Flow Dynamic Factors Correlated With Device-Related Thrombosis After Left Atrial Appendage Occlusion.

Background: Device-related thrombosis (DRT) occurs in up to 4% of patients undergoing left atrial appendage occlusion (LAAO) and is associated with substantial morbidity and mortality. However, its pathophysiology, predictors, and optimal management remain unclear. Objectives: This study aims to assess flow dynamic factors correlating to DRT. Methods: A multicenter registry of patients who underwent LAAO and had pre- and post-computed tomography imaging was used. Patient-specific 3-dimensional digital models of the left atrium were created, and finite element simulations were performed to implant an LAAO device into each model in a position that matched the clinical deployment. Computational fluid dynamic simulations were performed to quantify the following flow dynamic parameters: time averaged wall shear stress, oscillatory shear index, and endothelial cell activation potential. Results: A total of 38 patients (19 with DRT and 19 without DRT) were included. Left atrium volumes and mitral valve areas were larger in the DRT cohort compared with controls. Patients with DRT had a significantly lower time averaged wall shear stress (1.76 ± 1.24 Pa vs 2.90 ± 2.70 Pa), a higher oscillatory shear index (0.19 ± 0.11 vs 0.17 ± 0.11), and a higher endothelial cell activation potential (0.23 ± 0.58 Pa-1 vs 0.17 ± 0.30 Pa-1) than the controls (P < 0.001 for all). Thrombus locations identified from in-vivo images correlated well with the flow dynamic parameters tested. Conclusions: Flow dynamic parameters may be able to predict the risk of DRT after LAAO. Further investigation with a larger patient cohort and long-term follow-up is needed to assess the role of computational fluid dynamics in the risk stratification of patients considered for LAAO.

Combined left atrial appendage occlusion and catheter ablation procedure for left atrial arrhythmias: A real-world, propensity-matched analysis.

INTRODUCTION: Real-world studies comparing safety and efficacy of combined percutaneous left atrial appendage occlusion (LAAO) and catheter ablation (CA) to LAAO alone are limited. METHODS: Patients from a large US hospital system undergoing combined LAAO and left-atrial CA from 8/2020 to 2/2024 were retrospectively analyzed and compared to a control group undergoing LAAO alone. Controls were identified using a 1:2 propensity score match based on LAAO device type (Watchman FLX vs. Amulet), CHA2D2-VASc and Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio [INR], Elderly, Drugs/alcohol (HAS-BLED) scores and compared for safety, sealing performance and clinical outcomes at 6 months. RESULTS: Patients were younger in the combined (n = 72) than in the control group (n = 144, 70.2 ± 7.3 vs. 76.7 ± 6.9 years, p < 0.001) but otherwise comparable with a mean CHA2D2-VASc score of 4.2 ± 1.1 and 4.4 ± 1.2 (p = 0.26) and HAS-BLED score of 2.2 ± 0.8 and 2.3 ± 0.7 (p = 0.34). Successful LAAO implantation rates were the same (95.8% vs. 95.8%, p = 0.99) with longer procedure times seen in the combined group (156.5 ± 53 vs. 56 ± 26 min, p < 0.001). Both major (1.4% vs. 2.1%, p = 0.72) and minor (27.8% vs. 19.4%, p = 0.17) in-hospital complications were similar between the combined and control group, respectively. At 45 days, presence of peri-device leak (18.3% vs. 30.4%, p = 0.07) and device related thrombosis (4.5% vs. 4.5%, p = 0.96) on transesophageal echocardiogram did not differ. Finally, all-cause mortality (0% vs. 1.4%, p = 0.99), thromboembolic (0% vs. 0%, p = 0.99) and bleeding (6.1% vs. 4.4%, p = 0.73) events during follow-up were comparable. CONCLUSION: This large, real-world analysis indicates comparable safety and efficiency of combined LAAO and CA when compared with LAAO alone.

Device-Assisted Left Atrial Appendage Exclusion: From Basic Sciences to Clinical Applications.

