Amplatzer Amulet Device Research Articles

Long-term cardiac computed tomography follow-up after left atrial appendage occlusion.

Left atrial appendage occlusion (LAAO) is performed increasingly, but long-term follow-up imaging data are lacking. The aim of this study was to evaluate the safety and durability of the Amplatzer Amulet device >4 years after LAAO. This was a prospective observational cohort study including 52 patients implanted with the Amplatzer Amulet device at Aarhus University Hospital, Denmark. A >4-year follow-up cardiac computed tomography (CT) scan after LAAO was performed and compared with the results from the 2-month and 12-month scans. The primary outcome was left atrial appendage (LAA) sealing based on distal LAA contrast patency and peridevice leakage (PDL), stratified into complete occlusion (grade 0 [G0]) and grade 1-3 leakage (G1-3), respectively. Secondary outcomes were low- and high-grade hypoattenuated thickening (HAT), device-related thrombosis (DRT) and device durability. The median (interquartile range [IQR]) follow-up time from LAAO to the latest CT scan was 5.8 years (4.5; 6.3). At 2-month (n=52), 12-month (n=27) and >4-year CT follow-ups (n=52), rates of both complete occlusion (33%, 37%, 35%) and G2 leaks (52%, 52%, 48%) remained stable. Rates of G1 leaks varied (14%, 4%, 6%) and G3 leaks rose (2%, 7%, 12%) from earliest to latest follow-up. The median left atrial (LA) volume increased from 127 mL (96; 176) to 144 mL (108; 182) and 147 mL (107; 193). No DRT was found. The structural device integrity was preserved. This study indicates a stable LAA sealing status throughout the follow-up period, emphasising the importance of the procedural result in avoiding PDL. Few patients displayed PDL progression, which might partly be related to LA remodelling with increasing volume. The long-term device durability appears excellent. Larger studies are warranted to confirm these findings.

Percutaneous left atrial appendage occlusion can impair pulmonary vein isolation with pulse field ablation

Abstract Background Pulsed-field ablation (PFA) is a promising new ablation modality for pulmonary vein isolation (PVI). However, the feasibility in the presence of a percutaneous left atrial appendage occluder (LAAO) has not yet been investigated. We observed that PFA applications in the left pulmonary veins after LAAO can be interrupted. The aim of this analysis was to investigate the feasibility of PFA with a single-shot device for PVI after LAAO. Methods / Results: Retrospective multicenter analysis. A total of 16 patients (male 81.3%, mean age 71.6 +/-7.4) underwent PVI with PFA after LAAO at 5 different centers in Switzerland and Germany, from August 2021 until July 2023. In 5 patients PFA application at the left-sided PVs was aborted due to interference with the LAAO (Figure). In one patient, the left superior PV could be isolated by repositioning the PFA catheter, in 2 cases successful PVI was achieved after switching to radiofrequency ablation, and in 2 cases the respective left sided PV was not isolated. In all 5 patients the LAAO was an Amplatzer Amulet device (Amplatzer Amulet vs. other LAAO, p=0.069). Mean LAAO size was not significantly different among both groups. Conclusions LAAO can interfere with PFA applications around the left superior pulmonary vein. This effect may be associated with the design of the LAAO.

Adverse events associated with amplatzer left atrial appendage occlusion delivery system: A Food and Drug Administration MAUDE database study.

Dual occlusive closure mechanism (disc and lobe type), Amulet device (Abbott; a second-generation device that has replaced Amplatzer Cardiac Plug) was approved by the Food and Drug Administration (FDA) in August 2021 for percutaneous left atrial appendage occlusion (LAAO). However, real-world safety data on the delivery system (Amplatzer Cardiac Plug and Amplatzer Amulet device) are lacking. We sought to assess the type of adverse events associated with the Amplatzer LAAO delivery system using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. A MAUDE database search was conducted on March 31, 2023, for reports received between February 2013 and March 2023 to capture all adverse events. A total of 59 adverse events were reported, of which 58 were sheath-related events, and one was a wire-related event. The most commonly encountered issue was air embolism (19%, 11 events), followed by sheath thrombosis (13.8%, eight events, two of which were also associated with device thrombosis), kinked sheath (10.3%, six events), and sheath deformation (8.6%, five events). Patient-related adverse events included pericardial effusion requiring pericardiocentesis (22.4%, 13 events), vascular complications (20.7%, 12 events), and device dislodgement (5.2%, three events). LAAO-related adverse events are increasingly being reported using the Amplatzer LAAO delivery sheath. It is anticipated that improvements in device technology, the advent of steerable sheaths, and operator experience will minimize these complications.

