Some research has demonstrated that performing elective percutaneous coronary interventions (PCI) in low-volume facilities, especially those without onsite cardiac surgery, can result in positive outcomes. Critics say, however, that these studies are mostly single-center investigations, which do not reflect the real risk of performing elective PCI without onsite surgical backup. In fact, critics point to studies using Medicare data, which do show an increase in mortality for patients treated at facilities without surgical backup.
Part of the controversy seems to center around those who say that establishing a cath lab without surgical backup in areas of close proximity to Centers of Excellence is simply a way to make a quick buck without concern for patient safety. The contrary position, however, will point to a need within rural communities, along with a glut of recent studies that show a trend toward positive outcomes in centers without surgical backup. How this disagreement will play out remains to be seen, but the consensus seems to be settling on the fact that low-volume facilities without onsite cardiac surgery are here to stay.
|States that Pay for PCI without Surgical Backup|
|The majority of U.S. states cover PCI without onsite cardiac surgery support. Source: Carl L. Tommaso, MD, Rush North Shore Medical Center, Skokie, Ill.|
Should it be done?
Elective PCI is currently a Class III indication, which means there is “evidence and/or agreement that it is not useful or effective and may be harmful.” The ACC/AHA/SCAI guidelines state that elective PCI should not be performed at institutions that do not provide onsite cardiac surgery. An update to the guidelines in 2005, however, stated that the recommendations “may be subject to revision as clinical data and experience increase,” due to the fact that several centers without onsite surgical backup have reported satisfactory results.
“Just because it’s a Class III indication doesn’t mean we don’t do it,” says Carl L. Tommaso, MD, director of the cath lab at Rush North Shore Medical Center in Skokie, Ill. He points to other commonly performed PCI procedures designated as Class III that are the “bread and butter” of the interventional community:
- PCI in patients with multivessel disease
- PCI in patients with failed or multiple saphenous vein grafts
- PCI in patients with impaired left ventricular function, and
- PCI in patients with left main disease.
Because of the sophistication of interventionalists today, surgery during elective PCI is rarely required. So the issue is not necessarily the lack of surgical backup but rather that it has become a surrogate for low volume, says Timothy Henry, MD, an interventional cardiologist at the Minneapolis Heart Institute in Minnesota. “In general, sites without surgical backup have low volumes, whereas sites with surgical backup have higher volumes.”
The guidelines state that for a cath lab to maintain proficiency it needs to perform a minimum of 150 PCIs annually, of which 36 should be primary PCI. “This is not a very large volume, not even enough to support a program,” according to Gregory J. Dehmer, MD, director of the cardiology division at Scott & White Hospital and Clinic in Temple, Texas. He says the reason community hospitals began performing elective PCI in the first place was to maintain a higher volume for the physicians and the support staff.
Outposts of experienced labs
Tommaso says that elective PCI is most effective for community hospitals when they serve as an “outpost of an experienced lab, where they rotate the professional staff and doctors through a hospital that has a high volume.” He concurs with Henry that the distinguishing factor in proficiency is volume experience, not onsite surgical backup.
One example of a successful “outpost” site is Immanuel St. Joseph’s Hospital (ISJ), a 150-bed community hospital in Mankato, Minn., serving an area of about 300,000 people. ISJ has a fully equipped cardiac cath lab, but does not have cardiac surgical capability. Saint Mary’s Hospital (SMH), a tertiary care facility with onsite cardiac surgery, is located 85 miles away in Rochester, Minn. Both hospitals are part of the Mayo network.
Researchers from Mayo, led by Kirsten J. Long, PhD, matched 257 patients at ISJ to 514 patients at SMH, all undergoing low-risk, elective PCI. Investigators found similar clinical outcomes between the two facilities, with slightly more procedural success at ISJ (Medical Care 2006;44:406-413). Long says the study shows that a facility without surgical backup can achieve the same clinical outcomes as one with surgical backup given that strict protocols are established, such as:
- Careful patient selection
- Detailed training of all clinicians and allied health staff in high-volume institutions
- Formal interventionalist training at U.S. accredited programs, and
- An elaborate transport system in case of emergencies.
Long also says that a key component of the Mayo protocol was that the physicians and allied staff at ISJ maintained procedural volume compliance. “They were coming to SMH in Rochester to perform procedures, as well as those they performed at ISJ.”
Interestingly, Long and colleagues found that those treated at ISJ incurred significantly increased direct medical costs compared to SMH: $13,771 versus $10,746, respectively, in estimated total costs. ISJ-treated patients also incurred about $6,000 more in billed charges than SMH, but had similar length-of-stay postprocedure (1.53 days). Long attributes the increase in costs to a more liberal use of expensive drugs, such as glycoprotein IIb/III inhibitors, as well as more liberal stent use. “This might indicate practice patterns aimed at trying to reduce ischemic complications to minimize the risk of need for cardiac surgery, which contributed greatly to the cost differentials between the two sites,” she says.
Despite the increased costs to patients at ISJ, Long says they are providing a necessary service for their rural population.
Trials in question
Still, many criticize these single-center studies, not because they doubt the successful outcomes of protocol-laden environments, but because they are not randomized controlled trials, the gold standard. No such trials have been completed as of yet. However, an analysis of the American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR) supports the assertion that primary and elective PCI procedures in hospitals with or without on-site surgery can have similar outcomes. (Circulation 2005;112[Suppl II]:II-737). However, ACC-NCDR data are collected only from those facilities that choose to submit them.
A contradicting retrospective review of Medicare patients revealed a 2.8 percent higher mortality rate in primary/rescue PCI patients treated at sites without surgical backup. The increase was primarily confined to hospitals performing 50 or less PCIs per year (JAMA 2004;292:1961-1968). The authors concluded that policies aimed at increasing access to primary/rescue PCI “through promoting PCI in hospitals without cardiac surgery may inadvertently lead to an overall increase in mortality related to PCI.” Even though it is based on administrative data, the Medicare study is more revealing because data from all patients are submitted, as opposed to single-center studies that might tend to omit negative outcomes, according to some experts. The trend is clear, says Dehmer. More and more rural and community hospitals realize that they need to start a cath lab program to remain competitive and attractive to patients. But as they do, they leach volume from surrounding institutions, particularly in urban and suburban areas, potentially interfering with physician competency in higher-volume facilities. A cynic might say that the proliferation of cath labs is not an altruistic pursuit, especially when research has revealed that the vast majority of Americans already live within 30 minutes of a cath lab.
“The decision to begin or operate a PCI program without onsite surgical backup should be based on the health needs of a local area, not on desires for personal or institutional gain, prestige, market share, or other similar motives,” Dehmer says.
Despite the controversy over the specific types of clinical trials, evidence exists to suggest that PCIs can be performed successfully in institutions without cardiac surgical backup. Experts caution, however, to be wary of letting these data from single-center studies be the sole driver for the increasing growth of cath labs, particularly in urban and suburban areas where the actual geographic need may not be as great as in rural areas.
|The average quarterly increase in rates of elective PCI (20 percent) were significantly higher at facilities without onsite surgical backup (shown above), compared to the average quarterly rate (8 percent) for facilities with onsite surgical backup. The increase occurred despite national guidelines that state elective PCI should not be done in centers without onsite cardiac surgery. Source: American Journal of Cardiology 2007;99(3):329-332|