Recent Development of Biodegradable Occlusion Devices for Intra-Atrial Shunts.

Atrial septal defect (ASD) is the third most common type of structural congenital heart defect. Patent foramen ovale (PFO) is an anatomical anomaly in up to 25% of the general population. With the innovation of occlusion devices and improvement of transcatheter techniques, percutaneous closure has become a first-line therapeutic alternative for treatment of ASD and PFO. During the past few decades, the development of biodegradable occlusion devices has become a promising direction for transcatheter closure of ASD/PFO due to their biodegradability and improved biocompatibility. The purpose of this review is to comprehensively summarize biodegradable ASD/PFO occlusion devices, regarding device design, materials, biodegradability, and evaluation of animal or clinical experiments (if available). The current challenges and the research direction for the development of biodegradable occluders for congenital heart defects are also discussed.

Percutaneous retrieval of an embolized Watchman device on a papillary muscle in the left ventricle.

The use of left atrial appendage occlusion (LAAO) devices have gained prominence as an alternative to long-term anticoagulation therapy in patients with atrial fibrillation at risk of stroke and high risk of bleeding. While these devices have shown efficacy in reducing stroke risk, there have been reported cases of embolization of the Watchman device. There are very few cases of successful percutaneous retrieval of embolized Watchman devices from the left ventricle (LV), as many of these cases require open heart surgery for safe removal. We are presenting a case of an 80-year-old male whose Watchman device embolized to the LV and was entrapped on the LV papillary muscle that was then successfully retrieved via percutaneous methods, which shows the percutaneous options remain a viable strategy to retrieve LAAO devices from the LV.

Echocardiography in Percutaneous Left Atrial Appendage Occlusion and Related Complications.

Atrial fibrillation (AF) is a devastating disease with a large global prevalence. The left atrial appendage (LAA) is a major source of thrombi in patients with AF. Echocardiography plays an important role in identifying LAA thrombi and has become an invaluable imaging tool in planning for LAA occlusion (LAAO) in patients intolerant to anticoagulation. This review article will discuss the role of echocardiography in selecting patients for LAAO, intraprocedural monitoring, and identifying procedure-related complications.

LARIAT or AtriClip: Complications Profile and Comparison in Patients with Atrial Fibrillations Based on Manufacturer and User Facility Device Experience Database.

Background and Objectives: Left atrial appendage closure is an alternative treatment to reduce thromboembolism in patients with atrial fibrillation in whom oral anticoagulation (OAC) is contraindicated. The aim of this study was to evaluate the complications profiles of the LARIAT and AtriClip devices and perform a comparison between them based on the MAUDE (Manufacturer and User Facility Device Experience) database. Materials and Methods: The Manufacturer and User Facility Device Experience database was searched on 15 January 2023. For AtriClip, only reports regarding isolated procedures or procedures associated with minimally invasive ablation were included. Adverse effects and causes of death were defined based on the literature on the topic and the causes described in the reports. In total, 63 patients were included in the LARIAT group and 53 patients were included in the AtriClip group. Results: With the LARIAT device, the most common complication without device problems was pericardial effusion (n = 18, 52.9%), whereas this complication was not observed with AtriClip (p < 0.001). Postoperative bleeding was a second complication that occurred significantly more often in the LARIAT group-in 15 (44.1%) cases versus 1 (2.7%) case with AtriClip (p < 0.001). In addition, significant differences were found in the prevalence of stroke (LARIAT n = 0 vs. AtriClip n = 7, 18.9%, p = 0.012) and thrombus (LARIAT n = 2, 5.9% vs. n = 11, 29.7%, p = 0.013). Conclusions: Each type of left atrial appendage closure procedure is associated with device-specific requirements and complications that, if known, can be avoided.

Racial and ethnic differences in left atrial appendage occlusion wait time, complications, and periprocedural management.