Amplatzer amulet versus watchman device for percutaneous left atrial appendage closure: A systematic review and meta-analysis.

The Amplatzer Amulet (AA) and Watchman devices (WD) are the 2 most frequently used devices for percutaneous LAA closure globally. To evaluate the safety and clinical outcomes associated with these 2 devices in patients undergoing percutaneous LAA closure. We systematically searched all electronic databases from inception until February 21, 2023. The primary endpoint was procedure related complications. Secondary endpoints were device related thrombus, stroke, cardiovascular mortality, peri device leak, systemic embolism, and all-cause mortality. A total of 3 randomized clinical trials with 2150 patients were included in this meta-analysis. The mean age was 75 and 76 years in the Amplatzer group and in the Watchman group, respectively. The odds of procedure-related complications (OR, 1.80 [95% CI: 1.21-2.67], P < .001) were significantly higher among patients with AA compared to the WD. However, the odds of all-cause mortality (OR, 0.75 (95% CI: 0.49-1.16), P = .20), stroke (OR, 0.79 [95% CI: 0.47-1.34], P = .39), systemic/pulmonary embolism (OR, 1.34 [95% CI: 0.30-6.04], P = .70), and major bleeding (OR, 1.10 [95% CI: 0.83-1.48], P = .50) were comparable between the two devices. The odds of device related thrombus (OR, 0.72 [95% CI: 0.46-1.14], P = .17) was comparable between both the group of patients, however the incidence of peri device leak was significantly lower in AA group (OR, 0.41 [95% CI: 0.26-0.66], P < .001) compared with WD group of patients. The AA was not superior to the Watchman device in terms of safety and efficacy. However, the Amulet occluder was associated with a higher incidence of procedure-related complications, and lower peri device leak.

Double Device Approach for Percutaneous Closure of Postmyocardial Infarction Ventricular Septal Defect

The benefit related to the use of preprocedural computed tomography angiography (CCTA) on top of periprocedural echocardiography to plan percutaneous left atrial appendage closure (LAAC) procedures is still unclear.The authors sought to evaluate the impact of preprocedural CCTA on LAAC procedural success.In the investigator-initiated SWISS-APERO (Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure) trial, patients undergoing echocardiography-guided LAAC were randomly assigned to receive the Amulet (Abbott) or Watchman 2.5/FLX (Boston Scientific) device across 8 European centers. According to the study protocol ongoing at the time of the procedure, the first operators had (CCTA unblinded group) or did not have (CCTA blinded group) access to preprocedural CCTA images. In this post hoc analysis, we compared blinded vs unblinded procedures in terms of procedural success defined as complete left atrial appendage occlusion as evaluated at the end of LAAC (short-term) or at the 45-day follow-up (long-term) without procedural-related complications.Among 219 LAACs preceded by CCTA, 92 (42.1%) and 127 (57.9%) were assigned to the CCTA unblinded and blinded group, respectively. After adjusting for confounders, operator unblinding to preprocedural CCTA remained associated with a higher rate of short-term procedural success (93.5% vs 81.1%; P = 0.009; adjusted OR: 2.76; 95% CI: 1.05-7.29; P = 0.040) and long-term procedural success (83.7% vs 72.4%; P = 0.050; adjusted OR: 2.12; 95% CI: 1.03-4.35; P = 0.041).In a prospective multicenter cohort of clinically indicated echocardiography-guided LAACs, unblinding of the first operators to preprocedural CCTA images was independently associated with a higher rate of both short- and long-term procedural success. Further studies are needed to better evaluate the impact of preprocedural CCTA on clinical outcomes.

