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result(s) for
"left atrial appendage closure"
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Left Atrial Appendage Closure after Ablation for Atrial Fibrillation
by
Wazni, Oussama M.
,
Stein, Kenneth M.
,
Kanagasundram, Arvindh
in
Ablation
,
Administration, Oral
,
Aged
2025
After atrial fibrillation ablation, left atrial appendage closure was associated with a lower risk of bleeding than oral anticoagulation and was noninferior to oral anticoagulation with respect to clinical outcomes at 36 months.
Journal Article
Overcoming barriers for left atrial appendage thrombus: a systematic review of left atrial appendage closure
2024
Background
Approximately 90% of intracardial thrombi originate from the left atrial appendage in non-valvular atrial fibrillation patients. Even with anticoagulant therapy, left atrial appendage thrombus (LAAT) still occurs in 8% of patients. While left atrial appendage closure (LAAC) could be a promising alternative, the current consensus considers LAAT a contraindication to LAAC. However, the feasibility and safety of LAAC in patients with LAAT have yet to be determined.
Methods
This systematic review synthesizes published data to explore the feasibility and safety of LAAC for patients with LAAT.
Results
This study included a total of 136 patients with LAATs who underwent successful LAAC. The Amulet Amplatzer device was the most frequently utilized device (48.5%). Among these patients, 77 (56.6%) had absolute contraindications to anticoagulation therapy. Cerebral protection devices were utilized by 47 patients (34.6%). Transesophageal echocardiography (TEE) is the primary imaging technique used during the procedure. Warfarin and novel oral anticoagulants were the main anticoagulant medications used prior to the procedure, while dual antiplatelet therapy was primarily used post-procedure. During a mean follow-up period of 13.2 ± 11.5 months, there was 1 case of fatality, 1 case of stroke, 3 major bleeding events, 3 instances of device-related thrombus, and 8 cases of peri-device leakage.
Conclusions
This review highlights the preliminary effectiveness and safety of the LAAC procedure in patients with persistent LAAT. Future large-scale RCTs with varied LAAT characteristics and LAAC device types are essential for evidence-based decision-making in clinical practice.
Journal Article
Comparing Effectiveness and Safety of Left Atrial Appendage Closure Devices: A Network Meta‐Analysis of Randomized Controlled Trials
by
Reisler, Jenna
,
Davis, Elizabeth
,
Rich, Michael W.
in
Anticoagulants
,
Anticoagulants - therapeutic use
,
Atrial Appendage - physiopathology
2025
Atrial fibrillation-related stroke is a leading cause of morbidity and mortality. The comparative effectiveness and safety of left atrial appendage closure (LAAC) devices, compared with one another and with anticoagulation, is unclear.
We conducted a systematic review and network meta-analysis (NMA) of all clinical trials comparing the Watchman and Amplatzer Amulet LAAC devices with each other or with warfarin or direct oral anticoagulants (DOACs). The primary comparison was between LAAC devices with secondary comparisons to anticoagulation. The primary effectiveness outcomes were any stroke and all-cause death. Safety outcomes included any thromboembolism, device embolization, and pericardial effusion.
There were 476 articles identified from the search and 6 eligible RCTs were included (n = 3666). There was no difference in the risk of stroke with Amulet versus Watchman (RR = 1.48, 95% CI: 0.64-3.46, I
= 41.3%), nor in the risk of death (RR = 1.00, 95% CI: 0.59-1.70, I
= 45.0%). Risk of thromboembolism was not significantly different with Amulet versus Watchman (RR = 0.73, 95% CI: 0.18-2.97, I
= 0%), nor was risk of device embolization (RR = 2.29, 95% CI: 0.71, 7.43, I
= 0%). Both devices exhibited increased risk of pericardial effusion compared with warfarin, with Amulet at highest relative risk (RR = 27.08, 95% CI: 3.53-207.98, I
= 0%) followed by Watchman (RR = 12.79, 95% CI: 1.73-94.85, I
= 0%). Amulet also carried higher relative risk of pericardial effusion than Watchman (RR = 2.12, 95% CI: 1.45-3.09).
