Retrieval of Embolized WATCHMAN® Flex Atrial Appendage Occlusion Device.

This case report documents the management of a 66-year old man with atrial fibrillation with recent placement of a WATCHMAN® Flex atrial appendage occlusion device. The patient presented with renal failure, abdominal pain, and difficulty walking 2 months after placement. The WATCHMAN® Flex device was found to have embolized to his abdominal aorta at the level of the renal arteries with associated thrombus. Extensive workup revealed reduced left ventricular cardiac function and decreased renal function, both of which were felt to be potentially reversible with device removal. The patient then underwent retrieval of the device and all associated thrombus via an open retroperitoneal approach. This case demonstrates a potential consequence of implanting devices such as an atrial appendage occlusion device and describes a technique for removal.

A case report of postcardioversion device-related thrombus in a patient with left atrial appendage occlusion device on apixaban.

Background: Current guidelines recommend proceeding with cardioversion, without the explicit need for preprocedural transesophageal echocardiography (TEE), in patients compliant with oral anticoagulation for at least 3 weeks. The relevance of these guidelines remains unclear in those undergoing repeat cardioversion. Case summary: A 66-year-old male with a history of atrial fibrillation (AF) and a left atrial appendage occlusion (LAAO) device, compliant with apixaban, presented with dyspnea and lightheadedness. He was cardioverted into sinus rhythm, 10 days before symptom onset, with TEE unremarkable at the time. An ECG revealed that the patient converted back into AF and a repeat cardioversion was scheduled. At the patient's request, a TEE was obtained, revealing a new 2 cm×1 cm thrombus in the left atrium above the WATCHMAN device. Cardioversion was canceled and the patient was hospitalized for AF management. Discussion: Cardioverted patients are at risk for thrombus formation due to atrial stunning, a transitory dysfunction of the atrial appendage and atrium, which occurs immediately after cardioversion and can persist for several weeks. The likelihood of a thrombus is further propagated by individual risk factors for stroke. Conclusion: Anticoagulation does not eliminate the risk of thrombus formation in those with increased risk factors for stroke. Further studies are warranted to assess the need for routine TEE, after cardioversion, in those with stroke risk factors on anticoagulation or who have LAAO.

Feasibility of contrast-free left atrial appendage closure with WATCHMAN FLX device for patients with chronic kidney disease.

Contrast media are generally necessary for transcatheter left atrial appendage closure (LAAC), however, it should be avoided in patients with chronic kidney disease (CKD). The objective of this study was to evaluate the safety and feasibility of contrast-free LAAC with WATCHMAN FLX device for patients with CKD. Among 141 patients undergoing LAAC using the WATCHMAN FLX between May 2021 and March 2023, we performed LAAC without contrast media in 10 patients. Procedural and follow-up results were evaluated. The device size was selected based on the transesophageal echocardiographic (TEE) measurements. The device shape was assessed by fluoroscopy, and the device position was adjusted by TEE images. The mean age was 78 ± 4.9 years, CHADS2 score was 3.2 ± 1.1, and the estimated glomerular filtration rate (eGFR) was 28 ± 12 mL/min/1.73m2. The procedure was completed without contrast media in ten patients. Partial recapture of the device was required in four patients, but the initially selected device was finally implanted in all patients. Mean procedure time was significantly shorter in the contrast-free LAAC than in the contrast-use LAAC (41.6 ± 14.1 min vs 30.3 ± 7.6 min, p = 0.01). Postprocedural eGFR did not change from baseline, and there were no adverse events during the hospital stay. Follow-up TEE or cardiac computed tomography performed within 3 months after the procedure revealed no device-related thrombus or peri-device leak > 3 mm, and oral antithrombotic therapy was discontinued in all patients. Our experience shows that contrast-free LAAC using the WATCHMAN FLX device was safe and feasible. Non-contrast LAAC is one of the therapeutic options for patients with severe CKD.

Comparison of Figure-of-Eight Suture and Perclose ProGlide Suture-Mediated Closure in Large Bore Venous Access Hemostasis: A Randomized Controlled Trial.

