• Swiss medical weekly · Oct 2008

    Clinical Trial

    Safety and feasibility of percutaneous closure of patent foramen ovale without intra-procedural echocardiography in 825 patients.

    • Andreas Wahl, Fabien Praz, Jessica Stinimann, Stephan Windecker, Christian Seiler, Krassen Nedeltchev, Heinrich P Mattle, and Bernhard Meier.
    • Cardiology, University Hospital Bern, Switzerland.
    • Swiss Med Wkly. 2008 Oct 4;138(39-40):567-72.

    BackgroundPercutaneous closure of patent foramen ovale (PFO) is generally performed using intra-procedural guidance by transoesophageal (TEE) or intracardiac (ICE) echocardiography. While TEE requires sedation or general anaesthesia, ICE is costly and adds incremental risk, and both imaging modalities lengthen the procedure.MethodsA total of 825 consecutive patients (age 51 +/- 13 years; 58% male) underwent percutaneous PFO closure solely under fluoroscopic guidance, without intra-procedural echocardiography. The indications for PFO closure were presumed paradoxical embolism in 698 patients (95% cerebral, 5% other locations), an embolic event with concurrent aetiologies in 47, diving in 51, migraine headaches in 13, and other reasons in 16. An atrial septal aneurysm was associated with the PFO in 242 patients (29%).ResultsPermanent device implantation failed in two patients (0.2%). There were 18 procedural complications (2.2%), including embolization of the device or parts of it in five patients with successful percutaneous removal in all cases, air embolism with transient symptoms in four patients, pericardial tamponade requiring pericardiocentesis in one patient, a transient ischaemic attack with visual symptoms in one patient, and vascular access site problems in seven patients. There were no long-term sequelae. Contrast TEE at six months showed complete abolition of right-to-left shunt via PFO in 88% of patients, whereas a minimal, moderate or large residual shunt persisted in 7%, 3%, and 2%, respectively.ConclusionsThis study confirms the safety and feasibility of percutaneous PFO closure without intra-procedural echocardiographic guidance in a large cohort of consecutive patients.

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