Fracture of the GORE HELEX septal occluder: Associated factors and clinical outcomes

Fracture of the GORE HELEX Septal Occluder:Associated Factors and Clinical Outcomes

Thomas Fagan,1* MD, Dennis Dreher,2 BS, Warren Cutright,2 DVM, Joth Jacobson,2 MS,and Larry Latson,3 MD, For the GORE HELEX Septal Occluder Working Group

Objectives: This study examines factors associated with, and clinical effects of, wireframe fractures (WFF) of the GORE HELEXTM Septal Occluder (HELEX). Methods: Inves-tigator-reported data from every HELEX implanted in the United States between 4/2000and 4/2005 were reviewed. Clinical and procedural data from patients who experiencedWFF were compared with data from patients who did not. The echocardiographic andfluoroscopic images for HELEX with WFF were reviewed for predictors of WFF andalterations in HELEX function. Results: With 90% of subjects followed for >12 months,19/298 (6.4%) HELEX implanted were found to have WFF. Thirty WFFs were observed,with multiple WFFs occurring in 8/19 HELEX. Univariate predictors of WFF were largedevice size (P 5 0.0003) and balloon defect size (P 5 0.001); however, large device size(P 5 0.0003) was the only significant predictor of WFF by multivariate analysis. WFF ofthe 30-mm and 35-mm HELEX accounted for 84% (16/19) of all WFFs. Review of HELEXimages with WFF revealed all WFF occurred along the circumferential wire, except one(straight portion of locking loop). Seventeen of 29 (59%) circumferential WFFs were onthe right disk. Residual defect status remained clinically insignificant (6/19) or becamecompletely occluded (13/19) during follow-up. There were no clinical sequelae due toWFF; however, secondary to right atrial disk mobility, the HELEX with locking loop WFFwas percutaneously removed 6 weeks after implantation. Conclusions: WFF occurred in6.4% of HELEX and were most common in large devices. With the exception of onedevice removed for theoretical risks, no clinical sequelae were related to WFF. WFF didnot alter the function of the HELEX. ' 2009 Wiley-Liss, Inc.

Key words: congenital heart disease; atrial septal defect; septal occluder device; framefracture; catheterization

INTRODUCTION

Transcatheter closure of a simple secundum atrialseptal defect (ASD) has become the preferred methodof therapy in most institutions. Several different devi-ces have been used for this purpose. There have beensporadic reported instances where there has been lossof integrity of almost all of these devices. The loss ofstructural integrity described has ranged from simplewire frame fracture (WFF) to complete separation ofdisks with device embolization [1–14]. However, therehave been no studies reported, for any ASD closuredevices to date, which specifically evaluate the riskfactors associated with such events and their effect ondevice safety and performance. Therefore, we con-ducted a review specifically examining factors thatmay be associated with, and the clinical effects of,WFF of the GORE HELEXTM Septal Occluder(HELEX) (W.L. Gore and Associates, Flagstaff, Ari-zona). The HELEX is the latest device approved bythe United States Food and Drug Administration spe-cifically for ASD closure.

Description of the Device

The design of the HELEX has been described pre-viously [15–20], but for the purposes of this discus-sion, a review of pertinent aspects of the HELEXdesign is warranted. HELEX is a double-disk devicecomposed of a single nitinol wire frame >90%encased within an expanded polytetrafluoroethylene

1Division of Pediatric Cardiology, The Children’s Hospital, Uni-versity of Colorado, Aurora, Colorado2W.L. Gore and Associates, Flagstaff, Arizona3Division of Pediatric Cardiology, Cleveland Clinic Foundation,Cleveland, Ohio

*Correspondence to: Thomas Fagan, MD, Division of Cardiology,

The Children’s Hospital, 13123 E. 16th Avenue, Cardiac Care Unit,

B100, Aurora, CO 80045. E-mail: [email protected]

Received 17 September 2008; Revision accepted 17 November 2008

DOI 10.1002/ccd.21929

Published online 11 February 2009 in Wiley InterScience (www.

interscience.wiley.com).

