Author + information
- Björn Söderberg1,
- Laura Vaskelyte2,
- Kolja Sievert2,
- Sameer Gafoor2,
- Ilona Hofmann2,
- Andreas Mellmann3,
- Jerome Bernhard3 and
- Horst Sievert4
The objective of this trial is to investigate the effectiveness and safety of a new septal occluder with bioresorbable framework (Carag Bioresorbable Septal Occluder CBSO, CARAG AG, Switzerland) in the treatment of secundum ASD or PFO. Device closure of ASD/PFO is standard of care in most countries. Current devices use a metal framework and occlusive patch material. Metal frameworks are reported to cause serious complications (eg erosion, perforation, arrhythmia) as late as 10 years following implantation. A septal occluder with bioresorbable framework has long been desired. Until now, development of a clinically effective bioresorbable framework has been elusive. We report on the initial 14 subjects implanted at the CardiovascularCenter, Frankfurt.
The CBSO employs a poly lactic-co-glycolic acid (PLGA) framework with polyester patches. Available in 3 sizes, it treats defects ≤25mm balloon diameter. It is delivered over a guidewire via a 12F transseptal sheath under fluoro/TEE guidance. Follow-up is at 1, 6, 12 and 24 months & includes clinical examination echo, ECG & blood panel. Closure effectiveness is determined by TEE at 6 months. In this FIH trial, only ASD with atrial rims ≥5mm or PFO tunnels ≤4mm are treated.
14 patients (age 50.5±11.4 years) have been treated: ASD (n=8) ranged from 12.9-21mm in diameter, PFO (n=6) ranged from 5.4-10.8mm in diameter. All devices were successfully implanted without complication. Mean time for loading and placement was 30±25.0 minutes. At 6 months, echo exam showed complete closure in 4/6 PFO patients and complete closure in 6/7 ASD and one small residual shunt (2mm). TTE at long term follow-up (2 at 24 months; 8 at 12 months) confirmed flat septum and showed no re-canalization. There have been no procedure or device related serious adverse events, no thrombus formation and no new occurring arrhythmias during follow-up.
CBSO is the first clinically effective septal occluder with a bioresorbable framework. It can be easily and safely implanted in humans with excellent closure results at procedure and long term. A learning curve may be required. Additional patients and longer follow-up is needed to further assess outcome.
OTHER: Pre-Clinical/First In-Human Studies