Amplatzer Cardiac Plug Research Articles

Delayed left atrial appendage contrast filling in computed tomograms after percutaneous left atrial appendage occlusion

BackgroundThe gold standard for the follow-up of left atrial appendage occlusion (LAAO) is performing transesophageal echocardiogram (TEE) at 45 days after LAAO; however, the duration for complete LAA seal-off after percutaneous LAAO is unknown in humans. We retrospectively evaluated the LAA contrast-filling (CF) rate in follow-up cardiac computed tomography (CT) scans after LAAO. MethodsWe included 35 patients (age 67.5±10.9 years, CHA2DS2VASc 4.2±1.6, HAS-BLED 3.7±1.5) who underwent LAAO [16 WATCHMAN, 19 Amplatzer cardiac plug (ACP)] and follow-up cardiac CT within 6 months after LAAO, and evaluated the LAA-CF rates. Eighteen patients (51.4%) underwent multiple episodes of CT follow-up. Results1. The proportions of patients with LAA-CF were 54.2% (19/35) at 6 months, 55.5% (5/9) at 6–18 months, and 33.3% (3/9) at >18 months after LAAO. 2. Among 23 patients with no peridevice leak at the 2 months TEE, LAA-CFs were found in 12 patients at 2.8±1.5 months (66.6% in WATCHMAN and 36.3% in ACP; p=0.158). 3. Among eight patients with consecutive follow-up CT (≥3 times), LAA-CFs were partially reduced in three; however, there was no complete LAA seal-off at 19.0±11.3 months. 4. A larger LAA landing zone diameter was independently associated with LAA-CF in follow-up CT [OR 1.45 (1.08–1.96), p=0.013, adjusted for age, sex, and device type]. ConclusionsDelayed LAA-CF is common after LAAO, with considerable discrepancies between cardiac CT and TEE findings. Although the clinical significance of LAA-CF is unclear, 45 days seem to be insufficient for complete LAA seal-off after LAAO.

Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation and Previous Major Gastrointestinal Bleeding (from the Amplatzer Cardiac Plug Multicenter Registry)

History of major gastrointestinal (GI) bleeding may represent a frequent clinical indication for left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). This study aims to investigate the procedural safety and long-term outcome of patients with previous major GI bleeding (MGIB) who underwent LAAO. Data from the Amplatzer Cardiac Plug multicenter registry on 1,047 patients were analyzed. Patients with previous MGIB as indication for LAAO were compared with patients without previous MGIB. A total of 151 patients (14.4%) with previous MGIB were identified. Periprocedural major bleeding events were more frequent in patients with previous MGIB (4.0% vs 0.8%, p= 0.001). With an average follow-up of 1.3years, the observed annual rate of stroke/transient ischemic attack and major bleeding for patients with previous MGIB were 2.1% (61.4% relative reduction according to the Congestive Heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular disease, Age 65-74, and Sex (female) [CHA2DS2-VASc] score) and 4.6% (20.1% relative reduction according to the expected rate based on the Hypertension, Abnormal renal/liver function (1 point each), Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs/alcohol concomitantly (1 point each) [HAS-BLED] score), respectively. In conclusion, in patients with non-valvular atrial fibrillation and previous MGIB, LAAO was associated with a low annual rate of stroke/transient ischemic attack. Periprocedural major bleeding events were more frequent in this specific population although the annual major bleeding rate showed a 20.1% relative risk reduction according to the HAS-BLED score.

Role of Imaging in Left Atrial Appendage Occlusion

Percutaneous left atrial appendage (LAA) occlusion is now a valid alternative to long-term oral anticoagulation in patients with non-valvular atrial fibrillation at high thrombo-embolism risk, especially for patients who are considered ineligible for anticoagulation. The most frequently used occluders worldwide include the WATCHAMN (Boston Scientific, Natick, MA, USA) and the Amplatzer Cardiac Plug or Amulet (St. Jude Medical/Abbott, St Paul, MN, USA) devices. Multimodality imaging is key in the understanding of 3D aspects of the LAA and surrounding structures anatomy. Imaging is essential for procedural planning, during each step of the procedure and for device surveillance after implantation. Multimodality imaging, including 2D/3D echocardiography, fluoroscopy, and cardiac computed tomography can increase the safety and efficacy of the procedure.