Suture-mediated closure device and Figure-of-Eight suture are commonly used to achieve hemostasis after use of large bore venous access. Although both methods of closure are commonly used in clinical practice, a head-to-head comparison in a controlled setting has not been performed. Patients presenting to a single center for elective left atrial appendage occlusion or transcatheter edge-to-edge mitral valve repair were randomized to large bore venous closure using the Perclose ProGlide suture-based closure or a Figure-of-Eight suture closure. The patients were followed for 1 month after the procedure. Primary outcome, a composite of access site large ecchymosis, hematoma, infection, pain, need for unscheduled venous ultrasound and need for transfusion, was compared between the 2 arms. A total of 40 patients were randomized in a 1:1 fashion to the 2 venous closure strategies. Baseline characteristics were similar between the 2 groups. Perclose ProGlide arm required use of more devices for hemostasis (1.5 ± 0.5 vs 1 ± 0 respectively, p <0.0001), and there was a significant difference in the cost of closure device ($367.00 ± 122.00 vs $1.00 ± 0 respectively, p <0.001). At 1 month post-procedure, the primary outcome occurred in 4 patients (20%) in the Perclose arm and 7 (35%) patients in the Figure-of-Eight arm, a difference that was not statistically significant (p = 0.48). Time to hemostasis between Figure-of-Eight and Perclose arms did not reach statistical significance (2.5 ± 2.1 vs 3.7 ± 2.3, p = 0.09). In conclusion, both Perclose ProGlide suture-based device and Figure-of-Eight closure are equally feasible and safe for patients who underwent large bore venous access. Figure-of-Eight-based closure is more cost effective.

Who watches the WATCHMAN? A rare case of lower extremity paralysis.

We present a case study involving an elderly patient who experienced dislodgement of a recently implanted WATCHMAN device. Initially, the patient exhibited multiple musculoskeletal symptoms, which raised concerns about alternative causes such as cauda equina syndrome or spinal epidural hematoma. Despite vascular surgery removing the device, the patient's condition deteriorated due to ischemia leading to multisystem organ failure. This case highlights the critical need for emergency physicians to promptly diagnose acute aortic obstruction caused by embolization, given the increasing use of the WATCHMAN device in the aging population to reduce the reliance on anticoagulation. The potential for significant ischemic consequences necessitates immediate intervention to mitigate complications.

Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation and Cancer.

Background: The prevention of stroke in patients with atrial fibrillation (AF) and cancer is challenging because patients are at increased bleeding and thrombotic risk. Objectives: The authors sought to assess left atrial appendage occlusion (LAAO) as a safe and effective strategy for reducing stroke at no increased bleeding risk in cancer patients with AF. Methods: We reviewed patients with nonvalvular AF who underwent LAAO at Mayo Clinic sites from 2017 to 2020 and identified those who had undergone prior or current treatment for cancer. We compared the incidence of stroke, bleeding, device complications, and death with a control group who underwent LAAO without malignancy. Results: Fifty-five patients were included; 44 (80.0%) were male, and the mean age was 79.0 ± 6.1 years. The median CHA2Ds2-VASc score was 5 (Q1-Q3: 4-6), with 47 (85.5%) having a prior bleeding event. Over the first year, ischemic stroke occurred in 1 (1.4%) patient, bleeding complications in 5 (10.7%) patients, and death in 3 (6.5%) patients. Compared with controls who underwent LAAO without cancer, there was no significant difference in ischemic stroke (HR: 0.44; 95% CI: 0.10-1.97; P = 0.28), bleeding complication (HR: 0.71; 95% CI: 0.28-1.86; P = 0.19), or death (HR: 1.39; 95% CI: 0.73-2.64; P = 0.32). Conclusions: Within our cohort, LAAO in cancer patients was achieved with good procedural success and offered a reduction in stroke at no increased bleeding risk similar to noncancer patients.

Real-world clinical outcomes with a next-generation left atrial appendage closure device: the FLXibility Post-Approval Study.

AIMS: The FLXibility Post-Approval Study collected data on unselected patients implanted with a WATCHMAN FLX in a commercial clinical setting. METHODS AND RESULTS: Patients were implanted with a WATCHMAN FLX per local standard of care, with a subsequent first follow-up visit from 45 to 120 days post-implant and a final follow-up at 1-year post-procedure. A Clinical Event Committee adjudicated all major adverse events and TEE/CT imaging results were adjudicated by a core laboratory. Among 300 patients enrolled at 17 centres in Europe, the mean age was 74.6 ± 8.0 years, mean CHA2DS2-VASc score was 4.3 ± 1.6, and 62.1% were male. The device was successfully implanted in 99.0% (297/300) of patients. The post-implant medication regimen was DAPT for 87.3% (262/300). At first follow-up, core-lab adjudicated complete seal was 88.2% (149/169), 9.5% (16/169) had leak <3 mm, 2.4 (4/169) had leak ≥3 mm to ≤5 mm, and 0% had >5 mm leak. At 1 year, 93.3% (280/300) had final follow-up; 60.5% of patients were on a single antiplatelet medication, 21.4% were on DAPT, 5.6% were on direct oral anticoagulation, and 12.1% were not taking any antiplatelet/anticoagulation medication. Adverse event rates through 1 year were: all-cause death 10.8% (32/295); CV/unexplained death 5.1% (15/295); disabling and non-disabling stroke each 1.0% (3/295, all non-fatal); pericardial effusion requiring surgery or pericardiocentesis 1.0% (3/295); and device-related thrombus 2.4% (7/295). CONCLUSION: The WATCHMAN FLX device had excellent procedural success rates, high LAA seal rates, and low rates of thromboembolic events in everyday clinical practice.

