Cardiac Erosion Research Articles

Atrial septal defect occluder devices and embolization – a case series

Introduction: Atrial Septal Defect (ASD) secundum is a commonly occurring congenital heart disease. Patients with unstable hemodynamic may require closure, which can be accomplished either percutaneous transcatheter of an atrial septal occluder (ASO) device or open surgery. Closure using an occluder carries the risk of device embolization (DE). Case Presentation: This case series presents two patients who had dislodgement after ASD closure using ASO. The demographic data, comorbidities, surgical details, and follow-up results are all summarized. A 9-year-old girl and a 12-year-old boy admitted to our centre. The girl echocardiography evaluation revealed dislodgment of ASD occluder in a large secundum ASD, right upper PV blockage, and a high chance of pulmonary hypertension (PH). While the boy showed the occluder device that was misplaced and positioned in the right ventricle. A secundum ASD with a left to right shunt and moderate TR with a peak pressure gradient of 21.5mmHg were also found. During the procedure, we discovered that the girl had an occluder in the superior rim of ASD II 3x2 cm, which was dislodged towards the lower right PV, above the mitral valve, and the posterior occluder leaflet was removed by replacing a section of the rim. We discovered a secundum ASD with a dimension of 2x1cm on the boy The occluder was found behind the anterior cusp of the tricuspid valve. The retrieved occluder device appeared intact, and the tricuspid valve was injured, but no rupture. Conclusion: The occurrence of ASO migration is uncommon, necessitating further surgery for device removal, closure of the remaining defect, and ensure there is no cardiac erosion or rupture. Surgery can also alleviate symptoms including shortness of breath and palpitations

Progress of biodegradable polymer application in cardiac occluders.

Cardiac septal defect is the most prevalent congenital heart disease and is typically treated with open-heart surgery under cardiopulmonary bypass. Since the 1990s, with the advancement of interventional techniques and minimally invasive transthoracic closure techniques, cardiac occluder implantation represented by the Amplazter products has been the preferred treatment option. Currently, most occlusion devices used in clinical settings are primarily composed of Nitinol as the skeleton. Nevertheless, long-term follow-up studies have revealed various complications related to metal skeletons, including hemolysis, thrombus, metal allergy, cardiac erosion, and even severe atrioventricular block. Thus, occlusion devices made of biodegradable materials have become the focus of research. Over the past two decades, several bioabsorbable cardiac occluders for ventricular septal defect and atrial septal defect have been designed and trialed on animals or humans. This review summarizes the research progress of bioabsorbable cardiac occluders, the advantages and disadvantages of different biodegradable polymers used to fabricate occluders, and discusses future research directions concerning the structures and materials of bioabsorbable cardiac occluders.

Long-term follow-up of percutaneous secundum-type atrial septal defect closure using Amplatzer Septal Occluder since 1995: a single-centre study.

The goal of this single-centre study was to evaluate long-term results of percutaneous closure of secundum-type atrial septal defect using Amplatzer Septal Occluder with the follow-up to 25 years. A retrospective analysis of patients who underwent percutaneous closure of secundum-type atrial septal defect between September 1995 and October 2012 in our institution was performed. All procedures were performed after fulfilling strict indication criteria. More than 5 years follow-up was reached in 651/803 patients (81%) with median follow-up time of 12 (5-25) years. The mean stretched defect diameter was 14,0 ± 5,2 mm. Early reintervention due to moderate or severe residual atrial septal defect had to be performed in 3/803 patients (0,03%). The incidence of long-term moderate or severe residual atrial septal defect was 0,0%. The complete closure rate at 10-year follow-up was 98,5%, as trivial residual shunts persisted in 8/508 patients (1,5%). A significant rate of the echocardiographic right ventricular end-diastolic diameter post-procedural normalisation (p < 0,05) was encountered. The rate of major complications was 0,5%. One device embolisation, one thrombus formation at the occluder surface, and one cardiac erosion in periprocedural or short post-procedural course were experienced. Only one late complication of infective endocarditis at the region of implanted occluder and the aortic valve was detected. The survival rate of all followed patients was 100%. Percutaneous closure of secundum-type atrial septal defect using Amplatzer Septal Occluder is a safe and effective procedure accounting for a very low incidence of major complications in the long-term follow-up.

