Left atrial appendage closure in a patient previously implanted with an interatrial shunt device: a case report.

Patients with previous interatrial shunt device (IASD) implantation may face greater challenges during future left atrial interventional procedures. Herein, we report the first case of left atrial appendage closure (LAAC) in a patient with previous IASD implantation. The patient successfully underwent LAAC using the LAmbre device without complications.

Impact of left atrial appendage orifice diameter on the safety and efficacy of left atrial appendage closure using the LAmbre device.

BACKGROUND: The diameter and shape of the left atrial appendage (LAA) orifices may influence occluder selection and the outcomes of left atrial appendage closure (LAAC) procedure. This study aimed to evaluate the impact of LAA orifice diameter on the safety and efficacy of LAAC using the LAmbre device. METHODS: A total of 133 patients with nonvalvular atrial fibrillation (AF) who underwent LAAC with the LAmbre device between June 2018 and June 2020 were included in this study. The patients were categorized into two groups based on the maximal diameter of the LAA orifice: the large LAA group (n = 45) with a maximal orifice diameter of ≥31 mm, and the normal LAA group (n = 88) with a maximal orifice diameter of <31 mm. The study assessed periprocedural characteristics and long-term clinical follow-up. RESULTS: Successful implantation of the LAmbre device was observed in all patients. The incidence of periprocedural peridevice leakage (PDL) was significantly higher in the large LAA group (P < 0.001), while the incidence of acute pericardial effusion (PE) during the procedure was comparable between the two groups (P = 1.000). After a mean follow-up period of 4.8 ± 1.7 years, three patients in the large LAA group developed delayed PE, while no patients in the normal LAA group did (P = 0.037). Additionally, a larger LAA maximal orifice diameter was associated with a higher prevalence of PDL (P = 0.001) and PE (including both acute and delayed PE) (P = 0.027). The optimal cutoff value of the LAA maximal orifice diameter for predicting PDL and PE after LAAC with the LAmbre device was determined to be 30 mm. CONCLUSION: The findings suggest that the LAmbre device is a safe and feasible option for occluding the LAA, regardless of its orifice diameter. However, it is important to note that a larger LAA orifice diameter may increase the risk of PDL and delayed PE.

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

BACKGROUND: Percutaneous 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. METHODS: We 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. RESULTS: Twenty-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. CONCLUSIONS: Occlusion 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.

Closing gigantic left atrial appendage using a LAmbre Closure System: First implant experience in North America.

INTRODUCTION: Despite maturing experience and growing procedural familiarity, there remain challenges in percutaneous left atrial appendage (LAA) closure due to anatomical complexities. METHODS: We report a complex and extremely large LAA that was successfully closed percutaneously using a LAmbre Closure System (Lifetech Scientific Corp.). Cardiac computed tomography angiography demonstrated a gigantic multilobed LAA measuring 48 × 45.3 mm at the level of the ostium that cannot be occluded by the currently approved LAA closure devices in Canada. RESULTS: The manufacturer custom-made a LAmbre 30/50 mm (lobe/disc) device to fit this patient's LAA according to his CTA, which was successfully deployed under fluoroscopy and transesophageal echocardiogram guidance without procedure-related complications. CONCLUSION: The LAmbre device may be considered to close very large LAAs.

Delayed pericardial effusion after left atrial appendage closure with the LAmbre device: Importance of a fully open umbrella.

INTRODUCTION: We aimed to investigate whether a modified implantation method facilitating a fully open umbrella can reduce the pericardial effusion/pericardial tamponade (PE/PT) rate after left atrial appendage closure (LAAC) with the LAmbre device compared with the conventional method (CM) in patients with non-valvular atrial fibrillation (NVAF). METHODS AND RESULTS: Patients with NVAF who received either isolated LAAC or combined catheter ablation and LAAC using the LAmbre device at the First Affiliated Hospital of Wenzhou Medical University from January 2018 to December 2019 were enrolled. CM was used for device implantation in the initial 59 patients, while a modified method (MM) was used in the remaining 165 patients. Successful implantation was achieved in 98.3% of patients in the CM group and 98.8% in the MM group. A higher rate of a fully open umbrella (98.8% vs. 69%, p < .001), less requirement for recapture (46% vs. 62.1%, p = .036), and a lower incidence of delayed PE/PT (1.2% vs. 8.6%, p = .005) were found in the MM group compared with the CM group. All of the five delayed PT events occurred in patients with combined treatment. An umbrella that was not fully open was the only factor associated with delayed PE/PT events in a multivariable Cox model. CONCLUSIONS: LAAC with the LAmbre device using an MM significantly increases the rate of a fully open umbrella and decreases the requirement for recapture and the incidence of delayed PE/PT. This method is more effective in patients with combined treatment.

