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Sahar S. Abdelmoneim, M.D., M.S.; Mathieu Bernier, M.D.;

Safety of Contrast Agents during Stress Echocardiography: A Cohort Study from a Single Center , 4 Years Experience With 26,774 Patients. Sahar S. Abdelmoneim, M.D., M.S.; Mathieu Bernier, M.D.; Christopher G. Scott, M.S.; Abhijeet Dhoble, M.D.;

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Sahar S. Abdelmoneim, M.D., M.S.; Mathieu Bernier, M.D.;

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  1. Safety of Contrast Agents during Stress Echocardiography: A Cohort Study from a Single Center , 4 Years Experience With 26,774 Patients Sahar S. Abdelmoneim, M.D., M.S.; Mathieu Bernier, M.D.; Christopher G. Scott, M.S.; Abhijeet Dhoble, M.D.; Sue Ann C. Ness, R.N; Mary E. Hagen, R.N, R.D.C.S; Stuart Moir, M.D.; Robert B. McCully, M.D.; Patricia A. Pellikka, M.D.; Sharon L. Mulvagh, M.D Mayo Clinic , Rochester –MN

  2. Disclosure Information Sharon L. Mulvagh, M.D. Safety of Contrast Agents during Stress Echocardiography: a Cohort Study from a Single Center Experience Spanning 4 years and 26,774 Patients FINANCIAL DISCLOSURE: • Research Grants- Lantheus Medical Imaging, GE Healthcare • No conflicts of interest to disclose for remaining authors UNLABELED/UNAPPROVED USES DISCLOSURE: • None

  3. Specific Aims • To evaluate the safety (short- and long-term) of contrast agents during stress echocardiography (SE) using endpoints of death and myocardial infarction (MI) • To compare annualized rates of combined events (death and MI) in patients receiving contrast and those not • To determine nature and frequency of contrast-related side effects

  4. Methods Research Design • A retrospective cohort study Study Population • November 1, 2003 and December 31, 2007 • Stress Echo Database: electronic, clinical & demographic info, prospectively collected, indexed and stored • 2 Cohorts : contrast vs. non contrast • Contrast Cohort: clinically indicated contrast study for LVO • Contrast agents: Definity and Optison Outcomes of Interest • Short term safety within 72 hours and 30 days after SE • Long term safety of contrast use up to 4.5 years after SE • Endpoints: death & MI • Arrhythmias • Contrast related side effects

  5. Methods Identification of Outcomes Death : • Cross matching of the stress echo database with the Death Database of the Mayo Clinic • Individual chart review to confirm occurrence and timing, in relation to contrast administration • Cardiac death within 30 days was also determined Myocardial Infarction : • ICD-9 for MI (410) including: cardiac infarction, infarction of heart, myocardium, or ventricle, ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction • Individual chart review to confirm occurrence and timing, in relation to contrast administration

  6. Methods Statistical Analysis Plan* • Numbers (%) presented for categorical variables and differences between contrast groups were tested using the Pearson chi-square or Fischer’s Exact test • For continuous variables, mean and standard deviation are presented and differences between groups were tested using the two-sample T-test • Survival was estimated using the Kaplan Meier (KM) method • Multivariable Cox proportional hazards regression models were used to test for differences in long term outcomes after adjusting for known confounders • Contrast-related side effects were reported as percentage of the total documented side effects starting in year 2007 • Annualized rates of combined death and MI events in both cohorts were reported *SAS Version 9.1 (SAS Institute Inc, Cary, North Carolina, USA).

