Thrombosis, Fracture, and Percutaneous Removal of aPatent Foramen Ovale Closure Device 1 Month After

Successful Deployment

Tommaso Gori,1 MD, PhD, Rainer Schrader,2 MD, and Sabine Genth-Zotz,1* MD

Several different devices have been developed for the percutaneous closure of inter-atrial defects and patent foramen ovale. Although the implantation of these devices isboth safe and effective, a number of complications, both in the early and the late fol-low-up, may occur. We describe a case of device fracture manifested early (1 monthafter implantation) with the formation of massive thrombosis on the right atrial disc.The patient was treated with anticoagulants and the device was percutaneouslyretrieved. Our images allowed early noninvasive therapy and emphasize the need forechocardiographic follow-up early after implantation. VC 2010 Wiley-Liss, Inc.

Key words: patent foramen ovale; fracture; thrombosis

INTRODUCTION

A 55-year-old woman was admitted to our catheteri-zation laboratory for the closure of a patent foramenovale (PFO). The patient’s clinical history included acerebral ischemic event which had occurred 3 monthsbefore and had left no neurological deficit. History alsoincluded a deep vein thrombosis 10 years before andhypothyroidism well controlled under hormone replace-ment therapy. The patient was a smoker (15 pack/years) and had elevated cholesterol levels; her physicalexamination was unremarkable except for a body massindex of 39. A full workup for hypercoagulability wasnegative. At transesophageal echocardiography (TEE),the interatrial septum was hypermobile; the septumsecundum was 15 mm long and thick (9 mm), and thetunnel was ca. 7 mm long. Under local anesthesia andsystemic heparin infusion, a 25-mm Cardia Atriaseptdevice (Cardia, Gent, Belgium) was successfullydeployed using fluoroscopic and TEE guidance througha right femoral vein 11-French delivery catheter. Intra-procedural TEE confirmed optimal positioning of thedevice with both discs well adherent to the septum(Fig. 1A). A minimal residual left-right shunt was pres-ent. After the procedure, the patient was administereda 300 mg oral bolus of clopidogrel and was dischargedon combined aspirin (100 mg o.d.) plus clopidogrel (75mg o.d.) therapy for the following 3 months. At 1-month scheduled TEE follow-up, the right atrial discwas poorly adherent to the interatrial septum (Fig. 1B).No sign of device fracture was evident and there wasno residual shunt. Remarkably, a 2.1 cm long, widelymobile structure was evident in the right atrium

attached to the device (Movie 1, Supporting Informa-tion). Initial differential diagnosis of this structureincluded device thrombosis and/or endocarditis. Morematerial, also suggestive of thrombosis/endocarditis,was evident on the surface of the right atrium disc. C-reactive protein and blood counts were negative andthe patient was afebrile. The patient was admitted tothe hospital to start anticoagulant therapy with heparinfollowed by oral anticoagulation with warfarin.

At repeat TEE 6 weeks into effective oral anticoagu-lation, the right atrial disc was broadly mobile andmarkedly off-axis (Fig. 1C). TEE and fluoroscopy sug-gested the presence of a rupture of the articulation

1II Medizinische Klinik fur Kardiologie/Angiologie, JohannesGutenberg University, Mainz, Germany2CCB—Cardioangiologisches Centrum Bethanien Medizi-nisches Versorgungszentrum, Frankfurt, Germany

Additional Supporting Information may be found in the online

version of this article.

Conflict of interest: Nothing to report.

*Correspondence to: Sabine Genth-Zotz, MD, II Medizinische Klinik

fur Kardiologie/Angiologie, Langenbeckstrasse 1, 55131 Mainz.

E-mail: genth@2-med.klinik.uni-mainz.de

Received 10 September 2009; Revision accepted 30 September

2009

DOI 10.1002/ccd.22320

Published online 20 January 2010 in Wiley InterScience (www.

interscience.wiley.com)

VC 2010 Wiley-Liss, Inc.