' 2009 Wiley-Liss, Inc.

Catheterization and Cardiovascular Interventions 73:941–948 (2009)

(ePTFE) membrane (Fig. 1a). The nitinol wire is0.012-inch in diameter; the same wire diameter isused for all device sizes. The wire is preshaped toform the circumference of both left and right atrialdisks (Fig. 1a–d). The proximal, central, and distalportions of the wire are wound tightly to form eye-lets. The last portion of the wire frame is the lockingloop which is formed from the distal end of thewire. This is a portion of the wire, which extendsfrom the left atrial eyelet, and in the configuredstate, passes through the central and proximal eyeletsto ‘‘lock’’ them together (Fig. 1c and e). The secondcomponent of the HELEX is an ePTFE curtain whichforms the occlusive disks. There are two sections ofePTFE, one corresponding to each of the right andleft atrial disks. The ePTFE is bonded to and encasesits corresponding portion of the nitinol wire frame(Fig. 1a). There are five device sizes manufactured;increasing in size by 5 mm disk diameter incrementsranging from 15 to 35 mm disk diameter.

METHODS

Investigator-reported data from every HELEXimplanted in the United States between 4/2000 and 4/2005 were reviewed. The implantations were performedunder the auspices of three FDA monitored investiga-

tional device exemption protocols of this device; feasi-bility, pivotal, and continued access. The data was sup-plied with approval from each of the 16 participatingcenter’s institutional review board and with study sub-ject’s written consent. Two additional, nonimplantationcenters provided core review of all procedural and fol-low-up echocardiograms (Table I). Demographic, ana-tomic, procedural, and follow-up data from patients whoexperienced WFF were compared with data frompatients who did not have WFF. Scheduled follow-upoccurred at 1 day, 1 month, 6 months, and 12–18 monthspost procedure for all protocols. According to these pro-tocols, fluoroscopic images were performed at the 6 and12 month follow-up evaluations. Additional fluoroscopicimages were performed on certain patients when clini-cally indicated. These fluoroscopic images were used toidentify device WFF (Fig. 2). WFF was defined as dis-placement of fractured wire ends or acute wire angula-tion (Fig. 2b and c).The fluoroscopic and echocardiographic images for

HELEX with WFF were reviewed for predictors ofWFF and alterations in HELEX function. Data obtainedfrom fluoroscopic review included, time to fracture,location of fracture, and changes in device configura-tion. To identify the specific location of the fracture,we viewed the RAO/Caudal and LAO/Cranial projec-tions of the device. We divided the circumference of thedevice into four quadrants and named these segments

Fig. 1. (a) Photograph of an extended HELEX. (b) Diagram of a partially extended HELEXwire frame prior to setting the locking loop. Note the locking loop within the delivery mandrel(arrow). (c) Diagram of a configured HELEX wire frame after setting the locking loop (arrow-head). (d) Fluoroscopic image of a HELEX in an RAO/Caudal projection. Note the typical‘‘figure eight’’ wire pattern made by the overlapping portion of both disks. (e) Fluoroscopicimage of a HELEX in an LAO/Cranial projection. Locking loop is indicated by the arrowhead.

942 Fagan et al.

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

relative to the face of a clock (11:00–1:00 o’clock,2:00–4:00 o’clock, 5:00–7:00 o’clock, and 8:00–10:00o’clock) (Fig. 3). The categories of fracture locationincluded the following: right vs. left atrial disk, over-lapping vs. nonoverlapping portion of the disk, clockface quadrant, and position relative to the orientationof the locking loop (toward vs. away). Data obtainedfrom echocardiographic review included presence ofmultiple atrial defects, presence of an atrial septal an-eurysm, device configuration and profile relative to theatrial septum, and residual leak status. For the purposeof this study, we defined an atrial septal aneurysm as agreater than 10 mm atrial septal wall excursion duringthe cardiac cycle and clearly redundant atrial tissueextending into right atrium (Fig. 4). Insignificant resid-

ual leak was defined as a color flow shunt �3 mm(clearly <6 mm) and no need for repeat intervention.Significant residual leak was defined as a color flowshunt �6 mm or any residual shunt requiring repeatintervention.The Chi-Square, the Fisher exact test, and logistic

regression were used for statistical analysis.

