Introduction

Transcatheter occlusion of the patent arterial duct isnow an accepted modality for duct treatment. Manychildren and adults world-wide have one or more devic-es implanted [1±6]. Different types of devices have beenutilised; occasionally, more than one device has beenused to achieve total occlusion of the duct [7±9]. Our ob-jective is to show the radiographic appearance of theRashkind double umbrella device in the position of theduct.

Material and methods

The AP (children), PA (adults) and lateral chest radiographs of 69patients (52 F, 17 M) who underwent closure of their patent arteri-al duct between March 1990 and August 1994 were reviewed. Themedian age of this population was 60 months (range 12 months±66 years) and the median weight was 17 kg (range 6±85 kg). Onlysix patients (9%) were older than 18 years of age. Eight patientswere in congestive heart failure. Three had rubella syndrome, andone had Down's syndrome.

Omar GalalWalter von SinnerNawal AzhariFadel Al-FadleyMichael de MoorJana BoÈ ckerMohammed E. FawzyZohair Al-Halees

Clinical results and radiographicappearance of the Rashkind doubleumbrella device in patients withocclusion of the ductus arteriosus

Received: 20 January 1997Accepted: 23 June 1997

O. Galal ⋅ W. von Sinner ⋅ N. AzhariF. Al-Fadley ⋅ M. de Moor ⋅ J. BoÈ cker ´M. E. Fawzy ⋅ Z. Al-HaleesKing Faisal Specialist Hospital andResearch Centre, Riyadh, Saudi Arabia

M.O. Galal ())Department of Cardiovascular Diseases,MBC 16, King Faisal Specialist Hospitaland Research Centre, PO Box 3354,Riyadh 11211, Saudi Arabia

Abstract Background. The Rash-kind double umbrella device for pa-tent arterial duct occlusion has beenused in many patients. Its radio-graphic appearance has not beensufficiently described.Objective. To present the varyingradiographic appearances of theRashkind double umbrella deviceon the chest X-ray.Materials and methods. The chestradiographs of 69 patients (medianage 60 months; median weight17 kg), who underwent closure oftheir patent arterial duct betweenMarch 1990 and August 1994, werereviewed. The following parameterswere evaluated: 1) the size of theheart (cardio-thoracic ratio) andpulmonary vessels, 2) the position ofthe device in AP/PA and lateralprojections. The results of occlusionof the patent arterial duct were alsoreviewed.

Results. Sixty-two of 69 (90 %) pa-tients had complete occlusion after afollow-up between 2 months and 31/2

years. The cardio-thoracic ratioshowed significant reduction at fol-low-up (P < 0.001). The two differ-ent size devices could be welldifferentiated in the AP and the lat-eral projection. In 14 patients (20 %)the device was in an asymmetricalposition. There was no significantcorrelation between position of thedevice and success of occlusion inour material.Conclusion. Complete occlusion ofthe arterial duct using Rashkinddouble umbrella devices can beachieved in 90% of our population.In 20 % the device will have anasymmetrical position. There isno correlation between asymmetri-cal position of the device in thechest radiograph and residualshunting.

Pediatr Radiol (1997) 27: 936±941 Springer-Verlag 1997

Procedure

The technique of implantation of the 12-mm or the 17-mm Rash-kind device has been described elsewhere [10]. In brief, femoralvenous and arterial access was established. After having obtainedpressures and saturations in the right and left side of the heart, an-giography was performed in the descending aorta near the duct to

visualise its shape and estimate its narrowest diameter. Accordingto its narrowest diameter either a 12-mm, or in case of a duct largerthan 4 mm, a 17-mm device was deployed. Ten minutes after im-plantation repeat aortic angiography was done to assure the cor-rect position of the device and to document any residual shunting.All patients had cephazolin at a dosage of 30 mg/kg for endocardi-tis prophylaxis during the procedure and 6 h later. Before dis-

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1a 1b

2a 2b

2c 2d

Fig.1 a A 12-mm Rashkinddouble umbrella device fromthe view of the proximal um-brella which is usually posi-tioned in the main pulmonaryartery. The 12-mm device hasthree legs on each umbrella andwhen implanted will usuallycreate a ªstarº appearancefrom this view. b A 17-mmRashkind double umbrella de-vice from the view of the distalumbrella which is usually posi-tioned in the ampulla of the ar-terial duct. This device has fourlegs on each umbrella, andwhen implanted will usuallycreate a ªcart wheelº appear-ance

