Case Reports

Fracture of a GORE HELEX Septal OccluderFollowing PFO Closure in a Diver

Paul Scott,1 MBChB, MRCP, Neil Wilson,2 MBBS, FRCP, and Gruchen Veldtman,3* MBChB, MRCP

Decompression illness (DCI) is more common in divers with a patent foramen ovale(PFO), and transcatheter PFO closure is being increasingly performed in patients withan episode of DCI who want to continue diving. A range of closure devices are avail-able and the choice in an individual case depends on operator preference and PFOanatomy. The GORE HELEX Septal Occluder, introduced in 1999 primarily for secun-dum atrial defect closure, is a compliant non self-centering device composed of a wirehelical framework on which a microporous membrane is mounted. The device is fixedin place by a unique interlocking mechanism that passes through the center of the de-vice from the left to the right atrial disc, thereby securing it onto the interatrial septum.Here, we present a case of a locking loop fracture and review the literature concerningthis unusual complication. ' 2009 Wiley-Liss, Inc.

Key words: patent foramen ovale; congenital heart disease; HELEX device; decom-pression illness

INTRODUCTION

Patent foramen ovale (PFO) has been implicated ina diverse range of medical conditions, including cryp-togenic stroke, migraine, and decompression sickness[1]. Since it was demonstrated that PFO closure usingpercutaneous devices was both feasible and safe, therehas been widespread uptake of the procedure and vari-ous closure devices are now available depending onoperator preference and PFO anatomy. Although gener-ally safe in the short term, data on longer term compli-cations is currently lacking [2]. With their increasinguse, the reporting of late complications is essential toimprove patient safety and ensure optimal patient anddevice selection. Here, we describe a case of late frac-ture of the locking loop in a HELEX closure device(W.L. Gore and Associates, Flagstaff, AZ) 3 monthsafter implantation for decompression illness (DCI)associated with a PFO. We also review the literatureconcerning this rare complication.

CASE REPORT

A 43-year-old professional diving instructor wasreferred to the Wessex Adult Congenital Heart Unitfor consideration of transcatheter PFO closure. He hadsuffered an episode of neurological decompressionsickness with vestibular symptoms following a dive. A

transesophageal echocardiogram (TOE) had demon-strated a PFO with evidence of significant right to leftshunting. The PFO was composed of a long tunnel andthe secundum septum was relatively thick, measuring8 mm in diameter (Fig. 1A and B). The eustachianvalve’s attachment to the atrial septum was in theproximity of the PFO, adding to its overall thickness.There were also overlapping portions of septum pri-mum and secundum contributing to the increased widthof the interatrial partition. The patient was keen to

Conflict of interest: Nothing to report.

1Wessex Cardiothoracic Unit, Southampton University Hospi-tals NHS Trust, Southampton, United Kingdom2Department of Cardiology, John Radcliffe Hospital, Oxford,United Kingdom3Congenital Cardiac Unit, Southampton University HospitalNHS Trust, Southampton, United Kingdom

*Correspondence to: Gruschen R. Veldtman, Wessex Adult Congen-

ital Heart Unit, Wessex Cardiothoracic Centre, Southampton Univer-

sity Hospital, Tremona Road, Southampton, United Kingdom.

E-mail: gruschen@aol.com

Received 22 July 2008; Revision accepted 29 October 2008

DOI 10.1002/ccd.21901

Published online 29 January 2009 in Wiley InterScience (www.

interscience.wiley.com).

' 2009 Wiley-Liss, Inc.

Catheterization and Cardiovascular Interventions 73:828–831 (2009)

continue diving and was therefore put forward for PFOclosure.The procedure was performed under general anesthe-

sia using fluoroscopic and TOE guidance. A 25-mmGORE HELEX Septal Occluder device was chosen aswe thought it would adequately cover the length of thetunnel and have sufficient support on each side of theseptum. The device was delivered through a 10 Frenchcatheter introduced through the right femoral vein, andsuccessfully deployed across the septum without com-plication using previously described techniques [3](Fig. 1C). A postprocedural TOE confirmed appropri-ate positioning of the device with both discs welldeployed and no residual shunt (Fig. 1D). The devicewas well apposed to the septum but protruded some-what into the atria, presumed secondary to a widerseparation of the left and right atrial discs by the thickinteratrial septum.Three months following the initial procedure, the

patient was noted as having a small PDA and wasbrought back for percutaneous closure of this in thecathlab. However, during fluoroscopic screening it wasnoted that there was a fracture of the locking loop ofthe HELEX device (Fig. 2A). A subsequent TOE con-firmed that the left atrial component of the device waspoorly adherent to the interatrial septum with somemovement of the outer most portion of the left atrial

disc during the cardiac cycle. Associated with thisthere was also a large residual right to left shunt (Fig.2B). The device appeared stable, and we elected totake a conservative approach with a repeat bubble con-trast study at 6 months. This revealed only a tinyresidual shunt, and a subsequent TOE demonstratedadherent right atrial and inner left atrial discs, whilethe outer portion of the left atrial disc was still rela-tively mobile. He had suffered no thromboembolic orother device-related complications at 6-month review.

