Left Atrial Appendage Closure Research Articles

Clinical Effectiveness and Safety Comparison between Reduced Rivaroxaban Dose and Dual Antiplatelet Therapy for Nonvalvular Atrial Fibrillation Patients Following Percutaneous Left Atrial Appendage Closure: A Prospective Observational Study

Clinical Effectiveness and Safety Comparison between Reduced Rivaroxaban Dose and Dual Antiplatelet Therapy for Nonvalvular Atrial Fibrillation Patients Following Percutaneous Left Atrial Appendage Closure: A Prospective Observational Study

Antithrombotic Regimen After Percutaneous Left Atrial Appendage Closure - A Real-World Study.

Antithrombotic therapy after left atrial appendage closure (LAAC) in patients at high risk of bleeding remains controversial. We present real-world clinical outcomes of LAAC.Methods and Results: Data from 74 consecutive patients who received LAAC therapy between January 2020 and June 2022 were analyzed. Patients received 1 of 3 antithrombotic therapies according to the bleeding risk category or clinical event. Regimen 1 was based on a prior study, regimen 2 comprised a lower antiplatelet drug dose without dual antiplatelet therapy, and regimen 3 was antiplatelet drug administration for as long as possible to patients with uncontrollable bleeding who were required to stop anticoagulant drugs. Overall, 73 (98.6%) procedures were successful. Of them, 16 (21.9%) patients were selected for regimen 1, 46 (63.0%) for regimen 2, and 11 (15.1%) for regimen 3. Device-related thrombosis (13% vs. 0% vs. 0%, P=0.0257) only occurred with regimen 1. There was no difference in major bleeding event rates (6% vs. 2% vs. 9%, P=0.53). The post-LAAC antithrombotic regimen was modified without major concerns.

Body Surface Radiation Exposure in Interventional Echocardiographers during Left Atrial Appendage Closure: Monte Carlo Simulation

Body Surface Radiation Exposure in Interventional Echocardiographers during Left Atrial Appendage Closure: Monte Carlo Simulation

Pacing for better visualization of the left atrial appendage prior to transcatheter left atrial appendage closure.

Pacing for better visualization of the left atrial appendage prior to transcatheter left atrial appendage closure.

Rationale and design of a randomized clinical trial evaluating the efficacy of mechanical neuroprotection in reducing the risk of silent brain infarcts associated with percutaneous left atrial appendage closure: study protocol for a LAAC-SBI trial

BackgroundLeft atrial appendage closure (LAAC) procedures prevent cardioembolic stroke in patients with atrial fibrillation who have contraindications to oral anticoagulant medications. However, these procedures carry certain risks of peri-procedural complications. One such complication is silent brain infarcts (SBI), which can lead to cognitive impairment and mood disturbances. The implementation of mechanical neuroprotection systems during LAAC procedures may reduce the risk of SBI and associated cognitive and mood disorders.MethodsThe LAAC-SBI trial is a prospective, multicenter, randomized, and double-blind interventional study. The study aims to enroll a total of 240 patients, with 120 patients allocated to each group. The study group will evaluate the use of the Sentinel CPS during LAAC, while the control group will undergo LAAC procedures without the Sentinel CPS. The primary endpoint of the study is the number of new SBIs or stroke foci detected by diffusion-weighted magnetic resonance imaging (DW MRI). Secondary endpoints include deterioration of cognitive function, development of dementia syndrome, and occurrence of depressive disorders. These endpoints will be assessed using questionnaire tools such as the Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT), Controlled Oral Word Association Test (COWAT), and Hospital Anxiety and Depression Scale (HADS). The observational period for patients in the study is 2 years.DiscussionIf the study demonstrates a favorable outcome with reduced incidence of SBI and improved cognitive and mood outcomes in patients receiving cerebral protection devices during LAAC, it will have significant implications for clinical management standards. This would support the use of neuroprotection devices not only for LAAC but also in procedures such as atrial fibrillation ablation or transcatheter mitral valve interventions, where the risk of embolic events and subsequent brain injury may also be present.Trial registrationClinicalTrials.gov NCT05369195. Registration on 11.05.2022.

