Low-Volume Cath Labs without Surgical Backup are Here to Stay

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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
  • No PCI without onsite cardiac surgery
  • Primary PCI without onsite cardiac surgery performed
  • Primary and elective PCI without onsite cardiac surgery performed
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