Current Trends in Device and Size Selection for Transcatheter Atrial Septal Defect Closure in Adults　― Insights From a Japanese Nationwide Registry ―

Abstract

Background: This study investigated current trends in transcatheter atrial septal defect (ASD) closure among adult patients, with an emphasis on device and size selection, as well as acute complications.

Methods and Results: This study used the Japanese Structural Heart Disease (J-SHD) registry database, which is a prospective nationwide multicenter registry. In all, 1,921 patients who underwent transcatheter ASD closure between 2019 and 2022 were analyzed in this study. The specifics of the procedures, including device type, size selection, and acute complications, were assessed. The mean (±SD) age of participants was 57±18 years, with 37.6% being male. Aortic rim deficiency was observed in most patients (50.3%). The prevalence of aortic rim deficiency was 32.5% for the Amplatzer^® Septal Occluder (ASO), 65.6% for the Occlutech^® Figulla Flex II Septal Occluder (FSO), and 57.8% for the GORE^® CARDIOFORM ASD Occluder. In patients in whom the ASO or FSO was used, device size was 2–3 and 5–6 mm larger than defect size, respectively. Device migration was observed in 8 (0.4%) patients, and occurred regardless of device oversizing or undersizing relative to defect size.

Conclusions: This study reports the trends in clinical features, device and size selection, and acute complications in adult patients who underwent transcatheter ASD closure.

Atrial septal defect (ASD) is among the most common congenital heart diseases.^1–4 Young patients with isolated ASD are usually asymptomatic, and physical examinations, including auscultation, are inconclusive. Therefore, many ASDs are first diagnosed in adult life.^2,5 Recently, transcatheter closure has become the preferred approach in the treatment of adult ASD,^2,6–8 and several different types of closure devices have become available.^2,6,7,9 Distinct features in a wide variety of devices have made transcatheter closure a viable approach to treat various types of ASD.

However, the absolute number of transcatheter ASD closures is overwhelmingly small compared with percutaneous coronary intervention or other structural heart disease interventions, including transcatheter aortic valve implantation.⁸ Therefore, data regarding transcatheter ASD closure are still limited. As a result, the procedural strategy for transcatheter ASD closure, including device type and size selection for each device, has not been standardized yet.

The aim of this study was to investigate current trends in transcatheter ASD closure in adults, focusing on device type, size selection, and acute complications for available devices, from a Japanese nationwide registry.

Methods

Study Design and Participants

The present study used a database from the Japanese Structural Heart Disease (J-SHD) registry between 2019 and 2022. The J-SHD is a prospective nationwide multicenter registry organized by the Japanese Association of Cardiovascular Intervention and Therapeutics^10,11 that enrolls patients who have undergone various interventions for structural heart disease. Registration of all structural heart disease intervention procedures is mandatory for interventionalists and their associated cardiovascular centers for board certification and application renewal in the association, ensuring a high level of data completeness. All transcatheter ASD closures are registered in the J-SHD registry, except those performed in specialized pediatric departments.

In Japan, transcatheter closure of ASD was first approved in 2005. The procedure can only be performed by operators and centers approved by the certification board of the Japanese Society of Congenital Interventional Cardiology and the Japanese Association of Cardiovascular Intervention and Therapeutics. Approval is granted based on strict facility criteria, including the number of catheter interventions for congenital heart disease and structural heart disease, the number of open-heart surgeries for congenital heart disease, and education programs. In terms of devices, the Amplatzer^® Septal Occluder (ASO; Abbott, Abbott Park, IL, USA) has been commercially available in Japan since 2005, the Occlutech^® Figulla Flex II Septal Occluder (FSO; Occlutech Holding AG, Schaffhausen, Switzerland) has been available since 2016, and the GORE^® CARDIOFORM ASD Occluder (GCA; W.L. Gore & Associates, Flagstaff, AZ, USA) has been available since 2022.

In this study, all cases of transcatheter ASD closure between 2019 and 2022 were identified (Figure 1). To focus on device type and size (3 major devices available in Japan: ASO, FSO, GCA) and acute complications in adult patients, procedures involving patients aged <18 years, those treated with an Amplatzer^® Cribriform Occluder (ACO; Abbott) or other devices, and those treated with multiple devices were excluded from the study, as were patients for whom data regarding acute complications, rim, defect size, or device size were unavailable.

Figure 1.