Severity of Ischemic Stroke After Left Atrial Appendage Closure vs Nonwarfarin Oral Anticoagulants

BackgroundStrokes after left atrial appendage closure (LAAC) prophylaxis are generally less severe than those after warfarin prophylaxis—thought to be secondary to more hemorrhagic strokes with warfarin. Hemorrhagic strokes are similarly infrequent with direct oral anticoagulant (DOAC) prophylaxis, so the primary subtype after either LAAC or DOAC prophylaxis is ischemic stroke (IS). ObjectivesThe purpose of this study was to compare the severity of IS using the modified Rankin Scale in atrial fibrillation patients receiving prophylaxis with DOACs vs LAAC. MethodsA retrospective analysis was performed of consecutive patients undergoing LAAC at 8 centers who developed an IS (ISLAAC) compared with contemporaneous consecutive patients who developed IS during treatment with DOACs (ISDOAC). The primary outcome was disabling/fatal stroke (modified Rankin Scale 3-5) at discharge and 3 months later. ResultsCompared with ISDOAC patients (n = 322), ISLAAC patients (n = 125) were older (age 77.2 ± 13.4 years vs 73.1 ± 11.9 years; P = 0.002), with higher HAS-BLED scores (3.0 vs 2.0; P = 0.004) and more frequent prior bleeding events (54.4% vs 23.6%; P < 0.001), but similar CHA2DS2-VASc scores (5.0 vs 5.0; P = 0.28). Strokes were less frequently disabling/fatal with ISLAAC than ISDOAC at both hospital discharge (38.3% vs 70.3%; P < 0.001) and 3 months later (33.3% vs 56.2%; P < 0.001). Differences in stroke severity persisted after propensity score matching. By multivariate regression analysis, ISLAAC was independently associated with fewer disabling/fatal strokes at discharge (OR: 0.22; 95% CI: 0.13-0.39; P < 0.001) and 3 months (OR: 0.25; 95% CI: 0.12-0.50; P < 0.001), and fewer deaths at 3 months (OR: 0.28; 95% CI: 0.12-0.64; P < 0.001). ConclusionsIschemic strokes in patients with atrial fibrillation are less often disabling or fatal with LAAC than DOAC prophylaxis.

Left atrial appendage closure for stroke prevention in atrial fibrillation patients: A promise that came true.

Anticoagulation therapy plays a crucial role in the management of atrial fibrillation (AF), considering the high morbidity and mortality of AF-related ischemic strokes. With the plausible hypothesis that left atrial appendage is the main source of thrombus in AF patients, left atrial appendage closure (LAAC) has been regarded as a potential substitute to oral anticoagulation in order to meet the unmet needs for stroke prevention, particularly in patients with high bleeding risk. Notable advancements in safety, efficacy, and device innovation have been made in recent years, albeit concerns still remain regarding the insufficient efficacy data, device-related complications, and the need for procedural optimization. We aim to review current knowledge about LAAC and provide potential future directions for the remaining key issues.

LARIAT or AtriClip: Complications Profile and Comparison in Patients with Atrial Fibrillations Based on Manufacturer and User Facility Device Experience Database.

Background and Objectives: Left atrial appendage closure is an alternative treatment to reduce thromboembolism in patients with atrial fibrillation in whom oral anticoagulation (OAC) is contraindicated. The aim of this study was to evaluate the complications profiles of the LARIAT and AtriClip devices and perform a comparison between them based on the MAUDE (Manufacturer and User Facility Device Experience) database. Materials and Methods: The Manufacturer and User Facility Device Experience database was searched on 15 January 2023. For AtriClip, only reports regarding isolated procedures or procedures associated with minimally invasive ablation were included. Adverse effects and causes of death were defined based on the literature on the topic and the causes described in the reports. In total, 63 patients were included in the LARIAT group and 53 patients were included in the AtriClip group. Results: With the LARIAT device, the most common complication without device problems was pericardial effusion (n = 18, 52.9%), whereas this complication was not observed with AtriClip (p < 0.001). Postoperative bleeding was a second complication that occurred significantly more often in the LARIAT group-in 15 (44.1%) cases versus 1 (2.7%) case with AtriClip (p < 0.001). In addition, significant differences were found in the prevalence of stroke (LARIAT n = 0 vs. AtriClip n = 7, 18.9%, p = 0.012) and thrombus (LARIAT n = 2, 5.9% vs. n = 11, 29.7%, p = 0.013). Conclusions: Each type of left atrial appendage closure procedure is associated with device-specific requirements and complications that, if known, can be avoided.

Morphometrical features of left atrial appendage in the atrial fibrillation patients subjected to left atrial appendage closure.

