Left Atrial Appendage Occlusion Research Articles

Impact of left atrial appendage occlusion in atrial flow evaluated through 4D flow cardiac magnetic resonance

Abstract Introduction Device-related thrombus (DRT) and peri-device leak constitute significant complications following left atrial appendage occlusion (LAAO), primarily due to its association with strokes and thromboembolic events. Patient-specific fluid simulations have been employed to explore this hypothesis(1). However, these simulations require detailed anatomical and physiological data, rely on certain assumptions when defining boundary conditions, and involve long computational times. Recently, there has been growing interest in the use of 4D flow cardiac magnetic resonance (CMR) imaging for various cardiovascular diseases, owing to its capability to reproduce blood flow. While its role in the LAAO scenario has been evaluated in silico(2), there are no reported cases of its application in patients undergoing LAAO. Purpose Our objective was to evaluate the impact of LAAO in atrial flow through 4D flow CMR. Methods Five patients undergone LAAO were included in the pilot study. A pre- and 90-days post-procedure 4D flow CMR scans were performed. One of the patients was excluded due to suboptimal image quality. To assess the impact of LAAO on atrial flow dynamics, three parameters were evaluated: a) mean velocity, b) stasis velocity ratio, and c) endothelial cell activation potential (ECAP) index — all associated with an elevated risk of thrombus formation(3,4). Results Baseline and procedural characteristics, along with imaging results, are presented in Table 1. Preprocedural 4D flow CMR for all patients revealed low velocities (Figure 1A) and a high ECAP index (Figure 2A) in the left atrial appendage, indicating flow stasis and an elevated risk of thrombus formation. Successful device implantation was performed in all cases, and no periprocedural complications were detected. Postprocedural 4D flow CMR was feasible in all cases, and no artifacts were detected despite the presence of the LAAO device. An objective increase in velocities and a decrease in the ECAP index were observed in all cases following LAAO. No DRT or ischemic events were reported during follow-up. Conclusions Our preliminary study demonstrates that 4D flow CMR provides valuable information on left atrial flow dynamics following the LAAO procedure. Further studies are warranted to evaluate this promising technique.Table 1.Patient characteristicsFigure 1 and 2.Representative example

Anticoagulation status and left atrial appendage occlusion indications in hospitalized cardiology patients with atrial fibrillation: a Hellenic Cardiorenal Morbidity Snapshot (HECMOS) sub-study

Abstract Background Proper use of oral anticoagulants is crucial in the management of non-valvular atrial fibrillation (NVAF) patients. Left atrial appendage occlusion (LAAC) may be considered for stroke prevention in patients with NVAF and contraindications for long-term anticoagulant treatment. Purpose We aimed to assess the anticoagulation status and LAAC indications in patients with NVAF from HECMOS (Hellenic Cardiorenal Morbidity Snapshot) survey. Methods HECMOS was a nationwide snapshot survey of cardiorenal morbidity in hospitalized cardiology patients. HECMOS used an electronic platform to collect demographic and clinically relevant information from all patients hospitalized on March 3, 2022, in 55 different cardiology departments. In this substudy, we included patients with known AF without mechanical prosthetic valves and moderate to severe mitral valve stenosis. Patients with poor adherence to anticoagulants, high bleeding risk, previous major bleeding, and previous stroke were considered candidates for LAAC. Results Two hundred fifty-six patients (mean age 76.6±11.7, 148 males) were included in our analysis. Most of them (n=159; 62%) suffered from persistent AF. Mean CHA 2 DS 2 - VASc score was 4.28±1.7, while mean HAS-BLED score was 1.47±0.9. Three out of 3 patients with a CHA 2 DS 2 -VASc 0 or 1 (female) received improperly anticoagulants. Sixteen out of 18 patients with a CHA 2 DS 2 -VASc 1 or 2 (female) received anticoagulants. Thirty-three out of 235 patients with a CHA 2 DS 2 -VASc > 1 or 2 (for female) did not receive improperly anticoagulants. Among 221 under anticoagulant therapy, 191 (86.4%) received non-vitamin K antagonist oral anticoagulants (NOACs) and 30 (13.6%) received vitamin K antagonists. Relative indications for LAAC were present in 77 patients with NVAF (53 had only one risk factor, while 22 had two and 2 patients had three concurrent risk factors). In detail, 15 reported poor or no adherence to the anticoagulant therapy, 17 patients had a history of major bleeding, 36 had a prior stroke and 35 had a HAS-BLED score ≥3. No LAAC treatment was recorded. Conclusion Αnticoagulation status was nearly optimal in a high thromboembolic risk population of cardiology patients, mainly treated with NOACs. Three out of ten AF patients should be screened for LAAC.Anticoagulation by thrombotic riskPotential LAAC candidates

