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

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

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

objective
Objective
  • To examine the relationship of targeted peri-operative BP control to mortality
setting
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
treatment
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
inclusion criteria
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
exclusion criteria
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
statistical analysis
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
auc analysis
AUC Analysis

SBP

Upper

Lower

0

6

12

18

24

Time (hours)

logistic regression model selection
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

slide16

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

conclusions
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