Left Atrial Appendage Closure Procedure Research Articles

Left atrial appendage closure guided by fusion of 3D computational modelling on real-time fluoroscopy: A multicenter experience

BackgroundPatient-specific 3-dimensional (3D) computational modelling offers a tailored approach with promising results, but experience using digital-twin fusion on real-time fluoroscopy to guide left atrial appendage closure (LAAC) is unreported. ObjectivesTo assess whether LAAC guided by fusion of a 3D computational model on real-time fluoroscopy is safe and effective. MethodsWe included retrospectively through a multicenter registry all consecutive patients with non-valvular atrial fibrillation (AF) who underwent LAAC guided by artificial intelligence (AI)-enabled computer simulations (FEops, Gent, Belgium) fusion with real-time fluoroscopy. Operators selected the appropriate device size and position in relation to the LAA using FEops HEARTguide™, and a digital twin was provided for image fusion. The primary efficacy endpoint was successful LAAC with the use of a single device, without moderate or greater peri-device leak and/or device related thrombus (DRT) on follow-up imaging. The primary safety endpoint was a composite of major procedural complications including tamponade, stroke, systemic embolism, major bleeding, and device embolization. ResultsA total of 106 patients underwent LAAC with an Amulet™ or Watchman FLX™ device using CT-model-fluoroscopy fusion imaging. Device implantation was successful in 100 % of cases. The primary efficacy endpoint was met in 82 patients (89 %). A single-device SINGLE-deployment LAAC procedure was observed in 49 cases (46 %). The primary safety endpoint occurred in 2 patients (1.9 %). After a median follow-up of 405 days, two patients suffered an ischemic stroke and four expired. ConclusionsFusion of a CT-based 3D computational model on real-time fluoroscopy is a safe and effective approach that may optimize transcatheter LAAC outcomes.

Tissue Oedema Following Pulsed Field Ablation Recognized during a Concomitant Left Atrial Appendage Closure Procedure. A Case Report

Abstract Background In patients with non-valvular atrial fibrillation (AF), at high stroke risk and who are ineligible for long-term oral anticoagulation the left atrial appendage closure (LAAC) could be an alternative to anticoagulation. Pulsed field ablation (PFA) is a new nonthermal method for cardiac ablation modality based on high-voltage electrical energy for irreversible electroporation. We first report a case of a concomitant PFA pulmonary vein isolation and LAAC. Case Summary A 74-year-old female patient was referred to our department for pulmonary vein isolation (PVI) for persistent AF (CHA2DS2-VASc Score 5). A concomitant percutaneous LAAC was proposed because of a history of previous cerebellar transient ischemic attack despite continuous oral anticoagulation therapy. PVI was achieved with a pentaspline PFA catheter, LAAC performed with a WATCHMAN FLXTM device (Boston Scientific, Plymouth, MN, USA). After PVI, a swelling of the left atrial ridge was observed, yet a 27 mm LAAC device was successfully implanted. The follow-up transesophageal echo (TEE) after 6 weeks showed complete resolution of the oedema, no device related thrombus but a slight proximal tilting of the LAAC device without leakage could be observed. The 6-month follow-up demonstrated a stable sinus rhythm, no stroke or bleeding events were recorded. Discussion In this case of synchronous PFA-PVI procedure in AF and Watchman FLXTM device implantation, the electroporation created an acute oedema at the ridge level which at the TEE follow-up after 6 weeks was resolved. This resulted in a slightly tilted Watchman device position which was nevertheless stable and showed no leakage.

Long-term outcomes after echocardiography versus fluoroscopy-guided left atrial appendage closure: Is there still a role for a simplified approach?