A novel bionic constructional left atrial appendage occlude device: the result of preclinical experiment and first-in-human study

Abstract Objectives Left atrial appendage occlusion (LAAO) has emerged as a viable substitute for oral anticoagulation (OAC) for stroke prevention among individuals with atrial fibrillation (AF) these years. The high variability of left atrial appendage (LAA) in different individuals would lead to failure of LAAO or significant PDL post procedure using the existing occluders. Therefore, novel occluder which could address these issues is of great urgent. Methods SimuLock® occluders were implanted in 18 healthy canines percutaneously. Angiography and transesophageal echocardiography were employed to evaluate the effect of closure. The canines were sacrificed post-procedure immediately or on 30th, 90th and 180th. Subsequently, the gross anatomy was examined and endothelialization of device surface was evaluated by HE staining. 3 patients who had non-valvular AF and underwent LAAO in Zhongshan hospital, Fudan University using SimuLock® were enrolled in this study. They all had a follow-up of 3 months. Results All animals were implanted with the SimuLock® device. In 27.8% of animal cases, a LAA occluder of the "large umbrella and small disc" type which could adapt to LAA morphology well was employed, and all surpassed the specifications of existing occluders. None of residual shunt was observed all canines in 180 days post procedure. In addition, none adverse events were documents during the 6-month follow-up. In the first-in-human study, the SimuLock® occluder were successfully implanted in 3 subjects, all subjects achieved complete occlusion, without residual shunt > 3mm. The incidence of major adverse events, operation-related serious adverse events and device-related serious adverse events in all subjects were not documented in 3 months after operation. Conclusions In the animal experiment and first-in-human study, SimuLock® device showed the ability of adapting to various LAA morphology well and rapid endothelialization. The utilization of SimuLock® for LAAO exhibited high efficacy and safety.Central figure

Concomitant left atrial appendage occlusion and transcatheter aortic valve replacement among patients with atrial fibrillation: an updated systematic review and meta-analysis

Abstract Background Atrial fibrillation (AF) is a prevalent arrhythmia in patients undergoing transcatheter aortic valve replacement (TAVR). Left atrial appendage occlusion (LAAO) has emerged as a viable strategy to prevent stroke in selected patients with AF. While both devices can be implanted simultaneously during a single procedure, the safety and efficacy of this approach remain uncertain. Purpose This study aims to evaluate the efficacy and safety of concomitant LAAO in patients with AF and aortic valve disease undergoing TAVR. Methods We conducted a systematic review and meta-analysis of randomized controlled trials and observational studies that compared concomitant TAVR and LAAO with isolated TAVR. The study's primary outcomes were all-cause mortality, stroke or transient ischemic attack (TIA), and major bleeding. We established a minimum follow-up time of six months. Results Three studies met our eligibility criteria, including one randomized controlled trial and two observational studies. The meta-analysis included 570 patients, 249 (44%) who underwent LAAO and TAVR, with a mean follow-up of 16.3 months. In the overall population, there was no significant difference between the groups in all-cause mortality (relative risk [RR] 0.95; 95% confidence interval [CI] 0.67-1.35; p = 0.78; figure 1A), major bleeding (RR 1.15; 95% CI 0.75-1.77; p = 0.51; 1B), and stroke or TIA (RR 0.70; 95% CI 0.33-1.45; p = 0.33; figure 1C). Conclusion In conclusion, concomitant LAAO and TAVR did not demonstrate discernible clinical differences compared to isolated TAVR in patients with AF and aortic valve disease. We recommend that this therapeutic approach be individualized until more robust data become available.

