Project description:Prevention of stroke represents a goal of primary importance in health systems due to its associated morbidity and mortality. As several patient groups with increased stroke rates have been identified, multiple approaches have been developed and implemented: oral anticoagulation (OAC) for patients with atrial fibrillation, surgical and percutaneous revascularisation in patients with carotid disease, device closure for patients with patent foramen ovale, and now, left atrial appendage occlusion (LAAO) for selected patients with non-valvular atrial fibrillation (NVAF). The latter group of patients are the focus of this review which evaluates the pathophysiology, selection of patients, procedural performance, outcomes of treatment both during and post-procedure, adjunctive therapy, complications, and longer-term outcomes.
Project description:Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide and associated with an elevated risk of thromboembolic stroke and systemic embolization. The evidence suggests that ~90% of thrombi in patients with non-valvular AF are localized to the left atrial appendage (LAA). Therefore, it seems reasonable to consider LAA exclusion in selected patients with AF for stroke prevention. LAA exclusion can be achieved through a variety of surgical and percutaneous techniques. Surgical methods include LAA amputation, ligation, clipping and stapling. Whereas percutaneous strategies consist of endocardial closure using an LAA occlusion device and epicardial LAA ligation using a snare device. Even though several trials and registries of LAA exclusion have yielded promising outcomes, at this time evidence for long term safety and efficacy seems insufficient to recommend this approach to all patients with non-valvular AF. Future prospective randomized trials are needed to assess the precise role for these therapeutic options. Furthermore, there is a paucity of data on the comparison of these strategies to the novel oral anticoagulants which also deserves further attention. This review will carefully examine the current LAA exclusion techniques and the available data.
Project description:Left atrial appendage occlusion (LAAO) is a suitable alternative to oral anticoagulant therapy to prevent stroke in patients with AF. Most procedures are performed under transoesophageal echocardiography (TOE) guidance, which facilitates transseptal puncture, reduces the risk of procedurerelated complications and provides an additional method for device selection and real-time monitoring during device deployment. However, TOE has significant shortcomings, including the need for general anaesthesia/deep sedation as well as a significant risk of procedure-related adverse events. More recently, intracardiac echocardiography has been proposed as an alternative to TOE guidance during LAAO procedures. In this review, we summarise the available evidence as well as providing a step-by-step approach for intracardiac echocardiography-guided LAAO.
Project description:BackgroundLeft atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited.ObjectivesThe purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years.MethodsThe authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates.ResultsA total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare.ConclusionsThe LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials.
Project description:Left atrial appendage occlusion (LAAO) is an established alternative to oral anticoagulation for stroke prevention in atrial fibrillation. Antithrombotic therapy is used in the post-procedural period to prevent device-related thrombosis (DRT). The risk of DRT is considered highest in the first 45-90 days after device implantation, based on animal studies of the device healing process. Clinically applied antithrombotic regimens vary greatly across studies, continents, and centers. This article gives an overview of the evidence behind current antithrombotic regimens, ongoing randomized trials, and future post-procedural management.
Project description:BackgroundThe optimal antithrombotic therapy following left atrial appendage occlusion (LAAO) remains debated. Ideally, this therapy should effectively prevent device-related thrombosis (DRT) while minimising the associated bleeding risk.AimsWe aimed to evaluate the long-term safety and efficacy of a postprocedural single antiplatelet therapy (SAPT) strategy following Amplatzer LAAO in a large consecutive cohort.MethodsThis retrospective, single-centre, observational study included all patients discharged on SAPT after LAAO with the Amplatzer Cardiac Plug (ACP) or Amplatzer Amulet between March 2010 and December 2021 at Aarhus University Hospital, Denmark. Baseline, procedural, and imaging data were obtained locally, while clinical outcomes and medication data were extracted from the Danish national health registries.ResultsA total of 553 patients underwent Amplatzer LAAO during the specified time frame. Of these, 431 (77.9%) high bleeding risk patients were discharged on SAPT with either acetylsalicylic acid (n=403, 72.9%) or clopidogrel (n=28, 5.1%). At 6 months, 173 (41.7%) patients were not on any antithrombotic therapy. The mean CHA2DS2-VASc and HAS-BLED scores were 3.9±1.5 and 3.4±1.1, respectively. DRT was detected in 6 (1.5%) patients on 8-week follow-up imaging using cardiac computed tomography (n=386, 89.6%) or transoesophageal echocardiography (n=27, 6.3%). The 1-year ischaemic stroke rate was 2.2% (95% confidence interval [CI]: 1.1-4.2). One-year rates for major bleeding and cardiovascular death were 5.9% (95% CI: 4.0-8.9) and 2.9% (95% CI: 1.6-5.1), respectively.ConclusionsSAPT following Amplatzer LAAO displayed rates of DRT and stroke comparable to those reported with more intensive antithrombotic regimens. Meanwhile, we observed low rates of major bleeding.