Fig.2 a Angiogram in the de-scending aorta in the lateralview, showing the orientation ofthe duct which is directed hori-zontally and anteriorly, with itsnarrowest diameter at the ante-rior border of the trachea.b Angiogram in the descendingaorta in the lateral view 10 minafter occlusion of the duct usinga 12-mm umbrella device. Notethat the proximal legs of thedevice are not as well seen asthe distal legs. c Chest radio-graph showing, in the AP view,a symmetrical 12-mm device inthe position of the duct. Noticethe star appearance of the de-vice which is positioned to theleft of the vertebrae and justabove the left bronchus. d Lat-eral chest radiograph showing asymmetrical 12-mm device inthe position of the duct

charge, a colour Doppler echocardiography was taken to docu-ment any residual shunting. The patients received a chest X-rayand repeat colour Doppler echocardiography on a yearly basis.The results of device implantation were reviewed and the compli-cations, as well as the complete occlusion rates, are presented.

The Rashkind double umbrella device

The Rashkind double umbrella device is produced in two sizes.Both sizes have two polyurethane foam umbrellas with metalframe structures connected in a divergent direction. The 12-mmdevice (Fig. 1a) has only three legs, while the 17-mm device(Fig. 1b) has four legs on each umbrella. The distal umbrella ofboth devices should be positioned in the ampulla of the arterialduct, while the proximal umbrella should be in the main pulmo-nary artery.

Radiography

On the AP view the patent arterial duct is usually positioned to theleft of the trachea, above the left main bronchus. On the lateralview, the narrowest diameter of the duct is usually located at theanterior border of the tracheal shadow (Fig.2a). Ducts are, in gen-eral, horizontally and anteriorly directed. The legs of the devicesare radiopaque. The proximal legs of the 12-mm device are less ra-diopaque than the distal legs (Fig. 2b). The final position of the dis-tal legs of each device should optimally fit into the ductal ampulla,while the proximal legs will be positioned into the main pulmonaryartery. The centre of the device should ideally fit into the area ofthe narrowest diameter of the duct (Fig. 2c,d). Radiographs of thechest were reviewed at first admission, before the procedure andon final follow-up. On the chest X-ray the following parameterswere evaluated: (1) the size of the heart and pulmonary vessels(cardio-thoracic ratio) and (2) the position of the device in thefrontal and lateral projections. Device position was judged sym-metrical when all legs were regularly symmetrically opened andthe device positioned in the AP view to the left of the trachea,above the left main bronchus. On the lateral view the centre ofthe device should be approximately at the anterior border of thetracheal shadow and aligned with the duct direction. Asymmetricalposition was defined by having with the device not aligned to thenormal direction of the ampulla of the patent arterial duct and

not demonstrating the typical ªcart wheel appearanceº on thefrontal view (Fig. 3a±c).

Statistics

The chi-square test was used for comparison between the positionof the device and residual shunting. The paired two-tailed Stu-dent's t-test was used for comparing the mean of the cardio-thorac-ic ratio before and after transcatheter occlusion of the arterial duct.A value of < 0.05 was significant.

Results

The median narrowest angiographic diameter of the pa-tent arterial duct before device implantation was3.5 mm (range 0.7±6 mm). The median pulmonary arte-rial systolic pressure was 30 mmHg (range 16±64 mmHg). Eight patients had systolic pulmonary pres-sure above 40 mmHg.

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Fig.3 A patient with a largepatent arterial duct showingmarked cardiomegaly and ple-thoric lungs due to a left to rightshunt. a PA and b lateral view,before the introduction of a 17-mm device. c PA chest radio-graph showing good position ofthe 17-mm Rashkind devicewith its legs showing regulardistance from each other in aªcart wheelº appearance. Notemarked decrease of cardiac sizeand spectacular disappearanceof pulmonary plethora

3a 3b

3c

Complications

The following complications occurred during the proce-dure. In one case embolisation of the device into the leftpulmonary artery occurred, but the device was success-fully retrieved by a transcatheter approach. In nine pa-tients inadvertent pull-through of the device occurred.The same or a new device was then implanted safely.ªPull-throughº of the device occurs when the distal um-brella in the ampulla of the duct is pulled through intothe pulmonary artery, before detaching the device fromthe delivery system. Usually, underestimating the size ofthe duct or excessive traction on the delivery systemleads to pull-through of the opened distal umbrella intothe pulmonary artery. Unlike embolisation of the device,the two umbrellas are still attached to the delivery systemand can be retrieved safely into the long Mullins sheath.