Impact of Preprocedural Computed Tomography on Left Atrial Appendage Closure Success: A Swiss-Apero Trial Subanalysis

BackgroundThe benefit related to the use of preprocedural computed tomography angiography (CCTA) on top of periprocedural echocardiography to plan percutaneous left atrial appendage closure (LAAC) procedures is still unclear. ObjectivesThe authors sought to evaluate the impact of preprocedural CCTA on LAAC procedural success. MethodsIn the investigator-initiated SWISS-APERO (Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure) trial, patients undergoing echocardiography-guided LAAC were randomly assigned to receive the Amulet (Abbott) or Watchman 2.5/FLX (Boston Scientific) device across 8 European centers. According to the study protocol ongoing at the time of the procedure, the first operators had (CCTA unblinded group) or did not have (CCTA blinded group) access to preprocedural CCTA images. In this post hoc analysis, we compared blinded vs unblinded procedures in terms of procedural success defined as complete left atrial appendage occlusion as evaluated at the end of LAAC (short-term) or at the 45-day follow-up (long-term) without procedural-related complications. ResultsAmong 219 LAACs preceded by CCTA, 92 (42.1%) and 127 (57.9%) were assigned to the CCTA unblinded and blinded group, respectively. After adjusting for confounders, operator unblinding to preprocedural CCTA remained associated with a higher rate of short-term procedural success (93.5% vs 81.1%; P = 0.009; adjusted OR: 2.76; 95% CI: 1.05-7.29; P = 0.040) and long-term procedural success (83.7% vs 72.4%; P = 0.050; adjusted OR: 2.12; 95% CI: 1.03-4.35; P = 0.041). ConclusionsIn a prospective multicenter cohort of clinically indicated echocardiography-guided LAACs, unblinding of the first operators to preprocedural CCTA images was independently associated with a higher rate of both short- and long-term procedural success. Further studies are needed to better evaluate the impact of preprocedural CCTA on clinical outcomes.

Amplatzer amulet versus watchman device for percutaneous left atrial appendage closure: a systematic review and meta-analysis

Abstract Funding Acknowledgements Type of funding sources: None. Background The Amplatzer Amulet and Watchman devices are the two most frequently used devices for percutaneous LAA closure globally. Aim To evaluate the safety and clinical outcomes associated with these two devices in patients undergoing percutaneous LAA closure. Method A systematic literature search was performed in PubMed, Scopus, Embase, and Cochrane databases for studies comparing the safety and outcomes of patients undergoing LAA closure using either Amulet or Watchman devices. The primary outcome was all-cause mortality. Secondary outcomes were incidence of ischemic stroke, systemic/pulmonary embolism, major bleeding, and procedure-related complications. Results A total of 3 randomized clinical trials with 2150 patients were included in this meta-analysis. The mean age was 75 years and 76 years in the Amplatzer group and in the Watchman group, respectively. The mean CHA2DS2-VASc score (4.2 vs. 4.34) and mean HAS-BLED score (3.46 vs. 3.56) were comparable between both groups. The odds of all-cause mortality (OR, 0.74 (95% CI: 0.48-1.13), p = 0.16), ischemic stroke (OR, 0.81 (95% CI: 0.27-2.49), p = 0.72), systemic/pulmonary embolism (OR, 1.33 (95% CI: 0.29-6.00), p = 0.71), and major bleeding (OR, 1.10 (95%CI: 0.82-1.48), p = 0.51) were comparable between the two devices. In contrast, procedure-related complications (OR, 2.11 (95%CI: 1.31-3.40), p = 0.002) were significantly higher among patients with Amplatzer Amulet compared to the Watchman device. Conclusion The Amplatzer Amulet was non-inferior to the Watchman device in terms of safety and efficacy. However, the Amulet occluder was associated with a higher incidence of procedure-related complications.

Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device

BackgroundThe left atrial appendage (LAA) sealing properties of the Amplatzer Amulet and Watchman FLX devices were compared using cardiac computed tomography (CT) follow-up.MethodsSingle-center cohort study of patients undergoing LAAO between 2017 and 2020. Two consecutive cohorts were enrolled, one treated with the Amplatzer Amulet (n = 150) up till 2019, and a second cohort treated with the Watchman FLX (n = 150) device from 2019. Cardiac CT was performed 2 months postprocedure. The primary outcome was complete LAA occlusion defined as no visible peri-device leak (PDL) and absence of contrast patency in the distal LAA. Secondary outcomes included PDL, contrast patency without visible PDL, PDL area, and periprocedural complications.ResultsComplete occlusion was achieved in 39 (30.5%) of the Amulet group, compared to 89 (71.8%) of the FLX group, p < 0.001. A PDL at the Amulet disc was present in 65 (50.8%), at the lobe in 16 (12.5%), and at both the disc and lobe in 13 (10.2%). For FLX, a PDL was present in 20 (16.1%). Contrast patency without visible PDL was observed in 24 (18.8%) and 15 (12.1%) of the Amulet and FLX group, respectively. The PDL area at the Amulet mid-lobe was 92 mm2 (59–158) and 32 mm2 (IQR 28–96) for FLX, p = 0.019. Device-related thrombosis occurred in 1 (0.7%) and 2 (1.3%), respectively (p = 0.99), with periprocedural adverse events occurring in 6 (4%) and 8 (5.3%) of the Amulet and FLX group (p = 0.79).ConclusionComplete LAA occlusion was achieved in a significantly higher proportion treated with the Watchman FLX compared to the Amulet device. PDL was smaller with the FLX than the Amulet. Conceptual device design differences make interpretation of results complex, and additional studies with clinical outcomes are needed.

Left atrial appendage occlusion should be offered only to select atrial fibrillation patients.

Left atrial appendage occlusion should be offered only to select atrial fibrillation patients.

Short term outcome after left atrial appendage occlusion with the AMPLATZER Amulet and WATCHMAN device: results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure)

BackgroundVarious randomized multicenter studies have shown that percutaneous left atrial appendage closure (LAAC) is not inferior in stroke prevention compared to vitamin K antagonists (VKA) and can be performed safely and effectively.AimsThe prospective multicenter ORIGINAL registry in the Free State of Saxony (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure) investigated the efficiency and safety of LAAC with Watchman or Amulet device in a real word setting. A special focus was put on the influence of LAAC frequency on periprocedural efficiency and safety.Methods and resultsThe total of 482 consecutive patients (Abbott Amulet N = 93 and Boston Scientific Watchman N = 389) were included in the periinterventional analyses. After 6 weeks, 353 patients completed the first follow-up including transoesophageal echocardiography (TEE) (73.2%). Successful LAAC could be performed in more than 94%. The complication rate does not significantly differ between device types (p = 0.92) according to Fischer test and comprised 2.2% in the Amulet and 2.3% in the Watchman group. The kind of device and the frequency of LAAC per study center had no influence on the success and complication rates. Device related thrombus could be revealed more frequently in the Watchman group (4.5%) than in the Amulet group (1.4%) but this difference is still not significant in Fisher test (p = 0.14). Same conclusion can be made about residual leakage 1.1% versus 0% [not significant in Fisher test (p = 0.26)]. Dual antiplatelet therapy followed the intervention in 64% and 22% of patients were discharged under a combination of an anticoagulant (VKA/DOAC/Heparin) and one antiplatelet agent.ConclusionsThe ORIGINAL registry supports the thesis from large, randomized trials that LAAC can be performed with a very high procedural success rate in the everyday clinical routine irrespective of the used LAA device (Watchman or Amulet). The postprocedural antithrombotic strategy differs widely among the participating centers.Trial registration Name of the registry: "saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure", Trial registration number: DRKS00023803; Date of registration: 15/12/2020 'Retrospectively registered'; URL of trial registry record: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023803.