RESULTS

There were 298 HELEX successfully implantedbetween 4/2000 and 4/2005 with 94.2% (281/298) ofpatients followed for greater than 12 months fromimplant. Of the 298 HELEX, 19 (6.4%) were found tohave WFF. Two fractured HELEX were found by

Fig. 2. Fluoroscopic images of a HELEX device shown in an LAO and cranial projection.RAD 5 right atrial disk; LAD 5 left atrial disk. (a) Device without WFF at 6 months. (b) WFF ofLAD circumferential wire at 18 months indicated by overlap of the fractured ends (arrow).(c) Typical angulated fractures of the RAD (arrowheads) found at 30 months.

TABLE I. U.S. Helex Septal Occluder Working Group

Sarah Badran, MD Children’s Hospital of LA Los Angeles

Kak-Chen Chan, MD The Denver Children’s Hospital Denver

Collin Crowley, MD Primary Children’s Hospital Salt Lake City

Michael DeMoor, MD Massachusetts General Hospital Boston

Hitendra Patel, MD New England Medical Center Boston

Thomas Fagan, MD Children’s Hospital of Iowa Iowa City

Craig Fleismann, MD Arnold Palmer Children’s Hospitala Orlando

Frank Ing, MD Children’s Hospital of San Diego San Diego

Thomas Jones, MD Children’ Hospital Medical Center Seattle

Alexander Javois, MD Hope Children’s Hospital Oak Lawn

Larry Latson, MD Cleveland Clinic Foundation Cleveland

Ricardo Pignatelli, MD Texas Children’s Hospitala Houston

John Rhodes, MD Duke University Medical Center Durham

Jonathan Rome, MD Children’s Hospital of Philadelphia Philadelphia

Ziad Saba, MD Children’s Hospital of Oakland Oakland

Robert Vincent, MD Children’s Egleston-Sibley Heart Atlanta

E. Zahn/D. Nykanen, MD Miami Children’s Hospital Miami

Thomas Zellers, MD UT Southwestern Medical Center Dallas

aNonimplantation centers providing core review of all procedural and follow-up echocardiograms.

Wire Frame Fracture of HELEX Septal Occluder 943


1 month, 10 fractured devices by 6 months, and 7 at12–18 months. Thirty individual WFFs were observed,with multiple WFFs occurring in eight of the 19 (42%)fractured HELEX. There were six HELEX with twofractures and single devices had three fractures andfour fractures.Data from the 19 HELEX with WFF was compared

with HELEX without WFF (Table II). Univariate predic-tors of WFF were device size �30 mm (P 5 0.0003) anda balloon defect size �17 mm [median 17 mm (range13–22) vs. median 14 mm (range 5–26); P 5 0.001].However, large device size (P 5 0.0003) was the onlyindependent predictor of WFF found by multivariateanalysis. In fact, nine of the 50 (18%) 35-mm HELEXused in these protocols accounted for 47% of all WFF.WFF of the 30-mm and 35-mm HELEX accounted for84% (16/19) of all WFFs. All other predictors (includingage, device/defect, device/wt, device/BSA, defect/wt,defect/BSA, multiple fenestrations, and operator experi-ence) were not significant.

Image Review

Review of fluoroscopic images from HELEX withWFF revealed all WFF occurred along the circumfer-ential wire, except one device which had the fractureon the straight portion of locking loop (Fig. 5). Therewere no radial arm fractures observed. Seventeen of29 (59%) circumferential WFFs were on the right

atrial disk with the remaining 12 occurring on the leftatrial disk. Of the 29 circumferential WFF, 23 (79%)occurred at the nonoverlapping portion of the disk.The data related to WFF location relative to a clockface and the WFF location relative to the orientationof the locking loop is summarized in Table III. Thecircumferential WFF location was found somewhatmore frequently in the superior and inferior clock facequadrants. The WFF location was nearly evenly di-vided between those occurring toward the direction ofthe locking loop and those occurring away from thedirection of the locking loop.The presence of an atrial septal aneurysm at implant

