Underwent Left Atrial Appendage Occlusion Research Articles

Long-term safety and efficacy of left atrial appendage occlusion in dialysis patients with atrial fibrillation: a multi-center, prospective, open label, observational study.

The prevalence of atrial fibrillation (AF) in end stage kidney disease (ESKD) patients undergoing dialysis is high, however, the high risk of bleeding often hampers with a correct anticoagulation in ESKD patients with AF, despite high thromboembolic risk. Left atrial appendage (LAA) occlusion is a anticoagulation (OAT) for thromboembolism prevention in AF populations with high hemorrhagic risk. The purpose of the study was to evaluate the efficacy and safety of LAA occlusion in a cohort of dialysis patients undergoing the procedure (LAA occlusion cohort, n=106), in comparison with two other ESKD cohorts, one taking warfarin (Warfarin cohort, n=114) and the other without anticoagulation therapy (No-OAT cohort, n=148). After a median follow-up of 4 years, a Cox regression model, adjusted for possible confounding factors, showed that the hazard ratios (HRs) of thromboembolic events in the LAA occlusion cohort were 0.19 (95%CI 0.04-0.96; p=0.045) and 0.16 (95%CI 0.04-0.66; p=0.011) as compared with Warfarin and No-OAT cohorts, respectively. The HR of bleeding in the LAA occlusion cohort was 0.37 (95%CI 0.16-0.83; p=0.017) compared to Warfarin cohort, while there were no significant differences between the LAA occlusion and the No-OAT cohort (HR 0.51; 95%CI 0.23-1.12; p=0.094). Adjusted Cox regression models showed lower mortality in patients undergoing LAA occlusion as compared with both the Warfarin cohort (HR 0.60; 95%CI 0.38-0.94; p=0.027) and no-OAT cohort (HR 0.52; 95%CI 0.34-0.78; p=0.002). Thromboembolic events in the LAA occlusion cohort were lower than expected according to the CHA2DS2VASc score (1.7 [95%CI 0.3-3.0] vs 6.7 events per 100 person/years, p<0.001). In ESKD patients with AF, LAA occlusion is safe and effective and is associated with reduced mortality compared with OAT or no therapy.

Usefulness of a novel sizing chart for left atrial appendage occlusion with the Amplatzer Amulet.

The present article aims to compare a novel sizing chart based on both maximum and minimum diameters (novel MATRIX) with the current sizing recommendationinstructions for use(IFU) based on the maximum diameter. Current IFUwith the Amulet device are still based on the maximum left atrial appendage (LAA) diameter, which might lead to inappropriate oversizing, especially in elliptic appendages. This was a retrospective analysis of patients undergoing LAA occlusion in two high-volume centers. Two hundred patients were included (100 patients with baseline cardiac computed tomography angiography[CCTA] and 100 with baseline 2D and 3D-transesophageal echocardiography[TEE]). The degree of concordance between the predicted device size recommendation and the actual device selection was the primary outcome. The novel MATRIX showed a higher level of concordance between the predicted and implanted device size, regardless of imaging modalities. CCTA showed the strongest, and 2D-TEE the weakest concordance between the predicted and implanted device for both MATRIX and IFU charts. The percentage of patients in whom the disagreement among the predicted and implanted device represented &gt;1 size was higher when using the IFU chart. In elliptical LAA anatomies, the differences favoring the use of MATRIX compared to the IFU in terms of predicted/implanted agreement were higher. Finally, no significant differences in clinical or imaging endpoints were observed between the two different sizing charts. Incorporating both the LAA maximum and minimum diameters, as opposed to just maximum diameter, appears to improve sizing accuracy. The proposed MATRIX sizing chart offered a higher level of concordance between predicted and implanted device compared to the current IFU.