Advances in Neurocardiology: Focus on Atrial Fibrillation.

Advances in Neurocardiology: Focus on Atrial Fibrillation.

Feasibility of preprocedural LAA occluder sizing

Abstract Background Implantation of occluders in the left atrial appendage (LAA) has been established to prevent patients with atrial fibrillation (AF) from stroke and embolisation. Currently, the individual occluder sizing will be done intraprocedurally using fluoroscopy and/or transesophageal echo (TEE) imaging. Purpose Development of a new approach allowing preprocedural occluder sizing and its validation by conventional intraprocedural methods. Methods The CARTO electro-anatomical mapping system was used in 62 consecutive patients (40 m, 22 f, age: 69.8±8.4 years) to preprocedurally predict the size of Watchman (n=34) or Amplatzer Amulet (n=28) devices. During device implantation, 23 of the patients (37.1%) were in AF. LAA morphologies were Chicken Wing (40.0%), Cauliflower (31.7%), Windsock (20.0%) and Cactus (8.3%). CHA2DS2-VASc Score was 3.7±1.9 and HAS-BLED-Score was 3.6±1.3. Preprocedurally, routine cardiac CT scans were imported into the CARTO segmentation tool for segmentation of the left atrium. The resulting volume images (VI) and slice images (SI) were adjusted in their 3-dimensional orientation to fit the manufacturer's sizing recommendations. Subsequently, the match between pre- and intraprocedural sizing was compared with the actually implanted device size. Results In the Watchman group, preprocedural VI corresponded with 38.1% (8/21) and SI with 42.3% (11/26), while intraprocedural fluoroscopy corresponded with 29.6% (8/27) and TEE with 40.0% (12/30) of all actually implanted devices. According to clinical routine an aberration of one size is common practice. After including one additional size to the estimation, VI corresponded with 81.0% (17/21), SI with 84.6% (22/26), while fluoroscopy corresponded with 85.2% (23/27) and TEE with 80.0% (24/30) of all actually implanted occluders. In the Amplatzer Amulet group, VI corresponded with 37.0% (10/27), SI with 57.1% (16/28) and fluoroscopy with 71.4% (20/28) of all actually implanted devices. After including one additional size to the estimation, VI corresponded with 66.7% (18/27), SI with 85.7% (24/28) and fluoroscopy with 100% (28/28) of all actually implanted occluders. The remaining were selected empirically. Conclusion In this study cohort of 62 patients, feasibility of a preprocedural sizing using the CARTO segmentation tool was demonstrated for Watchman occluders providing results comparable with conventional intraprocedural fluoroscopy and/or TEE based intraprocedural sizing. Possibly due to the different manufacturer measuring recommendation, 10 to 12 mm away from the LAA ostium, results for the Amplatzer Amulet system were found to be less accurate. Nevertheless, the proposed approach offers the advantage of preoperative visualisation of the individual LAA anatomy and morphology. Funding Acknowledgement Type of funding sources: None.

One year outcome and analysis of peri-device leak of left atrial appendage occlusion devices

