CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY/EDITORIAL COMMENT
Coronary intervention at hospitals without on-site cardiac surgery: are we pushing the envelope too far?*
Gregory J. Dehmer, MD, FACC1,2,* and
D. Scott Gantt, DO, FACC1,2
1 Department of Medicine, Division of Cardiology, Scott & White Memorial Hospital and Clinic, Temple, USA
2 Texas A&M University System Health Science Center College of Medicine, College Station, Texas, USA
* Reprint requests and correspondence: Dr. Gregory J. Dehmer, Division of Cardiology, Scott & White Clinic, 2401 South 31st Street, Temple, Texas 76508, USA.
gdehmer{at}swmail.sw.org
Invasive cardiologists who lived through the early years of balloon angioplasty remember those initial terrible moments when we realized something was very wrong. The ST-segments were rising, the blood pressure was falling, and we heard our patient utter that dreadful statement, "Doc, I feel like I'm gonna die." We knew right then it was going to be a long day in the cath lab. It is easy to forget that in the early days of balloon angioplasty 1% to 2.5% of patients died and 1.9% to 5.8% required urgent coronary artery bypass graft (CABG) surgery (1–3).
The incidence of emergency CABG surgery after failed percutaneous coronary intervention (PCI) clearly has diminished over the last 20 years (4). The American College of Cardiology/American Heart Association Guidelines for PCI cites an incidence of 0.2% to 3% for emergency surgery after elective PCI (3). In the registry of The Society for Cardiac Angiography and Interventions from 1996 to 1998, 0.3% to 0.7% of all patients who received PCIs required emergency CABG surgery (5). Recently in a survey of 18,593 patients receiving PCIs from the Cleveland Clinic, the need for emergency CABG surgery decreased from 1.5% in 1992 to 0.14% in 2000 (6). In addition to defining the incidence of emergency CABG surgery, these and other studies identify the many clinical, procedural, and lesion-related variables associated with a higher likelihood of emergency CABG surgery. Patients with acute coronary syndromes, including ST-segment elevation myocardial infarction (STEMI), important baseline hemodynamic abnormalities and complex lesion morphology, such as calcification, angulation, and thrombus, are at greater risk (3). As the techniques for PCI evolved and results improved, it was only natural we pushed the envelope to treating unstable patients, those with STEMI and more complex and difficult lesions subsets.
The article by Lotfi et al. (7) in this issue of the Journal indirectly asks an important question that is becoming more relevant as some desire to push the envelope to the setting of elective PCI in laboratories without on-site cardiac surgery. The question is: What if something really goes wrong and there is a delay before urgent CABG surgery? If you have performed enough PCIs, you know how awful that delay feels. There you are, standing in the laboratory watching your patient with an occluded or perforated artery that you cannot fix deteriorate before your eyes despite your best efforts. The surgeon is coming, but the minutes it takes for the operating room crew to arrive seem like hours. Perhaps us "old doctors" remember this better because it happened more frequently to us in the past than it does to the newer generation of interventional cardiologists. After all, we now have a better knowledge of who is at risk, we have perfusion balloons, glycoprotein IIb/IIIa antagonists, better thrombin inhibitors, and stents. Nevertheless, the question remains important because of a simple fact. Although the risk of PCI failure resulting in urgent CABG surgery is now very low, it is not zero. Lotfi et al. (7) attempt to define the key issue: What is the potential for harm if something really goes wrong and surgery is delayed?
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Is their answer correct?
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To answer this question, Lotfi et al. (7) carefully identified all patients having urgent CABG surgery after failed PCI at their facility, a tertiary care hospital with experienced operators performing roughly 1,500 PCIs per year. Although the number of operators is not provided, this fits every definition of a high-volume laboratory. During this time period, 45 patients (0.7%) required CABG surgery during the same hospital admission. In our current era, we realize that many times even if things go badly during PCI, we can stabilize the patient and avoid the all-out rush to the operating room. Accordingly, the authors had three prespecified criteria that they used to identify patients who most likely could be harmed if surgery were delayed. Their three criteria were hemodynamic instability, severe ischemia, and coronary perforation with effusion or tamponade. These criteria could be debated but seem reasonable based on published studies of outcome after urgent CABG surgery for failed PCI (3,6,8–13). Using their criteria, one to two patients per 1,000 PCIs might be in big trouble if they experienced a delay before CABG surgery for a failed PCI, a reasonable number equivalent to other contemporary data from high volume programs (6,8,9,11–14). Some might quibble, saying that this is just a "potential for risk" and, in fact, they have not demonstrated that patients were harmed by waiting or that patients actually had a better outcome with immediate versus delayed surgery despite meeting their criteria for an urgent situation. We must concede that point, but does common sense always need verification in a randomized trial?
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Is their estimate relevant to the real-life question?
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Lotfi et al. (7) derived their data from experienced operators working in a high-volume laboratory at a tertiary care hospital. As such, the authors basically treated "all comers." About half were urgent PCI procedures and, by our estimate, approximately 65% of the lesions observed were of type B2 or C morphology, both of which are associated with a higher risk of adverse outcome. The relevant question, however, is not "What if something goes wrong at a tertiary care hospital with an operating room down the hall?" Indirectly but very clearly, the authors demonstrate that answer—100% of their patients who had the prespecified criteria were in the operating room in < 2 h. The relevant question is "What if something really goes wrong when elective PCI is being performed at a hospital without on-site cardiac surgery?" In that regard, the study of Lotfi et al. leaves some remaining questions.