Device-assisted left atrial appendage exclusion plays a crucial role in the prevention of fatal ischemic complications in patients with atrial fibrillation and contraindications to anticoagulation treatment. Various devices with different safety profiles and device-related complications are available in daily practice to perform this procedure. In this review, the anatomy, physiology, and functions of the left atrial appendage were detailed, and all available devices used for epicardial and endocardial exclusion of the left atrial appendage and their clinical outcomes were discussed. Future research should aim to further investigate the long-term effects of left atrial appendage exclusion on body homeostasis, blood coagulation, and cardiac function.

Association of Physician Certification and Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion.

BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) is indicated in patients with atrial fibrillation for whom long-term oral anticoagulation is contraindicated. Whether outcomes are different based on operator certification [interventional cardiology (IC) versus electrophysiology (EP)] is unclear. OBJECTIVES: To compare LAAO outcomes by physician certification (EP versus IC) in the NCDR LAAO Registry. METHODS: We identified patients from 2020-2022 undergoing implantation of a Watchman FLX or Amulet LAAO device and stratified patients by primary operator certification. Outcomes of interest included: (1) any major adverse event (MAE), 2) mortality, 3) ischemic stroke, and 4) major bleeding during the initial hospitalization and at 45 days. We performed multivariable Cox proportional hazards regression analysis to determine the risk of adverse events by physician certification. RESULTS: A total of 1,638 physicians (57% electrophysiologists) performing 91,711 procedures during the study period were included. EPs were more likely to use intracardiac echocardiography (25.2% vs 9.7%, p<0.001) and had lower radiation total (235 mGy vs 305 mGy, p<0.001). EPs were more likely than ICs to discharge patients on DOAC+aspirin, whereas ICs were more likely to discharge patients on single or dual antiplatelet therapy (all p<0.001). In-hospital death (0.1% vs. 0.1%, p=0.46) and MAE (1.5% vs 1.6%, p=0.42) were similar by physician certification. At 45 days, there was no difference in death [HRdeath 1.03, 95% CI (0.89-1.2)] or MAE [HRMAE 0.97, 95% CI (0.91-1.03)] after multivariable regression. CONCLUSIONS: Contemporary LAAO is safe with low rates of procedural complications and no significant differences in procedural outcomes by operator subspecialty after multivariable adjustment. Continued utilization of technology by EPs and ICs is necessary to allow for broad access to this treatment for eligible patients.

Cerebral Embolic Protection: Is There a Benefit for Left Atrial and Mitral Valve Procedures?

PURPOSE OF REVIEW: This review aims to highlight the current evidence on the use of cerebral embolic protection devices (CEPD) in left atrial and transcatheter mitral valve procedures. It also aims to summarize the antithrombotic management of patients undergoing such procedures. RECENT FINDINGS: Ischemic stroke is one of the most devastating complications of structural heart procedures. The manifestation of periprocedural stroke can range from asymptomatic and detectable only through brain imaging to major stroke with neurological deficits. CEP devices were initially developed to mitigate the risk of stroke associated with transcatheter aortic valve replacement (TAVR). However, the efficacy of such devices during different cardiac interventions is yet to be fully demonstrated, especially in left atrial appendage closure (LAAO), and mitral valve interventions. Few studies demonstrated that the risk of periprocedural strokes after LAAO and mitral valve interventions is not negligible and is highest during the periprocedural period and then falls. The majority of patients undergoing those procedures have cerebral ischemic injuries detected on diffusion-weighted magnetic resonance imaging (DW-MRI). Moreover, a reasonable number of those patients had debris embolization on the filters of the CEPD. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is crucial and should be tailored to each patient's risk of bleeding and ischemia. Close monitoring that includes a full neurological assessment and frequent follow-up visits with cardiac echocardiography are important. The risk of periprocedural stroke in left atrial and transcatheter mitral valve procedures is not negligible. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is important to mitigate the risk of stroke, especially the long-term risk. More prospective studies are needed to assess the efficacy of CEPD in such procedures.

Impact of moderate sedation on electrophysiology lab time for left atrial appendage occlusion using 4D-intracardiac echocardiography.

