Tailored extracellular matrix-mimetic coating facilitates reendothelialization and tissue healing of cardiac occluders.

Minimally invasive transcatheter interventional therapy utilizing cardiac occluders represents the primary approach for addressing congenital heart defects and left atrial appendage (LAA) thrombosis. However, incomplete endothelialization and delayed tissue healing after occluder implantation collectively compromise clinical efficacy. In this study, we have customized a recombinant humanized collagen type I (rhCol I) and developed an rhCol I-based extracellular matrix (ECM)-mimetic coating. The innovative coating integrates metal-phenolic networks with anticoagulation and anti-inflammatory functions as a weak cross-linker, combining them with specifically engineered rhCol I that exhibits high cell adhesion activity and elicits a low inflammatory response. The amalgamation, driven by multiple forces, effectively serves to functionalize implantable materials, thereby responding positively to the microenvironment following occluder implantation. Experimental findings substantiate the coating's ability to sustain a prolonged anticoagulant effect, enhance the functionality of endothelial cells and cardiomyocyte, and modulate inflammatory responses by polarizing inflammatory cells into an anti-inflammatory phenotype. Notably, occluder implantation in a canine model confirms that the coating expedites reendothelialization process and promotes tissue healing. Collectively, this tailored ECM-mimetic coating presents a promising surface modification strategy for improving the clinical efficacy of cardiac occluders.

Novel endoscopic approach for treatment of malignant tracheoesophageal fistula (TEF): A case report.

Cardiac septal occluder (CSO) can be used endoscopically in treatment of tracheoesophageal fistula (TEF). We present a case of metastatic cervical cancer with direct tracheal invasion resulting in malignant TEF treated previously with radiotherapy and tracheal stenting twice. This TEF was closed by CSO - patent foramen ovale (PFO) occluder as palliative management to prevent recurrent aspiration pneumonia, decrease morbidity and improve quality of life.

Evaluating cost-effectiveness of PFO management strategies: closure with cardioform vs. amplatzer, and treatment with medical therapy alone, for secondary stroke prevention.

AIM: The aim of this study was to evaluate the cost-effectiveness of patent foramen ovale (PFO) closure using CARDIOFORM Septal Occluders versus AMPLATZER Septal Occluders, as well as compared to Medical Therapy Alone, from a payor perspective in the United States. METHODS: An economic evaluation compared the value of CARDIOFORM, AMPLATZER, and Medical Therapy Alone. A Markov model simulated a cohort of 1,000 individuals with PFO and a history of cryptogenic stroke, with baseline demographic and clinical characteristics reflecting individuals enrolled in the REDUCE and RESPECT trials over a five-year time horizon. The costs and health consequences associated with complications and adverse events, including recurrent stroke, were compared over a time horizon of 5 years. RESULTS: PFO closure using CARDIOFORM was economically dominant, providing both cost-savings and improved effectiveness compared to closure with AMPLATZER. It resulted in an estimated savings of over $1.3 million, an additional 24.8 quality-adjusted life-years (QALYs) gained, and 26 strokes avoided in a cohort of 1,000 patients. When compared to Medical Therapy Alone, closure with CARDIOFORM was found to be cost-effective, with an incremental cost-effectiveness ratio (ICER) of $36,697 per QALY gained. Sensitivity and scenario analysis showed the model findings to be highly robust across reasonable changes to baseline input values and assumptions. CONCLUSIONS: The results of this analysis suggest that PFO closure using the CARDIOFORM Septal Occluder is the most cost-effective treatment strategy for patients with a PFO-associated stroke, particularly compared to AMPLATZER where it resulted in both cost-saving and improved patient outcomes.

