Failure of Complete Endothelialization of a Watchman Device 3 Years Post-Implantation.
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ABSTRACT:
SUBMITTER: Batnyam U
PROVIDER: S-EPMC8310938 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:AimsCardiac computed tomography (CT) is increasingly utilized during follow-up after left atrial appendage closure (LAAC). Hypoattenuated thickening (HAT) is a common finding and might represent either benign device healing or device-related thrombosis (DRT). The appearance and characteristics of HAT associated with the Watchman FLX have not been previously described. Therefore, we sought to investigate cardiac CT findings during follow-up after Watchman FLX implantation with a focus on HAT and DRT.Methods and resultsRetrospective single-centre, observational study including all patients with successful Watchman FLX implantation and follow-up cardiac CT between March 2019 and September 2021 (n = 244). Blinded analysis of CT images was performed describing the localization, extent, and morphology of HAT and correlated to imaging and histology findings in a canine model. Relevant clinical and preclinical ethical approvals were obtained.Overall, HAT was present in 156 cases (64%) and could be classified as either subfabric hypoattenuation (n = 59), flat sessile HAT (n = 78), protruding sessile HAT (n = 16), or pedunculated HAT (n = 3). All cases of pedunculated HAT and five cases of protruding sessile HAT were considered as high-grade HAT (n = 7). Subfabric hypoattenuation and flat sessile HAT correlated with device healing and endothelialization in histological analysis of explanted devices.ConclusionSubfabric hypoattenuation and flat sessile HAT are frequent CT findings for Watchman FLX, likely representing benign device healing and endothelialization. Pedunculated HAT and protruding HAT are infrequent CT findings that might represent DRT.
| S-EPMC9867931 | biostudies-literature
Project description:Blood clots (90%) originate from the left atrial appendage (LAA) in non-valvular atrial fibrillation patients and are a major cause of embolic stroke. Long-term anticoagulation therapy has been used to prevent thrombus formation, but its use is limited in patients at a high risk for bleeding complications. Thus, left atrial appendage closure (LAAC) devices for LAA occlusion are well-established as an alternative to the anticoagulation therapy. However, the anticoagulation therapy is still required for at least 45 days post-implantation to bridge the time until complete LAA occlusion by neoendocardium coverage of the device. In this study, we applied an endothelium-mimicking nanomatrix to the LAAC device membrane for delivery of nitric oxide (NO) to enhance endothelialization, with the goal of possibly being able to reduce the duration of the anticoagulation therapy. The nanomatrix was uniformly coated on the LAAC device membranes and provided sustained release of NO for up to 1 month in vitro. In addition, the nanomatrix coating promoted endothelial cell proliferation and reduced platelet adhesion compared to the uncoated device membranes in vitro. The nanomatrix-coated and uncoated LAAC devices were then deployed in a canine LAA model for 22 days as a pilot study. All LAAC devices were not completely covered by neoendocardium 22 days post-implantation. However, histology image analysis showed that the nanomatrix-coated LAAC device had thicker neoendocardium coverage compared to the uncoated device. Therefore, our in vitro and in vivo results indicate that the nanomatrix coating has the potential to enhance endothelialization on the LAAC device membrane, which could improve patient outcomes by shortening the need for extended anticoagulation treatment.
| S-EPMC9205336 | biostudies-literature
Project description: Not available
| S-EPMC8305713 | biostudies-literature
Project description:Highlights•Device leaks may be noted on initial or follow-up TEE.•Leaks through the Watchman device are rare.•Clinical implications of small intradevice leaks are unknown.
