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      Reassuring but not convincing - another registry to support left atrial appendage closure but randomized data remains scarce

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          Abstract

          Left atrial appendage closure (LAAC) is considered an established therapy for patients with contraindications to long-term oral anticoagulation [1]. As per study design, LAAC was initially deemed a true alternative to vitamin K antagonists [2,3]. However, with the advent of direct oral anticoagulants (DOACs) and its compelling data from thousands of patients, interventional LAAC was pushed back to become a niche indication for patients with a high bleeding risk. Contemporary use and effectiveness were well described in two large-scale prospective registries mainly performed in Europe [4,5]. In the present edition of the International Journal of Cardiology Heart & Vasculature, Philips and co-workers present on the Asian-Australian experience with Watchman™ for LAAC in 201 patients [6]. The data documents the continuous effort of the researchers as well as the manufacturer to build evidence for LAAC. Outcome data were well in line with the European experience in the Ewolution registry reporting a high procedural success rate with few serious complications and an excellent device performance reflected by a high sealing rate. Moreover, the authors focused on a comparison between Asians and non-Asians without identifying any relevant differences for LAAC. This is of particular importance taking into consideration the increased risk for Asians to suffer from an intracerebral hemorrhage on oral anticoagulation with vitamin K antagonists as well as with dabigatran [7,8]. It is striking to see the consistency of ischemic stroke/systemic embolism rate across all Watchman™ registries and studies ranging between 1.3 and 2% per year. Surprisingly, the annual major bleeding rate was low at 2.2%, in fact much lower as reported in the European experience being 2.7%/year after 2 years of follow-up [9]. Nonetheless, we also need to focus on the weak points of the present data. First, a registry cannot answer the most important question which is the best therapy in this particular patient population at high risk for bleeding thus deemed contraindicated to continued oral anticoagulation. Second, the number of patients is very small (n = 201) compared to contemporary registries. Last, the number of participating centers is even smaller (n = 9) indicating that LAAC has not been established in the entire Asia Pacific region yet, thus it may be difficult to draw universal conclusions. Major bleeding remains the most frequent complication after LAAC. Several different therapy regimens have been proposed including short-term dual antiplatelet therapy for six weeks as well as single antiplatelet therapy in high-risk populations [10,11]. Surprisingly, in the WASP registry DOACs were the predominant type of post-implant antithrombotic registry. Later, non-Asians were mostly switched to single antiplatelet therapy while most Asians remained on dual antiplatelet therapy. Despite the more intense antithrombotic therapy the observed rate of bleeding in Asians was lower also paralleled by a lower thrombembolic event rate. While this may not explained by differences in patient characteristics, it might be advisable to interpret the data with caution given the small number of patients. It has to be highlighted that no hemorrhagic stroke occurred in the WASP registry during the 2 year follow-up, which again underscores the value of LAAC for this disease entity in particular for secondary prophylaxis [12]. The present data is certainly reassuring that LAAC is also applicable in this part of the world, but to convince critics of LAAC we urgently require more randomized controlled data to compare medical treatment and LAAC both in patients deemed contraindicated to oral anticoagulation (ASAP-TOO; NCT02928497), [13] as well as in patients at high risk for bleeding (CLOSURE AF; NCT03463317). Conflict of interest BS is consultant to Boston scientific and Abbott, BS and KRJC received research grants and speaker honoraria form BSCI and Abbott, SB has no COI to disclose.

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          Most cited references 8

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          Dabigatran versus warfarin: effects on ischemic and hemorrhagic strokes and bleeding in Asians and non-Asians with atrial fibrillation.

          Intracranial hemorrhage rates are higher in Asians than non-Asians, especially in patients receiving warfarin. This randomized evaluation of long-term anticoagulation therapy subgroup analysis assessed dabigatran etexilate (DE) and warfarin effects on stroke and bleeding rates in patients from Asian and non-Asian countries.
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            Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry

            Aims Left atrial appendage closure is a non-pharmacological alternative for stroke prevention in high-risk patients with non-valvular atrial fibrillation. The objective of the multicentre EWOLUTION registry was to obtain clinical data on procedural success and complications, and long-term patient outcomes, including bleeding and incidence of stroke/transient ischaemic attack (TIA). Here, we report on the peri-procedural outcomes of up to 30 days. Methods and results Baseline/implant data are available for 1021 subjects. Subjects in the study were at high risk of stroke (average CHADS2 score: 2.8 ± 1.3, CHA2DS2-VASc: 4.5 ± 1.6) and moderate-to-high risk of bleeding (average HAS-BLED score: 2.3 ± 1.2). Almost half of the subjects (45.4%) had a history of TIA, ischaemic stroke, or haemorrhagic stroke; 62% of patients were deemed unsuitable for novel oral anticoagulant by their physician. The device was successfully deployed in 98.5% of patients with no flow or minimal residual flow achieved in 99.3% of implanted patients. Twenty-eight subjects experienced 31 serious adverse events (SAEs) within 1 day of the procedure. The overall 30-day mortality rate was 0.7%. The most common SAE occurring within 30 days of the procedure was major bleeding requiring transfusion. Incidence of SAEs within 30 days was significantly lower for subjects deemed to be ineligible for oral anticoagulation therapy (OAT) compared with those eligible for OAT (6.5 vs. 10.2%, P = 0.042). Conclusion Left atrial appendage closure with the WATCHMAN device has a high success rate in complete LAAC with low peri-procedural risk, even in a population with a higher risk of stroke and bleeding, and multiple co-morbidities. Improvement in implantation techniques has led to a reduction of peri-procedural complications previously limiting the net clinical benefit of the procedure.
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              Left atrial appendage occlusion with the AMPLATZER Amulet device: periprocedural and early clinical/echocardiographic data from a global prospective observational study.

              The global, prospective AMPLATZER Amulet observational study documents real-world periprocedural, transoesophageal echocardiographic (TEE) and clinical outcomes from left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device. The aim of this report is to describe the periprocedural and early clinical/TEE results from this study.
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                Author and article information

                Contributors
                Journal
                Int J Cardiol Heart Vasc
                Int J Cardiol Heart Vasc
                International Journal of Cardiology. Heart & Vasculature
                Elsevier
                2352-9067
                09 May 2019
                June 2019
                09 May 2019
                : 23
                Affiliations
                Cardioangiologisches Centrum Bethanien, AGAPLESION Markus Krankenhaus, Frankfurt/M., Germany
                Author notes
                [* ]Corresponding author at: Cardioangiologisches Centrum Bethanien, AGAPLESION Markus Krankenhaus, Wilhelm-Epstein Str. 4, 60431 Frankfurt/Main, Germany. b.schmidt@ 123456ccb.de
                Article
                S2352-9067(19)30079-X 100371
                10.1016/j.ijcha.2019.100371
                6514719
                © 2019 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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