Incidence, risk factors, and clinical impact of peridevice leak following left atrial appendage closure with the LAmbre device-Data from a prospective multicenter clinical study.

BACKGROUND: In the present study, we sought to explore the incidence, risk factors, and clinical impact of peridevice leaks (PDLs), following LAmbre-assisted left atrial appendage closure (LAAC). METHODS: We performed transesophageal echocardiography (TEE) on patients participating in the LAmbre multicenter study, at Day 1 postimplantation, then at 3 and 12 months to assess PDL, device-related thrombus, left atrial appendage (LAA) thrombus, and left atrial thrombus. Clinical events were recorded during follow-up. RESULT: A total of 152 patients with atrial fibrillation successfully completed LAAC. At 3 months follow-up, 123 patients underwent TEE, with 21 (17%) of them presenting PDL. Among the 121 patients who underwent TEE at 12 months follow-up, 19 (15.7%) presented PDL. Patients with PDL exhibited larger LAA orifice diameters and larger device sizes compared to those in the no leak group. In addition, we found no significant differences in thromboembolic events between patients in the PDL and no leak groups. CONCLUSION: LAmbre-assisted LAA closure resulted in a relatively low PDL occurrence, and its rate decreased over time. In addition, PDL was more prominent in patients with larger LAA orifice diameter and larger device size. However, the condition was not associated with an increased risk for thromboembolic events.

Feasibility and safety of left atrial appendage occlusion guided by procedural fluoroscopy only: A pilot study.

BACKGROUND: Left atrial appendage occlusion (LAAO) is usually performed via the guidance of procedural transesophageal echocardiography (TEE) companied by general anesthesia (GA). OBJECTIVE: To investigate the feasibility and safety of LAAO guided by procedural fluoroscopy only. METHODS: The patients eligible for LAAO were enrolled into the current study and received implantation of either Watchman device or LAmbre device. The procedure was carried out with procedural fluoroscopy only and no companied GA; the position, shape, and leakage of the device were assessed by contrast angiography. TEE was performed after 3-month follow-up to evaluate the thrombosis, and leakage of device. RESULTS: Ninety-seven patients with atrial fibrillation (AF) with either Watchman device (n = 49) or LAmbre device (n = 48) were consecutively enrolled. Watchman device group was of lower CHA2 DS2 -VASc and HAS-BLED scores compared with LAmbre device groups (p < .05); the two groups had similar distributions of other baseline characteristics (p > .05), including procedural success rate (98.0% vs. 97.9%), mean procedure time, mean fluoroscopy time, total radiation dose, contrast medium dose, percentage of peri-device leakage. Pericardial effusions requiring intervention occurred in two of the Watchman group. TEE follow-up found no patient with residual leakage ≥5 mm at 3 months and no device related thrombosis (DRT). During the 22.0 ± 11.1 months follow-up, two patients experienced ischemic stroke. CONCLUSIONS: LAAO with the procedural imaging of fluoroscopy only exhibited the promising results of efficacy and safety. A prospective randomized multicenter study would be required to verify the observations in this study.

Percutaneous retrieval of a dislocated LAmbre left atrial appendage occluder in a canine model.