Left atrial appendage closure (LAAC) represents an alternative to oral anticoagulation for stroke prevention in patients with non-valvular atrial fibrillation (AF). While transoesophageal echocardiography is the current standard for guiding LAAC procedures, several centers have employed fluoroscopic guidance alone. However, data on long-term outcomes are lacking. A total of 536 patients with AF undergoing LAAC and with available data on long-term follow-up were included in the retrospective, single-center analysis. Outcomes of patients undergoing fluoroscopy-guided LAAC were compared with those undergoing echocardiography guided LAAC. Time-dependent analysis was performed with the Kaplan-Meier method. A total of 234 (44%) and 302 (56%) patients were treated with echocardiography and fluoroscopy guidance, respectively. Baseline characteristics did not differ between the two groups. Procedural success rates were high in both groups (97% of fluoroscopy vs. 98% of echocardiography guided procedures; p = 0.92) and rates of relevant peri-device leaks (p = 0.50) and device-related thrombus formation (p = 0.22) did not differ between groups. Median clinical follow-up time was 48 (IQR 19-73) months. Rates of all-cause mortality (p = 0.15, HR 0.83, CI 0.64-1.07) and stroke (p = 0.076, HR 2.23, CI 0.90-5.54) were comparable among groups. LAAC with fluoroscopy guidance alone is equally safe and leads to similar clinical outcome compared to LAAC with additional echocardiography guidance.

Gender differences in outcomes after left atrial appendage closure with Watchman FLX device: insights from the Italian-FLX registry.

Recent studies have shown gender differences in cardiovascular outcomes after left atrial appendage closure (LAAC), highlighting different complication rates and adverse events, particularly in short-term assessments. As a result, there remains a significant knowledge gap on how these differences directly impact the efficacy and safety of LAAC procedures. The aim of this retrospective study was to investigate the clinical outcomes of LAAC in women and men using the Watchman FLX device. This retrospective, multicenter study analyzes gender-specific outcomes in 650 patients who underwent LAAC with the Watchman FLX device between March 2019 and May 2022, drawn from the ITALIAN-FLX registry. The results show comparable rates of all-cause mortality, stroke, transient ischemic attack and major bleeding in men and women 12 months after the procedure. Notably, no significant gender differences were found for periprocedural complications. In conclusion, this study shows that LAAC with the Watchman FLX device has comparable clinical outcomes between genders at both short-term and long-term follow-up.

Real-world experience utilizing the nuvision 4D intracardiac echocardiography catheter for left atrial appendage closure

Transesophageal echocardiography (TEE) has been the preferred imaging modality to help guide left atrial appendage closure. Newer technologies such as the Nuvision 4D Intracardiac echocardiography (ICE) catheter allow for real-time 3D imaging of cardiac anatomy. There are no direct comparison studies for procedural imaging between TEE and 4D ICE. To evaluate the performance and safety of left atrial appendage (LAA) closure procedures with the Watchman FLX and Amulet, guided by the Nuvision 4D ICE Catheter. This retrospective observational analysis was conducted on institutional LAAO National Cardiovascular Data Registry from January 2022 to March 2023. Patients had undergone LAA closure procedures with the Watchman FLX or Amulet device guided by TEE or a 4D ICE Catheter. The primary outcome evaluated was successful LAAO device placement. A total of 121 patients underwent LAAO device placement with 46 (38.0%) patients guided by 4D ICE during LAAO implantation. The 4D ICE group had a shorter procedural time compared with TEE guidance. Post procedural 45-day TEE post implant was also comparable for both groups with no patients in either group having incomplete closure of the left atrial appendage and peri-device leak > 5 mm. No device related complications (device related access, stroke, or pericardial effusion) occurred in either group at follow-up. There was no significant difference in device implant success or post procedural outcomes at 45 days in either the TEE or 4D ICE group. However, there was a noticeable improvement in procedural time with the 4D ICE catheter.