Why was this study done? Patent foramen ovale (PFO) is a small opening in the heart that can allow blood clots to pass from one side to the other, increasing the risk of strokes, particularly those without a clear cause, known as cryptogenic strokes. Closing the PFO can help prevent these strokes. This study aimed to determine which treatment option is the best value for money and most effective for preventing secondary strokes in patients with PFO: using the CARDIOFORM Septal Occluder, the AMPLATZER Septal Occluder, or using only medications.What did the researchers do? We used a computer model to simulate the health outcomes and costs for 1,000 patients with PFO who had experienced a cryptogenic stroke. The model followed these patients over five years and compared three treatment strategies: closing the PFO with the CARDIOFORM device, closing it with the AMPLATZER device, and using medications alone (Medical Therapy Alone).What did the researchers find? Our findings showed that:The CARDIOFORM device was more cost-effective and provided better health outcomes than the AMPLATZER device.Using the CARDIOFORM device saved over $1.3 million, added nearly 25 more years of good-quality life (measured as quality-adjusted life years or QALYs), and prevented 26 strokes in a group of 1,000 patients.Compared to using medications alone, the CARDIOFORM device was cost-effective, with a cost of about $36,700 for each year of good-quality life gained. What do the results mean? These results suggest that using the CARDIOFORM device to close a PFO is the best strategy for preventing secondary strokes when compared to AMPLATZER and Medical Therapy Alone. This approach not only saves money but also improves patient outcomes compared to the AMPLATZER device and using medications alone.How could this study help patients? This study provides clear and well-grounded information that helps patients, healthcare providers, and policymakers make informed decisions about the best treatment strategies for preventing secondary strokes in patients with PFO. Using the CARDIOFORM device can lead to better health outcomes and cost savings, ultimately improving the quality of life for patients.

Successful occluder removal and reocclusion of an atrial septal defect after occluder immigration to aortic arch: a case report.

BACKGROUND: Atrial septal defect (ASD) is a common congenital heart disease, and currently, transcatheter intervention is the most common clinical treatment method. However, certain complications still occur during the percutaneous process, among which occluder loss and displacement are rare but serious complication. Although the probability of occluder loss and displacement is low, severe cases can endanger life. CASE PRESENTATION: Here, we report the case of a patient who underwent ASD closure in which the occluder fell off into the aortic arch, the detached occluder was recovered through catheter intervention, and the patient underwent ASD closure again. CONCLUSIONS: In this case report, we highlight that although percutaneous closure of an ASD is regarded as a routine procedure, clinicians should remember the possibility of complications, especially occluder loss and displacement. Therefore, interventionist should carefully evaluate the situation before intervention closure, establish standardized interventional treatment procedures, and provide timely treatment follow-up.

Successful treatment of acute device thrombosis of patent foramen ovale with slow infusion of low-dose thrombolytic therapy.

Background: Percutaneous closure of patent foramen ovale (PFO) is used in selected individuals to eliminate the risk of recurrent cerebral embolism due to paradoxical embolization. Although device thrombosis is rare, it can cause serious complications. Herein, we report a 40-year-old woman who developed acute PFO closure device-associated thrombus and was subsequently treated with slow infusion of low-dose tissue plasminogen activator (t-PA) (25 mg/6 h). Case summary: A 40-year-old woman was admitted to the hospital because of an cerebrovascular accident (CVA). Computed tomography and magnetic resonance imaging of the brain demonstrated the presence of an ischaemic lesion in the right cerebellar infarct. Since no pathological finding was detected that could cause CVA, it was considered that there might be paradoxical embolism due to PFO. Percutaneous PFO closure was decided by the heart and brain team. The occluder was implanted under transoesophageal echocardiography (TEE) and fluoroscopy guidance. Although activated clotting time was 250 s, hypermobile acute thrombus measuring 11 × 5 mm was seen on the left atrial side of the PFO device. Slow infusion of low-dose t-PA treatment was given. As soon as after a single-dose t-PA, control TEE was performed and it was seen that almost the entire thrombus was lysed. The patient did not have any complications during the treatment period. Discussion: Acute PFO device thrombosis is a rare but important complication. If there is no contraindication for lytic treatment in acutely developing large PFO device thrombosis, slow infusion of low-dose t-PA may be useful.

Safety, effectiveness, and complications of the first-in-human minimally invasive transthoracic ventricular septal defect closure using a bioabsorbable occluder: a cohort study with 12-month follow-up.

