Percutaneous Coronary Interventions in Facilities without OnSite Cardiac

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Percutaneous Coronary Interventions in Facilities without On-Site Cardiac Surgery: A Report from the National

Percutaneous Coronary Interventions in Facilities without On-Site Cardiac Surgery: A Report from the National Cardiovascular Data Registry (NCDR) ACC/SCAI – i 2 Summit Late Breaking Clinical Trials March 29, 2008

Study Population NCDR Cath. PCI Registry Consecutive PCI cases January 1, 2004 to March

Study Population NCDR Cath. PCI Registry Consecutive PCI cases January 1, 2004 to March 30, 2006 308, 161 patients 465 centers OFF-SITE Surgery Back-Up 9, 029 patients 61 centers ON-SITE Surgery Back-up 299, 132 patients 404 centers

MI Presentation

MI Presentation

Procedural Success and Complications

Procedural Success and Complications

Observed Outcomes: All PCI Patients (P<. 0001) (P=0. 3560) (P=0. 8838) (P<. 0001)

Observed Outcomes: All PCI Patients (P<. 0001) (P=0. 3560) (P=0. 8838) (P<. 0001)

Risk Adjusted Outcomes Odds Ratio (OR): outcomes for patients at On-Site (vs. Off-Site) facilities

Risk Adjusted Outcomes Odds Ratio (OR): outcomes for patients at On-Site (vs. Off-Site) facilities adjusting for site correlations and potential confounding variables

Conclusions • Compared to On-Site PCI centers, Off-Site PCI programs participating in the NCDR:

Conclusions • Compared to On-Site PCI centers, Off-Site PCI programs participating in the NCDR: Ø Have smaller bed capacities. Ø Are predominantly located in rural and suburban areas. Ø Have lower annual PCI volume. Ø Treat a higher percentage of patients who present with subsets of MI (STEMI and NSTEMI). Ø Have better reperfusion times in primary PCI.

Conclusions • Compared to On-Site PCI centers, Off-Site PCI programs have similar observed: Ø

Conclusions • Compared to On-Site PCI centers, Off-Site PCI programs have similar observed: Ø Procedure success Ø Morbidity Ø Emergency surgery rates Ø Mortality in cases that require emergency surgery • The risk-adjusted mortality rate in Off-Site facilities was comparable to those PCI centers that have cardiac surgery on-site.

Implications • Off-Site PCI centers can provide excellent care to patients – if the

Implications • Off-Site PCI centers can provide excellent care to patients – if the program is developed with thoughtfulness and safety. • Our results are derived from PCI programs who have demonstrated a strong commitment to quality and attention to key structure, process, and outcomes measurements. Without such a commitment, similar results might not be achievable.

Implications • The results of our study should not be extrapolated to encourage the

Implications • The results of our study should not be extrapolated to encourage the wide-spread proliferation of Off-Site PCI programs. • Our study confirms the safety of an Off-Site PCI strategy at centers where rigorous clinical, operator, and institutional criteria are in place and are monitored to assure high quality outcomes.