PURPOSE: Non-white patients are underrepresented in left atrial appendage occlusion (LAAO) trials, and racial disparities in LAAO periprocedural management are unknown. METHODS: We assessed sociodemographics and comorbidities of consecutive patients at our institution undergoing LAAO between 2015 and 2020, then in adjusted analyses, compared procedural wait time, procedural complications, and post-procedure oral anticoagulation (OAC) use in whites versus non-whites. RESULTS: Among 109 patients undergoing LAAO (45% white), whites had lower CHA2 DS2 VASc scores, on average, than non-whites (4.0 vs. 4.8, p = .006). There was no difference in median time from index event (IE) or initial outpatient cardiology encounter to LAAO procedure (whites 10.5 vs. non-whites 13.7 months, p = .9; 1.9 vs. 1.8 months, p = .6, respectively), and there was no difference in procedural complications (whites 4% vs. non-whites 5%, p = .33). After adjusting for CHA2 DS2 VASc score, OAC use at discharge tended to be higher in whites (OR 2.4, 95% CI [0.9-6.0], p = .07). When restricting the analysis to those with prior gastrointestinal (GI) bleed, adjusting for CHA2 DS2 VASc score and GI bleed severity, whites had a nearly five-fold odds of being discharged on OAC (OR 4.6, 95% CI [1-21.8], p = 0.05). The association between race and discharge OAC was not mediated through income category (total mediation effect 19% 95% CI [-.04-0.11], p = .38). CONCLUSION: Despite an increased prevalence of comorbidities amongst non-whites, wait time for LAAO and procedural complications were similar in whites versus non-whites. Among those with prior GI bleed, whites were nearly five-fold more likely to be discharged on OAC than non-whites, independent of income.

Transcatheter Retrieval of Embolized Atrial Septal Defect Occluder Device by Waist Capture Technique.

This case study describes the successful percutaneous transcatheter retrieval of an embolized Amplatzer occluder device using the "waist capture technique" in a patient with an atrial septal defect. This technique allowed for stability of the Amplatzer device, compression of the atrial discs for easier removal, prevention of further embolization, and minimal injury to vasculature during device retrieval. This novel and effective technique can be used safely for the retrieval of Amplatzer devices in the venous system.

A novel endovascular occlusion device with a steerable introducer for embolization in a porcine model.

OBJECTIVES: It has been reported that vascular plugging has become a therapeutic alternative to coil embolization in certain cases that require occlusion. However, the use of a relatively large and rigid delivery sheath may be a limiting factor in vascular plug use. In this study, we aimed to determine the safety and efficacy of a novel transcatheter occlusion device with unique design and delivery system in a pig model. METHODS: The Cera vascular plug was delivered and deployed through the FuStar steerable introducer sheath, which can control tip direction during advancement. Twelve pigs were randomized to undergo an embolization procedure in which the Cera vascular plug was implanted into the left internal iliac artery (IIA) with the FuStar steerable introducer (n = 6) or a control introducer sheath. Another eight pigs were assigned to undergo an embolization procedure in which the test device was implanted into either the splenic artery (SA, n = 4) or the lower segmental branch of left renal artery (LRA, n = 4). Angiography and pathological examinations were performed to evaluate the outcomes. RESULTS: A total of 20 target vessels were embolized with a total of 22 test plugs. Compared with the control introducer, plug embolization through the FuStar steerable introducer was associated with shorter fluoroscopy time (21.50 ± 3.62 vs. 28.33 ± 2.16 min, P = 0.003) and less contrast medium (129.17 ± 22.68 vs. 162.50 ± 13.69 mL, P = 0.012). At the 2-month follow-up, angiography and pathological examinations did not show any evidence of migration, and persistent occlusion was observed in 18 of the 20 target vessels. Organ ischemia occurred when plugs were deployed within the lower segmental branch of the LRA. CONCLUSION: This novel device is suitable for therapeutic vascular embolization with the use of flexible delivery systems. The different outcomes of SA and LRA plugging suggested that the occluding device should be placed within the appropriate portion of the target vessel to allow the development of collateralization.