INTRODUCTION: Left atrial appendage occlusion (LAAO) can be performed using diverse anesthetic approaches ranging from moderate sedation (MS) to general anesthesia (GA), and guided by intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE). Prior studies have demonstrated shorter time in lab for heart rhythm procedures performed under MS. The objective of this study was to compare laboratory times, acute procedural outcomes and complication rates for LAAO procedures performed using MS and 4-dimensional ICE as opposed to GA. METHODS AND RESULTS: This was a retrospective observational cohort study of 135 consecutive patients who were referred for LAAO to be performed with either GA or MS between June 2022 and April 2024. The primary endpoints were total laboratory time, procedure time, nonprocedure time, and fluoroscopy time. The secondary endpoints were stroke, peri-device leak (>5 mm), device-related left atrial thrombus, cardiovascular mortality, and all-cause mortality at 45 days and 6 months postprocedure, where data were available. The mean age of patients in the study was 78.8 ± 7.8 years and 64.4% were male with no difference between GA and MS. In the MS group, 4D-ICE was used for intraprocedural imaging in 95.5% of patients and 2 dimensional-ICE (2D-ICE) was used in 4.5% of patients. In the GA group, intra-procedural imaging was done using TEE in 51.5%, 2D-ICE in 32.4% and 4D-ICE in 16.2% of cases. Total laboratory time was significantly lower in the MS group compared to the GA group (68.3 ± 23.1 vs 117.1 ± 34.3 min; p < 0.001), due to shorter nonprocedure time (15.2 ± 9.1 vs 63.7 ± 22.0 min; p < 0.001), with no significant difference in procedure time and fluoroscopy time. There was no significant difference in complications at 45 days and 6 months postprocedure. CONCLUSION: In this single center study, MS reduced total lab time by reducing nonprocedure time when compared to GA for LAAO, without affecting clinical outcomes.

Percutaneous or surgical LAAO for stroke prevention in patients with atrial fibrillation: A network meta-analysis.

Background: Stroke, which is mainly caused by thrombus formation in the left atrial appendage, represents the most prevalent complication of atrial fibrillation (AF). Both percutaneous left atrial appendage occlusion (p-LAAO) and surgical LAAO (s-LAAO) are used to treat AF and prevent stroke events. However, no head-to-head randomized controlled trials (RCTs) compared these strategies. Objective: To examine the efficacy and safety of diverse strategies for reducing stroke risk using a network meta-analysis (NMA). Methods: PubMed, EMBASE, and Cochrane repositories were explored to identify RCTs involving p-LAAO or s-LAAO, and five were included for NMA. This investigation adhered to the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-analyses. The NMA was pooled using the Bayesian random effect framework. All findings were expressed as odds ratios accompanied by a 95 % confidence interval.The primary efficacy endpoint was any stroke (AS), and the secondary efficacy endpoint was combined AS and systematic embolism (AS/SE). The primary and secondary safety endpoints were major bleeding (MB) and all-cause death (ACD), respectively. Results: Our meta-analysis incorporated 6337 individuals diagnosed with AF. The NMA demonstrated a reducing trend in AS and AS/SE for s-LAAO versus p-LAAO, while p-LAAO showed a benefit in reducing MB and ACD. Conclusions: and Relevance: s-LAAO could potentially benefit individuals at elevated risk for stroke, whereas p-LAAO may be linked to a reduced likelihood of bleeding.

Late-onset left atrial appendage occlusion device-related thrombus attributed to mitral bioprosthetic stenosis: a case report.