Abstract Background The prevalence of peri-device leak (PDL) of left atrial appendage occlusion (LAAO) devices has been previously reported. However, there have been only few data that compared different existing devices. The aim of this study was to assess the incidence of PDL with both devices WATCHMAN® and AMPLAZER Amulet®, and to evaluate the clinical outcome at 12 months. Methods Consecutive patients who underwent LAAO between January 2018 and 2020 were randomly assigned to either WATCHMAN or AMPLATZER Amulet implantation based on a systematic two-week alternation between both devices. LAA measurements were assessed using cardiac computed tomography angiography (CCTA) prior to, and transesophageal echocardiography (TEE) during the procedure. At 8 weeks post-LAAO, patients underwent TEE and/or CCTA to identify the presence of PDL and/or device-related complications. Patients were then followed for 12 months to identify major adverse cardiovascular/embolic events. Results The cohort consisted of 51 patients (25 WATCHMAN, 26 AMPLATZER Amulet; mean age 76±7 years; male gender 76%). Both groups were identically matched for demographics, comorbidities and indication for LAAO. There were 19 patients who had PDL (13 WATCHMAN vs 6 AMPLATZER Amulet, P-value=0.033). Of them, 8 (15%) patients had significant PDL (7 WATCHMAN vs. 1 AMPLATZER Amulet, P-value=0.018). On CCTA, the landing zone maximal diameter of the AMPLATZER Amulet device had the strongest correlation with the final deployed device size (Spearman'rho 0.92, P-value&amp;lt;0.0001). In the multivariate analysis, male gender and device type were independent predictors of any PDL (P-values 0.016 and 0.031, respectively). On a mean follow-up of 12 months, the total number of events was more prevalent in the WATCHMAN group (P-value 0.008), but the incidence of cardio-embolic events reached borderline significance (16% vs. 0%, P-value=0.051). Conclusions Among patients who underwent LAAO, almost 15% had significant PDL with the majority belonging to the WATCHMAN group. Still, larger studies are warranted to evaluate its effectiveness in stroke prevention. Funding Acknowledgement Type of funding sources: None. Table 1Table 2

One year outcome and analysis of peri-device leak of left atrial appendage occlusion devices.

The prevalence of peri-device leak (PDL) of left atrial appendage occlusion (LAAO) devices has been previously reported. However, there have been only few data that compared different existing devices. The aim of this study was to assess the incidence of PDL with both devices WATCHMAN®, Boston Scientific and AMPLATZER Amulet®, Abbott Laboratories and to evaluate the clinical outcome at 12months. Consecutive patients who underwent LAAO between January 2018 and 2020 were randomly assigned to either WATCHMAN or AMPLATZER Amulet implantation based on a systematic 2-week alternation between both devices. LAA measurements were assessed using cardiac computed tomography angiography (CCTA) prior to and transesophageal echocardiography (TEE) during the procedure. At 8weeks post-LAAO, patients underwent TEE and/or CCTA to identify the presence of PDL and/or device-related complications. Patients were then followed for 12months to identify major adverse cardiovascular/embolic events. The cohort consisted of 51 patients (25 WATCHMAN, 26 AMPLATZER Amulet; mean age 76 ± 7years; male gender 76%). Both groups were identically matched for demographics, comorbidities, and indication for LAAO. There were 19 patients who had PDL (13 WATCHMAN vs. 6 AMPLATZER Amulet, P-value = 0.033). Of them, 8 (15%) patients had significant PDL (7 WATCHMAN vs. 1 AMPLATZER Amulet, P-value = 0.018). On CCTA, the landing zone maximal diameter of the AMPLATZER Amulet device had the strongest correlation with the final deployed device size (Spearman's rho 0.92, P-value < 0.0001). In the multivariate analysis, male gender and device type were independent predictors of any PDL (P-values 0.016 and 0.031, respectively). On a mean follow-up of 12months, the total number of events was more prevalent in the WATCHMAN group (P-value 0.008), but the incidence of cardio-embolic events reached borderline significance (16% vs. 0%, P-value = 0.051). Among patients who underwent LAAO, almost 15% had significant PDL with the majority belonging to the WATCHMAN group. Still, larger studies are warranted to evaluate its effectiveness in stroke prevention.

Clinical Outcomes Associated With LeftAtrial Appendage Occlusion VersusDirect Oral Anticoagulation in Atrial Fibrillation.