--LAA Occluder View for post-implantation Evaluation (LOVE)--standardized imaging proposal evaluating implanted left atrial appendage occlusion devices by cardiac computed tomography.

BACKGROUND: A standardized imaging proposal evaluating implanted left atrial appendage (LAA) occlusion devices by cardiac computed tomography angiography (cCTA) has never been investigated. METHODS: cCTA datasets were acquired on a 3(rd) generation dual-source CT system and reconstructed with a slice thickness of 0.5 mm. An interdisciplinary evaluation was performed by two interventional cardiologists and one radiologist on a 3D multi-planar workstation. A standardized multi-planar reconstruction algorithm was developed in order to assess relevant clinical aspects of implanted LAA occlusion devices being outlined within a pictorial essay. RESULTS: The following clinical aspects of implanted LAA occlusion devices were evaluated within the most appropriate cCTA multi-planar reconstruction: (1) topography to neighboring structures, (2) peri-device leaks, (3) coverage of LAA lobes, (4) indirect signs of neo-endothelialization. These are illustrated within concise CT imaging examples emphasizing the potential value of the proposed cCTA imaging algorithm: Starting from anatomical cCTA planes and stepwise angulation planes perpendicular to the base of the LAA devices generates an optimal LAA Occluder View for post-implantation Evaluation (LOVE). Aligned true axial, sagittal and coronal LOVE planes offer a standardized and detailed evaluation of LAA occlusion devices after percutaneous implantation. CONCLUSIONS: This pictorial essay presents a standardized imaging proposal by cCTA using multi-planar reconstructions that enables systematical follow-up and comparison of patients after LAA occlusion device implantation.

Acute, subacute, and long-term evaluation of a novel endovascular occlusion system in a large animal model.

OBJECTIVES: Endovascular occlusion of blood vessels represents a key component of interventional therapy. While coils are most commonly used, vessel occlusion is generally not achieved immediately and may necessitate a large number of devices. It has been suggested that endovascular plugs may overcome these limitations; however, immediate and durable occlusion remains a challenge with plugs as well. This study evaluates a newly designed endovascular occlusion system (EOS) METHODS: The EOS combines a nitinol coil with an impermeable membranous cap made of expanded polytetrafluoroethylene. The coil offers sufficient radial force to expand the membrane and minimize post-deployment migration. Fifteen test devices were deployed in the iliac (external and internal) and femoral arteries of five miniature swine, while two commercially available devices (platinum coils and a vascular plug) were used as controls in one miniswine. Angiography was performed 1, 5, and 10 minutes after device implantation. Follow-up angiography was obtained either on day 29 or day 61, prior to devices harvesting for histological evaluation and biocompatibility assessment. RESULTS: No clinical complications were observed in the animals throughout the study course. All test devices were deployed as intended, and produced complete and immediate vessel-occlusion. No recanalization or acute migration was observed within 10 minutes of deployment, whereas five test devices had migrated between 5 and 15 mm at follow-up angiography. Complete and durable vessel-occlusion without any sign of recanalization was observed in all EOS devices during the follow-up period. CONCLUSION: The EOS is a safe and reliable device resulting in immediate and durable vessel occlusion in the peripheral arterial circulation. While no device migration was observed in the pelvic area, it was observed with five test and one control devices in the vicinity of highly mobile articulations, leading to the conclusion that occlusion devices should not be placed within hypermobile areas such as the hip joint.

Left atrial catheter ablation subsequent to Watchman® left atrial appendage device implantation: a single centre experience.

