Percutaneous Watchman FLX implantation in a patient with previous mitral valve surgery and large-sized left atrial appendage.
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ABSTRACT:
SUBMITTER: Martellini A
PROVIDER: S-EPMC7649466 | biostudies-literature | 2020 Oct
REPOSITORIES: biostudies-literature
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Percutaneous Watchman FLX implantation in a patient with previous mitral valve surgery and large-sized left atrial appendage.
Martellini Antonio A Meucci Francesco F Mattesini Alessio A Ristalli Francesca F Stolcova Miroslava M Di Mario Carlo C
European heart journal. Case reports 20200821 5
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Project description:BackgroundCardiac computed tomography imaging with contrast is being used increasingly to image left atrial appendage occlusion (LAAO) devices. Contrast flow across a device, also known as a transfabric leak (TFL), may indicate a lack of complete LAAO-device endothelialization. The data on the rate, predictors, and clinical events associated with TFL are limited.MethodsAll patients who underwent an LAAO-device implantation with a WATCHMAN FLX device and received a postimplantation computed tomography scan were included in this single-centre retrospective cohort study. Patients were classified as either having or not having a TFL, according to 3 currently proposed definitions of TFL. Clinical and procedural differences between the 2 groups were determined. An exploratory univariate logistic regression model to evaluate predictors of TFL was constructed.ResultsA total of 56 individuals were included in the cohort. The rate of TFL varied from 27% to 52%, depending on the radiographic definition employed. No clinically important patient or procedural characteristics were noted between the groups with vs without TFL. No predictors of TFL were identified. Six deaths and one stroke occurred during a median follow-up period of 673 days.ConclusionsTFLs occur commonly post-LAAO procedures, suggesting that complete endothelialization of LAAO devices in humans may not be similar to that reported in animal models. Additional study into the best imaging approach to identify TFLs, and clinical events associated with TFLs, is necessary to clarify the significance of TFLs.
| S-EPMC11681346 | biostudies-literature
Project description:An 82-year-old man who had undergone Watchman FLX (Boston Scientific) device implantation presented with dyspnea. Multimodality evaluation demonstrated a small fistula from the proximal circumflex artery to the left atrial appendage. Anatomically, the left circumflex artery is close to the atrial appendage; therefore, it is plausible that fistula formation could be a late complication of implantation of the device.
| S-EPMC10874893 | biostudies-literature
Project description:BackgroundIn patients with non-valvular atrial fibrillation, the vast majority of thrombi originate in the left atrial appendage (LAA). Thus, occluding the LAA significantly reduces one's risk for developing an ischaemic stroke. To date, many different surgical methodologies in LAA occlusion (LAAO)/exclusion have been studied and utilized. Unfortunately, patients are often left with incomplete closure of their LAA, leaving behind residual lobes that continue to allow thrombus formations. With the recent rise in percutaneous approaches and devices such as the WATCHMAN FLX, there have been proven success rates in achieving total closure of the LAA. Reports and investigations regarding the utilization of WATCHMAN FLX devices in patients with surgically incomplete LAAO remain limited.Case summaryWe present three cases of patients who had previously undergone surgical exclusion of the LAA yet unfortunately were left with residual LAA that continued to place them at high risk for an ischaemic stroke. Percutaneous LAAO with the WATCHMAN FLX was utilized to successfully achieve complete sealing of the residual lobes in failed LAA surgical closures.DiscussionOur multicentre case series elucidates that an increased risk of stroke due to surgical LAAO failure is a real-world possibility that is likely to be encountered in clinical practice. We demonstrate in this series how the WATCHMAN FLX may provide a feasible and safe method to supplement a surgically incomplete LAAO to allow for improved ischaemic stroke and systemic embolization risk reduction.
