Assessment of Cardioversion Using Transesophageal Echocardiography - ACUTE
Description:
The goal of the trial was to compare three weeks of anticoagulation to an early transesophageal echocardiographic (TEE) approach prior to cardioversion for atrial fibrillation.
Hypothesis:
Cardioversion of atrial fibrillation using an early TEE-guided approach may reduce the bleeding risks associated with the conventional three weeks of anticoagulation without an increased incidence of embolic events.
Study Design
Study Design:
Patients Enrolled: 1,222
Mean Follow Up: Eight weeks
Mean Patient Age: Mean of 64
Female: 34
Patient Populations:
- At least 18 years old
- Atrial fibrillation for at least two days
- Atrial flutter with documented history of atrial fibrillation
Exclusions:
- History of atrial flutter with no history of atrial fibrillation
- Hemodynamic instability
- Patients receiving warfarin therapy for more than seven days' duration
- Patients with contraindication to warfarin or TEE
- Women of childbearing potential
- Impending procedure that would preclude anticoagulation
Primary Endpoints:
Composite primary endpoint: cerebrovascular accident, transient ischemic attack, and peripheral embolism
Secondary Endpoints:
- Functional status assessed by the Duke Activity Status Index
- Successful restoration and maintenance of sinus rhythm at eight weeks
- Major and minor hemorrhage
- Death
Drug/Procedures Used:
- Conventional treatment group with warfarin (targeted to international normalized ratio (INR) of 2.0-3.0) for three weeks, followed by cardioversion
- TEE-guided cardioversion with antecedent warfarin for five days (if outpatient) or intravenous heparin immediately prior to cardioversion (if inpatient)
Concomitant Medications:
All patients received warfarin for four weeks following cardioversion.
Principal Findings:
- No significant difference in the composite endpoint of embolic events (0.8% for TEE-guided group vs. 0.5% for conventional group, p=0.5).
- Total hemorrhagic events occurred more often in the conventional treatment group (5.5% vs. 2.9%; p=0.03) with no difference in major hemorrhagic events.
- Patients in the TEE group were cardioverted earlier than those in the warfarin group (3 ± 5.6 days vs. 30.6 ± 10.6 days).
- At eight weeks: Sinus rhythm was maintained in 52.7% and 50.4% of the TEE and warfarin groups, respectively (p=0.43).
- There was no significant difference in functional status or death at eight-week follow-up.
Interpretation:
Among patients with atrial fibrillation of more than a two-day duration, there was no significant difference in the rate of embolic events with an early TEE-guided approach compared to a conventional approach of three weeks of warfarin anticoagulation prior to cardioversion. The conventional approach was associated with a higher overall rate of hemorrhage, although no significant difference was found in the incidence of major bleeding.
References:
Klein AL, Grimm RA, Murray RD, et al. Use of transesophageal echocardiography to guide cardioversion in patients with atrial fibrillation. N Engl J Med 2001;344:1411-20.
Keywords: Thrombosis, Warfarin, Electric Countershock, Heparin, Atrial Fibrillation, Echocardiography, Transesophageal, Atrial Flutter
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