Dr Michael A Kutcher

Kutcher stressed, however, that the results should not be seen as carte blanche for hospitals to go ahead and set up PCI coverage without surgical backup. "The implications of this are that off-site PCI centers can provide excellent care to patients if the program is thoughtfully developed. But we shouldn't be extrapolating from this to encourage the widespread proliferation of off-site PCI. We don't want this to be a message that every hospital should go out and develop an off-site program," he noted.

Discussant Dr Stephan Windecker (University Hospital, Bern, Switzerland) congratulated Kutcher and his team "for putting an end to a controversy that is as long as the history of angioplasty itself." The findings, said Windecker, "give impetus to update the present guidelines."

We don't want this to be a message that every hospital should go out and develop an off-site [PCI] program.

Kutcher explained that the performance of PCI without backup cardiac surgery on site is controversial in the US but becoming more common. Clinical guidelines accept this practice for primary PCI in patients who are experiencing an MI but advise against it in elective PCI when the procedure is less urgent. But medical centers that offer primary PCI argue that they need to include elective PCI in the mix to survive economically and to keep staff skill levels high.

Kutcher told heartwire that there are around 300 centers in the US thought to be offering PCI without surgical backup, and only around one-third of these are participating in any kind of registry, something he believes is vital to ensure good quality control.

The NCDR is a large ongoing prospective multicenter registry "that offers a unique opportunity to provide contemporary insights into these issues," he said. For this analysis, Kutcher and colleagues assessed consecutive PCI cases reported to NCDR between January 1, 2004 and March 30, 2006 and compared 9029 patients who had PCIs performed in 61 centers without on-site cardiac surgery with 299 132 patients at 404 centers that had cardiac surgery available on site.

Off-site PCI programs had smaller bed capacities, were more likely to be in rural areas, were more likely to treat high-risk patients presenting with an MI, and had lower annual PCI volumes (70% performed fewer than the recommended 200 PCI procedures annually). Despite this, they had rates of procedural success, morbidity, emergency surgery, and risk-adjusted mortality that were comparable to on-site PCI centers.

The fact that the hospitals in this study voluntarily chose to submit data to the NCDR is one sign of their commitment to quality, Kutcher said, adding that other indicators of this are the fact that 92% of the off-site PCI centers offered PCI 24 hours a day, seven days a week, and off-site PCI centers had better reperfusion times than on-site PCI centers.

"These medical centers are very accomplished and represent the premier programs offering PCI with off-site cardiac surgical backup," he noted. "And they are doing angioplasty for the right reasons: to improve outcomes for heart-attack patients and to better serve patients in remote geographic areas."

You can get good results, but only if you submit to a very structured process with outcomes assessment.

He stressed that considering geographic areas individually was key to this approach. "Each area is different—you have to collect the data, assess outcomes, and look at the logistics and what is most cost-effective."

He told heartwire that "if I were a patient, I would ask the center how long they have been doing angioplasty; whether they are board certified; how experienced the staff are; the volumes; and, if there is no on-site surgery, what the transit time is to a center that does have surgery." If the answers to any of these are unsatisfactory, "I would ask for a second opinion, particularly if it's an elective procedure," he noted.

Nevertheless, he said, the new data provide reassurance to patients who use these off-site PCI centers: "You can get good results, but only if you submit to a very structured process with outcomes assessment."

Dr George Dangas (Columbia University Medical Center, New York), who moderated a press conference on the late-breaking trials, said he did not want attendees to go away with the impression that hospitals could just set up shop willy-nilly to do PCIs without surgical backup: "Institutions have to make a formal application to the state. We don't want anyone to have the perception that people can just open up on a Monday morning."

Dangas said that the Society for Cardiac Angiography and Interventions is looking at specific ways to help people with regulatory requirements, and Kutcher said that certain states (eg, West Virginia) mandate that data go to a registry such as NCDR before they are permitted to perform PCI without on-site surgery.

Kutcher and his colleagues would like to see the roughly 200 centers in the US that are performing PCI without surgical backup and not participating in any registries to do so. They cite examples of the UK, where around 25% to 30% of PCI centers don't have surgical backup but where participation in a registry is mandatory, and Sweden, where the situation is similar to that of the UK.

"We would encourage institutions that offer PCI without surgical backup to look for sponsoring institutes to work with," Kutcher added, "and we would like to develop prospective online collaborations with on-site PCI centers and encourage more sites with off-site PCI to participate in registries such as NCDR."

In his discussion, Windecker said that PCI has advanced immensely since the first days, and, "accordingly, the incidence of emergency CABG is exceedingly low—0.1% to 0.3%—and importantly, as shown in the current study and recently in the SCAAR registry, there is no difference in mortality rates [between off-site and on-site PCI centers]."

He noted, however, that there has been one study published looking at Medicare patients using the MEDPAR database that showed that mortality was significantly higher in those undergoing nonemergent PCI at an off-site facility [1]. But the data have been consistent in terms of mortality after primary PCI, he said, with no differences across the current NCDR study, the SCAAR registry, and the MEDPAR data.

The time has come to change recommendations, he announced, adding that the current study "gives impetus to update the ACC/AHA/SCAI guidelines, which currently state that elective PCI should not be performed at off-site PCI centers—this should be changed from a class 3 recommendation to a class 2a recommendation. As with primary PCI, the recommendations could be updated for patients with STEMI, from class 2b to class 2a."

Finally, Windecker said, "it's worthwhile to consider the recommendations of the British Cardiac Society, which advises that there be adequate provision of cardiac surgery as a prerequisite for safe PCI, recommending that all PCI centers without on-site surgical facilities have measures to perform CABG within 90 minutes of referral."