New PCI Guidance Aims to Increase Safety, Maintain Quality

A new guidance document on percutaneous coronary intervention (PCI) cites the need for new safety and quality protocols to address the increasing number of PCIs performed at centers with no on-site cardiac surgery backup available.

A new guidance document on percutaneous coronary intervention (PCI) issued by the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology (ACC), and the American Heart Association (AHA) cites the need for new safety and quality protocols to address the increasing number of PCIs performed at centers with no on-site cardiac surgery backup available.

The document, which updates the SCAI’s 2007 recommendations and consolidates a number of previously released recommendations, concludes that new programs offering PCI without on-site surgical backup are not appropriate unless they clearly serve geographically isolated populations.

“Desires for personal or institutional financial gain, prestige, market share, or other similar motives are not appropriate considerations for initiation of PCI programs,” the recommendation states.

Overall, a third of facilities performing PCI have no on-site cardiac surgery, and of those, two-thirds performed fewer than 200 PCIs per year, according to the consensus document. According to Gregory J. Dehmer, MD, FACC, FSCAI, director of the Division of Cardiology at Baylor Scott & White Health, Central Texas, and the lead author of the consensus document, noted that having strict protocols in place is essential as the number of low-volume centers increases.

The statement covers per-year case volume requirements for interventional cardiologists; necessary facility requirements; necessary interactions and meetings for cardiologist and cardiac surgeons about cases, procedures, treatment times, patient-consent procedures, and transfer agreements; and patient and lesion characteristics that would label patients as unsuitable for treatment at facilities that lack surgical backup.

“As the technique and equipment for PCI has improved, the evidence from randomized studies suggests that procedures can be performed safely without on-site surgery,” Dehmer said in a statement. “But at the same time, the number of low-volume centers is increasing, making it essential that those facilities without backup cardiac surgery have strict protocols in place to ensure the highest level of patient safety.”