Left Atrial Appendage Occlusion Device Societal Overview | Ten Points to Remember
- Masoudi FA, Calkins H, Kavinsky C, et al.
- 2015 ACC/HRS/SCAI Left Atrial Appendage Occlusion Device Societal Overview. J Am Coll Cardiol 2015;Jun 29:[Epub ahead of print].
The American College of Cardiology (ACC), Heart Rhythm Society (HRS), and Society for Cardiovascular Angiography and Interventions (SCAI) have collaborated in writing this overview on the left atrial appendage (LAA) occlusion device as the first of a series of documents to address issues critical to the appropriate integration of new technologies into the care of patients with atrial fibrillation (AF). The following are 10 points to remember:
- There is reasonable evidence that the LAA is the most common source of thrombus resulting in stroke or systemic embolism in patients with nonvalvular AF.
- Although there exist a variety of LAA occlusion devices that may be implanted percutaneously, the WATCHMAN device (Boston Scientific) has been studied most extensively.
- The WATCHMAN device is indicated as an alternative to long-term oral anticoagulation with warfarin in patients with nonvalvular AF who are at increased risk of stroke.
- The WATCHMAN device is implanted into the LAA (via trans-septal puncture) using transesophageal echocardiography (TEE) and fluoroscopy. The patient is treated with warfarin until a follow-up TEE (at 45 days) confirms stable occlusion of the LAA. At that time, warfarin is discontinued for dual antiplatelet therapy with clopidogrel and aspirin. After 6 months, the former is discontinued.
- Acute procedure-related complications occur in about 4% of patients undergoing implantation of the WATCHMAN device, and are lower than the very early experience during the PROTECT-AF trial. Complications include pericardial effusion requiring drainage, stroke, access-site bleeding, device embolization, and others.
- The experience with WATCHMAN in patients in whom oral anticoagulation is contraindicated is limited.
- Data from the PROTECT-AF trial showed that the rate of hemorrhagic stroke and cardiovascular death was lower in the WATCHMAN arm as compared to oral anticoagulation with warfarin.
- The LARIAT (SentreHEART) device, approved for “soft-tissue closure,” requires both LA and pericardial access. Its advantage is that it does not involve endocardial implantation, and hence eliminates the risk of device embolization and related problems. The rate of complications, and the fact that its relative effectiveness as compared to oral anticoagulation is unknown, are ongoing concerns.
- A multidisciplinary team is essential in building a successful appendage occlusion program. The disciplines include cardiac electrophysiology, interventional cardiology, echocardiography, anesthesiology, cardiac surgery, radiology, and nursing.
- The authors also advocate for post-marketing surveillance of LAA occlusion devices by way of a registry akin to the program for transcatheter valve therapy.
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