In this NMA, the Amulet and Watchman LAAC devices were associated with similar risks for stroke, mortality, thromboembolism, and device embolization. Pericardial effusion risk was higher with Amulet than Watchman.
Journal Article
Migration of the left atrial appendage closure device to the aorta
by
Paguay Fernández, Martha Magaly
,
González-Suárez, Susana
,
Barbosa, José Carlos Sureda
in
Aorta
,
Appendages
2024
Percutaneous closure of the left atrial appendage may be indicated in patients with contraindications to anticoagulation therapy, for example, after recurrent gastrointestinal bleeding. It is an effective and safe procedure but is not without complications. We present a patient who presented with severe aortic insufficiency due to migration of the left atrial appendage closure device, which required urgent cardiac surgery for its removal.
Journal Article
WATCHMAN versus LACbes® device for percutaneous left atrial appendage closure: a single-center, propensity-matched study
2025
Background
Different left atrial appendage closure (LAAC) devices have been introduced into the clinical setting. A new dual-seal mechanism LACbes® occluder with isogenous barbs for LAAC has been designed to facilitate easier delivery and improve safety. The purpose of this study is to compare the clinical outcomes of the WATCHMAN with those of the LACbes® device for LAAC.
Methods
Consecutive patients with atrial fibrillation (AF) who had undergone LAAC performed using a WATCHMAN or LACbes® device from June 2016 to February 2022 were included. The primary efficacy endpoint included ischemic stroke, cardiovascular/unexplained death and device-related thrombus, while the primary safety endpoint included major peri-procedural complications and major bleeding events during clinical follow-ups. 1:1 propensity score matching (PSM) was performed.
Results
After PSM, 184 patients were included in each group. The mean CHA
2
DS
2
-VASc score was 3.1 ± 1.5 (LACbes®) vs. 3.1 ± 1.4 (WATCHMAN), and the HAS-BLED score was 2.7 ± 1.1 vs. 2.7 ± 1.0. At a mean follow-up of 2.5 ± 1.5 vs. 2.4 ± 0.9 years, the defined three endpoints were comparable between the two groups. The occurrence of all-cause stroke was lower in 5/452 (1.8%) with LACbes® vs. 16/433 (3.7%) with WATCHMAN occluders (HR, 0.40, 95% confidence interval (CI), 0.18–0.89, P = 0.023), and the incidence of any bleeding was higher in the WATCHMAN group (41/433, 9.5% vs. 8/452, 1.8%; HR, 0.19, 95% CI, 0.11–0.33).
Conclusion
The LACbes® occluder exhibited comparable safety and efficacy of stroke prevention for AF when compared with the WATCHMAN device.
Journal Article
Safety and effectiveness of left atrial appendage closure in atrial fibrillation patients with different types of heart failure
2024
Background
Both atrial fibrillation (AF) and heart failure (HF) are common cardiovascular diseases. If the two exist together, the risk of stroke, hospitalization for HF and all-cause death is increased. Currently, research on left atrial appendage closure (LAAC) in patients with AF and HF is limited and controversial. This study was designed to investigate the safety and effectiveness of LAAC in AF patients with different types of HF.
Methods
Patients with non-valvular atrial fibrillation (NVAF) and HF who underwent LAAC in the First Affiliated Hospital of Army Medical University from August 2014 to July 2021 were enrolled. According to left ventricular ejection fraction (LVEF), the study divided into HF with reduced ejection fraction (LVEF < 50%, HFrEF) group and HF with preserved ejection fraction (LVEF ≥ 50%, HFpEF) group. The data we collected from patients included: gender, age, comorbid diseases, CHA
2
DS
2
-VASc score, HAS-BLED score, NT-proBNP level, residual shunt, cardiac catheterization results, occluder size, postoperative medication regimen, transthoracic echocardiography (TTE) results and transesophageal echocardiography (TEE) results, etc. Patients were followed up for stroke, bleeding, device related thrombus (DRT), pericardial tamponade, hospitalization for HF, and all-cause death within 2 years after surgery. Statistical methods were used to compare the differences in clinical outcome of LAAC in AF patients with different types of HF.
