Animal Experimental Study of the Fully Biodegradable Atrial Septal Defect (ASD) Occluder

This study was conducted to evaluate the feasibility, safety, biocompatibility, and degradation features of a fully biodegradable occluder for closure of atrial septal defect (ASD) in an acute canine model. The ASD was created in 20 healthy mongrel dogs by the brockenbrough needle, and the fully biodegradable occluders were implanted by self-made delivery system. The success rate and complications were observed. Acute ASD models were successfully created in 18 dogs, and 16 occluders were successfully implanted in the ASD models. Animals were sacrificed at different times after procedure. The cardiac gross anatomy showed that all occluders were stable in the interatrial septum, no vegetation or thrombus formation was observed on the surface of all occluders. They were embedded into endogenous host tissue gradually at 12-week follow-up. Different periods of pathological observations suggested that the occluders degraded gradually over about 24 weeks and essentially became an integral part of the septum. Transcatheter closure of ASD in acute canine model using the fully biodegradable ASD occluder has the potential of a high successful rate of technique, excellent biocompatibility, and fewer complications with adequate, immediate, and short-term results.

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A New Coated Nitinol Occluder for Transcatheter Closure of Ventricular Septal Defects in a Canine Model

BioMed Research International ◽

10.1155/2013/507919 ◽

2013 ◽

Vol 2013 ◽

pp. 1-7 ◽

Cited By ~ 1

Author(s):

Yong Zhou ◽

Feng Chen ◽

Xinmiao Huang ◽

Xianxian Zhao ◽

Hong Wu ◽

...

Keyword(s):

Ventricular Septal Defect ◽

Septal Defect ◽

Thrombus Formation ◽

Canine Model ◽

Control Group ◽

New Type ◽

Good Biocompatibility ◽

The Right ◽

Microscopy Examination

Aims. This study evaluated feasibility and safety of implanting the polyester-coated nitinol ventricular septal defect occluder (pcVSDO) in the canine model.Methods and Results. VSD models were successfully established by transseptal ventricular septal puncture via the right jugular vein in 15 out of 18 canines. Two types of VSDOs were implanted, either with pcVSDOs (n=8) as the new type occluder group or with the commercial ventricular septal defect occluders (VSDOs,n=7, Shanghai Sharp Memory Alloy Co. Ltd.) as the control group. Sheath size was 10 French (10 Fr) in two groups. Then the general state of the canines was observed after implantation. ECG and TTE were performed, respectively, at 7, 30, 90 days of follow-up. The canines were sacrificed at these time points for pathological and scanning electron microscopy examination. The devices were successfully implanted in all 15 canines and were retrievable and repositionable. There was no thrombus formation on the device or occurrence of complete heart block. The pcVSDO surface implanted at day 7 was already covered with neotissue by gross examination, and it completed endothelialization at day 30, while the commercial VSDO was covered with the neotissue in 30th day and the complete endothelialization in 90th day.Conclusion. The study shows that pcVSDO is feasible and safe to close canine VSD model and has good biocompatibility and shorter time of endothelialization.

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Atrial septal aneurysms in childhood: prevalence, classification, and concurrent abnormalities

Cardiology in the Young ◽

10.1017/s1047951113000607 ◽

2013 ◽

Vol 24 (3) ◽

pp. 453-458 ◽

Cited By ~ 10

Author(s):

Andreas Giannopoulos ◽

Christoforos Gavras ◽

Stavroula Sarioglou ◽

Fotini Agathagelou ◽

Irene Kassapoglou ◽

...

Keyword(s):

