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Blood Pressure Control is an Independent Predictor of Short-term Mortality in Cardiac Surgery Patients:

Blood Pressure Control is an Independent Predictor of Short-term Mortality in Cardiac Surgery Patients:. Analysis from the Three Randomized ECLIPSE Trials. Solomon Aronson, M.D. FACC,FCCP,FAHA,FASE Professor and Executive Vice Chairman Dept of Anesthesiology Duke University Health System .

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Blood Pressure Control is an Independent Predictor of Short-term Mortality in Cardiac Surgery Patients:

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  1. Blood Pressure Control is an Independent Predictor of Short-term Mortality in Cardiac Surgery Patients: Analysis from the Three Randomized ECLIPSE Trials Solomon Aronson, M.D. FACC,FCCP,FAHA,FASE Professor and Executive Vice Chairman Dept of Anesthesiology Duke University Health System

  2. Disclosures • Abbott (Research Support) • Baxter (Speaker) • Medwave (Director) • Regado Biosciences (Consultant) • The Medicines Company (Consultant)

  3. Acknowledgements

  4. Background • Maintaining optimal BP control during cardiac surgery is a significant and common challenge1-5 • No studies to-date have shown an association between targeted peri-operative blood pressure control and mortality • This relationship was examined as part of the ECLIPSE safety program 1 Aronson, S. Circulation 115,733-42,2007 2 Cheung, A. J Card Surg, 2006, S8 3 Aronson, S. Anesth Analg 2002; 94:1079-84 4 Estafanous, F. Am J Cardiol, 1980, p685; 5 Landymore, R. Can J Surg, 1980

  5. Objective • To examine the relationship of targeted peri-operative BP control to mortality

  6. Setting • ECLIPSE, a phase III safety program required for FDA registration of Clevidipine • 1512 randomized cardiac surgery pts • Comparators: Nitroglycerin (NTG), Sodium nitroprusside (SNP), Nicardipine (NIC) • BP measurements were captured over 24 hours • Frequency: Q5 min (pre-/intra-op), Q15 min (post-op) up to 4h and Q60 min after 4h

  7. Treatment • Clevidipine • Initiated 2 mg/hr • Titrated doubling increments Q 90s to 16 mg/hr • 40 mg/hr maximum • Comparators (NTG, SNP, NIC) admin per institutional practice • Treatment duration up to discharge from the ICU • Concomitant anti-hypertensives discouraged

  8. Inclusion Criteria Pre-randomization • ≥ 18 years of age • Written informed consent • Planned CABG, OPCAB, MIDCAB surgery and/or valve repair/replacement surgery Post-randomization • Require treatment for peri-operative HTN

  9. Exclusion Criteria • Women of child bearing potential • CVA ≤ 3 months of randomization • Intolerance to calcium channel blockers • Hypersensitivity to NTG, SNP or NIC • Allergy to the lipid vehicle • Permanent ventricular pacing • Any disease/condition that would put the patient at risk • Participation in another trial within 30 days

  10. Statistical Analysis • Data pooled for 1512 patients • A multiple logistic regression analysis was performed to determine the association of BP control with 30-day mortality • BP control was expressed as the cumulative area under the curve (AUC) outside specified SBP ranges • AUC was analyzed as a continuous variable

  11. AUC Analysis SBP Upper Lower 0 6 12 18 24 Time (hours)

  12. Baseline Characteristics

  13. Procedural characteristics

  14. Logistic Regression Model Selection • Candidate variables included: • Demographics • Baseline characteristics • Medical history • Treatment group • AUC • Procedural characteristics p<0.05 required for inclusion in final output

  15. Logistic Regression Results: Predictors of Mortality

  16. 30-Day Mortality by Magnitude of AUC I mmHg x 60 min 2 mmHg x 60 min 3 mmHg x 60 min 4 mmHg x 60 min 5 mmHg x 60 min

  17. Conclusions • Excursions outside a targeted BP range are correlated with 30-day mortality • This relationship is direct and proportionate to the magnitude of excursions outside the BP range • These data suggest that great attention should be given to precise peri-operative BP control • Future analysis of this finding is warranted

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