OBJECTIVES: In patients with atrial fibrillation (AF), we sought to evaluate the feasibility and safety of a new transesophageal echocardiography (TEE)-guided strategy, aimed at selecting, 7 days post-cardioversion, those patients who are at low risk (i.e. who can terminate anticoagulation after a second TEE) and those at high risk (i.e. who have to continue it). METHODS: We enrolled 206 patients with non-valvular AF into a randomized, multicenter clinical trial. Group A patients underwent a TEE-guided cardioversion with heparin and at least 4 weeks of oral anticoagulation therapy (OAT) after cardioversion. Group B patients received enoxaparin and underwent a TEE-guided cardioversion. After 7 days, a second TEE was carried out. In the absence of TEE thromboembolic risk factors and left atrial appendage (LAA) dysfunction anticoagulation was discontinued. RESULTS: In group A, 88 out of 102 patients underwent TEE and cardioversion was efficacious in 77 of 78. In group B, 100 out of 104 patients underwent TEE and cardioversion was efficacious in 80 of 87 patients; 55 patients underwent the second TEE and enoxaparin was stopped in 50 without LAA dysfunction. In group A, one transient ischemic attack and one sudden cardiac death occurred. In group B, one patient with complex aortic plaques suffered a stroke during enoxaparin. There was a minor hemorrhage in groups A and B, and a severe hemorrhage in a patient during OAT because of persistent atrial stunning. Hospitalization length and duration of anticoagulation were significantly shorter in group B. CONCLUSIONS: The pre/post-cardioversion TEE strategy with enoxaparin in AF may constitute a feasible and safe approach in selecting patients at low thromboembolic risk who can benefit from precocious termination of anticoagulation (7 days after cardioversion). It may be also useful to identify those patients in whom a life-lasting anticoagulation could be beneficial. A larger trial to confirm these findings is under way.
RCT Entities:
OBJECTIVES: In patients with atrial fibrillation (AF), we sought to evaluate the feasibility and safety of a new transesophageal echocardiography (TEE)-guided strategy, aimed at selecting, 7 days post-cardioversion, those patients who are at low risk (i.e. who can terminate anticoagulation after a second TEE) and those at high risk (i.e. who have to continue it). METHODS: We enrolled 206 patients with non-valvular AF into a randomized, multicenter clinical trial. Group A patients underwent a TEE-guided cardioversion with heparin and at least 4 weeks of oral anticoagulation therapy (OAT) after cardioversion. Group B patients received enoxaparin and underwent a TEE-guided cardioversion. After 7 days, a second TEE was carried out. In the absence of TEE thromboembolic risk factors and left atrial appendage (LAA) dysfunction anticoagulation was discontinued. RESULTS: In group A, 88 out of 102 patients underwent TEE and cardioversion was efficacious in 77 of 78. In group B, 100 out of 104 patients underwent TEE and cardioversion was efficacious in 80 of 87 patients; 55 patients underwent the second TEE and enoxaparin was stopped in 50 without LAA dysfunction. In group A, one transient ischemic attack and one sudden cardiac death occurred. In group B, one patient with complex aortic plaques suffered a stroke during enoxaparin. There was a minor hemorrhage in groups A and B, and a severe hemorrhage in a patient during OAT because of persistent atrial stunning. Hospitalization length and duration of anticoagulation were significantly shorter in group B. CONCLUSIONS: The pre/post-cardioversion TEE strategy with enoxaparin in AF may constitute a feasible and safe approach in selecting patients at low thromboembolic risk who can benefit from precocious termination of anticoagulation (7 days after cardioversion). It may be also useful to identify those patients in whom a life-lasting anticoagulation could be beneficial. A larger trial to confirm these findings is under way.