Late erosion of Amplatzer septal occluder device 9 years after the implantation. A case report.

Cardiac erosion is a rare but life-threatening complication after the interventional closure of an atrial septal defect. We present the case of a patient who developed cardiac erosion 9 years after the placement of an Amplatzer Septal Occluder. The patient presented to our hospital with symptoms of tamponade. Surgical exploration revealed a tear in the roof of the left atrium. To our knowledge, this is one of the most delayed presentations reported. In these cases, diagnosis is difficult and a level of clinical suspicion is demanded.

Clinical analysis and medium-term follow-up of simultaneous interventional therapy for compound congenital heart disease in children: a single-center retrospective study.

This study aimed to explore the safety and efficacy of simultaneous interventional therapy for compound congenital heart disease (CCHD) in children. In total, 155 children with CCHD who received simultaneous interventional therapy at the Children's Hospital of Chongqing Medical University between January 2007 and December 2021 were included in study. Data on clinical manifestations, transthoracic echocardiography, electrocardiogram, and follow-up were retrospectively analyzed. The most common type of CCHD was atrial septal defect (ASD) combined with ventricular septal defect (VSD), accounting for 32.3% of the patients. Simultaneous interventional therapy was successfully administered to 151 children (97.4%). The pulmonary gradient of patients with pulmonary stenosis decreased from 47.3 ± 21.9 mmHg to 15.2 ± 12.2 mmHg (P < 0.05) immediately after the procedure. One patient had failed PBPV as he had residual PS >40 mmHg post procedure. The right ventricular dimension and left ventricular end-diastolic dimension significantly decreased in the first month after the procedure in patients with ASD combined with VSD. Twenty-five (16.1%) patients had mild residual shunt, which spontaneously disappeared in more than half of these patients 6 months after the procedure. The major adverse events were minimal (n = 4, 2.58%), including one patient requiring drug treatment for complete atrioventricular block and three patients receiving surgical treatment because of cardiac erosion, anterior tricuspid valve chordae rupture, and hemolysis, respectively. ASD combined with VSD is the most common type of CCHD in children, and simultaneous interventional therapy for CCHD in children is safe and effective with satisfactory results. Ventricular remodeling can be reversed in patients with ASD combined with VSD 1 month after the procedure. Most adverse events associated with interventional therapy are mild and manageable.

Transcatheter closure of patent foramen ovale using the Cocoon occluder: A multicenter retrospective study

BackgroundThe Cocoon patent foramen ovale (PFO) occluder is a new device especially designed for transcatheter closure of PFO. This occluder has some distinctive structural modifications aimed at reducing the risk of major complications of transcatheter PFO closure. In this report we present our initial experience to evaluate the efficacy and safety of the Cocoon PFO occluder in 253 patients who underwent transcatheter PFO closure. MethodsThe study cohort included 253 patients (median age 45 years) with embolic stroke of undetermined source who underwent attempted transcatheter closure of PFO for secondary prevention of paradoxical embolism. Patients were enrolled retrospectively from five sites in Greece and one in Romania between December 2016 and January 2021, and the median follow-up period was 28 months (range 12–48 months). Clinical and laboratory data from each participating center were sent to an electronic registry for evaluation and statistical analysis. ResultsThe Cocoon PFO occluder was permanently implanted in all patients. At 6 months, complete occlusion of PFO was observed in 251/253 (99.2%) patients. Three (1.2%) patients had a trivial residual shunt. Thrombus formation on the device, which was successfully treated with recombinant tissue plasminogen activator infusion, was observed in one (0.4%) patient. No other complications occurred. During a median follow-up period of 28 months, 3 (1.2%) patients, aged 64–67 years, developed new onset paroxysmal atrial fibrillation. No neurologic events, cardiac erosions, allergic reactions to nickel, or thrombus formation occurred. ConclusionThe Cocoon PFO occluder is an effective and safe device that adds to our armamentarium for transcatheter closure of PFO.