Patient flowchart. ACO, Amplatzer^® Cribriform Occluder; ASD, atrial septal defect; J-SHD, Japanese Structural Heart Disease.

The study was performed in accordance with the guidelines of the Declaration of Helsinki. Approval for the use of the J-SHD data was obtained from a third-party central ethics committee at the Clinical Research Promotion Network Japan. Participating institutions provided the necessary documentation for patient consent and, in most cases, the requirement for written informed consent was waived due to the retrospective and observational nature of the study. All data were fully anonymized before the present analysis was performed. The data were accessed for research purpose on December 21, 2023.

Registered Data

The registered data of transcatheter ASD closure included baseline patient characteristics (age, sex), clinical condition (New York Heart Association class), comorbidities (diabetes, hypertension, chronic obstructive pulmonary disease, dyslipidemia, smoking, renal failure, maintenance dialysis, coronary artery disease, cerebrovascular disease), antithrombotic therapy before the procedure (aspirin, P2Y₁₂ inhibitor, cilostazol, other antiplatelet agent, warfarin, direct oral anticoagulant), procedural and anatomical characteristics (urgency, amount of contrast medium, fluoroscopic time, ratio of pulmonary blood flow to systemic blood flow [Qp/Qs], rim deficiency [<5 mm], defect size [short- and long-axis], device type, device sizes, type of anesthesia [local or general], type of echocardiography during the procedure [transesophageal echocardiography, intracardiac echocardiography]), and acute complications related to the procedure (device migration, erosion, atrioventricular block, death). Atrioventricular block was defined as second- or third-degree atrioventricular block persisting for more than 24 h.

Devices

The ASO is a self-centering double disc made with a nitinol mesh that contains a polyester patch inside.² The ASO device size is described as device waist size, and 24 sizes are available in Japan, ranging from 6 to 38 mm.

The FSO is a self-centering double disc made with nitinol containing a Dacron patch inside.² The FSO device size is also described as device waist size. Sixteen sizes are available in Japan, ranging from 6 to 36 mm.

The difference between the device size and defect size for the ASO and FSO was calculated as the device size minus the long-axis defect diameter.

The GCA comprises a platinum-filled nitinol wire frame covered with expanded polytetrafluoroethylene.^9,12 The GCA device size is described as the entire disc diameter, and only 5 sizes (27, 32, 37, 44, and 48 mm) are available. Regarding GCA, the defect size by device size is presented.

Statistical Analysis

Continuous variables are expressed as the mean±SD and categorical variables are expressed as numbers and percentages. Statistical significance was set at P<0.05 (two-tailed). When comparing data among the 3 groups, one-way analysis of variance was used for continuous data, Fisher’s exact test was used for discrete variables, and the Kruskal-Wallis test was used for rank variables. For variables with significant among-group differences, we also compared data between 2 of the 3 groups using the unpaired t-test for continuous data, Fisher’s exact test for discrete variables, and the Mann-Whitney U test for rank variables. During the post hoc analyses, we used Bonferroni correction to protect the type I error at 5%, making the significance criterion P<0.05/3≒0.017. When examining trends by year (2019, 2020, 2021, and 2022), the P value for trend (P_trend) was tested by linear regression analysis for continuous data, the Cochran-Armitage test for binary variables, and Spearman’s rank correlation coefficient for rank variables. We also compared data between patients aged ≥61 and ≤60 years using the unpaired t-test for continuous data, Fisher’s exact test for discrete variables, and the Mann-Whitney U test for rank variables. All analyses were performed using R version 4.1.1 (R development Core Team, Vienna, Austria).

Results

Figure 1 shows the patient flowchart for this study. Of 2,269 procedures registered in the J-SHD, 143 procedures involved patients aged <18 years, 75 procedures used devices other than the 3 major devices (ASO, FSO, GCA) that are the focus of this study, 124 procedures involved the use of multiple devices, and 6 procedures lacked data regarding acute complication, rim deficiency, defect size, or device size; therefore, these procedures were excluded. The remaining 1,921 procedures were analyzed in this study.

Table 1 presents baseline patient characteristics, anatomical data on the ASD, and procedural characteristics of transcatheter closure. Overall, the mean patient age was 57±18 years, with 37.6% of the procedures performed in male patients. Certain comorbidities were observed in patients, with 30.8%, 17.5%, 9.3%, and 8.3% exhibiting hypertension, dyslipidemia, diabetes, and cerebrovascular disease, respectively. The mean long-axis defect size was 16.3±6.2 mm. Figure 2 shows the distribution of defect size across all cases included in the study. Aortic rim deficiency was observed in most patients (50.3%). The prevalence of aortic rim deficiency was 32.5% for the ASO, 65.6% for the FSO, and 57.8% for the GCA.