Changes in Coagulation and Platelet Activation Markers Following Transcatheter Left Atrial Appendage Closure

The recommendations for antithrombotic treatment after left atrial appendage closure (LAAC) remain empirical, and no data exist on the changes in hemostatic markers associated with LACC. The objective of the present study is to determine the presence, degree, and timing of changes in the markers of platelet and coagulation activation after LAAC. Forty-three patients (mean age 76 ± 9years, 23 men) with atrial fibrillation who underwent successful LACC with the Watchman (n= 27) or Amplatzer Cardiac Plug (n= 16) devices were included in the study. Patients received antiplatelet therapy after LAAC (aspirin+ clopidogrel: 27 patients; single antiplatelet therapy with aspirin or clopidogrel: 16 patients). Prothrombin fragment 1+2 and thrombin-antithrombin III were used as markers of coagulation activation, and soluble P-selectin and soluble CD40 ligand were used as markers of platelet activation. Measurements of all hemostatic markers were performed at baseline just before the procedure, followed by days 7, 30, and 180 after LAAC. Prothrombin fragment 1+2 and thrombin-antithrombin levels increased from 0.27nmol/L and 4.68ng/ml, respectively, at baseline to peak values of 0.43nmol/L and 9.76ng/ml, respectively, at 7days, partially returning to baseline levels at days 30 and 180 after LAAC (p <0.001 for both markers). No clinical or procedural factors were associated with a greater increase in the markers of coagulation activation after LAAC. Levels of soluble P-selectin and soluble CD40 ligand did not change at any time after LAAC. In conclusion, transcatheter LAAC is associated with significant activation of the coagulation system, yet without evidence of significant platelet activation.

Transcatheter left atrial appendage occlusion in patients with atrial fibrillation and a high bleeding risk using aspirin alone for post-implant antithrombotic therapy.

The aim of the study was to evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) or Amulet using aspirin alone (ASA) as post-implantation antithrombotic treatment. This was a single-centre, prospective, non-randomised study on LAAO with the ACP or Amulet in a consecutive cohort (n=110) treated by ASA alone post implantation. The primary outcome was device-related thrombosis, while secondary outcomes were ischaemic stroke or major bleeding. Clinical follow-up was conducted after six weeks and 12 months with TEE and cardiac CT. One hundred and seven patients were included in the analysis. Three patients were excluded due to a mechanical valve prosthesis. CHA2DS2-VASc score was 4.4±1.6 and HAS-BLED 4.1±1.1. Successful implantation was obtained in all patients with a periprocedural complication rate of 4.6%. Median follow-up was 2.3 years, with a total of 265 patient-years. Device-related thrombosis was detected in 2/107 (1.9%) cases. Stroke occurred in 6/107 patients, with an annualised rate of 2.3%, which is a 61% risk reduction compared to the predicted rate. Annual risk of major bleeding was reduced by 57%. LAAO with the ACP or Amulet was safely performed with ASA monotherapy after implantation without an increased risk of device-related thrombosis or stroke.

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

Patients with intracranial bleeding and atrial fibrillation treated with left atrial appendage occlusion: Results from the Amplatzer Cardiac Plug registry

