PURPOSE: To assess the incidence and severity of adverse events (AE) associated with cardiovascular magnetic resonance (CMR) in a large cohort of patients with congenital heart disease and to identify independent risk factors for their occurrence. METHODS: AEs were prospectively recorded from October 2002 through December 2004 and graded by 3 independent observers for severity, preventability, and attributability. The rate of adverse events was analyzed for each candidate variable using Fisher's exact test and independent predictors were identified by multiple logistic regression analysis. RESULTS: There were 22 AEs among 1334 CMR studies (1.6%); 14 (63.5%) minor, 7 (32%) moderate, and 1 (4.5%) major. General anesthesia (GA) was used in 274 studies (20.5%) with 12 AEs (4.4%, p<0.001). There were 7 AEs (6.3%, p=0.001) in 112 studies on hospitalized patients, 5 AEs (5.2%, p=0.018) in 97 patients under 1 year of age, and 3 AEs (2.2%, p=0.479) in 134 patients with functional single ventricle. The highest rate of AEs was noted in inpatients under GA (10.4%, p<0.001); most were in the intensive care unit. Use of anesthesia (OR 3.91 [95% CI 1.46, 10.48] p=0.007) and inpatient status (OR 3.56 [95% CI 1.16, 10.89], p=0.026) were independent predictors of AEs. CONCLUSIONS: CMR in patients with congenital heart disease has a low rate of AEs. Use of GA and examinations on hospitalized patients are independent risk factors for AEs with the most acutely ill patients at highest risk.
PURPOSE: To assess the incidence and severity of adverse events (AE) associated with cardiovascular magnetic resonance (CMR) in a large cohort of patients with congenital heart disease and to identify independent risk factors for their occurrence. METHODS:AEs were prospectively recorded from October 2002 through December 2004 and graded by 3 independent observers for severity, preventability, and attributability. The rate of adverse events was analyzed for each candidate variable using Fisher's exact test and independent predictors were identified by multiple logistic regression analysis. RESULTS: There were 22 AEs among 1334 CMR studies (1.6%); 14 (63.5%) minor, 7 (32%) moderate, and 1 (4.5%) major. General anesthesia (GA) was used in 274 studies (20.5%) with 12 AEs (4.4%, p<0.001). There were 7 AEs (6.3%, p=0.001) in 112 studies on hospitalized patients, 5 AEs (5.2%, p=0.018) in 97 patients under 1 year of age, and 3 AEs (2.2%, p=0.479) in 134 patients with functional single ventricle. The highest rate of AEs was noted in inpatients under GA (10.4%, p<0.001); most were in the intensive care unit. Use of anesthesia (OR 3.91 [95% CI 1.46, 10.48] p=0.007) and inpatient status (OR 3.56 [95% CI 1.16, 10.89], p=0.026) were independent predictors of AEs. CONCLUSIONS: CMR in patients with congenital heart disease has a low rate of AEs. Use of GA and examinations on hospitalized patients are independent risk factors for AEs with the most acutely ill patients at highest risk.
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