Left Atrial Appendage Closure Research Articles

Innovative Surgical Left Atrial Appendage Closure Technique: Early Experience of Inverted Spiral Closure Technique

Objective: Simultaneous closure of the left atrial appendage (LAA) during cardiac procedures has become a common preventive measure against cardiogenic embolic events associated with atrial fibrillation. However, this strategy encounters limitations during minimally invasive mitral valve surgery through a right minithoracotomy because access to the LAA is limited. The use of endocardial sutures for surgical exclusion of the LAA is also well established but has a notable rate of closure failure. We introduced a new surgical LAA closure technique called the inverted spiral closure technique (ISCT). Methods: Between July 2020 and August 2021, 26 patients underwent LAA closure with ISCT concomitant to mitral valve surgery in our hospital. Early postoperative outcomes and any stroke or thromboembolic event during the follow-up were evaluated. Transthoracic or transesophageal echocardiography (TEE) was used to assess LAA patency. Results: The ISCT procedure was performed successfully in all cases. No significant persistent flow between the left atrium and LAA was observed on intraoperative TEE. During a median follow-up of 1.1 years, no patients experienced stroke, myocardial infarction, or death. Postoperative echocardiography showed no significant residual flow within the LAA. One patient was incidentally found to have recanalization between the left atrium and LAA several months after surgery on an enhanced computed tomography scan during coronary evaluation. Conclusions: The ISCT can be performed reliably through the same left atriotomy for mitral valve surgery and is a useful and effective technique for surgical LAA exclusion. There are still not enough patients and modalities for postoperative evaluation.

Presence of Patent Foramen Ovale Does Not Increase Cerebrovascular Event Rates in Patients with Atrial Fibrillation Following Left Atrial Appendage Closure

ObjectiveBoth atrial fibrillation (AF) and patent foramen ovale (PFO) has been associated with occurrences of ischemic stroke. The aim of this study was to investigate whether patients with concomitant AF and PFO were at an increased risk of stroke, and whether PFO closure was necessary for the prevention of stroke in AF patients who underwent left atrial appendage closure (LAAC). MethodWe retrospectively analyzed 614 patients who underwent LAAC at Wuhan Asia Heart Hospital from May 2014 to April 2021. We compared the baseline clinical characteristics and ischemic stroke rates before LAAC, major adverse cardiovascular events (MACEs) and other long-term outcomes between AF patients with and without PFO after LAAC. The predictor for ischemic stroke or TIA after LAAC was analyzed with univariate and multivariable Cox regression, and the long-term cumulative survival rates of AF patients with PFO compared to those without PFO after LAAC were analyzed with the Kaplan–Meier graph. ResultsA total of 614 patients who underwent LAAC and had completed follow-up data were included in our study. Among them, 74 patients were diagnosed with AF with PFO, and 540 with AF without PFO. There was no significant difference between their baseline clinical data, including ischemic stroke rates (p = 0.961). Patients with and without PFO had similar device implantation success rates (98.6% vs 99.4%, P=0.403) and procedure-related complications. During follow-up (medium follow-up period 36.9 months), no significant difference was observed in the incidence of MACEs (8.1% in PFO group vs 5.7% in non-PFO group, P=0.432) or the cumulative ischemic stroke/TIA rates (5.4% in PFO group vs 4.3% in non-PFO group, P = 0.554). The Cox multivariable regression analysis indicated that the presence of PFO in patients with AF had no correlation with ischemic stroke or TIA after LAAC implantation (HR 1.685, 95% CI 0.570-4.978, P = 0.345). The only predictor for ischemic stroke/TIA events after LAAC was major leakage (>5mm) seen on transesophageal echocardiography (TEE) or left atrial CTA at the 45-day follow-up (HR 10.352, 95% CI 1.221-87.736, P = 0.032). ConclusionAF patients with PFO are not at increased risk for ischemic stroke or TIA before LAAC. The presence of PFO in AF patients did not affect the success rate and safety of LAAC. The presence of mild PFO is not a viable predictor of stroke events in AF patients who underwent LAAC during long-term follow-up. Major leakage (>5 mm) is associated with a higher ischemic stroke/TIA rate in AF patients who underwent LAAC.

