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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Low stroke risk after elective cardioversion of atrial fibrillation: an analysis of the Flec-SL trial
Stavros Apostolakis1, Karl Georg Haeusler, Michael Oeff
1Centre for Cardiovascular Sciences, School for Clinical and Experimental Medicine, University of Birmingham, and SWBH NHS Trust, Birmingham, UK.
Insights
Anticoagulation management during cardioversion for atrial fibrillation (AF) is crucial. This study found stroke and bleeding events to be rare, supporting current anticoagulation recommendations for AF cardioversion.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- Current anticoagulation management for cardioversion relies on limited data and expert opinion.
- Elective cardioversion for atrial fibrillation (AF) requires careful consideration of thrombotic and bleeding risks.
Purpose of the Study:
- To assess current practices in anticoagulation during and after elective cardioversion for AF.
- To evaluate the incidence of stroke, transient ischemic attack (TIA), and major bleeding events following cardioversion.
Main Methods:
- Analysis of 635 patients from the Flec-SL trial (ISRCTN62728743, NCT00215774) undergoing elective cardioversion for AF.
- Assessment of periprocedural anticoagulation, adequacy of anticoagulation, and cardioversion methods (electrical vs. pharmacological, TEE-guided).
- Prospective follow-up for stroke, TIA, and major bleeding events.
Main Results:
- 99.1% of patients received periprocedural anticoagulation; 87.6% were adequately anticoagulated.
- Stroke/TIA event rate was 0.9% (5 strokes, 3 TIAs), and major bleeding rate was 0.8%.
- Events were infrequent and not associated with cardioversion type or transesophageal echocardiography (TEE) use.
Conclusions:
- Stroke and bleeding events are rare in patients undergoing cardioversion for AF with contemporary antithrombotic therapy.
- Findings support the continued adherence to established anticoagulation guidelines for AF cardioversion.
- Low event rates suggest current practices are safe and effective in this patient population.
Background:
Current recommendations for anticoagulation management during cardioversion are largely based on historical data and expert consensus.
Methods And Results:
To characterize current practice of anticoagulation during and after elective cardioversion for AF and the risk of stroke and bleeding events, all patients enrolled into the Flec-SL trial were analyzed for stroke/transient ischemic attack and major bleeds after cardioversion. Flec-SL (ISRCTN62728743, NCT00215774) enrolled 635 patients (mean age 63.7 ± 10.9, 66% male). 629 (99.1%) patients received periprocedural anticoagulation, 556 (87.6%) were adequately anticoagulated following current recommendations. 202 (31.8%) patients underwent transesophageal echocardiography-guided cardioversion. Electrical cardioversion was used in 508 patients (80.0%), pharmacological cardioversion in 127 (20%). Six patients suffered from stroke (n = 5) or transient ischemic attack (3 TIAs in 1 patient, event rate 0.9%, 95% CI 0.4-2.1), five others from major bleeds (event rate 0.8%, 95% CI 0.3-1.9), consistent with the low reported event rates in prior studies. Three strokes occurred in the first 5 days after cardioversion. Events were independent of type of cardioversion or the use of TEE to exclude thrombi.
Conclusion:
Strokes are rare in this large, prospectively followed cohort of patients undergoing cardioversion for AF and receiving antithrombotic therapy following local routine. These results support adherence to current recommendations for anticoagulation during cardioversion of AF.
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