Results
Overall, 288 NVAF patients with HF were enrolled in this study, including 142 males and 146 females. There were 74 patients in the HFrEF group and 214 patients in the HFpEF group. All patients successfully underwent LAAC. The CHA
2
DS
2
-VASc score and HAS-BLED score of HFrEF group were lower than those of HFpEF group. A total of 288 LAAC devices were implanted. The average diameter of the occluders was 27.2 ± 3.5 mm in the HFrEF group and 26.8 ± 3.3 mm in the HFpEF group, and there was no statistical difference between the two groups (
P
= 0.470). Also, there was no statistically significant difference in the occurrence of residual shunts between the two groups as detected by TEE after surgery (
P
= 0.341). LVEF was significantly higher in HFrEF group at 3 days, 3 months and 1 year after operation than before (
P
< 0.001). At 45–60 days after surgery, we found DRT in 9 patients and there were 4 patients (5.4%) in HFrEF group and 5 patients (2.3%) in HFpEF group, with no significant difference between the two groups (
P
= 0.357). One patient with DRT had stroke. The incidence of stroke was 11.1% in patients with DRT and 0.7% in patients without DRT (
P
= 0.670). There was one case of postoperative pericardial tamponade, which was improved by pericardiocentesis at 24 h after surgery in the HFpEF group, and there was no significant difference between the two groups (
P
= 1.000). During a mean follow-up period of 49.7 ± 22.4 months, there were no significant differences in the incidence of stroke, bleeding, DRT and HF exacerbation between the two groups. We found a statistical difference in the improvement of HF between HFrEF group and HFpEF group (
P
< 0.05).
Conclusions
LAAC is safe and effective in AF patients with different types of HF. The improvement of cardiac function after LAAC is more pronounced in HFrEF group than in HFpEF group.
Journal Article
Association between preprocedural thromboembolic and bleeding events under oral anticoagulation therapy and mid-term outcomes after percutaneous left atrial appendage closure
2024
Currently, no consensus has been established on the most effective antithrombotic therapy to prevent thromboembolic and bleeding events in patients undergoing percutaneous left atrial appendage closure (LAAC) with preprocedural thromboembolic or bleeding events under oral anticoagulation (OAC) therapy. We retrospectively investigated the incidence of device-related thrombosis (DRT), thromboembolic events, and bleeding events in patients who underwent LAAC from September 2019 to October 2022. After categorizing patients into three groups based on preprocedural thromboembolic or bleeding events under OAC therapy, we compared the incidence of DRT and prognosis according to the postprocedural antithrombotic therapy. In patients who received the conventional antithrombotic therapy (OAC with and without single antiplatelet therapy for 45 days after LAAC and dual-antiplatelet therapy from 45 days to 6 months followed by single antiplatelet therapy), preprocedural thromboembolic events despite OAC were independently associated with DRT or postprocedural thromboembolic events at the 3 year follow-up (hazard ratio [HR] 4.55; 95% confidence interval [CI] 1.32–15.6;
P
= 0.016), whereas preprocedural bleeding events were independently associated with postprocedural bleeding events (HR 8.01, 95% CI 1.45–58.3;
P
= 0.036). Continuation of OAC for 12 months among patients who developed preprocedural thromboembolic events during OAC significantly decreased the incidence of DRT or postoperative thromboembolic events (
P
= 0.002) with no increase in the bleeding events (
P
= 0.522). Preprocedural thromboembolic and bleeding events can predict adverse events after LAAC with the conventional antiplatelet-based antithrombotic therapy. Patients who develop thromboembolic events under continuous OAC may benefit from continuous OAC for 1 year after LAAC.
Journal Article
Left atrial appendage closure in a patient previously implanted with an interatrial shunt device: a case report
2024
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.