| S-EPMC10118629 | biostudies-literature
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| S-EPMC9904382 | biostudies-literature
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| S-EPMC10307589 | biostudies-literature
Project description:BackgroundIntracardiac echocardiography (ICE) is an alternative to transesophageal echocardiography to guide left atrial appendage occlusion (LAAO). However, 2-dimensional ICE has important limitations that hinder its adoption in routine practice.ObjectivesThis prospective multicenter study (NCT04569734) investigated the feasibility and safety of ICE-guided LAAO with Watchman FLX using a novel 3-dimensional ICE catheter (VeriSight Pro, Philips).MethodsA total of 100 patients undergoing LAAO with the Watchman FLX device were recruited. All cases were performed under moderate sedation. A simplified 2 orthogonal view ICE imaging protocol was adopted to assess PASS (position, anchoring, sizing, and sealing) criteria. The feasibility endpoint was successful implantation of the FLX device and adequate seal (peri-device leak <5 mm) at 45 days. The safety endpoint was the incidence of major complications at 7 and 45 days. Physician experience and imaging quality scores were collected (1 = lowest, 5 = highest).ResultsThe mean age was 77.0 ± 8.1 years, and 39 (39%) were women. CHA2DS2-VASc score was 4.8 ± 1.5 and HAS-BLED score was 3.2 ± 1.1. Total procedural time was 54 ± 25 minutes. Mean contrast volume was 41 ± 46 ml, with no contrast used in 16 patients. The feasibility endpoint was achieved in 95 patients (95%); 4 patients were not implanted due to unsuitable anatomy, and 1 patient had a leak >5 mm at 45 days. There was 1 periprocedural stroke and 2 gastrointestinal bleeds requiring transfusion at 7 days with no other major complications. Physicians' rating of overall ICE imaging quality was 4.6 ± 0.6.ConclusionsThe novel 3-dimensional ICE VeriSight Pro Probe can safely and effectively guide LAAO with Watchman FLX using a simplified imaging protocol.
| S-EPMC11782859 | biostudies-literature
Project description:BackgroundDevice-related thrombosis (DRT) is a known complication to left atrial appendage closure (LAAC). The surface of a LAAC device should ideally have antithrombotic properties. The novel WATCHMAN FLX Pro (WFP) incorporates a fluoropolymer-coated fabric membrane designed to increase thromboresistance and facilitate endothelialization. Such features could potentially allow for a minimal post-procedural antithrombotic regimen. Radiopaque platinum markers at the device shoulders and a large 40 mm device are other novel features of the WFP.Case summaryA 75-year-old man with atrial fibrillation was referred for LAAC due to prior subdural haemorrhage during direct-acting anticoagulation treatment. He underwent the first-in-human WFP implantation as part of the WATCHMAN FLX Pro CT study (NCT05567172). Computed tomography (CT) was used for pre-planning, and the procedure was performed under local analgesia guided by intracardiac echocardiography from the left atrium (LA) without any complications. Post-procedural antithrombotic treatment consisted of acetylsalicylic acid 75 mg/day only, and 45-day CT, transoesophageal echocardiography (TEE), and magnetic resonance imaging demonstrated optimal device position with complete LAAC. Hypoattenuated thickening (6 mm) appeared on the device as a smooth surface in continuity with the left atrial wall on CT and TEE. A specific magnetic resonance T1-weighted scan, used for visualization of fresh thrombus, suggested this to represent tissue ingrowth rather than thrombus.DiscussionThe advanced follow-up imaging protocol suggested a good WFP implantation result with signs of tissue ingrowth at 45 days. The added radiopaque markers facilitated optimal deployment, evaluation of device stability during tug test, and assessment of device protrusion into the LA.
| S-EPMC11014679 | biostudies-literature
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| S-EPMC10716089 | biostudies-literature
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| S-EPMC10513000 | biostudies-literature
Project description:ObjectiveTo determine trends in real-world utilization and in-hospital adverse events from Watchman implantation since its approval by the Food and Drug Administration in 2015.BackgroundThe risk of embolic stroke caused by atrial fibrillation is reduced by oral anticoagulants, but not all patients can tolerate long-term anticoagulation. Left atrial appendage occlusion with the Watchman device has emerged as an alternative therapy.MethodsThis was a retrospective cohort study utilizing data from National Inpatient Sample for calendar years 2015-2017. The outcomes assessed in this study were associated complications, in-hospital mortality, and resource utilization trends after Watchman implantation. Trends analysis were performed using analysis of variance. Multivariable adjusted logistic regression analysis was performed to determine predictors of mortality.ResultsA total of 17 700 patients underwent Watchman implantation during the study period. There was a significantly increased trend in the number of Watchman procedures performed over the study years (from 1195 in 2015 to 11 165 devices in 2017, p < .01). A significant decline in the rate of complications (from 26.4% in 2015% to 7.9% in 2017, p < .01) and inpatient mortality (from 1.3% in 2015% to 0.1% in 2017, p < .01) were noted. Predictors of in-hospital mortality included a higher CHA2 DS2 -VASc score (odds ratio [OR]: 2.61 per 1-point increase, 95% confidence interval [CI]: 1.91-3.57), chronic blood loss anemia (OR: 3.63, 95% CI: 1.37-9.61) and coagulopathy (OR: 4.90, 95% CI: 2.32-10.35).ConclusionIn contemporary United States clinical practice, Watchman utilization has increased significantly since approval in 2015, while complications and in-patient mortality have declined.
| S-EPMC8383872 | biostudies-literature