Pericardial effusion and cardiac erosion due to occluding devices of interatrial defects

Pericardial effusion and cardiac erosion due to occluding devices of interatrial defects

Patent foramen ovale occlusion with the Cocoon PFO Occluder. The PROS-IT collaborative project.

The Cocoon patent foramen ovale (PFO) Occluder is a new generation nitinol alloy double-disk device coated with nanoplatinum, likely useful in patients with nickel hypersensitivity. Early results and mid-term outcomes of this device in percutaneous PFO closure are missing. To assess the preliminary efficacy and safety profile of PFO closure with Cocoon device in an Italian multi-center registry. This is a prospective registry of 189 consecutive adult patients treated with the Cocoon PFO Occluder at 15 Italian centers from May 2017 till May 2020. Patients were followed up for 2 years. Closure of the PFO with Cocoon Occluder was carried out successfully in all patients, with complete closure without residual shunt in 94.7% of the patients and minimal shunt in 5.3%. Except from a case of paroxysmal supraventricular tachycardia and a major vascular bleeding, no procedural and in-hospital device-related complications occurred. No patient developed cardiac erosions, allergic reactions to nickel, or any other major complications during the follow-up. During the follow-up period, 2 cases of new-onset atrial fibrillation occurred within thirty-day. Percutaneous closure of PFO with Cocoon Occluder provided satisfactory procedural and mid-term clinical follow-up results in a real-world registry.

Early and Mid-Term Follow-Up Results After Transcatheter Closure of Secundum Atrial Septal Defect.

Transcatheter secundum type atrial septal defect closure is an alternative to surgical closure in many cases when conditions are appropriate. In this study, the demographic data and follow-up results of patients with secundum atrial septal defect undergoing transcatheter closure were discussed. Data of patients who underwent transcatheter closure of secundum atrial septal defect between 2004 and 2017 were investigated retrospectively. Gender, age at intervention, defect size, procedure duration, fluoroscopy time, periprocedural complications, residual shunt existence, and early and mid-term follow-up results were collected. A total of 179 patients [41% males; 10% adults, median age: 8.1 years (1.3-58.6); weight: 28 kg (11-90)] were admitted to catheterization for atrial septal defect closure and their median atrial septal defect size was 13 mm (6-30); 74 (41%) patients had a large atrial septal defect (≥12 mm). Suitable defects for closure were observed in 165 of 179 patients. The procedural success rate was 95.7%. No death was observed; however, minor complications occurred in 3 patients during the procedure (1.6%). The rate of residual shunt after 1 year was 1.3%, and all shunts were mild. After a median follow-up of 2.8 years (range, 6 months to 13.6 years), delayed major complications such as death, cardiac erosion, and infective endocarditis were not experienced. The delayed minor complication was supraventricular extrasystole in 1 patient. Transcatheter atrial septal defect closure is safe in children and adults with a minimal rate of periprocedural and delayed complications. It has a favorable early and mid-term outcome in our study, especially with no death or major complications.

Outcomes After Transcatheter Closure of Atrial Septal Defect Without Using a Balloon-Sizing Technique: A Randomized Controlled Comparison with Closures Using a Balloon-Sizing Technique.

The transcatheter closure of atrial septal defect could be completed without the balloon-sizing technique, so we evaluated long-term outcomes compared with closure using balloon sizing, which was the conventional method. Even without using the balloon-sizing technique, transcatheter closure of atrial septal defect might be safe and effective. We included 124 patients with isolated atrial septal defects who underwent device closure without balloon sizing between 2012 and 2016, and we further included 257 patients as a control group. Patients who received closure with multiple devices or who experienced postoperative residual defects were excluded. Immediate procedural results, as well as long-term outcomes for closure without balloon sizing, were investigated and compared with the control group. The procedural success rate was 96.7%, and there were no mortalities. No embolization or cardiac erosions were observed; however, one patient experienced residual shunt, and another developed progressed mitral regurgitation during the follow-up period (983±682 days). Newly onset persistent atrial fibrillation developed in one patient (1.0%). There were no significant differences in procedures or follow-up between the study and control groups. Despite the shorter procedural time in the study group, fluoro time was not different. Atrial arrhythmias were more frequently observed in the control group, but the difference was not significant. Persistent atrial fibrillation was observed in two patients in the control group (0.8%). Transcatheter closure of atrial septal defect can be performed safely and effectively without using the balloon-sizing technique. The long-term outcomes were similar to outcomes with balloon sizing.