This study aimed to evaluate the morphometrical features of left atrial appendage (LAA) in patients with atrial fibrillation, subjected to LAA percutaneous closure (LARIAT) for stroke prevention. Computed tomography (CT) scans of 51 patients with atrial fibrillation subjected to LARIAT procedure were comparatively evaluated with 50 patients with sinus rhythm (control group). Three-dimensional reconstructions were created using volume-rendering for evaluation. No differences were found in LAA types of distribution (cauliflower: 25.5 vs. 34.0%, chicken wing: 45.1 vs. 46.0%, arrowhead: 29.4 vs. 20.0%, all p > 0.05) between groups. However, the study group was characterized by LAAs with a lower number of lobes. The LAA orifice anteroposterior and transverse diameters (19.3 ± 4.12 vs. 17.2 ± 4.0 mm, p = 0.01 and 25.1 ± 5.1 vs. 20.5 ± ± 4.4 mm, p = 0.001), orifice area (387.2 ± 133.9 vs. 327.1 ± 128.3 mm2, p = 0.02) and orifice perimeter (70.2 ± 12.5 vs. 61.2 ± 11.6 mm, p = 0.04) was significantly larger in atrial fibrillation patients. More oval LAA orifices was found in atrial fibrillation group (94.0 vs. 70.4%, p = 0.001). No statistically significant differences were found in LAA body length (47.4 ± 15.4 vs. 43.7 ± 10.9 mm, p = 0.17), body width (24.7 ± 5.6 vs. 24.4 ± 5.8 mm, p = 0.81), and chamber depth (17.7 ± 3.5 vs. 16.5 ± 3.8 mm, p = 0.11). Calculated LAA ejection fraction was significantly lower in study group compared to healthy patients (16.4 ± 14.9 vs. 48.2 ± 12.9%, p = 0.001). Important morphometrical differences in LAA orifice have been found, which was significantly larger and more oval in patients with atrial fibrillation compared to healthy controls. Although no difference in LAA body type and size was observed; the LAA ejection fraction was significantly lower in atrial fibrillation rhythm patients.

Peri-device leak after left atrial appendage closure: echocardiographic characteristics and thromboembolism risk

Abstract Background Structural variations in left atrial appendage (LAA) ostial morphology can contribute to incomplete closure of the LAA and peri-device leak (PDL) after LAA closure (LAAC). Prior data suggests that there is an increased residual risk of thromboembolism in patients with PDL after LAAC. However, there is a paucity of information on the interpretation of imaging data to risk stratify patients with PDL. Purpose We evaluated echocardiographic characteristics on post-LAAC imaging, and their association with residual risk of thromboembolism. Methods We analyzed data from follow up imaging with transesophageal echocardiograms (TEEs) which were performed at ∼1-year follow up after the LAAC with either the Watchman or Watchman-FLX device (Boston Scientific Inc). The images were reviewed in a blinded manner with regard to thromboembolic events after LAAC. In our analyses, we further classified the TEE images into 3 categories: 1) no leak, and completely thrombosed distal LAA, 2) no leak, but echolucent distal LAA (indicative of some residual, but undetectable, connection), or 3) presence of leak and echolucent distal LAA (Figure 1). Results A total of 650 patients underwent LAAC at our center between 3/2015 and 12/2021: age 75.8±8.9 years, 64% male, and CHA2DS2-Vasc 4.2±1.4. TEE imaging data (performed at 1-year or later after LAAC) was available for review in 460 patients. In 238 of 460 patients (51.7%) there was no leak and the LAA was completely thrombosed (Cohort 1). In 83 of 460 (18%) patients there no detectable leak but the LAA was echolucent (Cohort 2), and in 139 of 460 (30.2%) patients there was a discernible leak and the LAA was echolucent (Cohort 3). In this subset of 460 patients, there were 29 (3.2% per year) thromboembolic events (stroke or transient ischemic attack) over 2.0±0.2 years of follow-up; of these, only 3 (0.6% per year) strokes were disabling, and none were fatal. The median NIH stroke scale in patients with stroke/TIA was 2 (range 0-14; NIHSS &amp;lt; 5 is considered mild to moderate severity). During follow-up (2.0±0.2 years), the incidence of thromboembolism was highest in Cohort 3 (7.5% per year) in comparison to Cohort 2 (3.1% per year) and Cohort 1 (0.84% per year) (Figure 2). Upon analysis with 2 separate multivariable models, the risk of thromboembolism was highest in Cohort 3 vs Cohort 1 (adjusted OR 10.0, 95% CI: 3.3-30.0; p &amp;lt; 0.001) after adjusting for age, gender, CHA2DS2-VASc and LVEF. In contrast, when comparing Cohort 2 vs Cohort 1 in a multivariable model, the difference in thromboembolic risk was an adjusted OR 3.4 (95% CI: 0. 9-13.1; p = 0.07). Conclusions The presence of PDL after LAAC is not uncommon and confers a significant residual thromboembolic risk in patients with AF. TEE imaging characteristics aid in risk stratification of patients with PDL, and may help guide management decisions such as leak closure or resumption/continuation of anticoagulation to mitigate stroke risk.Figure 1:Classification based on reviewFigure 2:Comparison of incidence of th

