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

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)

scholarly journals Cryoballoon Atrial Fibrillation Ablation in a Patient with an Atrial Septal Defect Closure Device

2021 ◽  
Author(s):  
Meisam Mokhtari ◽  
Zahra Khajali ◽  
Mona Heidarali ◽  
Majid Haghjoo
Keyword(s):  
Atrial Fibrillation ◽  
Atrial Septal Defect ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Septal Defect ◽  
Closure Device ◽  
Atrial Septal Defect Closure ◽  
Occluder Device ◽  
Asd Closure

Atrial fibrillation (AF) is the most commonly treated arrhythmia in clinical practice and is often found in association with an atrial septal defect (ASD). However, ASD closure rarely confers complete arrhythmia control. A 23-year-old man presented to our center with frequent episodes of palpitations. AF was documented in 12-lead electrocardiography, and echocardiography showed a secundum-type ASD, 14 mm in size, with a significant left-to-right shunt. ASD closure was performed successfully with an ASD occluder device with no residual shunting. During follow-up, the patient experienced several episodes of AF. Thirteen months after the ASD closure, cryoballoon pulmonary vein isolation was done successfully with no complications. During a 12-month follow-up, he had no symptoms or AF recurrences, and echocardiography showed no residual shunting. This study showed that cryoballoon pulmonary vein isolation could be performed successfully without residual shunts in patients with ASD closure devices.

scholarly journals Corynebacterium diphtheriae-infective endocarditis in a patient with an atrial septal defect closure device

2019 ◽  
Vol 12 (5) ◽  
pp. e229478 ◽  
Author(s):  
Jacinta Ng ◽  
Teesha Downton ◽  
Natalie Davidson ◽  
James Marangou
Keyword(s):  
Infective Endocarditis ◽  
Atrial Septal Defect ◽  
Septal Defect ◽  
Corynebacterium Diphtheriae ◽  
Blood Cultures ◽  
Flank Pain ◽  
Closure Device ◽  
Atrial Septal Defect Closure ◽  
Asd Closure

An 18-year-old woman presented to our institution with fever, bilateral flank pain, headache and photophobia. She had a previous atrial septal defect (ASD) closure device inserted at the age of 9 years. Blood cultures on admission were positive forCorynebacterium diphtheriae, and transoesophageal echocardiogram (TOE) revealed an echodensity associated with the ASD closure device, most consistent with a vegetation. She was treated for infective endocarditis with 6 weeks of intravenous benzylpenicillin, and follow-up TOE showed resolution of the echodensity. To our knowledge, no cases ofC. diphtheriaeendocarditis of an ASD closure device have previously been reported.

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

2012 ◽  
Vol 15 (2) ◽  
pp. 111 ◽  
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.

scholarly journals The benefit of atrial septal defect closure in the elderly patients

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P.J Prochownik ◽  
T Przewlocki ◽  
B Sobien ◽  
U Gancarczyk ◽  
M Olszowska ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Atrial Septal Defect ◽  
Septal Defect ◽  
Transcatheter Closure ◽  
Color Doppler ◽  
The Elderly ◽  
Atrial Septal Defect Closure ◽  
Exercise Tests ◽  
The Mean

Abstract Objective Closure of the atrial septal defect in the elderly patients is controversial. The aim of the study was to evaluate the outcomes of transcatheter closure of secundum atrial septal defect (ASD) in elderly patients. Methods From a total of 650 pts with ASD who underwent transcatheter closure 120 pts over 60 years (70 F, 50 M) with a mean age of 66.7±18.1 (60–78) were analyzed. All patients had an isolated secundum ASD with a mean Qp:Qs: 2.79±1.8 (1.5–3.9). A symptom-limited treadmill exercise tests with respiratory gas exchange analysis and transthoracic color Doppler echocardiographic study as well as Quality of life (QoL) measured using the SF36 questionnaire (SF36q) were repeated in all pts before procedure and after 12 months of follow-up. Results The device was successfully implanted in all pts (procedure time 30.1±9.9 (10–59) minutes, fluoroscopy time 10.1±7.2 (6–40) minutes). There were no major complications. The defect echo diameter was 19.5±15.4 (12 - 34) mm. The mean balloon stretched diameter of ASD was 22.0±7.8 (14 - 36) mm. The diameter of the implanted devices ranged 16 - 38 mm. After 12 months of ASD closure, all the pts showed a significant improvement of exercise capacity parameters. Seven QoL parameters (except mental health) improved at 12 months follow up compared to their baseline data. The mean SF36q scale increased significantly in 96 (80.2%) pts of mean 41.6±26.1 (4–71). The right ventricular dimension decreased in 101 pts (84.2%) (Table 1). Conclusions Closure of ASD in elderly patients caused a significant clinical and hemodynamic improvement after percutaneous treatment, which is maintained to long-term follow-up what justified this procedure in old age. Funding Acknowledgement Type of funding source: None