BACKGROUND: Dislocated left atrial appendage (LAA) occluders can be retrieved by percutaneous intervention when performing device embolization into the left atrium (LA), aorta (AO), or left ventricle (LV). However, few reports exist regarding LAmbre LAA occluder dislocation. OBJECTIVE: The study was aimed to explore the outcome of retrieving dislocated LAmbre LAA occluder. METHODS: Sixteen healthy dogs received LAmbre implants. After implantation of an occlusion device (not released), the occlusion device was completely retrieved. Subsequently, the device was released in the LA, resulting in the dislocation of the device. Angiography and transesophageal echocardiography (TEE) were performed to check the occluders position. Disposable grasping rat-tooth forceps were used to percutaneously retrieve the LAA occluder. RESULTS: All the 16 dogs were successfully implanted with the LAmbre LAA occluder and the success rate was 100%. After the occluder was released, TEE and angiography confirmed that the device was located in the LA in eight cases (50%), in the AO in five cases (31%), and in the LV in three cases (19%). One subject died due to cardiogenic shock before the retrieval procedure was complete as the device fell into the LV. Two cases of device-related aortic valve injury occurred during the retrieval procedure when the device was located in the LV. No complications were observed when the device was located in the LA or AO. CONCLUSIONS: Device retrieval is feasible in most cases. However, potentially lethal complications may occur once the device is dislocated into the LV/AO.

Late clinical outcomes of lambre versus amplatzer occluders for left atrial appendage closure.

INTRODUCTION: The LAmbre (LifeTech Scientific, Shenzhen, China) is a novel occluder for left atrial appendage closure (LAAC) in patients with atrial fibrillation. This study compares late clinical outcomes of LAmbre and the established Amplatzer devices (Abbott, St Paul, MN). METHODS: Between 2012 and 2018, 265 consecutive patients underwent LAAC with LAmbre and Amplatzer devices at a single center. After a 3:1 propensity score matching, 40 (LAmbre) vs 107 (Amplatzer) patients were compared by the primary efficacy endpoint of all-cause stroke, systemic embolism and cardiovascular/unexplained death, the primary safety endpoint of major periprocedural complications and major bleeding events at follow-up, and the combined hazard endpoint, a composite of all the above-mentioned hazards. RESULTS: The mean age 75.6 ± 8.9 (LAmbre) vs 75.5 ± 9.0 (Amplatzer) years, CHA2 DS2 -VASc score 4.8 ± 1.7 vs 4.8 ± 1.7 and HAS-BLED score 3.1 ± 0.9 vs 3.2 ± 0.8 were similar. After 3.6 ± 1.9 vs 2.5 ± 1.4 years, the clinical efficacy (12/146, 8.2% [LAmbre] vs 28/266, 10.5% [Amplatzer]; hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.38-1.40; P = .34) and safety (5/146, 3.4% vs 14/266, 5.3%; HR, 0.47; 95% CI, 0.14-1.6; P = .22), as well as the combined hazard endpoint (15/146, 10.3% vs 36/266, 13.6%; HR, 0.67; 95% CI, 0.36-1.25; P = .21) were comparable. CONCLUSION: In the presented report, in patients with nonvalvular atrial fibrillation, the LAmbre offered similar long-term efficacy and safety in comparison to Amplatzer devices.

Forceps through a 14F flexible sheath for safe retrieval of a dislodged left atrial appendage occluder.

The LAmbre occluder (Lifetech Scientific, Shenzhen, China), a new device for left atrial appendage occlusion (LAAO), is increasingly used, but the retrieval procedure for dislodgements has rarely been reported in humans. We herein reported a case of safe retrieval of dislodged LAmbre occluder. The occluder dislodged to the left atrium (LA) at the end of the LAAO procedure. We failed to retrieve the device in the LA using a LASSO catheter and forceps through an 8.5F sheath. After it suddenly flowed into the aortic arch, we successfully retrieved it using the same forceps through a 14F flexible sheath. We also discuss the reasons for device dislodgment and experiences of device retrieval. We think that forceps can be used to retrieve an embolized LAmbre device in the aorta through a 14F flexible sheath.

Systematic review on left atrial appendage closure with the LAmbre device in patients with non-valvular atrial fibrillation.

