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Presenter Disclosure Information. Robert E. Michler, M.D. Influence of Left Ventricular Volume Reduction on Outcome After Coronary Artery Bypass Grafting With or Without Surgical Ventricular Reconstruction Financial Disclosure: NIH STICH Grants NHLBI CT Surgery Network

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  1. Presenter Disclosure Information Robert E. Michler, M.D. Influence of Left Ventricular VolumeReduction on Outcome After Coronary Artery Bypass Grafting With or Without Surgical Ventricular Reconstruction Financial Disclosure: NIH STICH Grants NHLBI CT Surgery Network Unlabeled/Unapproved Uses Disclosure: No

  2. Influence of Left Ventricular Volume Reduction on Outcome After Coronary Artery Bypass Grafting With or Without Surgical Ventricular Reconstruction Robert E. Michler, Gerald M. Pohost, Krzysztof Wrobel, Robert O. Bonow, Jan Pirk, Jae K. Oh, Carmelo A. Milano, Patricia A. Pellikka, Francois Dagenais, Thomas A. Holly, Anne S. Hellkamp, Kerry L. Lee, Marisa Di Donato, on behalf of the STICH Investigators Late-Breaking Clinical Trial Update American College of Cardiology March 16, 2010

  3. Introduction • Ischemic cardiomyopathy resulting from progressive LV volume increase due to CAD and anterior-apical myocardial scar compromises clinical outcome. • The objective of surgical ventricular reconstruction (SVR) is to create a smaller left ventricle with a more natural shape. • One STICH (Surgical Treatment for Ischemic Heart Failure) Trial specific aim was to determine if adding SVR to CABG provided patient benefit beyond that of CABG alone.

  4. SVR Hypothesis Question Does adding SVR to CABG in medically-treated ischemic heart failure patients decrease death/cardiac rehospitalization? 1000 patients randomized 2002-2006 CAD, EF ≤ 35% Anterior akinesia/dyskinesia amenable to SVR Randomized 499 CABG only 501 CABG + SVR Follow-up 99% complete at 48-months

  5. Purpose • To determine whether any magnitude of postoperative change in LV ESVI identified a subgroup of CABG + SVR patients who have increased survival when compared to patients undergoing CABG alone.

  6. Analysis Design • Cohort identified with paired core laboratory studies of fair to excellent quality permitting accurate assessment of end-systolic volume index (ESVI). • Individual preoperative and postoperative ESVI illustrated for patient groups with: 1. ESVI <60 mL/m2 2. ESVI 60-90 mL/m2 3. ESVI >90 mL/m2 • Kaplan-Meier curves and hazard ratios calculated on cohorts to examine for a differential effect of adding SVR to CABG.

  7. Paired Left Ventricular Studies Before and After Operation in 979 SVR Hypothesis Patients 86 (9%) of operated patients 16 NO baseline study sent to core lab 107 NO 4-month study sent to core lab 175 patients without both paired studies of fair to excellent quality Observational cohort defined by ESVI taken from a Randomized population

  8. Cumulative Distribution of 595 SVR Hypothesis Patients by Baseline ESVI

  9. Preoperative to Postoperative Change in ESVI by Operation Received160 Patients with Baseline ESVI < 60 mL/m2GROUP 1

  10. Preoperative to Postoperative Change in ESVI by Operation Received200 Patients with Baseline ESVI 60–90 mL/m2GROUP 2

  11. Preoperative to Postoperative Change in ESVI by Operation Received235 Patients with Baseline ESVI > 90 mL/m2GROUP 3

  12. ESVI Change

  13. Hazard Ratios and 95% Confidence IntervalsAll-Cause Mortality All Patients (n=1000) (as randomized) All Patients (n=979) (by operation received) Patients with Pre & Post Surgery Studies (n=595) Patients Excluded (n=384) CABG+SVR Better CABG Only Better

  14. Hazard Ratios and 95% Confidence IntervalsAll-Cause Mortality Patients with Pre & Post Surgery Studies (n=595) Baseline ESVI > 90 ml/m2 (n=235) Baseline ESVI 60- 90 ml/m2 (n=200) Baseline ESVI < 60 ml/m2 (n=160) CABG+SVR Better CABG Only Better