Background: Left atrial appendage occlusion (LAAO) is an alternative to anticoagulation for stroke prevention in select patients with atrial fibrillation (AF). In this study, we describe the case of a patient with delayed device-related thrombus (DRT) at 13 months post-LAAO in a setting of atrial stasis due to a worsening mitral bioprosthetic stenosis. Case summary: A 69-year-old woman with a history of rheumatic mitral stenosis and regurgitation post-bioprosthetic mitral valve replacement (6 years prior) and paroxysmal AF was referred for percutaneous LAAO due to recurrent severe gastrointestinal bleeding while on anticoagulation. She underwent an uncomplicated LAAO, for which a 35 mm Watchman Flx device was used. Peri-procedural transoesophageal echocardiogram (TEE) at the time of implant showed thickened and calcified mitral bioprosthetic leaflets and a mild mitral stenosis. Her 45-day post-LAAO TEE showed a mild mitral stenosis and no peri-device leak or DRT. At 12 months, the patient had worsening exertional dyspnoea and pedal oedema. Her 12-month transthoracic echocardiogram (TTE) showed a moderate mitral stenosis and LAAO remained free of DRT. Her symptoms were deemed secondary from a worsening mitral valve stenosis. Mitral valve-in-valve (MViV) replacement was planned because the patient was deemed a prohibitive risk for a redo surgical replacement. Transthoracic echocardiogram on the day of MViV showed a large thrombus on the LAAO device. MViV was postponed. After the patient completed 45 days of anticoagulation with warfarin, a repeat TTE was performed, which showed a resolution of DRT. Transcatheter MViV was performed successfully. Discussion: This case demonstrates that increased stasis and left atrial dysfunction from prosthetic mitral stenosis can be a risk factor for late DRT after successful LAAO. The use of a LAAO occlusion device in the presence of a mitral bioprosthesis requires more frequent echocardiographic monitoring to assess both the function of the prosthesis and a delayed formation of thrombus. More studies need to be conducted to assess the safety of percutaneous LAAO devices in those with mitral bioprosthesis.

Impact of Operator Experience on Left Atrial Appendage Occlusion Outcomes.

BACKGROUND: The relationship between long-term outcomes and operator experience for left atrial appendage occlusion (LAAO) is still unknown. OBJECTIVES: This study sought to explore the association between operator LAAO experience and one-year clinical outcomes. METHODS: The RECORD study (Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology; NCT03917563) was a multicenter, prospective registry that included patients with the WATCHMAN LAAO device (Boston Scientific) in China from April 1, 2019, to October 31, 2020. The current analyses included patients with solely LAAO from the registry; those who had concomitant LAAO and ablation/other procedures were excluded. The primary outcome was a composite endpoint of death, stroke, systemic embolism, and Bleeding Academic Research Consortium (BARC)-defined type 3 or 5 bleeding at 1 year. RESULTS: A total of 1,547 LAAO patients and 111 operators were included. The mean ± SD CHA2DS2-VASc and HAS-BLED scores of patients were 4.0 ± 1.8 and 2.5 ± 1.1, respectively. The mean ± SD age of operators was 47.0 ± 7.2 years, 15 (13.5%) were female, and 52 (46.8%) were electrophysiologists. Utilizing maximally selected log-rank statistics, the thresholds to categorize an experienced operator were performing ≥32 LAAOs annually or ≥134 LAAOs in total. Performing ≥32 LAAOs annually is the better criterion than ≥134 LAAOs in total (absolute net reclassification index: 25.79%; P < 0.001). Compared with the ≥32 LAAO annually group, the <32 group was associated with a 1.8-fold (HRadjusted: 1.79; 95% CI: 1.16-2.78; P = 0.009) increase in the risk of the primary endpoint, and such risk in the <32 group can be reduced by ∼12% after performing each additional 5 cases (HRadjusted per 5 cases: 0.88; 95% CI: 0.78-0.99; P = 0.033). CONCLUSIONS: Performing ≥32 LAAOs annually could be a threshold to categorize an experienced operator. Before reaching this threshold, the risk of death, stroke, systemic embolism, and BARC-defined type 3 or 5 bleeding decreased by 12% after every 5 cases performed.

Catheter ablation for atrial fibrillation in patients with prior left atrial appendage occlusion device.

