Document provides safety, quality metrics for PCI facilities without on-site surgery

Three cardiology societies have released an expert consensus document today that addresses the steps hospitals can take to provide the safest possible environment for PCI in facilities that do not provide on-site surgical backup.

Perspective from

The consensus document — written by a committee representing the Society for Cardiovascular Angiography and Interventions, American College of Cardiology Foundation and American Heart Association — updates a document from 2007 and features new recommendations to increase safety while maintaining quality in PCI facilities without surgical backup.

“There have been a number of different documents that have touched upon PCI in facilities without on-site surgery,” Gregory J. Dehmer, MD, FACC, FAHA, FSCAI, co-author of the document, told Cardiology Today’s Intervention. “The main thing we tried to accomplish with this document was to look at everything out there and bring it together in one combined resource, so that facilities engaged in doing this will need only one reference document.”

Advances, changes since 2007

According to Dehmer, who is professor of medicine at Texas A&M Health Science Center College of Medicine and director of the cardiology division at Baylor Scott & White Health in central Texas, there have been several changes since the paper was published in 2007 that have been incorporated into the new consensus document. Most notable among these changes, according to Dehmer, are those addressed in the 2011 PCI guidelines.

Gregory J. Dehmer

“The latest version of PCI guidelines upgraded PCI at facilities without on-site surgery for STEMI from IIb to IIa for patients with STEMI, and from class III to class IIb for elective patients,” Dehmer said. “This reflects the fact that now we are more comfortable with PCI without onsite surgery. Based on a survey conducted specifically for the new document, PCI without onsite surgery is being performed in all but one state in the United States.”

The other big change, Dehmer said, is there are now two randomized trials reporting outcomes of elective PCI in facilities without on-site surgery, specifically CPORT-E and MASS COMM.

“Both studies reached the same conclusion: There was no evidence that elective PCI without on-site surgery is harmful. Although there were some minor differences in secondary endpoints, the bottom line is it’s safe,” Dehmer said.

The document also takes into account that in the 7 years since the paper was first published, PCI use has dropped significantly. The authors attribute this decrease to many factors, including the increased use of drug-eluting stents, the use of modalities like fractional flow reserve to evaluate blockages, a greater emphasis on heart disease prevention and risk factor management, and the development of the appropriate use criteria for coronary artery revascularization.

Quality, safety take center stage

In the document, Dehmer and fellow authors provide a compilation of recommendations from several organizations and documents. These recommendations address facility and personnel requirements for PCI programs without on-site surgery, as well as offer recommendations for off-site surgical backup and case selection, and patient and lesion characteristics that may be unsuitable for nonemergency procedures at facilities without surgical backup.

In addition, the document provides several new recommendations, from which Dehmer highlighted two.

“In the previous documents, if you had a facility without on-site surgery, it was considered ideal to have IVUS and FFR equipment available. We have upgraded that to a requirement,” he said. “This is because of the growing emphasis on interrogating more lesions and making sure they are flow limiting.”

The other change Dehmer highlighted involves the meaning of the phrase “geographic isolation,” which had been used in previous documents to indicate that facilities should not be too close in proximity to one another, although it had never been clearly defined.

“In order to define this, we moved away from the distance concept of geographic isolation and made it a time-based metric. We did this because much of this is driven by the need to provide rapid care for patients with STEMI,” he said. “We patterned it after the 30/30/30 rule. Accordingly, if the transfer time exceeds 30 minutes a facility is considered geographically isolated.”

This new consensus document will be published online today in Catheterization and Cardiovascular Interventions, Journal of the American College of Cardiology and Circulation: Journal of the American Heart Association. – by Brian Ellis

Disclosure: Dehmer reports no relevant financial disclosures.

Perspective

The writing committee of the consensus document is to be commended for their efforts to formulate professional society recommendations for the performance of PCI in facilities without cardiothoracic surgical backup on-site with the intent of assuring quality patient care. Although the recommendations are sound and evidence based, they stand in stark contrast to the reality of current clinical practice. The writing committee reaffirmed prior recommendations regarding institutional and operator annual PCI volumes, but fell short on guidance regarding definition(s) of “satisfactory outcomes” following PCI, particularly at lower volume centers.

Specifically, the writing committee recommends that “any (low volume <200 PCIs/year) laboratory that cannot maintain satisfactory outcomes be closed.” They state that definitions for satisfactory outcomes should “be defined by each PCI center, including those with on-site surgery, as part of their quality review process, using national benchmark data.” Notwithstanding the limitations of site self-reported data to the ACC/NCDR by persons with widely variable training, understanding and motivation without systematic monitoring, adjudication or audit, the concept of “self-prescribed” definition(s) for satisfactory outcomes to be established by the individual reporting centers is curious. Furthermore, unless a composite of clinical outcomes is used as the quality metric to be monitored, risk adjusted mortality alone becomes increasingly problematic as PCI volumes decrease and is inadequate to provide efficient differentiation.

Although the 2014 consensus document represents a step forward, more concrete recommendations are required to assure quality care and patient safety.

Dean J. Kereiakes, MD, FACC, FSCAI
Medical Director
The Christ Hospital Heart and Vascular Center/
The Lindner Research Center, Cincinnati
Professor of Clinical Medicine, Ohio State University
Cardiology Today’s Intervention Editorial Board member

Timothy D. Henry, MD, FACC
Chief of Cardiology
Cedars-Sinai Heart Institute, Los Angeles

Disclosures: Kereiakes and Henry report no relevant financial disclosures. Kereiakes serves as a chairperson for the Ohio AHA Mission: Lifeline Steering Committee.