PROCEDURAL TECHNICALITIES AND OUTCOME OF TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT USING OCCLUTECH DEVICE IN TERTIARY CARE CENTRE

Objective: To determine the safety and efficacy of transcatheter closure of atrial septal defects and to evaluate the initial, midterm and long-term results of the treatment.&#x0D; Study Design: Cross sectional study.&#x0D; Place and Duration of Study: Department of Paediatric Cardiology, Rawalpindi Institute of Cardiology, Rawalpindi, from Jul 2017 to Jun 2018.&#x0D; Methodology: Sixty-four patients underwent transcatheter closure of atrial septal defect. Size of the defect was measured by Transoesophageal/Transthoracic. Follow up was carried out at twenty-four hours, one month, six months and at twelve months. Early, Midterm and late complications after device occlusion were analysed using SPSS-22 statistical software.&#x0D; Results: Minimum size of atrial septal defect on echocardiography was 7 mm and maximum size was 31 mm with mean of 18.3 ± 5.7 mm. The procedure was successful in 96.8% cases. There was only one device embolization (1.56%). Cobrahead” configuration malformation of the device occurred in one case (1.56%). Mitral valve regurgitation did not occur in any of the case. There was no residual shunt across the device in the present study. ECG abnormalities associated with transcatheter closure did not occur in any of the patient. In intermediate and long-term follow up, no complication like cardiac erosion was seen in all cases under study.&#x0D; Conclusion: Transcatheter occlusion of ASD with device was found effective and safe procedure with minimal complication rate, short hospital stay, good short, intermediate and long-term results.

Case report of worsening of preexisting pericardial effusion after ASD device closure: is it calamitous?

BackgroundSecundum-type atrial septal defects (ASD) constitute 8% to 10% of congenital heart defect. Secundum ASDs can be closed either percutaneously or surgically. However, ASD device closure has proven to be technically safe and feasible; it is not free of complications. These complications include device embolization/malposition which have been reported in 3.5% of cases, arrhythmia, and pericardial effusion in 2.6% and 0.5–1.5% respectively, device thrombus, residual shunting, and impingement of the device on the adjacent structures.Case presentationWe introduce three patients with secundum ASD who had preexisting pericardial effusion, device closure was performed for them, and after the procedure, the effusion size progressed significantly. We used multimodality imaging to diagnose the cause of pericardial effusion (PE). Cardiac erosion was diagnosed in one of the patients that managed surgically. We did not found any specific procedure-related cause for worsening the pericardial effusion in the other two patients.ConclusionSeveral reasons include procedure-related complication and other systemic causes should be considered in patients who develop pericardial effusion after trans catheter closure of ASDs.

Perforation of the atrial wall and aortic sinus after closure of an atrial septal defect with an Atriasept occluder: a case report

BackgroundWhile the perforation of the atrial wall and aortic sinus after closure of an atrial septal defect (ASD) is rare, it’s life-threatening, with rapid progress and high mortality. To the best of our knowledge, 21 similar cases have been reported since 1976.Case presentationWe report a 16-year-old male whose atrial septal defect (ASD) was closed using a 12-mm Amplatzer septal occluder (ASO). Atrial wall and aortic sinus perforation occurred 3 months after transcatheter closure, and the patient was discharged after emergency operation. He was discharged on the 12th postoperative day in good overall condition.ConclusionsWith this case report, we want to illustrate that although percutaneous closure of ASD is regarded as a routine procedure, we should not forget the potentially lethal complications, especially cardiac erosion. Therefore, we should carefully evaluate the risk of erosion before surgery, and careful lifelong follow-up is needed.

