Does
your doctor meet the guidelines?
New guidelines for angioplasty/stenting
raise the bar for cardiologists. Before
having either of these procedures performed, you should make sure your
doctor and your hospital meet the latest standards.
By DrRich
In April, 2001, for the first time since 1993, the American College of Cardiology (ACC) and the American Heart Association (AHA) released an updated set of guidelines for percutaneous coronary intervention. (Percutaneous coronary intervention - PCI – is the term used for angioplasty and stenting in the coronary arteries). This updated set of guidelines will not be formally published until June, but have already been posted on the websites of both the ACC and AHA.
The “ACC/AHA Guidelines for Percutaneous Coronary Intervention” are intended to provide a set of standards that every cardiologist and every hospital performing angioplasty and stenting are expected to meet.
Several features of the newest set of guidelines should be of interest to patients. Anyone who is going to be having angioplasty and/or coronary artery stenting should make sure their doctor and the hospital in which the procedure is to be performed meets these latest standards.
What’s changed since 1993?
Virtually every aspect of interventional cardiology has changed since the last guidelines were published 8 years ago. Balloon technology has improved tremendously, and stents – a rare experimental procedure in 1993 – are now routine. In addition, with the use of new drugs, cardiologists have learned how to prevent and treat the most devastating complication of angioplasty/stent – abrupt vessel closure due to clotting. Strides also have been made in preventing long-term restenosis. These changes – and many others – have made it high time for a new set of guidelines.
Patients should pay attention to the following guidelines:
New definition of “successful procedure”
Advances in techniques and in technology have improved so much that the definition of a “successful procedure” (that is, a successful angioplasty and/or stent placement) has had to be revised. Under the former guidelines, improving the blockage to less than 50% narrowing was considered successful. Under the new guidelines, in order for a procedure to be counted as a success, the remaining blockage needs to be reduced to less than 20% of the artery’s diameter.
This redefinition of “success” is relevant when doctors are describing to you their overall success rate, and when doctors are reporting on the success of a procedure they have just performed on you.
The trick here is to let the doctor know prior to your procedure that you understand the new definition of success. When the doctor tells you his success rate, you reply, “You are of course referring to a residual stenosis of less than 20%, correct?” This will notify the doctor that a) he’s got a savvy patient on his hands, and b) this patient fully expects good results by modern standards, not the standards of the past.
Expected success rates
According to the new guidelines and to the new definition of success, doctors should achieve an initial success rate for elective procedures of 96 – 99%. (Elective procedures are angioplasties and stents that are done as a matter of choice, not as a matter of emergency. The initial success rate refers to the success rate at the end of the procedure.) Heart attacks should occur during the procedure in no more than 1 – 3% of patients, and no more than 0.2 to 3% should require emergency bypass surgery. The mortality rate while in the hospital for these patients should be no higher than 0.5 to 1.4%.
Your doctor should be more than willing to discuss his personal success/failure rates with you. If he or she is not, consider going elsewhere.
Performing PCI in the elderly, in women, and in diabetics
Over the last 8 years, new data has been accumulated on the success rate with angioplasty and stenting in various subsets of patients. The new guidelines discuss this issue.
For the elderly (i.e., greater than 75 years of age), for women, and for diabetics, the results with angioplasty and stenting are worse than for young people, men, and non-diabetics.
The elderly and women most often still benefit from these procedures, but their risk is somewhat higher. In the case of the elderly, the likelihood that they are suffering from medical problems in addition to heart disease may account for the increased risk. Why women have a higher risk with angioplasty and stenting is largely speculative, but it appears that restenosis is more likely to occur in women as compared to men, perhaps due to hormonal differences. Research is underway to identify the cause of increased risk in women.
In the case of diabetics, those with coronary artery disease affecting more than one blood vessel seem to do significantly better with bypass surgery. The new guidelines indicate that these patients should have bypass surgery procedure performed instead of angioplasty.
The use of stents to reduce restenosis
The guidelines note that one of the most effective ways to reduce the incidence of restenosis it to use coronary artery stents, instead of balloon angioplasty alone. While cardiologists have understood this “rule” for several years, hospital administrators and others responsible for cost containment have encouraged the use of angioplasty alone. If your doctor is considering the use of angioplasty without stenting, you should challenge this plan. Make sure your doctor is treating you, and not your health plan.
The use of radiation to reduce restenosis within stents
The new guidelines recognize the fact that intracoronary radiation reduces restenosis (by 30 – 50%) in stents that have already experienced restenosis. This suggests that patients being treated for restenosis within a stent should ask their doctors about coronary artery radiation therapy.
The guidelines do not mention “primary” radiation therapy – that is, radiation therapy at the time of initial angioplasty, in an attempt to reduce the risk of even one restenosis. This is not an oversight. The latest data from randomized trials show no benefit from primary radiation therapy, and even appear to show some detriment. Click here for a recent review of coronary artery radiation.
It should be noted that the new guidelines recognize the promise of drug-eluting stents. These stents – currently investigational – have the potential of greatly reducing the risk of restenosis, and, one hopes, may render the need for intracoronary radiation obsolete within several years. Click here for a recent review of restenosis.
Which centers and which doctors should perform PCI?
Perhaps the most controversial section of the new guidelines is the one that addresses the issue of who should perform interventional cardiology procedures. The guidelines, citing several studies that have consistently shown that smaller centers performing relatively few procedures have a high incidence of complications, recommend that angioplasty and stenting be performed in high-volume institutions by doctors who perform a lot of these procedures.
Specifically, results with angioplasty and stenting are significantly improved in centers in which at least 400 such procedures are performed each year, and by doctors who personally perform at least 75 such procedures yearly. Furthermore, angioplasty and stenting should be done in institutions that have rapid access to emergency cardiac surgery (since even in high-quality centers up to 3% of patients having angioplasty/stenting require such surgery.)
This recommendation will doubtlessly not sit well with the scores of smaller institutions that have recently and enthusiastically established interventional cardiology programs that are performing a relatively small number of procedures. Such institutions (and the doctors that work in them) will no doubt argue that the ACC and AHA committees are dominated by cardiologists that work in the big institutions, and are thus merely protecting their turf.
Yet, while there may be some truth to such arguments, the data remains compelling. If you need to have these procedures performed, the odds of a good outcome are better in institutions that do a lot of them – and the odds of surviving a complication are also better.
Click here for the full version of the new ACC/AHA Guidelines for Percutaneous Coronary Intervention.
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