Percutaneous Atrial Septal Defect Closure Using the Occlutech Figulla Device in Adults: More than 800 Patient-Years of Follow-Up

Abstract

Purpose. The Occlutech Figulla occluder has been proven safe and effective at midterm follow-up after percutaneous atrial septal defect (ASD) closure. We describe the safety and efficacy at long-term follow-up in adults. Methods. All consecutive adult patients that underwent ASD closure between 2008 and 2015 were included. All complications were registered. Residual left-to-right shunt (LRS) was diagnosed using color-Doppler transthoracic echocardiography (TTE). Right-to-left shunting was diagnosed using contrast TTE. Successful closure was defined as no LRS at follow-up. Results. In total, 166 patients (mean age 56.7 ± 16.1 years; 62% female) underwent percutaneous ASD closure using the Occlutech Flex I (70%) or Flex II (30%) device (diameter 24 mm; range 10–40 mm) under general anaesthesia and transoesophageal echocardiographic guidance. Long-term follow-up data were available for 144 patients (87%) with a mean follow-up of 5.9 ± 2.6 years, a total of 814 patient-years. During hospitalization, device embolization occurred in three patients (1.8%) with successful extraction in all. During the long-term follow-up, 15 patients (9.8%) suffered new-onset atrial fibrillation and stroke occurred in 2.1%. There was no residual LRS at 12-month follow-up. No device embolization occurred during the long-term follow-up. Conclusion. Percutaneous ASD closure using the Occlutech device appears to be safe at long-term follow-up with a high successful closure rate at one year.

Preliminary Experience With the New Amplatzer™ Trevisio™ Delivery System in Transcatheter Atrial Septal Defect Closures in Children

“…The screw mechanism of the ASO was replaced by a ball-shaped connector design that allows a tilt angle up to 45° with better septum alignment during implantation. The system was even upgraded in the third-generation device (Flex II) to a bioptome-like innovative delivery system that comes along with a steerable catheter, allowing full circular movement of the device on the delivery wire and facilitating closure of larger or asymmetric defects ( 20 , 21 ). However, this device carries 2 major drawbacks ( 7 , 8 ).…”

Closure of the interatrial septum: should we do it?

“…The Cardioseal/Starflex device is no longer available for ASD closure due to a high complication rate (device embolization and device fracture). Though, Butera et al found a non-significant difference in embolization rate between the Cardioseal/Starflex device and the Amplatzer device (respectively 2.5% and 0.7%), our embolization rate was 10.7% using the Cardioseal/Starflex device [77,[80][81][82][83]. One of the difference between both studies is the lager diameter of the ASD closed and used device, which is known to be associated with embolization.…”

“…There were no AV-blocks in our studies using the Occlutech-, Amplatzer-or Cardioseal/Starflex device [77,82]. There was one patient with device thrombosis in our study using the Occlutech device, however, this patient was noncompliant using coumadin for atrial fibrillation [82]. The etiology of pericardial effusion remains unclear.…”

“…An AV-block mostly occurs due to oversizing of the device and resolves after device extraction [64,66,68,71]. There were no AV-blocks in our studies using the Occlutech-, Amplatzer-or Cardioseal/Starflex device [77,82]. There was one patient with device thrombosis in our study using the Occlutech device, however, this patient was noncompliant using coumadin for atrial fibrillation [82].…”

“…In our study, embolization occurred in 1.8% using the Occlutech device, which is comparable to literature. All devices could be extracted and the ASDs were successfully closed surgically [82]. Kefer et al and Masura et al included a total of 263 patients that underwent percutaneous ASD closure using the Amplatzer device and none of these patients experienced embolization; in-hospital and after more than 5-years follow-up [78,79].…”