What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial septal defect (n=269). Intervention: Very large atrial septal defect (≥35 mm) vs. Large atrial septal defect (25-34 mm). Primary outcome: Procedural success rate (p=0.620).

January 1, 2019Open Access

Procedural, Early and Long-term Outcomes after Percutaneous Closure of Atrial Septal Defect: Comparison between Large and Very Large Atrial Septal Defect Groups

SJSe Yong JungYonsei University AKAh Young KimYonsei University JJJo Won JungSeverance Hospital

Key Result

Percutaneous closure in patients with very large atrial septal defects (≥35 mm) achieved a 100% procedural success rate, comparable to the 99.1% success rate in patients with large defects (25-34 mm).

Study Design

Type

Cohort (n=269)

Multicenter

Structured PICO

Does percutaneous closure of very large ASDs have similar procedural and long-term outcomes compared to large ASDs in adult patients?

Population

269 patients with large (≥25 mm) atrial septal defects who underwent percutaneous closure, followed for a mean of 43.6 months.

Exposure

Percutaneous closure using Amplatzer septal occluder for very large ASD (≥35 mm, n=53).

Comparator

Percutaneous closure using Amplatzer septal occluder for large ASD (25 mm ≤ ASD < 35 mm, n=216).

Outcome

Procedural parameters, early complications, and long-term follow-up results.safety

Percutaneous closure of very large ASDs (≥35 mm) is safe and effective, with procedural and long-term outcomes comparable to those of large ASDs (25-35 mm), despite requiring more modified implantation techniques.

Main Result

Absolute Event Rate: 100% vs 99.1%

p-value: p=0.620

Limitations

Non-randomized retrospective study design
Small number of device migrations prevented analysis of risk factors
Detailed analysis of hemodynamic assessment was not performed
Comprehensive evaluation of quality of life or survey for migraine headache was not obtained
Cardiopulmonary function tests were not included in the analysis

Abstract

BACKGROUND: This study aimed to compare procedural, early and long-term outcome of device closure of atrial septal defect (ASD) between large ASD patients and very large ASD patients. METHODS: We carried a retrospective study of adult large ASD (defined as ≥25 mm) treated by percutaneous closure using Amplatzer septal occluder during 12-year period (May 2003-February 2015) at a single tertiary center. A total of 269 patients were divided into 2 groups, according to the pre-procedural maximal ASD diameter; 25 mm≤ASD<35mm, group 1 (n=216) and 35 mm≤ASD, group 2 (n=53). We compared procedural parameters, early complications and long-term follow-up results between 2 groups. RESULTS: The need of modified implantation techniques (MITs) was higher group 2 (23.6% vs. 37.7%, p=0.034). Procedural success rate was considerably high in both groups (99.1% in group 1 vs. 100% in group 2, p=0.620). Major complications were occurred in 4 (1.5%) patients (1.4% vs. 1.9%, p=0.804). Minor complication rate was not different between 2 groups. During long-term follow-up (47.2±32.0 months, range, 6.0-135.5), there was one major complication (0.4%) of stroke. Most common long-term minor event was migraine headache (3.9%) followed by arrhythmias (1.9%) without statistical difference between 2 groups. CONCLUSIONS: Although MIT was more frequently required in very large ASD groups, the procedural, early and long-term outcomes after percutaneous ASD closure were similar in both groups. This suggested that percutaneous ASD closure for very large ASD could be considered a good treatment option.

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