BackgroundIn patients with non-valvular atrial fibrillation (NVAF), intracranial bleeding (ICB) constitutes a very challenging situation in which the rate of both ischemic and hemorrhagic events is increased. In these patients, left atrial appendage occlusion (LAAO) might represent a very valid alternative. ObjectivesTo investigate the procedural safety and long-term outcome of patients undergoing LAAO therapy due to previous ICB. MethodsData from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients were analyzed. Patients with previous ICB as indication for LAAO were compared to patients with other indications. ResultsA total of 198 patients (18.9%) with previous ICB were identified. The CHA2DS2-VASc score was similar (4.5±1.5 vs. 4.4±1.6, p=0.687) and the HAS-BLED score was higher in patients with previous ICB compared to those without (3.5±1.1 vs. 3.1±1.2, p<0.001). No significant differences in peri-procedural major adverse events were observed (2.5 vs 5.4%, p=0.1). Patients with previous ICB were more frequently on single acetylsalicylic acid therapy after LAAO (42.4% vs. 28.3%; p<0.001). With an average follow-up of 1.3years, the observed annual stroke/TIA rate (procedure and follow-up) for patients with previous ICB was 1.4% (75% relative risk reduction). The observed annual major bleeding rate (procedure and follow-up) for patients with previous ICB was 0.7% (89% relative risk reduction). ConclusionsIn patients with NVAF and previous ICB, LAAO seemed to be a safe procedure and was associated with a significant reduction in stroke/TIA and a remarkably low frequency of major bleeding during follow-up.

Incidence and Clinical Impact of Device-Associated Thrombus and Peri-Device Leak Following Left Atrial Appendage Closure With the Amplatzer Cardiac Plug

ObjectivesRoutine device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events. MethodsCenters participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-device leak, device-associated thrombus, device embolization, device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center. ResultsOf the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients’ mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither device-associated thrombus nor peri-device leak was associated with an increased risk for cardiovascular events. Independent predictors of device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027). ConclusionsFollowing successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-device leak was relatively low, and device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.

Device‐associated thrombus formation after left atrial appendage occlusion: A systematic review of events reported with the Watchman, the Amplatzer Cardiac Plug and the Amulet

This study aimed to provide a systematic review of device-associated thrombosis (DAT) after left atrial appendage occlusion (LAAO) with the Watchman, Amplatzer Cardiac Plug, and Amulet devices. DAT is known as a complication of LAAO but data about its clinical impact is scarce. A systematic review of studies evaluating the incidence, treatment and clinical implications of DAT from January 2008 to September 2015 was conducted. A total of 30 studies describing DAT events were included in the analysis. The overall incidence of DAT was 3.9% (82 DAT for 2118 implanted devices). The median time from procedure to diagnosis of DAT was 1.5 months (IQR: 0-2.9). Most cases were diagnosed with transesophageal echocardiogram (TEE). The treatment consisted of low molecular weight heparin (LMWH) in 45.5% of cases, and oral anticoagulation (OAC) or other treatment modalities in 54.5%. Complete thrombus resolution was achieved in 95.0% of cases (100% with LMWH and 89.5% with OAC). Treatment duration varied greatly with a median treatment duration of 45 days (IQR: 14-135). Clinical events related to DAT consisted of neurologic events namely two transient ischemic attacks (2.4%) and four ischemic strokes (4.9%). DAT is an infrequent complication of percutaneous LAAO. It occurs mainly early after the procedure and is associated with a low rate of neurological complications. In the majority of cases, diagnosis is made during follow-up imaging with TEE. Anticoagulation treatment seems to be safe and highly effective. Further studies are needed to evaluate the optimal management of DAT. © 2017 Wiley Periodicals, Inc.

Left Atrial Appendage Closure with Amplatzer Cardiac Plug in Nonvalvular Atrial Fibrillation: Safety and Long-Term Outcome.

