Retiro de dispositivo de oclusión septal transcateterismo en una paciente con comunicación interventricular

Introducción: Las complicaciones asociadas al procedimiento de colocación de un dispositivo de oclusión septal se presentan en menos del 10 % de los casos. La embolización requiere de cirugía cardíaca, por lo que se incrementa el riesgo de la mortalidad. Objetivo: Presentar el caso en una paciente con comunicación interventricular e hipertensión pulmonar severa que se le retiró el dispositivo de oclusión septal transcateterismo. Presentación de caso: Se presentó una mujer de 24 años de edad con comunicación interventricular, insuficiencia cardíaca (New York Heart Association) clase IV e hipertensión pulmonar tipo 2, que se programó para la colocación de dispositivo de oclusión septal, sin embargo, presentó fallo en la colocación del dispositivo y defecto residual de 7 mm, por lo que se realizó el retiro de este 48 h después sin presentar complicaciones. Conclusiones: Aunque el cierre transcateterismo de la comunicación interventricular es una alternativa segura y efectiva a la cirugía, no está exento de complicaciones. En caso de translocación del dispositivo de oclusión septal este debe ser retirado durante el mismo procedimiento, ya que el riesgo de embolización es elevado y en caso de presentarse, el riesgo de muerte se incrementa.

Introduction: Complications associated with the placement procedure of a septal occlusion device occur in less than 10% of cases. Embolization requires cardiac surgery, which increases the risk of mortality. Objective: To report the case of a patient with ventricular septal defect and severe pulmonary hypertension who had the transcatheter septal occlusion device removed. Case report: We report the case report of a 24-year-old woman with ventricular septal defect, heart failure (New York Heart Association) class IV and type 2 pulmonary hypertension. She was scheduled for placement of a septal occlusion device, however, the placement of the device failed and had a residual defect of 7 mm, so the placement was removed 48 hours later without complications. Conclusions: Although transcatheter closure of the ventricular septal defect is a safe and effective alternative to surgery, it is not free of complications. In case of translocation of the septal occlusion device, it must be removed during the same procedure, since the risk of embolization is high and if it occurs, the risk of death increases.

Atrial Septal Defect Occluder Device Embolization: Experience of a Tertiary Care Cardiac Center

Background: Percutaneous device closure of atrial septal defect (ASD) has become an increasingly popular procedure as it offers several advantages. However, it is associated with infrequent, but life?threatening complications such as device embolization. Objective: To analyze the risk factors, common sites of embolization, associated complications, timing of embolization, and the treatment executed. Settings and Design: A retrospective study was performed at a tertiary referral center for cardiac services. Material and Methods: Pre?procedure, intra?procedure, and post?procedure data of patients whose ASD device embolized was collected retrospectively and analyzed for risk factors, common sites of embolization, associated complications, timing of embolization, and the treatment executed. Results: Thirty devices were embolized, out of which 13 were retrieved percutaneously in the Catheter laboratory, whereas 17 patients underwent surgery. Fourteen patients had an unfavorable septal morphology for device closure. Ten devices were embolized in the catheter laboratory, five in the intensive care unit, and two in the ward. The devices were embolized to almost all chambers of the heart and great vessels. One patient had an inferior vena cava rim tear while attempting percutaneous retrieval. One patient required a short period of total circulatory arrest (TCA) for retrieval of the device from ascending aorta, while another required a lateral position for retrieval from descending aorta. One patient required re?exploration for bleeding, while another had an air embolism and succumbed. Conclusions: Once embolization occurs, the risks associated increase manifold. Most of the surgical extractions are uneventful; however, there could be certain complications that may need repair of valvular apparatus, the institution of TCA, or the need for the lateral position. Air embolization though very rare can occur which could be fatal.