Pericardial Effusion After Left Atrial Appendage Closure: Timing, Predictors, and Clinical Impact

BackgroundPericardial effusion (PE) is the most common serious left atrial appendage closure (LAAC) complication, but its mechanisms, time course, and prognostic impact are poorly understood. ObjectivesThis study sought to assess the frequency, timing, predictors and clinical impact of PE after LAAC. MethodsData on consecutive patients undergoing percutaneous LAAC between 2009 and 2022 were prospectively collected including the 1-year follow-up. Both single (Watchman 2.5/FLX, Boston Scientific) and double (Amplatzer Cardiac Plug or Amulet, St. Jude Medical/Abbott) LAAC devices were used. An imaging core laboratory adjudicated the PEs and categorized them as early (≤7 days) and late (8-365 days). Logistic regression analysis was used to identify predictors of early and overall PE. ResultsOf 1,023 attempted LAAC procedures, PE was observed in 44 (4.3%) patients; PE was categorized as early in 34 (3.3%) and late in 10 (0.9%) patients. The majority of PEs occurred within 6 hours after LAAC (n = 25, 56.8%) and were clinically relevant (n = 28, 63.6%). Independent predictors of early PE were double-closure left atrial appendage devices (adjusted OR: 8.20; 95% CI: 1.09-61.69), female sex (adjusted OR: 3.41; 95% CI: 1.50-7.73), the use of oral anticoagulation (OAC) at baseline (adjusted OR: 2.60; 95% CI: 1.11-6.09), and advanced age (adjusted OR: 1.07; 95% CI: 1.01-1.23), whereas female sex and OAC at baseline remained independent predictors of overall PE. ConclusionsIn this large LAAC registry, PE was observed in <1 in 20 patients and usually occurred within 6 hours after procedure. The majority of early PEs were clinically relevant and occurred in the Amplatzer Cardiac Plug/Amulet procedures. Independent predictors included the use of double-closure devices, female sex, OAC at baseline, and advanced age. (LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure; NCT04628078)

Segmentation of the left atrial appendage based on fusion attention.

In clinical practice, the morphology of the left atrial appendage (LAA) plays an important role in the selection of LAA closure devices for LAA closure procedures. The morphology determination is influenced by the segmentation results. The LAA occupies only a small part of the entire 3D medical image, and the segmentation results are more likely to be biased towards the background region, making the segmentation of the LAA challenging. In this paper, we propose a lightweight attention mechanism called fusion attention, which imitates human visual behavior. We process the 3D image of the LAA using a method that involves overview observation followed by detailed observation. In the overview observation stage, the image features are pooled along the three dimensions of length, width, and height. The obtained features from the three dimensions are then separately input into the spatial attention and channel attention modules to learn the regions of interest. In the detailed observation stage, the attention results from the previous stage are fused using element-wise multiplication and combined with the original feature map to enhance feature learning. The fusion attention mechanism was evaluated on a left atrial appendage dataset provided by Liaoning Provincial People's Hospital, resulting in an average Dice coefficient of 0.8855. The results indicate that the fusion attention mechanism achieves better segmentation results on 3D images compared to existing lightweight attention mechanisms.

A comparison of conventional and advanced 3D imaging techniques for percutaneous left atrial appendage closure.

Understanding complex cardiac anatomy is essential for percutaneous left atrial appendage (LAA) closure. Conventional multi-slice computed tomography (MSCT) and transesophageal echocardiography (TEE) are now supported by advanced 3D printing and virtual reality (VR) techniques for three-dimensional visualization of volumetric data sets. This study aimed to investigate their added value for LAA closure procedures. Ten patients scheduled for interventional LAA closure were evaluated with MSCT and TEE. Patient-specific 3D printings and VR models were fabricated based on MSCT data. Ten cardiologists then comparatively assessed LAA anatomy and its procedure relevant surrounding structures with all four imaging modalities and rated their procedural utility on a 5-point Likert scale questionnaire (from 1 = strongly agree to 5 = strongly disagree). Device sizing was rated highest in MSCT (MSCT: 1.9 ± 0.8; TEE: 2.6 ± 0.9; 3D printing: 2.5 ± 1.0; VR: 2.5 ± 1.1; p < 0.01); TEE, VR, and 3D printing were superior in the visualization of the Fossa ovalis compared to MSCT (MSCT: 3.3 ± 1.4; TEE: 2.2 ± 1.3; 3D printing: 2.2 ± 1.4; VR: 1.9 ± 1.3; all p < 0.01). The major strength of VR and 3D printing techniques was a superior depth perception (VR: 1.6 ± 0.5; 3D printing: 1.8 ± 0.4; TEE: 2.9 ± 0.7; MSCT: 2.6 ± 0.8; p < 0.01). The visualization of extracardiac structures was rated less accurate in TEE than MSCT (TEE: 2.6 ± 0.9; MSCT: 1.9 ± 0.8, p < 0.01). However, 3D printing and VR insufficiently visualized extracardiac structures in the present study. A true 3D visualization in VR or 3D printing provides an additional value in the evaluation of the LAA for the planning of percutaneous closure. In particular, the superior perception of depth was seen as a strength of a 3D visualization. This may contribute to a better overall understanding of the anatomy. Clinical studies are needed to evaluate whether a more comprehensive understanding through advanced multimodal imaging of patient-specific anatomy using VR may translate into improved procedural outcomes.