was associated with 12 WFFs in 6/19 (31.5%)HELEX.After WFF was identified in the 19 HELEX, the resid-

ual defect status remained insignificant in 6 (31.6 %) orbecame completely occluded in 13 (68.4%) during fol-low-up. In one patient with multiple ASDs and HELEXWFF, a significant residual shunt was present at 12months. Core laboratory review determined this 6 mmshunt was remote to the HELEX. The defects covered bythe fractured HELEX were completely occluded. Theechocardiographic appearance of the HELEX after WFFimproved in 11/19 (57.9%) (Fig. 6), remained unchangedin 5/19 (26.3%), or worsened in 3/19 (15.8%).There were no clinical sequelae due to WFF in this

group; specifically, device embolization did not occur(neither device fragments nor the entire device). How-ever, secondary to excessive right atrial disk mobility/instability, the HELEX with locking loop WFF waspercutaneously removed 6 weeks after implantation.

Fig. 3. Fluoroscopic image of a HELEX device shown in theRAO and caudal projection. The circumference of the devicewas divided into four quadrants and these segments werenamed relative to the face of a clock (white numbers). Thisscheme was used to categorize location of WFF.

Fig. 4. 2-Dimensional transesophageal images of the intra-atrial septum. Arrow indicates the atrial septal aneurysm.RA 5 right atrium; LA 5 left atrium.

944 Fagan et al.


DISCUSSION

In a continually growing number of centers, percuta-neous device placement has become the treatment ofchoice for closure of hemodynamically significant ASDs.

To date, several different devices have been used for thispurpose. Although these devices have varied in design, acommon basic structure has been used for almost all; anocclusive material used to close the defect, held in posi-tion by a metallic wire frame. Intuitively, the integrity ofthe wire frame would need to be maintained in order forthe device to remain safe and effective; at least, until theforeign body reaction of the heart secures the device inposition. To date, all devices used clinically to closeASD have had reported frame fractures, malfunctions, orabnormal configurations [1–11,15–20]. Systematic eval-uation of these occurrences is necessary because signifi-cant complications may result [2,5,7,12,13,21]. Interest-ingly, however, WFF of certain devices have had verylittle, if any, clinical effect [1,3,4,6,8–11].

TABLE II. Predictors of HELEX Wire Frame Fractures

Variable With WFF W/O WFF N OR (95% CI) P value

Univariate Patient age (Years) 10.4 6.2 298 1.02 (0.99,1.05) 0.1854

Weight (kg) 35.9 22.4 298 1.01 (0.99,1.02) 0.4186

Size of device implanted (mm) 30 25 298 1.25 (1.11,1.41) 0.0003

Defect balloon size (mm) 17 14 294 1.27 (1.10,1.46) 0.0010

Device/Defect ratio 1.84 1.94 294 0.49 (0.11,2.18) 0.3477

Device/Weight ratio 0.90 1.12 298 0.86 (0.41,1.82) 0.6988

Device/Height ratio 0.23 0.22 298 1.98 (0.08,46.59) 0.6724

Device/BSA ratio 27.7 29.7 298 1.00 (0.96,1.04) 0.9805

Defect size/Weight ratio 0.52 0.59 294 1.11 (0.31,3.97) 0.8768

Defect/Height ratio 0.13 0.11 294 9.79 (0.05,1986.1) 0.3998

Defect/BSA ratio 15.7 14.8 294 1.02 (0.96,1.07) 0.5858

Multiple fenestrations 26% 19% 298 1.52 (0.53,4.41) 0.4385

Operator experience – – 298 0.98 (0.96,1.01) 0.1576

Multivariate Size of device implanted (mm) – – 288 1.26 (1.11,1.43) 0.0003

Median within group presented for With WFF and W/O WFF.

P value from Wald Chi-Square test in logistic regression. Univariate P values reported regardless of significance. Multivariate model uses stepwise

selection with entry level 0.1 and variable remains if meets the 0.05 level using stepwise selection.