Trombocitopenia severa inducida por un oclusor para DAP: reporte de caso en tecnovigilancia

Introducción: El ductus arterioso persistente (DAP) es una cardiopatía congénita de especial interés. La oclusión intervencionista es el tratamiento de elección, no obstante, el dispositivo médico "oclusor para DAP", usado en este procedimiento, puede dar lugar a la aparición de eventos adversos de rara frecuencia como hemorragia, trombocitopenia, entre otros. Reporte de caso: Se presenta un caso de una paciente pediátrica con trombocitopenia severa posterior a la intervención. Durante su hospitalización, la paciente mantuvo niveles bajos de plaquetas hasta que logra su recuperación y sale de alta sin una nueva manifestación hematológica. El caso fue reportado como sospecha de incidente adverso asociada al oclusor para DAP. Conclusión: Al realizarse el análisis causa-raíz, se concluye que el tamaño del oclusor para DAP podría ser la principal causa de la trombocitopenia. El presente caso es una muestra que los dispositivos médicos pueden causar eventos adversos severos, por lo que, es necesaria la implementación de tecnovigilancia, principalmente a los dispositivos médicos de alto riesgo.

Introduction: Patent ductus arteriosus (PDA) is a congenital heart condition of special interest. Interventional occlusion is the treatment of choice; however, a PDA occlude, used in this procedure, is a medical device that rarely could lead to adverse events such as hemorrhage, thrombocytopenia, etc. Case report: We present a case of a pediatric patient with severe thrombocytopenia after surgery. During her hospitalization, platelet levels remained lower and, finally, she was fully recovered without any hematological manifestation. The case was reported as a suspected adverse incident related to PDA occlude. Conclusion: After performing a cause-root analysis, we concluded that the size of the PDA occlude may be the main cause of thrombocytopenia. This case demonstrates that medical devices could lead to adverse events. Thus, it is important for clinicians to implement medical device surveillance, mainly for high-risk medical devices.

Clinical analysis of 10 cases of refractory tracheoesophageal fistula treated with novel double disc-shaped gastrointestinal occluder / 中华消化杂志

Objective:To evaluate the safety and clinical efficacy of the novel double disc-shaped gastrointestinal occluder (hereinafter referred to as occluder) in treatment of refractory tracheoesophageal fistula (TEF).Methods:From July 1, 2020 to January 31, 2021, 10 patients with refractory TEF treated with occluder at Department of Gastroenterology, the First Affiliated Hospital with Nanjing Medical University were collected. The patients′ clinical data such as gender, age, body mass index and fistula diameter were recorded. The success rate of operation, intraoperative and postoperative complications, operation time, postoperative hospital stay, efficacy of fistula closure and postoperative recovery were analyzed. The Karnofsky score and body mass index of patients 1 month and 3 months after operation were compared with those before operation for curative effect evaluation. Paired t test was used for statistical analysis. Results:Among the 10 TEF patients, there were 7 males and 3 females, the median age was 64.5 years old (ranged from 49.0 to 78.0 years old), the body mass index was (18.0±2.5) kg/m 2 and the diameter of the fistula was (1.2±0.6) cm. Occluder placement was successful in all patients. The operation time was (17.6±7.8) min (ranged from 7.0 to 30.0 min). Two cases had little bleeding during the operation, and there was no bleeding after the operation. The postoperative hospital stay was (5.9±4.0) d (ranged from 1.0 to 12.0 d). Among the 10 TEF patients, fistula of 5 patients were completely blocked, 4 cases were partially blocked and 1 case was ineffectively blocked, the effective rate of blocking was 9/10. One month follow-up after operation showed that the symptoms of choking and coughing during eating were significantly improved in 9 patients, and the symptoms of choking and coughing during eating were significantly improved in 1 patient after waist diameter of 12 mm occluder was replaced with the occluder of 15 mm. The 3-month follow-up after operation showed that the occluders were in the right place in 8 patients, the occluder was displaced in 1 patient and the occluder was removed and treated with enteral nutrition. One patient died due to the recurrence of esophageal cancer. The Karnofsky score of TEF patients 3 months after operation and the body mass index of TEF patients 1 month and 3 months after operation were higher than those before operation (70.0±34.0 vs. 46.0±10.7, (19.32±2.59) and (19.73±2.92) kg/m 2 vs. (18.03±2.50) kg/m 2), and the differences were statistically significant ( t=-3.09, -2.37 and -2.82, all P<0.05). Conclusions:Gastrointestinal occluder is safe and effective in the treatment of refractory TEF.

