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HTA of left atrial appendage closure in Austria
The most frequently occurring complication in patients with atrial fibrillation is thromboembolism and in particular ischaemic stroke. Surgical closure using a particular clip or percutaneous closure of the left atrial appendage (LAA) aims to eliminate the LAA from systemic circulation in order to prevent thromboembolic events, such as ischaemic stroke. This procedure is a non-pharmaceutical alternative to the “gold standard” therapy of atrial fibrillation - oral anticoagulation (OAC) with non-vitamin K antagonist oral anticoagulants (NOACs).
Interventional atrial appendage can be done using percutaneous LAA occlusion devices. In the cardiac catheterization laboratory, under transoesophageal echocardiography (TEE), a catheter containing the implant is inserted through the right femoral vein. Via the inferior vena cava, the catheter is advanced to the heart, and after puncture of the atrial septum the device is placed in the left atrial appendage, expanded and thereby fixed. Within a few weeks, the surface of the device is covered with the body’s own tissue, resulting in complete occlusion of the left atrial appendage. For this process, currently three CE-certified systems exist:
- AMPLATZER ™ Cardiac Plug (AGA Medical, Corp., North Plymouth, MN, USA)
- WATCHMAN® Left Atrial Appendage Closure Technological/Device/System (Atritech, Inc., North Plymouth, MN, USA)
- Coherex WaveCrest ™ LAA Occluder System (Coherex Medical, Inc., Salt Lake City, Utah, USA)
The authors have performed a systematic review of the literature in order to compare the efficacy and safety of percutaneous LAA closure and surgical closure using a special clip, respectively to prevent thromboembolic events with that of OAC in patients with atrial fibrillation. This article reports on the third update of the systematic review published in 2011.
The authors have searched for the literature on the following databases: Medline, Embase, Cochrane Library, CRD, PubMed. Articles dating December 2014 – December 2017 were taken into consideration. Furthermore, in January 2018 the websites, clinicaltrials.gov and WHO-ICTRP, were searched. Finally, 21 publications were included, one (1) of which was an RCT (based on two (2) studies) and twenty (20) of which were case-series (based on sixteen (16) studies). The exhaustive judgement on the quality of evidence was done according to the GRADE approach.
Regarding the effectiveness, the 5-year results of the two RCTs of LAA closure with the Watchman device are conflicting. While the first study demonstrated non-inferiority of the Watchman device compared to OAC for the primary composite endpoint of efficacy (occurrence of stroke, systemic embolism, or cardiovascular/unexplained death), while the second study could not provide proof of non-inferiority of the Watchman system.
Regarding the safety, only the first study provides the 5-year results. Slightly higher event rates were found in the group with the Watchman device compared to the warfarin group for the primary composite outcome for safety (occurrence of life-threatening events including embolization of the implant and severe bleeding) and for serious adverse events, respectively. For other percutaneous LAA occlusion devices, no RCTs were identified, and thus these weren’t assessed.
Considering this evidence, the authors do not recommend the inclusion in the hospital benefit catalogue, neither for percutaneous left atrial appendage occlusion nor for surgical closure using a special clip. There are thirteen (13) RCTs and sixteen (16) observational studies that are taking place right now; thus, a re-evaluation is scheduled for 2023.
See the full report in German (with summary in English) here.
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