DISCUSSION

DCI is more common in divers with a PFO, and therisk of a major episode of DCI is directly related tothe size of the septal defect [4]. Consequently, in com-mercial divers with an episode of DCI, as in our case,closure of a PFO with a significant shunt is broadlyadvocated if the patient wishes to continue diving,though there are no consensus guidelines to supportthis indication [5]. A range of devices available forPFO closure have been demonstrated to be safe in theshort term. Longer term data however is still lacking.The HELEX device used in our case is made of a

single spiral-shaped nitinol wire with an expandedpolytetrafluoroethylene (ePTFE) patch attached alongits length. Its safety has been evaluated in three series

Fig. 1. A: Transoesophageal echocardiographic view (bicavalview) demonstrating the long tunneled structure of the PFO(arrow). B: Transoesophageal echocardiographic view (4-chamber view) demonstrating the thick secundum septum (�8mm) (arrow). C: Fluoroscopic image of the fully deployed

GORE HELEX Septal Occluder at initial implantation. D: Trans-oesophageal echocardiographic view (bicaval view) demon-strating the fully deployed HELEX device at initial implanta-tion. Note the generous separation of the two discs (arrow).

Fracture of a GORE HELEX Septal Occluder 829

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

enrolling 229 patients with PFOs [6–8]. In a multicen-ter study enrolling 128 patients during a mean followup of 22 (611) months there were 11 adverse events,including two cases of device wire frame fracture,however there were no reports of locking loop frac-tures [6]. In a single centre study of 68 patients with3-month follow-up, six patients needed device removalfollowing deployment, but there were no other compli-cations and no cases of wire fracture [7]. In a single-center study using the device in 33 patients there wereno reported complications [8]. There has been onlyone previous report of a locking loop fracture with theGORE HELEX Septal Occluder [9]. In this case, thefractured device was removed percutaneously 6 weeksafter implantation because of right atrial disc mobilitybut there were no clinical sequelae. Though rare, lock-ing loop fracture is an important complication becauseof the associated risk of residual shunt and throm-boembolism. In addition there is concern about devicestability, particularly should a wire frame fractureevolve because of the increased device mobility.There is considerable variation in PFO size and

morphology, and it has been suggested that with a va-riety of different closure devices available these factorsare important when choosing the most appropriate de-vice to optimize closure for an individual patient[10,11]. Such anatomical differences may also be im-portant in predisposing to specific device-associatedcomplications. In our case, the secundum septum wasrelatively thick with a long tunneled PFO. It is possi-ble that this anatomical variation placed the lockingloop under increased tension by transferring forcesexerted by the contracting atrial myocardium directlyto the loop, and thus contributing to its fracture.The HELEX device was initially designed for clo-

sure of secundum atrial septal defects, though it is

now licensed in Europe (but not the United States) forPFO closure. Although in Europe the manufacturers donot recommend its use for PFO closure in patientswith a septal thickness of greater than 8 mm in thearea of occluder placement, the suitability of specificPFO anatomy in relation to the HELEX device has notbeen formally evaluated. In cases similar to ours, witha relatively thick septum coupled to a long tunneledPFO, another device may be more suitable to avoidthis rare but potentially important complication. Iffaced with similar anatomy in the future we wouldadvocate using a less compliant device that is morelikely to distort the PFO anatomy to such a degree thatthe device predetermined shape is maintained. Suchdevices that are currently available include the Amplat-zer PFO occluder (AGA Medical Corp., Golden Val-ley, MN) and the Solysafe Septal Occluder (Swissim-plant AG, Solothurn, Switzerland).Following PFO closure in divers, our standard prac-

tice is to repeat a bubble study at 6 months to look fora residual shunt. In patients anxious to recommencediving this is occasionally performed earlier, thoughnot before 6 weeks, as early residual leaks may sponta-neously resolve after the process of endothelializationis complete. Our conservative strategy thus far hasproved appropriate in that the residual shunt is signifi-cantly reduced, and though mobile, the outer compo-nent of the left atrial disc has remained intact. We arekeeping the patient under close surveillance for anyfurther changes in the device. Some authors may arguethat a more aggressive strategy with needle punctureof the soft device and implantation of a 2nd devicethrough the center of the current device to achieveapposition is suitable. We believe this to be a reasona-ble strategy, and will review the patient once sufficienttime has elapsed to reassess the degree of residual

Fig. 2. A: Fluoroscopic image of the GORE HELEX SeptalOccluder following fracture of the locking loop. There is a sig-nificantly increased distance between the two discs comparedto Fig. 1C. The remaining fragments can be seen on the leftand right atrial discs (arrows). B: Transoesophageal echocar-

diographic view (bicaval view) following fracture of the lockingloop. The right atrium is opacified with bubbles. The outeroverlapping portion of the left atrial disc (white arrow) is nowseparated from the inner left atrial disc (black arrow) whichappears still applied to the septum.

830 Scott et al.

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

shunting. Until then the patient has been advised torefrain from diving.

CONCLUSION

Although percutaneous PFO closure has become anestablished therapeutic procedure it is not without risk.Although rare, locking loop fracture of the GOREHELEX Septal Occluder is a potentially importantcomplication that may lead to continued intra-atrialshunting and possibly device instability when associ-ated with wire frame fracture. There is significant indi-vidual variation in PFO anatomy, and such anatomicaldifferences are important in choosing the most suitableclosure device in an individual patient. A wide inter-atrial septum, in association with a long PFO tunnel,may represent unfavorable anatomy for the HELEXdevice.

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