Long-term outcomes of left atrial appendage closure with or without concomitant pulmonary vein isolation:a propensity score matching analysis based on CLACBAC study

BackgroundThe combined procedure of left atrial appendage closure (LAAC) with concomitant pulmonary vein isolation (PVI) has demonstrated its efficacy and safety. However, there is still a lack of comparative investigations regarding the long-term benefits of the combined procedure when compared to LAAC alone. Our study aims to assess the long-term outcomes of combined procedure of LAAC with concomitant PVI in comparison with a propensity matched LAAC alone group.MethodsPropensity score matching (PSM) was employed to rectify covariate imbalances, resulting in the inclusion of 153 comparable patients from the initial cohort of 333 non-valvular atrial fibrillation (AF) patients. Clinical outcomes, encompassing thrombotic events, major cardiocerebrovascular adverse events (MACCE), re-hospitalization due to cardiovascular disease (CVD), and atrial tachycardia (AT), were juxtaposed between the two groups. Bleeding events and peri-device complications, such as residual flow, device-related thrombus, and device replacement, were also compared. Additionally, a patients group underwent PVI alone was included for comparing AF recurrence rates between the PVI alone group and the combined group.ResultsFollowing PSM, 153 patients (mean age 70.3 ± 8.9, 62.7% men) were included, with 102 undergoing the combined procedure and 51 undergoing LAAC alone. No significant differences were found in baseline characteristics between the two groups. The mean follow-up time was 37.6 ± 7.9 months, and two patients were lost to follow-up in the combined procedure group. Thrombotic events were observed in 4 (7.8%) patients in the LAAC alone group and 4 (4.0%) in the combined group (Log-rank p = 0.301). The proportion of patients experiencing MACCE, re-hospitalization due to CVD, and AT between the two groups was comparable, as were bleeding events and peri-device complications. Among patients from the combined procedure group without AF recurrence, a significant difference was noted in prior-procedure left ventricular ejection fraction (LVEF) and LVEF at the 12th month after the procedure (57.2% ± 7.1% vs. 60.5% ± 6.5%, p = 0.002).ConclusionThe concomitant PVI and LAAC procedure did not increase procedure-related complications, nor did it confer significant benefits in preventing thrombotic events or reducing other cardiovascular events. However, the combined procedure improved heart function, suggesting potential long-term benefits.

Left atrial appendage closure in patients with left atrial appendage thrombus guided by intracardiac echocardiography

BackgroundData regarding left atrial appendage closure (LAAC) in patients with left atrial appendage (LAA) thrombus are limited. Recently published cases have mostly been guided by transesophageal echocardiography. Intracardiac echocardiography (ICE) is now widely used during LAAC procedures. ObjectiveThis is the first study to report the feasibility of LAAC in patients with LAA thrombus guided by ICE. MethodsPatients with persistent LAA thrombus despite anticoagulation or contraindications to anticoagulation who underwent a modified ICE-guided LAAC procedure between June 2021 and April 2023 were included. Periprocedural events and clinical outcomes during follow-up were recorded. ResultsA total of 12 patients (mean age 65 ± 7 years; 92% male) were included: 10 with persistent LAA thrombus and 2 with contraindications to anticoagulation. Most of the thrombus was at the apex (n = 6), followed by the body (n = 3) and the ostium (n = 3). A LAmbre device was used and successfully implanted in all patients with the guidance of ICE. No thrombotic material was retrieved from patients with the protection of cerebral protection device (n = 11). No patient experienced severe periprocedural complications. All patients completed transesophageal echocardiography follow-up, and no device-related thrombus or peridevice leak > 3 mm was detected. None of the patients experienced stroke/transient ischemic attack, systemic embolism, or major bleeding events during a median follow-up of 147 days (interquartile range 80–306 days). ConclusionLAAC using the LAmbre device guided by ICE may be feasible in patients with LAA thrombus when performed by experienced operators.

