The CFA Perspective

Elective PCI without SOS Debate Continues

Posted by Peter Rastello

6/12/12 9:25 AM

It’s amazing how some issues get resolved so slowly.  Take the continuing debate over allowing hospitals to perform elective PCI on patients without cardiac surgery-on-site (SOS).  Evidence mounts of its safety, effectiveness and efficacy; surveys validate that the majority of cardiologists support even elective PCI without SOS; the ACC/AHA updates and liberalizes its standards; Europe has done without SOS for many years (20 or more in many settings); blogs and opinion pieces decry the fact that it still isn’t allowed everywhere; yet, other studies and pilot programs are actively in process to further study the issue in specific states.  Additionally, there are still strong opinions voiced by some cardiologists that it is not needed, not clinically appropriate, of questionable quality, doesn’t pass the “would you send your mother there” test, or just plain morally wrong.  Is this a case of robust clinical debate, or a case of the “haves” and the “have not’s” fighting over issues of control, case volumes and dollars?  It’s probably some of both, but unfortunately with a tilt towards the latter.  Cardiology is big business and (at least currently) big dollars.

Here’s the positive news:

  • The Cardiovascular Patient Outcomes Research Team Elective (C-PORT E) study results (with six week outcomes) were presented at the AHA Scientific Sessions in November 2011 and published in NEJM (www.nejm.org, March 26, 2012) with both six week and nine month outcomes both concluded that patients who had elective PCI at experienced U.S. hospitals without on-site cardiac surgery had comparable results (mortality at six weeks and major adverse cardiac events at nine months) regardless of the hospital type.
  • A large Meta analysis of 15 controlled studies reported in JAMA (2011: 306:2487-2494) concluded that there was no material difference in outcomes between PCI with or without SOS.
  • A U.S. News & World Report/theheart.org survey of more than 17,000 cardiologists reported that two-thirds of respondents said that elective PCI at centers without SOS could be done safely and effectively.  Of note is that one-third said it could not be done safely and effectively.
  • The AHA/ACC’s new guidelines on coronary revascularization previously relegated elective PCI without SOS to Class III (Not useful/effective and may be harmful), has moved to Class 2b (may be considered).  Primary PCI, a different question, was upgraded to Class 2a (Is “reasonable” to perform).

The blogs of Dr. Melissa Walton-Shirley are well regarded and her take on this subject (PCI without surgery on site:  Is your conscience clear? posted December 13, 2011) presents her personal struggle with the issue as she weighs the very real human cost from the perspective of a practicing cardiologist in a Kentucky hospital prohibited by state regulation from performing PCI.  She concludes that: “The shortsightedness of our complacency for myocardial rescue is unforgivable in this country.” She continues, “It is time we checked unfounded fear and the unforgivable darkness of greed that taints this issue.  I submit that if we diffuse the hiding behind the unfounded fears of excessive risks and monetary losses, we will save lives…”  Her forthrightness and passion for this subject are commendable.

For many, this issue represents either a very simple response (as in, “it’s a no-brainer; why aren’t we doing this?” or, “it’s all about the money - period.”), or represents the onion that is peeled away only to reveal more layers.  Additional study and demonstration projects continue (notably in California and Massachusetts) to prove principle on a specific state level.  There are legitimate caveats galore that have been raised, such as issues of:  operator volumes, appropriateness criteria, staff training, minimum program volume requirements, quality outcomes, “access versus convenience,” regulations (by whom and at what level?), unintended or unexpected consequences (such as pushing appropriateness to attain minimum volumes), and others.  These do need to be addressed.

Don’t think for a minute that this debate will go away soon.  Without question, research findings continue to support the changing of regulation specific to PCI without SOS.  There is a general trend towards states opening up their existing prohibitions – many by fostering specific criteria or thresholds to be met.  However, pushback does exist and should not be underestimated.  In the end, this is a public health issue.  The promotion of, and accessibility to, life-saving/myocardial muscle-sparing therapy should not be governed by provincialism, self-interest or monetary gain.

As always, CFA invites your comments, suggestions, opinions and questions.