AIMS: Left atrial appendage device occlusion is an increasingly accepted therapy for stroke prevention in atrial fibrillation. The feasibility and safety of left atrial catheter ablation procedures in the presence of a left atrial appendage device implant is unclear. We report on 10 cases of successful left atrial catheter ablation therapy for atrial fibrillation in patients with an implanted Watchman® device. METHODS AND RESULTS: Consecutive patients with an existing Watchman® left atrial appendage implant and symptomatic antiarrhythmic-drug refractory atrial fibrillation or atrial tachycardias requiring left atrial catheter ablation therapy were included. Open irrigated tip ablation and circular mapping catheters were positioned in the left atrium via double transseptal access. Ten patients underwent successful left atrial geometry creation and complex atrial arrhythmia mapping and ablation in the presence of a chronically implanted Watchman® device. Arrhythmia targets included left atrial flutters, a focal tachycardia, left atrial CFAE zones, and pulmonary vein electrical isolation. The appearances of the Watchman® device position and device integrity were confirmed to be satisfactory in all patients at the end of the procedure based on fluoroscopy and intracardiac echocardiography imaging. There were no procedural complications. CONCLUSION: Left atrial catheter ablation therapy in the presence of an implanted Watchman® left atrial appendage occlusion device was efficacious and uncomplicated in our small single centre experience.

Preprocedural Planning of Left Atrial Appendage Occlusion: A Review of the Use of Additive Manufacturing.

Stroke is a significant public health problem, with non-valvular atrial fibrillation (NVAF) being one of its main causes. This cardiovascular arrhythmia predisposes to the production of intracardiac thrombi, mostly formed in the left atrial appendage (LAA). When there are contraindications to treatment with oral anticoagulants, another therapeutic option to reduce the possibility of thrombus formation in the LAA is the implantation of an occlusion device by cardiac catheterization. The effectiveness of LAA occlusion is dependent on accurate preprocedural device sizing and proper device positioning at the LAA ostium, to ensure sufficient device anchoring and avoid peri-device leaks. Additive manufacturing, commonly known as three-dimensional printing (3DP), of LAA models is beginning to emerge in the scientific literature to address these challenges through procedural simulation. This review aims at clarifying the impact of 3DP on preprocedural planning of LAA occlusion, specifically in the training of cardiac surgeons and in the assessment of the perfect adjustment between the LAA and the biomedical implant.

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.

Cardiac myxoma following transcatheter closure of an atrial septal defect.

To date, no significant association has been reported between atrial septal defects (ASD) and cardiac myxomas. This study reports a 56-year-old woman with cardiac myxoma following transcatheter closure of ASD. She presented with a 3-month history of recurrent dizziness, vertigo, palpitations, and generalized weakness after undergoing ASD occlusion a year earlier. Echocardiography and cardiac computed tomography scans identified a large, mobile mass (7.2 cm × 2.8 cm) in the left atrium, protruding through the mitral valve. The patient underwent median sternotomy and pericardiotomy, and the histopathological examination confirmed the diagnosis of atrial myxoma. The current case illustrates the challenges in determining whether an atrial mass is a benign myxoma or a dangerous thrombus. While there is no definitive link between the implantation of an ASD closure device and the formation of a myxoma, the emergence of this tumor is a potential occurrence.

Percutaneous left atrial appendage closure for stroke prevention in hypertrophic cardiomyopathy patients with atrial fibrillation.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is an effective alternative strategy for stroke prevention in patients with atrial fibrillation (AF) at high risk for bleeding with anticoagulation (AC). Efficacy of this strategy in hypertrophic cardiomyopathy (HCM) remains uncertain. OBJECTIVE: The study aimed to compare risk of stroke in HCM-AF patients treated with LAAC with those treated with AC. METHODS: By use of the TriNetX Global Research Network, HCM-AF patients from 2015 to 2024 were assigned to categories of treatment with LAAC and treatment solely with AC and observed for 3 years for ischemic stroke, systemic embolism, and all-cause mortality. Propensity score matching was used to limit confounders. RESULTS: Of 14,867 HCM-AF patients identified, 364 (2.5%) were treated with LAAC vs 14,503 (97.5%) treated with AC. HCM LAAC patients were older (72 vs 67 years; P < .001) and had more comorbidities and more prior bleeding events, including higher rate of prior gastrointestinal bleeding (68% vs 18%; P < .001), compared with HCM patients treated solely with AC. After propensity score matching, there was no baseline difference between groups including prior bleeding events (P > .05). During follow-up, HCM patients treated with LAAC had higher rates of ischemic stroke (13% vs 8%; hazard ratio, 1.9; P = .006) and systemic embolism (14% vs 9%; hazard ratio, 1.8; P = .006) but no difference in mortality compared with matched HCM patients receiving AC. CONCLUSION: These real-world data do not support percutaneous LAAC in HCM-AF patients as the primary treatment strategy during long-term AC to reduce stroke risk. However, LAAC may remain a reasonable option for HCM-AF patients who are unable to tolerate AC because of prohibitive bleeding risk.