Feasibility of three-dimensional CT axial sequence assisted volumetric measurement for atrial septal defect evaluation / 中华放射学杂志

Objective:To explore the feasibility of three-dimensional CT axial sequence assisted volumetric measurement (CTAS) in evaluating atrial septal defect (ASD).Methods:The patients with single secundum ASD who successfully underwent interventional therapy in Fuwai Hospital from January 2016 to December 2019 were retrospectively collected. The patients underwent coronary CT angiography (CTA) before and on the second day after closures, and DSA examinations during operation. A total of 52 cases met the inclusion conditions, among them, there were 37 patients with large defects which had deficient inferior rims ≤3 mm, and 15 patients with severe pulmonary arterial hypertension that occluded with fenestrated ASD occluder. The CT data of patients before and after operation were reconstructed by CTAS. Then the anatomical structure of ASD before the operation was evaluated, including the long diameter and short diameter of ASD, and the CT three-dimensional volume diameter of ASD was calculated by using the equivalent circle conversion formula of ellipse. The waist diameter of occluder and rims of the ASD were measured after occlusion on postoperative CT three-dimensional volume reconstruction images. Meanwhile, the deployed occluder waist dimension was measured in DSA examination during the operation by simulating the balloon measurement of ASD. Lastly, paired t-test and consistency analysis were carried out among the values of parameters. Results:Before operation, the equivalent circle diameter of ASD was (32.3±5.4) mm measured by CTAS. After ASD occlusion, the size of the waist dimension measured by DSA and CTAS were (32.5±4.9) mm and (32.6±4.9) mm. There were no significant differences between them ( P>0.05). There were also no significant differences for each rims of the ASD pre and post operation on CTAS except for the inferior rims and the total length of atrial septum in superior-inferior direction ( P>0.05). Conclusion:As an alternative to balloon sizing, CTAS can be used as a reference standard to conduct ASD interventional treatment.

Advances in ventricular septal defect treatment with different types of occluders / 国际儿科学杂志

Ventricular septal defect(VSD) is the most common congenital heart disease, accounting for approximately 25% to 40% of all congenital heart diseases.The traditional treatment for VSD is transthoracic repair under extracorporeal circulation, which is more effective but more traumatic for the patient, and this method cannot completely avoid potential complications related to extracorporeal circulation.In the past 35 years, various types of occluders have been gradually used for the treatment of VSD by means of percutaneous intervention under X-ray or ultrasound guidance, and the main occluders widely used in clinical practice are the domestic membrane VSD occluders(symmetric occluder, eccentric occluder, thin-waist occluder), the domestic muscular VSD occluders and the Amplatzer duct occluders(first and second generation). This article reviews the advantages and disadvantages, indications and use of different types of occluders for transcatheter intervention of VSD.

Embolic stroke of undetermined source: potential etiology and secondary prevention / 国际脑血管病杂志

The source of the emboli of embolic stroke of undetermined source (ESUS) is still unclear, and the effect of antithrombotic therapy is also different. The recurrence rate of stroke in patients with ESUS is higher, and antiplatelet therapy is still a commonly used secondary prevention scheme. This article reviews the potential causes, pathogenesis and secondary prevention of ESUS.

Echocardiography-guided transcatheter closure of atrial septal defects for three pregnant women / 中华围产医学杂志

Objective:To investigate the feasibility of echocardiography-guided transcatheter closure of atrial septal defect (ASD) during pregnancy and summarize the multidisciplinary treatment experience for such women.Methods:A retrospective analysis was performed on three women receiving echocardiography-guided secondum ASD closure during pregnancy in Guangdong Provincial People's Hospital from January 2018 to October 2021. Perioperative and perinatal multidisciplinary treatment and prognosis were described.Results:All three patients underwent cardiac ultrasonography due to abnormal electrocardiogram during routine prenatal examination and were diagnosed with secondum ASD. Progressive cardiac dysfunction was found during close follow-ups and all cases met the criteria for ASD closure during pregnancy after multidisciplinary evaluation. Echocardiography-guided ASD closure was successfully performed in all patients. Pulmonary arterial pressure was significantly reduced and the cardiac function was stable after the operation. All patients delivered vaginally at term without complications such as miscarriage, premature birth, postpartum hemorrhage or fetal growth restriction and had their cardiac function recovered during postpartum follow-up.Conclusions:Echocardiography-guided ASD closure during pregnancy is technically feasible. Good maternal and fetal outcomes can be obtained through multidisciplinary and close monitoring and treatment during perioperative and perinatal periods.