Incidence and predictors of device-related thrombus after left atrial appendage closure with Watchman device.

Left atrial appendage closure (LAAC) with Watchman device prevents thromboembolism in patients with atrial fibrillation (AF). However, thrombus may develop on the atrial surface of the device. To investigate the incidence and predictors of device-related thrombus (DRT) in patients with AF who were treated with LAAC. Ninety-one consecutive patients with AF underwent LAAC procedure using first-generation Watchman 2.5 device followed by antiplatelet therapy. In our analysis we have included all patients (n = 78) who had clinical follow-up visits with transesophageal echocardiography (TEE) after the procedure. The median (IQR) CHA2DS2-VASc score was 4 (4.0-6.0) and HAS-BLED score was 3 (3.0-4.0). DRTs were observed in 5 (6.4%) patients. When compared with patients without DRT, those with DRT presented more often with lower median ejection fraction (40% (23.5-45.5) versus 55% (48.0-60.0); p = 0.005), lower emptying velocity of LAA (25 cm/s (17.5-27.0) versus 53 cm/s (26.5-78.0); p = 0.009), and with greater depth of implantation (18 mm (14.0-20.5) versus 8 mm (5.0-11.0); p < 0.001). Furthermore, patients with DRT had greater depth of LAA (35 mm (29.5-41.0) versus 29 mm (25.5-31.0); p = 0.003), greater mean (SD) dimension in 900 (22.4 mm (3.2) versus 19 mm (2.7); p = 0.02). Patients with DRT were also younger than those without DRT (67.4 years (7) versus 75 years (8.3), p = 0.045). The DRT after Watchman device implantation remains a rare complication. Its formation was related to several patient and procedural characteristics, which need to be confirmed in larger studies.

Prevalence and outcomes of left atrial appendage closure procedures with indication abiding or not to current French guidelines consensus

Prevalence and outcomes of left atrial appendage closure procedures with indication abiding or not to current French guidelines consensus

Anticoagulants versus Left Atrial Appendage Occlusion in Patients with Atrial Fibrillation and Co-Morbid Thrombocytopenia.

Left atrial appendage closure (LAAC) is an alternative approach to anticoagulants. Nonetheless, data regarding the outcomes of LAAC procedures in patients with thrombocytopenia remain lacking. The primary objective was to determine the incidence of the composite endpoint comprising ischemic stroke, intracranial hemorrhage, major bleeding, and cardiac cause of death among patients with atrial fibrillation (AF) and thrombocytopenia who were either undergoing LAAC or receiving oral anticoagulants. The secondary endpoint was the determination of total mortality. Data from a prospective, single-center registry of patients undergoing LAAC procedures were analyzed. A subset of 50 consecutive patients with thrombocytopenia were selected. Thrombocytopenia was defined as a thrombocyte count below 150,000. Subsequently, from patients hospitalized with AF receiving oral anticoagulants, 50 patients were further chosen based on propensity score matching, ensuring comparability with the study group. The primary endpoint occurred in 2% of patients in the LAAC group and 10% of patients in the non-LAAC group (p = 0.097). Additionally, a significant difference was noted in the occurrence of the secondary endpoint, which was observed in 0% of patients in the LAAC group and 10% of patients in the non-LAAC group (p = 0.025). In patients with thrombocytopenia the LAAC procedure improves prognosis compared with continued anticoagulant treatment.

