Surgical strategies for a failed Watchman device.
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SUBMITTER: Palmer ST
PROVIDER: S-EPMC8305713 | 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: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:We report an unusual case of incomplete endothelialization of the Watchman device >3 years after its implantation. Animal data suggest that device endothelialization occurs ∼45 days post-implantation; however, data on humans are lacking. Guidelines on anticoagulation are based on expectation from animal studies. (Level of Difficulty: Advanced.).
| S-EPMC8310938 | biostudies-literature
Project description:BackgroundIn the recent ESC/EACTS guidelines, left atrial appendage (LAA) occlusion or exclusion in patients undergoing (thoracoscopic) atrial fibrillation (AF) ablation surgery is recommended. The Watchman device (WD, Boston Scientific, Minnesota) has proved to reduce the risk of thromboembolic events by closing of the LAA, yet no data exist on WD implantation during surgical AF ablation. The objective is to determine if WD implantation is safe and feasible in a hybrid AF ablation setting (i.e., combination of thoracoscopic epicardial surgical and endocardial catheter ablation) and could become subject of further testing to serve as a bail-out in cases in which surgical LAA occlusion methods cannot be applied, due to, for example, severe adhesions.MethodsIn this prospective, single center, pilot study, 10 consecutive patients undergoing a hybrid ablation qualifying for LAA exclusion (CHA2DS2-VASc ≥ 1) were included. At the end of the hybrid ablation, the LAA was occluded endocardially using the WD. The feasibility endpoint was successful implantation. The safety endpoint concerned major complications.ResultsOne patient was excluded and replaced because the LAA was insufficiently visible on transesophageal echocardiography. In 10/11 patients, device delivery was successful (mean time: 35 minutes). No major complications occurred. Transesophageal echocardiography after 6 weeks and 6 months showed successful occlusion of the LAA without significant peridevice flow.ConclusionImplantation of the WD seems to be feasible and safe in the setting of hybrid AF ablation and could be an alternative to epicardial occlusion in surgical AF ablation procedures. Larger studies are required to confirm these findings. This trial is registered with NCT02471131.
| S-EPMC6739757 | biostudies-literature
Project description:BACKGROUND:Imaging guidance for left atrial appendage (LAA) closure (LAAC) conventionally consists of transesophageal echocardiography (TEE) and fluoroscopy under general anesthesia (GA). Intracardiac echocardiography (ICE) can eliminate the need for GA, expedite procedural logistics, and reduce the patient experience to a simple venous puncture. OBJECTIVE:The purpose of this study was to define optimal ICE views and compare procedural parameters and cost of ICE vs TEE during LAAC with the Watchman device. METHODS:Optimal ICE views of the LAA for Watchman implant were delineated using Carto-Sound and 3-dimensional rendition of the LAA in 6 patients. Procedural and financial parameters of 104 consecutive patients with standard indications for LAAC undergoing Watchman implant using ICE guidance through a single transseptal puncture (n = 53 [51%]) were compared with those of TEE-guided implants (n = 51 [49%]) in 3 centers. RESULTS:Clinical characteristics were similar between the 2 groups. Total in-room, turnaround, and fluoroscopy times all were shorter using ICE (P <.05) under local anesthesia compared to the TEE group. Implant success was 100% in both groups without peri-device leaks or procedural complications. Follow-up TEE showed no significant peri-device leak in both groups. Total hospital charges for ICE with local anesthesia vs TEE were similar, as were total hospital direct and indirect costs. Professional fees were significantly lower with ICE and local anesthesia than with TEE because the charge of anesthesia staff was avoided. CONCLUSION:ICE-guided Watchman implant is safe, feasible, and comparable in cost to TEE during LAAC with a Watchman device but avoids GA and expedites procedure turnaround.
| S-EPMC6400300 | biostudies-literature
Project description:BackgroundEmbolization of a Watchman device in patients undergoing percutaneous left atrial appendage (LAA) closure is a rare complication. Retrieval of the device can be achieved percutaneously with a snaring technique or a bioptome.Case summaryWe present an illustrative case of Watchman closure device embolization during an LAA closure attempt in a 77-year-old man. The complication was caused by anatomical restraints of the LAA, in particular limited depth resulting in poor stability of the closure device after implantation. By the use of a double snaring technique, however, we managed to retrieve the device percutaneously. By applying such strategy, a more invasive surgical approach can be prevented.DiscussionPrompt response is needed when embolization of a Watchman device occurs. A snaring technique can be used in most cases to attempt device retrieval. A double snaring technique is in this case associated with higher retrieval success than a single snaring technique.
| S-EPMC7780468 | biostudies-literature
Project description:Recruiting participants into clinical trials is notoriously difficult and poses the greatest challenge when planning any investigative study. Poor recruitment may not only have financial ramifications owing to increased time and resources being spent but could adversely influence the clinical impact of a study if it becomes underpowered. Herein, we present our own experience of recruiting into a nationally funded, multicentre, randomised controlled trial (RCT) of the Endobarrier versus standard medical therapy in obese patients with type 2diabetes. Despite these both being highly prevalent conditions, there were considerable barriers to the effectiveness of different recruitment strategies across each study site. Although recruitment from primary care proved extremely successful at one study site, this largely failed at another site prompting the implementation of multimodal recruitment strategies including a successful media campaign to ensure sufficient participants were enrolled and the study was adequately powered. From this experience, we propose where appropriate the early engagement and investment in media campaigns to enhance recruitment into clinical trials. Trial Registration: ISRCTN30845205.
| S-EPMC6886935 | biostudies-literature
Project description:Background Recurrence of mitral regurgitation (MR) after surgical mitral valve repair (SMVR) varies and may require reoperation. Redo mitral valve surgery can be technically challenging and is associated with increased risk of mortality and morbidity. We aimed to assess the feasibility and safety of MitraClip as a treatment strategy after failed SMVR and identify procedure modifications to overcome technical challenges. Methods and Results This international multicenter observational retrospective study collected information for all patients from 16 high-volume hospitals who were treated with MitraClip after failed SMVR from October 29, 2009, until August 1, 2017. Data were anonymously collected. Technical and device success were recorded per modified Mitral Valve Academic Research Consortium criteria. Overall, 104 consecutive patients were included. Median Society of Thoracic Surgeons score was 4.5% and median age was 73 years. At baseline, the majority of patients (82%) were in New York Heart Association class ≥III and MR was moderate or higher in 86% of patients. The cause of MR pre-SMVR was degenerative in 50%, functional in 35%, mixed in 8%, and missing/unknown in 8% of patients. The median time between SMVR and MitraClip was 5.3 (1.9-9.7) years. Technical and device success were 90% and 89%, respectively. Additional/modified imaging was applied in 21% of cases. An MR reduction of ≥1 grade was achieved in 94% of patients and residual MR was moderate or less in 90% of patients. In-hospital all-cause mortality was 2%, and 86% of patients were in New York Heart Association class ≤II. Conclusions MitraClip is a safe and less invasive treatment option for patients with recurrent MR after failed SMVR. Additional/modified imaging may help overcome technical challenges during leaflet grasping.
| S-EPMC8174343 | biostudies-literature
Project description: Not available
| S-EPMC8311989 | biostudies-literature