Intracardiac vs transesophageal echocardiography for percutaneous LAA occlusion: a meta-analysis

Abstract Background Percutaneous left atrial appendage occlusion (LAAO) is typically performed under the guidance of transesophageal echocardiography (TEE) and fluoroscopy. Intracardiac echocardiography (ICE) appears to be a potential alternative to guide implantation. Purpose We sought to perform a meta-analysis comparing ICE and TEE for endocardial LAAO. Methods A comprehensive literature search was performed in PubMed and Google Scholar regarding published abstracts and manuscripts on July 1, 2023. Studies reporting clinical outcomes comparing ICE vs TEE for endocardial LAAO were included. Results A total of 16 studies with 123,444 patients (ICE-5,122 patients and TEE-122,667 patients) (mean age 75±4 years, 59%male) fulfilled the criteria. Five included Watchman, four included the Amplatzer Cardiac Plug/ Amulet device, and seven included both devices. There was no significant difference in CHA2DS2VASC or HAS-BLED scores between both groups. Outcomes assessed including procedural success between ICE vs TEE (risk ratio [RR], 1.01; 95% CI, 1.00-1.01), fluoroscopy time (mean difference [MD], 1.25 minutes; 95% CI, -1.63- 4.14) and total procedure time (MD, −3.74 minutes; 95% CI, − 13.42-5.94) were found to be similar between both groups. There was also no significant difference in complications including vascular complications, bleeding events, device embolization, and stroke between both groups. Of note, patients undergoing LAA closure under ICE guidance had higher risk for pericardial effusion and/or cardiac tamponade compared to those in the TEE group (RR 1.72; 95% CI, 1.32-2.23). Conclusions Although TEE is the gold standard for perioperative guidance of LAAO, imaging with ICE is a feasible alternative associated with similar efficacy outcomes in LAAO procedures. However, further studies needed to clarify safety of ICE as an alternative perioperative imaging technique.

Prevention of thromboembolic events in atrial fibrillation patients with persistent leaks following the watchman implantation

Abstract Introduction Peri-device leak is not uncommon after percutaneous occlusion of left atrial appendage using the Watchman device. Prior studies have reported the clinical relevance of small leaks (<5mm) as they were associated with a significant increase in ischemic events. Purpose We evaluated the prevalence of stroke in patients with post-watchman leaks on half-dose non-vitamin K oral anticoagulants (HD-NOAC) vs antiplatelet therapy (APT). Methods This consecutive series included post-watchman cases that had a residual leak of ≤5 mm at the 45-day echocardiogram and were unwilling to undergo any leak-closure procedure. Based on their subsequent antithrombotic therapy, they were classified into group 1: HD-NOAC and group 2: dual-APT for 6 months followed by Aspirin only. Patients were closely monitored for thromboembolic (TE) events via telemedicine. Stroke/transient ischemic attacks that occurred while the patients were in full compliance with the anti-thrombotic therapy, were counted as the reportable TE events. Results A total of 141 (age: 66.89± 8.76 years, male: 88 (62.4%), CHA2DS2-VASc score: 3.41 ± 1.56, HAS-BLED: 3.72 ± 1.01) and 154 (age: 72.45 ±7.05 years, male: 99 (64.3%), CHA2DS2-VASc score: 3.75 ± 1.61, HAS-BLED: 3.89 ± 1.05) patients were included in group 1 and 2 respectively. All leaks were between 3-5 mm. TE events were reported in 2 (2/141, 2.12%) patients in group 1 and 9 (9/154, 5.8%) in group 2 while being on antithrombotic therapy (p=04). No residual neurological deficits were detected in the 2 patients from group 1 contrary to the 9 subjects in group 2 that had neurological deficits persistent at follow-up. Of note, 8 (5.6%) patients in group 1 experienced stroke after discontinuing the drug for other medical procedures or due to poor compliance. Conclusion Under full compliance, HD-NOAC is associated with significantly lower TE rate compared to the APT therapy in post-watchman cases with persistent leaks of ≤5 mm. However, discontinuation of the HD-NOAC increases the stroke-risk to a comparable level.

Investigation of age-related in-hospital outcomes of left atrial appendage occlusion in germany

Abstract Background The aim of this study was to assess demographics, in-hospital mortality and baseline characteristics of hospital cases with a left atrial appendage occlusion (LAAO) procedure in relation to patient age. Methods This is a retrospective observational analysis of all German in-hospital cases from 2016 to 2022 with a coded LAAO procedure using the Diagnose Related Groups (DRG) statistics database of the Research Data Center of the Federal Statistical Office. Results In total 40435 cases were observed in the investigated time period. Over the 5 years studied we found a significant shift towards an older patient collective. Compared to 28,3% in 2016, in 2022 40,1% of all patients were over 80 years of age (a rise of 152 %). Cases of patients with over 85 years of age increased from 7.7 % to 11.4 % during the same time period. We observed an in-hospital death rate for patients <70, 70-75, 80-85 and >85 years of age in 0.8, 1.0, 1.4 and 2.2 % respectively. Further we saw significant higher rates of intensified care treatment, pericardial effusion, acute kidney injury and red blood cell transfusion for patients >80 years of age. In unadjusted and adjusted logistic regression models age was significantly associated with a higher rate of in-hospital death. Conclusions In this study we present real world data from a health-care-system level. Our main findings were an increasing age in patients undergoing LAAO procedures and an independent association of age with in-house mortality and complications. This data provides a further basis to balance risks and benefits of LAAO procedure as a preventive treatment.

