1. Percutaneous Coronary Interventions in Facilities without On-Site Cardiac Surgery: A Report from the National Cardiovascular Data Registry (NCDR) ACC/SCAI – i2 Summit Late Breaking Clinical Trials March 29, 2008

2. On Behalf of the National Cardiovascular Data Registry Michael A. Kutcher, MD Lloyd W. Klein, MD Thomas P. Wharton, Jr., MD Mandeep Singh, MD, MPH Gregory J. Dehmer, MD H. Vernon Anderson, MD John S. Rumsfeld, MD, PhD William S. Weintraub, MD Eric D. Peterson, MD, MPH Fang-Shu Ou, MS Sarah Milford-Beland, MS Al Woodward, PhD. MBA Ralph G. Brindis, MPH Wake Forest University Health Sciences Rush University School of Medicine Exeter Hospital, Exeter, NH Mayo Clinic Texas A&M School of Medicine Univ Texas Health Science, Houston Chief Science Officer, NCDR Christiana Health Care, Wilmington, DE Duke Clinical Research Institute (DCRI) DCRI NCDR Chief Executive Officer, NCDR

3. Special Thanks Jessica Morris Data Clarification Project Contact Staff Kristi Mitchell, MPH Data Clarification Project Coordinator NCDR and DCRI support staff Matthew Sacrinty, MS Wake Forest University Health Sciences  All the hospitals and their staff that have committed to participate in the NCDR

4. No Disclosures Related to this presentation

5. Background There are few published large studies that have examined whether the procedural outcomes at PCI facilities that do not have surgery on-site are as safe and effective compared to those facilities that have cardiac surgery on-site. Wennberg DE et al. JAMA 2004;292:1961-68. Ting HH et al. J Am Coll Cardiol 2006;47:1713-21. Carlsson J et al. SCARR. Heart 2007;93:335-8.

6. Background The National Cardiovascular Data Registry (NCDR) CathPCI Registry is a large ongoing multi-center database that offers a unique opportunity to provide contemporary insights into this controversial issue.  Standard data sets  Written definitions  Uniform data entry  Secure transmission requirements  Data quality and auditing checks  Risk adjustment algorithms

7. Study Population NCDR CathPCI 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

8. Off-Site Data Clarification Project A Data Clarification (DC) Project was undertaken to address potentially ambiguous data issues unique to Off-Site PCI centers. Sites with questionable data were sent a Data Clarification Form (DCF) to clarify whether a patient “transferred for CABG” was elective or emergency and to verify eventual survival. An additional Off-Site Capabilities Survey (OSCS) was developed to gather information regarding organization, staffing, and logistics.

9. Off-Site Data Clarification Project Each Off-Site PCI program was formally contacted with follow-up by NCDR staff over a 4 month time period. 44 sites with 174 patients had data points that required verification. 38 sites (86%) were able to fill out the DCF to reconcile transfer and/or mortality data on 153 patients (88%). 49 out of 61 sites (80%) filled out the Off-Site Capabilities Survey (OSCS).

10. Statistical Analysis by DCRI Major endpoints  In-hospital death from all causes following PCI  Incidence of emergency surgery (version 3.04 definitions):  Emergency – CABG performed within <24 hours following PCI in which there was evidence of active ischemia or mechanical dysfunction.  Emergent/Salvage – patient required cardiopulmonary resuscitation en route to the OR or before anesthesia. Secondary endpoints  Cerebrovascular accident  Renal failure  Hemorrhage  Myocardial infarction  Reperfusion time in cases of primary PCI

11. Off-Site Capabilities Survey Transportation Logistics

12. Off-Site Capabilities Survey Organization and Staff

13. Institutional Characteristics * Two sites had missing CMS bed data

14. MI Presentation

15. Procedural Success and Complications

16. Observed Outcomes: All PCI Patients (P=0.3560) (P=0.8838)(P<.0001)

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

18. Limitations In-hospital outcomes were analyzed – long term follow-up was not available. Definitions did not discriminate whether emergency surgery was performed for complications of a PCI or whether PCI was a temporizing measure prior to staged surgery. Our study was based on a voluntary observational registry and a selection bias cannot be excluded.

19. Discussion Our study involves the largest clinical analysis and comparison of diverse PCI centers in the United States with and without on-site cardiac surgery support. The results of the Off-Site Capabilities Survey provides detailed information regarding the organization and logistics of the Off-Site PCI programs participating in the NCDR.

20. Conclusions Off-Site PCI centers participating in the NCDR are well organized with good logistical plans:  Dedicated staff and facilities.  Travel time, distances, and modality of transport are generally within range for timely transfer to the off-site surgery center.  92% of sites provide 24/7 coverage.  All sites are committed to provide primary PCI for STEMI.

