PEDIATRIC AND CONGENITAL HEART DISEASE

Original Studies

The Amplatzer Duct Occluder II AdditionalSizes Device for Transcatheter PDA Closure:

Initial Experience

Elchanan Bruckheimer,1* MBBS, Max Godfrey,1 BSc, MBBS, Tamir Dagan,1 MD,Michael Levinzon,2 MD, Gabriel Amir,3 MD, PhD, and Einat Birk,1 MD

Objectives: To present our initial experience with the Amplatzer Duct Occluder II Addi-tional Sizes (ADOIIAS) device. Background: The ADOIIAS is a modified PDA closure de-vice of various lengths and widths with small disks to avoid flow disturbance in thepulmonary arteries and descending aorta. Methods: Patient population: All patients whounderwent attempted closure with an ADOIIAS device at our institution Catheterization:Following aortography the PDA was closed using a 4–5Fr delivery system from the pulmo-nary or aortic side with an ADOIIAS. Aortography to confirm position and leak was per-formed before and after device release. Echocardiography was performed before dischargethe following day. Results: Between June 2011 and December 2012, 60 patients [33 female],median age 3.3 yrs [0.6–15.8 years], and weight 14.5 kg [4–79] underwent attempted PDAclosure with an ADOIIAS device. 56/60 [93.3%] ADOIIAS devices were successfully deployed[52 aortic side]. In 55/56 [98.2%], the PDA was closed on follow up echocardiogram usuallyon the next day. In one case, there was a small residual PDA of no hemodynamic signifi-cance on follow up. In four cases, the ADOIIAS was unstable, including one device emboli-zation which was retrieved with no sequelae, and the PDA was closed in all cases with analternative device in the same procedure. The mean ratio of ADOIIAS height:PDA pulmonarydiameter was 2.4 6 0.5:1. Conclusions: We report a large single-center experience withthe new ADOIIAS device which proved to be versatile, safe, effective, and easy to use inthe appropriate ductal anatomy. VC 2014 Wiley Periodicals, Inc.

Key words: patent ductus arteriosus; pediatric intervention; congenital heart defects

INTRODUCTION

The percutaneous transcatheter closure of a patent

ductus arteriosus has become an established procedure

with surgical methods reserved, in the main, for prema-

ture infants [1]. Paralleling the evolution of transcatheter

techniques has been the development of a range of devi-ces to enable closure of a wide range of ductal anato-mies. Effective and safe PDA transcatheter closurerequires a device which is suited to the specific ductalanatomy, and which is also appropriate for the patient’ssize. The new Amplatzer Duct Occluder II Additional

1Section of Pediatric Cardiology, Schneider Children’s MedicalCenter of Israel, Petach Tikva, Israel2Section of Pediatric Anesthesiology, Schneider Children’sMedical Center of Israel, Petach Tikva, Israel3Section of Pediatric Cardiothoracic Surgery, Schneider Child-ren’s Medical Center of Israel, Petach Tikva, Israel

Elchanan Bruckheimer and Max Godfrey contributed equally to this

work.

Conflict of interest: Nothing to report.

*Correspondence to: Dr. E. Bruckheimer, Director of Cardiac

Catheterization, Section of Pediatric Cardiology, Schneider

Children’s Medical Center Israel, Kaplan 14, Petach Tikva, Israel.

E-mail: elchananb@bez.net

Received 6 July 2013; Revision accepted 8 February 2014

DOI: 10.1002/ccd.25445

Published online 15 February 2014 in Wiley Online Library

(wileyonlinelibrary.com)

VC 2014 Wiley Periodicals, Inc.

Catheterization and Cardiovascular Interventions 83:1097–1101 (2014)

Sizes (St Jude Medical, St. Paul, Minnesota) device isdesigned with a range of diameters and lengths as wellas small retention disks for the closure of PDAs of a di-ameter less than 4 mm associated with small or shallowductal ampullae. We present our initial experience withthis new device.

METHODS

Patient Population

All patients with a diagnosis of PDA who underwentan attempt at transcatheter closure with the ADOIIASdevice at our institution were identified from the car-diac catheterization database. Patient data, proceduralcharacteristics, hemodynamic and angiographic find-ings, echocardiographic findings, and clinical statuswere recorded from the patient records. The study wasapproved by the Institutional Review Board. Informed,written consent was obtained before the procedure.

Device

The ADOIIAS, similar to its predecessor the ADOII,is made of nitinol braid and comprises two retentiondiscs and a central portion that is designed to lie withinthe ductal lumen. The discs add to the occlusive prop-erties of the device and anchor it on both the pulmo-nary and aortic sides. The shape of the discs has beenaltered from curved to flat, and the retention discshave been reduced in size to minimize the risk of pro-trusion causing flow disturbance in the aorta or pulmo-nary artery [2].