Atrial Septal Defect ◽

Patent Foramen Ovale ◽

Septal Defect ◽

Interatrial Septum ◽

Paediatric Population ◽

Point Of View ◽

Atrial Septal Aneurysm ◽

Foramen Ovale ◽

Increased Risk

AbstractObjectives: This study sought to investigate the prevalence of atrial septal aneurysms in the paediatric population and to define coexisting abnormalities and their incidence. Background: Few papers refer to the prevalence of atrial septal aneurysms in childhood. Methods: We enrolled a total of 4522 children aged more than 12 months who underwent a transthoracic echocardiography. Atrial septal aneurysm was defined as a protrusion of the interatrial septum or part of it >15 mm beyond the plane of the atrial septum or phasic excursion of the interatrial septum during the cardiorespiratory cycle of at least 15 mm in total amplitude and a diameter of the base of the aneurysm of at least 15 mm. Results: Atrial septal aneurysms were found in 47 children (1.04%). They involved almost the entire septum in 14 patients (28.89%) and were limited to the fossa ovalis in 33 (71.11%). An atrial septal aneurysm was an isolated structural defect in 17 (35.56%). In 30 (64.44%) patients, it was associated with interatrial shunting – atrial septal defect and patent foramen ovale. At the echo follow-up after a year, no changes were recorded. Conclusions: Prevalence of atrial septal aneurysms is almost 1%. The most common abnormalities associated are interatrial shunts, that is, a patent foramen ovale and an atrial septal defect. From a medical point of view, it is suggested that no action is to be taken during childhood, as a child with an atrial septal aneurysm is not at increased risk compared with a child without one. Follow-up is scheduled on an individual basis.

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P4166Efficacy and safety of novel biodegradable device for closure of atrial septal defect: from preclinical study to first-in-man experience

European Heart Journal ◽

10.1093/eurheartj/ehz745.0737 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

Y F Li ◽

Y M Xie ◽

Z F Xie ◽

S S Wang ◽

B N Li ◽

...

Keyword(s):

Atrial Septal Defect ◽

Septal Defect ◽

Preclinical Study ◽

Closure Device ◽

Swine Model ◽

Procedure Time ◽

Short Term ◽

The Mean ◽

Asd Closure

Abstract Background closure of atrial septal defect (ASD) has emerged as the treatment of choice for the majority of defect. The biodegradable ASD closure device is a novel, absorbable device made of poly-L_latic acid (PLLA). This study evaluates the feasibility, safety and effectiveness of PLLA biodegradable ASD closure device in a swine model and for the first time in human. Objective The study reports on the 24- and 36- month follow-up results of PLLA device implanted in a swine model and the first-in- man experience with 6-month follow-up. Method Preclinical study was done in a swine ASD model. In a clinical setting, 5 pediatric patients with a secundum ASD who a clinically left-to-right shunt were enrolled in our center. Percutaneous ASD closure procedure with PLLA device was performed with fluoroscopic and transcatheter echocardiography (TTE) guidance. Procedure results and clinical outcomes at 1 day, 30 days, 3 months and 6 months after closure procedure were analyzed. Results 24- and 36-month follow-up results of preclinical study demonstrated that the PLLA device exhibited good endothelialization and degradability in a swine model. In clinical study, device implantation was successfully achieved in all of 5 patients (median age, 3.6 years; range, 3.1–6.5 years). The mean ASD size was (13.4±2.4)mm (range, 10–16mm). The mean pulmonary-to-systemic blood flow ratio (Qp:Qs) was (1.7±0.2):1 with a range of 1.5:1 to 2.0:1. The mean procedure time and the mean fluoroscopy time were (36.2±11.3) and (6.4±1.0)minutes, respectively. There was no evidence of short-term complications related to the device or the delivery system. No device dislodgement, significant aortic valve or mitral valve regurgitation, new onset cardiac arrhythmia, or other adverse events were reported. Characteristics and procedure data of the 5 patients who underwent ASD closure procedure with PLLA device Patient No. Age Weight Gender Defect size Qp:Qs Mean Pulmonary Pressure Device size (mm) Sheath (Fr) Procedure time Fluoroscopy time Immediate residual shunt (years) (kg) (mm) (mmHg) (mm) (Fr) (min) (min) 1 4.9 23.5 Male 17 1.7:1 22 24 12 52 7.6 None 2 3.1 10.0 Male 14 2.0:1 19 20 12 26 5.4 None 3 6.5 21.0 Male 15 1.8:1 22 20 12 31 6.0 None 4 3.2 14.5 Female 12 1.5:1 13 18 10 44 7.3 None 5 3.6 12.5 Male 10 1.5:1 17 14 10 28 5.5 None Conclusion This study is the first to demonstrate the feasibility, safety and effectiveness of PLLA biodegradable device in human, with no evidence of short-term complications and a high rate of early shunt closure. Acknowledgement/Funding National Key R&D Program of China (Grant Number: 2016 YFC1100305)

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Short-Term and Midterm Follow-Up of Transthoracic Device Closure of Atrial Septal Defect in Infants

The Annals of Thoracic Surgery ◽

10.1016/j.athoracsur.2017.02.085 ◽

2017 ◽

Vol 104 (4) ◽

pp. 1403-1409 ◽

Cited By ~ 1

Author(s):

Qiang Chen ◽

Hua Cao ◽

Gui-Can Zhang ◽

Liang-wan Chen ◽

Fan Xu ◽

...