Occluding morphologically complicated left atrial appendage using the small-umbrella LAmbre device

BackgroundPercutaneous left atrial appendage (LAA) occlusion is effective for stroke prevention in patients with atrial fibrillation. LAA can have a complex anatomy, such as multiple lobes or a large orifice, which may render it unsuitable for occlusion using regular devices. We aimed to investigate the feasibility, safety, and short-term efficacy of the small-umbrella LAmbre device for morphologically complicated LAA.MethodsWe retrospectively enrolled 129 consecutive patients who underwent LAA occlusion using the LAmbre device; the small-umbrella LAmbre device was used in 30 of these patients. We analyzed patients’ characteristics, procedural details, and outcomes.ResultsTwenty-two patients (73.3%) had multilobed (≥ 2) LAA. The umbrella of the occluder was anchored in the branch in 9 patients and in the common trunks of branches in 13 patients. The landing zone and orifice diameters were 19.0 ± 4.39 mm and 27.4 ± 3.95 mm, respectively. The sizes of the umbrella and occluder cover were 22.0 ± 3.42 mm and 34.3 ± 2.75 mm, respectively. At 3-month follow-up transesophageal echocardiography in 24 patients, no peri-device residual flow was reported. Device thrombosis was detected in one patient at 3 months and disappeared after 3 months of anticoagulation. Ischemic stroke occurred in one patient; no other adverse events were reported.ConclusionsOcclusion of morphologically complicated LAA using the small-umbrella LAmbre device was feasible, safe, and effective in patients with atrial fibrillation in this study. This occluder provides an alternative for patients who cannot be treated with regular-sized LAA occlusion devices.

Cardiac Rehabilitation in Atrial Fibrillation Patients With Left Atrial Appendage Occlusion: A RANDOMIZED TRIAL.

Left atrial appendage (LAA) occlusion for atrial fibrillation (AF) is an invasive therapy that reduces stroke incidence and death. The impact of cardiac rehabilitation (CR) on patients with AF with LAA occlusion remains unknown. We aimed to evaluate the effects and safety of CR in patients with AF with LAA occlusion. This 6-mo single-center randomized controlled trial compared an exercise-based CR program with a control group. Patients with AF who underwent LAA occlusion from December 2018 to December 2020 were randomized into two groups: exercise-based CR and usual care (control). All patients underwent echocardiography, cardiac computed tomography, scale survey, physical function, and exercise capacity at baseline and at 3 and 6 mo follow-up. There were 33 and 30 patients in the control and CR groups, respectively, in the final analysis. After the study period, the 6-min walk test distance, handgrip and leg strength, and left ventricular ejection fraction increased significantly in the CR group compared with baseline. Significant between-group differences were found in the mental and physical component summary scales, including all eight subscales, of the Short Form 36. The incidence of incomplete endothelialization in the CR group at 3 and 6 mo was significantly lower than that in the control group. Cardiac rehabilitation was shown to accelerate device endothelialization in patients with AF with LAA occlusion, while also improving the quality of life, exercise capacity, and physical function.

Occlusion of Bilobulated Left Atrial Appendage Using the Dual-Watchman Technique: A Long-Term Follow-Up Study.

BackgroundPercutaneous left atrial appendage (LAA) occlusion has been considered an efficient alternative to oral anticoagulation to prevent embolic events in patients with non-valvular atrial fibrillation (NVAF). Due to the complexities and heterogeneous anatomy of the LAA structure, the single-device approach may not always fit a large bilobulated LAA. This study aimed to evaluate the feasibility and safety of one-stop dual Watchman implantation for patients with bilobulated LAA.MethodsIncluded in the analysis were patients who underwent complete LAA closure with dual Watchman devices between December 2015 and December 2021. The anatomic morphology, procedure characteristics, procedure safety, and procedural complications were analyzed. Cardiac CT or transesophageal ultrasound was obtained at 7 days, 6 months, 1 year, and 2 years post-operatively to evaluate the effect of occlusion.ResultsAmong the 330 patients who underwent LAA occlusion during the study period, 7 (2.1%) patients were occluded with one-stop implantation of the double Watchman strategy. Successful occlusion was achieved in all patients. One patient had the double-access sheath strategy for implantation, and 6 patients had only a single-access sheath strategy for implantation. Pericardial effusion occurred in one case during the 7-day perioperative period. There was no device embolization, thrombosis, or obvious peridevice leakage (≥l mm) during the 2-year follow-up, with the exception of two cases with 2 mm of incomplete LAA sealing.ConclusionThe one-stop implantation of a dual Watchman is feasible and safe and might provide a strategy to occlude a large bilobulated LAA when incomplete closure is inevitable with a single device.