Watchman Device Procedure Complicated by Rare Perclose ProGlide Embolization: Case Report and Literature Review.

Atrial fibrillation (AF) is the most common cardiac arrhythmia with significant morbidity and mortality. In this case, we present a 69-year-old man with a past medical history of atrial fibrillation on warfarin who came to the hospital for placement of the Watchman device (Boston Scientific Corporation, Marlborough, Massachusetts, United States). His procedure was complicated by Perclose ProGlide™ Suture-Mediated Closure system (Abbott Laboratories Inc., Chicago, Illinois, United States) embolism. The vascular surgery department was consulted STAT in the electrophysiology lab and was unable to fully visualize the vessel. The patient was then brought emergently to a hybrid operating room where venotomy was made. He tolerated the procedure well and was eventually discharged home.

Percutaneous extraction of a large device-related thrombus on a Watchman™ device: a case report.

BACKGROUND: Left 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 SUMMARY: In 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. DISCUSSION: Percutaneous 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.

The prevalence and characteristics of candidates for percutaneous left atrial appendage occlusion using a WATCHMAN device among patients who underwent atrial fibrillation ablation in a Japanese population.

BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) using a WATCHMAN device could be a treatment option for patients with non-valvular atrial fibrillation (AF) with thromboembolic and bleeding risk. We sought to determine the prevalence and characteristics of patients with AF ablation who are potential candidates for WATCHMAN implantation in a Japanese population. METHODS: We enrolled 2443 consecutive patients who had previously undergone AF ablation and transesophageal echocardiography (TEE). We assessed their clinical characteristics and measured their LAA orifice diameter and depth retrospectively using the obtained TEE images. We defined patients who met both anatomical criteria (LAA orifice max diameter: 17-31 mm and LAA max depth > LAA orifice max diameter) and clinical criteria (CHA2DS2-VASc score ≥ 2 and HAS-BLED score ≥ 3) as LAAO candidates. RESULTS: Among the 2443 enrolled patients, 361 (15%) met the clinical criteria, and 1928 (79%) met the anatomical criteria. Thus 12% (293/2443) of the total patient group met the criteria of LAAO candidates. LAAO candidates showed larger left atrial (LA) volume (77.6 ± 30.1 vs. 67.7 ± 29.1 mL, P < 0.001), larger LAA orifice diameter (22.5 ± 3.2 vs. 22.0 ± 4.3 mm, P = 0.026), and larger LAA depth (28.9 ± 4.6 vs. 27.0 ± 4.8 mm, P < 0.001). LAAO candidates made up only 23% of patients with CHA2DS2-VASc score ≥ 2 (N = 1295), whereas 78% of patients with a HAS-BLED score ≥ 3 (N = 378) were LAAO candidates. CONCLUSION: Twelve percent of patients who underwent AF ablation were potential candidates for LAAO using a WATCHMAN device in this Japanese population. It is imperative to evaluate bleeding risk when considering the indications for LAAO.

Feasibility and safety of left atrial appendage occlusion guided by procedural fluoroscopy only: A pilot study.

BACKGROUND: Left atrial appendage occlusion (LAAO) is usually performed via the guidance of procedural transesophageal echocardiography (TEE) companied by general anesthesia (GA). OBJECTIVE: To investigate the feasibility and safety of LAAO guided by procedural fluoroscopy only. METHODS: The patients eligible for LAAO were enrolled into the current study and received implantation of either Watchman device or LAmbre device. The procedure was carried out with procedural fluoroscopy only and no companied GA; the position, shape, and leakage of the device were assessed by contrast angiography. TEE was performed after 3-month follow-up to evaluate the thrombosis, and leakage of device. RESULTS: Ninety-seven patients with atrial fibrillation (AF) with either Watchman device (n = 49) or LAmbre device (n = 48) were consecutively enrolled. Watchman device group was of lower CHA2 DS2 -VASc and HAS-BLED scores compared with LAmbre device groups (p < .05); the two groups had similar distributions of other baseline characteristics (p > .05), including procedural success rate (98.0% vs. 97.9%), mean procedure time, mean fluoroscopy time, total radiation dose, contrast medium dose, percentage of peri-device leakage. Pericardial effusions requiring intervention occurred in two of the Watchman group. TEE follow-up found no patient with residual leakage ≥5 mm at 3 months and no device related thrombosis (DRT). During the 22.0 ± 11.1 months follow-up, two patients experienced ischemic stroke. CONCLUSIONS: LAAO with the procedural imaging of fluoroscopy only exhibited the promising results of efficacy and safety. A prospective randomized multicenter study would be required to verify the observations in this study.

