Transvenous Closure of Patent Foramen Ovale: Preliminary Results with a New Self-Expanding Nitinol Wire Mesh in a Swine Model

[摘要] Objectives. The transvascular closure of patentforamen ovale (PFO) with self-expanding devices carries the riskof left atrial thrombus formation related to material protrudinginto the left atrium. Thus, we developed a novel device with flatleft atrial disc geometry. We evaluated feasibility, handling, andbiocompatibility in a porcine animal model.Methods. Implantation of an Occlutech Figulla PFOdevice was performed in 10 mini pigs using fluoroscopy andintra-cardiac ultrasound after transseptal puncture of theinteratrial septum. Angiographic follow-up was performed after sixand twelve weeks.Results. Implantation wassuccessful in 100%. There were no further implant relatedcomplications. One procedure related death occurred, as one animaldied of ventricular tachycardia due to mispunture of theinteratrial septum. Angiographic studies showed no residual shuntduring follow-up. Histopathological evaluation could demonstratepartial neoendothelialization after 6 weeks with completion after12 weeks. The devices were incorporated into connective tissuecontaining fibro muscular cells. An only mild inflammatoryreaction was detected locally related to the polyester fibers.Conclusion. In terms of feasibility and handling,the new device does not seem to be inferior to other presentlyused implantation systems. Good biocompatibility was demonstratedwith rapid and complete neoendothelialization.

[学科分类] 心脏病和心血管学