Dr William O'Neill

Dr William O'Neill (Beaumont Hospital, Royal Oak, MI) pointed out that, like the 2001 guidelines, the 2005 guidelines put special emphasis on operational volumes, specifying that operators performing elective PCI should do at least 75 procedures per year, at high-volume centers where more than 400 procedures per year are performed and that have on-site emergency backup. "There should be a red flag for physicians doing fewer than 75 procedures per year," O'Neill stated. "There are very clear data that demonstrate both operator and hospital volumes correlate with outcomes both in terms of success and complication rates. A clear issue with the development of angioplasty programs in sites without on-site surgery is the dilution of the volumes at other institutions, which will have a clear and measurable impact on quality of care for the patient."

O'Neill also highlighted a separate recommendation, new to the 2005 guidelines, stating that distal embolic-protection devices should be used in patients undergoing PCI for diseased saphenous vein grafts.

Dr Ted Feldman (Northwestern University, Evanston, IL) underscored several new anatomic indicators in the 2005 guidelines. For example, unlike its predecessor, the 2005 document specifically states that stenting of left main coronary arteries is "reasonable" in patients with greater than 50% stenosis not eligible for coronary bypass surgery.

Dr Sidney C Smith Jr

Dr Sidney C Smith Jr (University of North Carolina, Chapel Hill), who chaired the task force committee, focused on one of the most divisive issues tackled by the guidelines—elective and emergency angioplasty at sites with and without surgical backup. The 2005 guidelines give a class IB recommendation to the performance of elective PCI by operators who meet volume and institutional criteria and grant a class IIIC recommendation, meaning that the practice is not recommended, to the performance of elective PCI at institutions without on-site cardiac surgery. However, the guidelines give a class IIB recommendation for primary PCI for patients with STEMI without surgical backup. Such a strategy, say the guidelines, "might be considered in hospitals without on-site cardiac surgery, provided that appropriate planning for program development has been accomplished, including appropriately experienced physician operators" performing >75 PCIs and at least 11 primary PCI procedures per year at qualified institutions.

"Of all the areas in the guidelines, this is the area that's going to raise the most controversy and the most interest, because there is no access-to-care issue in the US about elective angioplasty," O'Neill commented. "We have minimal waiting times, unlike Canada or the UK, where it may take weeks or months to get an angioplasty. The average wait time in the US is hours, if not days, for having elective procedures. This is really primarily driven by finances. There really is no proof that doing these procedures [without on-site surgery] enhances the outcome to the patient or makes it safer. If anything, it could make things worse."

Smith agreed, noting that there are clear differences between primary and elective PCI recommendations. "For primary PCI, it's recognized that you can save a life if it's done correctly and it's immediate and available. The studies that have been done list the circumstances in which the environment should be structured. . . . We don't have a comparable amount of experience with elective PCI. If you take a patient who is totally stable who could, by choice, have gone to a hospital that is 10 minutes away—what type of patient selection and what type of requirements should you have if that hospital wants to start to do elective angioplasty without on-site surgery? It's important to distinguish between whether it is the patient who wants the procedure done there, the physician who wants those privileges, or the hospital administrators who want it to be done there, for economic reasons. We've chosen to focus on what's best for the patient."

Dr Ted Feldman

Asked why European guidelines seemed less strict about the requirements for on-site surgical backup, Feldman observed that "on-site surgery" is an "unfortunate term," since really what's required is rapid emergency surgery, if needed. "There are many centers in Europe that have no backup but have off-site surgery available to them that is actually more rapid than a lot of on-site surgery in the US."

Smith pointed out that transfer times in Europe are also much shorter between centers, permitting door-to-needle times closer to 90 minutes (as shown in the DANAMI-2 and PRAGUE trials), as opposed to 180 minutes in the US National Registry of Myocardial Infarction database.

Other new additions to the guidelines include recommendations on the use of drug-eluting stents, repeat PCI for in-stent restenosis, and bivalirudin as a "reasonable" alternative to unfractionated heparin and GP IIb/IIIa antagonists in low-risk patients.