| S-EPMC6200693 | biostudies-other
Project description:Number of left ventricular assist device (LVAD) implantations increases every year, particularly LVADs for destination therapy (DT). Right ventricular failure (RVF) has been recognized as a serious complication of LVAD implantation. Reported incidence of RVF after LVAD ranges from 6% to 44%, varying mostly due to differences in RVF definition, different types of LVADs, and differences in patient populations included in studies. RVF complicating LVAD implantation is associated with worse postoperative mortality and morbidity including worse end-organ function, longer hospital length of stay, and lower success of bridge to transplant (BTT) therapy. Importance of RVF and its predictors in a setting of LVAD implantation has been recognized early, as evidenced by abundant number of attempts to identify independent risk factors and develop RVF predictor scores with a common purpose to improve patient selection and outcomes by recognizing potential need for biventricular assist device (BiVAD) at the time of LVAD implantation. The aim of this article is to review and summarize current body of knowledge on risk factors and prediction scores of RVF after LVAD implantation. Despite abundance of studies and proposed risk scores for RVF following LVAD, certain common limitations make their implementation and clinical usefulness questionable. Regardless, value of these studies lies in providing information on potential key predictors for RVF that can be taken into account in clinical decision making. Further investigation of current predictors and existing scores as well as new studies involving larger patient populations and more sophisticated statistical prediction models are necessary. Additionally, a short description of our empirical institutional approach to management of RVF following LVAD implantation is provided.
| S-EPMC4295071 | biostudies-literature
Project description:IntroductionRight ventricular failure (RVF) after left ventricular assist device (LVAD) placement is associated with worse outcomes. We hypothesized that decreased right ventricular (RV) ejection fraction (EF) as well as qualitative assessments of RV function and dilation, as assessed by first pass radionuclide angiography (FPRNA), are associated with an increased risk of RVF following LVAD implantation.MethodsWe retrospectively identified 46 patients from 1/2008 to 11/2017 that underwent FPRNA and LVAD implantation. RVF was defined as requiring inotropes for greater than 14 days after LVAD implantation or requiring a right ventricular assist device. FPRNA-derived variables of RV performance and structure were compared between those that did and did not have RVF post implant. Statistical analyses were performed with Mann-Whitney U tests for ordinal and continuous variables. Fisher's exact tests and Pearson's χ2 tests were used for categorical variables.ResultsEight patients developed RVF after device implantation. The average RV EF on FPRNA was 41.45% in those that did not develop RVF and 40.13% in those that did (P = 0.787). RV dilation (P = 0.896) and global RV function (P = 0.827) by FPRNA were not statistically different between the two groups.ConclusionIn patients that required FPRNA for further assessment of RV function prior to LVAD implantation, decreased RV EF, RV dilation and global RV function on FPRNA were not associated with an increased risk of RVF.
| S-EPMC7085956 | biostudies-literature
Project description:RationaleAmong atrial fibrillation patients with high risk of bleeding, left atrial appendage occlusion has emerged as an alternative to long-term oral anticoagulation therapy for stroke prevention. Device-related thrombus remains a major concern because it may result in recurrent embolic events. To date, there is no consensus on the optimal method of treating device-related-thrombus.Patient concernsA 78-year-old man with atrial fibrillation had an episode of intracranial hemorrhage while taking warfarin. He subsequently underwent percutaneous placement of a 30-mm Watchman device to the left atrial appendage. He was prescribed dual anti-platelet therapy with aspirin and clopidogrel.DiagnosisReassessment echocardiography 3 months later found device-related thrombus.InterventionsThe antithrombotic regimen was switched from dual antiplatelet therapy to apixaban.OutcomesReassessment echocardiography 3 months later revealed complete resolution of the device-related thrombus. Apixaban was stopped. He had dual antiplatelet therapy for 6 more months followed by life-long aspirin. There was no bleeding complication since implantation of Watchman device.LessonsWe demonstrated successful treatment of device-related thrombus with a short course of apixaban with complete resolution of thrombus. Further randomized controlled trials are required to determine the choice and duration of drug therapy for device-related thrombus.