This study sought to investigate clinical outcomes associated with left atrial appendage occlusion (LAAO) versus direct oral anticoagulants (DOACs) in patients with high-risk atrial fibrillation (AF). LAAO has been shown to be noninferior to warfarin for stroke prevention in AF. However, anticoagulation with DOACs is now preferred over warfarin as thromboprophylaxis in AF. Patients with AF enrolled in the Amulet Observational Registry (n=1,088) who had successful LAAO with the Amplatzer Amulet device (n=1,078) were compared with a propensity score-matched control cohort of incident AF patients (n=1,184) treated by DOACs identified from Danish national patient registries. Propensity score matching was based on the covariates of the CHA2DS2-VASc (congestive heart failure, hypertension, age≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category) and HAS-BLED (hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores for predicting stroke and bleeding. The primary outcome was a composite of ischemic stroke, major bleeding (Bleeding Academic Research Consortium≥3), or all-cause mortality, and follow-up was 2 years. AF patients treated with LAAO had a significantly lower risk of the primary composite outcome as compared with patients treated with DOACs (hazard ratio [HR]: 0.57; 95% confidence interval [CI]: 0.49 to 0.67). Total events and event rates per 100 patient-years were (LAAO vs. DOACs) 256 vs. 461 and 14.5 vs. 25.7, respectively. The risk of ischemic stroke was comparable between groups (HR: 1.11; 95%CI: 0.71 to 1.75), while risk of major bleeding (HR: 0.62; 95%CI: 0.49 to 0.79) and all-cause mortality (HR: 0.53; 95%CI: 0.43 to 0.64) were significantly lower in patients treated with LAAO. Among high-risk AF patients, LAAO in comparison with DOACs may have similar stroke prevention efficacy but lower risk of major bleeding and mortality.

Abstract 16527: Peri-Procedural and 45-Day Outcomes in the Roll-In Cohort of the Amplatzer Amulet Ide Trial of Left Atrial Appendage Occlusion

Background: The Amulet IDE trial is an ongoing, randomized, worldwide trial, enrolled but following patients with non-valvular atrial fibrillation (AF) at high risk of stroke. The study is comparing the safety and effectiveness of the Amplatzer™ Amulet™ left atrial appendage (LAA) Occluder to the Watchman device. At US sites, the implanting physicians only had experience with the Watchman device; therefore, up to three roll-in subjects with Amplatzer Amulet device implantation were permitted prior to randomization. The purpose of this analysis is to describe the peri-procedural outcomes for the roll-in cohort. Methods: Roll-in subjects met the same eligibility criteria and have the same data collection requirements as randomized subjects. Adverse events were adjudicated by an independent clinical events committee and LAA occlusion was assessed by an independent core laboratory based on the 45-day TEE. Major adverse events included all cause death, ischemic stroke, systemic embolism or device-/procedure-related events requiring open cardiac surgery or major endovascular intervention within 7 days post implant or hospital discharge, whichever is later. Results: From August 2016 to November 2018, 201 patients with non-valvular AF at high risk of stroke and bleeding were enrolled at 82 sites as roll-in subjects. Mean age was 74.2 ± 7.5 years and 62% of subjects were male. The Amplatzer Amulet device was successfully deployed in 99% of subjects. Major adverse events within 7 days or hospital discharge occurred in 2.5% of patients and included death (n=3), ischemic stroke (n=1) and vascular access site bleeding (n=1). The majority (79%) of patients were discharged on antiplatelet therapy only or no anti-thrombotic medication. TEE follow-up at the 45-day visit revealed adequate (≤ 5 mm jet) occlusion of the appendage in 98.9% (178/180) of patients. Device-related thrombus (DRT) was identified by the core laboratory in 6 patients (3%); no patient experienced a thrombo-embolic event. Conclusions: In the roll-in cohort, with implanting physicians having no prior experience using the Amplatzer™ Amulet™ device, there was a low rate of procedural complications and high rates of both implant success and adequate LAA sealing at follow up.