BACKGROUND: Percutaneous closure (LAAC) of the left atrial appendage (LAA) is an efficacious preventive procedure for patients with non-valvular atrial fibrillation (NVAF) and considerable bleeding risk. We sought to systematically review the available LAAC data on the novel occluder device LAmbre™. METHODS: For this systematic review, a search of the literature was conducted by 3 independent reviewers, reporting the safety and therapeutic success of LAAC in patients being treated with a LAmbre™. Publications reporting the safety and therapeutic success of LAAC using LAmbre™ in n > 5 patients were included. RESULTS: The literature search retrieved n = 10 publications, encompassing n = 403 NVAF patients treated with a LAmbre™ LAAC, with relevant data regarding safety and therapeutic success of the procedure. The mean CHA2DS2-VASc Score was 4.0 + 0.9, and the mean HAS-BLED score was 3.4 + 0.5. The implantation success was 99.7%, with a mean procedure time of 45.4 ± 18.7 min, and a fluoroscopy time of 9.6 ± 5.9 min, and a contrast agent volume of 96.7 ± 0.7 ml. The anticoagulation regimen was switched to DAPT post procedure in the majority of the patients (96.8%). Partial and full recapture were done in 45.5% and in 25.6%, respectively. Major complications were reported in 2.9%, with 0.3% mortality, 1.7% pericardial tamponade, 0.3% stroke, and 0.6% major bleeding complications; no device embolization was observed. During follow up at 6 or 12 months, major adverse cardiovascular events were reported in 3.3%: Stroke or TIA in 1.7%, thrombus formation on the device in 0.7%, and residual flow > 5 mm in 1.0%. In some publications, the favorable implantion properties of the LAmbre™ for difficult anatomies such as shallow or multilobular LAA anatomies were described. CONCLUSIONS: This systematic review on the LAmbre™ LAA-occluder including n = 403 NVAF patients demonstrates an excellent implantion success rate, promising follow-up clinical data, and favorable properties for also challenging LAA anatomies,. While its design seems to be helpful in preventing device embolization, pericardial tamponade may not be substantially reduced by the LAmbre™ as compared with other established LAAC devices. Further larger prospective multicenter registries and randomized trials are needed to scrutinize the value of the LAmbre™ compared with established LAAC devices.

Feasibility of percutaneous left atrial appendage closure using a novel LAmbre occluder in patients with atrial fibrillation: Initial results from a prospective cohort registry study.

BACKGROUND: The LAmbre™ occluder is a novel device for percutaneous left atrial appendage closure (LAAC). The presented study aimed to report the initial experience in implantation of the novel LAmbre for LAAC in patients with nonvalvular AF. METHODS: We conducted a prospective, observational, cohort registry study to evaluate the feasibility of percutaneous LAAC using the LAmbre system. RESULTS: Thirty patients (15 female, mean age 77.6 ± 8.9 years) who had high risks of stroke and contraindications for oral anticoagulation were prospectively enrolled in this registry study. The mean CHA2DS2-VaSc was 3.9 ± 1.5, and the mean HAS-BLED score was 4.1 ± 1.0. Twenty (66.7%) patients had chicken-wing LAA morphology. The implant success rate was 100%. The mean fluoroscopic time and procedure time were 3.5 ± 1.9 and 29.0 ± 10.1 minutes, respectively. No significant procedure-related complications were observed during in-hospital and acute clinical follow-up. CONCLUSION: In this preliminary study, the LAmbre occluder showed an excellent implant success rate, favorable implant property, and very low incidence of complications. Larger sample, randomized studies are further warranted.

Left atrial appendage closure in patients with left atrial appendage thrombus guided by intracardiac echocardiography.

BACKGROUND: Data regarding left atrial appendage closure (LAAC) in patients with left atrial appendage (LAA) thrombus are limited. Recently published cases have mostly been guided by transesophageal echocardiography. Intracardiac echocardiography (ICE) is now widely used during LAAC procedures. OBJECTIVE: This is the first study to report the feasibility of LAAC in patients with LAA thrombus guided by ICE. METHODS: Patients with persistent LAA thrombus despite anticoagulation or contraindications to anticoagulation who underwent a modified ICE-guided LAAC procedure between June 2021 and April 2023 were included. Periprocedural events and clinical outcomes during follow-up were recorded. RESULTS: A total of 12 patients (mean age 65 ± 7 years; 92% male) were included: 10 with persistent LAA thrombus and 2 with contraindications to anticoagulation. Most of the thrombus was at the apex (n = 6), followed by the body (n = 3) and the ostium (n = 3). A LAmbre device was used and successfully implanted in all patients with the guidance of ICE. No thrombotic material was retrieved from patients with the protection of cerebral protection device (n = 11). No patient experienced severe periprocedural complications. All patients completed transesophageal echocardiography follow-up, and no device-related thrombus or peridevice leak > 3 mm was detected. None of the patients experienced stroke/transient ischemic attack, systemic embolism, or major bleeding events during a median follow-up of 147 days (interquartile range 80-306 days). CONCLUSION: LAAC using the LAmbre device guided by ICE may be feasible in patients with LAA thrombus when performed by experienced operators.