BackgroundAtrial fibrillation (AF) is a cardiac arrhythmia with high risk for thromboembolic events, specially stroke.ObjectiveTo assess the safety of left atrial appendage closure (LAAC) with the Amplatzer Cardiac Plug for the prevention of thromboembolic events in patients with nonvalvular AF.MethodsThis study included 15 patients with nonvalvular AF referred for LAAC, 6 older than 75 years (mean age, 69.4 ± 9.3 years; 60% of the male sex).ResultsThe mean CHADS2 score was 3.4 ± 0.1, and mean CHA2DS2VASc , 4.8 ± 1.8, evidencing a high risk for thromboembolic events. All patients had a HAS-BLED score > 3 (mean, 4.5 ± 1.2) with a high risk for major bleeding within 1 year. The device was successfully implanted in all patients, with correct positioning in the first attempt in most of them (n = 11; 73.3%).ConclusionThere was no periprocedural complication, such as device migration, pericardial tamponade, vascular complications and major bleeding. All patients had an uneventful in-hospital course, being discharged in 2 days. The echocardiographic assessments at 6 and 12 months showed neither device migration, nor thrombus formation, nor peridevice leak. On clinical assessment at 12 months, no patient had thromboembolic events or bleeding related to the device or risk factors. In this small series, LAAC with Amplatzer Cardiac Plug proved to be safe, with high procedural success rate and favorable outcome at the 12-month follow-up.

Evolution of left atrial appendage exclusion

Atrial fibrillation is independently associated with an increased risk of thromboembolic stroke. While anticoagulants decrease this risk, they also carry a substantial risk of bleeding. Most left atrial thrombi arise from the left atrial appendage (LAA), which has led to several investigations into surgical and percutaneous methods of LAA exclusion for stroke reduction. The PubMed database was queried, and over 400 articles were considered for inclusion in this review. Of the surgical methods of LAA exclusion, complete excision is the most effective. Other methods, including ligation and stapling, may be incomplete and associated with left atrial thrombus formation. Surgical LAA exclusion has been commonly performed during mitral valve surgery although it has not been shown to prevent stroke in many retrospective studies. In patients unable to take warfarin, several percutaneous LAA exclusion devices have been studied, including the PLAATO system, Amplatzer Cardiac Plug (ACP), Watchman device, and Lariat. Both the ACP and Watchman have shown a significant stroke reduction and improved procedural safety with greater experience. The Lariat ligates the LAA using a combined endocardial and epicardial approach but is currently associated with substantial procedural risks. With better patient selection for the different options of LAA exclusion, thromboembolic stroke protection can be maximized with fewer complication risks.

Safety of Percutaneous Left Atrial Appendage Occlusion in Patients with Atrial Fibrillation after Acute Coronary Syndrome: A Single Center Experience

Aims: In patients with atrial fibrillation (AF) and indication to Dual Antiplatelet Therapy (DAPT) for Acute Coronary Syndrome (ACS), triple therapy is recommended. However, this issue is still largely debated. Percutaneous Left Atrial Appendage (LAA) occlusion may represent an alternative therapeutic approach in this subset of patients, as it could lead to a reduction in the incidence of bleeding. Nevertheless, due to lack of clinical evidence, this approach does not represent the gold standard treatment for these patients. The objective of this study is to evaluate the safety of percutaneous LAA occlusion in patients with Atrial Fibrillation and indication of concomitant DAPT for ACS. Methods and Results: Fifteen AF-patients with indications to anticoagulant and DAPT after ACS underwent LAA occlusion with Amplatzer Cardiac Plug (ACP) or Amulet ACP (St. Jude) from October 2014 to May 2016. Procedural success was achieved in 14/15 patients, while in 1 patient a clinically non-relevant pericardial effusion was registered before the trans-septal puncture, without implantation of the device. No peri-procedural death, major bleeding and dislocation or thrombi of the device were recorded. During a median follow-up of 182 days (interquartile range [IQR]: 169 to 183 days), one peri-procedural minor bleeding and two non cardiovascular death were described. Conclusions: LAA occlusion represents a relatively safe procedure for patients with atrial fibrillation and the need of DAPT due to ACS. Randomized trials should be designed to evaluate the efficacy and safety of this procedure in this clinical setting.

First results of the Brazilian Registry of Percutaneous Left Atrial Appendage Closure.