OR, odds ratio; 95% CI, 95% confidence interval.

Fig. 5. Fluoroscopic images of a fractured HELEX device shown in an LAO and cranial projec-tion. RAD 5 right atrial disk; LAD 5 left atrial disk. Arrowhead indicates WFF of the straight por-tion of the look loop. Arrows indicates WFF of the LAD circumferential wire. These WFFsresulted in an excessively mobile RAD. (a) and (b) are from different phases of the cardiac cycle.Note the change in angle and change in separation of the inferior margins of the two disks.

TABLE III. Fluoroscopic Location of Circumferential WFF

n

Clock face quadrant11–1 o’clock 6 (12 o’clock 5 6)

02–4 o’clock 5

05–7 o’clock 13 (6 o’clock 5 9)

08–10 o’clock 5

WFF relative to lock loop

Toward lock loop 16

Away from lock loop 13



The HELEX was not impervious to this issue. Ofthe HELEX used in the United States between 4/2000and 4/2005, WFF occurred at a rate of 6.4%. ThisWFF rate is equal to or lower than the reported rate ofWFF for most other ASD closure devices [1,6–11].WFFs of the HELEX had no deleterious effects on de-

vice function. All defects covered by the 19 HELEXwith WFF either persisted with an insignificant residualshunt (31.6%) or became completely occluded (68.4%).As has been reported with certain other ASD closure

devices, WFF of the HELEX produced no clinical seque-lae. On the contrary, 84.2% of HELEX with WFF eitherremained unchanged in echocardiographic appearance orconformed more appropriately to the intracardiac anat-omy. The HELEX is not only a more soft, compliantASD closure device than most others, but perhaps the oc-currence of WFFs allows the ‘‘device to conform to theheart’’ rather than forcing the ‘‘heart to conform to thedevice’’. Most other ASD closure devices have causedcardiac erosions or fistula [5,7,13,21–27]. To date, withworld-wide use of the HELEX there has not been a sin-gle reported cardiac perforation or erosion of the aorticroot or atrial free wall. Additional long term follow-up isneeded to determine whether the HELEX will prove tobe a much more cardiac friendly ASD closure device.Although there were no clinical sequelae directly at-

tributable to WFF of the HELEX, one patient didundergo percutaneous removal of a HELEX with WFF 6weeks after implantation. This patient’s HELEX wasfound to have a WFF on the straight portion of the lockloop. There was also a WFF on the circumferential wireof the left disk, near the radial arm extending from thecentral eyelet. The left atrial disk was in proper position

and completely occluded the ASD. The right atrial diskhad excessive mobility within the right atrium. Based onthe theoretic risks of thrombus formation, incompleteendotheliazation or right atrial disk embolization, the de-cision was made to remove the device. As with all ASDclosure devices with WFF or other loss of structural in-tegrity, there is a risk of embolization [5,7,12–14], notonly of the entire device, but also portions or fragmentsof the device. Device embolization did not occur withWFF of the HELEX. Considering that >90% of the wireframe of the HELEX is encased by ePTFE, the risk of awire fragment embolizing is remote. The only portion ofthe wire frame at risk would be the lock loop. In the sin-gle occurrence of a lock loop fracture found in ourreview, the lock loop was embedded in the ePTFE of theright atrial disk and thus could not embolize.WFF may occur as the result of added loading con-

ditions placed on the HELEX. This stress placed onthe wire frame may produce maximum fatigue at sitesof imperfections in the nitinol wire. These imperfec-tions are known as inclusions and are present in allgrades of nitinol. The inclusions may act as the incit-ing area for the initiation of the WFF. With continuedstress, the wire may continue to fatigue and a patternof progressive propagation could result, eventually pro-ducing a complete break.To receive approval from the FDA to conduct clini-

cal trials and obtain marketing approval, the designand wire frame of the HELEX underwent rigorous pre-clinical testing that included wire durability, fatigue re-sistance, and finite element analysis. The design fea-tures of the device were evaluated using computer sim-ulations, in vitro and in vivo tests. Finite element

Fig. 6. 2-Dimensional transthoracic 4-chamber images of a HELEX within the intra-atrialseptum. Bracket indicates the HELEX; RA 5 right atrium; LA 5 left atrium. (a) At day 1—Bulkyprofile of the HELEX. (b) At 12 months—Significantly improved profile.