Keyword(s):

Atrial Septal Defect ◽

Septal Defect ◽

Device Closure ◽

Short Term

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Transcatheter Closure of Atrial Septal Defect with Amplatzer Device in Adolescence and Adults: Short Term Results: MCVTC Experience

Cardiology Open Access ◽

10.33140/coa.05.02.03 ◽

2020 ◽

Vol 5 (2) ◽

Keyword(s):

Atrial Septal Defect ◽

Congenital Heart ◽

Septal Defect ◽

Transcatheter Closure ◽

Heart Diseases ◽

Device Closure ◽

Short Term ◽

Amplatzer Device ◽

Invasive Cardiology

Introduction: Atrial septal defect (ASD) is one of the common congenital heart diseases accounting for 8% to 10% of total congenital heart disease at birth and one of the most common diseases in adulthood. Ostium Secundum (OS) ASD has been successfully closed surgically for over several decades. But even though the results are better, it is associated with discomfort, morbidity, and a thoracotomy scar. Transcatheter closure in these patients has advanced rapidly in recent years and represents a growing field in invasive cardiology. Methods: This prospective study was conducted at Manmohan cardiothoracic vascular and transplant center, Maharajgung, Kathmandu, Nepal. Fifty-two (52) patients with a diagnosis of OS ASD assessed for device closure. Patients underwent transthoracic and trans oesophageal echocardiography for the defect location, size, number, and associated anomalies. All patients with OS ASD fulfilling the inclusion criteria enrolled for device closure. The procedure conducted under fluoroscopy and transesophageal guidance. The cases were followed up at 3 and 6 months, reassessed clinically and by echocardiography for any complications. Results: The patients with ASD who enrolled in this study belonged to the age group of 14 to 63 years. The device closure attempted in 46 patients, and the remaining six patients excluded from the procedure due to unsuitable anatomy after GA guided TEE done. Among 46 patients, 44 (95%) had successful device closure. The mean age of the patient was 35.7+ 10 and 33 (71.7%) female, with 13 (28.3%) males. Conclusions: The transcatheter device closure of ASD in adolescents and adults has a high success rate with fewer complications and found to be safely documented during immediate and short term follow up. However, long terms follow up is required to conclude it.

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Late-term development of an atrial defect and thrombus formation after device fracture following successful transcatheter closure of an atrial septal defect with a STARFlex device

Cardiology in the Young ◽

10.1017/s1047951116002547 ◽

2016 ◽

Vol 27 (5) ◽

pp. 975-977 ◽

Cited By ~ 1

Author(s):

Molly J. Rose ◽

Priscila C. Cevallos ◽

Laura Gellis ◽

Lisa Bergersen

Keyword(s):

Atrial Septal Defect ◽

Septal Defect ◽

Transcatheter Closure ◽

Thrombus Formation ◽

Defect Closure ◽

Atrial Septal Defect Closure

AbstractDevelopment of a new defect following transcatheter closure of an atrial septal defect has yet to be reported. In this study, we present an acutely successful atrial septal defect closure with a STARFlex device, resulting in surgical explantation after discovery of device fracture, thrombus formation, and a second atrial defect 5 years after catheterisation. This case highlights the need for ongoing device surveillance, even in late follow-up.

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Very late (>5 years) thrombus formation on an atrial septal defect device: a case report

International Journal of Research in Medical Sciences ◽

10.18203/2320-6012.ijrms20204923 ◽

2020 ◽

Vol 8 (11) ◽

pp. 4149

Author(s):

Sudheer Venkata Bolinera ◽

Srinivas Soma ◽

Sanivarapu Srinivasa Reddy ◽

Vijaya Pamidimukkala ◽

Michael Naronha ◽

...

Keyword(s):

Atrial Septal Defect ◽

Septal Defect ◽

Thrombus Formation ◽

Device Closure ◽

Atrial Septal Defect Closure ◽

Septal Occluder Device ◽

Occluder Device ◽

History Of

Though percutaneous transcatheter atrial septal defect closure with newer generation occluder devices is a standard treatment at present, these devices have significant long-term risks (>1 year) associated with such as thrombus formation. Here, we present a case of 28 year-old patient presented with few symptoms and had a history of ASD device closure using amplatzer septal occluder device five years back. The patient was found to have a large thrombus (30×33 mm) attached to the device which was managed using anticoagulants and patients was advised for regular echocardiographic follow-up.