Management Strategies to Prevent Stroke in Patients with Atrial Fibrillation and Malignant Left Atrial Appendage

BackgroundPatients with atrial fibrillation (AF) and malignant left atrial appendage (LAA) may benefit from LAA closure (LAAC); however, evidence is limited. ObjectiveTo determine management strategies and clinical outcomes in patients with AF and malignant LAA. MethodsMalignant LAA was defined as ischemic stroke or LAA thrombus formation despite continuous oral anticoagulation (OAC) therapy (continuous for ≥3 weeks). We studied 80 patients with malignant LAA treated with LAAC. We compared these patients first against 44 patients with malignant LAA treated with OAC alone, and second against 114 patients without malignant LAA who were treated with LAAC for conventional indications. ResultsIn patients with malignant LAA (first-comparison), patients treated with LAAC had a higher 1-year cumulative incidence of ischemic stroke than patients treated with OAC alone (6.3% vs. 5.3%, log-rank P=0.09) whereas, the difference in stroke risk while receiving OAC was comparable (2.7% vs. 5.3%, log-rank P=0.84). Furthermore, all disabling stroke events among patients with malignant LAA treated with LAAC occurred only while not receiving OAC. In patients treated with LAAC (second-comparison), those with malignant LAA had a higher 1-year cumulative incidence of ischemic stroke (and ischemic stroke due to device-related thrombosis) than patients without malignant LAA (6.3% vs. 2.2%, log-rank P=0.009; 2.2% vs. 0%; log-rank P=0.04, respectively). However, these differences in stroke risk were no longer significant while receiving OAC (2.7% vs. 1.0%, log-rank P=0.11). ConclusionsBoth performing LAAC and continuation of OAC may be options to prevent ischemic stroke in patients with high thromboembolic risk and malignant LAA.

Left Atrial Appendage Closure in Atrial Fibrillation Patients with Cancer

Background: There are limited data about left atrial appendage closure (LAAC) in patients with cancer. We therefore sought to compare the outcome after LAAC in patients with vs. without cancer in a multicentre registry. Methods: In this sub-analysis of the prospective Austrian LAAC Registry, we analysed consecutive patients undergoing LAAC to assess the relationship between baseline characteristics and outcome in patients with vs. without cancer. Inverse probability weighting was performed to adjust for differences in baseline characteristics. Results: A total of 486 consecutive patients from 9 centres with a median age of 75 years (IQR 70–79 years; 35.8% female) were included. Fifty-seven patients (11.7%) had a history of cancer. The median CHA2DS2-VASc and HAS-BLED scores were similar in both groups (median [IQR], 4 [4–6] vs. 5 [3–5], p = 0.415; 4 [3–4] vs. 3 [3–4], p = 0.428 in cancer vs. other patients). Cancer patients were significantly older, and anaemia and gastrointestinal bleeding were significantly more common. Major procedural complications occurred in 5.3% vs. 7.0% (p = 0.276) of patients. The cumulative five-year survival rates were 80.7% and 84.8% in cancer vs. other patients (adjusted hazard ratio for death 1.29 [95% CI 0.67–2.48], p = 0.443). There were also no differences in one-year survival (96.1% vs. 94.0%, p = 0.582) and five-year event-free survival (64.9% vs. 74.4%, p = 0.124). Conclusions: In daily clinical practice, LAAC has already been accepted as a treatment option in patients with cancer. This retrospective analysis shows that short-term and adjusted long-term complications are similar in patients with vs. without cancer undergoing LAAC.