Outcomes of left atrial appendage occlusion vs. non-vitamin K antagonist oral anticoagulants in atrial fibrillation

BackgroundThe effects of left atrial appendage (LAA) occlusion compared to non-vitamin K antagonist oral anticoagulant (NOAC) therapy in patients with atrial fibrillation (AF) remain unknown.AimsWe aimed to evaluate the outcomes in patients with AF who received LAA occlusion vs. NOAC therapy.MethodsWe utilised data from TriNetX which is a global federated health research network currently containing data for 88.5 million patients. ICD-10 codes were employed to identify AF patients treated with either LAA occlusion or NOAC between 1st December 2010 and 17th January 2019. Clinical outcomes of interest were analysed up to 2 years.Results108,697 patients were included. Patients who underwent LAA occlusion were younger, more likely to be white Caucasian and male, had a greater incidence of comorbidities, and were less likely to be prescribed other cardiovascular medications. Using propensity score matching, the risk of all-cause mortality was significantly lower among patients who received LAA occlusion compared to NOAC therapy [1.51% vs. 5.60%, RR 0.27 (95% CI 0.14–0.54)], but there were no statistical differences in the composite thrombotic or thromboembolic events [8.17% vs. 7.72%, RR 1.06 (95% CI 0.73–1.53)], ischaemic stroke or TIA [4.69% vs. 5.45%, RR 0.86 (95% CI 0.54–1.38)], venous thromboembolism [1.66% vs. 1.51%, RR 1.10 (95% CI 0.47–2.57)] and intracranial haemorrhage [1.51% vs. 1.51%, RR 1.00 (95% CI 0.42–2.39)].ConclusionOverall, LAA occlusion might be a suitable alternative to NOAC therapy for stroke prevention in patients with AF.Graphical abstract

475 Is left atrial appendage device compression rate a predictor of incomplete occlusion in patients undergoing watchman device implantation?

Abstract Aims Transesophageal echocardiography (TEE) is a standard peri-procedural imaging modality in patients undergoing percutaneous left atrial appendage (LAA) occlusion. An accurate device sizing is pivotal to assess stability and achieve successful closure. In this prospective study, we sought to evaluate the correlation between Watchman device compression rates (DCRs) and risk of incomplete LAA occlusion at follow-up in patients undergoing Watchman device implantation. Methods and results Two-dimensional TEE via a commercially available transducer (Vivid, Philips) was performed during the procedure and within 3 months after the procedure. LAA size, morphology, and DCRs [(original device size—size after deployment)/original device size; %] were assessed in a mid-oesophageal view at 0°, 45°, 90° and 135°, according to company recommendations. Residual leaks ≥ 3 mm were classified as significant. Between 2016 and 2018, 116 patients underwent LAA occlusion with a Watchman device at our institution. The mean age was 74 ± 9 years and 60.4% (n = 70) were males. The average CHA2DS2-VASc and HAS-BLED scores were 4.7 ± 1.7 and 2.5 ± 1.1, respectively. The final device size was 21 mm in 11 (9.5%) patients, 24 mm in 28 (24.1), 27 mm in 27 (23.3%), 30 mm in 26 (22.4%), and 33 mm in 24 (20.7). At follow-up TEE, 16 (13.8%) patients were found to have a significant (≥3 mm) residual leak. The average DCRs measured at different angles in patients with and without leak were not significantly different (24 ± 8% vs. 26 ± 7% at 0°, P = 0.47; 23 ± 9% vs. 25 ± 7% at 45°, P = 0.58; 23 ± 8% vs. 23 ± 6% at 90°, P = 0.61; 22 ± 8% vs. 21 ± 7% at 135°, P = 0.61). At receiver operating characteristic (ROC) analysis, the areas under the curve to discriminate between patients with/without leak were 0.58, 0.57, 0.55, and 0.46 for DCRs measured at 0°, 45°, 90°, and 135° angles. Conclusions Peri-procedural assessment of DCRs does not appear to be an accurate method to predict LAA complete occlusion in patients undergoing Watchman device implantation.

The impact of percutaneous left atrial appendage closure on left ventricular diastolic function and natriuretic peptide levels.

