Oclusão do apêndice atrial esquerdo com o Amplatzer Cardiac Plug em pacientes com fibrilação atrial (original) (raw)
Related papers
2012
Background: Percutaneous left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OA) for prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation (NVAF). Objective: To describe the immediate results and short-to medium-term clinical follow-up (FU) of patients that underwent LAAC with Amplatzer Cardiac Plug (ACP) implantation in a single reference center. Methods: Eighty-six consecutive patients with NVAF, contraindication to OA, and CHADS2 score=2.6±1.2 underwent LAAC with ACP implantation. Clinical and echocardiographic FU was performed at least four months after the procedure. Results: All implants were guided by angiography alone. Procedural success was 99% (one patient suffered a cardiac tamponade requiring pericardiocentesis, and the procedure was waived). There were four major complications (the already mentioned cardiac tamponade, two transient ischemic attacks and one device embolization with percutaneous retrieval) and two minor complications (one pericardial effusion without clinical significance and one non-significant ASD evidenced at FU). There was one in-hospital death after six days, unrelated to the procedure. All other patients were discharged without OA. After 25.9 patient-years of FU (69 patients), there were no strokes and no late device embolization. The LAA was completely closed in 97% of the cases. Six patients showed evidence of thrombus formation on the device, which resolved after three months of OA. Conclusion: LAAC is associated with high success, acceptable complication rates, and promising FU results, and may be considered a valuable alternative or complement to OA for stroke prevention in patients with NVAF.
PubMed, 2016
Aims: Percutaneous left atrial appendage occlusion (LAAO) may be considered for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). Data on device implantation safety and feasibility and long-term follow-up are limited. Methods and results: LAAO was performed using the AMPLATZER Cardiac Plug (ACP) device in 134 NVAF patients with long-term OAC contraindication, with median (interquartile range) CHA2DS2-VASc and HAS-BLED scores of four (3-5) and three (2-3.75), respectively. Follow-up data were collected over a mean follow-up period of 680 days (range: 42 days to 4.3 years) comprising a total implant experience of 238 patient-years. Device implantation was successful in 95.5% of the procedures and associated with a rate of major procedural complications of 2.2%. At the most recent follow-up, almost all patients were receiving antiplatelet therapy. Ischaemic stroke was observed at an annual rate of 0.8% and the annual rate of any thromboembolic (TE) event was 2.5%. Major bleeding during follow-up occurred at an annual rate of 1.3%. Conclusions: LAAO is a safe and effective stroke prevention therapy in a high-risk NVAF cohort, both at implantation and over longer follow-up periods. The long-term assessed ischaemic stroke rate in patients treated with LAAO is markedly reduced compared to the expected rate based on the patients' risk scores.
Advances in Interventional Cardiology, 2020
Introduction: Indications for left atrial appendage occlusion (LAAO) are varied and patients require individual management strategies. However, currently no guidelines exist for postprocedure oral anticoagulation (OAC) after an LAAO procedure. Aim: To evaluate the effect of OAC on thromboembolism, bleeding and mortality following the LAAO procedure for patients with AF. Material and methods: One hundred and thirty-nine consecutive patients with nonvalvular atrial fibrillation (NVAF) who underwent LAAO with the LARIAT device were followed for at least 40 months. Decisions about OAC and its modifications were individualized based on clinical presentation, patient and physician preferences. Results: Following LAAO, 52 (41%) patients did not receive OAC (No-OAC group) and 75 (59%) patients received OAC (OAC group), without any intergroup differences in CHADS 2 , CHA 2 DS 2-VASc score or other thromboembolic risk factors. The median HAS-BLED score was higher in the OAC-group (median 3 (3-4) vs. 3 (2-4), p = 0.014). During a median follow-up time of 51 (43-57) vs. 55 (48-59) months in the No-OAC group and in the OAC group (p = 0.19) there were no significant differences between groups in ischemic stroke/TIA, 0 (0%) vs. 2 (2.7%), other thromboembolic events, 0 (0%) vs. 1 (1.3%), life-threatening, disabling or major events, 2 (3.7%) vs. 2 (2.7%), or annual mortality rate, 1.9% vs. 0.9%, respectively. Conclusions: There is no need for OAC after the LAAO procedure. Omitting OAC after an LAAO procedure in AF patients: (1) has similar stroke prevention rates as patients on OAC, (2) has similar bleeding prevention rates as patients on OAC, (3) has similar safety endpoints and long-term efficacy as patients on OAC.
