Introduction

Atrial septal defect (ASD) is one of the most common congenital heart diseases, accounting for 10%-15% of cases in both children and adults. The secundum subtype predominates and, when left untreated, may lead to progressive right-sided volume overload, arrhythmia, pulmonary hypertension, and early mortality.^1-3 Closure is therefore recommended in symptomatic patients and in those with evidence of right ventricular dilation regardless of age.³

Surgical repair has long been the definitive treatment for ASD, achieving excellent long-term outcomes and near-complete defect closure. However, since the 1990s, transcatheter closure has emerged as a less invasive alternative for anatomically suitable patients, offering shorter recovery, reduced postoperative morbidity, and superior cosmetic results.^4,5 Current guidelines increasingly support transcatheter closure as first-line therapy when feasible.^4-6

Despite these advantages, comparative evidence remains inconsistent. Most available data originate from observational studies rather than randomized trials, and reported outcomes vary considerably across age groups and clinical settings. Some studies suggest that transcatheter closure provides comparable or even superior safety profiles with fewer complications, while others emphasize the procedural durability of surgery, particularly in cases with complex or unfavorable anatomy.^6-9 Additionally, children and adults exhibit distinct technical challenges and comorbidity profiles that influence procedural success and complication risk, complicating comparative interpretation.⁹

Given these uncertainties, an updated synthesis is needed to clarify outcome differences between transcatheter and surgical closure across age groups. A systematic review and meta-analysis of observational studies comparing both approaches was conducted, focusing on procedural success, complication patterns, and peri-procedural characteristics in children and adults.

Methods

Study Design

We conducted a systematic review and meta-analysis of observational studies comparing transcatheter and surgical ASD closure. This review adhered to PRISMA 2020 guidelines.¹⁰ The protocol was registered prospectively in the International Prospective Register of Systematic Reviews (PROSPERO;CRD420251052612). Because the published data was analyzed and did not include new patient contact, no ethical approval or consent was required.

Eligibility Criteria

We included observational studies such as prospective cohort studies, retrospective cohort studies, case-control studies, and national registries that reported outcomes of transcatheter or surgical ASD closure in children or adults. A study was eligible if it reported at least one of the following outcomes: procedural success, procedural characteristics including procedure duration, fluoroscopy duration, radiation exposure, length of stay, or complications during the procedure or follow-up period. Case reports, review articles, conference abstracts, and studies without extractable quantifiable outcome data were excluded.

Search Strategy

We conducted a comprehensive search of PubMed, Embase, Scopus, and Web of Science up to December 2024. Search terms included “atrial septal defect,” “ASD,” “transcatheter closure,” “device closure,” “surgical repair,” and “outcomes” combined with Boolean operators. Reference lists from eligible studies were manually screened to identify additional publications.

Study Selection

Three reviewers independently screened titles and abstracts. Full text review followed for studies that met preliminary criteria. Disagreements were resolved through discussion with a fourth reviewer. The selection process is summarized in the PRISMA flow diagram.¹⁰

Data Extraction

Three reviewers extracted data independently using a structured data form. Extracted variables included study design, publication year, country, sample size, patient demographics including age, sex, and weight, anatomical characteristics of the defect, type of intervention, success rates, intra-procedural and follow-up complications, procedure duration, fluoroscopy duration, and length of hospital stay. Device type and device diameter for transcatheter closure were recorded when available and are presented in Supplementary Tables 1 and 2.

Procedural success was defined in this review as successful closure confirmed by imaging without major complications during the same admission. The included studies did not use a uniform definition because some investigators defined success based on device deployment alone, while others required the absence of complications or complete closure on follow-up imaging. To address these differences, a single operational definition was applied and the data elements that matched this definition as closely as possible were extracted. Only a limited number of studies used identical criteria; therefore, a sensitivity analysis restricted to studies with fully consistent definitions could not be performed.

Risk of Bias Assessment

We assessed methodological quality using the Newcastle–Ottawa Scale (NOS).¹¹ This tool evaluates 3 domains: patient selection, comparability of groups, and outcome assessment. Studies with a score of 7 or higher were classified as high quality.

The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Assessment

We assessed certainty of evidence using the GRADE framework. A summary of grading for each outcome is provided in Supplementary Table 3.