BACKGROUND: The safety and efficacy of CA for AF and left-sided atrial arrhythmias (AA) in patients with left atrial appendage occlusion (LAAO) devices are lacking. METHODS: This is a single-center retrospective registry that included all patients with prior LAAO who underwent catheter ablation for AF or left-sided atrial arrhythmia from January 2020-January 2023. The primary outcomes were procedure-related complications, device-related complications, AA recurrence, and stroke. RESULTS: A total of 30 patients with prior LAAO were included in the analysis (mean age 75.1 ± 7.1 years old, 50% male, mean CHA2DS2-VASc score 4 ± 1.6, 46.7% paroxysmal AF, 73.3% had prior AF ablation, mean time to ablation 475 ± 365 days). 93.3% (n = 28) and 6.6% (n = 2) patients had ablation for AF (46.7% paroxysmal, 36.7% persistent, 10% long-standing persistent) and left-sided atrial tachycardia, respectively. 16.7% (n = 5) patients underwent ablation along the left atrial appendage ostium, and 3.3% (n = 1) underwent Vein of Marshall alcohol ablation. There were 3 (10%) peri-procedural complications (1 access hematoma and two pericardial effusions requiring intervention-none related to left atrial appendage ostium or alcohol ablation). During the mean follow-up of 440 ± 379 days, 40% (n = 12) patients had AA recurrence (91.6% AF, 8.3% atrial tachycardia), of which five patients needed repeat ablation, and two patients were readmitted for heart failure. There was no stroke or any device-related complications, including new peri-device leaks or device-related thrombosis in patients who had follow-up imaging studies (n = 11, 36.7%). CONCLUSION: Catheter ablation for AF (including VoM alcohol ablation) in patients with prior LAAO devices is feasible and safe with favorable outcomes.

Iatrogenic atrial septal defects in structural heart interventions: Opening the Pandora's box.

In the modern era of structural heart interventions, the total number of transseptal procedures is growing exponentially, thus increasing the rate and need for management of iatrogenic atrial septal defects (iASDs). To date, there are no official guidelines on the assessment and management of iASDs, due to inconclusive evidence on whether patients benefit more from the percutaneous closure of iASD than from conservative management and vigorous follow-up. Despite the abundance of observational studies on iASDs, there is still a lack of randomized studies. Evidence so far show that percutaneous closure is no superior over conservative treatment in patients with iASDs, however, it has been demonstrated that patients with spontaneous closure of iASDs experience less heart failure (HF) hospitalizations. On the other hand, researchers have investigated the beneficial nature of interatrial shunt therapy in patients with HFpEF and, more recently, with HFrEF, due to the presumed hemodynamic benefits. Herein, we provide an updated review of relevant literature, focusing on iASD persistence rates, predicting factors for their persistence, and clinical outcomes of iASD persistence, to summarize available evidence and discuss future directions in the field.

Percutaneous LAAO and Pulsed-Field Isolation in a Canine Model: Feasibility and Safety Evaluation.

In this study, we investigated the feasibility, safety, and efficiency of using a novel device system to perform percutaneous left atrial appendage occlusion concomitant with left atrial appendage electrical isolation (LAAEI) via pulsed field ablation. In the acute phase, LAAEI was successful in 10 of 10 canines. At follow-up, full endothelialization was observed in 5 of 5 (100%) cases at 6 months. LAAEI was durable in 8 of 10 (80.00%) canines. Histologic examination in 4 of 6 LAAs with durable isolation showed transmural scars comprising fibrosis and fat. No pericardial effusion or phrenic paralysis was observed at follow-up. This preliminary study provides the scientific basis for first-in-human studies.

Efficacy and safety of the VASCADE® MVP venous vascular closure device in patients undergoing percutaneous left atrial appendage occlusion with WATCHMAN.