International experience with the use of Cocoon septal occluder for closure of atrial septal defects

BackgroundThe Cocoon septal occluder (CSO) is a new generation double disk occluder device for catheter closure of the secundum atrial septal defect (ASD). Initial clinical evaluations with the use of this device have shown quite satisfactory results but large follow-up studies are missing. In this international multicenter study, we present procedural and follow-up data from 4008 patients with secundum ASD who underwent catheter closure with the use of CSO. MethodsThe study cohort consisted of 1853 pediatric and 2155 adult patients with secundum ASD treated with the CSO. Patients were enrolled retrospectively from 11 international centers and were followed for a mean period of 43 months (range 12–84 months), postprocedural. Clinical, electrocardiographic, echocardiographic, procedural, and follow-up data were collected from each collaborating hospital. ResultsThe CSO was permanently implanted in 3983 patients (99.4%). Echocardiographic evaluation at one month follow-up revealed complete closure in 99.6% of those patients who had a device implanted. Thrombus formation in one adult patient was the only major device related to procedural complication. During the follow-up period, no patient developed cardiac erosions, allergic reactions to nickel, or other major complications. ConclusionsImplantation of CSO provided satisfactory procedural and follow-up results with high success and no device-related cardiac erosions and nickel allergy.

Cardiac Erosions with the Amplatzer Septal Occluder: Adverse Events in the Manufacturer and User Facility Device Experience (MAUDE) Database since the 2012 FDA Review

ABSTRACT Background: Transcatheter closure is the preferred treatment for atrial septal defects. The available devices are effective and safe though concerns persist over cardiac erosion risk. A review of the FDA Manufacturer and User Facility Device Experience (MAUDE) database has not been performed since early reports covering the first decade of device experience. Methods: The FDA MAUDE database was queried for adverse event (AE) reports from 2012 through 2018 involving the Amplatzer Septal Occluder (ASO), Cribriform Occluder (ACO) and PFO Occluder (PFO) devices (Abbott Vascular, Santa Clara, California). Device and event descriptions were analyzed based on report classification, device type and event description. The incidence of AEs was analyzed over time for all event types and devices. Results: There were 732 MAUDE reports describing 764 AEs. The majority of AEs involved the ASO, and the most common AE was device embolization (n = 347). Ninety erosion events were reported (ASO 83, ACO 6, and PFO 1) and 4 erosions were associated with death. The annual number of AE and erosion reports declined from 2012 to 2015 but increased in 2018. Five ASO sizes accounted for 60% of erosions with the 26 mm ASO device being most common. Conclusions: The overall frequency of erosion events in the MAUDE dataset remains low and consistent with prior studies. Adverse events and erosions declined from 2012 to 2015 but have increased in recent years, necessitating future review of this database to ensure that real-world device performance remains consistent with the safety profile demonstrated elsewhere.

Efficacy and Safety of the Atrial Septal Defect Closure for Patients with Absent or Malaligned Aortic Rim Using a Figulla Flex II Device Flared and Straddling Behind the Aorta

Background: Although transcatheter closure of atrial septal defect (ASD) is safe and effective for patients with sufficient rim, ASD patients with absent and/or malaligned aortic and/or superior rim have higher risks of device embolization and cardiac erosion. We have treated such high-risk patients using a Figulla Flex II (FFII) device shaped flared and straddling behind the aorta because this method would avoid such serious complications. However, its long-term efficacy and safety remain unclear. Therefore, the midterm efficacy and safety of this method were studied. Methods: We retrospectively evaluated the outcome of 47 consecutive patients with such rim (age 6–73 years, weight 17–75 kg, 31 females) treated with this method at our hospital between February 2016 and September 2019. To make the flared and straddling shape, we selected a FFII 4–6 mm larger than the balloon sizing diameter by stop-flow technique. We also studied the device shape, the disc pressure to the Valsalva wall and their changes over 6 months by transesophageal echocardiography. Results: All procedures were successful, and leakage disappeared within 1 year. During a mean follow up of 37 ± 12 months, complications included a transient sinus node dysfunction and one I° atrioventricular block within 3 months. Whole device shape changed from bulky to thin: the device waist and thickness significantly decreased by around 1.5 mm and 3.5 mm, respectively (p < 0.05), but the two discs remained flared and straddling behind the aorta over 6 months; therefore, the disc edges seldom pressed the Valsalva wall perpendicularly, even though the inner plane of either disc often slightly pressed the wall. Conclusions: ASD closure using a FFII shaped flared and straddling behind the aorta is probably effective and safe for patients with absent and/or malaligned aortic and/or superior rim although requiring care for conduction disorders.