Significant reduction of complications applying an optimized vascular access and post-interventional groin-site management during electrophysiology procedures

Abstract Background Catheter ablation of cardiac arrhythmias is an established treatment strategy. However, the optimal femoral vascular access strategy and post-interventional management in the electrophysiology (EP) setting is still under debate. Purpose To assess the impact of ultrasound-guided versus conventional femoral vascular puncture and of a modified post-interventional groin-site management strategy on complication rates. Method Patients undergoing EP procedures at the our university heart and vascular center are included in an institutional prospective registry. Conventional vascular access as well as post-interventional groin site pressure-bandage and bed rest of 6 hours (group I) was compared to a new strategy including ultrasound-guided vascular access, venous closure by a Z-suture and groin site pressure-bandage for only 2 hours plus additional 4 hours bed rest (group II). Incidences of minor and major groin site complications for both groups were compared. Hematoma, bleeding, arteriovenous fistula or pseudoaneurysm of the femoral artery without need for intervention (e.g. transfusion, thrombin injection, surgery) were classified as minor complications. Complications requiring intervention or retroperitoneal hematoma were defined as major complications. Results A total of 1535 procedures in 1381 patients (779 (51 %) procedures in 705 (51%) patients in group I and 756 (49%) procedures in 676 (49%) patients in group II) were analyzed. In group I and group II, respectively, 39%/44% procedures were index pulmonary vein isolations, 30%/29% repeat atrial fibrillation, 16 %/15% supraventricular tachycardia, 12%/11% PVC or VT ablations, and 4%/2% left atrial appendage occlusions. The total groin site complication rate was 9% (70/779 procedures) for group I, and 5% (38/756 procedures) for group II (OR 0.54 [95%-CI 0.35-0.82], p=0.003). Major groin site complications occurred in 2% (19/779 procedures) in group I and were reduced to 1% (10/756 procedures) in group II (OR 0.53 [95%-CI 0.22-1.22], p=0.156). Conclusion The overall groin site complication rate in EP-procedures was significantly reduced by implementing a novel institutional standard for vascular access management including ultrasound-guided puncture and a modified post-interventional groin site management.

Sex differences in outcomes of percutaneous left atrial appendage closure

Abstract Background Atrial fibrillation (AF) is the most common arrhythmia in adults and is associated with an increased risk of embolic stroke. In a previous survey, 91% of nonrheumatic AF-related left atrial thrombi was originated in the left atrial appendage (LAA). Percutaneous left atrial appendage closure (LAAC) with the Watchman device has been shown to be noninferior to anticoagulation therapy in clinical trials for stroke prevention in nonrheumatic AF. 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. Since long time ago, sex differences have been attracting attention in the cardiology. Due to the cardiovascular protective effects of endogenous estrogens, premenopausal women are thought to be less likely to develop cardiovascular disease. Whereas, in area of AF, Female with AF have higher stroke risk and female with AF have severe after effect. However, there are few studies on sex differences in LAAC implantation outcomes. Purpose We aimed to identify the sex differences of outcomes of LAAC in Japanese patients. Methods A total of 118 consecutive patients who underwent LAAC at our hospital from January 2020 to August 2023 were prospectively analyzed. Various patient characteristics, comorbidities, and outcomes were identified and compared between male and female. Results Results are shown in Table. Female were older (79 vs. 73 years, p = 0.0009), thinner (Body mass index 22 vs. 24 kg/m2, p = 0.0326), and less likely to have had diabetes (19 vs. 40%, p = 0.0340). Pulmonary embolism was significantly more common in female after LAAC. If anticoagulants are discontinued after LAAC, women’s susceptibility to coagulation may become apparent. Conclusions LAAC was feasible and safe for Japanese patients of both genders. However, these results could have a relevant impact on the antithrombotic management of patients who are at the high risk of embolic considering sex difference. Especially, we should pay great attention when discontinuing anticoagulants after LAAC in female.