Complicaciones a corto plazo del cierre percutáneo de comunicación interauricular / Short-term complications of percutaneous atrial septal defect closure

Resumen Introducción: El cierre percutáneo de la comunicación interauricular ostium secundum ha pasado a ser una alternativa a la cirugía convencional. En ese caso, los dispositivos de autocentrado son los más usados entre los cardiólogos intervencionistas. El tipo y la tasa de complicaciones difieren para los distintos dispositivos. Objetivo: Reportar las complicaciones a corto plazo del cierre percutáneo de la comunicación interauricular ostium secundum. Método: Entre abril de 2001 y diciembre de 2017, 129 pacientes (media de edad: 26 años; desviación estándar: 20,39 años) fueron sometidos a cierre percutáneo de comunicación interauricular ostium secundum. Las complicaciones fueron identificadas y clasificadas como mayores y menores. Resultados: 14 pacientes experimentaron complicaciones menores durante la hospitalización y en el primer año de seguimiento (10.85 %), y uno tuvo una complicación mayor que requirió cirugía electiva 4 meses después para la remoción del dispositivo mal posicionado. Entre los que presentaron complicaciones menores, dos tuvieron shunt residual leve, cinco presentaron arritmias interoperatorias, uno refirió dolor torácico y seis tuvieron migraña posimplante. Conclusiones: Esta serie de pacientes muestra que el cierre percutáneo de la comunicación interauricular ostium secundum es un procedimiento seguro y efectivo en casos bien seleccionados. Con el fin de reducir la tasa de complicaciones, están indicados el diagnóstico y el tratamiento tempranos, así como la observación de los criterios de selección de acuerdo con la morfología de la comunicación interauricular ostium secundum. La profilaxis antiagregante con clopidogrel para todos los pacientes requiere mayor investigación.

Abstract Introduction: Percutaneous closure of ostium secundum atrial septal defects has become an alternative to conventional surgery. Self-centering devices are the ones most used by interventional cardiologists in these cases. The type and rate of complications varies according to the various devices. Objective: To report the short-term complications of percutaneous closure of ostium secundum atrial septal defects. Method: Between April 2001 and December 2017, 129 patients (mean age: 26; standard deviation: 20.39 years) underwent percutaneous closure of ostium secundum atrial septal defects. Complications were identified and classified as major or minor. Two types of devices were used: the Amplatzer™ Septal Occluder in 98 patients, and the Figulla® Septal Occluder in 31 patients. Results: 14 patients had minor complications during hospitalization and the first year of follow up (10.85%), and one had a major complication which required elective surgery four months later to remove the misaligned device. Of those who experienced minor complications, two had mild residual shunting, five had intraoperative arrhythmias, one reported chest pain, and six had post-implant migraines. Conclusions: This series of patients shows that percutaneous closure of ostium secundum atrial septal defects is a safe and effective procedure in carefully selected cases. Early diagnosis and treatment are needed to decrease the rate of complications, along with adherence to the selection criteria according to the morphology of the ostium secundum atrial septal defect. Antiplatelet prophylaxis with clopidogrel for all patients requires further study.

Clinical application research of a novel gastrointestinal occluder device for endoscopic closure of gastrobronchial fistula (with video) / 中华消化内镜杂志

To evaluate the therapeutic effectiveness and safety of a novel gastrointestinal occluder device for gastrobronchial fistula. Data of 5 patients diagnosed as having gastrobronchial fistula who received treatment by a novel gastrointestinal occluder device at the First Affiliated Hospital of Nanjing Medical University from July to August 2020 were retrospectively analyzed. The total operation time, occluding time, intraoperative and postoperative complications, postoperative hospital stay and patients′ satisfaction were reviewed. Regular follow-up was conducted, and the short-term curative effect of occluding was evaluated 1 month after operation.All patients were males with age of 58-69 years. The course of fistula ranged 3-16 months and the diameter ranged 0.3-1.0 cm. All 5 patients achieved technical success with operation time of 38-88 minutes and occluding time of 8-24 minutes. The postoperative hospital stay ranged 3-5 days and the patients′ satisfaction score was 10. No severe complications occurred during or after operation. One month after endoscopic therapy, fistula was completely occluded in 4 patients. One patient died due to severe pulmonary infection and multiple organ failure although the bucking symptom after drinking and eating recovered before. Endoscopic closure of gastrointestinal fistula by means of the novel gastrointestinal occluder device is safe and effective.