Several groups have reported their experience with elective PCI at hospitals without on-site cardiac surgery (15–18). The most recent comes from Ting et al. (18), who work in a laboratory 85 miles from the nearest hospital with on-site cardiac surgery. Their report never states how many patients were evaluated and then referred to a hospital with on-site surgery, but certainly there were some. Even the strongest advocates of elective PCI without on-site cardiac surgery recommend stringent screening criteria designed to identify low-risk patients with a high likelihood of success. To that end, Ting et al. (18) describe treating 196 clinically stable patients with type A or B1 lesions, a system where images could be transmitted to the supporting hospital for immediate consultation, and a "fail-safe" transportation protocol, including the confirmed availability of three separate helicopter ambulances, two ground ambulances, and a fixed-wing air ambulance. Moreover, cases were cancelled or delayed if there was inclement weather that could interfere with transport (18). They report procedural success in 99.5% of the procedures and one late in-hospital death that was not related to a lack of on-site surgery. However, given their small sample size, the 95% confidence interval for death was 0.01% to 2.8%, the latter number clearly excessive for elective PCI by today's standards.
Because Lotfi et al. (7) made their determination in the absence of any screening to exclude high-risk clinical or lesion subsets, it is logical to assume that if such patients were excluded, the actual number of patients at risk would be lower. In fact, all of their patients who required urgent CABG surgery and manifested one of their prespecified criteria had type B2 or C lesions. Theoretically, these patients would be excluded from treatment in Ting's laboratory, making the solution very simple. If you want to avoid trouble, simply exclude type B2 and C lesions. That would make everything very easy if it were true, but there are data to the contrary. In two large contemporary surveys of PCIs, both with a high usage of coronary stents, 5% and 15% of those requiring emergency CABG surgery had type A lesion morphology (6,12). This reminds us that it is not always the lesion causing the problem. Guiding catheters are stiffer and less forgiving than diagnostic catheters and some, such as the Amplatz and multipurpose, can unexpectedly jump deeply onto the coronary artery, causing vascular trauma. Reports of left main dissection secondary to guide catheter manipulation also exist (19). Although the number of patients at risk for harm may be overestimated by Lotfi et al. (7), one must respect the fact that despite every precaution, an adverse event requiring urgent CABG surgery may occur.
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Are we not already pushing the envelope?
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Data continue to accumulate that urgent PCI for reperfusion in the setting of STEMI is not only equivalent but in some respects superior to fibrinolytic therapy (20,21). We have already started to push the envelope to emergency PCI for STEMI at hospitals with cardiac catheterization laboratories but without on-site cardiac surgery (22–24). The most recent American College of Cardiology/American Heart Association PCI guidelines state this is acceptable under certain well-defined circumstances (3). Is elective PCI without surgical back up not the next logical step in this progression? Some will argue it is, but it is critical to make the distinction between urgent PCI for acute STEMI and elective PCI. In the setting of STEMI, our treatment goal is to prevent mortality or reduce the morbidity associated with the loss of viable myocardium, and this is well supported in the literature (3,23). Time is also critical because the sooner the artery is opened, the better the outcome. Much of what we do in medicine is a balance of risk versus benefit; for example, the risk a medication will cause a bad side effect versus the benefit for treating a condition. It is no different for the situation of PCI for STEMI at hospitals without on-site cardiac surgery. We are balancing the risks (stroke if fibrinolysis is used, need for transfer should emergency CABG surgery be required, vascular complications) versus the benefits (salvage of myocardium, reduced mortality, shortened length of stay). In this setting, pushing the envelope to PCI for STEMI at hospitals without on-site surgery is an attempt to provide a potential life-saving and muscle-sparing procedure to as many patients as possible in the fastest time possible. For certain there are risks in doing this without surgical back up, but in most people’s minds, the risk of harm if something really goes wrong is outweighed by the potential benefits.
If the envelope is pushed farther, then what is the risk versus benefit of elective PCI at hospitals without on-site surgery? Lotfi et al. (7) may overestimate the risk, but maybe not, because it is unlikely a hospital without on-site cardiac surgery will have the same case volume and experience as a high-volume center with experienced operators. We may never agree on the exact number, but given there is some small but finite risk, is it outweighed by the benefit of elective PCI in this setting? Treatment guidelines suggest that elective PCI is appropriate for functionally significant lesions to relieve angina (3). The relief of angina is a wonderful thing for patients, but there are no data suggesting PCI for the relief of angina lowers short-term mortality. By definition, elective PCI cannot be urgent like the treatment of STEMI, and the benefits are not dependent on time. What then is the specific benefit? Those advocating elective PCI in hospitals without on-site cardiac surgery suggest there are geographic or socioeconomic factors that limit access of the patient to hospitals with on-site surgery. We can imagine an elderly couple living in a small town on a fixed income who do not like to drive into the big city and have no family or friends who are willing to help them. In this circumstance perhaps, the expense of travel or drive on the busy interstate highway is a barrier. However, could it be possible that these geographic and economic factors relate more to the physician or local hospital wanting the business to stay in their own backyard? Whatever the risk of harm attributed to a delay for urgent CABG surgery, the ultimate question is whether any additional risk is acceptable in the setting of elective PCI at a hospital without on-site surgical back-up? In the final analysis, this becomes a comparison of very serious risks that are unlikely to occur versus benefits that are very soft end points.
Recently, there have been several expert opinions published calling for specialized "Centers of Excellence" to treat patients with acute coronary syndromes (25–27). This is similar to the concept of trauma centers that have been validated to improve outcomes. Although patients with acute coronary syndromes are a high-risk group who often require immediate treatment, does the Center of Excellence concept also not make sense for elective PCI? Is the extra risk something you would accept for your PCI?
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Footnotes
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* Editorials published in the Journal of the American College of Cardiology reflect the views of the authors and do not necessarily represent the views of JACC or the American College of Cardiology. 
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Is their answer correct?
Is their estimate relevant...