Novel predictor of thrombosis after left atrial appendage closure -Neutrophil to Lymphocyte Ratio (NLR), platelet to LymPhocyte Ratio (PLR), and Lymphocyte to Monocyte Ratio (LMR)-

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. The WATCHMAN family is the only left atrial appendage closure (LAAC) device in Japan. After percutaneous left atrial appendage closure (LAAC), DRT is an important issue in some cases. Neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), and lymphocyte to monocyte ratio (LMR) are known as cancer prognostic factors and indicators of immune status. There are few reports on the predictor for device related thrombosis (DRT), transient ischemic attack (TIA), and ischemic stroke. Finding novel biomarkers could help clinical decision in antithrombotic therapy post LAAC and follow-up intervals. Purpose To investigate the association of NLR, PLR, and LMR with device related thrombosis, transient ischemic attack, and ischemic stroke in patients with LAAC. Methods Our database of LAAC was respectively analyzed. All LAAC cases were performed between January 2020 and September 2023. Blood cell counts were sampled in three days before LAAC. Postoperative antithrombotic therapy was individualized based on the patient’s background. We examined their background and clinical events. Results A total of 116 consecutive patients underwent LAAC in our institution excepting for one case that could not be performed due to a huge LAA (follow-up period, 610±37 days; age, 75±1 years; male sex, 73%; left ventricular ejection fraction, 58±1%; CHAD2S2-VASc, 4.6±0.1; HAS-BLED, 3.4±0.1). The results are shown in the Figure. Receiver-operating characteristic curve analysis confirmed the best cut-off value of NLR, PLR, and LMR for composite of DRT, TIA, and ischemic stroke (AUC = 0.69; 0.70; 0.67). In the univariate analysis, NLR<1.88, PLR<144, and LMR>3.40 are the independent predictor for the combination of DRT, TIA, and ischemic stroke (p-value = 0.02; 0.04; 0.05, respectively). Conclusion Low NLR, low PLR, and high LMR are the independent predictor for the combination of DRT, TIA, and ischemic stroke. These parameters can be useful in routine use because they can be easily calculated without additional costs.

Strategy optimization for the combined procedure of left atrial appendage occlusion plus catheter ablation in patients with atrial fibrillation (COMBINATION): a multi-center, randomized study

Abstract Background The long-term efficacy and safety of combining left atrial appendage closure (LAAC) plus catheter ablation (CA) in patients with atrial fibrillation (AF) in a single procedure have been established. However, the optimal combining strategy has not been well elucidated. Objective To determine the impact of different combining strategies on long-term clinical outcomes. Methods In this prospective multicenter study, patients with non-valvular AF referred for the combining procedure were randomly assigned to the ablation-first or occlusion-first groups at a 1:1 ratio. We evaluated the outcomes of LAAC with a Watchman device and CA using a contact-force sensing catheter during long-term follow-up. Results Of the 202 randomized patients, 194(96.0%) completed the trial with 97 patients in each group. Baseline characteristics were comparable between groups. All procedures were accomplished with acute successful LAAC and restoration of sinus rhythm. Incidences of periprocedural complications were similar. Higher chronic peri-device leak (PDL, 15.5% vs 5.2%, P=0.031) and device-related thrombus (DRT, 8.2% vs 1.0%, P=0.035) rates were observed in the ablation-first group. The event-free survival rate of the primary endpoint (composite of stroke/transient ischemic attack, thromboembolism, clinically-relevant bleeding, cardiovascular rehospitalization/death) was significantly higher in the occlusion-first group (83.5% vs 71.1%, log-rank P=0.036, HR 0.53, 95%CI 0.29-0.95) during a median 2.5-year follow-up. Patients with male gender and higher CHA2DS2-VASc score were at lower risk in the subgroup analysis. Long-term freedoms from AF (77.3% vs 63.5%, log-rank P=0.039) and atrial tachyarrhythmias (70.1% vs 55.7%, log-rank P=0.044) were higher in the occlusion-first group, respectively. Conclusions The occlusion-first approach is recommended for combined procedures where a plug-like device is implanted due to its superior long-term clinical benefits.Flowchart of the COMBINATION trialIncidences of primary endpoint

Novel morphological classification of left atrial appendage using 3-dimensional printer -rock, paper and scissors-