Three-dimensional printer guided new morphological classification of left atrial appendage -rock, paper and scissors-

Abstract Background Cardiogenic embolism by left atrial thrombi is one of the most important atrial fibrillation (AF)-related clinical problems. In a previous survey, 91% of nonrheumatic AF-related left atrial thrombi was originated in the left atrial appendage (LAA). The WATCHMAN device was developed as a permanent implantable device to seal off the LAA to prevent cardiogenic embolism. It has been used in Japan since September 2019 only for patients who are at the high risk of bleeding events. The WATCHMAN family is the only left atrial appendage closure (LAAC) device in JAPAN. It is known that the LAA diameter of Asians is larger than that of non-Asians. Furthermore, the LAA of the Japanese are more complicated, compared to the Western. Whereas the four classifications from previous reports are widely used in the world, the classification differs with different physicians in the real-world practice. Purpose We aimed to identify the relationship between morphological features of LAA and clinical events such as ischemic stroke in Japanese patients. Methods The LAAC database of our institution was respectively analyzed. All LAAC cases were performed between February 2020 and February 2022. The three-dimensional printing of LAA was generated from cardiovascular computed tomography imaging data. The shapes of the LAA were classified into 3 morphological types: (1) The LAA with bi lobe was defined as "Scissors" type; (2) The one with complicated erasing branches was "Paper" type; (3) The simple one was "Rock" type. We retrospectively examined the relationship between the risk of ischemic stroke and the morphological features of the LAA. Results The cohort consisted of 63 consecutive patients (age, 73±8 years; male gender, 73%; BMI, 24±4 kg/m²; the size of WATCHMAN device, 29±42 mm). Of those, 14 (22%), 21 (33%) and 28 (44%) patients were divided into the Scissors, Paper and Rock types, respectively. All groups were identically matched for comorbidities. Table shows the patient characteristics and the results of univariate and multivariate analysis. There were 35 (56%) patients who had a history of ischemic stroke (4 vs. 9 vs. 22; Rock vs. Scissors vs. Paper types, p-value=0.01). In the multivariate analysis, the Paper type is the potential risk factor of ischemic stroke (p-value&amp;lt;0.01, respectively). Conclusions The morphological features of LAA by three-dimensional printing may be related to cardioembolic stroke. Patients with Paper type LAA were significantly more likely to have had a history of ischemic stroke. These results could have a relevant impact on the antithrombotic management of patients who are at the high risk of embolic and bleeding events and, moreover, LAAC could be the best option for these patients.Table 1Table 2

Safety and healthcare resource utilisation in patients undergoing left-atrial appendage closure - A nationwide analysis