Background: Ventricular septal defect (VSD) is one of the most common congenital heart diseases. This study aims to evaluate the clinical value and benefit of transesophageal echocardiography (TEE) in transthoracic minimally invasive closure of VSDs using a completely biodegradable occluders, summarize the main points of surgical procedures, and analyze the follow-up results of short-term and medium-term treatment. Methods: We conducted a retrospective analysis of 24 pediatric cases of VSD, successfully treated with TEE-guided minimally invasive closure using fully biodegradable occluders between June 2019 and June 2022. The preoperative TEE meticulously examined the defect's location, size, and surrounding anatomical relationships, aiding in the selection of appropriate occluders and guiding the entire closure process. All patients were followed up for 1 year. Results: In our cohort, 13 cases were perimembranous inlet VSDs, and 11 involved VSDs with membranous aneurysm formation. The effective shunt size of VSD measured by TEE preoperatively ranged from 2.8 to 4.9 mm, with the defect located 2-6 mm from the aortic valve. Occluders used were 6-8 mm in diameter. All 24 procedures were successful. TEE confirmed that the occluders were tightly fitted at the edges of the VSDs. Twenty-three cases had no residual shunt post-surgery, while one case exhibited a small left-to-right shunt (<1.5 mm) at the occluder's edge. Follow-up was conducted on postoperative day 3, and in months 1, 3, 6, and 12, showing that the occluder's position remained normal in all patients. Except for one child who had a 1.2 mm left-to-right shunt at the edge of the occluder, no residual shunts were observed in the others. The occluder started to degrade from month 6, and the sizes of the left and right occluder discs were significantly smaller compared to those on postoperative day 3 (P=0.003). Conclusions: TEE-guided minimally invasive VSD occlusion using fully biodegradable occluders has the advantages of minimal trauma, high safety, and few complications, with satisfactory recent efficacy, and good prospects for clinical safety applications.

Off-label uses of the Amplatzer Piccolo Occluder in children with congenital and acquired heart diseases.

Aim: The Amplatzer Piccolo Occluder (APO) is approved for patent ductus arteriosus (PDA) occlusion in infants weighing >700 g but could offer versatility to treat other lesions.Methods: Retrospective review of children in whom APO was utilized for defects other than PDA between January 2022 and June 2023.Results: The APO was used in nine patients; three for ventricular septal defects, four with coronary fistulas, one for a ventricular pseudoaneurysm and one where APO deployed within a fenestration of a previously placed Amplatzer Septal Occluder. All nine patients had successful occlusions without complications.Conclusion: The APO is a versatile device that can be used to treat various small diameter lesions in children besides the PDA for which it is currently approved for.

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Atrial Septal Defect Occlusion Device Closure of Ascending Aortic Pseudoaneurysm: Can Percutaneous Treatment Become the Solution?

This paper presents 2 cases of middle-aged men submitted to aortic valve replacement surgery that were complicated with ascending aortic pseudoaneurysms treated percutaneously with an atrial septal defect occlusion device (Amplatzer, Abbott Cardiovascular). Percutaneous closure may be an effective treatment in selected patients with high surgical risk.

Fatigue strength analysis of a new left atrial appendage occluder at different release scales.

Owing to its low incidence, small trauma, fast recovery, and high efficiency, left atrial appendage occlusion has become a new strategy for preventing stroke caused by atrial fibrillation. Due to a lack of relevant research information on this emerging technology, the effectiveness, stability, or related complications of occluders are mostly observed from a clinical perspective. However, there are fewer studies on the mechanical properties and safety of these occluders. In this study, a new left atrial appendage occluder is proposed, and a complete numerical simulation analysis framework is established through the finite element method to simulate the actual implantation and service process of the left atrial appendage occluder. Besides, the influence of the structural size and release scale of the occluder on its support performance, occluding effect, and safety is also explored. The results demonstrate that the structural size and release scale exert a significant impact on the support performance, occluding effect, and safety of the occluder. The structural optimization of the occluder contributes to enhancing its mechanical performance, thus ensuring its stability and effectiveness after implantation. Overall, these efforts may lay a scientific foundation for the structural optimization, safety evaluation, and effectiveness prediction of the occluder. Furthermore, these findings also provide effective reference for the application of numerical simulation technology in the research on the left atrial appendage occlusion.

Persistent Fistula Closure After Endoscopic Ultrasound-Directed Transgastric Endoscopic Retrograde Cholangiopancreatography by Postinfarct Ventricular Septal Defect Occluder.

A gastrogastric fistula is a delayed complication of the endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography. Endoscopic closure of these fistulae poses a significant challenge, and surgical intervention may be required in some patients. In this study, we discuss the case of a 69-year-old woman with persistent fistula following the endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography procedure. Despite the failure of conventional advanced endoscopic fistula closure methods, successful closure of the fistula was achieved using a postinfarct ventricular septal defect occluder.

Midterm follow-up results of implantation of a fully biodegradable ventricular septal defect occluder. / å®Œå ¨ç”Ÿç‰©å¯é™è§£å®¤é—´éš”ç¼ºæŸå°å µå™¨æ¤å ¥çš„ä¸­æœŸéšè®¿ç»“æžœ.