Abstract Background 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. 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 All LAAC cases in our institution performed between February 2020 and December 2023 were retrospectively analyzed. 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 peripheral branches was "Paper" type; (3) The simple one was "Rock" type. We examined the between the risk of cardioembolic stroke and the morphological features of the LAA. The left atrial appendage was classified by two cardiologists, and when they made different choices, we used the operator's choice. Results The cohort consisted of 116 patients, excluding 22 patients without CT scans. Of those, 30 (26%), 38 (33%) and 48 (41%) patients were divided into the Rock, Scissors and Paper types, respectively. All groups were identically matched for comorbidities. Table shows the patient characteristics and the results of univariate and multivariate analysis. There were 51 (44%) patients who had a history of cardioembolic stroke (18% vs. 30% vs. 53%; Rock vs. Scissors vs. Paper types, p-value = 0.05). In the multivariate analysis, the Paper type is the potential risk factor of cardioembolic stroke (p-value = 0.01). In addition, of those, 36 (31%), 32 (28%), 28 (24%) and 20 (17%) patients were divided into the Chicken wing, Cactus, Cauliflower and Windsock types, respectively. The four types were not associated with prior cardioembolic stroke events (18% vs. 25% vs. 55%; Chicken wing vs. Cactus vs. Cauliflower vs. Windsock types, p-value = 0.83). The match rate of cardiologists’ choice was 86.2% for the new classification and 44.8% for the classical classification. Conclusions The morphological features of LAA by three-dimensional printing was significantly related to cardioembolic stroke in this population. Patients with Paper type LAA were significantly more likely to have had a history of cardioembolic 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.

Center-Related Variation in Hospitalization Cost for Patients Undergoing Percutaneous Left Atrial Appendage Occlusion

BackgroundThe commercial use of percutaneous left atrial appendage occlusion with the Watchman device is increasing in the United States. The purpose of this study was to evaluate center-related variation in total hospital costs for Watchman device implantation and identify factors associated with high hospital costs at a national level. MethodsAll adults undergoing elective left atrial appendage occlusion with Watchman were identified in the 2016-2018 National Inpatient Database. Mixed models were used to evaluate the impact of center on total hospital costs, adjusting for patient and center characteristics and length of stay. ResultsA total of 30,175 patients underwent Watchman device implantation at a median cost of $24,500 and demonstrated significant variability across admissions (interdecile range, $13,900-37,000). Nearly 13% of the variability in patient-level costs was related to the center performing the procedure rather than patient factors. Higher-volume centers had lower total costs and demonstrated lesser total cost variation. Centers with low procedural volume, occurrence of procedural complications, congestive heart failure, and length of stay were independent predictors of a high-cost hospitalization. Though complications were associated with increased expenditure, they did not explain the observed cost variation related to the center. ConclusionsA significant proportion of variation in total hospital cost was attributable to the center performing the procedure. Addressing variability of Watchman-related costs is necessary to achieve high-quality value-based care.

Minimalist approach to left atrial appendage occlusion through three-dimensional intracardiac echocardiography: Procedural steps and single-center experience

Atrial fibrillation (AF), the most prevalent arrhythmia worldwide, is associated with an annual risk of ischemic stroke of up to 5%, with approximately 98% of thrombi originating from the left atrial appendage (LAA). Direct oral anticoagulants or vitamin K antagonists remain the gold standard for preventing systemic thromboembolism in patients with AF. LAA occlusion (LAAO) is an alternative stroke prevention technique for patients with AF who cannot tolerate long-term anticoagulation. Percutaneous LAAO typically employs a multimodal imaging approach with contrast fluoroscopy and transesophageal echocardiography (TEE) for visualization, device selection and deployment, and complication monitoring. TEE is also used for follow-up imaging. However, it necessitates general anesthesia or deep sedation and is associated with a high risk of adverse events. Three-dimensional intracardiac echocardiography (3D ICE) has been proposed as a viable alternative to TEE for LAAO procedures. In this review, we summarized the current evidence regarding ICE guidance in LAAO procedures. We also presented a case series of consecutive patients presenting at our center who underwent LAAO, which was performed by a single operator using a minimalist approach of moderate sedation, 3D ICE, and same-day discharge. We also presented a summary of the minimalist approach to LAAO using 3D ICE and detailed procedural steps of 3D ICE catheter manipulation for successful LAAO intervention.

