Outcomes Analysis of Transcatheter Closure of Atrial Septal Defects
Zakhia S Saliba1, Lea Bou Karam2, Nelly Sleiman2
1Department of Pediatric Cardiology, Hotel Dieu de France University Medical Center Saint Joseph University Beirut Lebanon.
Insights
Transcatheter atrial septal defect closure is highly successful. Balloon- and guidewire-assisted implantations, along with smaller device-to-balloon sizing differences, predict clinical failure in atrial septal defect device closure.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pediatric Cardiology
Background:
- Atrial septal defect (ASD) device closure is a common procedure.
- Clinical success and long-term outcomes of ASD device closure are often under-evaluated.
- This study identifies factors predicting failure and examines long-term outcomes.
Purpose of the Study:
- To identify predictive factors for clinical failure in transcatheter atrial septal defect closure.
- To describe the long-term outcomes of atrial septal defect device closure.
- To evaluate the safety and efficacy of transcatheter closure for atrial septal defects.
Main Methods:
- A retrospective review of 400 patients undergoing transcatheter atrial septal defect closure from 2006 to 2021.
- Primary endpoint: 6-month composite clinical success (technical success, device retention, closure success, no serious adverse events, no reintervention).
- Secondary endpoints: technical success, procedural success, closure success, and safety.
Main Results:
- High rates of technical (95.8%) and procedural (94.8%) success were observed.
- Long-term closure success was excellent (98.7% at 6 months, 98.9% at 96 months).
- Predictors of clinical failure included balloon-assisted implantation (OR 4.494), guidewire-assisted implantation (OR 6.559), and smaller device-to-balloon sizing difference (OR 0.8000).
Conclusions:
- Transcatheter atrial septal defect closure demonstrates high success rates and favorable long-term outcomes.
- Balloon- and guidewire-assisted implantations are associated with increased risk of clinical failure.
- Optimizing device-to-balloon sizing is crucial for successful atrial septal defect device closure.
Background:
Atrial septal defect device closure is routine, yet clinical success and long-term outcomes are often overlooked. We aim to identify predictive factors for failure and describe long-term outcomes.
Methods:
A single-center retrospective review (2006-2021) of 400 patients undergoing transcatheter atrial septal defect closure was conducted. Primary end point was 6-month composite clinical success, including technical success (implantation and device retention), closure success (trivial/no residual shunt), absence of 30-day serious adverse events, and no device removal/reintervention. Secondary end points were technical success, procedure success (technical success with less than moderate residual shunt), closure success (clinically insignificant/absent residual shunt), and safety.
Results:
The cohort included 43.2% males, with a median age of 14.5 years [Q1-Q3: 8.3-37] and weight of 47.5 kg [25-68]. At baseline, the median stop-flow defect diameter was 24 mm [18.9-29]; 22.3% had a diameter ≥30 mm, 4.9% had a diameter-to-weight ratio of 1.5-1.8, 17.7% were multi-fenestrated, 39.3% had margin deficiency, and 10.7% had an atrial septal aneurysm. A single device was used in 98.8% of procedures (75.7% Amplatzer, 23.0% Occlutech). Median difference between device size and balloon-sizing diameter was 1 mm [0-2]. Implantations were pulmonary vein-assisted in 26.8%, guidewire-assisted in 2.5%, and balloon-assisted in 3.8%. Technical success at hospital discharge was 95.8%, and procedural success was 94.8%. Closure success was 98.7% (377/382) at 6 months and 98.9% (193/194) at 96 months. Freedom from SAEs was 95.5% at 30 days. Freedom from device events was 97.4% at 6 months. Six-month composite clinical success rate was 89.3%. Balloon-assisted implantation (odds ratio [OR], 4.494, [95% CI 1.471-13.729]), guidewire-assisted implantation (OR 6.559 [95% CI 1.759-24.454]), and smaller device-to-balloon sizing difference (OR 0.8000 [95% CI 0.663-0.967]) were independent predictors of failure.
Conclusions:
Transcatheter atrial septal defect closure shows high success, with balloon- and guidewire-assisted implantations and smaller device-to-balloon-sizing differences as predictors of clinical failure.
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