Bleeding complications in patients with atrial fibrillation undergoing cardioversion randomized to transesophageal echocardiographically guided and conventional anticoagulation therapies.
In a multicenter randomized trial, we studied a transesophageal echocardiography (TEE) guided strategy with short-term anticoagulation compared with a conventional strategy for patients with atrial fibrillation >2 days' duration and undergoing cardioversion. Composite major and minor bleeding was a predetermined secondary end point of the study. The objective of the study was to assess the incidence, location, and predictors of bleeding in the 2 treatment groups. A total of 1,222 patients were assigned to a TEE guided or conventional strategy and followed over 8 weeks. We present data on major and minor adjudicated bleeding complications for the 2 study groups during the 8-week study period. Composite major and minor bleeding complications occurred in 51 of 1,222 patients (4.2%) and were significantly lower in the TEE guided group compared with the conventional group (2.9 vs 5.5%, p = 0.025). The TEE group had fewer cancellations of cardioversion as a result of bleeding (0% vs 0.7%, p = 0.003). Major (n = 14) and minor (n = 38) bleeding complications were predominantly gastrointestinal (71.4% and 31.6%, respectively) and were associated with warfarin use. Predictors of bleeding included patient age, conventional group assignment, inpatient status, and functional status. Thus, composite major and minor bleeding complications occurred in 4.2% of the 1,222 patients and were significantly lower in the TEE guided group compared with the conventional group. Treatment variables affecting length of anticoagulant therapy in the conventional arm combined with advancing age and functional status are important concerns in patients who undergo cardioversion of atrial fibrillation.
Klein
Allan L
AL
Department of Cardiovascular Medicine/Desk F15, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA. kleina@ccf.org
Murray
R Daniel
RD
Grimm
Richard A
RA
Li
Jianbo
J
Apperson-Hansen
Carolyn
C
Jasper
Susan E
SE
Goodman-Bizon
Ariel S
AS
Lieber
Elizabeth A
EA
Black
Ian W
IW
D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects*; D001281:Atrial Fibrillation / Q000000981:diagnostic imaging* / Q000628:therapy*; D017548:Echocardiography, Transesophageal / Q000009:adverse effects*; D004554:Electric Countershock / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006493:Heparin / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D019106:Postoperative Hemorrhage / Q000000981:diagnostic imaging* / Q000209:etiology*; D011237:Predictive Value of Tests; D025321:Surgery, Computer-Assisted; D013997:Time Factors; D014859:Warfarin / Q000009:adverse effects*
D000925:Anticoagulants; D014859:Warfarin; D006493:Heparin