Efficacy and Safety of Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke: A Systematic Review and Meta-analysis

Introduction: Stroke remains a major cause of morbidity and mortality after cardiac surgery. One factor associated with stroke occurrence is postoperative AF (pAF), which predisposes to the formation of atrial thrombus. As most thrombi form in the left atrial appendage (LAA), there is significant interest in LAA as a potential therapeutic target. While guidelines recommend direct oral anticoagulants (DOACs) as the preferred therapy for stroke prevention in patients with AF and a CHA2DS2-VASc score of ≥2, they cannot be administered to all patients who are poor candidates for long-term oral anticoagulation because of the high risk of bleeding, drug compliance and drug tolerance. There are limited data on the efficacy and safety of LAA occlusion (LAAO) during cardiac surgery for stroke prevention. Methods: A comprehensive and relevant search of randomised controlled trials, cohort and case–control studies was conducted. Outcome measures for ischaemic stroke events, all-cause mortality and pAF were extracted and analysed using a random-effects model. Results: Twelve studies were included and 18,982 subjects were analysed. There were 231 ischaemic stroke events in 9,473 patients who received LAAO compared with 371 ischaemic stroke events in 9,509 patients who did not receive LAAO. Concomitant LAAO showed a significant difference in ischaemic event rate (risk ratio [RR] 0.65; [95% CI: 0.55–0.77]; p<0.00001, I2=0%) and all-cause mortality (RR 0.74; 95% CI [0.57–0.97]; p=0.03; I2=68%). For pAF, there was no difference between the two groups (RR 1.08; 95% CI [0.95–1.22]; p=0.24; I2=72). Conclusion: Concomitant LAAO was more effective in preventing ischaemic stroke events and all-cause mortality, with an overall moderate certainty of evidence. However, pAF rates were similar between LAAO and non-LAAO groups.

Long-Term Outcome of Patients with Atrial Fibrillation and High Risk of Stroke Treated with Oral Anticoagulation or Left Atrial Appendage Occlusion: A Cardinality Matched Analysis

Introduction: Atrial fibrillation (AF) poses a significant risk of stroke. Left atrial appendage occlusion (LAAO) is an alternative for patients with contraindications to oral anticoagulation (OAC) or with high risk of bleeding. This study aims to compare the outcomes of LAAO versus conventional stroke prevention in high-risk AF-patients. Methods: This secondary analysis incorporates data from the prospective Swiss-AF and Beat-AF cohorts, and the Zurich LAAO Registry. Cardinality matching was performed to create two comparable cohorts: conventional treatment (92% OAC) and LAAO. The primary endpoint was a composite of stroke, cardiovascular (CV) death, and clinically relevant bleeding. Kaplan-Meier method with competing risk analysis was used. Results: Each group included 468 patients (age 76.4 [70.5, 82.0] years, 33% female). The LAAO group exhibited higher baseline bleeding risk (HAS BLED 2.0 [1.0–3.0] versus 3.0 [3.0–4.0]; p < 0.001). Median follow-up time: 6.0 (4.7–7.0) years in conventional treatment group and 4.0 (1.5–6.1) in LAAO group. No significant difference in the primary composite endpoint (HR 0.87, 95% CI: 0.72–1.06, p = 0.18), stroke risk (HR 1.14, 95% CI: 0.66–1.97, p = 0.64), or CV mortality (HR 1.08, 95% CI: 0.82–1.42, p = 0.60) was observed between groups. LAAO correlated with a significantly lower risk of clinically relevant bleeding (HR 0.61, 95% CI: 0.47–0.80, p < 0.001). Conclusion: In this cardinality matched analysis with long-term follow-up, LAAO showed similar stroke and CV death rates but lower clinically relevant bleeding risk compared to conventional therapy in high-risk AF-patients.

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

Real-world studies comparing safety and efficacy of combined percutaneous left atrial appendage occlusion (LAAO) and catheter ablation (CA) to LAAO alone are limited. 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. 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. This large, real-world analysis indicates comparable safety and efficiency of combined LAAO and CA when compared with LAAO alone.