Midterm outcomes of LAA occlusion with the AMPLATZER Cardiac Plug and AMPLATZER Amulet devices in a high-risk cohort

LAA occlusion has become a favourable option in patients with atrial fibrillation not eligible for oral anticoagulation therapy. Proof of effectiveness of LAA closure devices in a midterm follow-up period. This retrospective single-center cohort study analysed outcome in patients treated with AMPLATZER Cardiac Plug or AMPLATZER Amulet device. A standardized follow-up by phone call focusing on data of death, stroke and bleeding events was performed. Routine antiplatelet strategy was DAPT for 3 months post procedural. 212 patients (mean age 77 ± 6 years) were included. Follow up was performed in 197 (93%) patients. Patients were at high risk for thromboembolic or bleeding events (prior stroke/TIA 29%; prior bleeding 54%. Overall, there was a mean follow-up period of 1244.2 days (± 756.7) and a total of 674 patient years. We observed 25 events later than day 8 post procedure. We were able to demonstrate a high effectiveness of the AMPLATZER Cardiac Plug/AMPLATZER Amulet devices regarding the prevention of stroke and bleedings in a high-risk real-world cohort during a midterm follow-up period. Overall, we observed remarkably lower rates of stroke and bleedings as predicted with CHA2DS2–VASc and HASBLED scores.

Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study

BackgroundOptimal preprocedural planning is essential to ensure successful device closure of the left atrial appendage (LAA).DesignThe PREDICT-LAA study is a prospective, international, multicentre, randomised controlled trial (ClinicalTrials.gov NCT04180605). Two hundred...

Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study

To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer™ Amulet™ occluder. Patients with atrial fibrillation eligible for LAAO were recruited to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transoesophageal echocardiography (TOE) was undertaken 1-3 months post-LAAO. Implant and follow-up TOEs were evaluated by a CoreLab. The primary endpoint was a composite of ischaemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. A total of 1088 patients were enrolled, aged 75.2 ± 8.5 years; 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone. Peridevice flow was <3 mm in 98.4% at follow-up TOE. Device-related thrombus (DRT) was seen in 1.6% of cases. Cardiovascular death or ischaemic stroke occurred in 8.7% of patients at 2 years. The ischaemic stroke rate was 2.2%/year-a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥ 3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2). Following LAAO with the Amplatzer Amulet device, the ischaemic stroke rate was reduced by 67% compared to the predicted risk. Closure was complete in 98.4% of cases and DRT seen in only 1.6%.

284Outcomes after left atrial appendage occlusion with AMPLATZER Amulet and WATCHMAN device: Results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure)

Abstract Aims Left atrial appendage occlusion (LAAO) is a therapeutic option for patients with non-valvular atrial fibrillation (NVAF) and high risk of bleeding. This study reports outcomes of patients enrolled in the prospective multicentre, investigator initiated real life registry in the Free State of Saxony (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure). Methods and results Data of all consecutive 521 patients (64.7% adult males, 35.3% adult females, mean age: 75.1 (SD 7.9) years with non-valvular atrial fibrillation undergoing interventional left atrial appendage occlusion procedure in the ORIGINAL prospective registry were analysed. The CHA2DS2-VASc and HAS-BLED scores were 4.3 (SD 1.5) and 3.7 (SD 1.1), respectively. 78.9% of the patients had a history of bleeding. 89.3% of the patients were considered as non-eligible for long term oral anticoagulation. A left atrial appendage occlusion device was successfully implanted in 97.5% of cases. A mean follow-up of 463 days could be reached in 386 patients. Among these, the distribution of the follow-up length reached was as follows: 1 year 205, 2 years 118, 3 years 65 and 4 years 17 patients. In the follow-up the annual frequency of stroke was very low (0.4%), which resulted in the 4.98% absolute risk reduction in the amount of thromboembolic strokes, which would have been expected according to the calculated CHA2DS2-VASc score in the hypothetic group not receiving any anticoagulant therapy. The occurrence of major and minor bleeding in the follow-up was 1.55% and 3.37% respectively. Conclusions In this prospective multicentre study we included the patients who are at high risk of stroke and bleeding. The annual ischemic stroke rate was 0.4%, the LAA could be sealed in 97.5%. Six months after the LAA closure only 3.63% of all patients were further on treated using oral anticoagulation. Considering the stroke reduction rates, the implantation of an LAAO device proves to be effective and safe in the clinical routine in the studied population. Acknowledgement/Funding None