An anthropomorphic phantom for atrial transseptal puncture simulation training

BackgroundTransseptal puncture (TSP) is a critical prerequisite for left-sided cardiac interventions, such as atrial fibrillation (AF) ablation and left atrial appendage closure. Despite its routine nature, TSP can be technically demanding and carries a risk of complications. This study presents a novel, patient-specific, anthropomorphic phantom for TSP simulation training that can be used with X-ray fluoroscopy and ultrasound imaging.MethodsThe TSP phantom was developed using additive manufacturing techniques and features a replaceable fossa ovalis (FO) component to allow for multiple punctures without replacing the entire model. Four cardiologists and one cardiology trainee performed TSP on the simulator, and their performance was assessed using four metrics: global isotropy index, distance from the centroid, time taken to perform TSP, and a set of 5-point Likert scale questions to evaluate the clinicians’ perception of the phantom’s realism and utility.ResultsThe results demonstrate the simulator’s potential as a training tool for interventional cardiology, providing a realistic and controllable environment for clinicians to refine their TSP skills. Experienced cardiologists tended to cluster their puncture points closer to regions of the FO associated with higher global isotropy index scores, indicating a relationship between experience and optimal puncture localization. The questionnaire analysis revealed that participants generally agreed on the phantom’s realistic anatomical representation and ability to accurately visualize the TSP site under fluoroscopic guidance.ConclusionsThe TSP simulator can be incorporated into training programs, offering trainees the opportunity to improve tool handling, spatial coordination, and manual dexterity prior to performing the procedure on patients. Further studies with larger sample sizes and longitudinal assessments are needed to establish the simulator’s impact on TSP performance and patient outcomes.

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.

Cardiac amyloidosis and left atrial appendage closure: a multicenter retrospective study

Abstract Background Thromboembolic stroke risk remains a clinical challenge in cardiac amyloidosis (CA) patients with atrial fibrillation because of the increased prevalence of left atrial appendage thrombi irrespective of CHA2DS2-VASc score and a higher prevalence of factors that increase the risk of bleeding with anticoagulation. Left atrial appendage closure (LAAC) is an effective option in patients with atrial fibrillation and high bleeding risk; however, data describing a LAAC strategy for stroke prevention in patients with CA is limited. Among non-CA patients, procedural success and serious complication rates are around 98% and 3% respectively. Purpose In this multicenter retrospective study, we aimed to investigate whether left atrial appendage closure (LAAC) could reduce the risk of bleeding complications and ischemic cerebrovascular events in patients with CA. Methods In an international multi-center retrospective study, patients with CA that underwent LAAC were included. The diagnosis of CA was established on the basis of histologic confirmation or advanced multimodality cardiac imaging as per current consensus statements. Results A total of 28 patients (93% male; 87% ATTR-CA; 13% AL-CA; mean age 80 years) met inclusion criteria. At baseline, mean CHA2DS2-VASc and HAS-BLED scores were 4 and 3 respectively, mean left ventricular ejection fraction was 50%, and mean indexed left atrial volume was 58 mL/m2. 21% of patients had a prior history of ischemic stroke, 14% prior history of hemorrhagic stroke, 7% prior transient ischemic attack, and 54% had a prior history of major or minor bleeding. Procedural success was achieved in 26 patients (93%) with procedural complications occurring in 2 patients (vascular access site bleeding and cardiac tamponade). Regarding in-hospital and follow-up complications, 0% ischemic stroke, 0% hemorrhagic stroke, and major or minor bleeding in 4% of patients. During follow up, device thrombosis occurred in only 1 patient. Conclusion LAAC is a feasible and effective alternative to anticoagulation in patients with CA and excessive bleeding risk, with procedural success and complication rates similar to reported studies of non-CA patients.

Association between preprocedural thromboembolic or bleeding events under oral anticoagulation therapy and mid-term outcomes after percutaneous left atrial appendage closure