Clinical impacts of concomitant left atrial appendage occlusion during mitral valve surgery in patients with mitral regurgitation

Surgical occlusion of the left atrial appendage (LAA) during cardiac surgery in patients with atrial fibrillation (AF) is known to reduce thromboembolism. However, data on the clinical significance of LAA occlusion (LAAO) in patients with mitral regurgitation (MR) are lacking. A total of 237 AF patients with chronic severe MR who underwent mitral valve (MV) surgery were retrospectively analyzed. Patients were divided into two groups according to concomitant LAAO or LAA preservation. The primary outcome was a composite of all-cause death and thromboembolic events (ischemic stroke or systemic embolism). The LAA was surgically occluded in 98 (41%) patients and preserved in 139 (59%) patients. During the follow-up period (median, 37 months), 29 primary outcomes occurred. In the Kaplan–Meyer analysis, the LAA preservation group showed a greater cumulative incidence of the primary outcome (P = 0.002) and thromboembolic events (P = 0.003) than the LAAO group. In the univariate Cox regression analysis, coronary artery disease, CHA2DS2-VASc score, a cauliflower-shaped LAA, Maze, and no LAAO were significantly associated with the primary outcome. In the multivariate Cox regression analysis, concomitant LAAO was significantly linked to the primary outcome (hazard ratio [HR]: 0.30, 95% confidence interval [CI]: 0.10–0.91, P = 0.033) and thromboembolic events (HR: 0.19, 95% CI: 0.04–0.87, P = 0.032). These benefits from LAAO were consistent, even after propensity score–matched analysis. For patients undergoing surgery for chronic MR who also have AF, concomitant surgical LAAO is associated with favorable clinical outcome.

Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries.

Long-term outcomes following left atrial appendage occlusion outside clinical trials and small registries are largely unknown. Collecting these data was a condition of US market authorization of the WATCHMAN device. The aim of this analysis was to evaluate the rates of stroke, bleeding, and death among Medicare beneficiaries following left atrial appendage occlusion implantation during initial commercial availability of the WATCHMAN left atrial appendage occlusion device overall and in important subgroups. All Medicare fee-for-service beneficiaries ≥65 years of age who underwent left atrial appendage occlusion from April 1, 2016, to August 31, 2020, were included based on the International Classification of Diseases, Tenth Revision, and Current Procedural Terminology codes. Over a 5-year follow-up period, the cumulative incidence over time of mortality, ischemic stroke, and major bleeding were calculated using the International Classification of Diseases, Tenth Revision, diagnosis codes for the full study cohort and within important prespecified subgroups. WATCHMAN recipients (n=48 763) were a median of 77 (interquartile range, 72-82) years of age, 42% female, and mostly White (93%). The median CHA2DS2VASc score was 4 (interquartile range, 3-5) with prior major bleeding in 42% and prior stroke in 12%. At 5 years, death occurred in 44%, bleeding in 15% (with higher risk early following implantation), and ischemic stroke in 7%. Each of these end points was more common with greater baseline age. Male patients had greater 5-year mortality than female patients (46.9% versus 40.6%), but there was no difference between sexes in the rates of ischemic stroke (6.6% versus 7.5%) or major bleeding (14.9% for both). WATCHMAN recipients with prior ischemic stroke or a major bleeding event were older and frailer; these groups had higher rates of ischemic stroke, major bleeding, and death. Compared with patients enrolled in the pivotal clinical trials, Medicare beneficiaries undergoing WATCHMAN implantation were older, more female, and had more comorbid conditions. Substantial long-term mortality and major bleeding following WATCHMAN reflect the high-risk nature of the patient population, while the ischemic stroke rate was relatively low (<1.5% per year).

A high-fidelity personalised 3d printed simulator for the left atrial appendage occlusion procedure

Purpose This study aims to develop a realistic 3D printing-based simulator for the training and planning of the left atrial appendage occlusion (LAAO) to be used in the cath lab. Design/methodology/approach Starting from a pre-operative computed tomography dataset of a patient already treated with LAAO, the model was obtained, consisting in the right and left heart, opportunely assembled to replicate the position and orientation of the patient's anatomy while lying on the cath lab table. Different 3D printing techniques and materials were used to mimic the interaction between the cardiac tissue and the clinical instrumentation. The simulator was tested in the cath lab under proper image guidance by three LAAO expert operators. The clinicians were required to assign a score in terms of realism to each material used to fabricate the fossa ovalis and the LAA. Findings The simulated interventions were successfully performed by the operators, who were able to navigate in the system and release the occluder device as during a real procedure. The intraoperative images acquired during the simulations were highly comparable with data from a real intervention, with a mean percentage difference below 10%. Originality/value This study demonstrated the feasibility of the proposed simulator to faithfully replicate the LAAO procedure and its potentiality to be used for multiple purposes, including the training of the young clinicians, the evaluation of the most complicated cases and the design of novel occluder devices, in a fully realistic setting.