Aims: Previous comparisons between AMPLATZER septal occluders and other designs were retrospective, non-randomised, non-concurrent and involved fewer patients. A prospective concurrent head-to-head comparison of AMPLATZER (ASO), Cera (CSO) and Figulla (FSO) septal occluders was planned to study the patient outcomes.Methods and results: The three occluders were serially allocated in a cycle of three to consecutively included patients. Demographic, procedural details and complications were analysed. After calculating a sample size of 122 patients in each group, additional patients were recruited to ensure at least 80% follow-up. Four hundred and fifty (450) consecutive patients equally divided among the three designs were comparable in all parameters. There were no major complications and procedural success was 99.6%. The defects and device sizes were similar in all groups; the delivery system was significantly smaller with the ASO. The FSO needed special deployment techniques less often and formed a cobra deformity more often, though this was not statistically significant. Patient outcome was similar among the groups at a follow-up of 12-47 months. Conclusions:The new occluders are comparable to the ASO with good outcomes and low complication rates in the current era. The new modified structural designs do not show any advantages in terms of procedural complications on early and midterm follow-up, but long-term studies are warranted.

Objectives To study the feasibility of closure of large atrial septal defects (ASDs) using occluder devices >38 mm and assess the midterm complications. Background Feasibility and safety of large occluders >38 mm and their follow‐up are largely unknown. Methods All patients with ASDs closed using devices >38 mm were retrospectively analyzed. Since outcome of patients receiving 40 mm devices were known before, patients receiving 40 mm devices were compared with those receiving 42–46 mm devices on demographic, hemodynamic parameters and procedural characteristics. Results A total of 17 patients with 40‐mm device and 31 patients with >40‐mm device formed the cohort. The mean echocardiographic defect size was 36.3 ± 3.7 mm. In total 19 patients had deficient retroaortic margin; inferior margin was deficient in one. Larger defects needed special deployment techniques more often. There was acute technical success in all patients. Two procedures failed; one device embolization next day in a patient with deficient inferior margin needed surgery. Another elderly patient with restrictive left ventricular physiology died of multiorgan dysfunction. Two late deaths on follow‐up were unrelated to the procedure. All other patients had symptom improvement. There were no erosions, thromboembolism or valvar regurgitation at a median follow‐up of 39 (1–60) months. Apart from late‐onset atrial flutter in one, there were no arrhythmias on follow‐up. Conclusions Occluders larger than 38 mm in appropriately selected patients are feasible, successful and safe in majority and often require special deployment techniques. Complications during and after the procedure were infrequent. Very large defects with any deficient margin except retroaortic rim should be excluded from device closure.

ObjectivesNarrowed right ventricular (RV) outflow conduits and pulmonary arteries (PA) increase RV pressures and warrant interventions. Stent angioplasty is an alternative to more morbid redo-surgery in developing countries. We evaluate the efficacy and safety of stenting and assess need for redo-surgical reinterventions on midterm follow-up after stent angioplasty.MethodsPatients who underwent conduit, main PA and bilateral branch PA stenting for elevated RV pressures were analyzed retrospectively. Success was defined as 20% reduction in RV pressures or RV-aortic pressure ratio; 50% reduction in gradients or 50% increase of luminal diameter. Procedural results, complications and need for redo surgeries on follow-up were assessed.ResultsAmong 60 patients aged 1–46 years, 57 were post-operative patients, who needed stenting at a median period of 48 months after surgery. Stenting succeeded in 98% and reduced RV pressures from 105.42 ± 28.39 mmHg to 54.46 ± 16.89 mmHg. Direct major procedural complications in five (8%) patients included procedural failure in one, stent migration in three and lung hemorrhage in one. None of the stented conduits needed a surgical change on a follow-up ranging 3–120 months. Following bilateral PA stenting in twenty-four patients, only two needed a repeat open-heart surgery during follow-up ranging 3–108 months. Catheter reinterventions on follow-up included elective percutaneous pulmonary valve implantation in nine patients and stent redilation in seven patients.ConclusionsStent angioplasty was safe and effective. Surgery was postponed in all stenosed conduits. Elective redilation of stents after bilateral PA stenting may be needed for somatic growth; but open-heart repeat surgeries can be avoided in a majority.

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