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Review Article
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Table 2: HAS-BLED
Hypertension (systolic blood pressure > 160 mm Hg) 1
Abnormal renal and liver function (1 point each)
Stroke 1 Bleeding tendency/predisposition 1 Labile INRs (if on warfarin) 1 Elderly (age > 65 years) 1
Drugs or alcohol (1 point each)
Maximum score 9
thromboembolism. The individual techniques and de- vices involved require continued prospective study to demonstrate each device’s e cacy and safety as well as to determine speci c anticoagulation or antiplatelet regimens that may or may not be necessary. While data from the only randomized, controlled, trials available compared LAA closure to anticoagulation eligible pa- tients, it is likely that this technology will be limited until further con rmatory data are available. It is clear that a large percentage of patients are currently unable to be treated with oral anticoagulation of any kind. Another option is needed for patients. Further study may expand the indications as technologies continue to develop and more data are available.
Con ict of Interest
Sánchez reports having received consulting fees from Boston Scienti c, the manufacturer of the Watchman device. Dr. Holmes has received research grant support from Atritech/Boston Scienti c. In ad- dition, the Watchman LAA closure technology has been licensed to Atritech, and both Mayo Clinic and David Holmes have contractual rights to receive fu- ture royalties from this license. To date, no royalties have been received.
Comment on this Article or Ask a Question
HAS-BLED
Score
1 or 2
RE-LY(150mg) ROCKET-AF ARISTOTLE PROTECT-AF Total Mortality Relative Reduction versus Warfarin
1 or 2
Figure 8. Indirect comparison of total mortality reduction from major trials. RE-LY [13], ARISTOTLE [14], ROCKET-AF [15], and PROTECT AF [45] trials demonstrating relative risk reduction in total mortality.
plications, at high risk for thromboembolic stroke, or at risk of complications from a percutaneous procedure. Tools such as CHA2DS2VASc score allow for such deter- mination of CVA risk in nonvalvular AF patients. Assess- ment of bleeding risk is equally important. The HAS- BLED score [55] has been validated and can be used to determine risk of bleeding among patients who have an indication for anticoagulation (Table 2). The risk of each individual transcatheter technique must be established to accurately determine at what point LAA closure is indicated and the risks acceptable. Consideration of both procedure risks and long-term risks of the device themselves must be evaluated. It is important to note that bleeding and stroke risk con- tinue yearly with life-long anticoagulation, while pro- cedural risks of device implantation are usually short term and should be weighed as such. None the less, there is a large population of patients at this time in need of alternatives especially those with relative and absolute contraindications to anticoagulation use who are also at high risk of thromboembolic stroke from AF.
Conclusion
LAA closure is a rapidly developing area of cardiol- ogy with signi cant promise. Transcatheter LAA occlu- sion has shown that local therapy can reduce systemic
Sánchez, J.M. et al.
Where Do We Stand Now?
Relative Risk Reduction