With adequate preparation, community hospitals that lack cardiac surgery units can safely perform elective angioplasties or percutaneous coronary interventions (PCI) with no increase in either patient mortality at six weeks or adverse cardiac events at nine months, compared with hospitals that do, according to a large and potentially controversial report.
The study randomly assigned 14,149 patients to receive PCI at a hospital without on-site cardiac surgery, as long as it met certain criteria, and 4,718 patients to undergo the procedure at a hospital cardiac surgery capability. The trial involved more than 60 hospitals in 10 states.
There was no significant difference in adverse outcomes at six weeks or nine months, although there was a small increase in the need for target vessel revascularization in patients who received PCI at hospitals without on-site cardiac surgery.
The report could be interpreted as evidence that smaller or rural community hospitals without cardiac surgery could launch elective PCI programs, or petition state regulatory agencies with rules prohibiting the practice to reconsider, so their patients would not have to be sent to hospitals outside their local areas.
The study, led by Thomas Aversano, MD, an associate professor of cardiology at Johns Hopkins University and colleagues, was presented at the American College of Cardiology annual meeting in Chicago and is published in the March 29 edition of the New England Journal of Medicine.
Aversano acknowledged that it is a controversial topic. Many cardiologists firmly believe that hospitals without cardiac surgery backup should not perform PCI procedures because errors and adverse events do occur.
Historically, experience with the earliest PCI procedures in 1979 showed that "10% of the patients required emergency coronary artery bypass grafting," Aversano's paper said. Complications include coronary occlusion resulting in myocardial infarction, artery perforation, coronary dissection or so-called no reflow, or the patient having a heart attack mid procedure.
Guidelines from professional organizations such as the American College of Cardiology and the American Heart Association nixed elective angioplasty procedures at hospitals that could not promptly perform rescue surgery.
But by 2002, the rate had declined to .15, and since then, with increased operator and facility experience, those complications rates dropped even further. In California and some other states, many hospitals perform PCI without surgical backup as long as they have rapid transfer agreements with hospitals that do.
But Aversano cautions against over-interpreting or misunderstanding the study's findings. "One of the downsides is taking this research and saying, 'OK, now, anybody can do angioplasty. So let's just buy the catheters and let's have at it.' That's absolutely false."
Rather, the hospitals and interventionalists who participated in this research project met strict criteria. "They underwent a very formal, very detailed angioplasty development program that we supervised and that we monitored, part of which involved the application of guidelines, the development of logistics and care plans and pathways. And there are political issues that have to be addressed in each community hospital (first) to importantly affect patient care."
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."