No Impact on Safety Seen at Hospitals Performing PCI with No Surgical Backup

WASHINGTON, DC—Percutaneous coronary intervention (PCI) performed at hospitals without on-site surgical backup carries a high level of safety compared with hospitals with on-site surgeons and in some cases may even be safer, according to data from a pilot program presented March 29, 2014, at the American College of Cardiology/i2 Scientific Session.

William Bommer, MD, of the University of California, Davis (Davis, California), reported data from PCI-CAMPOS (PCI California Audit Monitored Pilot with Offsite Surgery), a pilot program involving 6 acute care California hospitals without on-site cardiac surgery backup. Under the program, PCI can be performed in both elective and emergency cases. The data encompass patients treated between July 1, 2010 and July 31, 2013.

For the prospective multicenter registry-controlled study, safety and efficacy of PCI-CAMPOS data were compared with data from the NCDR CathPCI registry and California Office of Statewide Health Planning and Development patient discharge data from hospitals with on-site surgical backup.

Safety Higher Despite No Surgical Backup

Baseline characteristics among patients who underwent PCI at the 6 off-site hospitals with no surgical backup (n = 3,773) were comparable with those of patients undergoing PCI at 120 centers with on-site surgery capability (n = 150,177). Off-site hospitals had a higher percentage of STEMI (32% vs 17.9%) and emergent PCI (34.6% vs 19.9%; P < 0.0001 for both) than on-site hospitals. While lesion and procedural characteristics were largely similar, on-site hospitals saw longer mean lesion length compared with off-site hospitals (18.8 mm vs 15.7 mm; P < 0.0001).

Overall, off-site hospitals had a 21% lower event rate for the co-primary composite safety endpoint (death, stroke or emergency CABG) compared with on-site hospitals (1.87% vs 2.36%; P = 0.009. The same was true for primary PCI (5.49% vs 7.14%; P = 0.013), but not the non-primary PCI group (1.11% vs 1.29%; P = 0.230).

Composite efficacy (< 20% TIMI 3), the other co-primary endpoint, was slightly lower in off-site hospitals compared with on-site hospitals (88.4% vs 91%; P < 0.0001). Again, the finding held true for primary PCI as well (P < 0.0001), but not for non-primary PCI procedures (P = 0.37).

When hospital safety ratings were assessed, 5 of the 6 off-site hospitals performed as expected, while 1 was better than expected. Of the 120 on-site hospitals, 106 performed as expected, 8 performed better than expected and 6 were classified as worse than expected (table 1).

Table 1. Risk-Adjusted Event Rate for Death, Stroke or Emergency CABG

 

Interestingly, Dr. Bommer reported that no significant hospital volume/outcome relationship was seen.

“In conclusion, we can say that pilot off-site hospitals showed slightly better PCI composite safety and worse PCI composite efficacy endpoints than on-site hospitals,” Dr. Bommer said. “Emergency CABG rates are low in both on-site and off-site hospitals, reducing the need for on-site cardiac surgery. Off-site hospitals perform more primary and fewer elective PCIs than on-site hospitals and a significant composite safety variation with outliers remains for on-site hospitals.”

Hope for the ‘Hinterlands’

The study comes on the heels of newly updated recommendations from the Society for Cardiovascular Angiography and Interventions (SCAI), ACC, and American Heart Association (AHA), affirming that PCI performed at hospitals lacking onsite surgical backup can be done in both urgent and elective cases without increasing the risk of mortality or emergency bypass surgery.

The consensus document, published online March 17, 2014, ahead of print in Catheterization and Cardiovascular Interventions, reviews the literature since the issue was last assessed in 2007 and provides recommendations for hospitals that do not provide cardiac surgery should complications occur.

Following  Dr. Bommer’s presentation, an audience member asked Dr. Bommer about implications for institutions in the “hinterlands” that may be an hour or more away from a facility with on-site cardiac surgery.

Dr. Bommer agreed that there are many so-called “hinterlands,” even among heavily populated states such as California, that could potentially benefit from broader use of off-site PCI, adding that the concept is a partial driver of the PCI-CAMPOS effort.

David E. Kandzari, MD, of the Piedmont Heart Institute (Atlanta, GA), who co-moderated the session, noted that the NCDR now captures Appropriate Use Criteria (AUC) and asked Dr. Bommer if he has noted differences in AUC criteria between on-site and off-site centers.

“Yes, we have tracked appropriate use criteria and interestingly it has improved,” Dr. Bommer said. “That is, the number of individuals [classified as] appropriate use has steadily increased over time so that has been an important aspect,” he agreed.

 

 

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Source:Bommer W. The percutaneous coronary intervention California audit monitored pilot with offsite surgery (PCI-CAMPOS) outcomes in 153,950 patients in hospitals with and without onsite cardiac surgery. Presented at: American College of Cardiology Annual Scientific Session; March 29, 2014; Washington, DC.

 

 

 

 

 

Related Stories:

• SCAI/ACC/AHA Statement: PCI Without Surgical Backup Safe When Done According to Protocol
• MASS COMM: On-site Surgical Back-up Not Necessary for Elective PCI
• Surgical Backup for PCI Makes No Difference in Rates of Death, CABG