Transesophageal echocardiography and computerized tomography angiography mismatch in left atrial appendage thrombus evaluation.

Transesophageal echocardiography (TEE) is the gold standard test for the diagnosis of left atrial appendage (LAA) thrombus. Nonetheless, computerized tomography angiography (CTA) is readily used to exclude LAA thrombus before pulmonary vein isolation (PVI) and LAA closure procedures. We aimed to assess the comparability of LAA thrombus diagnosis using chest CTA scans in patients with atrial fibrillation who underwent TEE. Retrospective collection of consecutive patients with atrial fibrillation who underwent TEE and chest CTA within 30 days and had evidence of spontaneous echo contrast (SEC) or LAA thrombus on TEE. Clinical, demographic, and echo data were collected. Prospective analysis of the CTA for evidence of LAA thrombus in the same group of patients was performed. We compared the findings of the two modalities. Out of 1550 patients with atrial fibrillation who underwent TEE examinations in the study period, 63 patients underwent TEE within 30 days of a chest CTA scan. Twenty-three patients had LAA thrombus and 40 had some degree of SEC according to TEE. On CTA, 11 were interpreted as positive with a high level of suspicion for the presence of an LAA thrombus. Six patients (26.1%) had LAA thrombus according to both CT and TEE. Therefore, low concordance was found between test results (chi-squared continuity correction = 5.5, df = 1, and P -value = 0.01902). The discrepancy between CTA and TEE results suggests these examinations might be more suitable as complementary examinations to exclude LAA thrombus.

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.

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.

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.

Abstract 14558: Causes and Predictors of Short-Term Readmissions Following Percutaneous Left Atrial Appendage Closure Procedure in Patients With and Without Rheumatic Mitral Valve Disease

Introduction: Atrial fibrillation (AF) is the most common cardiac arrhythmia, characterized by erratic heart beats. AF increases the risk of thromboembolic events particularly stroke. Percutaneous left atrial appendage closure (LAAC) is an alternative option to prevent embolic stroke in patients with AF who have contraindication to anticoagulants. Up to our knowledge, this is the first National Readmission Database (NRD) study to elucidate the difference in readmission rates between rheumatic vs non-rheumatic AF patients who underwent LAAC. Methods: We utilized the Nationwide Readmissions Database (NRD) between the years 2016-2020. The study involved hospitalizations with rheumatic mitral valve disease (R-MVD) and non-rheumatic mitral valve disease (NR-MVD) who underwent LAAC using ICD-10 diagnostic codes. We deemed this as the index admission. We excluded patients less than 18 years old and October-December hospitalizations from 90-day readmission analysis, due to lack of adjoining period to assess readmission. Results: Among 9,150 patients with mitral valve disease who underwent LAAC in their index hospitalizations, 9,122 were discharged alive. 4,200 patients (45.8%) were readmitted in 90-days. R-MVD 90-day readmission rate compared to NR-MVD (52.3% vs 40.7% respectively, p&lt;0.001). The most common cause of readmission in both groups was atrial fibrillation, 96% of total readmissions in R-MVD and 97% of total readmissions in NR-MVD group. This was followed by “accidental puncture and laceration of a digestive system organ or structure” in 0.3% of R-MVD group vs “mitral valve insufficiency” in 0.7% of NR-MVD readmission causes. Figure 1 shows the Forest plot of multivariate analysis of independent factors associated with readmissions. Conclusion: Among AF patients who underwent LAAC with or without history of mitral valve rheumatic heart disease, those with history of R-MVD had significantly higher 90-day readmission rate.