scholarly journals Successful simultaneous transcatheter treatment for secundum atrial septal defect with valvular pulmonary stenosis in children under transthoracic echocardiography guidance

2021 ◽  
Author(s):  
Xuning Lu ◽  
Ping Wen ◽  
Yuhang Liu ◽  
Quanwei Zhu
Keyword(s):  
Atrial Septal Defect ◽  
Transthoracic Echocardiography ◽  
Septal Defect ◽  
Pulmonary Stenosis ◽  
Secundum Atrial Septal Defect ◽  
Device Closure ◽  
The Mean ◽  
Valvular Pulmonary Stenosis ◽  
Transcatheter Device

Abstract BACKGROUND Transcatheter device closure of secundum atrial septal defect (ASD) with valvular pulmonary stenosis (PS) under fluoroscopy and/or transesophageal echocardiography (TEE) guidance is a mature technology. However, little study has focused on whether the technology can be guided totally by transthoracic echocardiography (TTE), even in children.METHODS Thirteen children with ASD combined with PS underwent transcatheter device closure totally guided by TTE at our cardiac center from March 2 016 to August 2 019. Percutaneous transcatheter pulmonary valvuloplasty was performed first and then transcatheter closure of the ASD uneventfully.RESULTS All cases were successfully treated with transcatheter balloon pulmonary valvuloplasty and closure of ASD respectively via femoral vein approach solely under TTE guidance. The mean defect size was 8.1±1.4 mm (range: 5.5-10 mm), the preoperative mean pressure gradient across pulmonary valve was 61.2±5.5 mmHg (range: 51-71 mmHg). The mean device size used was 11.1±1.9 mm (range: 8- 14 mm), the mean procedure time was 55.1±8.0 min (range: 45-71 min). There were no serious cardiovascular related complications. During the follow-up period (10 mon to 47mon), no arrhythmias device, thrombosis, residual fistulas or device frame fractures were detected. PS gradient had significant difference before and after procedure during the follow up (t=28.9, P =0.000).CONCLUSION Simultaneous transcatheter treatment for ASD complicated by PS in children under TTE guidance is an safe and effective therapeutic option.

Cost-Minimization Analysis of Transcatheter versus Surgical Closure of Secundum Atrial Septal Defect in Children

2020 ◽  
Vol 103 (12) ◽  
pp. 1269-1276
Keyword(s):  
Atrial Septal Defect ◽  
Surgical Procedure ◽  
Septal Defect ◽  
Cost Minimization ◽  
Secundum Atrial Septal Defect ◽  
Short Term ◽  
Us Dollar ◽  
Baseline Characteristics ◽  
Asd Closure ◽  
The Cost

Objective: Secundum atrial septal defect (ASD) is one of the congenital heart diseases commonly found in children, which can be treated by transcatheter closure as a standard treatment or by surgical treatment. Few studies have analyzed the cost of these two strategies. The present study is aimed to compare the short-term cost-minimization of both procedures. Materials and Methods: A retrospective single-center study analyzed all children aged 1 to 18 years, diagnosed with isolated secundum atrial septal defect, who were entirely treated by transcatheter or surgical ASD closure at Ramathibodi Hospital, Mahidol University between January 2005 and August 2016. The baseline characteristics, total hospital days, cost per case, clinical outcomes, and complications between these two procedures are compared. Results: Thirty-five patients were enrolled in the present study, divided into two groups, with 43% in the transcatheter group and 57% in the surgical group. The baseline characteristics of the transcatheter and surgical groups were not significantly different except for weight, which was 28.6 kg versus 16.5 kg (p=0.045), and for medical history of asymptomatic, which was seven versus 16 patients (p=0.04), respectively. Patients with transcatheter procedures had a shorter length of hospital stay at 2.3 days versus 8.1 days (p<0.001), respectively. The direct medical cost per case of surgical procedure was less than the transcatheter procedure at 116,993 Baht or 3,878 US Dollar versus 206,204.7 Baht or 6,835 US Dollar (p<0.001), respectively. The major complication of the transcatheter procedure was bleeding from the puncture site while it was intraoperative arrhythmia for the surgical procedure. Conclusion: The short-term clinical outcomes of the transcatheter and the surgical ASD closure were excellent. The cost analysis suggests that surgical procedures may incur fewer costs than transcatheter procedures from the hospital’s perspective. Surgical ASD closure may be a less costly strategy for Ramathibodi pediatric patients. Keywords: Atrial septal defect, ASD, Transcatheter, Cost-minimizing analysis, Device, Surgery