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

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

23. Implications Off-Site PCI centers can provide excellent care to patients – if the organization of the program is thoughtfully developed. The Off-Site programs in our study have demonstrated a strong commitment to key structure, process, and outcomes measurements. Without such a commitment, similar results may not be achievable.

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

25. Thank You

26. Backup Slides

27. Sensitivity Analysis Since there was some missing data for follow-up mortality that was not clarified, a sensitivity analysis was performed to assess the stability of the risk adjusted results. The analysis was comprised of 4 different models which imputed missing mortality to various potential scenarios.

28. Sensitivity Analysis * * ** *Worst case scenario – Patients with missing mortality were considered as all died **Best case scenario – Patients with missing mortality were considered as all alive

29. Sensitivity Analysis Although the Odds Ratio could change from 1.1 to 0.8, the sensitivity analysis of risk adjusted mortality for any of the 4 models was not statistically significant between Off-Site versus On-Site facilities. Based on these results, the missing data would not have significantly affected the stability or the conclusions of the risk adjusted model.

30. Statistical Analysis Data Analysis was performed by DCRI: To test for independence of a patient’s baseline characteristics, in-hospital care patterns and outcomes with respect to Off-Site vs. On-Site centers were analyzed. Mann-Whitney-Wilcoxon nonparametric tests were used for continuous variables. Pearson chi-square tests were used for categorical variables.

31. Statistical Analysis A multivariable logistic regression was utilized to estimate the association surgical status (On-Site versus Off-Site) and outcomes. The Generalized Estimate Equation (GEE) method was applied to account for within- hospital clustering, assuming patients at the same hospital are more likely to have similar responses relative to patients in other hospitals.

32. Variables in Risk Adjusted Mortality Model Age Gender Insulin treated diabetes Hypercholesterolemia Hypertension GFR/dialysis Cerebrovascular disease COPD PVD CHF Prior CABG Prior PCI Prior MI Cardiogenic shock MI presentation (STEMI, NSTEMI, no MI) Preoperative IABP PCI status (salvage, emergent, urgent, elective) Subacute thrombosis Treated left main lesion Treated total occlusion Treated lesion TIMI flow = 0 Treated lesion High/C Total number of lesions treated

33. Variables in Risk Adjusted Emergency Surgery Model Cardiogenic shock MI Presentation STEMI NSTEMI No MI Pre-operative IABP PCI status Salvage Emergent Urgent Elective Any treated left main lesion

34. Results

35. Patient Characteristics

36. Lesion Characteristics

37. Observed Outcomes: Primary PCI Patients (P=0.1213) (P=0.9439)(P=0.9195) (P=0.9833)

38. Background Since the introduction of PCI in 1977 by Andreas Gruntzig, a preferred practice has been to have cardiac surgery capabilities on-site to provide emergency CABG in the event of life threatening acute procedural failures.

39. Background Over the last 10 years, as a result of improvements in technology and pharmacology:  The incidence of emergency CABG surgery for failed PCI is now very infrequent (0.3-0.6%) Seshadri N et al. Circulation 2002;106:2346-50. Yang EH et al. J Am Coll Cardiol 2005;2004-20.  Primary PCI has been shown to be superior to fibrinolytic therapy for the treatment of STEMI Keely et al. Lancet 2003;361:13-20.

40. Background These developments have formed the justification for some hospitals without on-site cardiac surgery to develop PCI programs based on a strategy to:  Provide more rapid and superior care for STEMI in the form of primary PCI  Increase the availability of primary and elective PCI to patients residing in geographically underserved areas.

41. Background The safety and efficacy of performing primary PCI in facilities without on site surgical back-up has been documented in several trials. Wharton TP Jr. et al. J Am Coll Cardiol 1999;33:1257-65. Aversano T el. C-PORT trial. JAMA 2002;287:1943-51. Wharton TP Jr. et al. PAMI-NoSOS Study. J Am Coll Cardiol 2004;43:1943-50. There have been numerous observational reports that extend the Off-Site concept to both primary and elective PCI.

42. Background The ACC/AHA/SCAI 2005 PCI Guidelines designated the following indications for PCI at centers that do not have surgery on-site:  Primary PCI – Class IIb “may be considered”  Elective PCI – Class III “not recommended” Smith SC Jr. et al. J Am Coll Cardiol 2006;47:216-35. The 2007 Focused PCI Guideline Update did not address or change these designations. King SB III et al. J Am Coll Cardiol 2008;51:172-209.