Single antiplatelet therapy after left atrial appendage closure in patients with AF: safety and effectiveness.

INTRODUCTION AND OBJECTIVES: The optimal antithrombotic strategy following left atrial appendage closure (LAAC) is poorly defined in patients with nonvalvular atrial fibrillation. We assessed the safety and effectiveness of a single antiplatelet treatment (SAPT) strategy after LAAC in a population at high risk of ischemic and bleeding events. METHODS: This single-center, observational, prospective study included a consecutive cohort of patients who underwent LAAC using the LAmbre device (Lifetech Scientific, China) and who were discharged with SAPT. The primary outcome was a composite of stroke, systemic embolism, and device-related thrombosis during follow-up. Secondary endpoints were cardiovascular mortality and major bleeding events (BARC ≥3a). Clinical follow-up was performed at 1, 6, and 12 months and subsequently on an annual basis. Transesophageal echocardiography was performed at 1 and 12 months of follow-up. RESULTS: The study comprised 74 patients. The median age was 77 [72-83] years and 43% were women. The cohort exhibited a high prevalence of comorbidities and cardiovascular risk factors. The median CHA2DS2-VASc and HAS-BLED scores were 4 [3-6] and 4 [4-5], respectively. The median length of follow-up was 2.5 years (188 patients-year). During follow-up, device-related thrombosis occurred in 3 patients (4%). Ischemic stroke occurred in 1 patient (1.3%, rate 0.5%/y), representing a 90.9% relative risk reduction compared with the risk predicted by CHA2DS2-VASc. Major bleeding events occurred in 12 patients (16%, 6.4%/y), with a relative risk reduction of 26.4% of that predicted by HAS-BLED. Cardiovascular-related mortality was observed in 2 patients (2.7%). CONCLUSIONS: SAPT appears to be a safe and effective treatment following LAAC in patients at high ischemic and hemorrhagic risk. Further studies are needed to confirm our findings.

A giant left atrial appendage: a case report on the feasibility of closure with a custom-made device.

Background: Transcatheter left atrial appendage occlusion (LAAO) is a valuable therapeutic option for stroke prevention in patients with atrial fibrillation (AF) at high bleeding risk. However, complex LAA anatomies sometimes preclude the adoption of commercially available LAAO devices. The design of a custom-made LAAO device is a promising strategy in these cases. However, few examples of custom-made devices in case of giant LAAs have been reported. Case summary: An 85-year-old man with permanent AF with CHA2DS2-VASc 4 and recurrent active gastrointestinal major bleedings was referred for transcatheter LAAO at Parma University Hospital after multidisciplinary team evaluation. Pre-procedural coronary computed tomography angiography revealed a giant windsock LAA, with a maximum ostium diameter of 44 mm, a landing zone diameter of 34 mm, and maximal length of 49 mm. Patient's management was particularly challenging given that available LAAO devices were too small to completely exclude the LAA. In accordance with the manufacturer, a custom-made LAmbre™ Closure System (Lifetech Scientific, Shenzhen, China), which specifically fitted with patient's LAA anatomy, was designed and successfully deployed under transoesophageal echocardiography (TEE) and fluoroscopic guidance. Periprocedural TEE confirmed the appropriate position of the device and the absence of peri-device leaks. No adverse ischaemic and haemorrhagic events were reported at 3-months follow-up. Discussion: We present a case of a successful transcatheter LAAO procedure by deploying a custom-made LAmbre device 38/46 mm to mechanically exclude a giant windsock LAA. This case illustrates the effectiveness of a custom-made device strategy, which potentially enables the closure of all complex LAA anatomies.