Cardiac erosion causing an aortic dissection after a catheter closure of an atrial septal defect: first late erosion case with the Figulla Flex II septal occluder.

Cardiac erosion causing an aortic dissection after a catheter closure of an atrial septal defect: first late erosion case with the Figulla Flex II septal occluder.

Risk Factors and Predictors of Cardiac Erosion Discovered from 12 Japanese Patients Who Developed Erosion After Atrial Septal Defect Closure Using Amplatzer Septal Occluder.

Cardiac erosion is a rare serious complication following Amplatzer septal occluder (ASO) placement for atrial septal defect. Although multiple risk factors have been found, a useful predictor to prevent it has not been established yet. In 12 patients who developed erosion between 2005 and 2016 in Japan, we retrospectively observed patients' characteristics and transesophageal echocardiography findings immediately before and after ASO placement and at erosion onset. We compared risk factors of erosion, including absent aortic rim, device size/body weight ratio, device shape, or Valsalva sinus wall deformation pressed by either disk-edge, the maximum depth of which from the standard curve of the Valsalva wall was defined as Dent, between the 12 patients and 95 patients with Valsalva sinus wall deformation immediately after placement who did not develop erosion for 5 ± 3years. Of the 12 patients, nine developed pericardial effusion with eight cardiac tamponade and three aorta-atrium fistula; all were surgically rescued. Surgical findings revealed that erosion in all patients occurred at the right and/or left atrial roof beside the Valsalva in the non-coronary cusp on which the disk-edge seemed to be pressing. The mean Dent immediately after the placement in patients with erosion was significantly deeper than without (2.48 ± 0.32 vs. 1.28 ± 0.38; p < 0.001). There were no differences in the other risk factors between the two groups. Dent is believed to be a useful indicator of erosion development after ASO placement. If Dent is > 2.0mm, it is desirable to change the size or to replace the device.

Late cardiac erosion after percutaneous ventricular septal defect closure: a complication after ventricular septal defect device implantation.

Late cardiac erosion after percutaneous ventricular septal defect closure: a complication after ventricular septal defect device implantation.

A novel totally biodegradable device for effective atrial septal defect closure: A 2‐year study in sheep

To evaluate the feasibility, efficacy, and safety of a fully biodegradable poly lactic acid (PLA)-based occluder for atrial septal defect (ASD) closure in an animal model. ASDs, approximately 12-mm in diameter, were generated in sheep (n = 18) by needle puncture and balloon dilatation. For ASD closure, occluders were implanted by percutaneous transcatheter approach under echocardiographic guidance. Outcomes were evaluated by transthoracic echocardiography, electrocardiography, blood testing, and histology within the follow-up period ranging from 1 month to 2 years. All occluders were successfully implanted. During follow-up, no animal died; rectal temperatures, blood test results, and electrocardiograms were within normal ranges; and transthoracic echocardiograms, macroscopic studies, and histopathological and electron microscopic examination demonstrated that the occluders were well positioned, with no shifting, residual shunts, severe inflammation, thrombus formation, atrioventricular valve insufficiency, cardiac erosion or arrhythmias. The occluders gradually embedded into the endocardial tissue of the hosts with complete endothelialization and disk absorption at 12 months, and a distinct molecular weight decrease of the framework (to 9% of initial) at 24 months after implantation. In a sheep model, the use of totally biodegradable occluders appears feasible, efficacious and safe for ASD closure. Studies in humans are ongoing.