Complete occlusion

Repeat angiography 10 min after implantation of thedevice showed complete occlusion of the ductus in 25patients (36 %). In a further 14 patients (20 %) completeocclusion occurred before discharge and was document-ed by colour flow Doppler echocardiography. Elevenshowed spontaneous complete closure at follow-up,while eleven other patients needed a second device toachieve complete occlusion. Seven patients showed re-sidual leaks at follow-up. In summary, 62/69 (90 %)showed complete occlusion after a follow-up period ofbetween 2 months and 31/2 years.

In the patients in whom a second device was re-quired, the following additional implantations were per-formed. In four patients, the second device was a 12-mmRashkind device (Fig. 4 a, b), and in one patient the

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4a 4b

5a 5b

Fig.4 Chest radiograph show-ing two 12-mm devices on topof each other in the position ofthe arterial duct. a AP view,b lateral view

Fig.5 Chest radiograph, a PAand b lateral views, demon-strating poor positioning of two17-mm Rashkind devices. Notethe irregular arrangement ofthe legs. In the lateral view thedevice is tilted, its proximal legsfacing downwards and not an-teriorly as they should be

additional device was a 17-mm Rashkind umbrella(Fig.5 a,b). In six patients, either one Gianturco coil(Fig.6 a,b) or multiple coils (in one patient three coils)were used to achieve complete occlusion of the ductus.

Radiography

Radiographically, all devices could be seen well. In 55patients the device showed a symmetrical position, andin 14 patients (20 %) it displayed an asymmetrical posi-tion. In 6/55 patients with symmetrical position of thedevice there was a residual leak, while in 1/14 withasymmetrical position there was residual leak. Therewas no correlation between asymmetrical position andresidual shunt (chi-square = 0.1736, P = 0.699). Therewas no statistical difference in size between devices inasymmetrical position (12-mm device 9/38 implants vs

17-mm device 5/31 implants) and those in symmetricalposition (12-mm device 29/38 vs 17-mm device 26/31)(chi square = 0.6025, P = 0.4576).

The cardio-thoracic ratio was 0.547 ± 0.054 (mean ±SD; range 0.45±0.7). At follow-up after the procedurewhen a repeat chest X-ray was obtained, the heartshowed significant reduction of the ratio to 0.513 ±0.047 (range 0.43±0.6) (P < 0.001). Similarly, there wasa reduction of the calibre of the pulmonary vessels.One patient above the age of 60 years showed signifi-cant aneurysmal dilation of the pulmonary artery andcalcification of the patent ductus arteriosus (Fig. 7 a).This was completely occluded using a 17-mm device.Six months later, the heart showed a significant reduc-tion in size (Fig. 7 b).

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6a 6b

7a 7b

Fig.6 In this patient there wasa residual shunt following thepoor positioning of a 12-mmRashkind device. The insertionof a Gianturco coil resulted incomplete occlusion of the arte-rial duct. a PA and b lateralchest radiographs

Fig.7 A 66-year-old femalewith cardiomegaly and conges-tive heart failure. a The chestX-ray prior to interventionshows interstitial oedema, wid-ened right central pulmonaryarteries consistent with pulmo-nary arterial hypertension, acalcified aortic arch and aheavily calcified pulmonary ar-tery aneurysm. b After suc-cessful implantation of one 17-mm Rashkind device in thestandard position there is im-provement of cardiac size, pul-monary plethora and interstitialoedema

Discussion

Transcatheter occlusion of the patent arterial duct usingthe Rashkind double umbrella device was introduced in1979 [11]. With modifications, thousands of devices havebeen implanted in children and adults world-wide. Re-sidual shunting after implantation of the Rashkind de-vice has been relatively high with an average ofapproximately 20% of treated patients. In our seriesthere were residual leaks in 10% of patients (7/69). In15% of the patients a second device [7] or a Gianturcocoil [8] had to be deployed to achieve complete occlu-sion. Wrong selection of the device, in relation to ductsize or morphology, may be a possible cause. Asymmet-rical positioning of the device could be a further causefor residual shunting. Asymmetrical position was de-fined as having with the device not aligned the normaldirection of the ampulla of the duct and not demonstrat-ing the typical ªcart wheel appearanceº on the frontalview. However, our study shows that asymmetrical posi-tioning of the device did not correlate with increased re-sidual shunting. Though not statistically significant, the12-mm device tends to be asymmetrically positionedmore often than the 17-mm device. This is probablydue to the fact that the 12-mm device is softer, changingits original shape more easily during deployment.