BackgroundLeft atrial appendage closure (LAAC) is an effective alternative to oral anticoagulation (OA) for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF).ObjectiveTo present the immediate results and late outcomes of patients submitted to LAAC and included in the Brazilian Registry of Percutaneous Left Atrial Appendage Closure.Methods91 patients with NVAF, high stroke risk (CHA2DS2VASc score = 4.5 ± 1.5) and restrictions to OAC (HAS-BLED score = 3.6 ± 1.0) underwent 92 LAAC procedures using either the Amplatzer cardiac plug or the Watchman device in 11 centers in Brazil, between late 2010 and mid 2016.ResultsNinety-six devices were used (1.04 device/procedure, including an additional non-dedicated device), with a procedural success rate of 97.8%. Associated procedures were performed in 8.7% of the patients. Complete LAAC was obtained in 93.3% of the successful cases. In cases of incomplete closure, no residual leak was larger than 2.5 mm. One patient needed simultaneous implantation of 2 devices. There were 7 periprocedural major (5 pericardial effusions requiring pericardiocentesis, 1 non-dedicated device embolization and 1 coronary air embolism without sequelae) and 4 minor complications. After 128.6 patient-years of follow-up there were 3 deaths unrelated to the procedure, 2 major bleedings (one of them in a patient with an unsuccessful LAAC), thrombus formation over the device in 2 cases (both resolved after resuming OAC for 3 months) and 2 strokes (2.2%).ConclusionsIn this multicenter, real world registry, that included patients with NVAF and high thromboembolic and bleeding risks, LAAC effectively prevented stroke and bleeding when compared to the expected rates based on CHA2DS2VASc and HASBLED scores for this population. Complications rate of the procedure was acceptable considering the beginning of the learning curve of most of the involved operators.

Left atrial appendage occlusion versus standard medical care in patients with atrial fibrillation and intracerebral haemorrhage: a propensity score-matched follow-up study.

The aim of this study was to investigate the prognosis in patients with atrial fibrillation (AF) and intracerebral haemorrhage (ICH) having a left atrial appendage occlusion (LAAO) versus patients receiving standard medical therapy. A total of 151 patients from the Nordic countries with AF and previous ICH who underwent LAAO using the AMPLATZER Cardiac Plug or the AMPLATZER AMULET were compared to a propensity score-matched group of 151 patients receiving standard medical therapy. The two groups were matched so that their risks for stroke and bleeding were similar (CHA2DS2-VASc and HAS-BLED scores). The standard care patients were identified from the Danish Stroke Registry among 787 patients with AF and ICH. The primary endpoint was a composite of all-cause mortality, ischaemic stroke and major bleeding. Patients with AF and a prior ICH treated with LAAO had a lower risk of the composite outcome as compared to patients treated with standard medical care (events/1,000 years [95% confidence interval]: 53.3 [44.3-64.1] vs. 366.7 [298.2-450.9]; hazard ratio 0.16 [0.07-0.37]). LAAO is suggested to be of major clinical benefit in AF patients having sustained an ICH. These results have to be confirmed in a randomised clinical trial.

Percutaneous left atrial appendage occlusion using different technologies in the United Kingdom: A multicenter registry

This study aimed at assessing the feasibility and long-term efficacy of left atrial appendage occlusion (LAAO) in a "real world" setting. Although LAAO has recently emerged as an alternative to oral anticoagulants in patients with atrial fibrillation for the prevention of thromboembolic stroke, "real world" data about the procedure with different devices are lacking. Eight centers in the United Kingdom contributed to a retrospective registry for LAAO procedures undertaken between July 2009 and November 2014. A total of 371 patients (72.9 ± 8.3 years old, 88.9% males) were enrolled. The overall procedure success was 92.5%, with major events in 3.5% of cases. The device choice was Watchman in 63% of cases, Amplatzer Cardiac Plug in 34.7%, Lariat in 1.7%, and Coherex WaveCrest in 0.6%. A significant improvement in procedure success (from 89.2% to 95.7%; P = 0.018) and reduction of acute major complications (from 6.5% to 0.5%; P = 0.001) were observed between procedures in the first and the second half of the recruitment time. An annual 90.1% relative risk reduction (RRR) for ischemic stroke, an 87.2% thromboembolic events RRR, and a 92.9% major bleeding RRR were observed, if compared with the predicted annual risks based on CHADS2, CHA2DS2-Vasc, and HAS-BLED scores, respectively, over a follow-up period of 24.7 ± 16.07 months. LAAO can be performed safely in a real world setting with good implant success rates and procedural outcomes. The long-term benefits of the procedure are reassuring in terms of both ischemic events and avoidance of severe bleeding associated with anticoagulation in this patient group. © 2016 Wiley Periodicals, Inc.