OBJECTIVES: Ventricular septal defect (VSD) is a prevalent congenital cardiac anomaly. By enhancing the occluder design and optimizing procedural approaches, the indications for VSD closure can be broadened while minimizing associated complications. The utilization of fully biodegradable occluder holds promising potential in resolving conduction block issues encountered during VSD closure. This study aims to compare the results of the fully biodegradable occluder with the metal occluder in transoesophageal echocardiography-guided VSD closure via lower sternal level minor incision at the interim follow-up, and to find risk factors for the occurrence of electrocardiographic and valvular abnormalities postoperatively. METHODS: We reviewed the postoperative and 3-year follow-up data of all patients who underwent the randomized controlled study of VSD closure from January 1 to November 7, 2019 in the Second Xiangya Hospital of Central South University. The safety and efficacy of the procedure were assessed and compared between the 2 groups by electrocardiogram and echocardiography results, and the risk factors for the occurrence of postoperative electrocardiogram and valve abnormalities were studied with Logistic regression analysis. RESULTS: Twelve and fifteen patients underwent VSD closure with the metallic occluder and the fully biodegradable occluder, respectively. All patients survived during the follow-up period without major complications such as atrioventricular block, significant residual shunt, too rapid absorption of the occluder, and significant valvular regurgitation. There were no significant differences in the results of electrocardiograph and color Doppler ultrasonography the metal occluder group and the fully biodegradable occluder group 1, 2, and 3 years after operation (all P>0.05). The size of the occluder were risk factors for tricuspid regurgitation at 2 and 3 years postoperatively, and the difference between the occluder size and the VSD defect size were risk factors for tricuspid regurgitation at 2 years postoperatively (P<0.05). CONCLUSIONS: This study adequately demonstrates the safety and efficacy of fully biodegradable occluders in small VSD closure and shows the same postoperative effects as conventional nitinol occluders.

Feasibility and Success of Muscular Ventricular Septal Defect Occluders and Mushroom-Shaped Occluders in Transcatheter Patent Ductus Arteriosus Closure in Low-Weight Children: A Propensity Score-Matched Retrospective Analysis from a Chinese National Regional Health Center.

INTRODUCTION: Muscular ventricular septal defect occluders (MVSDOs) have been attempted as an option in low-weight patients with patent ductus arteriosus (PDA). However, few studies have assessed the safety of transcatheter patent ductus arteriosus closure (TCPC) using MVSDO. Therefore, we compared the outcomes in low-weight patients who used MVSDO and mushroom-shaped occluder (MSO). METHODS: Medical records of children under 10 kg (n = 417) who underwent TCPC from 2015 to 2021 at a Chinese health center were reviewed. They were divided into MSO (n = 372) and MVSDO (n = 45) groups. A 1:1 propensity score matching (PSM) was done considering gender, height, weight, body surface area (BSA), PDA diameter, and BSA-corrected PDA diameter. RESULTS: All 45 children in the MVSDO group (mean weight: 5.92 ± 1.32 kg) achieved successful immediate occlusion. One case in the MVSDO group experienced device migration within 24 h requiring unplanned surgery. MVSDO significantly ameliorated pulmonary artery hypertension. After PSM, each group comprised 41 children. The MVSDO group had a smaller effect on platelet counts (MVSDO vs. MSO = 259.85 ± 114.82 vs. 356.12 ± 134.37, p < 0.001), a reduced incidence of thrombocytopenia (MVSDO vs. MSO = 2/41 vs. 7/41, p = 0.001), and a higher rate of residual shunting (MVSDO vs. MSO = 16/41 vs. 5/41, p = 0.005), compared with the MSO group. Thrombocytopenia resolved during hospitalization and micro-shunts disappeared by 6 months. No pulmonary artery or descending aortic secondary stenosis was observed in 1-year follow-up. CONCLUSIONS: MVSDO used in low-weight children is feasible, with high success and satisfactory postoperative and short-term follow-up outcomes, including lower thrombocytopenia incidence, compared to MSO. Further long-term studies with larger samples are recommended.

[Key Points of Design and Risk Analysis in Production for Biodegradable Heart Occluder].

Biodegradable heart occluder uses a biodegradable medical polymer material to replace or completely replace the metal material. After completing the repair function of the heart defect, the device is gradually degraded and safely absorbed by the human tissue. So it may minimize the risk of long-term complications that traditional metal heart occluder causing in the body after implantation. Based on the quality management concept of the entire lifecycle of medical device, this article briefly introduces design and development, as well as the product realization of biodegradable heart occluder. It analyzes the main risk points in design and production, and corresponding suggestions have been put forward. These suggestions are combined with the medical device good manufacturing practice and the appendix of implantable medical equipment to provide a reference for regulators and industry professionals.