Three-dimensional transesophageal echocardiography evaluation of changes in parameters of mitral value pre- and post-left atrial appendage closure / 中华超声影像学杂志

Objective:To investigate the relationship between Watchman occluder and structure of mitral valve apparatus in patients with nonvalvular atrial fibrillation after left atrial appendage closure(LAAC) by transesophageal echocardiography.Methods:From January 2018 to December 2020, 29 patients [20 male, 9 female, (69.55±10.06)years old] with nonvalvular atrial fibrillation underwent LAAC in Zhongshan Hospital (implanted Watchman occluder), and all patients underwent pre-operative and follow-up two and three dimensional transesophageal echocardiography(2DTEE, 3DTEE) at 60 days after the operation. The quantitative parameters of mitral valve apparatus were obtained by offline analysis using the MVA module in QLab 13.0 (Philips Healthcare, Andover, MA), the differences between pre-operation and post-operation were compared, and the relationship between occluder compression ratio and mitral valve parameters with significant changes after operation was analyzed.Results:①The values of AL-PM diameter(AL-PM), 3D annulus circumference(3DAC), 2D annulus area(2DAA), 3D annulus area(3DAA), tenting volume(TnV), tenting area(TnA) and commissural diameter(CD) decreased significantly compared with pre-operative values(all P<0.05), while the annulus sphericity index(SPI) increased significantly ( P<0.05). ②In the quantitative mitral value parameters with significant pre- and post-operation changes, TnV was correlated with the occluder compression ratio ( r=0.403, P=0.030), but AL-PM, SPI, 3DAC, 2DAA, 3DAA, TnA, CD were not correlated with it(all P>0.05). Conclusions:3DTEE can accurately evaluate the effect of Watchman occluder on the morphology of mitral valve device. Implanting Watchman occluder in left atrial appendage can make three-dimensional mitral valve apparatus flat and decrease annulus left-right diameter and annulus area; the pre-operative TnV, the more susceptible to the occluder implantation, and TnV is correlated with the compression ratio.

Feasibility of transesophageal echocardiography-guided transthoracic micro-incisions for the treatment of aortic dissection / 中国基层医药

Objective:To investigate the feasibility of transesophageal echocardiography (TEE)-guided transthoracic micro-incisions for the treatment of aortic dissection.Methods:Ten patients with aortic dissection who received TEE before surgery between March 2017 and March 2019 in Zhejiang Provincial Hospital of Chinese Medicine, China were included in this study. They were divided into group A (involving the aorta, n = 5) and group B (aortic arch ulcer, n = 5). Diagnosis before and after surgery was analyzed in each group. Whether guide sheath tube and guide wire rapidly entered the interlayer during the surgery was assessed. In addition, the stability and position of the occluder device and its effect on local blood flow were assessed. Results:TEE findings revealed that occlusion treatment was effective and TEE-guided transthoracic micro-incisions successfully occluded the breaks of the aortic dissection. In group A, the occluded breaks of the aortic dissection disappeared, and thrombi formed in the false lumen. Blood flow velocity decreased from 230 cm/s to 120 cm/s. In group B, aortic wall was tightly bounded to the occluder device and the breaks disappeared. The velocity of the blood flow in the arch of the aorta was 120 cm/s. The occluder device was stable before and after occlusion. It had no effect on the velocity of local blood flow. At 40 days after surgery, the position of the occluder was not deviated.Conclusion:TEE before surgery for aortic dissection can effectively assess the injury degree and avoid missed diagnosis. TEE can guide the placement of the occluder device during the surgery. TEE can also help accurately assess the surgical outcomes.