Outcomes of Interest

The primary outcome was procedural success, defined according to the standardized operational definition applied in this review. Secondary outcomes included procedure duration, fluoroscopy duration, radiation exposure, length of stay, and peri-procedural or follow-up complications. Variation in follow-up duration across studies limited time-specific outcome comparison.

Statistical Analysis

Meta analyses were performed using random effects models (DerSimonian–Laird). All analyses were conducted in RStudio (RStudio version 2024.12.0).¹² Risk ratios for dichotomous outcomes and mean differences for continuous outcomes were reported, each with 95% CIs. Data distribution for continuous outcomes including procedure duration and fluoroscopy duration was visually inspected and demonstrated right skew patterns in several studies. However, because most publications reported only mean and standard deviation without providing median or interquartile range values, transformation into nonparametric effect measures was not possible. Mean difference was therefore retained for consistency in pooled synthesis.

For outcomes that included 1 or more 0 event cells, a continuity correction of 0.5 was applied to enable computation of risk ratios. Peto or modified Mantel–Haenszel estimators were not applied because several outcomes contained studies with unbalanced sample distribution, and risk ratios provided a more clinically interpretable measure for comparison.

Statistical heterogeneity was quantified using the I² statistic.¹³ Follow-up duration varied substantially across the included studies and ranged from early in-hospital assessments to long-term evaluations. Because the studies did not provide a consistent prespecified follow-up window, the outcome that most closely reflected the first systematic evaluation after the intervention was extracted. The analysis was not restricted to a single follow-up length because too few studies reported outcomes at identical time points. Stratified pooling based on short-term or long-term follow-up could not be performed for the same reason. The pooled estimates for late complications should therefore be interpreted as summaries of heterogeneous follow-up intervals rather than strictly comparable time-matched outcomes. Prespecified subgroup analyses were performed according to procedure type (transcatheter versus surgical) and age group (children versus adults). Sensitivity analyses restricted to high-quality studies with Newcastle Ottawa Scale score 7 or greater were conducted to assess the robustness of the pooled estimates. Publication bias was evaluated by funnel plot assessment and Egger regression.¹⁴

Results

Study Selection

The initial search retrieved 1683 records. After duplicate removal and screening of titles and abstracts, 36 observational studies met the eligibility criteria and were included in the quantitative synthesis. The study selection process is presented in the PRISMA 2020 flow diagram (Figure 1).

Study Characteristics

The 36 included studies comprised a total of 12 739 patients undergoing transcatheter or surgical ASD closure (7014 transcatheter; 5725 surgical). Study designs consisted of prospective and retrospective cohorts, case-control studies, and 1 nationwide registry. Mean age in adult cohorts ranged from 28 to 42 years, while pediatric cohorts ranged from 1.5 to 7 years. Baseline characteristics including age, sex, weight, and defect size on echocardiography or angiography are summarized in Table 1.

Most studies reported the type of device used for transcatheter closure.

Amplatzer devices predominated (78.9% of all transcatheter implants), with much smaller contributions from Starflex (4.7%), Occlutech (3.7%), CardioSEAL (2.6%), Helex (2.9%), and Angelwing (2.3%). Use of other devices was uncommon or not reported.

Risk of Bias Assessment

Newcastle–Ottawa Scale scores ranged from 6 to 9. Twelve studies (33%) achieved high quality (≥7 points), while the remainder were of moderate quality. The most common limitation was lack of a concurrent control group, which affected comparability. A detailed summary of NOS assessment is provided in Supplementary Table 4.

Procedural Success

The pooled procedural success rate for ASD closure without major complications was 95% (95% CI: 92%-97%; I² = 90.2%). To better quantify expected effect variability across future studies, a prediction interval (0.55-1.00) was calculated, indicating a wide range of possible true effects and reflecting substantial clinical heterogeneity among included cohorts. Leave-one-out sensitivity analysis (sequential exclusion of each study) demonstrated stability of the pooled procedural success estimate. Sequential removal of individual studies produced changes of ≤0.85% in the pooled estimate, with no single study altering the direction or magnitude meaningfully. These results are reported in Supplementary Table 5.

Baujat analysis identified 2 studies, Meyer et al⁹ and Marini et al³⁴, as the largest contributors to statistical heterogeneity while also exerting notable influence on the pooled success estimate. Several other studies, including Esraa, Formigari, and Martins, contributed moderate variability, whereas most remaining cohorts showed minimal impact on heterogeneity or the overall pooled effect. These findings are shown in Supplementary Figure 1.

