They also had to have agreements for transport with tertiary hospitals and agreements with cardiac life-support services capable of transporting patients requiring intraaortic balloon counterpulsation, with response times of 30 minutes or less.
Additionally, he says, hospitals in the study had had to meet strict criteria established by the ACC, AHA, and the Society for Cardiac Angiography and Interventions, for proficiency and experience, maintain primary PCI programs 24 hours a day, seven days a week, and be capable of performing 200 PCI procedures a year.
"They were not low-volume operators," Aversano says.
Depending on the state they were located in, most sites had to get waivers to participate in this program.
Late last year, the three societies modified their guidelines in a way that changed the identification for non-primary elective angioplasty procedures done in facilities without cardiac surgery from a class III, which means potential harm, to class IIB, in which "Elective PCI might be considered in hospitals without on-site cardiac surgery, provided that appropriate planning for program development has been accomplished and rigorous clinical and angiographic criteria are used for proper patient selection."
That was based on some smaller studies in Europe and information from cardiology registries "suggesting it was safe and efficacious to do non-primary angioplasty without cardiac surgery," Aversano said.
Aversano also cautioned that most state health facility licensing agencies with prohibitions against hospitals without cardiac surgery capability performing PCI will be slow to change their regulations without compelling evidence and demonstration of need that community hospital PCI will provide greater access to care for patients in the long run.
However, Aversano emphasizes that "This study was not performed to expand the number of angioplasty programs. It was to give healthcare regulators, policy makers and healthcare decision makers another tool to use to decide the appropriate geographic distribution of PCI capability in their local areas."