Circulation, 2002
Background-Thromboembolism due to atrial fibrillation (AF) is a frequent cause of stroke. More than 90% of thrombi in AF form in the left atrial appendage (LAA). Obliteration of the appendage may prevent embolic complications. Methods and Results-We evaluated the feasibility and safety of implanting a novel device for percutaneous left atrial appendage transcatheter occlusion (PLAATO). LAA occlusion using the PLAATO system was attempted in 15 patients with chronic AF at high risk for stroke, who are poor candidates for long-term warfarin therapy. The implant consists of a self-expanding nitinol cage covered with a polymeric membrane (ePTFE). The LAA was successfully occluded in 15/15 patients (100%). Angiography and transesophageal echocardiography (TEE) during the procedure showed that the device was well-seated in all patients and that there was no evidence of perforation, device embolization, or interference with surrounding structures. In 1 patient, the first procedure was complicated by a hemopericardium, which occurred during LAA access. A second attempt 30 days later was successful with no untoward sequela. No other complications occurred. At 1-month follow-up, chest fluoroscopy and TEE revealed continued stable implant position with smooth atrial-facing surface and no evidence of thrombus. Conclusions-Thus, transcatheter closure of the LAA is feasible in humans. This novel implant technology may be appropriate for patients with AF who are not suitable candidates for anticoagulation therapy. Further trials are needed to show the long-term safety and its efficacy in reducing stroke. (Circulation. 2002;105:1887-1889.
Journal of the American College of Cardiology, 2005
These studies were conducted to evaluate the feasibility of percutaneous left atrial appendage (LAA) occlusion using the PLAATO system (ev3 Inc., Plymouth, Minnesota). BACKGROUND Patients with atrial fibrillation (AF) have a five-fold increased risk for stroke. Other studies have shown that more than 90% of atrial thrombi in patients with non-rheumatic AF originate in the LAA. Transvenous closure of the LAA is a new approach in preventing embolism in these patients. METHODS Within two prospective, multi-center trials, LAA occlusion was attempted in 111 patients (age 71 Ϯ 9 years). All patients had a contraindication for anticoagulation therapy and at least one additional risk factor for stroke. The primary end point was incidence of major adverse events (MAEs), a composite of stroke, cardiac or neurological death, myocardial infarction, and requirement for procedure-related cardiovascular surgery within the first month. RESULTS Implantation was successful in 108 of 111 patients (97.3%, 95% confidence interval [CI] 92.3% to 99.4%) who underwent 113 procedures. One patient (0.9%, 95% CI 0.02% to 4.9%) experienced two MAEs within the first 30 days: need for cardiovascular surgery and in-hospital neurological death. Three other patients underwent in-hospital pericardiocentesis due to a hemopericardium. Average follow-up was 9.8 months. Two patients experienced stroke. No migration or mobile thrombus was noted on transesophageal echocardiogram at one and six months after device implantation. CONCLUSIONS Closing the LAA using the PLAATO system is feasible and can be performed at acceptable risk. It may become an alternative in patients with AF and a contraindication for lifelong anticoagulation treatment. (J Am Coll Cardiol 2005;46:9-14) © 2005 by the American College of Cardiology Foundation Atrial fibrillation (AF) is responsible for more than 15% of all strokes (1-3). Besides irregular heart rate and possible lowered endurance, AF leads to insufficient contraction of the left atrium. Stagnation of blood flow within the left atrium leads to hypercoagulability and thus to an increased risk for thrombus formation (4). Several surgical, echocardiographic, and autopsy studies have shown that more than 90% of all thrombi in patients with non-rheumatic AF forming in the left atrium
PubMed, 2009
Purpose: In more than 90% of patients with atrial fibrillation (AF), stroke is due to thrombotic embolization from the left atrial appendage (LAA). Transcatheter occlusion with percutaneous left atrial appendage transcatheter occlusion (PLAATO), a self-expanding, membrane- covered spherical nitinol cage, is feasible and an alternative to anticoagulation therapy. Methods: This was a single-center prospective registry study for verification of stroke risk reduction in patients with AF 2 years after PLAATO. Results: Seventy-three patients with AF (permanent 65, paroxysmal 8) in whom anticoagulation therapy was contraindicated or rejected underwent transcatheter LAA occlusion with PLAATO. One patient died periprocedurally due to implant embolization, and 1 patient underwent open-heart surgery because of implant instability. The remaining 71 patients were followed for 24 months. In 52 patients a stable anchoring of the PLAATO device without migration or dislocation was documented by transesophageal echocardiography (TEE). No thrombotic deposition was found on the LA luminal surface of the device. Statistically, in our patient cohort, 7 strokes would have been expected without any treatment within 24 months. In fact, no strokes were reported. Ten out of 71 patients died during follow up: 6 in our hospital and 4 at home. None of them died from a stroke. Conclusions: Ninety-seven percent of AF patients were successfully treated with PLAATO. After mechanical LAA occlusion, the 2-year risk of stroke in AF patients is markedly reduced. Therefore, this therapeutic concept is a clear alternative for patients with AF and contraindications for oral anticoagulation.