Although the efficacy and safety of left atrial (LA) appendage (LAA) closure in patients with atrial fibrillation (AF) have been well documented in randomized controlled trials and real-world experience, there are limited data in the literature about the impact of LAA closure on diastolic functions. The study aimed to examine the impact of LAA closure on diastolic function and natriuretic peptide levels in patients with AF. Twelve non-valvular AF patients with high risk for developing cardioembolic stroke and contraindications to warfarin underwent LAA occlusion with the WATCHMAN device (Atritech Inc., Plymouth, MN, USA). B-type natriuretic peptide levels and detailed diastolic parameters (mitral inflow velocities, deceleration time (DT), flow propagation velocity (Vp), isovolumetric relaxation time (IVRT), mitral annular e', TE-e', IVRT/TE-e', E/Vp, E/e', pulmonary vein flow parameters consisting of S, D, and S/D) were evaluated at baseline and 45 days after LAA closure. The median age of the patients was 69 (54-78) years and 75% (n: 9) of them were male. All patients completed forty-five days of follow-up. Compared to the baseline values, E/Vp ratio and BNP levels (1.95 (0.94-3.32) vs. 2.37 (1.09-4.46), p= 0.015; 290.0 (90-1271) pg/ml vs. 322.00 (106-1635) pg/ml, p=0.018, respectively) increased, and pulmonary vein S wave and S/D ratio (0.67 (0.33-0.92) vs. 0.38 (0.23-0.91) m/sec, p=0.048; 1.62 (0.86-5.75) vs. 1.33 (0.11-3.35), p=0.019, respectively) decreased after LAA closure. In the present study, we demonstrated that patients with AF have shown impaired diastolic functions and elevated BNP levels after the percutaneous closure of the LAA.

Feasibility of the AtriClip Pro Left Atrium Appendage Elimination Device via the Transverse Sinus in Minimally Invasive Mitral Valve Surgery.

BackgroundAchieving external access to and manual occlusion of the left atrial appendage (LAA) during minimally invasive mitral valve surgery (MIMVS) through a small right thoracotomy is difficult. Occlusion of the LAA using an epicardial closure device seems quite useful compared to other surgical techniques.MethodsFourteen patients with atrial fibrillation underwent MIMVS with concomitant surgical occlusion of the LAA using double-layered endocardial closure stitches (n=6, endocardial suture group) or the AtriClip Pro closure device (n=8, AtriClip group) at our institution. The primary safety endpoint was any device-related adverse event, and the primary efficacy endpoint was successful complete occlusion of blood flow into the LAA as assessed by transthoracic echocardiography at hospital discharge. The primary efficacy endpoint for stroke reduction was the occurrence of ischemic or hemorrhagic neurologic events.ResultsAll patients underwent LAA occlusion as scheduled. The cardiopulmonary bypass and aortic cross-clamp times in the endocardial suture group and the AtriClip group were 202±39 and 128±41 minutes, and 213±53 and 136±44 minutes, respectively (p=0.68, p=0.73). No patients in either group experienced any device-related serious adverse events, incomplete LAA occlusion, early postoperative stroke, or neurologic complication.ConclusionEpicardial LAA occlusion using the AtriClip Pro during MIMVS in patients with mitral valve disease and atrial fibrillation is a simple, safe, and effective adjunctive procedure.

Role of Different Antithrombotic Regimens after Percutaneous Left Atrial Appendage Occlusion: A Large Single Center Experience.

Background: Optimal antithrombotic therapy after left atrial appendage (LAA) occlusion is still not clear. The aim of this study was to investigate the role of different antithrombotic regimens after the procedure. Methods and Results: We retrospectively analyzed data of 260 patients who underwent LAA occlusion and divided them into four groups according to therapy at discharge: dual antiplatelet therapy (group A, 71.5%); oral anticoagulants (group B, 19%); “minimal” antithrombotic therapy (single antiplatelet agent or without any antithrombotic therapy; group C, 4.5%) and other therapeutic regimens (such as a combination of antiplatelets and anticoagulants; group D, 4.5%). We analyzed baseline characteristics, procedural data, and clinical and transesophageal follow-up for each group. The incidence of adverse events was low in the whole population and had a similar distribution among groups. The majority of bleeding events was registered during the first 3 months after the procedure (34 out of 46, 70%). Ischemic events (2%), as well as silent left atrial thrombosis, were rare and not significantly higher in the population discharged with “minimal” antithrombotic therapy. Conclusion: Our experience seems to suggest that LAA occlusion was associated with a low incidence of adverse events, regardless of antithrombotic therapy. A “minimal” drug regimen may be feasible without losing efficacy on embolic prevention for patients with high bleeding risk.

