Page 16 - Journal of Structural Heart Disease Volume 2, Issue 1

Review Article
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2.5 2.0 1.5 1.0 0.5 0.0
Figure 7. Comparison of stroke or systemic embolism event rate per 100 person-years. RE-LY [13], ARISTOTLE [14], ROCKET-AF [15], and PROTECT AF [45] trials demonstrating event rates of stroke or systemic embolism per 100 person-years.
Cardiology/Heart Rhythm Society guidelines for the management of patients with atrial brillation dis- cuss percutaneous LAA closure but do not provide any recommendations with regard to its use [54]. Though WATCHMAN has demonstrated noninferi- ority and superiority compared to warfarin eligible patients, no direct comparison to NOACs is currently available. Indirect comparisons of relative reduc- tion in mortality between NOACs and WATCHMAN compared to warfarin favor LAA closure with WATCH- MAN (Figure 7). Indirect comparisons with regard to stroke rate or rate of systemic embolism also appear similar (Figure 8). The debate continues whether the WATCHMAN device should be used as alternative to anticoagulation as in PROTECT AF, CAP and PREVAIL trials or indicated only for those patients with relative or absolute contraindications to anticoagulation as in ASAP. There is a paucity of data with other devices with no other randomized trial data to support LAA closure as an alternative to anticoagulation with such devices at this time. Such devices should be limited to patients with contraindications to anticoagulation until further data are available.
The patients who stand to bene t most from LAA closure include those at highest risk for bleeding. In- terestingly, these patients are also at the highest risk of thromboembolic stroke. Continued understanding of risks of transcatheter LAA closure techniques is needed to allow for more accurate risk assessment for patients facing the choice of being at high risk for bleeding com-
Figure 6. WAVECREST. The Wavecrest is an umbrella shaped de- vice constructed with a nitinol frame and covering material with anchoring barbs which are deployed after the covering face is rst positioned into place at the ostium. The covering material consists of non-permeable, Te on material at the face, and a foam cu around the face for direct contact with the endocardi- um (image courtesy of Coherex Medical, Inc.).
Discussion
Percutaneous transcatheter LAA closure provides an alternative in the treatment of patients with non- valvular AF at high risk for stroke. Warfarin alone has been the mainstay of therapy until recently with the introduction of NOAC agents. While these agents pro- vide some advantages over warfarin, they are not with- out risk of bleeding. While risk of intracranial bleeding is less with these agents, overall risk of bleeding is similar to warfarin with the exception of apixaban. Gastrointestinal bleeding is higher with both dab- igatran and rivaroxaban compared with warfarin [13, 15]. Currently, there are no approved antidotes for these agents presenting challenges for manage- ment. These agents also do not fully address the issue of noncompliance and intolerance with sig- ni cant discontinuation rates of all oral anticoagu- lants. Currently, the European Society of Cardiology guidelines for the management of atrial brillation support consideration of transcatheter closure of the LAA in patients with a high stroke risk and con- traindications for long-term oral anticoagulation [53]. The American Heart Association/American College of
RE-LY(110mg) RE-LY(150mg) ROCKET-AF ARISTOTLE PROTECT-AF NOAC/device warfarin
Journal of Structural Heart Disease, February 2016
Volume 2, Issue 1:1-14
Event rate per 100 person-years