Abstract Background Percutaneous left-atrial appendage closure (LAAC) has emerged as a non-pharmacological alternative for stroke prevention in patients with atrial fibrillation (AF) not suitable for anticoagulation therapy. Real-world data on peri-procedural outcomes are limited. Purpose To analyse outcomes of peri-procedural in-hospital safety and healthcare resource utilisation after percutaneous LAAC. Methods The US National Inpatient Sample was utilised to identify AF patients undergoing LAAC from 2016 to 2019. Primary outcomes (safety) were in-hospital stroke or systemic embolism (SE), pericardial effusion (PE), major bleeding, device embolisation and mortality. Secondary outcomes (resource utilisation) were adverse discharge disposition, hospital length of stay (LOS) and treatment costs. Logistic and Poisson regression models were used to analye outcomes by adjusting for 10 confounders. Results 11,240 adult patients (with 41.9% being female) with AF undergoing LAAC were included. SE decreased by 97% between 2016 and 2019 [95% Confidence Interval (CI) 0-0.24] (P=0.003), while a trend to lower numbers of other peri-procedural complications was determined. In-hospital mortality remained stable (0.14%). Hospital LOS decreased by 18% (0.78-0.87, P&amp;lt;0.001) and adverse discharge rate by 41% (95% CI 0.41-0.86, P=0.005) between 2016 and 2019, while hospital costs did not significantly change (P=0.2). Of note, female patients had a higher risk of PE (OR 2.86 [95% CI 2.41-6.39]) and SE (OR 5.0 [95% CI 1.28-43.6]), while patients with multiple comorbidities had higher risks of major bleeding (P&amp;lt;0.001), mortality (P=0.031), longer hospital LOS (P&amp;lt;0.001) and increased treatment costs (P=0.073). Male patients had the most peculiar decrease in adverse discharge rate between 2016 and 2019: OR 0.45 [95% CI 0.27-0.77]. Significant differences in all outcomes were observed between male and female patients across US regions (Figure). Subgroup analyses confirmed that female patients had a prolonged LOS and higher risk of adverse discharge disposition than male patients. Conclusions LAAC has become a safer and more efficient procedure. Significant sex differences existed across US regions. Careful considerations should be taken when performing LAAC in female and comorbid patients.

Pulmonary vein isolation durability after very high-power short-duration ablation utilizing a very-close protocol

Abstract Background Very high-power short-duration (vHP-SD) radiofrequency (RF) ablation of atrial fibrillation (AF) treatment by pulmonary vein isolation (PVI) aims for safer, more effective and faster procedures. The lesion formation of vHP-SD ablation creates wider but shallower lesions. Utilizing an individualized "very close-protocol" of 3-4mm inter-lesion distance (ILD) at the anterior and 5-6mm at the posterior aspect of the left atrium using vHP-SD only the close-protocol was adapted. Although acute efficacy for PVI was recently shown no data on chronic PVI durability has been assessed up to date. Here chronic PVI durability was evaluated during repeat electrophysiological procedures in patients after initial vHP-SD based PVI and recurrence of AF, atrial tachycardia or left atrial appendage closure. Methods and Results A total of 25 consecutive patients with repeat left atrial procedures after initial vHP-SD based PVI were included in this study. The median time to the repeat procedure was 5 (IQR 2, 10) months. The patients received a repeat procedure and verification of PVI due to recurrence of AF (n=8), atrial tachycardia (n=12), typical flutter (n=1) or left atrial appendage closure (n=4). During repeat procedures 3D electroanatomical mapping of the left atrium was conducted. Verified PVI durability of all PVs was found in 16/25 (64%) patients. In 1/25 (4%) patient PVI reconduction was found in 1 PV, in 6/25 (24%) patients PVI reconduction was found in 2 PVs and in 1/25 (4%) patient PVI reconduction was found in 3 PVs. A total of 81/100 PVs (81%) were found to be chronically isolated. For right sided PVs 42/50 PVs (84%) were isolated while for left sided PVs 39/50 PVs (78%) were isolated. All PVs were reisolated utilizing radiofrequency energy. Conclusions PVI solely utilizing vHP-SD via a very close-protocol provides high rates of chronically isolated pulmonary veins.

The predictive value of compression rate on residual leak after left atrial appendage occlusion with watchman FLX

Abstract Background Incomplete left atrial appendage (LAA) occlusion due to residual leaks may occur after percutaneous closure procedure with Watchman FLX. Before release of device PASS (position, anchor, size and seal) criteria must be verified. Optimal compression rate for watchman FLX device is between 10-30% according to company recommendations. Purpose The aim of this study is to evaluate the correlation between compression rate and leak presence after left atrial appendage closure. Methods This is an observational retrospective study including patients that underwent LAA closure under transesophageal echocardiography (TEE) with at least one follow-up where complete LAA closure was assessed by TEE in our center between January 2021 and August 2022. TEE images were reviewed by the first author. Compression rate was calculated based on intraprocedural TEE images using the following formula: (original device size—size after deployment)/original device size*100. Patients were divided into 2 groups based on the compression rate: group 1: 10-30%; group 2: &amp;gt;30%. The rate of leak between groups was compared using the Chi-square test. Results 203 patients (mean age 79± 8 years) were included in the study. The implanted device size was 20 mm in 7 (3.4%), 24 mm in 30 (14.8%), 27 mm in 49 (24.1%), 31 mm in 75 (36.9%) and 35 mm in 42 (20.7%) patients. Based on the compression rate, patients were classified into group 1: &amp;gt;30% [n=37 (18.2%)] and group 2: ≤30% [n=166 (81.8%)]. Mean compression rate was 38.5% and 21.3% in group 1 and 2 respectively. At follow-up TEE, 1 (2.7%) patient in group 1 and 32 (19.3%) patients in group 2 were found to have a residual leak of &amp;gt;1 mm. When comparing leaks between the two groups, there was 1 leak in group 1 whereas in group 2 there were 32 leaks (1/37 vs 32/166, p value 0.01, RR 0.14, 95% CI, 0.02-0.74). Conclusion Devices with compression rate ≤30% were associated with significantly higher risk of residual leak.

