SCAI wants to ensure safety of PCI without onsite surgery

Issue: March 2007

The Society for Cardiovascular Angiography and Interventions has released a consensus document on percutaneous coronary intervention at facilities without onsite surgery.

“We are not encouraging PCI without onsite surgery,” said Gregory J. Dehmer, MD, SCAI president and chair of the panel that created the expert consensus document, during a teleconference with reporters. “By making these recommendations, we are acknowledging the fact that this is going on very widely, not only in this country but around the world. All that we’re trying to do is ensure patient safety and high quality for PCI in this setting.”

Interventional cardiologist Peter Block, MD, professor of medicine, division of cardiology, Emory University School of Medicine, said the consensus document enters a “tricky area” and the standards may not be followed.

“The standards set forth in this document hold the bar at a high level.” Block, a member of the Interventional Cardiology section of the Today in Cardiology editorial board, said. “Nevertheless, especially for elective PCI, the data support that minimal volumes of about 200 cases per center most likely will predict better outcome. Careful monitoring of outcomes within each center in an ongoing fashion will help identify centers that should continue to do elective PCI without surgery on site and those that should not. Certainly this should be driven by outcomes in each institution — not programmatic issues for the hospital.”

Core of the document

Currently, centers in 28 states perform both primary and elective PCI without onsite surgery available. Based on data reported to the American College of Cardiology’s National Cardiovascular Data Registry, since 2001 the number of centers performing PCI without onsite surgery grew from about 3% to 16%.

Dehmer said SCAI examined existing guidelines for PCI across the world to see how it is handled, surveyed its members (approximately 3,700) and reviewed available literature on the subject to come up with its consensus.

The consensus document recommends that PCI programs operating without onsite cardiac surgery:

Maintain case volumes of at least 200 PCIs per year.
Employ highly skilled interventional cardiologists who have performed more than 500 PCIs throughout their career, have an annual case volume of more than 100 PCIs, and meet national benchmarks for procedural success and complication rates.
Train all support personnel in the management of PCI patients.
Select patients carefully to control the risk of complications.
Establish a close alliance with CV surgeons, including formalized and tested protocols for emergency transfer of patients.
Activate emergency transport at the first clear signs of a PCI complication, thereby ensuring that the time to the initiation of cardiopulmonary bypass does not exceed 120 minutes.
Collect appropriate outcomes data and submit them for comparison with state or national performance standards.

The document moves beyond the updated guidelines developed by the ACC, AHA and the SCAI in 2005, which do not recommend elective PCI without surgical backup. Dissent is not the intention of the document, Dehmer said. – by Judith Rusk

For more information:

Dehmer GJ, Blankenship J, Wharton TP, et al. The current status and future direction of percutaneous coronary intervention without on-site surgical backup: An expert consensus document from the Society for Cardiovascular Angiography and Interventions. Catheter Cardiovas Intervent. 2007, in press.
ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Available at www.acc.org.