In children, the raw procedural success rates were 87.3% (1445/1656) for transcatheter closure and 99.0% (505/510) for surgical closure (Table 3). The pooled meta-analytic model estimated success at 93% and 97%, respectively; differences reflect study weighting and between-study variance.

Device generation likely contributed to outcome variability. Early cohorts predominantly used first-generation Amplatzer/AGA devices, while more recent studies increasingly employed Occlutech and CERA systems, which may offer improved deployment control and stability. In the surgical group, outcomes represented a combination of sternotomy and minimally invasive approaches, although most studies did not report these separately, limiting direct comparison of technique-specific morbidity.

Cumulative meta-analysis of transcatheter procedures (studies added chronologically by publication year) showed early variability in pooled success rates with progressive stabilization after 2008. At the most recent cumulative step (including studies up to 2022), the pooled transcatheter success proportion was 0.788 (95% CI: 0.771-0.805). Supplementary Figure 2 provide the full cumulative plot.

Procedural Characteristics

Transcatheter closure demonstrated shorter procedure duration compared with surgery (adults: 43.2 ± 11.9 minutes vs 89.8 ± 32.6 minutes; children: 70.7 ± 37.2 minutes vs 83.2 ± 55.0 minutes; both P < .001). Hospital stay was also significantly shorter (mean difference: −3.86 days; 95% CI: −6.03 to −1.69; P = .0004). Fluoroscopy time averaged 12.0 ± 3.6 minutes in adults and 19.3 ± 34.5 minutes in children, although pediatric comparison was limited due to fewer surgical comparators. These findings are displayed in Figure 2.

Complications During Procedure

Transcatheter closure had lower intra-procedural complication rates.

Among children, the most frequent events were residual shunt (1.8%), arrhythmia (1.2%), and device embolization (1.0%). In adults, device embolization (1.3%) and arrhythmia (1.6%) were most commonly reported. Surgical closure was associated with higher rates of pleural effusion (0.7%), pericardial effusion (2.1%), pulmonary edema (1.1%), and shock (3.9%). Full complication distribution is summarized in Table 3 and visualized in Figure 3.

Complications on Follow-Up

During follow-up, residual shunt was observed in 4.6% of children and 7.2% of adults following transcatheter closure, compared with 1.7% in surgically treated children. Arrhythmia was lower after transcatheter closure versus surgery (0.7% vs. 5.8% in children). Late device-related complications such as embolization were rare (0.2%-0.8%). Surgical follow-up complications included heart failure (1.9%) and renal failure (0.5%). Complete outcome data are provided in Table 4 and Figure 4.

Sensitivity Analysis

Sensitivity analysis restricted to 12 high-quality studies (NOS ≥ 7) yielded similar results to the primary analysis, reinforcing robustness. Corresponding forest plots are shown in Supplementary Figure 3.

Publication Bias

Funnel plot distribution appeared largely symmetrical, and Egger’s regression test showed no significant small study effects (P = .069), although minor asymmetry suggests publication bias cannot be fully excluded.

Discussion

Principal Findings

This systematic review and meta-analysis of 36 observational studies involving more than 12 thousand patients provides updated comparative evidence for transcatheter and surgical ASD closure. Both approaches demonstrated very high procedural success, consistently above 95%. Transcatheter closure resulted in shorter hospital stays, shorter procedure duration, and lower complication rates, particularly in children. Surgical closure remained effective and continues to be the preferred option for patients with large defects, deficient rims, or anatomical variants that are not suitable for device placement.

Many factors caused the wide differences between studies. Centers used different device generations, starting from early Amplatzer and AGA devices and later moving to Occlutech and CERA models. Operators also became more skilled over time, so older studies often reflect early learning periods while newer studies show more stable practice. Each center also used different rules for choosing which patients were suitable for device closure, which changed the types of defects included. The length of follow-up and the way outcomes were defined also varied a lot. Some studies reported only events during the hospital stay, while others followed patients for months or years. Practice patterns also differed across countries, including the type of device used, the style of care, and whether surgeons preferred a small chest cut or a full chest opening. All these differences created the large variation seen in the results, and readers should keep this in mind when interpreting the pooled findings. Cumulative meta-analysis suggests that pooled transcatheter success rates became more consistent after 2008, supporting the hypothesis that improvements in device generation and growing operator experience contributed to more reliable procedural outcomes.