Abstract Background Currently, no consensus has been established on the most effective antithrombotic therapy to prevent thromboembolic and bleeding events in patients undergoing percutaneous left atrial appendage closure (LAAC). Methods We retrospectively investigated the incidence of device-related thrombosis (DRT), thromboembolic events, and bleeding events in patients who underwent LAAC from September 2019 to October 2022. After categorizing patients into groups based on preprocedural thromboembolic or bleeding events under oral anticoagulation (OAC) therapy, we compared the incidence of DRT and prognosis according to the postprocedural antithrombotic therapy. Results In patients who received the conventional antithrombotic therapy (OAC with and without single antiplatelet therapy for 45 days after LAAC and dual-antiplatelet therapy from 45 days to 6 months followed by single antiplatelet therapy), preprocedural thromboembolic events despite OAC were independently associated with DRT or postprocedural thromboembolic events at the 3-year follow-up (hazard ratio [HR] 4.55; 95% confidence interval [CI] 1.32–15.6; P = 0.016), whereas preprocedural bleeding events were independently associated with postprocedural bleeding events (HR 8.01, 95% CI 1.45–58.3; P = 0.036). Continuation of OAC for 12 months among patients who developed preprocedural thromboembolic events during OAC significantly decreased the incidence of DRT or postoperative thromboembolic events (P = 0.002) with no increase in the bleeding events (P = 0.522). Conclusions Preprocedural thromboembolic and bleeding events can predict adverse events after LAAC with conventional antiplatelet-based antithrombotic therapy. Patients who develop thromboembolic events under continuous OAC may benefit from continuous OAC for 1 year after LAAC.

Combined PVI and LAAC is feasible using RFA or PFA in a canine model despite acute tissue edema in PFA versus RFA

Abstract Background Combined procedure with pulmonary vein isolation (PVI) using thermal energy followed by left atrial appendage closure (LAAC) has been used in select patient populations with positive results. Pulsed field ablation (PFA) is a novel non-thermal ablation modality that ablates cardiac tissue by irreversible electroporation. The effect of PFA on cardiac tissue and its interaction with a LAAC device in a single procedure has not been studied. Purpose To evaluate using transesophageal echo (TEE) imaging the acute tissue response following ablation by PFA compared to radiofrequency ablation (RFA) and its interaction with the WATCHMAN FLX Pro LAAC device when used in a combined procedure in a healthy canine model. Methods Nine mongrel canines underwent PVI using either circumferential PFA (FARAPULSE) energy application (n=6) or RFA energy (n=3). TEE imaging was obtained at the time of the procedure before and immediately after ablation energy application. The general appearance and echogenicity of the left lateral ridge was assessed and the os of the left atrial appendage (LAA) was measured in the four standard TEE views (0, 45, 90, and 135 degrees). Decisions about device sizing were made accordingly. PVI was evaluated by entry and exit block in all veins except the right inferior pulmonary vein (RIPV), which was not ablated. Following ablation, the LAAC device was implanted using TEE and fluoroscopic guidance in all animals and the percentage of compression measured. PASS criteria were assessed before the release of each device. All animals received dual antiplatelet therapy post implant. Results PVI was confirmed in all animals (except RIPV which was not targeted for ablation) using PFA and RFA. LAA dimensions (at device landing site) did not change substantially after RF ablation. With PFA, there was evidence of more diffuse edema and decrease in LAA diameter (Table). The LAAC device was implanted successfully after meeting PASS criteria in all animals within 30 minutes post ablation. The device size was decreased following PFA in two (2/6) animals, whereas there was no deviation from baseline measurements in device size for any of the RFA animals. Average LAAC device compression was higher for PFA versus RFA animals (Table). TEE post implant confirmed absence of any peri-device leaks in all animals. Conclusion Concomitant PVI using PFA (FARAPULSE) and LAAC (WATCHMAN FLX Pro) is feasible with 100% success and no residual acute peri-device leak. In the canine model, PFA is associated with more diffuse edema compared to RFA, which might affect device sizing. Long term consequences of this acute edema need to be evaluated in serial imaging and future larger clinical trials.Table

Feasibility, accuracy, and reproducibility of device sizing in virtual reality for percutaneous left atrial appendage closure - a single center study

Abstract Background Left atrial appendage closure (LAAC) is a safe and effective procedure for stroke prevention in patient with non-valvular atrial fibrillation. Procedural planning and device sizing remains challenging due to the highly complex and variable three-dimensional (3D) anatomy of the left atrial appendage (LAA). Virtual reality (VR) is a innovative, recent technology allowing a superior spatial orientation visualization of 3D imaging datasets. Purpose Therefore, we aimed to evaluate feasibility and accuracy of LAA measurements in VR for device sizing in patients planned for LAAC. Methods Twenty-one patients (79±7 years, 62% male) with non-valvular atrial fibrillation scheduled for LAAC were randomly included in our study. Preprocedural a multi-slice computed tomography (MSCT) was performed for device sizing in all patients. MSCT-based 3D models were established and visualized in VR using a dedicated software (VMersive, Warsaw, Poland). LAA dimensions (Ostium, landing zone (LZ), and depth) were assessed directly in the virtual environment. Conventional measurements of LAA ostium, landing zone (LZ) and depth using commercially available software were compared to measurements in VR. Results 3D reconstruction of MSCT datasets and visualization in VR were successfully performed automatically in all patients within a few seconds. MSCT and VR demonstrated good correlations for ostium minimum (r = 0.93), maximum (r = 0.8) and mean (r = 0.88, all p<0.001) diameters. Additionally, LZ minimum (r=0.84), maximum (r=0.86) and mean (r=0.9) diameters showed good correlation (all p<0.001). Moderate correlation was observed for depth measurements (r=0.76, p<0.001). Furthermore, intraclass correlation coefficients ranging from 0.88 to 0.98 denoted high inter- and intraobserver agreement. Conclusion Immersive VR allows highly feasible, accurate and reproducible measurements of the LAA dimensions directly in the virtual environment, hence enabling accurate device sizing for LAAC.

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

Impact of left atrial appendage closure on left atrial function: insights from the OCEAN-LAAC registry

Abstract Background Percutaneous left atrium appendage closure (LAAC) is an effective therapy to prevent thromboembolic events among patients with atrial fibrillation (AF) (Ref 1). However, since the left atrium appendage (LAA) potentially serves as a part of the left atrium (LA) volume and a buffer for increasing LA pressure, this procedure may impair LA compliance (Ref 2). Purpose In this study, we sought to investigate the effect of LAAC on LA function. Methods/Results The OCEAN-LAAC registry is an ongoing, multicentre Japanese registry including patients who underwent LAAC in Japan (Ref 3). Among 225 patients from the registry, LA volume index (LAVI) and tricuspid regurgitation pressure gradient (TRPG) at baseline and 6 months after the procedure were analysed. In the overall population, no significant increase in LAVI (Abstract Picture 1A) and TRPG (Abstract Picture 1B) was observed (LAVI baseline vs 6 months, 55.0 [44.0, 70.0] ml/m2 vs 55.0 [42.0, 75.6] ml/m2; P = 0.31; TRPG, 25.0 [20.3, 32.0] mmHg vs 25.0 [20.0, 32.0] mmHg; P = 0.85). However, particular patients underwent an increase in LAVI (Abstract Picture 1C), and multivariable analysis showed smaller LAVI and elevated TRPG at baseline, rather than any procedural factors, were significantly associated with an increase in LAVI (Odds ratio (OR) for baseline LAVI: 0.98 [95% confidential interval (CI): 0.97 - 0.996]; OR for baseline TRPG: 1.04 [95% CI: 1.00 - 1.08]). A 5 ml/m2 increase in LAVI at a 6-month follow-up was significantly associated with subsequent heart failure hospitalization (HFH) (Hazard ratio: 3.37 [95% CI: 1.18 - 9.65]) (Abstract Picture 2A). However, this predictive value was not observed in patients with lower LAVI (≤ 55 ml/m2) at baseline; instead, it was observed in those with a baseline LAVI over 55 ml/m² (Abstract Picture 2B). Conclusions In summary, our study did not elucidate the negative impact of LAAC on LA function, yet demonstrated an increase in LAVI at 6 month follow-up was frequently observed in patients with lower LAVI and higher TRPG at baseline. Additionally, increase in LAVI was significantly associated with subsequent HFH, which was more evident in patients with higher LAVI at baseline.

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.