Peridevice Leak Following Amplatzer Left Atrial Appendage Occlusion: Cardiac Computed Tomography Classification and Clinical Outcomes.

This study aimed to investigate cardiac computed tomography (CT) and transesophageal echocardiography (TEE) peridevice leak (PDL) assessments, and the clinical relevance of PDL. PDL assessment is integral during follow-up after left atrial appendage (LAA) occlusion. Comparative studies of TEE and cardiac CT are sparse, and the clinical relevance of PDL is uncertain. This was a single-center observational study of consecutive patients undergoing LAA occlusion with Amplatzer devices (Amplatzer Cardiac Plug/Amulet) between 2010 and 2018 (N=415). Patients with both 8-week CT and TEE were included for analysis (n=346). Images were analyzed by blinded investigators (K.K. and A.S.). PDL on cardiac CT was classified from grade 1 to 3, based on PDL at the device disc, device lobe, and LAA contrast patency. Primary clinical outcome was a composite of ischemic stroke, transient ischemic attack, systemic embolism, or all-cause death. PDL was present in 110 patients (32%) by TEE, with 29 (8%) >3mm. By cardiac CT, 210 patients (61%) had PDL at the disc, with contrast patency in 204 patients (59%). A grade 3 PDL (gap at disc, lobe, and LAA contrast patency) was present in 63 patients (18%). Bland-Altman analysis showed poor agreement between CT and TEE for leak sizing. CT and TEE detected PDL was not significantly associated with worse outcome, hazard ratio: 1.82 (95 % confidence interval: 0.95 to 3.50); p=0.07 and hazard ratio: 1.43 (95% confidence interval: 0.74 to 2.76); p=0.28, respectively. PDL occurrence is substantially higher with CT compared with TEE, with a large discrepancy between modalities in leak quantification. A novel CT-based classification is proposed, yet PDL was not associated with worse clinical outcome.

Left atrial appendage occlusion in atrial fibrillation patients with previous intracranial bleeding: A national multicenter study

BackgroundIntracranial hemorrhage (ICH) represents the most serious complication of oral anticoagulant therapy (OAT) in patients with atrial fibrillation (AF), and AF patients with previous ICH are a challenge for clinicians. Left atrial appendage (LAA) occlusion has emerged as an alternative option for AF patients not suitable for OAT. Currently, few data are available on long term outcomes after LAA occlusion in this population. We evaluated the safety and efficacy of LAA occlusion in a cohort of patients with AF and previous ICH. MethodsThis is a multicenter, observational, retrospective study involving 5 LAA occlusion centers in Italy. It includes all consecutive patients (n = 120) with previous ICH who underwent LAA occlusion for nonvalvular AF and high thromboembolic risk. Procedural outcomes, post-procedural therapies and 12-months follow-up data were analyzed. ResultsThe device was successfully implanted in 100% of cases, with a 6% of major peri-procedural complications. 59% had a prior ICH during OAT. The sample had a high risk of stroke (5.18%/year) and bleeding (6.62%/year). 30% were discharged on single and 54.2% on dual antiplatelet therapy.The expected annual risk for thromboembolism was 5.1%. Excluding periprocedural ischemic complications, the stroke annual rate was 1.8%. The expected annual risk of bleeding was 6.7%. The observed annual bleeding rate was 5.45%. ConclusionsPercutaneous LAA occlusion is an effective option for AF patients and previous intracranial hemorrhage. After LAA occlusion, a single antiplatelet therapy strategy could be considered for patients with the highest risk of recurrent bleeding.

Safety and Efficacy of Single Versus Dual Antiplatelet Therapy After Left Atrial Appendage Occlusion