Journal Article
Efficacy and Safety of the WATCHMAN Left Atrial Appendage System for Stroke Prevention in Chinese Patients with Nonvalvular Atrial Fibrillation: A Single-center, Prospective, Observational Study
by
Wei-Ping Huang Yong-Hua Zhang Lei He Xi Su Xin-Wei Yang Zai-Xiong Guo
in
Aged
,
Aged, 80 and over
,
Anticoagulants
2017
Background: In patients with nonvalvular atrial fibrillation (NVAF), embolic stroke is thought to be associated with left atrial appendage (LAA) thrombi. The WATCHMAN LAA Occlusion Device has been shown to be noninferior to conventional oral anticoagulation with warfarin for stroke prevention in patients with NVAF. This study aimed to evaluate the procedural feasibility, safety and 12-month outcomes of the WATCHMAN LAA Occlusion Device in NVAF patients with high risk for stroke in China. Methods: The clinical data of 106 NVAF patients, who were consecutively underwent LAA closure with the WATCHMAN Device between April 2014 and May 2015, were collected. Patients were followed up at 1,3, 6, and 12 months after discharge. A transesophageal echocardiograph was performed at 45 days after implantation and repeated in case of an unexpected event during the follow-up period. Results: This study included 106 NVAF patients with a mean age of 64.2 ± 8.6 years (ranging from 50 to 88 years), and the mean CHA,DS,-VASc score of all patients was 3.6 ± 1.6 (ranging from 2 to 9). Among those 106 NVAF patients, 100 (94.3%) patients were implanted with the device successfully. The procedural success rate was 94.3% (100/106), and the occlusion rate was 100.0% (100/100). There were one tamponade, one ischemic stroke, and eight minor pericardial effusions during hospitalization. During 12-month follow-up period, two patients developed a tbrombus layer on the device that resolved with additional anticoagulation: one with visible device-thrombus experienced transient ischemic stroke, and one had a hemorrhagic stroke. There were no deaths in this study. The overall survival rate was 100.0%, and nonmajor adverse event rate was 95.0% (95/100). In this study, the expected annual rate ofischemic stroke risk in these patients according to the CHA2DS2-VASc score was 4.0%, while the observed ischemic stroke rate was 2.0% per year. Conclusions: LAA closure with the WATCHMAN Device was feasible, efficient, and safe for NVAF to prevent the accidence of stroke in Chinese patients. During the 12-month follow-up period, the observed ischemic stroke rate (2.0% per year) in our study was lower than the predicted annual stroke risk (4.0%) using the CHA2DS:-VASc score.
Journal Article
Percutaneous Left Atrial Appendage Closure in Patients with Non-Valvular Atrial Fibrillation and End-Stage Renal Disease on Hemodialysis: A Case Series
by
Narváez-Mejía, Carlos
,
Suárez, Alfonso
,
Tapia, Manuel
in
Aged
,
Aged, 80 and over
,
Angioplasty
2024
Non-valvular atrial fibrillation (NVAF) is the most common cardiac arrhythmia in the general population, and its prevalence increases among patients with chronic kidney disease (CKD) undergoing hemodialysis. This population presents high risk of both hemorrhagic and thrombotic events, with little evidence regarding the use of oral anticoagulation treatment (OAT) and multiple complications arising from it; however, stroke prevention with percutaneous left atrial appendage closure (LAAC) is an alternative to be considered. We retrospectively describe the safety and efficacy of percutaneous LAAC in eight patients with NVAF and CKD on hemodialysis during a 12-month follow-up. The mean age was 78.8 years (range 64–86; SD ± 6.7), and seven patients were male. The mean CHA2DS2-VASC and HAS-BLED scores were high, 4.8 (SD ± 1.5) and 3.8 (SD ± 1.3), respectively. Seventy-five percent of the patients were referred for this intervention due to a history of major bleeding, with gastrointestinal bleeding being the most common type, while the remaining twenty-five percent of the patients were referred because of a high risk of bleeding. The percutaneous LAAC procedure was successfully completed in 100% of the patients, with complete exclusion of the appendage without complications or leaks exceeding 5 mm. There was one death not related to the procedure four days after the intervention. Among the other seven patients, no deaths, cardioembolic events or major bleeding were reported during the follow-up period. In our sample, percutaneous LAAC appears to be a safe and effective alternative to anticoagulation in patients with NVAF and CKD on hemodialysis.
Journal Article