Role of Intracardiac Echography for Transcatheter Occlusion of Left Atrial Appendage.

Left atrial appendage closure (LAAC) is an increasingly common procedure for patients with nonvalvular atrial fibrillation and contraindications to long-term anticoagulation. Traditionally, LAAC has been performed under transesophageal echocardiography (TEE) guidance. Although most operators have become experienced and comfortable with TEE-guided appendage closure, there has been a growing interest in the use of intracardiac echocardiography (ICE) for LAAC. This article describes the rationale and technique for ICE-guided LAAC.

Pericardial effusion requiring intervention in patients undergoing percutaneous left atrial appendage occlusion: Prevalence, predictors, and associated in-hospital adverse events from 17,700 procedures in the United States.

BACKGROUND: Left atrial appendage occlusion has shown promise in mitigating the risk of stroke in selected patients with atrial fibrillation. OBJECTIVE: The purpose of this study was to determine the real-world prevalence and in-hospital outcomes in left atrial appendage occlusion (Watchman) recipients complicated by pericardial effusion requiring percutaneous drainage or open cardiac surgery-based intervention. METHODS: Data were derived from the National Inpatient Sample database from January 2015 to December 2017. The primary outcomes assessed were the prevalence of pericardial effusion requiring intervention and in-hospital outcomes including mortality, other major complications, hospital stay > 1 day, and hospitalization costs. Predictors of pericardial effusion requiring intervention were also analyzed. RESULTS: Pericardial effusion requiring intervention occurred in 220 total patients (1.24%). After multivariable adjustment, pericardial effusion requiring intervention was associated with in-hospital mortality (adjusted odds ratio [aOR] 511.6; 95% confidence interval [CI] 122-2145.3), other Watchman-related major complications (aOR 1.35; 95% CI 0.83-2.19), length of stay > 1 day (aOR 17.64; 95% CI 12.56-24.77), and hospitalization cost above the median of $24,327 (aOR 3.58; 95% CI 2.61-4.91). Independent patient predictors of pericardial effusion requiring intervention from the procedure included advanced age (aOR 1.029 per 1-year increase; 95% CI 1.009-1.05 per 1-year increase), higher CHA2DS2-VASc score (aOR 1.221 per 1-point increase; 95% CI 1.083-1.377 per 1-point increase), and obesity (aOR 2.033; 95% CI 1.464-2.823). CONCLUSION: In a large, contemporary real-world cohort of Watchman recipients in US practice, the prevalence of pericardial effusion requiring intervention was 1.24%. Pericardial effusion requiring intervention was associated with several adverse events including increased in-hospital mortality, other major complications, prolonged hospital stay, and hospitalization costs.

Successful WATCHMAN Device Placement Despite Left Atrial Appendage Perforation in Two Cases.

The WATCHMAN (Boston Scientific, Marlborough, USA) is a device used to occlude the left atrial appendage (LAA) in patients of non-valvular atrial fibrillation (NVAF) with a high CHA2DS2-VASc score who are poor candidates for oral anticoagulation. LAA perforation is a well-known complication of the WATCHMAN device placement. Here we present two cases of NVAF where oral anticoagulation was not advisable due to recurrent bleeding episodes. They underwent the WATCHMAN procedure for stroke prevention. During the placement of the WATCHMAN device into the left atrial appendage (LAA) in both cases, pericardial staining was noted that worsened over the next few minutes. It was decided to deploy the 27 mm WATCHMAN device into the LAA. In one case, satisfactory hemostasis was achieved with the device deployment eliminating the need for cardiothoracic surgery. However, the second case led to pericardial tamponade and was managed by the placement of a pericardial window. To our knowledge, this is the first case series describing the use of a WATCHMAN device upon detection of LAA perforation.

Association of Hospital Procedural Volume With Outcomes of Percutaneous Left Atrial Appendage Occlusion.