Prediction intervals are wider than CIs and reflect the expected range of effects in a new study; the wide prediction intervals that were observed indicate that effects may differ substantially between settings, underscoring caution when applying pooled estimates to individual centers.

Baujat influence analysis further demonstrated that heterogeneity in transcatheter success was disproportionately driven by a small subset of studies, particularly Meyer and Marini (2007), which deviated more prominently from the pooled effect relative to the larger evidence base. These cohorts likely reflect differences in operator experience, device era, anatomical case selection, or institutional technical protocol during earlier adoption phases. The concentration of heterogeneity within only a few influential studies indicates that the majority of included cohorts cluster closely around the pooled effect, supporting the robustness of the overall estimate despite substantial I².

These variations collectively contribute to the high heterogeneity, and they should be considered carefully when interpreting the pooled effect estimates. Leave-one-out analysis confirmed that the pooled procedural success estimate was robust; no individual study exerted a dominant influence on the overall result.

This finding increases confidence that the observed heterogeneity reflects between-study clinical and methodological variation rather than outlier-driven distortion. In addition to high I² values, prediction interval analysis further supported the presence of real-world variability. For procedural success, the prediction interval ranged from 0.55 to 1.00, indicating that while the pooled success rate was high, true effects in future clinical settings may lie anywhere within this broader distribution.

This implies that although most centers achieve excellent results, outcomes may differ depending on device generation, operator familiarity, anatomical complexity, and peri-procedural protocol differences, consistent with the clinical heterogeneity described above. Incorporating prediction intervals therefore improves interpretability and provides a more clinically realistic expectation range beyond the conventional pooled estimate.

Variation in the definition of procedural success across studies also contributes to inconsistency in the pooled estimates. Some investigators defined success based solely on successful device placement, while others required the absence of complications or complete closure on imaging. A single operational definition was applied to harmonize reporting, but the lack of uniform criteria across studies limits the ability to perform sensitivity analyses with consistent definitions. This limitation should be considered when the results are interpreted.

Variation in follow-up duration across studies also affects the interpretation of late outcomes such as arrhythmia and residual shunt. Some investigators reported outcomes within the first year while others included longer-term evaluations, which introduces inconsistency in the time frames represented in the pooled estimates. Because only a small number of studies reported outcomes at uniform intervals, stratified analyses could not be performed based on predefined follow-up lengths. As a result, the pooled findings reflect aggregated data from heterogeneous follow-up periods, and this should be considered when comparing late outcomes between transcatheter and surgical closure.

Assessment of publication bias showed no statistical evidence of small study effects because the Egger regression test did not demonstrate significant asymmetry. However, the test had limited power because several pooled outcomes included a small number of studies. Funnel plots for the major outcomes are provided in the supplementary material to enhance transparency and allow visual inspection of plot symmetry.

Differences in device design may also contribute to variation in procedural complexity and clinical outcomes. Most transcatheter studies used the Amplatzer septal occluder while others used Occlutech, CERA, or related double disk devices. Earlier generation devices tended to be stiffer or bulkier, whereas newer systems provide improved flexibility and more controlled deployment, which may reduce complications in anatomically challenging defects. Although the present analysis was not powered to compare individual device types, variation in device characteristics and generational improvements should be considered when interpreting pooled estimates from transcatheter closure cohorts. In the surgical group, several studies combined conventional sternotomy with minimally invasive thoracotomy approaches. Because the number of studies reporting minimally invasive techniques was limited and reporting formats were inconsistent, these approaches were pooled with standard surgery for quantitative analysis. This pooling may shorten length of stay or influence complication rates in some cohorts and represents an additional source of clinical variation across studies.

Comparison with Previous Evidence

Our findings align with earlier systematic reviews that demonstrated the non-inferiority of transcatheter closure compared with surgery in terms of success rates and safety.⁶ Xu et al¹ confirmed the superiority of transcatheter closure for children secundum ASDs with fewer complications and faster recovery. Similarly, national registry data demonstrated favorable long-term outcomes with transcatheter techniques, though residual shunts occurred more frequently compared with surgery.⁷ In contrast, surgical closure continues to show excellent durability and remains the preferred approach in complex anatomy or large defects not amenable to transcatheter closure.⁹ Furthermore, a recent Anatolian Journal of Cardiology case report highlighted successful transcatheter ASD closure in patients with challenging venous anatomy, illustrating the expanding applicability of transcatheter closure in complex clinical scenarios.^15,16

Children Versus Adult Considerations

Age subgroup analyses revealed clinically meaningful differences. In children, transcatheter closure reduced arrhythmia, bleeding, and pleural complications compared with surgical closure, supporting its role as first-line therapy when anatomy is favorable.^1,4 In adults, both approaches achieved high success, but surgery was more often associated with pulmonary edema and longer recovery. Conversely, adults undergoing transcatheter closure faced slightly higher risks of late residual shunt, which requires long-term echocardiographic monitoring.^7,9

Clinical Implications

These findings emphasize that treatment strategy should be individualized. Transcatheter closure offers clear advantages in terms of safety, recovery, and patient quality of life, particularly in younger patients. However, surgical closure remains critical for patients with very large defects, deficient septal rims, or concomitant cardiac anomalies requiring repair. The procedural decision should therefore integrate patient age, anatomy, comorbidities, and institutional expertise.

Strengths and Limitations

The main strengths of this meta-analysis include a large pooled sample size, adherence to PRISMA 2020 guidelines,¹⁰ a prospectively registered protocol in PROSPERO (CRD420251052612) that reduces the risk of selective reporting bias, and comprehensive subgroup analyses stratified by age and procedure type. Sensitivity analysis restricted to high-quality studies further confirmed the robustness of the findings. To enhance transparency, the certainty of evidence was assessed using the GRADE approach, which demonstrated moderate certainty for procedural success, peri-procedural complications, hospital stay, and procedure time, whereas outcomes with low event rates or inconsistent follow-up yielded lower certainty ratings.

However, several limitations should be acknowledged. All included studies were observational, which may introduce confounding. Heterogeneity across studies was substantial, reflecting differences in patient selection, operator experience, and device evolution. Because surgical cohorts frequently reported longer follow-up than transcatheter cohorts, the higher rate of some late complications after surgery may partly reflect longer observation time rather than a true difference in per-time risk. Long-term data beyond 10 years remain limited, particularly for device closure, which precludes definitive conclusions on durability. Outcomes between minimally invasive thoracotomy and conventional sternotomy could not be differentiated because most surgical studies did not stratify results by operative technique, which restricts interpretation of the relative morbidity of modern surgical approaches. Egger’s regression did not show statistically significant small study effects (P = .069), although the borderline value and asymmetry on visual inspection suggest that publication bias cannot be entirely excluded.

Future Directions

Future research should prioritize high-quality prospective comparative studies, particularly in adults with complex anatomy. Long-term durability data for transcatheter device closure remain limited, particularly regarding late adverse events such as device erosion, arrhythmia, and right ventricular dysfunction. Future work should therefore include long-duration registries and surveillance to better characterize late risk profiles.

Both transcatheter and surgical closure of ASDs are highly effective. Transcatheter closure offers advantages of shorter recovery and fewer complications, supporting its preferential use in anatomically suitable patients, whereas surgery remains essential for complex cases. Individualized treatment planning that incorporates patient-specific and anatomical factors is paramount to optimize outcomes.

Supplementary Materials

Footnotes

Ethics Committee Approval: This study was approved by the Health Research Ethics Committee of Universitas Sumatera Utara, Ministry of Education, Culture, Research, and Technology, Indonesia (Approval No.: 157/KEPK/USU/2024; Date: July 6, 2025).

Informed Consent: Informed consent was not required as this study was a systematic review and meta-analysis based exclusively on previously published data and did not involve direct patient contact.

Peer-review: Externally peer-reviewed.

Author Contributions: Concept and design were performed by J.K. and P.A.; supervision by P.A.; resources by P.A., A.D.R., and G.H.H.A.S.; materials by P.A.; data collection and/or processing by J.K., A.D.R., and G.H.H.A.S.; analysis and/or interpretation by J.K. and P.A.; literature search by P.A.; writing by J.K., A.D.R., G.H.H.A.S., and P.A.; and critical review by P.A., A.D.R., and G.H.H.A.S.

Acknowledgments: The authors would like to acknowledge the Library of Universitas Sumatera Utara for their support.

Declaration of Interests: The authors declare that none of them is a member of the Editorial Board or Advisory Board of the journal.

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