scholarly journals Impact of Right Ventricular Dilatation in Patients with Atrial Septal Defect

2020 ◽  
Vol 2020 ◽  
pp. 1-5
Author(s):  
Rie Nakayama ◽  
Yoichi Takaya ◽  
Teiji Akagi ◽  
Koji Nakagawa ◽  
Nobuhisa Watanabe ◽  
...  
Keyword(s):  
Right Ventricular ◽  
Atrial Septal Defect ◽  
Exercise Capacity ◽  
Septal Defect ◽  
Adult Patients ◽  
Volume Index ◽  
End Diastolic Volume ◽  
The Mean ◽  
Asd Closure ◽  
The Relationship

Objective. The aim of this study was to examine the relationship between right ventricular (RV) volume and exercise capacity in adult patients with atrial septal defect (ASD) and to determine the degree of RV dilatation for transcatheter ASD closure. Background. RV dilatation is an indication of transcatheter ASD closure; however, few studies have reported the clinical significance of RV dilatation. Methods. We enrolled 82 consecutive patients (mean age, 49 ± 18 years; female, 68%) who underwent cardiac magnetic resonance imaging and symptom-limited cardiopulmonary exercise test before ASD closure. The relationship between RV volume and peak oxygen uptake (VO2) was evaluated. Results. The mean RV end-diastolic volume index was 108 ± 27 ml/m2 (range, 46 to 180 ml/m2). The mean peak VO2 was 24 ± 7 ml/min/kg (range, 14 to 48 ml/min/kg), and the mean predicted peak VO2 was 90 ± 23%. There were significant negative relationships of RV end-diastolic volume index with peak VO2 (r = −0.28, p<0.01) and predicted peak VO2 (r = −0.29, p<0.01). The cutoff value of RV end-diastolic volume index <80% of predicted peak VO2 was 120 ml/m2, with the sensitivity of 49% and the specificity of 89%. Conclusions. There was a relationship between RV dilatation and exercise capacity in adult patients with ASD. RV end-diastolic volume index ≥120 ml/m2 was related to the reduction in peak VO2. This criterion of RV dilatation may be valuable for the indication of transcatheter ASD closure.

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

2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Yu-feng Zhu ◽  
Xin-miao Huang ◽  
Jiang Cao ◽  
Jian-qiang Hu ◽  
Yuan Bai ◽  
...  
Keyword(s):  
Atrial Septal Defect ◽  
Septal Defect ◽  
Thrombus Formation ◽  
Gross Anatomy ◽  
Interatrial Septum ◽  
Canine Model ◽  
Short Term ◽  
Animal Experimental Study ◽  
Brockenbrough Needle

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.

P4358The role of the “halo sign” for the accurate quantification of atrial septal defect size by 3D TEE

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Aggeli ◽  
I Dimitroglou ◽  
S Kastellanos ◽  
M Drakopoulou ◽  
K Moldovan ◽  
...  
Keyword(s):  
Atrial Septal Defect ◽  
Septal Defect ◽  
Transoesophageal Echocardiography ◽  
Closure Device ◽  
Halo Sign ◽  
Complex Anatomy ◽  
Significant Difference ◽  
Study Population ◽  
Asd Closure ◽  
Device Size