  7. Study Flow Chart November 2003 - December 2007 26,774 SE pts DSE: 12,760 Exercise: 14,014

  8. Clinical characteristics of 26,774 SE patients November 2003 - December 2007

  9. Short term Safety of Contrast Stress Echocardiography November 2003 - December 2007

  10. Deaths within 72 hours of Contrast Stress Echocardiography 1 case with contrast agent Definity Female 76 years old Diabetes Mellitus Preoperative evaluation of mycotic aneurysm repair Preoperative contrast dobutamine SE was negative for myocardial ischemia No reported immediate side effects from contrast Postoperative day 2 (48 hours of SE) , patient expired from multiorgan failure

  11. MI within 72 hours of Contrast Stress Echocardiography 3cases of MI (1 with Definity, and 2 with Optison)

  12. P =0.31 P =0.09 Arrhythmias During Contrast Stress Echocardiography Supraventricular tachycardia Contrast cohort: 30 patients (0.28%) Reference cohort: 34 patients (0.21%) Ventricular tachycardia Contrast cohort: 11 patients (0.10%) Reference cohort: 7 patients (0.04%)

  13. Long term Safety of Contrast Stress Echocardiography (A) Survival free of death Kaplan-Meier survival curves Presenting Survival Free of Major Cardiovascular Events Including Death and Myocardial Infarction over 4 years followup for the dobutamine SE and exercise SE subgroups. Patients in the contrast cohort received contrast agents during SE and patients in the noncontrast cohort did not P values are reported from the unadjusted model. After adjustment for known confounders, no differences in the hazard ratios for the events were observed between the contrast and noncontrast cohorts. SE, stress echocardiography

  14. Long term Safety of Contrast Stress Echocardiography (B) Survival free of MI Kaplan-Meier survival curves Presenting Survival Free of Major Cardiovascular Events Including Death and Myocardial Infarction over 4 years followup for the dobutamine SE and exercise SE subgroups. Patients in the contrast cohort received contrast agents during SE and patients in the noncontrast cohort did not P values are reported from the unadjusted model. After adjustment for known confounders, no differences in the hazard ratios for the events were observed between the contrast and noncontrast cohorts. SE, stress echocardiography

  15. Long term Safety of Contrast Stress Echocardiography After adjustment for known confounders*, no differences in events were observed between contrast-SE and non contrast-SE cohorts *Known confounders: Age , gender, BMI, EF, DM, previous CAD, positive SE and dobutamine study (as it had higher risk patients)

  16. P =NS P =NS The annualized event rate for combined (death & MI) events • Dobutamine –SE cohort • Contrast 9.6% (8.9, 10.3) • Non contrast 10.9% (10.2, 11.6) • Exercise –SE cohort • Contrast 2.2% (1.8, 2.6) • Non contrast 1.9% (1.6, 2.1)

  17. Contrast Related Adverse Events (AE) • AE’s were consistently documented by unique statements in EMR starting in January 2007 • In year 2007: 3,071 contrast SE (1,819 dobutamine-SE and 1,252 exercise-SE) were performed • AE from contrast: “possible” in 68 /3071 (2.2%) • Of 68 patients, a “definite” relation to contrast was established in 41/3071 (1.3%) patients: • Backache alone in 19 • Headache alonein 16 • Backache and headache in 4 • Transient wheezing in 1 • Urticaria with mouth swelling in 1 Acute anaphylactoid reaction in our study was in 0.03% (in ~3:10,000 patients)

  18. Limitations and Strengths Limitations • Retrospective • Use of ICD codes for outcomes retrieval • Contrast related side effects were consistently documented in the EMR for 1 year (2007, n=3071); however paper recording for previous 3 years showed same rate of AE’s. Strengths • Large sample size • Cohort design • Detailed demographic information and assessment of known confounders allowed thorough evaluation of the association between contrast use and the endpoint events using multivariate, and cox regression analysis

  19. Conclusions • The use of FDA-approved contrast agents during Stress Echocardiography IS NOT associated with an increased risk of death or myocardial infarction in either the short-term (within 72 hrs, and 30 days) or long- term (up to 4.5 years) • Contrast related side effects occur at an acceptable rate, comparable to contrast agents used in other imaging modalities • This large single center study provides further evidence supporting the safety of contrast use in ultrasound in general, and stress echocardiography, in particular

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