Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage

Phase 4

Completed

Brief Summary: The investigators intend to determine if using Optison echocardiography contrast increases sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal echocardiography studies as opposed to standard 2D and 3D TEE imaging without the use of echo contrast.

Detailed Description: Accurate determination of the presence or absence of left atrial appendage (LAA) thrombus has a large impact on the clinical course of patients with atrial fibrillation or ischemic stroke and has large financial implications as well. Misdiagnosing the presence of LAA thrombus can lead to unnecessarily cancelled procedures (cardioversion and atrial fibrillation ablation) and potentially hazardous, unnecessary changes in clinical care (such as prolonged Coumadin anticoagulation). Missing LAA thrombus can result in continuation of cardioversion or atrial fibrillation ablation procedures at a time when there is higher risk of subsequent embolic stroke.

Several of the patients with atrial fibrillation require transesophageal echocardiography (TEE) performed prior to cardioversion or atrial fibrillation ablation procedures. There is opportunity to enroll most of these patients in our proposed study. There has been essentially no work published about the use of echo contrast materials in TEE (other than agitated saline), particularly the use of Optison. Thus, the investigators will be exploring a new field in echocardiography and echo contrast.

Recruitment & Eligibility

Inclusion Criteria

> 18 years old
Cognitively sound and able to provide informed consent
Indicated for TEE as a standard clinical procedure for evaluation of cardiac health status.

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Echo arm	Optison echocardiography contrast agent	Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent

Primary Outcome Measures

Name	Time	Method
Percent Confidence in Assessment of Left Atrial Appendage Thrombus	One Transesophageal Echocardiography, up to 1 hour	Confidence among echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent. Percent confidence was calculated from a subjective assessment made by each reader after viewing the echo images. A six-point scale was used by the readers to grade the subjective assessment of their confidence in detecting thrombus; a score of 0 representing 0% (no confidence) up to a score of 5 representing 100% (total confidence) that the interpretation was correct for presence or absence of left atrial appendage thrombus. The reported percent confidence is the average of both echo readers.

Secondary Outcome Measures

Name	Time	Method
Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage	One transesophageal echocardiography, up to 1 hour	Percent agreement between echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial