Left Atrial Appendage Occlusion Procedure Research Articles

Strategy Optimization for a Combined Procedure in Patients With Atrial Fibrillation: The COMBINATION Randomized Clinical Trial.

The optimal strategy of combining left atrial appendage occlusion (LAAO) with catheter ablation (CA) in patients with atrial fibrillation (AF) during a single procedure remains unclear. To determine the effects of ablation-first vs occlusion-first strategies on long-term clinical outcomes among patients with atrial fibrillation undergoing a combined LAAO and CA procedure. The prospective, multicenter COMBINATION randomized clinical trial was conducted in 14 high-volume centers in China. Enrollment of patients with nonvalvular AF referred for the combined procedure began on July 24, 2020, and concluded on January 20, 2022. Patients were randomly assigned to either the ablation-first group or the occlusion-first group. Outcomes of LAAO using an occlusion device and CA using a contact force-sensing catheter following different combination strategies during long-term follow-up were evaluated. The primary end point was a composite of thromboembolic events including stroke or transient ischemic attack, device-related thrombus (DRT), clinically relevant bleeding, and cardiovascular rehospitalization or death. Freedom from AF or atrial tachyarrhythmia (ATA) after a single procedure without antiarrhythmic drugs, at both 1 year and long-term follow-up, was also evaluated. Of the 202 patients enrolled, 194 (96.0%) completed the trial (97 in the ablation-first group and 97 in the occlusion-first group). The mean (SD) age of the cohort was 67.3 (9.2) years, and 110 patients (56.7%) were male. All procedures achieved acute successful LAAO and restoration of sinus rhythm, with similar incidences of periprocedural complications. Compared with the ablation-first group, the occlusion-first group exhibited significantly higher event-free survival of the primary end point (83.5% vs 71.1%; hazard ratio [HR], 0.53 [95% CI, 0.29-0.95]; log-rank P = .04) during the median 2.5 (IQR, 2.3-2.8) years of follow-up. Subgroup analysis indicated that male patients and those with higher CHA2DS2-VASc scores (a composite of factors associated with stroke risk; higher scores indicate higher risk) were at lower risk of thromboembolic events. Rates of long-term freedom from AF (77.3% vs 63.5%; HR, 0.58 [95% CI, 0.34-0.97]; log-rank P = .04) and from ATA (70.1% vs 55.7%; HR, 0.62 [95% CI, 0.39-0.99]; log-rank P = .04) were higher in the occlusion-first group vs the ablation-first group. Additionally, a higher incidence of chronic peridevice leak (15 [15.5%] vs 5 [5.2%]; P = .03) and DRT (8 [8.2%] vs 1 [1.0%]; P = .04) was observed in the ablation-first group vs the occlusion-first group. In this randomized clinical trial, the occlusion-first approach was superior due to its higher event-free survival of the primary end point and long-term freedom from ATA. These findings suggest that the occlusion-first approach should be recommended for combined procedures with plug-like device implantation. Chinese Clinical Trial Registry Identifier: ChiCTR2000031486.

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.

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

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.

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

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.

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.

Transfabric Leaks After Percutaneous Left Atrial Appendage Occlusion Procedures with the WATCHMAN FLX Device

BackgroundCardiac computed tomography imaging with contrast is being used increasingly to image left atrial appendage occlusion (LAAO) devices. Contrast flow across a device, also known as a transfabric leak (TFL), may indicate a lack of complete LAAO-device endothelialization. The data on the rate, predictors, and clinical events associated with TFL are limited. MethodsAll patients who underwent an LAAO-device implantation with a WATCHMAN FLX device and received a postimplantation computed tomography scan were included in this single-centre retrospective cohort study. Patients were classified as either having or not having a TFL, according to 3 currently proposed definitions of TFL. Clinical and procedural differences between the 2 groups were determined. An exploratory univariate logistic regression model to evaluate predictors of TFL was constructed. ResultsA total of 56 individuals were included in the cohort. The rate of TFL varied from 27% to 52%, depending on the radiographic definition employed. No clinically important patient or procedural characteristics were noted between the groups with vs without TFL. No predictors of TFL were identified. Six deaths and one stroke occurred during a median follow-up period of 673 days. ConclusionsTFLs occur commonly post–LAAO procedures, suggesting that complete endothelialization of LAAO devices in humans may not be similar to that reported in animal models. Additional study into the best imaging approach to identify TFLs, and clinical events associated with TFLs, is necessary to clarify the significance of TFLs.

Clinical Protocol for Selecting Intracardiac or Transesophageal Echocardiography-Guided Left Atrial Appendage Occlusion

Intracardiac echocardiography (ICE) has emerged as an alternative to transesophageal echo (TEE) to guide left atrial appendage occlusion (LAAO). We established a protocol to select patients appropriate for ICE guidance. Patients undergoing LAAO with the Watchman or Watchman FLX device (Boston Scientific, Marlborough, MA) from January 2018-March 2022 at a large United States center were included. The novel protocol prospectively selected TEE or ICE guidance beginning in January 2020; previous LAAO procedures were retrospectively included. ICE was selected for patients with uninterrupted anticoagulation and appropriate LAA anatomy, renal function, and moderate sedation tolerance. In-hospital outcomes with successful implantation without conversion to TEE-guidance, no peridevice leak (PDL), and no procedural complications were compared. Composite 1-year outcome included freedom from PDL, device related thrombus, stroke, and all-cause mortality. A total of 234 patients were included; the mean age was 76.1 ± 8.3 years old, and 42.3% were female. ICE guidance was used for 63 procedures; TEE guidance was used for 171 procedures. For the composite outcome, ICE-guided LAAO was superior to TEE-guided LAAO (risk difference 0.102, 96.8% vs. 86.5%, 95% CI 0.003-0.203; p=0.029). In comparison to the TEE-guided group, ICE-guided procedures were shorter (89.1 ± 26.3 vs. 99.8 ± 30.0 minutes, p=0.0087) with less general anesthesia (26.6% vs. 98.8%, p<0.0001). One-year composite adverse outcomes did not differ significantly (80.7% vs. 88.9%, P=0.17). In conclusion, the protocol to select appropriate patients for ICE vs. TEE guidance for LAAO is safe and effective. Larger studies are indicated to validate this approach to improve outcomes, shorten procedures, and avoid general anesthesia.

Impact of Chronic Kidney Disease on the Outcomes of Patients Undergoing Left Atrial Appendage Occlusion: Insights from a Large National Database.

Studies exploring the effectiveness and safety of left atrial appendage occlusion (LAAO) in patients with chronic kidney disease (CKD) are limited. We utilized the National Inpatient Sample (NIS) to identify hospitalizations for LAAO from 2016 to 2020 and further identified cases with concomitant CKD. The primary outcome was mortality, and secondary outcomes were cerebrovascular accidents, major bleeding, vasopressor requirements, percutaneous coronary intervention, cardiac arrest, acute respiratory failure, transfusion, length of stay (LOS), and total hospital charges. Multivariable logistic regression was performed to further adjust for covariates. A total of 89,309 LAAO procedures from 2016 to 2020 were identified, of which 21,559 (24.1%) reported concomitant CKD, with males comprising the majority (62.2%). An increasing trend in LAAO procedures was seen from 2.24 to 13.9 per 10,000 patients from 2016 to 2020. Despite patients with CKD having a higher rate of most comorbidities, there was no difference in mortality (non-CKD vs. CKD, 0.07% vs. 0.42%; aOR: 1.3, 95% CI: 0.4-4.4, p = 0.686) and complications for CKD and non-CKD patients, while CKD patients had longer LOS and higher total hospital charge. No significant sex differences in outcomes among CKD patients were observed except for a longer LOS in females. Despite generally having more comorbidities, outcomes of patients with CKD following LAAO are similar to those without CKD, suggesting that LAAO can be offered as a safe option for the treatment of atrial fibrillation in eligible patients with CKD.

Feasibility study on atrial fibrillation ablation with pulsed field ablation and concomitant occlusion of the left atrial appendage.

Atrial fibrillation (AF) ablation and left atrial appendage occlusion (LAAO) are increasingly performed as individual procedures. Pulsed field ablation (PFA) has significantly reduced procedure duration and may be advantageous for the combined approach. We have launched a programme for simultaneous AF ablation using PFA and LAAO for patients qualifying for both treatments and excluding those with a complex anatomy. We compare procedure duration and fluoroscopy time against individual procedures (either AF ablation or LAAO alone), all performed by the same operators and using consistent technologies. We performed the combined procedure in 10 patients (50% males; median age 70 years) and excluded 2 patients (17%) because of a complex left atrial appendage anatomy. No death, stroke, or major bleeding events, including pericardial effusion, occurred. For single-procedure comparison, 207 AF ablation procedures and 61 LAAO procedures were available. The total median procedure duration was 79 min (range 60-125) for the combined procedure, 71 min (25-241) for individual AF ablation (51 min without and 78 min with 3-dimensional electroanatomic mapping), and 47 min (15-162) for individual LAAO. The respective fluoroscopy times were 21 (15-26), 15 (5-44), and 10 (3-50) min. For the combined procedure, femoral vein access to last PFA application lasted 49 min (34-93) and LAAO added 20 min (15-37). Simultaneous PFA-based AF ablation and LAAO in carefully selected patients is feasible and safe and can be executed within a short overall procedure duration.

Clinical Results and Safety of Intracardiac Echocardiography Guidance for Combined Catheter Ablation and Left Atrial Appendage Occlusion.

The goal of this study was to compare the procedural safety and long-term outcome associated with a combined catheter ablation and left atrial appendage occlusion (LAAO) procedure utilizing intracardiac echocardiography (ICE) guidance versus transesophageal echocardiography (TEE) guidance. The study focuses on implementing LAmbre and Watchman devices in patients diagnosed with nonvalvular atrial fibrillation (AF). A total of 363 patients diagnosed with nonvalvular AF and who underwent a combined procedure were prospectively enrolled between November 2017 and May 2022. Following 1:1 propensity score matching, the TEE group (n = 132) and ICE group (n = 132) were systematically compared in terms of the combined procedure, imaging parameters, events related to the procedure, and subsequent outcomes during follow-up, including mortality, stroke, bleeding, device-related thrombus (DRT), and peri-device leaks (PDLs). The ICE group exhibited a significant reduction in total procedural duration (153.71 31.71 vs. 174.74 18.79 min), fluoroscopy radiation dosage (207.24 108.39 vs. 268.61 122.88 mGy), left atrial appendage occlusion procedure time (34.69 10.91 vs. 51.46 15.84 min), and contrast agent exposure (108.71 37.59 vs. 158.41 45.00 mL) compared to the TEE group. Angiography and ICE demonstrated a substantial correlation between the left atrial appendage (LAA) orifice and landing zone/LAA ostium (Pearson's correlation coefficient r = 0.808 and 0.536/0.697, two-tailed p 0.001). No occurrences of device-related embolism, thromboembolism, significant bleeding, or unexpected fatalities were observed in either group. Comparable rates of all-cause death (0.76% vs. 0.76%), stroke or transient ischemic attack (2.27% vs. 1.52%), severe bleeding (1.52% vs. 0.76%), PDL (23.81% vs. 24.62%), and DRT (1.52% vs. 1.52%) were noted after an average follow-up of 18.46 7.70 months in both groups, with no discernible differences. Multivariate logistic regression analysis identified a correlation between LAA velocity and the risk of PDL. The effectiveness and safety of ICE-guided combined treatment were demonstrated to be comparable to TEE guidance, accompanied by the additional advantages of decreased procedure time and fluoroscopy radiation exposure. NCT04391504, https://register.clinicaltrials.gov.

BETWEEN SCYLLA AND CHARYBDIS: MULTIPLE LEFT ATRIAL THROMBI DESPITE ORAL ANTICOAGULATION AND ANTIPLATELET THERAPY IN A PATIENT CANDIDATE FOR LEFT ATRIAL APPENDAGE OCCLUSION

Abstract Introduction Left atrial (LA) thrombosis usually occurs in patients affected by atrial fibrillation (AF), generally involving the left atrial appendage (LAA). We present the unexpected echocardiographic finding of multiple LA thrombi despite an adequate antithrombotic strategy. Case Presentation A 76–year–old lady underwent transesophageal echocardiographic examination (TOE) to assess eligibility for percutaneous LAA occlusion (LAAO) procedure due to high bleeding risk. Her medical history included AF and a recent percutaneous coronary revascularization; therefore, her antithrombotic therapy included apixaban 2.5 mg bid and clopidogrel 75 mg od. The TOE showed LA structural and functional remodeling with spontaneous echo contrast and multiple thrombi involving the LAA (one [12 x 9 mm] overflowing the orifice and attached to the Coumadin Ridge and the second [12 x 7 mm] attached and arising from the tunnel of patent foramen ovale). Mitral valve stenosis was excluded (Fig.1). Due to TOE findings, the patient was not considered eligible for percutaneous LAAO. Due to the concomitant very high thromboembolic risk, despite the previous intracranial bleeding, we decided to stop apixaban and to start parenteral anticoagulation for 3 weeks with low–molecular weight heparin (100 UI/kg bid) followed by the switch to a vitamin k antagonist (VKA). We also prescribed a hematological evaluation to exclude a hypercoagulability disorder. Our patient’s daughter was a carrier of a mutation in both the methylenetetrahydrofolatereductase and Thrombin genes. A TOE after 30 days showed the persistence of LA thrombi, although with significantly reduced size and mobility (Fig.2). The follow–up was clinically uneventful. We suggested to continue anticoagulation therapy with VKA, and we planned a new TOE after 4 weeks. Discussion Although proper anticoagulation decreases cardioembolic risk in patients with AF, atrial thrombosis may occur due to LA remodeling, high CHA2DS2–VASc score and other factors, including hypercoagulability disorders. The presence of multiple LA thrombi represents a challenge for clinicians, especially in case of concomitant high thromboembolic and bleeding risk. However, the best treatment strategies for these extreme conditions are not defined, so far. Therefore, the therapeutic choice is often tailored to the single patient and based on the clinical judgment, bearing in mind that avoiding Charybdis means passing to close to Scylla and vice versa.

Feasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study

BackgroundAlthough expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO with the selected device. ObjectiveThis analysis aimed to characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent a subsequent attempt with an Amulet occluder in the EMERGE LAA postapproval study. MethodsPatients enrolled in the National Cardiovascular Data Registry LAAO Registry who had an Amulet occluder implantation attempt between Food and Drug Administration approval (August 14, 2021) and June 30, 2023, were evaluated. A safety end point through 7 days or hospital discharge (whichever was later) and major adverse events through 45 days were reported. ResultsA total of 8591 patients underwent attempted Amulet occluder implantation, of whom 244 patients had prior failed LAAO. Implantation success was 88.9% and 96.2% in patients with prior failed LAAO and index LAAO, respectively (P < .001). The safety composite end point was low, occurring in 1.6% and 0.8% of patients with prior failed LAAO and index LAAO, respectively (P = .148). Any major adverse event through 45 days occurred in 7.4% and 6.3% of prior failed LAAO and index LAAO patient cohorts, respectively (P = .497); most adverse events were similar between the groups (P > .05). At 45 days, peridevice leak ≤3 mm was achieved in >90% of patients in either group. ConclusionA high degree of implantation success with a low rate of adverse events can be achieved with the Amulet occluder. The findings imply that the dual occlusive mechanism Amulet occluder facilitates successful closure, even in challenging anatomic scenarios.

Minimalistic approach to left atrial appendage occlusion guided by cardiac computed tomography angiography.

To assess the feasibility and safety of the minimalistic approach to left atrial appendage occlusion (LAAO) guided by cardiac computed tomography angiography (CCTA). Ninety consecutive patients who underwent LAAO, with or without CCTA-guided, were matched (1:2). Each step of the LAAO procedure in the computed tomography (CT) guidance group (CT group) was directed by preprocedural CT planning. In the control group, LAAO was performed using the standard method. All patients were followed up for 12 months, and device surveillance was conducted using CCTA. A total of 90 patients were included in the analysis, with 30 patients in the CT group and 60 matched patients in the control group. All patients were successfully implanted with Watchman devices. The mean ages for the CT group and the control group were 70.0 ± 9.4 years and 68.4 ± 11.9 years (P = 0.52), respectively. The procedure duration (45.6 ± 10.7 min vs. 58.8 ± 13.0 min, P < 0.001) and hospital stay (7.5 ± 2.4 day vs. 9.6 ± 2.8 day, P = 0.001) in the CT group was significantly shorter compared to the control group. However, the total radiation dose was higher in the CT group compared to the control group (904.9 ± 348.0 mGy vs. 711.9 ± 211.2 mGy, P = 0.002). There were no significant differences in periprocedural pericardial effusion (3.3% vs. 6.3%, P = 0.8) between the two groups. The rate of postprocedural adverse events (13.3% vs. 18.3%, P = 0.55) were comparable between both groups at 12 months follow-up. CCTA is capable of detailed LAAO procedure planning. Minimalistic LAAO with preprocedural CCTA planning was feasible and safe, with shortened procedure time and acceptable increased radiation and contras consumption. For patients with contraindications to general anesthesia and/or transesophageal echocardiography, this promising method may be an alternative to conventional LAAO.

A real-world multicenter study on left atrial appendage occlusion: The Italian multi-device experience

BackgroundTranscatheter left atrial appendage occlusion (LAAO) has emerged as an alternative treatment for stroke prevention in patients with atrial fibrillation (AF) at high risk of thromboembolism, who cannot tolerate long-term oral anticoagulation (OAC). Questions persist regarding effectiveness and safety of this treatment and the optimal post-interventional antithrombotic regimen after LAAO. MethodsWe retrospectively gathered data from 428 patients who underwent percutaneous LAAO in 6 Italian high-volume centres, aimed at describing the real-world utilization, safety, and effectiveness of LAAO procedures, also assessing the clinical outcomes associated with different antithrombotic strategies. ResultsAmong the entire population, 20 (4.7 %) patients experienced a combination of pericardial effusion and periprocedural major bleeding: 8 (1.9 %) pericardial effusion, 1 (0.3 %) fatal bleeding, and 3 (0.7 %) non-fatal procedural major bleeding. Patients were discharged with different antithrombotic regimens: dual (DAPT) (27 %) or single (SAPT) (26 %) antiplatelet therapy, OAC (27 %), other antithrombotic regimens (14 %). Very few patients were not prescribed with antithrombotic drugs (6 %). At a medium 523 ± 58 days follow-up, 14 patients (3.3 %) experienced all-cause death, 6 patients (1.4 %) cardiovascular death, 3 patients (0.7 %) major bleeding, 10 patients (2.6 %) clinically relevant non-major bleeding, and 3 patients (0.7 %) ischemic stroke. At survival analysis, with DAPT as the reference group, OAC therapy was associated with better outcomes. ConclusionsOur findings confirm that LAAO is a safe procedure. Different individualized post-discharge antithrombotic regimens are now adopted, likely driven by the perceived thrombotic and hemorrhagic risk. The incidence of both ischemic and bleeding events tends to be low.

Inter-atrial septal balloon dilation to facilitate intracardiac echocardiography guided left atrial appendage occlusion.

Percutaneous left atrial appendage occlusion (LAAO) is traditionally performed under general anesthesia with trans-esophageal echocardiography guidance. Intracardiac echo (ICE)-guided LAAO closure is increasing in clinical use. The ICE catheter is crossed into LA via interatrial septum (IAS) after the septum is dilated with LAAO delivery sheath. This step can be time-consuming and requires significant ICE catheter manipulation, which increases the risk of cardiac perforation. Pre-emptive septal balloon dilation can potentially help with ICE advancement in the LA. We sought to evaluate the effect of pre-dilation of the IAS with an 8 mm balloon on the ease of crossing the ICE catheter, fluoroscopy time for crossing, and overall procedure time. The Piedmont LAAO registry was used to identify consecutive patients who underwent LAAO. The initial 25 patients in whom balloon dilation of the IAS was performed served as the experimental cohort, and the 25 consecutive patients before that in whom balloon dilation was not performed served as controls. In the experimental group, after a trans-septal puncture, the sheath was retracted to the right atrium with a guidewire still in the LA. An 8 × 40 mm Evercoss™ over the wire balloon was inflated across the IAS. The ICE catheter was then crossed into the LA using the fluoroscopic landmark of the guide wire and the ICE imaging. The sheath was then advanced along the ICE catheter via the transseptal puncture (TSP) and the procedure continued. Follow-up compputed tomography imaging was obtained at 4-8 weeks. Each group consisted of 25 patients. There were no significant differences in baseline characteristics. All procedures were performed successfully under conscious sedation and ICE guidance. There was a significant reduction in the overall procedure time, fluoroscopy time, and time for transseptal puncture to ICE in LA. There was no difference in the size of the acute residual interatrial shunt, as measured via ICE, or the size and presence of iatrogenic ASD at follow-up. Balloon dilation of TSP is safe and is associated with increased efficiency in ICE-guided LAAO procedures.