Complex left atrial appendage closure using 3D printing system simulation in a patient with mitral prosthetic valve: a case report

Abstract Background Left atrial appendage (LAA) closure (LAAc) has emerged as a safe and effective alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF) and contraindications to OAC. Case Summary A 61-year-old woman with permanent atrial fibrillation (AF) and a history of mitral surgery replacement with mechanical prosthesis was referred to our cardiology department to undergo left atrial appendage (LAA) closure (LAAc). The preoperative computed tomography (CT) revealed that the ostium of the left atrial appendage was close to the mitral prosthesis ring. As a result of the difficult LAA morphology a CT-image based virtual model was created, then a 3D printing model was prepared in our laboratory and procedure simulation was performed with the two different LAA occlusion devices (plug- vs. pacifier like models) to see which one was more suitable for the patient anatomy. Discussion In this case of complex LAAc in a patient with mechanical prosthetic mitral valve with the use of a 3D-printed model has guided prosthesis selection and device sizing reducing procedure time and complications.

Outcomes of left atrial appendage closure versus oral anticoagulant therapy in patients with atrial fibrillation: an updated meta-analysis of randomized control trials.

The purpose of this study is to compare the clinical results of Left Atrial Appendage Closure (LAAC) and oral anticoagulation (OAC) in individuals with AF. For randomized controlled trials (RCTs) comparing the clinical results of OAC to LAAC in patients with atrial fibrillation (AF), we searched PubMed, ScienceDirect, and Cochrane. The included publications were subjected to meta-analyses using Review Manager v5.4. In comparison to OAC, LAAC was linked with a decreased incidence of all stroke (OR 0.68; 95% CI 0.55-0.84; p = 0.0004). LAAC was also linked to a decreased risk of hemorrhagic stroke (OR 0.20, 95% CI 0.07-0.55; p = 0.002). There is no statistically significant difference between the two groups in terms of ischemic stroke (OR 1.05; 95% CI 0.59-1.84; p = 0.88) or systemic embolization (OR 1.02; 95% CI 0.42-2.46; p = 0.97). According to our meta-analysis, the LAAC was less likely than the OAC to have a complete or hemorrhagic stroke. For the two groups, however, there was no difference in the risk of ischemic stroke or systemic embolization.

Correlations Between Plasma BNP Level and Risk of Thrombotic-Hemorrhagic Events After Left Atrial Appendage Closure.

Background: Percutaneous left atrial appendage closure (LAAC) reduces the incidence of stroke/bleeding events in patients with non-valvular atrial fibrillation, high risk of stroke, and contraindication in continuing anticoagulation therapy. Of them, patients with heart failure may remain at high risk of these events after LAAC. Method: Patients who underwent LAAC and were listed for the multi-center, prospectively collected OCEAN-LAAC registry, were eligible. Of them, individuals without baseline plasma B-type natriuretic peptide (BNP) levels and those dependent on hemodialysis were excluded. The prognostic impact of baseline plasma BNP levels on the incidence of death or stroke/bleeding events after LAAC was evaluated. Results: A total of 937 patients (median 78 years, 596 men) were included. The LAAC device was successfully implanted in 934 (98%) patients. Over the 366 (251, 436) days after the LAAC, 148 patients encountered a primary outcome. The common logarithm of baseline plasma BNP was independently associated with the primary outcome with an adjusted hazard ratio of 1.46 (95% confidence interval 1.06-2.18, p = 0.043). A calculated cutoff of 2.12 (equivalent to 133 pg/mL of plasma BNP level) significantly stratified the cumulative incidence of the primary outcome (29% vs. 21% for 2 years, p = 0.004). Conclusions: Using prospectively collected large-scale multi-center Japanese registry data, we demonstrated that a baseline higher plasma BNP level was independently associated with a higher incidence of stroke/bleeding events and mortality after LAAC. Further studies are warranted to understand the optimal therapeutic strategy for LAAC candidates with elevated baseline plasma BNP levels.

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.

Augmented Reality-Supported Totally Thoracoscopic Epicardial Left Atrial Appendage Closure in a Patient With Liver Cirrhosis.

Augmented Reality-Supported Totally Thoracoscopic Epicardial Left Atrial Appendage Closure in a Patient With Liver Cirrhosis.

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

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. 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.