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Volume-Mortality, Surgery on Site and Other Considerations for PCI CON Decisions

Volume-Mortality, Surgery on Site and Other Considerations for PCI CON Decisions. Outline. Summary of Volume-Mortality Studies in New York More Detail on Last Published PCI Volume-Mortality Study in New York (2005) National Studies Since Then. Outline, Cont’d.

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Volume-Mortality, Surgery on Site and Other Considerations for PCI CON Decisions

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  1. Volume-Mortality, Surgery on Site and Other Considerations for PCI CON Decisions

  2. Outline • Summary of Volume-Mortality Studies in New York • More Detail on Last Published PCI Volume-Mortality Study in New York (2005) • National Studies Since Then

  3. Outline, Cont’d. • New NY Data on PCI Volume-Mortality • New York Studies on PCI With and Without CABG Surgery Backup • Other Considerations for CON Decisions (other outcomes, structural issues)

  4. Volume-Mortality Studies Investigation of the relationship between volume and mortality for surgical procedures performed in New York State hospitals. JAMA 1989;262: 503-510 • Hannan EL, O’Donnell JF, Kilburn H Jr, Bernard HR, Yazici A

  5. This study uses an improved measure of physician volume to test the combined relationship of hospital and physician volume with in-hospital mortality rates and to explore the existence of threshold volumes that optimally discriminate high- and low-volume providers. Five procedure groups have significant volume-mortality relationships. • For coronary artery bypass surgeries, physician volume was more significant than hospital volume, but hospital volume was marginally significant.

  6. NY Volume-Mortality Studies PCI Volume-outcome relationships for percutaneous coronary interventions in the stent area Hannan EL, Wu C, Walford G, King SB 3rd, Holmes DR Jr, Ambrose JA, Sharma S, Katz S, Clark LT, Jones RH. Circulation. 2005 Aug 23;112(8):1171-9. Coronary angioplasty volume-outcome relationships for hospitals and cardiologists Hannan EL, Racz M, Ryan TJ, McCallister BD, Johnson LW, Arani DT, Guerci AD, Sosa J, Topol EJ. JAMA. 1997 Mar 19;277(11):892-8.

  7. Cardiac Surgery Is the impact of hospital and surgeon volumes on the in-hospital mortality rate for coronary artery bypass graft surgery limited to patients at high risk? Wu C, Hannan EL, Ryan TJ, Bennett E, Culliford AT, Gold JP, Isom OW, Jones RH, McNeil B, Rose EA, VA. Circulation. 2004 Aug 17;110(7):784-9. Do hospitals and surgeons with higher coronary artery bypass graft surgery volume still have lower risk-adjusted mortality rates? Hannan EL, Wu C, Ryan TJ, Bennett E, Culliford AT, Gold JP, Hartman A, Isom OW, Jones RH, McNeil B, Rose EA, Subramanian VA. Circ 2003:198;795-801

  8. The decline in coronary artery bypass graft surgery mortality in New York State. The role of surgeon volume. Hannan EL, Siu AL, Kumar D, Kilburn H Jr, Chassin MR. JAMA. 1995 Jan 18;273(3):209-13. Coronary artery bypass surgery: the relationship between inhospital mortality rate and surgical volume after controlling for clinical risk factors. Hannan EL, Kilburn H Jr, Bernard H, O'Donnell JF, Lukacik G, Shields EP. Med Care. 1991 Nov;29(11):1094-107.

  9. Other NY Peer-Reviewed V-M Studies Bariatric surgery AAA surgery colectomies gastrectomies lung lobectomies carotid endarterectomies

  10. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, Circulation 2011;124:e574-e651.

  11. CLASS I 1. Elective/urgent PCI should be performed by operators with an acceptable annual volume (>75 procedures) at high-volume centers (>400 procedures) with on-site cardiac surgery (872,873). (Level of Evidence: C)

  12. CLASS IIa 1. It is reasonable that operators with acceptable volume (>75 PCI procedures per year) perform elective/urgent PCI at low-volume centers (200 to 400 PCI procedures per year) with on-site cardiac surgery (872). (Level of Evidence: C)

  13. 2. It is reasonable that low-volume operators (<75 PCI procedures per year) perform elective/ urgent PCI at high-volume centers (>400 PCI procedures per year) with on-site cardiac surgery. Ideally, operators with an annual procedure volume of fewer than 75 procedures per year should only work at institutions with an activity level of more than 600 procedures per year. Operators who perform fewer than 75 procedures per year should develop a defined mentoring relationship with a highly experienced operator who has an annual procedural volume of at least 150 procedures per year. (Level of Evidence: C)

  14. 2011 Guidelines Based on Following Studies • Volume-outcome relationships for percutaneous coronary interventions in the stent era. Circulation. 2005; 112: 1171– 9. Hannan EL, Wu C, Walford G, et al. • The relation between volume and outcome of coronary interventions: a systematic review and meta-analysis. Eur Heart J. 2010; 31: 1985– 92. Post PN et al.