Cryptogenic stroke in patients with patent foramen ovale: potential mechanisms and prevention strategies / 国际脑血管病杂志

Patent foramen ovale (PFO) is a congenital heart disease that occurs in about 25% of healthy adults. In recent years, more and more studies have shown that PFO is closely associated with cryptogenic stroke (CS). Although it is currently believed that paradoxical embolism is one of the main mechanisms of the pathogenesis of CS, but the exact mechanism is still controversial. In addition, the treatment of CS in patients with PFO is also the focus of controversy. Recent clinical trials have shown that PFO occlusion is significantly better than drug therapy alone in preventing stroke recurrence, especially for patients with a large right-to-left shunt and atrial septal tumor. This article reviews the potential mechanisms and prevention strategies of CS in patients with PFO.

Recent clinical development of minimally invasive closure for atrial septal defect / 中国胸心血管外科临床杂志

@#Atrial septal defect (ASD) is a congenital heart disease that causes blood communication between the left and right ventricles due to partial atrial septal tissue defects, accounting for about 13% of all heart malformations. Secondary ASD is the most common type of ASD and can generally be treated with minimally invasive closure. At present, the commonly used minimally invasive methods in clinical practice mainly include X-ray-guided percutaneous occlusion, transesophageal ultrasound-guided transthoracic occlusion and ultrasound-guided percutaneous occlusion. This review focuses on the basic research process of occluder materials, and advantages and disadvantages of three different surgical methods.

Percutaneous ASD Closure Requiring Emergency Surgical Removal of Embolized Cardiac Occluder Devices

Introduction: Atrial septal defect (ASD), ventricular septaldefect (VSD), patent ductus arteriosus (PDA) are mostcommon congenital acyanotic heart diseases. Surgery isthe gold standard treatment for these defects. Percutaneousdevice closure is now getting popular for closure of thesedefects (Ostium Secundum ASD, PDA, muscular VSD).Device dislodgement, migration and embolization is a causeof failure in this procedure. For this emergency surgicalretrieval of migrated device becomes necessary at times.Here two different scenarios of failed device closure of ASDare presented who required emergency surgical retrieval ofdevice.Case report: In the first case the device got embolized intothe main pulmonary artery which was retrieved surgicallyand his post-operative period was uneventful. In the secondcase the device got embolized into right ventricle. Surgicallythe device was retrieved but post operatively the patient wasfound to have CVA from which she recovered gradually anddischarged.Conclusion: Proper assessment of defect size and rim aroundthe defect is necessary. Devices of all sizes should be availablewith the team doing the procedure. During implantation incase of unsatisfactory device position it should be retrievedand elective surgical closure should be planned. Surgeonsshould be kept in backup in all catheter based procedure.

Development of biodegradable occluders in the treatment for congenital heart diseases / 中华实用儿科临床杂志

Percutaneous intervention with occluder has become the preferred radical therapy for most of common congenital heart diseases,such as atrial septal defect (ASD),ventricular septal defect and patent ductus arteriosus.At present,most occluders for clinical use are made of nitinol,which will permanently exist in human body after implantation,and lead to the risk of severe complications such as chronic inflammation,cardiac perforation and high-grade atrioventricular block.Biodegradable occluder will be gradually replaced by body tissues after implantation.Investigators are exploring to develop biodegradable occluder with different biodegradable materials.In particular,a completely biodegradable atrial septum occlusion system (AbsnowTM) developed by the team of professor Zhang Zhiwei has been approved for clinical trial by China Food and Drug Administration (CFDA) in 2018,which is the first completely biodegradable atrial septal defect occluder entered the clinical trial phase in the world.The results of human trial test demonstrated the initial safety and effectiveness of this occluder.However,multi-center clinical trials are needed for evaluation and verification.Currently,selecting suitable materials for developing new biodegradable occluders,and the effectiveness and safety of occluders are the focuses and development trend of studies on biodegradable occluders in the treatment of congenital heart diseases.