946 Fagan et al.


analysis of the device frame predicted no WFF underthe anticipated physiological loads. No WFFs werefound to have occurred in fatigue testing, simulating10 years within the body with differential pressuresbetween the sides [17]. Despite preclinical testing, thisstudy reports the finding of WFFs that occurred in thecircumferential wire. Although fatigue resistance canbe readily measured and assured through routine engi-neering methods, the ability to predict the time andlocation of WFF accurately for HELEX implanted inthe atrial septum continues to be uncertain. The chal-lenge in predictive modeling stems from the limitedoverall understanding of the in vivo boundary condi-tions associated with the dynamic change in pressureand motion in the atria and atrial septum. Understand-ing of atrial septal motion has improved by the adventof newer imaging modalities such as three-dimensionalechocardiography and cardiac MRI [28–31]. Furtherrefinement of motion and force measurements will leadto improvements in the predictive capabilities of finiteelement analysis and the in vitro tests associated withcardiac device design.It stands to reason that with atrial systole, the rela-

tively compliant HELEX may experience circumferen-tial compression or be forced to bend from its nominalconfiguration. Because it is not a fixed portion of thedisk’s circumference, the overlapping portion of eachdisk may be a site capable of absorbing some of thestress from either a forced bend or circumferentialcompression. However, sites opposite to the overlap-ping portion of the disk may then bear the maximumstress. These thoughts are corroborated by the fact thatwe found 79% of circumferential WFFs occurred onthe nonoverlapping portion of the disk.In keeping with the thought that normal anatomic

changes of the heart may lead to WFF, it would seemreasonable that a larger ratio of HELEX size to atrialsize would be risk factor for WFF. Because direct mea-surements of overall atrial size and atrial septal lengthwere not obtained during the prospective U.S. trials, thepreprocedure and procedural echocardiographic imagesavailable for review were, for the most part, notadequate to collect this data retrospectively. Interesting,however, indirect measures of a larger ratio of devicesize to atrial size, such as device/wt and device/bodysurface area, were not found to be statistically signifi-cant when compared with HELEX without WFF.In our review, the only factor found to independently

predict WFF was large HELEX size. In fact, 84% ofall fractures occurred in the two largest HELEX sizes.Considering all HELEX are manufactured with thesame diameter nitinol wire frame, the wire diameter issmaller relative to the device surface area for the largerHELEX compared with smaller HELEX. Therefore, if

the additional loading conditions placed on differentsized HELEX are equivalent, the larger device size willhave the highest likelihood of WFF. Theoretically then,the risk of WFF may be reduced by use of a smallersized HELEX when possible.In addition to anatomic changes during the normal

cardiac cycle, the risk of WFF may be compounded bythe stresses produced by an atypical HELEX configu-ration. This was commonly encountered when theHELEX was used in the presence of an atrial septal an-eurysm. In this setting, the left atrial disk tends to‘‘funnel’’ into the aneurysm increasing its profile to asmall extent. The right atrial disk retains a normal, flatconfiguration but the entirety of the disk may not comein contact with the right side of the atrial septum.Although the HELEX functioned normally when usedin this setting, the additional stress placed on the nitinolframe may account for the relatively high rate of WFF(31.5%) when the HELEX was used in association withan atrial septal aneurysm.In summary, WFF of the HELEX did occur at a low

rate of 6.4%, which is lower than most other wireframe ASD closure devices. The only independent pre-dictor of HELEX WFF was large device size. Use ofthe HELEX in association with an atrial septal aneu-rysm had a high rate of WFF. WFF had no deleteriouseffect on function of the HELEX. With the exceptionof one HELEX removed for theoretic reasons, therewere no clinical sequelae related to WFF.