OBJECTIVES: The aim of this study was to examine the association between percutaneous left atrial appendage occlusion (LAAO) procedural volume and in-hospital outcomes. BACKGROUND: Several studies have demonstrated an inverse volume-outcome relationship for patients undergoing invasive cardiac procedures. Whether a similar association exists for percutaneous LAAO remains unknown. METHODS: Patients undergoing LAAO in 2017 were identified in the Nationwide Readmissions Database. Hospitals were categorized into 3 groups on the basis of tertiles of annual procedural volume: low (5 to 15 cases/year), medium (17 to 31 cases/year), and high (32 to 211 cases/year). Multivariate hierarchical logistic regression and restricted cubic spline analyses were performed to examine the association of hospital LAAO volume and outcomes. The primary outcome was in-hospital major adverse events (MAE), defined as a composite of mortality, stroke or transient ischemic attack, bleeding or transfusion, vascular complications, myocardial infarction, systemic embolization, and pericardial effusion or tamponade requiring pericardiocentesis or surgery. RESULTS: This study included 5,949 LAAO procedures performed across 196 hospitals with a median annual procedural volume of 41 (interquartile range: 25 to 67). Low-volume hospitals had higher rates of in-hospital MAE (9.5% vs. 5.6%; p < 0.001), stroke or transient ischemic attack (2.1% vs. 1.3%; p = 0.049), and bleeding or transfusion (6.1% vs. 3.5%; p = 0.002) compared with high-volume hospitals. No differences were noted for other components of MAE and index length of stay. On multivariate analysis, higher procedural volume was associated with lower rates of in-hospital MAE, with an adjusted odds ratio for medium versus low volume of 0.69 (95% confidence interval: 0.46 to 1.04; p = 0.08) and for high versus low volume of 0.55 (95% confidence interval: 0.37 to 0.82; p = 0.003). CONCLUSIONS: Higher hospital procedural volume is associated with better outcomes for LAAO procedures. Further studies are needed to determine if this relationship persists for long-term outcomes.

Safety and effects of volume loading during transesophageal echocardiography in the pre-procedural work-up for left atrial appendage closure.

BACKGROUND: In patients undergoing left atrial appendage (LAA) closure, an accurate sizing of the LAA is key to optimize device sizing, procedural success and reduce complications. Previous studies have shown that intraprocedural volume loading increases LAA dimensions and improves device sizing. However, the safety and effects on LAA and device sizing of administering a fluid bolus during pre-procedural transesophageal echocardiography (TEE) are unknown. The aim of this study was to determine the safety and impact on LAA dimensions and device sizing of an intravenous (IV) fluid bolus administered during TEE in the setting of the pre-procedural work-up for LAA closure. METHODS: The study included a total of 72 patients who underwent TEE to assess suitability for LAAC and received a 500 ml IV bolus of normal saline. The LAA landing zone (LZ) and depth were measured by TEE before and after volume loading, and these measurements were used to predict the device size implanted during a subsequent percutaneous LAAC procedure. RESULTS: There were no complications associated with volume loading. The baseline mean LZ was 19.6 ± 3.6 mm at 90o, and 20.2 ± 4.1 mm at 135o. Following fluid bolus, the maximum diameter increased 1.5 ± 1.0 mm at 90o (p<0.001), and 1.3 ± 1.0 mm at 135o (p<0.001). The baseline mean depth of the LAA was 26.5 ± 5.5 mm at 90o, and 23.9 ± 5.8 mm at 135o. After fluid bolus, the mean depth increased by 1.5 ± 1.8 mm (p<0.001) and 1.6 ± 2.0 (p<0.001), at 90o and 135o, respectively. Sizing based on post-bolus measurements of the LZ significantly improved the agreement with the final device size selection during the procedure in 71.0% of cases (vs. 42.0% with pre-bolus measurements). CONCLUSIONS: Volume loading during ambulatory TEE as part of the pre-procedural work-up of LAAC is safe and significantly increases LAA dimensions. This strategy may become the new standard, particularly in centers performing LAAC with no TEE guidance, as it improves LAA sizing and more accurately predicts the final device size.

Isolated surgical left atrial appendage closure: Revisiting utility and indications in a burgeoning era of percutaneous therapy.

BACKGROUND AND AIM: Oral anticoagulation (AC) and percutaneous left atrial appendage (LAA) occlusion are the primary treatment modalities for stroke prevention in atrial fibrillation (AF), but there remains a subset of patients in whom these approaches present excess risk and isolated surgical LAA excision should be considered. We describe a 63-year-old female with AF and recurrent thromboembolic events who presented with an acute intraparenchymal hemorrhage and was found to have an intracardiac thrombus. METHODS: Given contraindications to AC and LAA occlusion, an isolated LAA surgical excision was pursued. RESULTS: She underwent successful surgical LAA excision and has since remained event-free. CONCLUSION: It is important to recall the utility of therapies that have been previously used with success for intracardiac thrombi and still remain as viable options.