| S-EPMC5708950 | biostudies-literature
Project description:BackgroundLeft atrial appendage occlusion devices are commonly used to prevent stroke in patients with persistent atrial fibrillation who are unable to tolerate anticoagulation. However, certain patient- and device-related characteristics increase the risk for the development of a device-related thrombus (DRT). The presence of a DRT increases the risk of stroke and should be treated. Management of DRT lacks consensus but is mostly focused on anticoagulation. In patients with large thrombi that need to be managed urgently, percutaneous extraction may be a viable option.Case summaryIn this report, we describe the successful management of a DRT via percutaneous thrombus extraction technology in an 81-year-old woman with a large thrombus attached to a WATCHMAN™ device. The patient initially presented with shortness of breath, and on imaging a pedunculated thrombus was detected. The thrombus was extracted using a Penumbra Lightning 12™ (Penumbra Inc., Alameda, CA, USA) catheter with a Sentinel™ (Boston Scientific, Marlborough, MA, USA) cerebral embolic protection device. The patient had no neurologic sequelae and was started on anticoagulation.DiscussionPercutaneous thrombectomy can be safely performed to extract large left atrial occlusion DRT that require urgent management, without any neurologic sequelae. We believe this can be used in patients with a large DRT who would not be adequately managed with anticoagulation and in whom surgery is not feasible.
| S-EPMC8759468 | biostudies-literature
Project description:BackgroundBoth stroke and right heart failure (RHF) are common and serious complications after left ventricular assist device (LVAD) implantation. The objective of this study was to evaluate relation between stroke and RHF early after LVAD implantation.MethodsThis is a retrospective observational cohort study. From January 2012 to December 2020, patients who underwent LVAD implantation in a single-center were enrolled. Patients with a non-dischargeable LVAD or without follow-up data were excluded. Early stroke was defined as a stroke event within 6 months after implantation. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definition was used for the diagnosis of RHF.ResultsA total of 70 patients underwent LVAD implantation. Sixty-seven patients (95.7%) were successfully discharged and 16 patients (22.9%) died during follow-up. 14 patients (20.0%) experienced a stroke within 6 months after implantation, and 0.28 stroke events per patient-year occurred during follow-up. Postoperative RHF was more common in the stroke group (64.3% vs. 23.2%, P=0.008) and the median time from implantation to RHF was 1 day. In the Cox multivariable analysis, postoperative RHF [hazard ratio (HR): 5.063; 95% confidence interval (CI): 1.682-15.245; P=0.004], and cerebral perfusion pressure (CPP) on postoperative day (POD) 1 (HR: 0.923; 95% CI: 0.858-0.992; P=0.030) were independent predictors for early stroke. A CPP of 62 mmHg (sensitivity, 71.4%; specificity, 59.3%) was the cutoff value for early stroke according to the receiver operating characteristic (ROC) analysis.ConclusionsRHF after LVAD implantation may be a risk factor for early stroke. Prevention and management of postoperative RHF with adequate CPP could prevent early stroke after LVAD implantation.
| S-EPMC10797350 | biostudies-literature
Project description:Background Current guidelines recommend at least 6 months of antithrombotic therapy and antibiotic prophylaxis after septal-occluding device deployment in transcatheter closure of atrial septal defect. It has been estimated that it takes ≈6 months for complete neo-endothelialization; however, neo-endothelialization has not previously been assessed in vivo in humans. Methods and Results The neointimal coverage of septal occluder devices was evaluated 6 months after implantation in 15 patients by angioscopy from the right atrium. Each occluder surface was divided into 9 areas; the levels of endothelialization in each area were semiquantitatively assessed by 4-point grades. Device neo-endothelialization was sufficient in two thirds of patients, but insufficient in one third. In the comparison between patients with sufficiently endothelialized devices of average grade score ≥2 (good endothelialization group, n=10) and those with poorly endothelialized devices of average grade score <2 (poor endothelialization group, n=5), those in the poor endothelialization group had larger devices deployed (27.0 mm [25.0-31.5 mm] versus 17.0 mm [15.6-22.5 mm], respectively) and progressive right heart dilatation. The endothelialization was poorer around the central areas. Moreover, the prevalence of thrombus formation on the devices was higher in the poorly endothelialized areas than in the sufficiently endothelialized areas (Grade 0, 94.1%; Grade 1, 63.2%; Grade 2, 0%; Grade 3, 1.6%). Conclusions Neo-endothelialization on the closure devices varied 6 months after implantation. Notably, poor endothelialization and thrombus attachment were observed around the central areas and on the larger devices.
| S-EPMC8649546 | biostudies-literature