REFERENCES

1. Hoepp HW, Deutsch HJ, La Rosee K, Schnabel P, Terheggen G,

Schneider CA, Korsten J, Babic UU. Transcatheter closure of

atrial-septal defects and patent foramen ovale in adults: Optimal

anatomic adaptation of occlusion device. Am Heart J 1999;138

(5 Part 1):941–949.

2. Hung J, Landzberg MJ, Jenkins KJ, King ME, Lock JE, Palacios

IF, Lang P. Closure of patent foramen ovale for paradoxical

emboli: Intermediate-term risk of recurrent neurological events

following transcatheter device placement. J Am Coll Cardiol

2000;35:1311–1316.

3. Kreutzer J, Ryan CA, Gauvreau K, Van Praagh R, Anderson

JM, Jenkins KJ. Healing response to the clamshell device for

closure of intracardiac defects in humans. Catheter Cardiovasc

Interv 2001;54:101–111.

4. Latson LA, Jones TK, Jacobson J, Zahn E, Rhodes JF. Analysis

of factors related to successful transcatheter closure of secundum

atrial septal defects using the HELEX septal occluder. Am Heart

J 2006;151:1129, e7–e11.

5. Mellert F, Preusse CJ, Haushofer M, Winkler K, Nill C, Pfeiffer D,

Redel D, Luderitz B, Welz A. Surgical management of compli-

cations caused by transcatheter ASD closure. Thorac Cardiovasc

Surg 2001;49:338–342.

6. Prieto LR, Foreman CK, Cheatham JP, Latson LA. Intermedi-

ate-term outcome of transcatheter secundum atrial septal defect

closure using the Bard clamshell septal umbrella. Am J Cardiol

1996;78:1310–1312.



7. Sievert H, Babic UU, Hausdorf G, Schneider M, Hopp HW,

Pfeiffer D, Pfisterer M, Friedli B, Urban P. Transcatheter closure

of atrial septal defect and patent foramen ovale with ASDOS de-

vice (a multi-institutional European trial). Am J Cardiol 1998;

82:1405–1413.

8. Sievert H, Horvath K, Zadan E, et al. Patent foramen ovale clo-

sure in patients with transient ischemia attack/stroke. J Interv

Cardiol 2001;14:261–266.

9. Kay JD, O’Laughlin MP, Ito K, Wang A, Bashore TM, Harrison

JK. Five-year clinical and echocardiographic evaluation of the

Das AngelWings atrial septal occluder. Am Heart J 2004;147:

361–368.

10. Carminati M, Chessa M, Butera G, Bini RM, Giusti S, Festa P,

Spadoni I, Redaelli S, Hausdorf G. Transcatheter closure of

atrial septal defects with the STARFlex device: Early results and

follow-up. J Interv Cardiol 2001;14:319–324.

11. Carminati M, Giusti S, Hausdorf G, et al. A European multicen-

tric experience using the CardioSEal and Starflex double um-

brella devices to close interatrial communications holes within

the oval fossa. Cardiol Young 2000;10:519–526.

12. Kabus M, Hahn G, Nachtrodt G, Lorenz N, Kropp J, Goldner B,

Hausdorf G. [Late complications after transcatheter closure of

atrial septal defect]. Z Kardiol 2001;90:516–521.

13. Rao PS, Ende DJ, Wilson AD, Smith PA, Chopra PS. Follow-up

results of transcatheter occlusion of atrial septal defects with

buttoned device. Can J Cardiol 1995;11:695–701.

14. Schlesinger AE, Folz SJ, Beekman RH. Transcatheter atrial sep-

tal defect occlusion devices: Normal radiographic appearances

and complications. J Vasc Interv Radiol 1992;3:527–533.

15. Delaney JW, Chan KC, Rhodes JF Jr. The design and deploy-

ment of the HELEX septal occluder. Congenit Heart Dis 2006;

1:202–209.

16. Jones TK, Latson LA, Zahn E, Fleishman CE, Jacobson J, Vincent

R, Kanter K. Results of the U.S. multicenter pivotal study of the

HELEX septal occluder for percutaneous closure of secundum

atrial septal defects. J Am Coll Cardiol 2007;49:2215–2221.