The optimal antiplatelet strategy after left atrial appendage (LAA) occlusion able to protect from device-related thrombosis, paying the lowest price in terms of bleeding increase, is unclear. In a real-world, observational study we performed a head-to-head comparison of single versus dual antiplatelet therapy (SAPT vs DAPT) in patients who underwent LAA occlusion. We included 610 consecutive patients, stratified according to the type of post-procedural antiplatelet therapy (280 on SAPT and 330 on DAPT). Primary outcome measure was the incidence of the net composite end point including Bleeding Academic Research Consortium classification 3-5 bleeding, major adverse cardiovascular events or device-related thrombosis at 1-year follow-up. The use of SAPT compared with DAPT was associated with similar incidence of the primary net composite end point (9.3% vs 12.7% p = 0.22), with an adjusted hazard ratio (HR) of 0.69, 95% confidence interval 0.41 to 1.15; p = 0.15) at multivariate analysis. However, SAPT significantly reduced Bleeding Academic Research Consortium classification 3-5 bleeding (2.9% vs 6.7%, p = 0.038; adjusted HR 0.37, 0.16 to 0.88; p = 0.024). The occurrence of ischemic events (major adverse cardiovascular events or device-related thrombosis) was not significantly different between the 2treatment strategies (7.8% vs 7.4%; adjusted HR 1.34, 0.70 to 2.55; p = 0.38). In patients who underwent LAA occlusion, post-procedural use of SAPT instead of DAPT was associated with reduction of bleeding complications, with no significant increase in the risk of thrombotic events. These hypothesis-generating findings should be confirmed in a specific, randomized study.

Outcomes on safety and efficacy of left atrial appendage occlusion in end stage renal disease patients undergoing dialysis

BackgroundIn patients with end stage renal disease and atrial fibrillation (AF), undergoing chronic dialysis, direct oral agents are contraindicated and warfarin does not fully prevent embolic events while increasing the bleeding risk. The high hemorrhagic risk represents the main problem in this population. Aim of the study was to estimate the safety and efficacy for thromboembolic prevention of left atrial appendage (LAA) occlusion in a cohort of dialysis patients with AF and high hemorrhagic risk.MethodsNinety-two dialysis patients with AF who underwent LAA occlusion were recruited. For comparative purposes, two cohorts of dialysis patients with AF, one taking warfarin (oral anticoagulant therapy, OAT cohort, n = 114) and the other not taking any OAT (no-therapy cohort, n = 148) were included in the study. Primary endpoints were (1) incidence of peri-procedural complications, (2) incidence of 2-year thromboembolic and hemorrhagic events, (3) mortality at 2 years. In order to evaluate the effect of the LAA occlusion on the endpoints with respect to the OAT and No-therapy cohorts, a multivariable Cox regression model was applied adjusted for possible confounding factors.ResultsThe device was successfully implanted in 100% of cases. Two major peri-procedural complications were reported. No thromboembolic events occurred at 2-year follow-up. The adjusted multivariable Cox regression model showed no difference in bleeding risk in the OAT compared to the LAA occlusion cohort in the first 3 months of follow-up [HR 1.65 (95% CI 0.43–6.33)], when most of patients were taking two antiplatelet drugs. In the following 21 months the bleeding incidence became higher in OAT patients [HR 6.48 (95% CI 1.32–31.72)]. Overall mortality was greater in both the OAT [HR 2.76 (95% CI 1.31–5.86)] and No-Therapy [HR 3.09 (95% CI 1.59–5.98)] cohorts compared to LAA occlusion patients.ConclusionsThe study could open the way to a non-pharmacological option for thromboembolic protection in dialysis patients with AF and high bleeding risk.

Incidence, Characteristics and Management of Persistent Peri-Device Flow after Percutaneous Left Atrial Appendage Occlusion

ABSTRACT Background : Severe peri-device leaks after left atrial appendage (LAA) occlusion requires continuation of life-long oral anticoagulation. However, the majority of patients referred for LAA occlusion are not suitable for anticoagulation. Data on the incidence, characteristics, and management of peri-device leak after LAA occlusion are scarce. Methods : We assessed the incidence of peri-device leak, its characteristics, and their management outcomes in 200 consecutive patients who underwent LAA occlusion between April 2016 and August 2018. Results : Severe persistent peri-device flow was present in 9/200 patients (4.5%) at 45 days. Baseline clinical characteristics were comparable between patients with or without severe leaks. However, patients with severe leaks had larger LAA diameter (24.5 ± 4.3 vs. 19.8 ± 3.7 mm, p < 0.001), and more sub-optimal deployments (100% vs. 26.7%, p < 0.001). Sub-optimal deployment parameters included: non-coaxial deployment, preferential single lobe deployment, incomplete coverage of a proximal side lobe, and shallow implantation. Among patients with severe leaks, 7 (78%) underwent percutaneous closure. Percutaneous closure with the Amplatzer Vascular Plug-II device had a 100% success rate and no short-term complications. Conclusions : Severe peri-device leak is present in ~5% of patients following LAA occlusion. Certain anatomical and procedural factors might contribute to the occurrence of peri-device leak. Severe leaks can be effectively closed with percutaneous techniques.