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Closure of Secundum Atrial Septal Defect with Autologous Right Atrial Patch: Case Report

The Heart Surgery Forum ◽

10.1532/hsf98.20041173 ◽

2005 ◽

Vol 8 (2) ◽

pp. 96 ◽

Cited By ~ 1

Author(s):

Osman Tansel Dar�in ◽

Alper Sami Kunt ◽

Mehmet Halit Andac

Keyword(s):

Atrial Septal Defect ◽

Right Atrium ◽

Septal Defect ◽

Complete Recovery ◽

Interatrial Septum ◽

Right Atrial ◽

Atrial Wall ◽

Residual Shunt ◽

Asd Closure ◽

The Right

Background: Although various synthetic materials and pericardium have been used for atrial septal defect (ASD) closure, investigators are continuing to search for an ideal material for this procedure. We report and evaluate a case in which autologous right atrial wall tissue was used for ASD closure. Case: In this case, we closed a secundum ASD of a 22-year-old woman who also had right atrial enlargement due to the defect. After establishing standard bicaval cannulation and total cardiopulmonary bypass, we opened the right atrium with an oblique incision in a superior position to a standard incision. After examining the secundum ASD, we created a flap on the inferior rim of the atrial wall. A stay suture was stitched between the tip of the flap and the superior rim of the defect, and suturing was continued in a clockwise direction thereafter. Considering the size and shape of the defect, we incised the inferior attachment of the flap, and suturing was completed. Remnants of the flap on the inferior rim were resected, and the right atrium was closed in a similar fashion. Results: During an echocardiographic examination, neither a residual shunt nor perigraft thrombosis was seen on the interatrial septum. The patient was discharged with complete recovery. Conclusion: Autologous right atrial patch is an ideal material for ASD closure, especially in patients having a large right atrium. A complete coaptation was achieved because of the muscular nature of the right atrial tissue and its thickness, which is a closer match to the atrial septum than other materials.

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Surgical Strategy in Patients with Atrial Septal Defect and Severe Pulmonary Hypertension

The Heart Surgery Forum ◽

10.1532/hsf98.20111085 ◽

2012 ◽

Vol 15 (2) ◽

pp. 111 ◽

Cited By ~ 9

Author(s):

Yang Hyun Cho ◽

Tae-Gook Jun ◽

Ji-Hyuk Yang ◽

Pyo Won Park ◽

June Huh ◽

...

Keyword(s):

Pulmonary Hypertension ◽

Atrial Septal Defect ◽

Tricuspid Regurgitation ◽

Septal Defect ◽

Maze Procedure ◽

Severe Pulmonary Hypertension ◽

Tricuspid Annuloplasty ◽

Pulmonary Arterial ◽

Asd Closure

The aim of the study was to review our experience with atrial septal defect (ASD) closure with a fenestrated patch in patients with severe pulmonary hypertension. Between July 2004 and February 2009, 16 patients with isolated ASD underwent closure with a fenestrated patch. All patients had a secundum type ASD and severe pulmonary hypertension. Patients ranged in age from 6 to 57 years (mean � SD, 34.9 � 13.5 years). The follow-up period was 9 to 59 months (mean, 34.5 � 13.1 months). The ranges of preoperative systolic and pulmonary arterial pressures were 63 to 119 mm Hg (mean, 83.8 � 13.9 mm Hg) and 37 to 77 mm Hg (mean, 51.1 � 10.1 mm Hg). The ranges of preoperative values for the ratio of the pulmonary flow to the systemic flow and for pulmonary arterial resistance were 1.1 to 2.7 (mean, 1.95 � 0.5) and 3.9 to 16.7 Wood units (mean, 9.8 � 2.9 Wood units), respectively. There was no early or late mortality. Tricuspid annuloplasty was performed in 14 patients (87.5%). The peak tricuspid regurgitation gradient and the ratio of the systolic pulmonary artery pressure to the systemic arterial pressure were decreased in all patients. The New York Heart Association class and the grade of tricuspid regurgitation were improved in 13 patients (81.2%) and 15 patients (93.7%), respectively. ASD closure in patients with severe pulmonary hypertension can be performed safely if we create fenestration. Tricuspid annuloplasty and a Cox maze procedure may improve the clinical result. Close observation and follow-up will be needed to validate the long-term benefits.

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