A multimodality review of gynecologic devices in the pelvis.

There are a wide variety of gynecologic devices encountered on pelvic imaging which may not be the focus or primary reason for imaging. Such devices include pessaries, menstrual products, radiation therapy devices, tubal occlusion devices, and contraceptive devices, including intrauterine devices and intravaginal rings. This manuscript offers a comprehensive review of multimodality imaging appearances of gynecologic devices encountered on pelvic imaging and discusses device indications, positioning, and complications.

Prevalence of respiratory failure and use of mechanical ventilation in heart failure patients undergoing left atrial appendage occlusion device implantation.

BACKGROUND: We sought to evaluate respiratory complications in heart failure patients undergoing left atrial appendage occlusion (LAAO) for stroke prevention in atrial fibrillation. METHODS: Adult admissions (>18 years) undergoing LAAO during 2016-2020 were identified from the National Inpatient Sample. Heart failure (HF) was stratified into systolic (SHF) and diastolic heart failure (DHF) and were compared to those without HF. Outcomes of interested included acute respiratory failure, use of non-invasive and invasive mechanical ventilation, and in-hospital mortality. RESULTS: Of 74,440 admissions for atrial fibrillation undergoing LAAO, SHF and DHF were noted in 8335 (11.2%) and 10,925 (14.7%), respectively. The SHF cohort was predominantly male (78%) whereas DHF cohort were female (53%). Compared to those without HF, presence of SHF (2.3% vs. 0.6%; adjusted odds ratio [OR] 1.61 [95% confidence interval {CI} 1.10-2.36]; p = 0.01) and DHF (2.8% vs. 0.6%; adjusted OR 2.20 [95% CI 1.58-3.06]; p < 0.001) were associated with higher rates of acute respiratory failure. SHF (1.7% vs. 0.6%; adjusted OR 1.70 [95% CI 1.07-2.71]; p = 0.02) group but not DHF (1.2% vs. 0.6%; adjusted OR 1.21 [95% CI 0.78-1.89]; p = 0.39) was associated with higher rates of non-invasive ventilation, whereas the DHF group (0.9% vs. 0.2%; adjusted OR 1.91 [95% CI 1.08-3.34]; p = 0.02) but not SHF (0.8% vs. 0.2%; adjusted OR 1.54 [95% CI 0.83-2.84]; p = 0.17) was associated with higher rates of invasive mechanical ventilation use. In-hospital mortality was comparable between cohorts. CONCLUSION: Compared to those without HF, atrial fibrillation admissions with HF undergoing LAAO had higher rates of acute respiratory failure and mechanical ventilation rates without differences in in-hospital mortality.

Impact of Chronic Kidney Disease on the Outcomes of Patients Undergoing Left Atrial Appendage Occlusion: Insights from a Large National Database.

