TY - JOUR
T1 - Left atrial appendage occlusion
T2 - Opportunities and challenges
AU - Holmes, David R.
AU - Lakkireddy, Dhanunjaya R.
AU - Whitlock, Richard P.
AU - Waksman, Ron
AU - Mack, Michael J.
N1 - Funding Information:
Dr. Holmes and the Mayo Clinic have a financial interest in technology related to this research. That technology has been licensed to Atritech. Dr. Lakkireddy has received speaker's honoraria from Boehringer Ingelheim, St. Jude Medical, Jansen, Pfizer, and Bristol-Myers Squibb; consulting fees from St. Jude Medical; and a research grant from SentreHEART . Dr. Waksman has received honoraria for his service on the speakers' bureaus of Boston Scientific, Medtronic, AstraZeneca, Biotronik, and Abbott Vascular; nonroyalty payments from Biotronik; and research grants from Boston Scientific , Medtronic , Volcano , Lilly Daiichi Sankyo , AstraZeneca , and Abbott Vascular . All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
PY - 2014/2/4
Y1 - 2014/2/4
N2 - Stroke prevention in patients with atrial fibrillation is a growing clinical dilemma as the incidence of the arrhythmia increases and risk profiles worsen. Strategies in patients with nonvalvular atrial fibrillation have included anticoagulation with a variety of drugs. Knowledge that stroke in this setting typically results from thrombus in the left atrial appendage has led to the development of mechanical approaches, both catheter-based and surgical, to occlude that structure. Such a device, if it were safe and effective, might avoid the need for anticoagulation and prevent stroke in the large number of patients who are currently not treated with anticoagulants. Regulatory approval has been difficult due to trial design challenges, balance of the risk-benefit ratio, specific patient populations studied, selection of treatment in the control group, and specific endpoints and statistical analyses selected. Accumulating data from randomized trials and registries with longer-term follow-up continues to support a role for left atrial appendage exclusion from the central circulation as an alternative to anticoagulation in carefully-selected patient populations.
AB - Stroke prevention in patients with atrial fibrillation is a growing clinical dilemma as the incidence of the arrhythmia increases and risk profiles worsen. Strategies in patients with nonvalvular atrial fibrillation have included anticoagulation with a variety of drugs. Knowledge that stroke in this setting typically results from thrombus in the left atrial appendage has led to the development of mechanical approaches, both catheter-based and surgical, to occlude that structure. Such a device, if it were safe and effective, might avoid the need for anticoagulation and prevent stroke in the large number of patients who are currently not treated with anticoagulants. Regulatory approval has been difficult due to trial design challenges, balance of the risk-benefit ratio, specific patient populations studied, selection of treatment in the control group, and specific endpoints and statistical analyses selected. Accumulating data from randomized trials and registries with longer-term follow-up continues to support a role for left atrial appendage exclusion from the central circulation as an alternative to anticoagulation in carefully-selected patient populations.
KW - Watchman device
KW - left atrial appendage occlusion
KW - nonvalvular atrial fibrillation
KW - stroke prevention
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U2 - 10.1016/j.jacc.2013.08.1631
DO - 10.1016/j.jacc.2013.08.1631
M3 - Review article
C2 - 24076495
AN - SCOPUS:84893175659
VL - 63
SP - 291
EP - 298
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 4
ER -