Abstract Introduction In patients undergoing percutaneous closure of secundum atrial septal defect (ASD), device selection is based on defect sizing by transoesophageal echocardiography (TEE) and in particular 3D measurement as well as 2D balloon-stretched derived measurements. We sought to investigate whether in patients with the presence of the “halo sign”, defined as increased tissue thickness at the edge of the ASD rims, there is an agreement between the aforementioned sizing methods with a view to avoid balloon sizing. Methods Consecutive patients referred to our department for single ASD closure without complex anatomy were included in our study. TEE was performed in all patients before and during the intervention. 3D datasets for ASD quantification as well as X-PLANE data sets for measurement of balloon-stretched 2D dimensions were acquired and analysed offline. During the analysis of 3D datasets, researchers were blinded to the 2D balloon-stretched measurements. Patients were stratified according to the presence of the halo sign and the correlation between 3D dimensions and balloon-derived diameter was calculated. Results Thirty-eight patients (14 males, 36.8%) with median age 46 [32–56] were included in our study. The “halo sign” was present in 16 patients (42.1%). In the whole study population, the median maximal and median minimal diameter measured by 3D TEE were 1.79cm [1.54–2.10] and 1.57cm [1.15–2.00] respectively while median circumference and area were 5.26cm [4.14–6.44] and 2.20cm2 [1.25–3.30] respectively. Median balloon-stretched diameter was 1.8cm [1.4–2.1]. In patients with the “halo sign” there was no significant difference between the medians of the ASD diameter calculated from 3D measurements and the 2D derived diameter (1.53cm; 1.6cm, p=0.170) whereas in patients with no “halo sign” there was significant difference (1.79cm; 2.0cm, p=0.001) (figure 1). The discrepancy between the aforementioned diameters was significantly lower in patients with the halo sign (0.04cm; 0.19cm, p=0.001). There was a good correlation between closure device size and 3D derived ASD circumference in the whole study population (R2=0.897) which was even higher in patients with the halo sign (R2=0.981). In this subgroup, the selected size of the closure device would not have differed significantly even without balloon sizing (p=0.414). Figure 1 Conclusion The ASD sizing by 3D echocardiography is accurate in patients with the “halo sign”. This study justifies further investigation concerning the reliability of 3D imaging in this population for the selection of the ASD device size with a view to avoid balloon sizing, decrease procedural time and thus simplify the procedure.

Enlarged right ventricular size at 11 years’ follow-up after closure of secundum-type atrial septal defect in children

2012 ◽  
Vol 23 (1) ◽  
pp. 7-13 ◽  
Author(s):  
Wilfred B. de Koning ◽  
Lennie M. van Osch-Gevers ◽  
Danielle Robbers-Visser ◽  
Ron T. van Domburg ◽  
Ad J.J.C. Bogers ◽  
...  
Keyword(s):  
Right Ventricular ◽  
Atrial Septal Defect ◽  
Exercise Testing ◽  
Septal Defect ◽  
Systolic Volume ◽  
Surgical Closure ◽  
End Systolic Volume ◽  
The Mean ◽  
Ventricular Dimensions

AbstractBackgroundThe fate of right ventricular dimensions after surgical closure of secundum-type atrial septal defects remains unclear. The objectives of this study were to assess ventricular dimensions, exercise capability, and arrhythmias of patients operated for secundum-type atrial septal defect and compare the results with those in healthy references.MethodsA total of 78 consecutive patients underwent surgical closure for a secundum-type atrial septal defect between 1990 and 1995. In all, 42 patients were included and underwent a cross-sectional evaluation including echocardiography, magnetic resonance imaging, exercise testing, and 24-hour ambulatory electrocardiography. Patients were matched with healthy controls for gender, body surface area, and age.ResultsThe mean age at surgery was 4.6 plus or minus 2.8 years, and the mean age at follow-up was 16 plus or minus 3 years. There were no residual intracardiac lesions. The mean right ventricular end-systolic volume was significantly larger in patients (142 ± 26 millilitres) than in references (137 ± 28 millilitres; p = 0.04). In 25% of the patients, right ventricular end-systolic volume was larger than the 95th percentile for references. No relevant arrhythmias were detected. Exercise testing did not reveal differences with healthy references: maximal power (169 ± 43 Watt patients versus 172 ± 53 controls; p = 0.8), maximal oxygen uptake (38 ± 8 versus 41 ± 13 millilitres per minute per kilogram; p = 0.1).CommentAfter surgical closure of secundum-type atrial septal defect, right ventricular end-systolic volume is increased. These findings have no impact on rhythm status or exercise capacity at this stage of follow-up, but may have implications for the timing of surgery or the technique of closure if confirmed in longer follow-up.

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