BACKGROUND: The VASCADE MVP venous vascular closure system is commonly used for percutaneous venotomy closure in catheter-based procedures utilizing sheath sizes 6-12 French. However, its application with larger sheaths such as ones required in left atrial appendage occlusion (LAAO) has yet to be explored. AIMS: This study compared the efficacy and safety of VASCADE MVP versus conventional Figure-of-8 sutures (Fo8) for femoral venotomy closure in patients undergoing Watchman LAAO. METHODS: This single-center retrospective analysis included patients who underwent post-LAAO femoral venotomy closure with either VASCADE MVP or Fo8 sutures. The primary efficacy endpoint was time to hemostasis (TTH). Primary safety endpoints were 30-day access site-related readmissions and major complications. Minor access-site-related complications were also assessed. RESULTS: 107 patients underwent post-LAAO femoral venotomy closure with VASCADE MVP, of which 101 were successful (94.4%). 99 patients underwent conventional closure with Fo8 sutures and supplemental manual pressure. Baseline characteristics were similar between groups. TTH was significantly shorter with VASCADE MVP (152.9 vs. 335.8 s, p = 0.001). Major safety outcomes were comparable. However, the conventional group experienced a higher incidence of ecchymosis (16.2% vs 4.7%, p = 0.007) and 30-day all-cause readmission (18.2% vs 8.4%, p = 0.038). CONCLUSIONS: VASCADE MVP significantly reduced TTH compared to Fo8 sutures after LAAO. While demonstrating a similar safety profile, VASCADE MVP may offer a more efficient approach to femoral vein closure in this patient population.

Stroke Prevention With Prophylactic Left Atrial Appendage Occlusion in Cardiac Surgery Patients Without Atrial Fibrillation: A Meta-Analysis of Randomized and Propensity-Score Studies.

BACKGROUND: The role of left atrial appendage occlusion (LAAO) in patients without previous atrial fibrillation (AF) is not established. This meta-analysis was conducted on patients with normal sinus rhythm who underwent cardiac surgery, with and without concomitant LAAO, to evaluate its effect on the incidence of cerebrovascular accidents (CVAs). METHODS: A systematic review was conducted from inception until December 2023 for randomized and propensity-score studies comparing CVA in patients without AF undergoing cardiac surgery with or without LAAO. RESULTS: Six studies met our inclusion criteria with a total of 4130 patients: 2146 in the LAAO group and 1984 in the no-LAAO group. The risk ratio of postoperative AF was 1.05 (95% CI, 0.86-1.28); P=0.628. The CVA rates at 5 years were 6.8±1.0% in the no-LAAO group and 4.3±0.8% in the LAAO group (log-rank P=0.021). The Cox regression analysis for CVA in patients undergoing LAAO reported a hazard ratio of 0.65 (95% CI, 0.45-0.94); P=0.022. Landmark analysis at 4 years highlighted a significant difference in overall survival between no-LAAO and LAAO groups, 86±12.2% versus 89.6±11.0%; P=0.041. CONCLUSIONS: In this meta-analysis of patients without previous AF undergoing cardiac surgery, LAAO was associated with a decreased risk of CVA, no difference in the incidence of postoperative atrial fibrillation, and a significant overall survival benefit at a 4-year landmark analysis. Although these findings support LAAO, the randomized LeAAPS trial (Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial), LAA-CLOSURE trial (A Randomized Prospective Multicenter Trial for Stroke Prevention by Prophylactic Surgical Closure of the Left Atrial Appendage in Patients Undergoing Bioprosthetic Aortic Valve Surgery), and LAACS-2 trial (Left Atrial Appendage Closure by Surgery-2) will help define the effectiveness of LAAO in patients undergoing cardiac surgery who have risk factors for AF and CVA. REGISTRATION: URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42024496366.

Left Atrial Septal Pouch (LASP) and Cryptogenic Stroke: A Narrative Review.

Over 20% of ischemic strokes are cardioembolic strokes, necessitating research into thrombus formation locations, particularly the left atrial appendage (LAA). The left atrial septal pouch (LASP), which is linked to thrombus development and stasis, has drawn attention recently as a possible thromboembolic location, especially in atrial fibrillation (AF). The primary aim of this review is to explore LASP's role in cryptogenic strokes and to discuss the methods used to assess LAA anatomy. Imaging modalities such as cardiac computed tomography (CT) and transesophageal echocardiography (TEE) are crucial for diagnosing and characterizing LASP. LASP, found in about one-third of individuals, provides an additional site for thrombus development in the left atrium. The potential clinical implications of LASP-related thromboembolic events include the need for targeted therapeutic strategies, such as anticoagulant medication and, in some cases, consideration of LASP closure to prevent recurrent strokes. Further investigation is required to elucidate LASP's involvement in thromboembolic events and to guide stroke prevention in at-risk patients.