GLP1 receptor agonists exhibit antioxidant and anti-inflammatory properties in human heart tissue via the canonical GLP1 receptor expression through a AMPK-mediated pathway

Abstract Background Clinical research has demonstrated that glucagon-like peptide-1 receptor (GLP1R) agonists (GLP1RA) can decrease the occurrence of major cardiovascular events in diabetic patients, regardless of their glycemic control. However, a significant challenge in understanding the positive effects of GLP1RA has been the lack of knowledge regarding the specific cellular types that express GLP1R. Despite the established cardiovascular benefits of GLP1RA, previous studies have been unable to confirm the expression of GLP1R in the heart. Aim The study aimed to investigate the expression and function of GLP1R in heart tissue. Methods We collected human cardiac tissue samples from 30 patients who underwent left ventricle (LV) biopsies (n=21) or right atrial (RA) appendage closure (n=9) at a university hospital. Gene expression levels were assessed using RT-qPCR, protein levels by Western blot analysis, in situ tissue localization of proteins by immunofluorescence (IF) staining, and the level of oxidative stress using dihydroethidium. Results LV biopsies and RA appendages showed a substantial heterogeneity in GLP1R mRNA levels. GLP1R mRNA levels exhibited a positive correlation with IL1B, IL6, TNFα, CCL2, CD68, ACE1, AT1R, and VCAM1 mRNA levels, but a negative correlation with NOS3 mRNA levels. High GLP1R expression in both RA appendages and LV biopsies was associated with increased oxidative stress levels, which were mitigated by the antioxidant N-acetylcysteine (NAC), NADPH oxidase inhibitor (VAS-2870), ACE inhibitor (perindoprilat), AT1R antagonist (losartan), TNF-α receptor neutralizing antibody (infliximab) and by GLP1R agonists (liraglutide and semaglutide) with inhibitory effects amounting to about 50-60 %. Exendin, a GLP1R antagonist reversed the effect of liraglutide and semaglutide which accounted for a receptor-mediated antioxidant effect. H-89, a PKA inhibitor equally reversed liraglutide and semaglutide effect on ROS generation suggesting a canonical GLP1R mediated effect involving the AMPK pathway. Conclusion These findings indicate that human cardiac GLP1R expression levels are correlated to low-grade inflammation and endothelial dysfunction. Increased expression levels of GLP1R were associated with higher levels of oxidative stress sensitive to GLP1RA in a canonical GLP1R AMPK-mediated manner. Therefore, the cardiovascular beneficial effects of GLP1RA might be attributable to their antioxidant and anti-inflammatory properties, specifically within the cardiac system.

In-hospital safety of catheter based left atrial appendage closure in Germany 2016 - 2020