Table 1.

Baseline Patient, Anatomical, and Procedural Characteristics

	Overall (n=1,921)	ASO (n=856)	FSO (n=937)	GCA (n=128)	P for difference among the 3 groups	P for difference between 2 groups*
						FSO vs. GCA	ASO vs. GCA	ASO vs. FSO
Male sex	723 (37.6)	321 (37.5)	352 (37.6)	50 (39.1)	0.94
Age (years)	57±18	58±18	57±18	56±18	0.38
NYHA class					0.12
I	1,070 (55.8)	475 (55.6)	513 (54.8)	82 (64.1)
II	743 (38.7)	324 (37.9)	377 (40.3)	42 (32.8)
III	85 (4.4)	43 (5.0)	39 (4.2)	3 (2.3)
IV	20 (1.0)	12 (1.4)	7 (0.7)	1 (0.8)
No data	3 (0.2)	2 (0.2)	1 (0.1)	0 (0.0)	0.68
Smoking	169 (8.8)	86 (10.0)	70 (7.5)	13 (10.2)	0.13
Hypertension	592 (30.8)	281 (32.8)	274 (29.2)	37 (28.9)	0.23
Dyslipidemia	338 (17.6)	148 (17.3)	164 (17.5)	26 (20.3)	0.67
Diabetes	179 (9.3)	98 (11.4)	72 (7.7)	9 (7.0)	0.017	>0.99	0.17	0.008
Chronic kidney disease	130 (6.8)	78 (9.1)	45 (4.8)	7 (5.5)	0.001	0.67	0.24	<0.001
Dialysis	11 (0.6)	8 (0.9)	3 (0.3)	0 (0.0)	0.20
Coronary artery disease	110 (5.7)	55 (6.4)	52 (5.5)	3 (2.3)	0.16
Cerebrovascular disease	159 (8.3)	71 (8.3)	70 (7.5)	18 (14.1)	0.049	0.016	0.046	0.54
Chronic obstructive pulmonary disease	32 (1.7)	15 (1.8)	16 (1.7)	1 (0.8)	0.88
Qp/Qs	2.08±0.79	2.05±0.80	2.15±0.81	1.83±0.53	<0.001	<0.001	0.003	0.005
No data	8 (0.4)	3 (0.4)	5 (0.5)	0 (0.0)	0.84
Defect size (mm)
Short-axis diameter	11.9±5.0	11.4±5.2	12.6±4.8	10.2±3.7	<0.001	<0.001	0.009	<0.001
Long-axis diameter	16.3±6.2	15.7±6.6	17.1±5.9	14.4±5.0	<0.001	<0.001	0.026	<0.001
Rim deficiency (<5 mm)					>0.99
Aortic	967 (50.3)	278 (32.5)	615 (65.6)	74 (57.8)
Coronary sinus	9 (0.5)	5 (0.6)	2 (0.2)	2 (1.6)
Inferior vena cava	22 (1.1)	17 (2.0)	5 (0.5)	0 (0.0)
Mitral	1 (0.1)	1 (0.1)	0 (0.0)	0 (0.0)
Posterior	57 (3.0)	40 (4.7)	15 (1.6)	2 (1.6)
Superior vena cava	19 (1.0)	9 (1.1)	9 (1.0)	1 (0.8)
No rim deficiency	846 (44.0)	506 (59.1)	291 (31.1)	49 (38.3)
Anesthesia					0.22
Local	432 (22.5)	206 (24.1)	195 (20.8)	31 (24.2)
General	1,489 (77.5)	650 (75.9)	742 (79.2)	97 (75.8)
Echocardiography during procedure
Transesophageal echocardiography	1,609 (83.8)	705 (82.4)	800 (85.4)	104 (81.2)	0.16
Intracardiac echocardiography	804 (41.9)	391 (45.7)	368 (39.3)	45 (35.2)	0.007	0.39	0.028	0.006
Device
ASO	856 (44.6)
FSO	937 (48.8)
GCA	128 (6.7)
Device size (mm)		18.2±6.6	21.8±6.4	34.7±5.7
Procedure year
2019	517 (26.9)	266 (31.1)	251 (26.8)	0 (0.0)
2020	442 (23.0)	195 (22.8)	247 (26.4)	0 (0.0)
2021	452 (23.5)	215 (25.1)	237 (25.3)	0 (0.0)
2022	510 (26.5)	180 (21.0)	202 (21.6)	128 (100.0)

Unless indicated otherwise, data are given as the mean±SD or n (%). *The significance criterion for between-group differences was P<0.05/3≒0.017, where a Bonferroni correction was applied to protect the Type I error at 5%. ASO, Amplatzer^® Septal Occluder; FSO, Occlutech^® Figulla Flex II Septal Occluder; GCA, GORE^® CARDIOFORM ASD Occluder; NYHA, New York Heart Association; Qp/Qs, ratio of pulmonary blood flow to systemic blood flow.

Figure 2.

Distribution of the long-axis size of atrial septal defects (ASD; Left) and rim deficiency (Right). Cases of migration and atrioventricular (AV) block are indicated by the closed circles. CS, coronary sinus; IVC, inferior vena cava; SVC, superior vena cava.

Table 1 also compares the characteristics among the device types used. The FSO was used to treat relatively larger defects, whereas the GCA was used to treat smaller defects. The frequency of aortic rim deficiency was relatively low in patients treated with the ASO.

Figure 3 shows the distribution of the difference between device size and defect size for the ASO and FSO. In patients in whom the ASO was used, the mean difference between device size and defect size was 2.5±3.2 mm, with the most frequently used devices being 2–3 mm larger than the defect size, followed by those 1–2 and 3–4 mm larger. Even when focusing on patients with or without aortic rim deficiency, the distribution of device size vs. defect size followed a similar trend (Figure 3). In patients in whom the FSO was used, the mean difference between device size and defect size was 4.7±2.9 mm, with the most frequently used devices being 5–6 mm larger than the defect size, followed by those 4–5 and 6–7 mm larger. When considering only patients with aortic rim deficiency, the distribution of device size vs. defect size showed a similar trend to the overall patients, with devices typically being 4–7 mm larger than the defect size. Conversely, in patients without aortic rim deficiency, the selected device sizes were smaller; the most frequently used devices were 2–3 mm larger than the defect size, followed by those 4–5 and 3–4 mm larger (Figure 3). Table 2 presents defect size by device size for patients in whom the GCA was used.

Figure 3.

Distribution of differences between device size and atrial septal defect (ASD) size for the Amplatzer^® Septal Occluder (ASO) and Occlutech^® Figulla Flex II Septal Occluder (FSO) overall and in patients with and without an aortic (Ao) rim deficiency separately. Cases of migration and atrioventricular (AV) block are indicated by the closed circles.

Table 2.

Defect Size by Device Size in for the GORE^® CARDIOFORM ASD Occluder

GCA size (mm)	n*	Defect size (mm)
		Long-axis diameter	Short-axis diameter
27	26	9.1±3.7	6.3±2.7
32	39	12.5±2.5	9.2±2.3
37	40	16.3±3.4	11.6±3.2
44	22	19.7±3.2	13.7±2.9
48	1	29.0	15.0

Unless indicated otherwise, data are given as the mean±SD. *The number of patients in whom the GCA of a particular size was implanted. GCA, GORE^® CARDIOFORM ASD Occluder.

The clinical features of all patients with major acute complications related to procedure are presented in Table 3. Device migration occurred in 8 (0.4%) patients, and atrioventricular block occurred in 1 (0.05%) patients. There were no instances of cardiac erosion (0%) or procedural death (0%). The 9 patients in whom complications occurred are indicated in the graphs showing the distribution of anatomical and device data (Figures 2,3). Figure 2 shows that device migration occurred in patients with a relatively large defect size, and occurred regardless of the presence or absence of rim deficiency. Figure 3 shows that device migration occurred regardless of device oversizing or undersizing vs. defect size.

Table 3.

Clinical and Anatomical Features of All Patients With an Acute Complication

Patient	Complication	Age (years)	Sex	Qp/Qs	Rim deficiency	Defect size (mm)		Device	Device size	Procedure year
						Long axis	Short axis
1	Migration	44	F	1.5	Aortic	17	10	FSO	19.5	2022
2	Migration	36	F	5.5	Posterior	24	16	ASO	28	2021
3	AV block	52	F	2.1	Aortic	11	10	ASO	14	2021
4	Migration	42	F	2.0	–	25	17	FSO	27	2020
5	Migration	88	M	3.0	Aortic	31	20	FSO	36	2020
6	Migration	72	M	2.1	–	24	24	ASO	28	2019
7	Migration	48	F	2.2	–	25	21	FSO	30	2019
8	Migration	84	F	2.2	–	18	12	ASO	22	2019
9	Migration	74	F	2.1	Aortic	22	18	FSO	27	2019

AV, atrioventricular; F, female; M, male. Other abbreviations as in Table 1.

Supplementary Table 1 shows trends by year (2019–2022) in transcatheter closure of ASD. Mean defect size decreased with each year, and the rates of general anesthesia and transesophageal echocardiogram use increased with each year.

To assess differences in treatment strategy between younger and older patients, anatomical and device data were compared by dividing patients into 2 groups according to age (Supplementary Table 2). The ASD defect size was larger in patients aged ≥61 years than in those aged ≤60 years, suggesting that ASD defect size may increase with age, whereas the device type and size did not differ significantly between the 2 age groups.

Discussion

The present study highlights current trends in transcatheter ASD closure for adult patients in Japan. The study focused on clinical and anatomical features, device selection, and size selection for each device, as well as data regarding the incidence and details of acute complications.

First, this study highlights the baseline characteristics of adult patients who recently underwent transcatheter ASD closure in Japan. The mean age of patients who underwent transcatheter ASD closure was 57 years and most were female (63.4%). Certain comorbidities were observed in patients, with 30.8%, 17.6%, 9.3%, 5,7%, and 8.3% of patients exhibiting hypertension, dyslipidemia, diabetes, coronary artery disease, and cerebrovascular disease, respectively. Prior studies reported that the prevalence of comorbidities increases with age.¹³ With regard to anatomical features of ASD, more than half the patients included in the present study exhibited aortic rim deficiency. A recent report suggested that aortic rim deficiency should not prevent transcatheter closure procedures being performed,¹⁴ with indications for transcatheter ASD closure expanding in recent years.

This study revealed current trends in device selection and sizing for each device with regard to transcatheter closure in Japanese adults. Regarding device selection based on anatomical features, the ASO was less frequently implanted in patients with aortic rim deficiency than the FSO and GCA. Furthermore, defect size was relatively larger in patients treated with an FSO than in those treated with a GCA. Regarding sizing, a larger devise size to defect size tended to be selected when using the FSO than ASO.^14–16 In the patients included in this study, ASO devices 1–4 mm larger than the long-axis diameter of the defect were most frequently used, with a similar trend observed in patients with and without aortic rim deficiency. In contrast, the trend for selected FSO device sizes differed based on the presence of aortic rim deficiency. Specifically, FSO devices 4–7 mm larger than the defect diameter were most frequently used in patients with aortic rim deficiency, whereas smaller devices, 2–5 mm larger than the long-axis defect diameter, were more commonly selected for cases without aortic rim deficiency. This sizing pattern was consistent with the recommendation in a previous report.¹⁴ Importantly, ASO devices were typically implanted in a closed shape, whereas 2 strategies were used for FSO implantation depending on the presence or absence of aortic rim deficiency: either in a closed shape or a flared shape with a larger size. Of the devices included in this study, the GCA was the most recent to be made available in Japan. Therefore, data from only 1 year were available for the GCA, namely the final year of the study period. The entire disc diameter is measured when recording GCA device size, making it difficult to compare it directly to the ASO and FSO. The present study revealed that oversized devices, compared with manufacturers’ recommendations, may be selected when using the GCA in adult patients, as reported previously.⁹ Thus, although guidelines for device selection and sizing have not been fully established, this report, showing current trends in Japan, may be used as a reference.

Transcatheter ASD closure is considered a safe procedure. Our study supports this notion, reporting no procedure-related mortalities among the 1,921 patients included in the study. However, some important complications have been reported.^2,6,7 Device embolization is major complication,⁶ with a frequency of approximately 1%.^7,17 Device undersizing, rim deficiency, and the presence of a floppy rim are considered risk factors for device embolization.^6,7 This study reports a low incidence of device embolization (0.4%), which occurred regardless of device undersizing and rim deficiency. However, because of the low incidence of this complication, our study may not have had sufficient statistical power to detect a true effect. Conversely, cardiac erosion is a more catastrophic, procedure-specific complication with a reported occurrence rate of 0–0.3%.^6,17 The risk factors previously reported for cardiac erosion included device oversizing, rim deficiency, and septal malalignment.^6,18–20 In the present study, there were no instances of cardiac erosion among adults who underwent transcatheter ASD closure during the study period. Prior reports suggested that a majority of cases of cardiac erosion occurred within days of the procedure,¹⁹ although it can also occur months or years after the procedure.^19,20 In the present study, we focused only on acute-phase complications, and further investigations with longer follow-up are needed. The risk of cardiac erosion is expected to be lower with the newly introduced GCA device.^6,9,12 Appropriate patient, device, and size selections are essential for safe and efficient procedures.

Study Limitations

This study has several limitations. First, this study used national registry data, therefore only predetermined factors were available for analysis. Some important factors for device and size selection, including balloon sizing, floppy rim, and septal malalignment, were not available.¹⁶ Second, only acute complications were included in the registry data, with long-term data being unavailable. Cardiac erosion, which is the most important complication, can occur months and years after closure.¹⁹ Third, data from only one location of rim deficiency was available. Therefore, the frequency of rim deficiency for each rim location may be underreported.

Conclusions

The present study highlights current trends in clinical features, device and size selection, and acute complications in transcatheter ASD closure procedures in adults. Further investigations with long-term follow-up are needed to establish the safety of these procedures.

Acknowledgments

The authors acknowledge the contribution of all investigators, clinical coordinators, and institutions involved in the J-SHD Registry.

Sources of Funding

This work was supported by the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT).

Disclosures

S.K. has received unrestricted research grants from Novartis Pharma K.K., and AstraZeneca. H.I. has received lecture fees from Astellas Pharma Inc., AstraZeneca Inc., Daiichi-Sankyo Pharma Inc., and MSD K.K. T.M. has received lecture fees from Bayer Pharmaceutical Co., Ltd., Daiichi-Sankyo Co., Ltd., Dainippon Sumitomo Pharma Co., Ltd., Kowa Co., Ltd., MSD K.K., Mitsubishi Tanabe Pharma Co., Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma K.K., Pfizer Japan Inc., Sanofi-Aventis K.K., and Takeda Pharmaceutical Co., Ltd; and unrestricted research grants for the Department of Cardiology, Nagoya University Graduate School of Medicine from Astellas Pharma Inc., Daiichi-Sankyo Co., Ltd., Dainippon Sumitomo Pharma Co., Ltd., Kowa Co., Ltd., MSD K.K., Mitsubishi Tanabe Pharma Co., Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma K.K., Otsuka Pharma Ltd., Pfizer Japan Inc., Sanofi-Aventis K.K., Takeda Pharmaceutical Co., Ltd., and Teijin Pharma Ltd. T.M., H.I., H.H., T.A., and K.K. are members of Circulation Journal’s Editorial Board. All other authors have no relationships relevant to the contents of this paper to disclose.

IRB Information

Approval for the use of J-SHD data was obtained from a third-party central ethics committee at the Clinical Research Promotion Network Japan (Reference no. 502).

Data Availability

The deidentified participant data will not be shared.

Supplementary Files

Please find supplementary file(s);

https://doi.org/10.1253/circj.CJ-24-0944

References

• 1.   Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol 2002; 39: 1890–1900, doi:10.1016/s0735-1097(02)01886-7.
• 2.   Geva T, Martins JD, Wald RM. Atrial septal defects. Lancet 2014; 383: 1921–1932, doi:10.1016/S0140-6736(13)62145-5.
• 3.   Kuraoka A, Ishizu T, Nakai M, Sumita Y, Kawamatsu N, Machino-Ohtsuka T, et al. Trends in unplanned admissions of patients with adult congenital heart disease based on the Japanese Registry of All Cardiac and Vascular Diseases-Diagnosis Procedure Combination Study. Circ J 2023; 88: 83–89, doi:10.1253/circj.CJ-23-0015.
• 4.   Soma K, Yao A. Hospitalizations in adult patients with congenital heart disease in Japan. Circ J 2023; 88: 90–92, doi:10.1253/circj.CJ-23-0822.
• 5.   Campbell M. Natural history of atrial septal defect. Br Heart J 1970; 32: 820–826, doi:10.1136/hrt.32.6.820.
• 6.   Turner ME, Bouhout I, Petit CJ, Kalfa D. Transcatheter closure of atrial and ventricular septal defects: JACC focus seminar. J Am Coll Cardiol 2022; 79: 2247–2258, doi:10.1016/j.jacc.2021.08.082.
• 7.   Tanaka S, Imamura T, Narang N, Fukuda N, Ueno H, Kinugawa K. Practical therapeutic management of percutaneous atrial septal defect closure. Intern Med 2022; 61: 15–22, doi:10.2169/internalmedicine.5944-20.
• 8.   Farooqi M, Stickley J, Dhillon R, Barron DJ, Stumper O, Jones TJ, et al. Trends in surgical and catheter interventions for isolated congenital shunt lesions in the UK and Ireland. Heart 2019; 105: 1103–1108, doi:10.1136/heartjnl-2018-314428.
• 9.   Hribernik I, Thomson J, Bhan A, Mullen M, Noonan P, Smith B, et al. A novel device for atrial septal defect occlusion (GORE CARDIOFORM). EuroIntervention 2023; 19: 782–788, doi:10.4244/EIJ-D-23-00378.
• 10.   Tanabe Y, Takahara M, Kohsaka S, Shinke T, Takamisawa I, Amano T, et al. Intracardiac echocardiography guidance for percutaneous transcatheter closure of atrial septal defects: Nationwide registry data analysis. Circ J 2023; 87: 517–524, doi:10.1253/circj.CJ-22-0530.
• 11.   Iwasaki M, Konishi A, Takahara M, Kohsaka S, Okuda M, Hayashi T, et al. Volume–outcome relationship in balloon aortic valvuloplasty: Results of a consecutive, patient-level data analysis from a Japanese nationwide multicentre registry (J-SHD). BMJ Open 2023; 13: e073597, doi:10.1136/bmjopen-2023-073597.
• 12.   Sommer RJ, Love BA, Paolillo JA, Gray RG, Goldstein BH, Morgan GJ, et al. ASSURED clinical study: New GORE^® CARDIOFORM ASD occluder for transcatheter closure of atrial septal defect. Catheter Cardiovasc Interv 2020; 95: 1285–1295, doi:10.1002/ccd.28728.
• 13.   Abrahamyan L, Dharma C, Alnasser S, Fang J, Austin PC, Lee DS, et al. Long-term outcomes after atrial septal defect transcatheter closure by age and against population controls. JACC Cardiovasc Interv 2021; 14: 566–575, doi:10.1016/j.jcin.2020.12.029.
• 14.   Takaya Y, Akagi T, Nakagawa K, Nakayama R, Miki T, Toh N, et al. Feasibility of transcatheter closure for absent aortic rim in patients with atrial septal defect. Catheter Cardiovasc Interv 2021; 97: 859–864, doi:10.1002/ccd.29457.
• 15.   Kitakata H, Itabashi Y, Kanazawa H, Miura K, Kimura M, Shinada K, et al. Appropriate device selection for transcatheter atrial septal defect closure using three-dimensional transesophageal echocardiography. Int J Cardiovasc Imaging 2021; 37: 1159–1168, doi:10.1007/s10554-020-02095-x.
• 16.   Takaya Y, Akagi T, Nakagawa K, Nakayama R, Miki T, Watanabe N, et al. Clinical significance of septal malalignment for transcatheter closure of atrial septal defect. J Interv Cardiol 2020; 2020: 6090612, doi:10.1155/2020/6090612.
• 17.   Abaci A, Unlu S, Alsancak Y, Kaya U, Sezenoz B. Short and long term complications of device closure of atrial septal defect and patent foramen ovale: Meta-analysis of 28,142 patients from 203 studies. Catheter Cardiovasc Interv 2013; 82: 1123–1138, doi:10.1002/ccd.24875.
• 18.   Amin Z, Hijazi ZM, Bass JL, Cheatham JP, Hellenbrand WE, Kleinman CS. Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: Review of registry of complications and recommendations to minimize future risk. Catheter Cardiovasc Interv 2004; 63: 496–502, doi:10.1002/ccd.20211.
• 19.   Amin Z. Echocardiographic predictors of cardiac erosion after Amplatzer septal occluder placement. Catheter Cardiovasc Interv 2014; 83: 84–92, doi:10.1002/ccd.25175.
• 20.   McElhinney DB, Quartermain MD, Kenny D, Alboliras E, Amin Z. Relative risk factors for cardiac erosion following transcatheter closure of atrial septal defects: A case-control study. Circulation 2016; 133: 1738–1746, doi:10.1161/CIRCULATIONAHA.115.019987.