In 2007, the Society for Cardiovascular Angiography and Interventions (SCAI) published an expert consensus document on the current status and future direction of PCI without on-site surgical backup. The document reviewed the existing literature and examined recommendations for performing PCI in this setting from several existing programs and other sources, thereby defining best practices for facilities and operators. “Since that time, new studies, meta-analyses, and randomized trials have been published in which PCI with and without on-site surgery has been compared,” says Gregory J. Dehmer, MD, FACC, FACP, FSCAI. “In addition, professional organizations have published appropriate use criteria for coronary revascularization and other documents affecting the practice of PCI.”
According to Dr. Dehmer, several noteworthy changes occurred in PCI guidelines that were released in 2011. “Elective PCI was upgraded to Class IIb, and primary PCI was upgraded to Class IIa at facilities without on-site surgery,” he says. In addition to the PCI guidelines, expert consensus documents and competency documents related to PCI plus additional research have provided more information on ways to optimize the structure and operation of PCI programs without on-site surgery.
Consolidating Recommendations
In 2014, SCAI—in collaboration with the American College of Cardiology and the American Heart Association—released a new expert consensus document on PCI at sites without on-site surgical backup. This document consolidates the myriad of recommendations that have been released in different forms since the 2007 document. “The recommendations are designed to improve safety while maintaining access to quality care,” says Dr. Dehmer, who was lead author of both the 2007 and 2014 consensus documents.
As cited in the new document, 11 original studies and three meta-analyses have been published since the 2007 recommendations for PCI at sites without on-site surgery. Over the same period, the number of states permitting both elective and primary PCI increased by 60%, while the number of states prohibiting any PCI without on-site surgery dropped significantly (Figure).
Examining Key Highlights
The updated consensus document covers a variety of important topics for clinicians and several new ones. With regard to procedure volume requirements and consistent with the new clinical competency document for PCI, interventional cardiologists are recommended to perform a minimum of 50 PCIs per year, averaged over a 2-year period that should include a minimum of 11 primary PCIs annually. Ideally, these procedures should be performed in institutions performing more than 200 PCIs per year and more than 36 primary PCI procedures for STEMI per year.
The new document also makes several changes to facility requirements, including an emphasis on internal quality-review programs and specific diagnostic modalities, such as intravascular ultrasound and fractional flow reserve. These were previously deemed “desirable” for performing PCI without on-site surgical backup but now are deemed “necessary.” In addition, requirements for cardiologist and cardiac surgeon interactions were updated. There are now recommendations for regular meetings and agreement on cases, treatment times, patient-consent procedures, and transfer agreements between hospitals (Table). Furthermore, clarification is offered on patient and lesion characteristics that would deem patients unsuitable for treatment at facilities without on-site surgical backup.
Throughout the country, there has been an initiative among hospitals and medical centers to provide patient-centered care, but money often becomes a driving factor in the expansion of PCI services in some regions. The new recommendations emphasize that desires for personal or institutional financial gain, prestige, market share, or other similar motives are not appropriate considerations for initiating PCI programs. New programs offering PCI without on-site surgical backup are only appropriate if they clearly serve geographically isolated populations.
Fostering a Heart Team Model
In addition to ensuring compliance with established protocols, it is important for interventional cardi-ologists and cardiac surgeons to establish clinical relationships that foster the heart team model. The role of cardiac surgeons should not be confined to the treatment of PCI complications but should include their participation in decisions about revascularization options.
“The key is to ensure that both surgical revascularization and PCI are appropriately considered in PCI programs operating without on-site surgical backup,” Dr. Dehmer says. “In the future, the focus should shift toward the development of rational plans for the distribution of PCI services.” He adds that small PCI programs with large fixed costs are inefficient and unnecessary if they fail to improve access in areas of need. Ongoing study and surveillance of all PCI programs is needed with participation in national databases. Further declines in PCI volumes might necessitate the closure of PCI programs in the future.