The value of the left atrial appendage orifice perimeter of 3D model based on 3D TEE data in the choice of device size of LAmbre™ occluder.

Preoperative optimal selection of the occluder size is crucial in percutaneous left atrial appendage (LAA) occlusion, and the maximal width of the LAA orifice is the main reference index, however it can not fully meet the practical operation requirements. We retrospectively analyzed three-dimensional (3D) transesophageal echocardiography (TEE) and computed tomography (CT) imaging dataset of the 41 patients who underwent LAA occlusion with LAmbre™ system. The LAA orifice parameters were overall evaluated to determine their role in device size selection. Eight LAA 3D models of the four cases who had been replaced their device during the procedure based on TEE and CT were printed out to verify the optimal parameter decision strategy. There was a significant concordance of the results between 3D TEE and CT in the LAA orifice evaluation. The correlations between the perimeter and maximal width measurements by 3D TEE and the closure disk of the device were stronger than that between the area measurements and the closure disk (r = 0.93, 0.95, 0.86, respectively and p < 0.001 all), and the result was similar to that by CT (r = 0.92, 0.93, 0.84, respectively and p < 0.001 all). The ratios of the maximal width to the minimal width of the four cases were all > 1.4, however the rest 37 cases were all ≤ 1.4. Based on the comprehensive assessment of the LAA orifice perimeter and maximal width of the 3D printed models, the experiments were all succeed just for one try. The LAA orifice perimeter of 3D printed model based on 3D TEE may help in choosing the optimal device size of LAmbre™, especially for the LAA with flater ostial shape.

Device Sizing Guided by Echocardiography-Based Three-Dimensional Printing Is Associated with Superior Outcome after Percutaneous Left Atrial Appendage Occlusion

Left atrial appendage (LAA) occlusion is an alternative to anticoagulation for stroke prevention in patients with atrial fibrillation. Accurate device sizing is crucial for optimal outcome. Patient-specific LAA models can be created using three-dimensional (3D) printing from 3D transesophageal echocardiographic (TEE) images, allowing invitro model testing for device selection. The aims of this study were to assess the association of model-based device selection with procedural safety and efficacy and to determine if preprocedural model testing leads to superior outcomes. In 72 patients who underwent imaging-guided LAA occlusion, 3D models of the LAA were created from 3D TEE data sets retrospectively (retrospective cohort). The optimal device determined by invitro model testing was compared with the actual device used. Associations of model-match and model-mismatch device sizing with outcomes were analyzed. In another 32 patients, device selection was prospectively guided by 3D models in adjunct to imaging (prospective cohort). The impact of model-based sizing on outcomes was assessed by comparing the two cohorts. Patients in the retrospective cohort with model-mismatch sizing had longer procedure times, more implantation failures, more devices used per procedure, more procedural complications, more peridevice leak, more device thrombus, and higher cumulative incidence rates of ischemic stroke and cardiovascular or unexplained death (P<.05 for all) over 3.0±2.3years after LAA occlusion. Compared with the retrospective imaging-guided cohort, the prospective model-guided patients achieved higher implantation success and shorter procedural times (P<.05) without complications. Clinical device compression (r=0.92) and protrusion (r=0.95) agreed highly with model testing (P<.0001). Predictors for sizing mismatch were nonwindsock morphology (odds ratio, 4.7) and prominent LAA trabeculations (odds ratio, 7.1). In patients undergoing LAA occlusion, device size selection in agreement with 3D-printed model-based sizing is associated with improved safety and efficacy. Preprocedural device sizing with 3D models in adjunct to imaging guidance may lead to superior outcomes.