Abstract Background New catheter based left atrial appendage (LAA) occlusion devices were introduced in the past decade. Catheter based LAA occlusion can be performed through a permanently implanted intracardiac LAA occlusion device or a loop stitch around the base of the LAA via an additional pericardial access. Knowledge about recent in-hospital safety trends and center volume dependent outcomes is limited. Methods Catheter based LAA closures in Germany were identified via ICD and OPS codes from 2016 - 2020. Adjusted risk differences for loop stitch procedures were calculated using an inverse probability weighting approach taking into account 17 predefined baseline characteristics. Center volume dependent outcomes were calculated using a risk adjusted logistics regression analysis taking into account the same predefined baseline characteristics. Results 28 039 permanently intracardiac implanted LAA occlusion device procedures and 213 loop stitch LAA occlusions were performed from 2016 - 2020. Numbers of permanently implanted occlusion device procedures increased from 5 259 in 2016 to 5 917 in 2020 (p = 0.020) without a significant trend for in-hospital safety parameters. Risk adjusted logistic regression analysis of center volume depended MACCE and pericardial puncture for permanently implanted occlusion devices did not show a significant trend. Patients receiving the loop stitch procedure were younger (76.17 +/- 8.16 vs. 73.16 +/- 8.99, p &amp;lt; 0.001), had a lower comorbidity index (2.29 +/- 1.93 vs. 1.92 +/- 1.64, 0.005) and less previous myocardial infarctions (7.82 % vs. 3.29 %, p = 0.014) or cardiac surgeries (12.34 % vs. 6.57 %, p = 0.011). Adjusted risk difference of pericardial effusion (8.04 %; 95% CI: 3.01 % – 13.08 %; p = 0.002) and pericardial puncture (6.60 %; 95% CI: 3.85 % – 9.35 %; p &amp;lt; 0.001) was higher for the LAA loop stitch procedure, while risk of bleeding (-1.85 %; 95% CI: -3.01 % to -0.69 %; p = 0.002), intracerebral bleeding (-0.37 %; 95% CI: -0.59 % to -0.15 %; p = 0.001) and shock (-1.41 %; 95% CI: -2.44 % to -0.39 %; p = 0.007) was lower. No significant difference was observed for in-hospital MACCE. Conclusions Permanently implanted occlusion devices were the major catheter based LAA closure procedure in Germany without improvements in in-hospital safety from 2016 – 2020. Center volumes did not influence in-hospital MACCE and pericardial puncture for the permanently implanted LAAC devices. LAA loop stitch occlusion was used much less frequently and was associated with a higher risk of pericardial effusion and pericardial puncture, a lower risk of bleeding and shock and no significant risk difference in MACCE.

Same day discharge after interventional electrophysiology procedures, first German experience

Abstract Background and purpose In most European countries, the current postprocedural gold standard following electrophysiological (EP) interventions implies the overnight monitoring of the patients in the hospital. Due to limited healthcare capacities and an increasing safety profile of ablation procedures, the mandatory overnight monitoring is under debate. Same day discharge protocol (SDD) ablation might be a safe and efficient alternative. We present the first German experience on SDD for EP interventions. Methods Patients receiving interventional EP procedures with a maximum of two VAs were discharged on the day of procedure, after the hemostasis and ambulation were proven. The VA hemostasis was achieved either by using a vascular closure system (VCS) or by a figure-of-eight suture followed by compressive bandage application. All patients were scheduled for a medical visit the day after procedure for groin examination and suture removal. Results A total of 12 patients (25% females, median age 64 (57.3, 66.8) years, median BMI 30.5 (22.3, 33.7) Kg/m2) undergoing EP procedures followed the SDD protocol in our center. All patients had an atrial fibrillation (AF) diagnosis, 66.7% of them paroxysmal. Five (45.5%) patients had a CHA2DS2VASc score of 1. A total of 4 (33.3%) patients presented arterial hypertension, 3 (25%) diabetes mellitus, 1 a history of stroke, 1 of myocardial infarction and 1 had chronic kidney disease and kidney transplantation. Eleven (91.7%) patients were under oral anticoagulation. The most common procedure was AF ablation, in 10 (83.3%) patients, while 1 (8.3%) patient underwent cavotricuspid isthmus (CTI) ablation and 1 (8.3%) a left atrial appendage closure procedure. In 10 (72.7%) AF ablations the energy source was cryoenergy, in 1 laserenergy and in 1 electroporation. The CTI ablation was performed by means of radiofrequency. A VCS was used in 7 (58.3%) patients. Six of these patients received 2 VCSs, while the patient with PFA based ablation had a single vascular access, thus only one VCS. The procedure was reported successful in all cases, and no intraprocedural complication occurred. During the next day visit, a groin hematoma has reported in 2 (16.7%) patients, no one requiring further therapeutical measures or hospitalization. All the other patients had no puncture related complications. The median FU time was 46.5 (26, 90.3) days. During FU only one patient had an unplanned ambulatory visit due to flecainide intolerance. Readmission during FU was reported in only 2 patients, none of them procedure related. Conclusions In selected patients undergoing EP procedures SDD seems to be safe and feasible. This approach increases healthcare capabilities, patients' comfort and reduces the cost of medical care.