Abstract 12823: As Anticoagulation Use Increases, Embolic Events Downtrend in Atrial Fibrillation Hospitalizations

Background: Direct oral anticoagulants and Left atrial appendage closure (LAAC) were approved for use in 2010 and 2015, respectively. Data on temporal changes in stroke prevention strategies and rates of embolic complications in atrial fibrillation (AF) in the 2010s decade are limited. Aims: Describe trends in long-term anticoagulation (AC), LAAC use, and in-hospital AF associated ischemic stroke (IS), transient ischemic attacks (TIA), and systemic embolic events (SEE) between 2010 and 2019. Methods: The national inpatient database was used to identify patients with AF from 2010 to 2019. Data were divided into 2 eras: 2010-2014 and 2015-2019. Results: A total of 40,787,136 inpatients with AF were identified: prevalence increased from 18,594,372 in 2010 to 2014 (46%; mean [SD] age 75.5 [12.0] years; 50.3% male) to 22,192,764 in 2015 to 2019 (54%; mean [SD] age 75.1 [11.8] years; 52.5% male). There was a marked increase in long-term AC use (27.2% to 40.2%; P=0.001) and rates of percutaneous LAAC procedures (0.01% to 0.6%; P &lt;0.001) from 2015 to 2019. IS rates among patients with AF increased from 2010 to 2014 (3.5% to 3.8%; P=0.04), with no significant temporal change from 2015 to 2019 (P=0.84). TIA rates declined from 2010 to 2014 (1.2% to 1.0%; P=0.017) and continued a downtrend from 2015 to 2019 (0.9% to 0.7%; P=0.002). There was no temporal change in SEE or the composite outcome of all embolic events from 2010 to 2014, followed by a decline from 2015 to 2019 in SEE (0.5% to 0.4%; P 0.012) and all embolic events (5.1% to 4.8%; P 0.026) ( Figure 1 ). Mean rates of major bleeding events increased from 5.7% in 2010-2014 to 9.1% in 2015-2019 (P &lt;0.001). Conclusion: In an inpatient AF population, the composite outcome of all embolic events and specifically SEE downtrend from 2015 to 2019, likely due to increased AC use. Further data assessing the risk-benefit ratio of available therapies for stroke prevention in inpatients with AF - AC and LAAC - are needed to optimize personalized strategies.

Abstract 17596: Association of Racial-Ethnic Disparities and Frailty on Adverse Outcomes in Geriatric Patients Undergoing Elective Percutaneous Left Atrial Appendage Closure With Watchman Device

Introduction: Use of left atrial appendage closure (LAAC) has become more widespread in the geriatric population. Frailty, a geriatric syndrome, is associated with significant morbidity and mortality. Hypothesis: Race/Ethnicity influences frailty status and may differentially impact adverse outcomes in elective LAAC procedure. Methods: Patients aged ≥65 years who underwent elective LAAC were identified using ICD-10 procedure code 02L73DK from 2016-2018 HCUP-NIS Database. Hospital Frailty Risk Score (HFRS) was calculated for each patient based on 109 ICD-10 diagnosis codes and classified into non-frail (HFRS &lt; 5) and frail (HFRS score ≥ 5) groups. Charlson comorbidity index (CCI) was used to assess comorbidity burden. In-hospital major adverse event (MAE) was defined as the composite of mortality, stroke (ischemic or hemorrhagic) or TIA, bleeding or transfusion, vascular complications, myocardial infarction, systemic embolization, and pericardial effusion or tamponade requiring pericardiocentesis or surgery. Outcome was in-hospital MAE. Multivariate regression analysis was used to assess the association of race/ethnicity and frailty on MAE. Results: 27,155 patients (Age = 77.3 ± 6.4 years; Female = 42.4%, White: 88%, Black: 3.4%, Hispanic:5.2%, Other: 3.4%) were included. Overall, the prevalence of frailty was 12.5% (White:12.4%, Black: 13.7%, Hispanic: 11.8%, Other: 13%). Overall, in-hospital MAE was 4.7%, with increased rates in frail patients (4% vs.9.6%; p&lt;0.001). Rates of in-hospital MAE were frail-White: 9.3%, frail-Black: 8%, frail-Hispanic:20.6%, and frail-Other: 4.2% (p&lt;0.001). On multivariate analysis, frail-White and frail-Hispanic patients were at increased risk of in-hospital MAE compared to non-frail patients (Figure). Conclusion: Further research is needed to highlight disparities by race/ethnicity and to identify potentially modifiable factors to mitigate adverse events in frail geriatric population undergoing LAAC.