Journal of Cardiology, 2013
Objectives: To evaluate patient selection, safety, feasibility, and midterm results of percutaneous left atrial appendage (LAA) occlusion. Background: Oral anticoagulants (OAC) are the gold standard for stroke prevention in most patients with atrial fibrillation (AF). As the LAA is the main source of AF-related thrombi, LAA occlusion might reduce the thromboembolic (TE) risk. Recently, LAA closure was implemented in the European Society of Cardiology guidelines for the management of AF. Methods: This retrospective single center study examined all LAA percutaneous closures (September 2003-September 2011. Results: Twenty-five patients were included in the study; median age at closure was 73 years (minimum maximum range 49-85 years), 68% men. Median CHA 2 DS 2 -VASc score and HAS-BLED score were 5 (IQR 4-6) and 4 (IQR 4-5), respectively. Most frequent reason for LAA closure was intracranial hemorrhage during OAC treatment (52%). Successful device implantation was achieved in 96%. During a follow-up of 60.6 patient years, the TE stroke event rate was 4.95 per 100 patient years, versus an expected rate of 8.78 and 2.90 without and with OAC, respectively. No peripheral embolism occurred. Major procedure-related adverse events occurred in two patients. Conclusions: Percutaneous closure of the LAA is feasible and safe. Intracranial hemorrhage was the most important indication for LAA closure. A low number of TE stroke events occurred during follow-up. LAA closure might be a good alternative in patients with a firm contraindication for OAC.
Journal of Interventional Cardiac Electrophysiology, 2019
Background Left atrial appendage occluder (LAAO) implantation is an alternative method for stroke prevention in atrial fibrillation (AF) patients who are not eligible for long-term oral anticoagulation. The present paper describes the acute and 1-year follow-up outcome data of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE). Methods LAARGE enrolled 641 patients who were scheduled for LAAO implantation. The data collected included demographics, clinical characteristics, procedure indication, details of implantation, and outcome; patients were followed at 1-year post-implant. Efficacy and safety during follow-up are assessed by the occurrence of thrombembolic and bleeding events, respectively. Results A total of 641 consecutive patients (mean age: 75.9 ± 8.0) were enrolled from July 2014 to January 2016 in 38 hospitals in Germany. Patient demographics represent a critically-ill population with a calculated mean CHA2DS2-VASc score and HASBLED score of 4.5 and 3.9, respectively, with bleeding events as the main indication for LAAO implantation (79.4%). One-year all-cause mortality post-procedure was 11.5% with a non-fatal stroke/TIA rate of 1.3% (8 patients) and a rate of major bleeding of 1.6% (10 patients). The anticoagulation regimen after 1 year consisted of oral anticoagulation in 5.5% of patients and an antiplatelet therapy (APT) rate of 84.1% (majority single APT with ASS (74.5%), dual APT in 6.7%). Conclusions LAARGE, a prospective multicenter real-world and all-comer registry, is unique in its concept, as it is nonmanufacturer sponsored and includes all commercially available devices. LAAO implantation is mainly performed in elderly, critically-ill patients with a history of bleeding. LAARGE demonstrates a favorable outcome at 1-year follow-up in terms of stroke/TIA (1.3%) and major bleeding (1.6%) while using a single APT in the vast majority of patients.
Early safety of the Amplatzer Cardiac Plug™ for left atrial appendage occlusion
International Journal of Cardiology, 2013
Objective: To assess the cumulative experience of a single operator using a strict set of deployment and release criteria for the Amplatzer Cardiac Plug™ (ACP) and the impact of these criteria on procedural success and complications. Background: Following strong evidence that the left atrial appendage (LAA) is the site of the majority of thrombus formation within the left atrium in patients with non-valvular atrial fibrillation, non-pharmacological approaches to LAA exclusion have been developed and shown to be effective. Methods: Procedural and in-hospital outcomes of LAA occlusion performed by or under the supervision of a single operator using the ACP™ in 100 anticoagulant ineligible patients with a high stroke risk were assessed. Results: One hundred patients with a mean CHADS 2 score of 3.21 ± 1.23 underwent catheterization for closure of LAA with the ACP™. The mean landing zone as assessed by TEE was 20.01 ± 3.21 mm, and 20.8 ± 3.19 mm by fluoroscopy. The mean difference between the TEE and the fluoroscopic measurements was 0.8 ± 1.13 mm. Device deployment was successful in 100/100 attempted cases with a mean deployed device size of 24.36 ± 3.27 mm. Procedural complications were limited to a single case of pericardial tamponade and one postprocedural pulmonary edema both of which were adequately treated with no long-term sequelae. Conclusions: In this single operator report, LAA occlusion using the double element ACP™ can be safely performed with excellent success rates. Using very specific deployment success, stability and release criteria, this device can achieve LAA occlusion with extremely low complication rates in an extremely frail oral anticoagulant ineligible population with multiple co-morbidities.