Embolization of percutaneous left atrial appendage closure devices: timing, management and associated clinical outcomes

Abstract Background Percutaneous left atrial appendage occlusion (LAAO) is a good option to mitigate stroke risk in patients with atrial fibrillation. Device embolization is infrequent but a serious complication. Objectives We aim to describe timing, management and clinical outcomes of device embolization in an international multi-center registry. Methods Patient characteristics, imaging findings, procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. Results Sixty-seven centers contributed data on 125 patients who underwent LAAO and experienced device embolization at an embolization rate between 0 and 3.9 % per 100 person-years. Device embolization within the first 24 hours post-procedural occurred in 69.4% of cases. The device was left in place in three (2.8%) patients, a percutaneous retrieval was attempted in 83 (76.1%) and surgery was preferred in 23 (21.1%) patients. In 27/83 (32.5%) patients with an initial percutaneous retrieval attempt a second, additional procedure was performed, which was associated with a high mortality (death first attempt: 2.7% vs. second attempt: 18.5%, p&amp;lt;0.001[HS1] ). The primary outcome (bailout surgery, cardiogenic shock, and/or death) occurred in 43 (38.7%) patients. Major complications related to LAAO device embolization occurred in 39 (35.1%) patients. Conclusions The majority of device embolizations after LAAO occurs early. The percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was not successful.

Left Atrial Appendage Closure: A Narrative Review.

Atrial fibrillation (AF) is the most commoncardiac arrhythmiaand the cause of thromboembolic events in elderly patients worldwide. AF is associated with a significantly increased risk of morbidity and mortality due to cardiac emboli, primarily from left atrial appendage (LAA) thrombus. Oralanticoagulation therapy is the standard treatment to effectively reduce the risk of thromboembolic events in patients with AF. However, anticoagulation treatment increases bleeding risk. LAA closure (LAAC) has recently been introduced as afeasible mechanical preventive intervention for thromboembolic events while minimizing the risk of bleeding. Transcatheter LAAC devices have evolved in the past decade, and several ongoing trials have demonstrated the improvements of safety and outcomes in newer generation devices. This review summarizes the current perspectives and outcomes regarding LAAC as an alternative to pharmacologic therapy.

Abstract 12536: Occurrence of New-Onset Atrial Fibrillation in Patients After Left Atrial Appendage Closure

Introduction: Left atrial appendage closure (LAAC) has evolved as a non-pharmacological alternative for stroke prevention in patients with Atrial fibrillation (AF). The occurrence of post-operative AF is well described after cardiac and percutaneous procedures. But, there is limited understanding of the possibility of new-onset AF as a result of LAAC. Aims: To investigate the incidence of, and factors associated with, AF after LAAC. Methods: We conducted a retrospective analysis of 121 patients with i) paroxysmal AF, 2) had undergone LAAC, and 3) had an implantable electronic devices (CIEDs): pacemaker, defibrillator or implantable loop recorder. Patients with persistent AF and those presenting in AF on the day of LAAC were excluded. Data were collected on baseline characteristics, Colchicine use, antiarrhythmic drugs and prior history of AF ablation. Remote transmissions and device interrogations were analyzed to ascertain new-onset AF during the 6 months follow up period after LAAC. Univariate and multivariable analyses were performed to analyze factors associated with the occurrence of AF after LAAC. Results: Of the total 121 patients, 39 (32.2%) developed AF during the 6 month follow up period after LAAC. On univariate analysis, a lower CHA2DS2-Vasc score was associated with a lower incidence of AF post LAAC (OR 0.74, 95% CI 0.55-0.98, p = 0.04). On multivariable analysis, including variables of age, gender, CHA2DS2-Vasc score, use of Colchicine and history of AF Ablation, we observed a statistical trend towards the protective effect of prior AF ablation on occurrence of AF after LAAC (adjusted OR 0.32, 95% CI 0.10-1.05, p =0.06). There was also a statistical trend towards the protective effect of Colchicine on occurrence of AF after LAAC (adjusted OR 0.15, 95% CI 0.02-1.29, p =0.08). Conclusions: In our study of paroxysmal AF patients undergoing LAAC, who presented in sinus rhythm on the day of the procedure, the incidence of CIED detected post-procedural AF was 32.2%. We observed statistical trends towards protective effects of prior AF Ablation and use of Colchicine during the peri-LAAC period on occurrence of AF after LAAC.