Project description:BACKGROUND:There is increasing interest in performing left atrial appendage (LAA) occlusion at the time of atrial fibrillation (AF) ablation procedures. However, to date there has been no description of the acute changes to the LAA immediately following pulmonary vein (PV) isolation and additional left atrium (LA) substrate modification. This study assessed changes in the size and tissue characteristics of the LAA ostium in patients undergoing PV isolation. METHODS:This series included 8 patients who underwent cardiovascular magnetic resonance evaluation of the LA with delayed enhancement magnetic resonance imaging and contrast enhanced 3-D magnetic resonance angiography pre-, within 48 h of, and 3 months post ablation. Two independent cardiac radiologists evaluated the ostial LAA diameters and area at each time point in addition to the presence of gadolinium enhancement. RESULTS:Compared to pre-ablation values, the respective median differences in oblique diameters and LAA area were +1.8 mm, +1.7 mm, and +0.6 cm(2) immediately post ablation (all NS) and -2.7 mm, -2.3 mm, and -0.5 cm(2) at 3 months (all NS). No delayed enhancement was detected in the LAA post ablation. CONCLUSION:No significant change to LAA diameter, area, or tissue characteristics was noted after PV isolation. While these findings suggest the safety and feasibility of concomitant PV isolation and LAA device occlusion, the variability in the degree and direction of change of the LAA measurements highlights the need for further study.
Project description:Atrial fibrillation (AF) is a commonly sustained atrial arrhythmia with associated morbidity and mortality. AF is associated with increased risk of thromboembolism and stroke, requiring use of anticoagulation. Anticoagulation decreases the risk of stroke but is associated with a higher risk of bleeding, necessitating discontinuation in some patients. The left atrial appendage is the likely source of thrombus in the majority of patients with AF. This has led to the development of left atrial appendage occlusion as a means to reduce stroke risk in patients who have a contraindication to long-term anticoagulation. Multiple implantable devices have surfaced in the last few years, with some promising prospects. The main purpose of this review is to highlight the indications and use of these devices for left atrial appendage occlusion.
Project description:BackgroundPivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific postprocedure treatment protocols.ObjectivesThis study sought to evaluate patterns of postprocedure care after LAAO with the Watchman device in clinical practice and compare the risk of adverse events for different discharge antithrombotic strategies.MethodsWe evaluated patients in the LAAO Registry of the National Cardiovascular Data Registry who underwent LAAO with the Watchman device between 2016 and 2018. We assessed adherence to the full postprocedure trial protocol including standardized follow-up, imaging, and antithrombotic agents and then evaluated the most commonly used antithrombotic strategies and compared the rates and risk of adverse events at 45 days and 6 months by means of multivariable COX frailty regression.ResultsAmong 31,994 patients undergoing successful LAAO, only 12.2% received the full postprocedure treatment protocol studied in pivotal trials; the most common protocol deviations were with discharge antithrombotic medications. The most common discharge medication strategies were warfarin and aspirin (36.9%), direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin only (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (5.0%). In multivariable Cox frailty regression, the adjusted risk of any adverse event through the 45-day follow-up visit were significantly lower for discharge on warfarin alone (HR: 0.692; 95% CI: 0.569-0.841) and DOAC alone (HR: 0.731; 95% CI: 0.574-0.930) compared with warfarin and aspirin. Warfarin alone retained lower risk at the 6-month follow-up.ConclusionsIn contemporary U.S. practice, practitioners rarely used the full U.S. Food and Drug Administration-approved postprocedure treatment protocols studied in pivotal trials of the Watchman device. Discharge after implantation on warfarin or DOAC without concomitant aspirin was associated with lower risk of adverse outcomes.