  15. Volume-Outcome Relationships for Percutaneous Coronary Interventions in the Stent Era. Circulation. 2005; 112: 1171– 9. Hannan EL, Wu C, Walford G, et al. • Data from New York's Percutaneous Coronary Interventions Reporting System in 1998 to 2000 (n=107 713) were used to examine the impact of annual hospital volume and annual operator volume on in-hospital outcomes. • For hospital volumes below 400 and operator volumes below 75, the respective odds of mortality, same-day CABG surgery, and same-stay CABG surgery were 5.92, 4.02, and 3.92 times the odds for hospital volumes of 400 or higher and operator volumes of 75 or higher.

  16. 2013 ACCF/AHA/SCAI Update of the Clinical Competence Statement Competency JACC 2013:62:357-396 • New minimums of 200 procedures per hospital and 50 per operator • Based on 2 additional HV studies, 3 additional OV studies, and observation that there are many LV providers

  17. New NY Volume Mortality Study • Based on PCIRS data from 2013-2015 using risk-adjusted in-hospital/30-day mortality

  18. New PCI Volume-Mortality Study

  19. New PCI Volume-Mortality Study * GEE was used to adjusting for clustering within same hospital and within same physician.

  20. What About Surgery on Site? Outcomes for Patients With ST-Elevation Myocardial Infarction in Hospitals With and Without Onsite Coronary Artery Bypass Graft Surgery : The New York State Experience CircCardiovascInterv. 2009;2:519-527 Hannan EL, Zhong Y, Racz M, Jacobs AK, Walford G, Cozzens K, Holmes DR, Jones RH, Hibberd M, Doran D, Whalen D, King SB III

  21. Background— The benefit of primary percutaneous coronary interventions (P-PCI) for patients with ST-elevation myocardial infarction (STEMI) has been well documented. However, controversy still exists as to whether PCI should be expanded to hospitals without coronary artery bypass graft surgery. Methods and Results— Patients who were discharged after PCI for STEMI between January 1, 2003, and December 12, 2006 in P-PCI centers (hospitals with no coronary artery bypass graft surgery, and PCI only for patients with STEMI) were propensity matched with patients in full service centers, and mortality and subsequent revascularization rates were compared.

  22. Conclusions— No differences in: • In-hospital/30-day mortality, • The need for emergency surgery, • 3-year mortality • Subsequent revascularization, • But P-PCI centers had higher repeat target vessel PCI rates and higher mortality rates for patients who did not undergo PCI.

  23. New Study on SOS vs No SOS: STEMI Patients with PCI: 1/13-11/15

  24. STEMI Patients with PCIIn-Hospital/30-Day Mortality * Logistic Regression with adjustment of all other significant risk factors.

  25. STEMI Patients with PCI: 1/13-11/152 Year Adjusted Mortality * COX model with adjustment of all other significant risk factors.

  26. STEMI Patients with PCI: 1/13-11/152 Year Adjusted TLPCI * COX model with adjustment of all other significant risk factors.

  27. New Study on SOS vs No SOS:All PCI Patients: In-Hospital/30-Day Adjusted Mortality * Logistic Regression with adjustment of all other significant risk factors.

  28. New Study on SOS vs No SOS:All PCI Patients: 2 Year Adjusted Mortality * COX model with adjustment of all other significant risk factors.

  29. New Study on SOS vs No SOS:All PCI Patients: 2 Year Adjusted TLPCI * COX model with adjustment of all other significant risk factors.

  30. All STEMI Patients: 1/13-11/15In-Hospital/30-Day Adjusted Mortality * COX model with adjustment of all other significant risk factors.

  31. Summary • Volume-Short-term Mortality • HV NS with about 10% elevation for LV Hosps • Borderline Signif at 75 for operators • SOS • NS for short-term or long-term mortality for PCI for all pts or for STEMI pts; • NS for for all STEMI pts • Non-SOS signif higher for 2-year TLPCI for STEMI pts but not for all pts.

  32. Other Considerations • Other outcomes • Longer term mortality • Complications • Appropriateness • Cost • Loss of economies of scale vs. competitive pricing? • Impact of Networks

  33. Adult and Pediatric Cardiac Surgery

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