Prospective concurrent head-to head comparison of three different types of nitinol occluder device for transcatheter closure of secundum atrial septal defects

Abstract

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.

A multi-center trial on efficacy and safety of the LifeTech CeraFlexTM ASD occluder for transcatheter closure in patients with secundum atrial septal defects

“…The CeraFlex TM ASD occluder is comparable to the Amplatzer ASD occluder, as it is a nitinol double-disk device with PET membranes sewn into each disk. It is comparable to the Amplatzer ASD occluder with good outcomes and low complication rates (20). However, the 360° flexible rotation features between the device and delivery cable facilitate safe device implantation.…”

FAST technique: fast atrial sheath traction technique for device closure of atrial septal defects

“…The median size of the non-stretched ASD on two-dimensional ultrasound was 19 mm (IQR, [16][17][18][19][20][21][22]. Six (35.3%) patients had large ASDs (≥20 mm), three (17.6%) had an ASD size-to-body weight ratio higher than 0.9, five (29.4%) had absent aortic rims, and two (11.8%) had elevated pulmonary arterial pressures.…”

“…Results: Seventeen patients (64.7% males) were involved with a median age of 9.8 years [interquartile range (IQR), 7.6-15.1] and a median weight of 34 kg (IQR,. The median ASD size on ultrasound was 19 mm (IQR,(16)(17)(18)(19)(20)(21)(22). Five (29.4%) patients had absent aortic rims, and three (17.6%) patients had an ASD size-tobody weight ratio higher than 0.9.…”

Percutaneous closure of atrial septal defect: a consensus document of the joint group of experts from the Association of Cardiovascular Interventions and the Grown-Up Congenital Heart Disease Section of the Polish Cardiac Society

“…The reaction occurs from 2 days to 1 month after the implantation and manifests as headaches, rash / urticaria, difficulty breathing, fewer, palpitations, and rarely pericardial effusion. 88,92,100 Fortunately, all patients respond to medical management by steroids and antiallergenic agents 100,101 and symptoms subside in a few months. In rare cases, if medical management is ineffective, the device should be explanted.…”

“…In rare cases, if medical management is ineffective, the device should be explanted. 88,100,101 A nickel skin test is available and may be performed in patients with allergy or those "suspected." 74 In case of allergy, platinum -coated device may be considered.…”