Intracardiac Shunt Reversal and Early Right Ventricular Failure after Left Ventricular Assist Device Implantation.

Right ventricular failure (RVF) is a common complication that occurs after a left ventricular assist device (LVAD) is implanted. We report an interesting case of severe and refractory hypoxia during the early postoperative period after HeartMate3 (HM3) (Abbott Laboratories, Lake Forest, IL) implantation resulting in the unmasking of a right-to-left intracardiac shunt through a patent foramen ovale (PFO), triggered by early RVF. Importantly, the patient had a small left-to-right shunt after receiving a left-sided Impella 5.5 micro-axial pump (Abiomed, Danvers, MA, USA) pre-LVAD implantation. We observed improved hypoxia but worsening RVF after percutaneous PFO closure, necessitating right-sided mechanical circulatory support. We outline potential reasons for the significant PFO-related shunting seen after HM3 implantation, but not after Impella 5.5 placement. Uncertainty exists regarding the approach to a PFO in patients undergoing LVAD implantation. We propose an approach based on existing literature.

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.

Fenestrated GORE® CARDIOFORM ASD occluder for transcatheter atrial septal defect closure in a geriatric patient.

An 82-year-old man with a secundum atrial septal defect (ASD) underwent transcatheter closure. The patient had a wide area of aortic and superior rim deficiency, with left ventricular diastolic dysfunction and moderate mitral regurgitation. These findings suggested the risk of both cardiac erosion and increased left atrial pressure after closure. To avoid cardiac erosion, a GORE® CARDIOFORM ASD (GCA) occluder (W.L. Gore & Associates, Flagstaff, AZ, USA) was considered an appropriate device in this patient. However, the possibility of excessively high left atrial pressure due to complete defect closure was a concern. Thus, we created a 4.5-mm fenestration using a surgical punch in the fabric membrane of a 44-mm GCA. The device was deployed in an appropriate position, and no significant elevation of pulmonary capillary wedge pressure was observed. One month after the closure, marked improvement in clinical symptoms and continuous flow through the fenestration were observed. This novel fenestration technique may contribute to expansion of the indications for transcatheter ASD closure in patients who require a GCA owing to an anatomically high risk of erosion accompanied by left ventricular diastolic dysfunction. Learning objective: In elderly patients with left ventricular diastolic dysfunction, transcatheter atrial septal defect (ASD) closure is difficult because rapid resolution of an ASD shunt can cause an increase in left atrial pressure. Previous reports described the creation of a fenestration in the closure device. The use of a GORE® CARDIOFORM ASD (GCA) occluder can reduce the erosion risk; however, creating a stable fenestration is difficult. We developed a novel technique to create a stable fenestration in a GCA.

Transcatheter Extraction of a Migrated Left Atrial Appendage Occluder Device.

A 69-year-old man presented at 10 weeks postimplantation with a 31-mm Watchman FLX migrating into the left atrium. Due to incomplete left atrial appendage seal and embolization risk, transcatheter device extraction was performed without complications. Herein we describe the technique and procedural steps, using cardiac computed tomography and benchtop models to guide practice.

PFO Leading to Concomitant Platypnea-Orthodeoxia Syndrome and Stroke.

Platypnea-orthodeoxia syndrome is a rare entity seen in patients with patent foramen ovale, characterized by dyspnea and arterial desaturation in the upright position. We describe a case of a patient who presented with cryptogenic stroke, evidence of right-to-left interatrial shunting, and refractory hypoxemia necessitating closure of his patent foramen ovale.

Upsizing of GORE® Cardioform ASD Occluder for Atrial Septal Defect With Atrial Septal Aneurysm.

Atrial septal defects (ASDs) often present with multiple foramina, including a patent foramen ovale (PFO) and atrial septal aneurysms (ASAs). Transcatheter device closure of an ASD may require additional supportive techniques in complex cases. Here, we report a case of a secundum ASD complicated by an ASA and a PFO in a man in his 50s. A GORE® Cardioform ASD Occluder (GCA) device of the optimal size for balloon sizing was implanted. However, edge leakage occurred from the front of the device because of a large, moving ASA. Implantation of a two-size-up GCA device successfully closed the ASD under controlled ASA movement.