Anticoagulation Alone vs Anticoagulation Plus Aspirin or DAPT Following Left Atrial Appendage Occlusion.

BACKGROUND: The prevalence of and outcomes associated with different antithrombotic strategies after left atrial appendage occlusion (LAAO) are not well described. OBJECTIVES: This study sought to evaluate patterns of antithrombotic medication strategies at discharge following LAAO with the Watchman FLX device in real-world practice and to compare the risk of adverse events among the different antithrombotic regimens. METHODS: The authors evaluated patients in the NCDR (National Cardiovascular Data Registry) LAAO Registry who underwent LAAO with the second-generation LAA closure device between 2020 and 2022. They grouped patients by mutually exclusive discharge antithrombotic strategies and compared the rates of adverse events at 45 days and 6 months using multivariable Cox proportional hazards regression. RESULTS: Among 53,878 patients undergoing successful LAAO with the second-generation LAA closure device, the most common antithrombotic discharge regimens were direct oral anticoagulant (DOAC) plus aspirin (48.3%), DOAC alone (22.6%), dual antiplatelet therapy (8.1%), warfarin plus aspirin (7.7%), and DOAC plus P2Y12 inhibitor (4.9%). In multivariate analysis, DOAC alone had a lower rate of major adverse events and major bleeding at 45 days of follow-up compared with DOAC plus aspirin (major adverse events: HR: 0.78; 95% CI: 0.68-0.91; major bleeding: HR: 0.69; 95% CI: 0.60-0.80). These differences persisted at 6 months. Warfarin without aspirin also showed lower rates of major bleeding at both time points. No differences were seen in stroke/transient ischemic attack or device-related thrombus. CONCLUSIONS: In real-world U.S. practice, discharge on DOAC alone or warfarin alone was associated with a lower rate of adverse events compared with DOAC plus aspirin.

Intracardiac vs transesophageal echocardiography for left atrial appendage occlusion: An updated systematic review and meta-analysis.

BACKGROUND: Multiple studies continue to evaluate the use of intracardiac echocardiography (ICE) and transesophageal echocardiography (TEE) for guiding left atrial appendage occlusion (LAAO). OBJECTIVE: The purpose of this study was to conduct an updated meta-analysis comparing the effectiveness and safety outcomes of both imaging modalities. METHODS: PubMed, Cochrane, and Embase were searched for studies comparing ICE vs TEE to guide LAAO. Odds ratios (ORs) with 95% confidence intervals (CIs) were pooled using a random-effects model. The primary effectiveness endpoint was procedural success. The primary safety endpoint included the overall complications rate. Additional safety outcomes were assessed as secondary endpoints. Subgroup analysis of primary endpoints was conducted according to device type (Amulet, LAmbre, Watchman, Watchman FLX) and study region (American, Asia, Europe). R Version 4.3.1 was used for all statistical analyses. RESULTS: Our meta-analysis included 19 observational studies encompassing 42,474 patients, of whom 4415 (10.4%) underwent ICE-guided LAAO. Compared with TEE, ICE was associated with a marginally higher procedural success (OR 1.33; 95% CI 1.01-1.76; P = .04; I2 = 0%). There was no significant difference in the overall complications rate (OR 1.02; 95% CI 0.77-1.36; P = .89; I2 = 5%). However, ICE showed higher rates of pericardial effusion (OR 2.11; 95% CI 1.47-3.03; P <.001; I2 = 0%) and residual iatrogenic atrial septal defect (iASD) (OR 1.52; 95% CI 1.15-2.03; P <.004; I2 = 0%). Subgroup analysis revealed variations in procedural success within the ICE group across study regions (P = .02). CONCLUSION: In this updated meta-analysis, the increasing adoption of ICE-guided LAAO demonstrated higher procedural success rates compared to TEE, although with limited statistical significance. Overall complication rates were similar; however, ICE showed higher rates of pericardial effusion and residual iASD.