17. Latson LA, Zahn EM, Wilson N. Helex septal occluder for clo-

sure of atrial septal defects. Curr Interv Cardiol Rep 2000;2:

268–273.

18. Pedra CA, Pedra SF, Esteves CA, Chamie F, Ramos S, Pontes

SC Jr, Tress JC, Braga SL, Latson LA, Fontes VF. Initial expe-

rience in Brazil with the Helex septal occluder for percutaneous

occlusion of atrial septal defects. Arq Bras Cardiol 2003;81:

435–452.

19. Vincent RN, Raviele AA, Diehl HJ. Single-center experience

with the HELEX septal occluder for closure of atrial septal

defects in children. J Interv Cardiol 2003;16:79–82.

20. Zahn EM, Wilson N, Cutright W, Latson LA. Development and

testing of the Helex septal occluder, a new expanded polytetra-

fluoroethylene atrial septal defect occlusion system. Circulation

2001;104:711–716.

21. Bohm J, Bittigau K, Kohler F, Baumann G, Konertz W. Surgical

removal of atrial septal defect occlusion system-devices. Eur J

Cardiothorac Surg 1997;12:869–872.

22. Amin Z, Hijazi ZM, Bass JL, Cheatham JP, Hellenbrand WE,

Kleinman CS. Erosion of Amplatzer septal occluder device after

closure of secundum atrial septal defects: Review of registry of

complications and recommendations to minimize future risk.

Catheter Cardiovasc Interv 2004;63:496–502.

23. Chun DS, Turrentine MW, Moustapha A, Hoyer MH. Develop-

ment of aorta-to-right atrial fistula following closure of secun-

dum atrial septal defect using the Amplatzer septal occluder.

Catheter Cardiovasc Interv 2003;58:246–251.

24. Divekar A, Gaamangwe T, Shaikh N, Raabe M, Ducas J. Car-

diac perforation after device closure of atrial septal defects with

the Amplatzer septal occluder. J Am Coll Cardiol 2005;45:

1213–1218.

25. Grayburn PA, Schwartz B, Anwar A, Hebeler RF Jr. Migration

of an amplatzer septal occluder device for closure of atrial septal

defect into the ascending aorta with formation of an aorta-to-

right atrial fistula. Am J Cardiol 2005;96:1607–1609.

26. Rickers C, Hamm C, Stern H, Hofmann T, et al. Percutaneous

closure of secundum atrial septal defect with a new self center-

ing device (‘‘angel wings’’). Heart 1998;80:517–521.

27. U.S. Food and Drug Administration. Manufacturer and User Fa-

cility Device Experience Database (MAUDE). U.S. Food and

Drug Administration, Center for Devices and Radiological Health;

June 1993–present.

28. Patel AR, Fatemi O, Norton PT, West JJ, Helms AS, Kramer

CM, Ferguson JD. Cardiac cycle-dependent left atrial dynamics:

Implications for catheter ablation of atrial fibrillation. Heart

Rhythm 2008;5:787–793.

29. Perea RJ, Tamborero D, Mont L, et al. Left atrial contractility is

preserved after successful circumferential pulmonary vein abla-

tion in patients with atrial fibrillation. J Cardiovasc Electrophy-

siol 2008;19:374–379.

30. Wylie JV Jr, Peters DC, Essebag V, Manning WJ, Josephson

ME, Hauser TH. Left atrial function and scar after catheter abla-

tion of atrial fibrillation. Heart Rhythm 2008;5:656–662.

31. Lickfett L, Dickfeld T, Kato R, Tandri H, Vasamreddy CR,

Berger R, Bluemke D, Luderitz B, Halperin H, Calkins H.

Changes of pulmonary vein orifice size and location throughout

the cardiac cycle: Dynamic analysis using magnetic resonance

cine imaging. J Cardiovasc Electrophysiol 2005;16:582–588.

948 Fagan et al.


Fracture of the GORE HELEX septal occluder: Associated factors and clinical outcomes

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