Intracardiac Echocardiography-guided Left Atrial Appendage Occlusion.

Left atrial appendage occlusion (LAAO) is a suitable alternative to oral anticoagulant therapy to prevent stroke in patients with AF. Most procedures are performed under transoesophageal echocardiography (TOE) guidance, which facilitates transseptal puncture, reduces the risk of procedurerelated complications and provides an additional method for device selection and real-time monitoring during device deployment. However, TOE has significant shortcomings, including the need for general anaesthesia/deep sedation as well as a significant risk of procedure-related adverse events. More recently, intracardiac echocardiography has been proposed as an alternative to TOE guidance during LAAO procedures. In this review, we summarise the available evidence as well as providing a step-by-step approach for intracardiac echocardiography-guided LAAO.

Predicting Major Adverse Events in Patients Undergoing Transcatheter Left Atrial Appendage Occlusion.

The National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry (LAAO) includes the vast majority of transcatheter LAAO procedures performed in the United States. The objective of this study was to develop a model predicting adverse events among patients undergoing LAAO with Watchman FLX. Data from 41 001 LAAO procedures with Watchman FLX from July 2020 to September 2021 were used to develop and validate a model predicting in-hospital major adverse events. Randomly selected development (70%, n=28 530) and validation (30%, n=12 471) cohorts were analyzed with 1000 bootstrapped samples, using forward stepwise logistic regression to create the final model. A simplified bedside risk score was also developed using this model. Increased age, female sex, low preprocedure hemoglobin, no prior attempt at atrial fibrillation termination, and increased fall risk most strongly predicted in-hospital major adverse events and were included in the final model along with other clinically relevant variables. The median in-hospital risk-standardized adverse event rate was 1.50% (range, 1.03%-2.84%; interquartile range, 1.42%-1.64%). The model demonstrated moderate discrimination (development C-index, 0.67 [95% CI, 0.65-0.70] and validation C-index, 0.66 [95% CI, 0.62-0.70]) with good calibration. The simplified risk score was well calibrated with risk of in-hospital major adverse events ranging from 0.26% to 3.90% for a score of 0 to 8, respectively. A transcatheter LAAO risk model using National Cardiovascular Data Registry and LAAO Registry data can predict in-hospital major adverse events, demonstrated consistency across hospitals and can be used for quality improvement efforts. A simple bedside risk score was similarly predictive and may inform shared decision-making.

Combining echocardiography and fluoroscopy imaging in real time for left atrial appendage occlusion - single center experience from Poland.

Atrial fibrillation (AF) presents a growing health concern, often requiring stroke prevention measures, primarily through oral anticoagulation (OAC). Surgical interventions such as left atrial appendage occlusion (LAAO) offer alternatives when OAC is contraindicated. In recent years, percutaneous procedures have gained traction as minimally invasive options, demanding precise anatomical insights. Fusion imaging (FI), which combines transesophageal echocardiography (TEE) and fluoroscopy, has emerged as a potential game-changer in transcatheter interventions. This study introduces FI to LAAO procedures in Poland, assessing its role in guiding interventions, highlighting advantages, and exploring its potential to reshape cardiovascular interventions. We conducted a retrospective study involving LAAO procedures from March 2015 to December 2018, all utilizing FI. Patient indications, procedural specifics, and safety metrics were collected and analyzed. Follow-ups were conducted at 3 and 6 months. A cohort of 83 patients (mean age: 72.1 ±8.4 years) underwent successful LAAO procedures. FI provided precise device placement and anatomical assessment. Mean procedure time was 54.9 ±34.3 min, contrast medium usage averaged 33.7 ±22.7 ml, and creatinine levels remained stable. Patients were discharged in about 4.2 ±3.4 days. Adverse effects were rare, including minimal bleeding and cardiac tamponade. Follow-ups demonstrated favorable outcomes with low adverse event rates. This study marks the inaugural application of FI in Polish LAAO procedures. FI, offering enhanced visualization and reduced procedure times, holds promise in improving patient safety and treatment efficacy. We recommend its consideration as a standard visualization technique for LAAO procedures.