September 17th, 2014
Is It Safe to Offer PCI at VA Centers Without On-Site Cardiothoracic Surgery?
CardioExchange’s Harlan M. Krumholz interviews Thomas M. Maddox about his research group’s study of post-PCI outcomes at VA centers with or without on-site cardiothoracic surgery. The article is published in Circulation.
Krumholz: Please summarize the main findings of your paper.
Maddox: We explored whether the VA’s policy of offering PCI at centers without on-site cardiothoracic (CT) surgery is safe and improves veterans’ access to PCI. From October 2007 through September 2010, PCI was conducted in 24,387 patients at 59 VA centers; 6616 of these patients underwent PCI at 18 facilities without on-site CT surgery. We found no significant differences in peri-PCI adverse outcomes, 1-year all-cause mortality, and rehospitalization for MI between centers with versus without on-site CT surgery. The availability of the 18 non-CT surgery PCI centers allowed patients to be a median of 91 minutes closer to a PCI center than they otherwise would have been. Therefore, the findings suggest that the VA policy for PCI is safe and improves access to PCI.
Krumholz: You found no difference between facilities with versus without CT surgery capabilities, but you cannot exclude a hazard as large as 20%. And you did find that revascularization rates in follow-up were higher for the patients who underwent PCI at centers without on-site surgery. How do you then respond to people who question the claim that outcomes are the same?
Maddox: It’s equally likely that centers without CT surgery had 13% lower rates of adverse outcomes. It is also comforting that the point estimate of the adverse outcome ratio was 1.02, suggesting nearly equivalent absolute rates of events between the two types of centers. With respect to the most important complication — peri-PCI need for emergent CABG — the rates at both types of centers were extremely low and, indeed, occurred less frequently at centers without on-site CT surgery. Therefore, VA interventional cardiologists seem to be selecting their patients carefully and performing PCI in a safe manner. Nevertheless, it will be important to follow annual outcomes for these patients, which is easy to do under the VA’s national Clinical Assessment, Reporting, and Tracking (CART) quality-oversight program for PCI. This periodic surveillance will allow us to detect and address any issues quickly.
The higher revascularization rates at centers without on-site surgery were confined only to elective cases — they were not the result of higher rates of MI. As we discuss in our article, this may be explained by interventional cardiologists’ more conservative approach to initial revascularization strategies, although similar rates of successful PCI and higher rates of complex PCI were noted in centers without on-site CT surgery. Another potential explanation is that centers without on-site CT surgery are more likely to take an ischemia-guided PCI approach to managing coronary disease, given that the logistics of getting patients to a CABG-capable center are more difficult or may not be in line with the patient’s preference. Regardless of the explanation, we were encouraged to see that the higher rates of revascularization were not associated with a signal of harm.
Krumholz: Do you think that patient consent protocols at facilities without CABG should mention the potential for increased risk?
Maddox: Given that we found no evidence of increased risk for peri-PCI or longer-term adverse outcomes at centers without on-site surgery, there is no rationale for different consent processes. Rather, we would suggest that, when discussing PCI with prospective patients, all centers describe the risks inherent to the procedure, as well as their local processes for handling complications. For centers without on-site CT surgery, their plans for patient stabilization and transfer to a CT surgery-capable center should be part of this discussion.
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Offer your thoughts on Dr. Maddox’s analysis of findings from the VA CART program.