As expected, the cardio-thoracic ratio of the heart onthe chest radiograph will get significantly smaller afterduct occlusion. Frequently patients who have had a ductoccluded are symptom free and will be discharged fromfollow-up in cardiology clinics after only a few years.They will be followed only by a radiologist, a general

practitioner or paediatrician. Since children often havechest infections, chest X-ray remains one of the most fre-quent and important examinations, and recognition ofthese current devices is important for the physician inter-preting these chest radiographs.

The Rashkind double umbrella device is well recog-nised radiologically on the usual AP/PA and lateralchest X-ray. The chest X-ray can clearly differentiatethe 12-mm from the 17-mm device. When two deviceshad to be implanted to achieve a complete occlusion,both devices are clearly identified. Furthermore, theasymmetrical position can be differentiated from thesymmetrical position.

Occlusion of the arterial duct using the Rashkinddouble umbrella is a nonsurgical and relatively safeand effective intervention. The procedure can be donesafely even as a day case procedure [12]. As there is atrend towards ªminimalº invasive approaches in medi-cine in general, it is expected that other devices willbe introduced for clinical use. With the increasing useof similar devices, they will appear on radiographs ob-tained in non-specialist clinics. Therefore, it is impor-tant to know the normal and abnormal anatomy andposition of the arterial duct. This knowledge can behelpful to avoid confusion between these new implantsand aspirated foreign bodies. Furthermore, it is impor-tant to know the normal and abnormal variations ofposition of such devices on the frontal and lateralview. Since most of these devices have metal skeletons,the use of magnetic resonance imaging is not recom-mended.

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References

1. Ali Khan MA, al Yousef S, Mullins CE,Sawyer W (1992) Experience with 205procedures of transcatheter closure ofductus arteriosus in 182 patients, withspecial reference to residual shunts andlong-term follow-up. J Thorac Cardio-vasc Surg 104: 1721±1727

2. Tynan M (1992) Transcatheter occlu-sion of persistent arterial duct. Reportof the European Registry. Lancet 340:1062±1066

3. Galal O, de Moor M, Al-Fadley F, HijaziZM (1996) Transcatheter closure of thepatent ductus arteriosus: comparisonbetween the Rashkind occluder deviceand the anterograde Gianturco coilstechnique. Am Heart J 131: 368±373

4. Rao PS, Sideris EB, Haddad J, Rey C,Hausdorf G, Wilson AD, Smith PA,Chopra PS (1993) Transcatheter occlu-sion of patent ductus arteriosus with ad-justable buttoned device. Initial clinicalexperience. Circulation 88: 1119±1126

5. Sievert H, Moor T, Ensslen R, Spies H,Scherer D (1995) Transcatheter closureof oversized persistent ductus arteriosusby simultaneous delivery of two Rash-kind umbrella devices. Cathet Cardio-vasc Diagn 36: 251±254

6. Galal O, Schmaltz AA, Fadley F, FawzyME, Wilson N, Mimish L (1993) Trans-katheter Verschluû des offenen DuktusArteriosus bei jungen Erwachsenen mitdem Rashkind-Occluder. Z Kardiol 82:432±435

7. Abbag F, Galal O, Fadley F, Oufi S(1995) Reocclusion of residual leaks af-ter transcatheter occlusion of patentductus arteriosus. Eur J Pediatr 154:518±521

8. de Moor M, Al-Fadley F, Galal O(1996) Closure of residual leak afterumbrella occlusion of the patent arteri-al duct using Gianturco coils. Int J Car-diol 56: 5±9

9. Huggon IC, Tabatabaei AH, QureshiSA, Baker EJ, Tynan M (1993) Use of asecond transcatheter Rashkind arterialduct occluder for persistent flow afterimplantation of the first device: indica-tions and results. Br Heart J 69: 544±550

10. Galal O, Wilson N, Fadley F, DuranCMG (1992) Novice experience withtranscatheter closure of patent ductusarteriosus. Cardiol Young 2: 285±290

11. Rashkind WJ, Cuaso CC (1979) Trans-catheter closure of patent ductus arteri-osus. Pediatr Cardiol 1: 63±65

12. Galal O, Abbag F, Fadley F, RedingtonA, Oufi S (1995) Transcatheter closureof patent ductus arteriosus as a day caseprocedure. Cardiol Young 5: 48±50

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