Construction of left atrial appendage three-dimensional model based on transesophageal echocardiography and its value in preoperative simulated left atrial appendage closure

Objective To evaluate the accuracy of simulated operation before the left atrial appendage (LAA) occlusion by filed LAA model with soft materials, which is based on transesophageal three-dimensional echocardiography (3D-TEE). Methods Silica and hydrogel were mixed to imitate cardiac tissue. Silica and hydrogel mixed materials, silica and Tangoplus were subjected to mechanical detection and ultrasonic shear wave elastography (SWE). The preoperative and postoperative 3D-TEE image processing was performed on 21 patients undergoing LAA occlusion. The silica and hydrogel LAA 3D model, silicone model and Tangoplus model were acquired to evaluate the accuracy of 3D model. LAA closure was simulated using the 3D models and the compression ratio of the device in models was compared with the value measured in operation. Results The silica and hydrogel mixed materials were successfully prepared. The elastic modulus and stress-strain curve were closer to the myocardial tissue. Twenty-one 3D printing models of three materials were obtained in 21 patients based on 3D-TEE images.There was no significant difference in the anchor zone between the 3D model and 3D-TEE (P>0.05). The 3D model measurements were consistent with the 3D-TEE measurements. The compression ratios of the decive in the 3D models of all three materials were greater than those measured in operation, and the compression ratio of the device in the 3D model of silica and hydrogel materials had a better correlation with that measured in operation (r=0.900, P<0.01). Conclusions The 3D model of LAA made of silica and hydrogel material based on 3D-TEE can improve the accuracy of the LAA occlusion simulation, also can optimize the preparation of LAA occlusion. Key words: Echocardiography, transesophageal, three-dimensional; Three-dimensional printing; Left atrial appendage; Soft printing material

Applications of cardiac computed tomography in electrophysiology intervention.

Cardiac electrophysiology is an evolving specialty that has seen rapid advances in recent years. Concurrently, there has been much progress in the field of cardiac imaging. Electrophysiologists are increasingly requesting cross-sectional imaging in advance of many procedures. Pulmonary vein isolation and left atrial appendage (LAA) occlusion are now an established treatment options for atrial fibrillation. In patients undergoing pulmonary vein isolation, applications of computed tomography (CT) include evaluating the left atrial and pulmonary venous anatomy, excluding LAA thrombus and assessing for pulmonary vein stenosis. In those undergoing LAA occlusion, CT may be of value in assessing the size, position, and morphology of the LAA as well as for determining correct positioning of the device and evaluating for peri-device leak. Implantable cardiac devices are now commonly used in the management of cardiac failure and cardiac arrhythmias. Applications of CT prior to device implantation include detecting myocardial scar, evaluating for mechanical dyssynchrony as well as visualising the coronary venous anatomy.

Application of transesophageal echocardiography in left atrial appendage closer with Amplatzer Cardiac Plug

Objective To assess the value of transesophageal echocardiography (TEE) in left atrial appendage (LAA) closer with Amplatzer Cardiac Plug (ACP). Methods Consecutive 32 atrial fibrillation patients (CHADS2≥1) with high risk bleeding underwent LAA occlusion with ACP LAA occlusion device under the guidance of TEE. Measurements of LAA anchoring area diameter (AAD) and LAA anatomical orifice diameter (AOD) including maximum, minimum values, and LAA depth on 2 dimentional TEE (2D TEE) were conducted before closer device implantation. The outcomes of LAA occlusion were analyzed. Results Among 32 patients, 27 cases achieved successful LAA occlusion, including 2 cases with peripheral leakage ≤5 mm, and 5 cases failed occlusion.Among 5 failed closed patients, 3 cases with LAA AAD≥ 30 mm, 1 case with LAA of short depth, and 1 case with anatomical variation of LAA of low position that access sheath could not be positioned in the LAA. LAA AAD maximum, minimum and LAA depth were (25.9±4.9)mm, (20.0±3.8)mm, (31.0±5.6)mm, respectively, and LAA AOD maximum, minimum diameters were (26.2±6.2)mm, (19.4±4.3)mm, respectively. Among 10 cases with LAA AAD≥30 mm, 7 cases achieved successful LAA occlusion, but 3 cases failed. The implanted device diameter was (26.4±3.8)mm, and device compression rate was (7.6±5.5)%. The coefficient of correlation between device diameter and large LAA AAD and AOD is 0.770 and 0.717, respectively. There was no complication but 1 case with pericardial effusion. Conclusions Two dimentional TEE measurements of LAA have clinical guiding significance in the selection of proper size of ACP LAA occluder. The AAD of 2D TEE has the good correlation with ACP occluder′s size, the AADs are important factors which affect the success of LAA occlusion. Key words: Echocardiography, transesophageal; Left atrial appendage; Occlusion; Amplatzer Cardiac Plug