Association between the morphology of the implanted atrial septal defect occluding umbrella and postoperative headache / 中华心血管病杂志

Objective: To explore whether the atrial septal defect(ASD) size, the type of occlusion umbrella selected, and the morphological changes after release of occlusion umbrella affect the headache symptoms of ASD patients after operation. Methods: A total of 567 ASD ptients, who underwent successful implantion with a single occlude from January 2014 to December 2017 in General Hospital of Northern Theater Command were enrolled. The patients were divided into symptomatic group and asymptomatic group according to the presence or absence of headache symptoms after occlusion. X-ray catheter calibration method was used to measure the diameter(d), thickness（L）, maximum diameter of the left umbrella surface after release(D2) and the value of i (i = D2/L). Risk factors related to headache were analyzed by multivariate logistic regression analysis. linear regression analysis was used to detect the relationship between the type of occluder umbrella and ASD diameter in asymptomatic group. Results: A total of 567 patients with one occluder umbrella were included, and 148(26.1%) cases were male. The age was (34.4±19.4) years old. The follow-up time was (12.7±2.8) months. There were 51 cases in the symptomatic group and 516 cases in the asymptomatic group. In 29 patients who were treated by extending the course or increasing the dose of aspirin, the symptoms disappeared or improved. There was no significant difference in the maximum ASD diameter (TTE measured) and the size of occluder between the symptomatic group and asymptomatic group(both P>0.05). The value of d ((19.80±6.67)mm vs.(17.40±7.28) mm, P=0.041) D2 ((43.29±7.41）mm vs. (39.20±9.59)mm， P=0.013)and L((13.06±3.72)mm vs. (10.19±2.90) mm，P=0.025) of the symptomatic group were all higher than that of the asymptomatic group，while the i value was smaller((3.54±0.88）vs.(3.99±0.93)，P=0.010）. The results of multivariate logistic regression analysis showed that the value of L(OR=1.286，95%CI 1.176-1.406, P=0.002) and the value of i(OR=0.916，95%CI 0.867-0.968, P<0.001) were independent factors of headache symptoms in patients after ASD occlusion, while the value of d and the value of D2 were not independent factors (both P>0.05). Linear equations obtained from asymptomatic patients showed the size of occluder =1.121×the maximum ASD diameter of TTE measured +6.414. Conclusions: There is no correlation between the symptoms with the expanded diameter and the maximum diameter of left umbrella's surface after released. The Postoperative discomfort symptoms is significantly correlated to the thickness of the occluder and the value of i. It is suggested that headache could be induced by the oversized occlude, thus choosing the appropriate size of the occluder is essential to reduce the occurrence of postoperative headache symptoms. Increasing the size of occluder because of worrying about the abscission and removal of the occlude is unreasonable. The antiplatelet therapy should also be strengthened to reduce the occurrence of symptoms and improve the symptoms of the patients if the occluder's size is too large. This regression equation (The size of occluder =1.121 × the maximum ASD diameter of TTE measured +6.414) could be used as a reference for the suitable selection of ASD occluder.

Development of biodegradable occluders in the treatment for congenital heart diseases / 中华实用儿科临床杂志

Percutaneous intervention with occluder has become the preferred radical therapy for most of common congenital heart diseases, such as atrial septal defect (ASD), ventricular septal defect and patent ductus arteriosus.At present, most occluders for clinical use are made of nitinol, which will permanently exist in human body after implantation, and lead to the risk of severe complications such as chronic inflammation, cardiac perforation and high-grade atrioventricular block.Biodegradable occluder will be gradually replaced by body tissues after implantation.Investigators are exploring to develop biodegradable occluder with different biodegradable materials.In particular, a completely biodegradable atrial septum occlusion system (Absnow™) developed by the team of professor Zhang Zhiwei has been approved for clinical trial by China Food and Drug Administration (CFDA) in 2018, which is the first completely biodegradable atrial septal defect occluder entered the clinical trial phase in the world.The results of human trial test demonstrated the initial safety and effectiveness of this occluder.However, multi-center clinical trials are needed for evaluation and verification.Currently, selecting suitable materials for developing new biodegradable occluders, and the effectiveness and safety of occluders are the focuses and development trend of studies on biodegradable occluders in the treatment of congenital heart diseases.