Appropriate use criteria of left atrial appendage closure devices: latest evidences.

Atrial fibrillation is the most common arrythmia and it is linked to an increased risk of stroke. Even if anticoagulation therapy reduces the rate of stroke the benefits of this therapy have to be balanced with the increased risk of hemorrhagic event. Left atrial appendage closure is a valid alternative to long-term anticoagulation in patients with atrial fibrillation and high hemorrhagic risk. Actually new devices with different features have been tested and introduced progressively in the clinical practice. Improvements in preprocedural imaging evaluation and the learning curve of the operators led to percutaneous left atrial appendage closure a safe and effective procedure. A good knowledge of different devices and the technique of implant is necessary for optimization percutaneous left atrial appendage closure and the reduction of complications during the acute phase and follow up.

Pericardial effusion following percutaneous left atrial appendage closure using the LAmbre device.

Background: Pericardial effusion (PE) is an uncommon but serious complication that occurs following percutaneous left atrial appendage closure (LAAC). There are few data regarding PE following implantation of the LAmbre device for LAAC. Methods: Patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous LAAC using the LAmbre device at the Arrhythmia Center of Ningbo First Hospital from October 2017 to March 2021 were retrospectively reviewed (n = 133). PE was defined as acute if diagnosed ≤7 days post LAAC (n = 3, 2.3%) or delayed if diagnosed >7 days post LAAC (n = 3, 2.3%). The clinical characteristics and procedural data were compared between patients with PE (PE group, n = 6) and without PE (non-PE group, n = 127). The predictors of PE were analyzed by logistic regression. Results: All patients with PE recovered following treatment by pericardiocentesis. Patients with PE were found to have a higher incidence of congestive heart failure (50.0% vs. 13.4%, P = 0.044) and had larger measured LAA orifice diameters (33.5 mm ± 6.0 mm vs. 28.3 mm ± 5.2 mm, P = 0.018) and landing zone diameters (27.8 mm ± 4.8 mm vs. 23.9 mm ± 4.8 mm, P = 0.054) compared with those without PE. The diameters of the device umbrellas (31.7 mm ± 5.6 mm vs. 26.9 mm ± 5.0 mm, P = 0.026) and covers (36.3 mm ± 4.6 mm vs. 33.4 mm ± 4.0 mm, P = 0.075) implanted were larger in the PE group compared to the non-PE group. Univariate logistic regression revealed that congestive heart failure (OR = 6.47, 95% CI = 1.21-34.71, P = 0.029) and LAA maximal orifice diameter (OR = 1.22, 95% CI = 1.02-1.45, P = 0.027) were both associated with PE following LAmbre device implantation. Conclusions: In this single-center experience, both acute and delayed PE were uncommon in patients with AF following LAmbre device implantation. Congestive heart failure and a larger LAA orifice were identified as predictors for the occurrence of PE.

Combined atrial fibrillation ablation and left atrial appendage closure: Watchman vs. LAmbre devices.