Peri-procedural silent cerebral infarcts after left atrial appendage occlusion.

To determine the rate of peri-interventional silent brain infarcts after left atrial appendage occlusion (LAAO). In this prospective, uncontrolled single-center pilot study, consecutive patients with atrial fibrillation undergoing LAAO between July 2013 and January 2016 were included. The Amplatzer Cardiac Plug, WATCHMAN or Amulet device was used. A neurological examination and cranial magnetic resonance imaging (MRI) were performed within 48 h before and after the procedure. MRI was evaluated for new diffusion-weighted imaging (DWI) hyperintensities, cerebral microbleeds (CMBs) and white-matter lesions (WMLs). Left atrial appendage occlusion was performed in 21 patients (mean age, 73.2 ± 9.5 years). Main reasons for LAAO were previous intracerebral hemorrhage (n = 11) and major systemic bleeding (n = 6). No clinically overt stroke occurred peri-interventionally. After the intervention, one patient had a small cerebellar hyperintensity on DWI (4.8%; 95% confidence interval, 0.0-14.3) that was not present on the MRI 1 day before the procedure. Among 11 patients with available MRI just before LAAO, there were no significant changes in the number of CMBs and the severity of WMLs after LAAO. This study of peri-interventional MRI in LAAO suggests a low rate of silent peri-procedural infarcts in this elderly population. Confirmation in larger studies is needed.

Characterization of Cerebrovascular Events After Left Atrial Appendage Occlusion

Cardioembolic strokes are generally more lethal and disabling than other source of strokes. Data from PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) suggest that strokes after left atrial appendage occlusion (LAAO) with the Watchman device are less disabling than those in the warfarin group. No data assessing the severity of strokes after LAAO with the AMPLATZER Cardiac Plug (ACP) are available. The objective of the study was to evaluate the severity of cerebrovascular events after LAAO with the ACP in a population mostly characterized by an absolute or relative contraindication to oral anticoagulation. Data from the ACP multicenter registry were analyzed. Disabling strokes were defined as those with a modified Rankin score of 3 to 6 at 90days after the event. A total of 1,047 subjects were included. The mean age and CHADS2 score were 75 ± 8years and 2.8 ± 1.3, respectively. Procedural success was achieved in 97.3% and 4.9% of the patients presented procedural major adverse events. Clinical follow-up was complete in 98.2% of patients with a median of 13months. There were 9 strokes (0.9%), 9 transient ischemic attacks (0.9%), and no intracranial hemorrhages (0%) at follow-up. After excluding 2 patients with pre-LAAO disability, functional assessment showed disabling events in 3 (19%) of the remaining 16 patients. The median time of presentation was 420days (interquartile range 234 to 671) after LAAO, and 17 patients (94%) were on single-antiplatelet therapy when the event occurred. According to our results, cerebrovascular events after LAAO with the ACP system were infrequent and mostly nondisabling.

Left atrial appendage occlusion in high-risk patients with non-valvular atrial fibrillation

ObjectivePercutaneous left atrial appendage (LAA) occlusion has been developed as a viable option for stroke and thromboembolism prevention in patients with non-valvular atrial fibrillation (NVAF) and at high risk for...

Percutaneous left atrial appendage occlusion: Effect of device positioning on outcome.