  15. Kaplan-Meier Estimates: Cumulative Risk of DeathPatients with Pre & Post Surgery Studies : Baseline ESVI ≤ 90 mL/m2 (n=360) HR=0.59 (95% CI: 0.35 – 1.00; rank test: p=0.0475) Total events (63): 20 in CABG+SVR and 43 in CABG Only

  16. Kaplan-Meier Estimates: Cumulative Risk of DeathPatients with Pre & Post Surgery Studies : Baseline ESVI > 90 mL/m2 (n=235) HR=1.24 (95% CI: 0.75 – 2.06; rank test: p=0.4071) Total events (60): 33 in CABG+SVRand 27 in CABG Only

  17. Hazard Ratios and 95% Confidence IntervalsAll-Cause Mortality Baseline ESVI ≤ 90 mL/m2 with Small or no Reduction (n=180) Baseline ESVI ≤ 90 mL/m2 with Large Reduction (n=180) Baseline ESVI > 90 mL/m2 with Small or no Reduction (n=117) Baseline ESVI > 90 mL/m2 with Large Reduction (n=118) CABG Only Better CABG+SVR Better

  18. Kaplan-Meier Estimates: Cumulative Risk of DeathPatients with Pre & Post Surgery Studies Baseline ESVI > 90 mL/m2 and Small/or No Reduction in Post_Op ESVI (n=117) HR=1.54 (95% CI: 0.80 – 2.98; rank test: p=0.1950) Total events (36): 17 in CABG+SVR and 19 in CABG Only Small/or no reduction = change from baseline ESVI ≤ -23.7 mL/m2

  19. Kaplan-Meier Estimates: Cumulative Risk of DeathPatients with Pre & Post Surgery Studies Baseline ESVI > 90 mL/m2 and Large Reduction in Post_Op ESVI (n=118) HR=1.20 (95% CI: 0.51 – 2.80; rank test: p=0.6777) Total events (23): 16 in CABG+SVR and 8 in CABG Only Large reduction = change from baseline ESVI > -23.7 mL/m2

  20. Limitations of Study • Baseline LV volume and regional function data were not available in every STICH patient. • Secondary structural and hemodynamic variables related to LV function, such as sphericity index or mitral regurgitation, were not considered in this analysis. • Bias of investigators towards not sending suboptimal postoperative studies cannot be excluded.

  21. Conclusions • A broad range of baseline ESVI is represented among STICH patients. • The postoperative ESVI decrease is significantly larger for CABG+SVR patients. • In patients with larger volumes, ESVI > 90 ml/m2, CABG alone resulted in a substantial reduction in ESVI. • Patients with preoperative ESVI values ≤ 90 ml/m2 trended toward benefit from CABG + SVR, whereas patients with preoperative ESVI values > 90 ml/m2 trended toward benefit from CABG alone. • No threshold of ESVI at baseline, ESVI at 4 months postoperative or ESVI volume change identified a patient group that benefited from adding SVR to CABG. • The post-op ESVI is the most important prognostic mortality measure. Its prognostic importance is significant even after accounting for the baseline ESVI or the pre-to-post change in ESVI.

  22. Discussion Slides

  23. Dyskinesia Normal Change in Regional Cardiac Function in 504 SVR Hypothesis Pts Group 1: LVESVI < 60 mL/m2 (N = 129) Postoperative Preoperative CABG N = 70 CABG + SVR N = 59

  24. Dyskinesia Normal Change in Regional Cardiac Function in 504 SVR Hypothesis Pts Group 2: LVESVI 60–90 mL/m2 (N = 170) Postoperative Preoperative CABG N = 96 CABG + SVR N = 74

  25. Dyskinesia Normal Change in Regional Cardiac Function in 504 SVR Hypothesis Pts Group 3: LVESVI > 90 mL/m2 (N = 205) Postoperative Preoperative CABG N = 105 CABG + SVR N = 100

  26. Hazard Ratios and 95% Confidence IntervalsAll-Cause Mortality Patients with Pre & Post Surgery Studies (n=595) Post-Op ESVI > 90 mL/m2 (n=150) Post-Op ESVI 60- 90 mL/m2 (n=198) Post-Op ESVI < 60 mL/m2 (n=247) CABG+SVR Better CABG Only Better

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