Background: Left atrial appendage closure (LAAC) combined with radiofrequency catheter ablation is an emerging one-stop hybrid procedure for non-valvular atrial fibrillation (AF). This study was performed to compare the efficacy and safety of the Watchman device vs. the LAmbre device for this combined procedure. Methods: Two hundred and thirty two patients with AF who underwent the combined procedure were enrolled and divided into two subgroups depending on the device choice: the Watchman-combined group (n = 118) and the LAmbre-combined group (n = 114). The periprocedural and follow-up adverse events in both groups were documented. Results: The mean CHA2DS2-VASc score and HAS-BLED score in the Watchman-combined group and LAmbre-combined group were 3.7 ± 1.5 vs. 3.8 ± 1.5 and 2.5 ± 1.1 vs. 2.3 ± 1.1, respectively (all P > 0.05). Successful LAAC was achieved in all patients. The rate of major periprocedural complications and AF recurrence at 6 months post-procedure were similar between the Watchman-combined group and LAmbre-combined group (0.8 vs. 0.9%, P = 1.00; 22.0 vs. 15.8%, P = 0.23). During 2.6 ±0 .7 vs.1.6 ± 1.6 years follow-up, the rate of major clinical adverse events, including stroke and major bleeding, were comparable between the Watchman-combined group and the LAmbre-combined group (2.6 vs. 1.1% per 100 patient-years, P = 0.33). The intraprocedural peri-device leakage (PDL) rate was similar between the Watchman-combined group and the LAmbre-combined group (5.1 vs. 6.1%, P = 0.73), but the PDL rate was significantly higher at 3-6 months transesophageal echocardiography (TEE) follow-up than the intraprocedural PDL rate in both groups (21.6 vs. 5.1%; 36.6 vs. 6.1%, respectively), with a more obvious increase in minimal PDL rate in the LAmbre-combined group than the Watchman-combined group (36.6 vs. 21.6%, P < 0.05). Conclusion: The Watchman and LAmbre devices were comparable in efficacy and safety for the combined procedure. The minimal PDL rate at short-term TEE follow-up was higher in the LAmbre-combined group than the Watchman-combined group.

Percutaneous left atrial appendage closure using the LAmbre device in patients with atrial fibrillation and left atrial appendage thrombus.

Background: Left atrial appendage closure (LAAC) is considered a valid alternative for the prevention of thromboembolic stroke in patients with persistent left atrial appendage thrombus (LAAT) despite adequate anticoagulation. However, the data on LAAC using the LAmbre device for patients with LAAT is limited. This study was performed to explore efficacy and safety as well as to share the experience of the modified LAAC procedure with the LAmbre device. Materials and methods: A total of 7 patients with persistent LAAT despite adequate anticoagulation underwent modified LAAC with the LAmbre device between November 2019 and April 2022. Transesophageal echocardiography was performed 3 months postoperatively to detect device-related thrombosis and peridevice leak. The patients' clinical events were evaluated during the perioperative and follow-up periods. Results: The median age, CHA2DS2-VASc score, and HAS-BLED score of all patients were 71 [53-73], 3 [2-4], and 2 [2-3], respectively. In the procedure, a cerebral protection system was used in two patients. LAAC with the LAmbre device was successfully performed in all patients without perioperative events. During the median follow-up of 383 [325-865] days, postoperative transesophageal echocardiography was performed in six (85.7%) patients. Device-related thrombosis was detected in one (16.7%) patient, and no significant peridevice leak was observed. No thromboembolic event or bleeding event occurred in any patients. Conclusion: LAAC with the LAmbre device is effective and safe when performed by experienced operators in highly selected patients with LAAT after adequate anticoagulation.

Effect of congestive heart failure on safety and efficacy of left atrial appendage closure in patients with non-valvular atrial fibrillation.

OBJECTIVES: To evaluate the influence of congestive heart failure (CHF) on safety and efficacy of left atrial appendage closure (LAAC) in non-valvular atrial fibrillation (NVAF) patients. METHODS: A total of 401 patients who consecutively underwent LAAC with Watchman and LAmbre devices were divided into CHF (85 cases) and non-CHF (316 cases) groups. Comparisons between groups were performed against data. RESULTS: No significant differences were found in implantation success and periprocedural complication rates between the two groups. During a mean 2.2 years of follow-up, the incidence rate of thromboembolism, major bleeding, device-related thrombus, and non-cardiovascular death was comparable. However, patients with CHF had significantly increased risk of all-cause death (P = 0.015), cardiovascular death (P = 0.014), and combined efficacy endpoints (P = 0.02). After performing propensity score matching, the risk of all-cause death (P = 0.01), cardiovascular death (P = 0.01), and combined efficacy endpoints (P = 0.006) was still higher. The logistic regression analyses identified CHF (OR: 3.642, 95% CI: 1.296-10.232, P = 0.014) as an independent predictor of cardiovascular death. CONCLUSIONS: Implantation of atrial appendage occluder is effective and safe in NVAF patients with CHF. The increased risk of mortality and combined efficacy endpoints in patients with CHF versus non-CHF after LAAC may be associated with the high risk of CHF itself.