Endovascular closure of patent foramen ovale: a critical appraisal of published trials / Fechamento endovascular do forame oval patente: análise crítica dos estudos publicados

ABSTRACT The treatment of cryptogenic stroke patients with a patent foramen ovale (PFO) is controversial. A critical review of these studies is presented. Methods A description of all trials comparing medical and endovascular treatment with closing devices is given. Additional pertinent studies are discussed to help construct a rational basis for treatment decisions. Results Initial negative trials evaluating PFO closure were followed by positive studies published in 2017 and 2018. All trials evaluated young patients (up to 60 years). Methodological problems are present in all trials including their open label construction. Most positive trials developed strategies to increase the percentage of patients with interatrial septal aneurysms or hypermobility and large right-to-left shunts. Even in these positive trials, large numbers of patients need to be treated to avoid one stroke. Atrial fibrillation occurred in 2-6% and other adverse effects related to the procedure and to the devices occurred in a substantial number of patients. Incomplete occlusion of the PFO is also frequent. Anticoagulant treatment has not been adequately studied as a therapeutic option. Conclusion Young patients with cryptogenic strokes seem to benefit from endovascular closure of a PFO in the presence of a large right-to-left shunt or an associated atrial septum aneurysm. For most other patients, a highly-individualized decision must be made, taking into account the low risk of recurrence in patients with a cryptogenic stroke attributable to a PFO, the high numbers needed to treat and the risks related to the procedure.

RESUMO O tratamento de pacientes com infarto cerebral criptogênico e forame oval patente (FOP) é controverso. Uma revisão crítica destes estudos é apresentada. Métodos São descritos em detalhes os estudos comparando tratamento médico com o uso de próteses de oclusão do FOP após infarto cerebral. Discutem-se outros estudos pertinentes para ajudar na tomada racional de decisões terapêuticas individualizadas. Resultados Estudos iniciais avaliando fechamento endovascular com próteses foram negativos, porém seguidos de outros estudos com resultados positivos em 2017 e 2018. Somente pacientes até 60 anos foram estudados. Os estudos apresentam vários problemas metodológicos, incluindo sua natureza aberta. A maioria dos estudos positivos desenvolveu estratégias para aumentar o percentual de pacientes com risco aumentado de recorrência, especificamente grandes shunts direita-esquerda e aneurismas/hipermobilidade do septo interatrial. Mesmo estes estudos positivos revelaram um alto NNT (número de pacientes tratados para evitar um evento de desfecho). Fibrilação atrial ocorreu em 2-6 % dos pacientes tratados. Outras complicações relacionadas ao procedimento e às endopróteses e ainda fechamento incompleto do FOP foram também frequentes. Anticoagulantes poderiam constituir estratégia alternativa de tratamento clínico, mas não foram adequadamente estudados. Conclusão Pacientes jovens com infartos criptogênicos parecem beneficiar-se de oclusão endovascular do FOP na presença de grandes shunts e principalmente aneurismas ou hipermobilidade de septo interatrial. Para a maioria dos outros pacientes, uma decisão altamente individualizada deve ser tomada, considerando o baixo risco de recorrência dos infartos atribuíveis ao FOP, o ato NNT e os riscos inerentes ao procedimento.

Endocarditis tardía en un portador de un Amplatzer: Manejo conservador en un paciente pediátrico / Late onset endocarditis in Amplatzer carrier: Conservative management in a pediatric patient

Desde su aparición, las técnicas percutáneas han ido sustituyendo la cirugía convencional como tratamiento de primera línea en los defectos septales interauriculares. Los dispositivos Amplatzer fueron los primeros aprobados por la Food and Drug Administration, y su colocación se ha convertido en un procedimiento habitual en cardiología pediátrica. La aparición de endocarditis bacteriana sobre este tipo de dispositivos es muy infrecuente. Se presenta el caso de una endocarditis bacteriana en un paciente pediátrico portador de un dispositivo Amplatzer, que se manejó de forma conservadora con antibioterapia intravenosa, con evolución satisfactoria.

Since their introduction, percutaneous techniques have been replacing conventional surgery as a first-line treatment for septal defects. Amplatzer devices were the first to be approved by the Food and Drug Administration, and their placement has become a standard procedure in pediatric cardiology. Bacterial endocarditis of intracardiac devices such as the Amplatzer septal occluder is very infrequent. We report a case of bacterial endocarditis in a pediatric patient with an Amplatzer device, who developed an infectious endocarditis six years after its placement and received conservative management with intravenous antibiotics, with satisfactory evolution.