INTRODUCTION: Studies exploring the effectiveness and safety of left atrial appendage occlusion (LAAO) in patients with chronic kidney disease (CKD) are limited. METHODS: We utilized the National Inpatient Sample (NIS) to identify hospitalizations for LAAO from 2016 to 2020 and further identified cases with concomitant CKD. The primary outcome was mortality, and secondary outcomes were cerebrovascular accidents, major bleeding, vasopressor requirements, percutaneous coronary intervention, cardiac arrest, acute respiratory failure, transfusion, length of stay (LOS), and total hospital charges. Multivariable logistic regression was performed to further adjust for covariates. RESULTS: A total of 89,309 LAAO procedures from 2016 to 2020 were identified, of which 21,559 (24.1%) reported concomitant CKD, with males comprising the majority (62.2%). An increasing trend in LAAO procedures was seen from 2.24 to 13.9 per 10,000 patients from 2016 to 2020. Despite patients with CKD having a higher rate of most comorbidities, there was no difference in mortality (non-CKD vs. CKD, 0.07% vs. 0.42%; aOR: 1.3, 95% CI: 0.4-4.4, p = 0.686) and complications for CKD and non-CKD patients, while CKD patients had longer LOS and higher total hospital charge. No significant sex differences in outcomes among CKD patients were observed except for a longer LOS in females. CONCLUSION: Despite generally having more comorbidities, outcomes of patients with CKD following LAAO are similar to those without CKD, suggesting that LAAO can be offered as a safe option for the treatment of atrial fibrillation in eligible patients with CKD.

Infective endocarditis associated with left atrial appendage occlusion device: a contemporary systematic review.

BACKGROUND: Data are limited regarding infective endocarditis (IE) complicating left atrial appendage occlusion (LAAO) device procedures. This systematic review examines the etiology, diagnosis, and management of infective endocarditis (IE) following LAAO. METHODS: A comprehensive search of six databases was performed between 2007 and 2022. In selecting studies, articles were included if they provided information about IE complicating LAAO, with relevant clinical and imaging details. Articles were excluded if they were editorials, study protocols, letters, or abstracts. RESULTS: We identified seven cases of IE complicating LAAO published between 2007 and 2022, from the United States and Europe, highlighting the exceedingly rare reported incidence of the condition. Staphylococcus aureus is the predominant organism implicated in LAAO infections. Echocardiography is a key imaging modality for diagnosing LAAO IE. Both antibiotic therapy and surgical intervention in appropriate patients are important for managing LAAO device-related IE. CONCLUSIONS: The limited data in the current literature regarding LAAO IE underscores the need for prospective clinical trials to establish evidence-based guidelines for infection prophylaxis, diagnosis, and management. Our findings emphasize the importance of vigilance for device-related infections, especially as the use of LAAO devices continues to grow worldwide.

Revascularization with BYCROSS atherectomy device- protocol of a prospective multicenter observational study.

BACKGROUND: The BYCROSS™ device is a novel device intended for use in atherectomy of the peripheral arterial disease (PAD). With the BYCROSS™ atherectomy system, also prolonged calcifying lesions can be treated in a minimally invasive manner, which was previously reserved for bypass surgery. The aim of this study is to collect additional clinical data on safety and performance of the BYCROSS™ from patients undergoing revascularization of severely stenotic or occluded peripheral arterial vessels with the BYCROSS™. METHODS AND DESIGN: This is an investigator-initiated national prospective multicenter observational study in patients with PAD. Sixty patients (20 per center) with PAD with stenosis higher than 80% or complete occlusion (de novo or recurrent stenosis) of vessels below the aortic bifurcation (min 3 mm vessel diameter) will be recruited. Three vascular surgery centers are participating in the study. The primary efficacy endpoint is procedural success, defined as passage of the occlusion through the BYCROSS device, and safety outcomes, explicated as freedom from device-related serious adverse events (SADEs). Secondary endpoints include primary and secondary patency rates, change in Rutherford classification, and freedom from amputation at 3 and 12 months. DISCUSSION: The BYCROSS atherectomy system may be a novel device for the minimally invasive treatment of prolonged calcified lesions previously reserved for bypass surgery. This national prospective multicenter observational study could represent another step in demonstrating the efficancy and safety of this device for treatment of PAD. TRIAL REGISTRATION: #DRKS00029947 (who.int). PROTOCOL APPROVAL ID: #22-0047(Ethics Committee at Ludwig-Maximilians-University Munich).