Catheterization and Cardiovascular Interventions 75:778–781 (2010)

between the two discs (Fig. 1D, Movie 2 and 3, Sup-porting Information), and, confirming our preliminarydiagnosis of right atrial thrombosis, the mobile struc-ture attached to the right disc had completely disap-peared after adequate anticoagulation. Given the highrisk of repeat thrombosis and embolization, it wasdecided to attempt percutaneous removal of the device.Effective closure of the PFO was confirmed via con-trast infusion through a 5-French multipurpose catheter.A 14-French Cook sheath (Bloomington) was thenintroduced into the right atrium via the right femoralvein. An Amplatz extra stiff wire (Cook) was used asguide and maintained in the right atrium to hold thesystem stable; the right atrium disc was snared with a40 mm Osypka snare wire (Osypka, Berlin, Germany),grabbed with a bioptome and pulled into the Cooksheath (Fig. 2). The left atrial disc remained well ad-herent to the interatrial septum throughout the proce-dure, held in place by its transseptal arms, and a finalcontrast injection showed no shunt. At inspection, the

right atrium disc was disrupted and several of the niti-nol arms were exposed. The coupling arms betweenthe two discs were fractured. At a 3-months TEE (Fig.2E and F), the left atrial disc was still in place, therewas neither residual shunt nor evidence of thrombosis.

Although percutaneous PFO closure is consideredboth safe and effective, occasionally it is associatedwith important complications. Once obtained a success-ful implantation, the most common late complicationsinclude erosion of the device into the aorta or leftatrium, allergic reactions to the nickel contained in thenitinol skeleton, arrhythmias and thrombus formationon the device. Of note, the incidence of the lattermight be dependent on the device chosen, with areported lower incidence with the Helex and Amplatzdevices, and on anatomical features of the PFO (e.g.,thick septum secundum) [1]. The device employedhere results from the modification of a previous device,which has been added an articulating center facilitatingthe alignment of the discs on the two sides of the

Fig. 1. A: intraoperative TEE. Both discs are well apposed tothe interatrial septum. B: 1-month follow-up: XPlane image.The right disc is dislodged and a 2 cm-long thrombus adheresto its surface (arrows). C: After 6 weeks of anticoagulant ther-apy the thrombus had disappeared; the right atrium disc(arrows) was definitely off-axis, suggesting fracture. D: Angio-

graphic picture of the device. The dashed line follows thecontour of the right atrial disc, almost parallel to the imagingplane. The left atrial disc lies almost perpendicular to thisplane (its axis is parallel to the continuous line). LA, leftatrium; RA, right atrium.

Patent Foramen Ovale Closure Device 779

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

interatrial septum. The safety and efficacy of this de-vice have been recently evaluated in large series enroll-ing, respectively 247 and 430 patients with a maximalfollow-up of 4.5 years [2,3]. In these series, no device-associated thrombi or fracture were reported. In thepresent case, the anatomy of the septum secundum(thick and relatively short) might have facilitated therupture of the device, exposing metallic componentsthat promoted blood coagulability, stasis, or causedendocardial injury.

We believe that a ‘‘cautious’’ approach, with a TEEfollow-up at 1 month, best addresses these risks. In arecent paper, we reported early thrombus formationon either disc in 5 patients that underwent implanta-tion of a similar device [4]: emphasizing the impor-tance of early follow-up TEE, no thrombosis wasdetected at 6 months. In this report, we describe acase of ‘‘sentinel’’ massive thrombosis on an initially‘‘occult’’ device fracture. These two complications,although very rare, might have catastrophic

Fig. 2. Percutaneous removal of the right atrial disc. A: Thedevice is snared and pulled into a 14-French sheath placed inthe right atrium. The left atrial disc, well adherent to the sep-tum, is held in place by its transseptal arms (B). A final con-trast injection (C) shows no shunt through the interatrial sep-

tum. D: At inspection, disruption of the polyvinyl alcohol discand exposure of the nitinol arms were evident. E, F: 3-monthsfollow-up TEE: Only the left atrial disc is visible. [Color figurecan be viewed in the online issue, which is available atwww.interscience.wiley.com.]

780 Gori et al.

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

consequences; effective early diagnosis and treatmentshould be warranted.

ACKNOWLEDGMENTS

The authors are grateful to Drs. Ascan Warnholtz,Margit Niethammer, R. Stephan von Bardeleben, andThomas Munzel for their contribution to the article.

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Patent Foramen Ovale Closure Device 781

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).