The study in patients with percutaneous left atrial appendage (LAA) occlusion investigates clinical outcomes according to the position of the Amplatzer Cardiac Plug (ACP) disc. The ACP consists of a disc and an anchoring lobe. The disc is meant to cover the ostium of the LAA, but frequently retracts partially or completely into the neck of the LAA. It is not known whether a retracted disc affects outcome. Outcomes of 169 consecutive patients (age 73.1 ± 10.4 years; 76% male) with successful LAA closure were analyzed according to the position of the ACP disc: group A had complete coverage of the LAA ostium; in group B the disc prolapsed partially or completely into the LAA-neck. Transesophageal echocardiography was performed 1-6 months after ACP implantation. The safety endpoint was the composite of clinically significant pericardial effusion, device embolization, procedure-related stroke/transient ischemic attack (TIA), major bleeding, or device thrombus. The efficacy endpoint was the composite of death, neurological events (ischemic and hemorrhagic stroke, TIA), or systemic embolism during follow-up. Group A comprised 76 patients (age 73.0 ± 9.9 years; 74% male) and group B 93 patients (age 73.3 ± 10.9 years; 79% male). Mean CHA2 DS2 -Vasc score and HASBLED score were 4.2 ± 1.7 (group A 4.3 ± 1.6; group B 4.2 ± 1.8) and 2.9 ± 1.1 (group A 2.9 ± 1.0; group B 3.0 ± 1.2), respectively. Mean follow-up of the study population was 13.0 ± 10.4 months. Overall, the composite safety and efficacy endpoints occurred in 20 (12%) and 6 patients (4%), respectively. There was no significant difference between groups A and B in the occurrence of the safety endpoint (13% vs. 11%, P = 0.64), or the efficacy endpoint (4% vs. 3%, P = 1.0). No evidence for a difference in the occurrence of the safety and efficacy endpoint was found between patients with complete vs. incomplete ACP disc coverage of the LAA ostium. The risk of repositioning attempts in case of incomplete coverage does not seem to be warranted. Current findings need further confirmation in a larger scale clinical trial. © 2016 Wiley Periodicals, Inc.

Predictors of Early (1-Week) Outcomes Following Left Atrial Appendage Closure With Amplatzer Devices.

The aim of this study was to assess predictors of adverse 1-week outcomes and determine the effect of left atrial appendage (LAA) morphology following LAA closure (LAAC) with Amplatzer devices. Percutaneous LAAC is a valuable treatment option for stroke prevention in patients with atrial fibrillation. Determinants of procedural safety events with Amplatzer occluders are not well established, and the possibly interrelating effect of LAA anatomy is unknown. Between 2009 and 2014, 500 consecutive patients with atrial fibrillation ineligible or at high risk for oral anticoagulation underwent LAAC using Amplatzer devices. Procedure- and device-related major adverse events (MAEs) were defined as the composite of death, stroke, major or life-threatening bleeding, serious pericardial effusion, device embolization, major access-site vascular complication, or need for cardiovascular surgery within 7 days following the intervention. Patients (mean age 73.9 ± 10.1 years) were treated with Amplatzer Cardiac Plug (n= 408 [82%]) or Amulet (n= 92 [18%]) devices. Early procedural success was 97.8%, and MAEs occurred in 29 patients (5.8%). Independent predictors of MAEs included device repositioning (odds ratio: 9.13; 95% confidence interval: 2.85 to 33.54; p< 0.001) and left ventricular ejection fraction<30% (odds ratio: 4.08; 95% confidence interval: 1.49 to 11.20; p= 0.006), with no effect of device type or size. Angiographic LAA morphology, characterized as cauliflower (33%), cactus (32%), windsock (20%), or chicken wing (15%), was not associated with procedural success (p= 0.51) or the occurrence of MAEs (p= 0.78). In this nonrandomized study, procedural success of LAAC using Amplatzer devices was high. MAEs within 7 days were predicted by patient- and procedure-related factors. Although LAA morphology displayed substantial heterogeneity, outcomes were comparable across the spectrum of LAA anatomies.