center, according to Yeh, these requirements are met through a dedicated CTO cart, days and procedure rooms that offer not only lower radiation but extended availability for the most challenging cases.

In the final analysis, one of the most vital parts of a carefully coordinated approach to CTO is selecting the right patients or, as Karmpaliotis puts it, “not burdening your cath lab with a five- or six-hour case that’s most likely to fail anyway.” Fact is, many of the approximately 20 percent of coronary artery disease patients who have total occlusions respond to medical therapy, including aspirin, P2Y12 receptor inhibitors, beta blockers, calcium channel blockers, nitrates and statins. Patients with significant symptoms who have tried and failed to achieve good results on medications are considered to be the strongest candidates for CTO PCI. The question for physicians then becomes risk vs. reward. “For every procedure we do, we ask beforehand, ‘Do the potential benefits exceed the anticipated risk?’” Brilakis says. “And if the benefits exceed the risk, then we go ahead and do it.”

The 2017 appropriate use criteria (AUC) for revascularization in stable ischemic heart disease illustrate how CTO PCI continues to evolve (J Am Coll Cardiol 2017;69[17]:2212-41). The AUC remove CTO PCI–specific recommendations, making CTOs subject to the same criteria governing all other elective PCIs, including severity of symptoms, extent of ischemia and the patient’s response to medical therapy. In addition, OPEN-CTO (Outcomes, Patient Health Status and Efficiency in Chronic Total Occlusion), a study funded by Boston Scientific, is underway to develop prediction tools to identify patients likely to reap the greatest symptomatic improvement from CTO PCI. The procedure continues to grow as more operators are being trained with increasingly sophisticated equipment and techniques. “There’s been a remarkable amount of education and sharing of best practices across the CTO community,” says Yeh, “and that’s really helped to drive the number of successful CTO PCIs both nationally and around the world.”