Catheterization

The techniques of transcatheter PDA closure withAmplatzer Duct Occluders I and II have been previ-ously described [3–5]. In brief, the procedure was per-formed under general anesthesia due to patient age.Percutaneous access by Seldinger technique wasobtained to a femoral artery [4 French] and, whenrequired, to a femoral vein [5 French]. Following hepa-rinization and a dose of intravenous antibiotic, hemo-dynamic and angiographic evaluations were performed.Angiography was performed in the descending aortausing a 4F pigtail catheter [Merit Medical, South Jor-dan, Utah] typically in right anterior oblique and lateralprojections to profile the PDA. An ADOIIAS devicewas chosen so that the diameter of the waist would beapproximately twice that of the narrowest part of theductus, typically at the pulmonary end. The length waschosen so that the aortic disk would lie in the ductus,in a conical-tubular shaped ductus, or in the ampullawithout extending in to the aortic lumen in other cases.The PDA was closed from the pulmonary or aortic

side using the 4Fr Amplatzer TorqVue LP catheter.Stability of the device was assessed by mild pullingand pushing of the delivery cable. Correct positioningof the device was confirmed by hand injection throughthe delivery sheath prior to device release. Repeat an-giography was performed after the device was releasedto evaluate the presence of residual shunts. Color-Doppler 2D echocardiography was performed the fol-lowing day to assess ductal closure.

RESULTS

Between June 2011 and December 2012, a total of118 transcatheter PDA closures were performed at ourinstitution, of whom 60 patients [50.8%], 33 female,median age 3.2 years [0.6–15.8], and weight 14.5 kg[4–79] underwent attempted PDA closure with anADOIIAS device.

On angiography, the Krichenko classification [6] ofthe PDAs was as follows: 37 type A, 19 type C, 1 typeD, and 3 type E. There were no type B since the man-ufacturer cautions against using the device in Kri-chenko type B (Window-like PDAs) [2].

A total of 56/60 [93.3%] ADOIIAS devices weresuccessfully deployed, 52 of which were from the aor-tic side. In 55/56 [98.2%], the PDA was closed on fol-low up echocardiogram usually on the next day. In onecase, there was a small residual PDA of no hemody-namic significance on follow up. Mean fluoroscopytime in the successful implantations was 5.2 6 2.7 min.The mean width of the pulmonary end, in all 60 cases,as well as in the 56 successful cases, was 1.6 6 0.4mm. The mean ratio of ADOIIAS:PDA pulmonary di-ameter was 2.4 6 0.5:1.

Complications and Follow Up

All patients were discharged the following day withnormal distal pulses palpated. Of the four implantationfailures, two were Krichenko type A and two weretype C. In three of these cases, the ADOIIAS wasunstable before release, as evidenced by mobility ofthe device with it moving in to the aortic or pulmonaryarterial lumen and out of the ductus on the push-pullmaneuver mentioned above. In these cases, the PDAwas closed successfully with an alternative device. Inone case (Krichenko type C), the device embolizedduring the procedure to the right pulmonary artery.The device was successfully retrieved during that cath-eterization, and the PDA closed with an alternate de-vice.

At median follow up of 2.3 months [range 0.1–17months], there were no complications, and on Dopplerechocardiography, there were only two cases of

1098 Bruckheimer et al.

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

minimal flow acceleration in the LPA with a peakDoppler velocity gradient of 1.7 m/s. None of thepatients had flow disturbance in the aorta. One patientwith mild narrowing of the aortic isthmus on angiogra-phy, and a peak catheter gradient of 8 mm Hg beforeductal closure, had no flow disturbance after PDA clo-sure.

DISCUSSION

The new ADOIIAS device was recently introducedinto clinical use for transcatheter ductal closure in2011 [2,7]. Preliminary experience with this devicewas published recently in small series [8–11], and onelarger multicenter report [12]. We report on our largesingle center experience in a series of patients and ourconclusions with reference to implantation technique,device sizing, safety, and effectiveness.

Transcatheter closure of a PDA has become a com-mon and straightforward procedure, initially with theuse of coils and more recently with the Amplatzer ductoccluders. The latter afforded transcatheter closure oflarger diameter ducti using a transvenous approach butthe retention disk limited its use in smaller patientsdue to its protrusion in to the aortic lumen. The secondgeneration device, the ADOII, with smaller angled

retention disks and the removal of the occlusive mate-rial made for a smaller profile, flexible device thatcould be delivered from the aortic or pulmonary side.However, the disks could protrude in to the aorticlumen or disturb flow in the left pulmonary artery inthe smaller patient [13,14].

The ADOIIAS, is very similar in its attributes to adetachable coil, in that it can easily be delivered fromthe aortic side through a 4Fr delivery catheter, requiresonly a small portion of the device for anchoring on thepulmonary aspect and the remainder of the device lieswithin the ductal lumen or ampulla on the aortic side.

Initially, we attempted to deliver the device from thepulmonary or aortic side and position the aortic disk inthe aortic ampulla. However, in the long [>6 mm],conical or tubular PDA the device was not always longenough and the disk was expanded in the ductal lumensince it was only 1 or 2 mm larger than its centralpart. The angiographic appearance was very satisfac-tory without much distortion of the ductus, the diskprovided excellent anchoring properties due to its over-size and excellent occlusion with all the components ofthe device packed close together. The aortic deliverywas preferable since from this approach the disk wasopened on the pulmonary side and gently pulled to-ward the narrowing until it met with resistance andthen the remainder of the device was expanded withgentle retraction of the delivery sheath. Stability wasconfirmed by gently pushing and pulling on the deliv-ery cable and feeling resistance while assessing diskposition and movement by fluoroscopy. If the devicedid not maintain its position during push-pull it waseasily collapsed, the ductus recrossed and device rede-ployed or exchanged. When delivering from the pul-monary approach, it was more difficult to keep thecentral portion of the device in the ductal lumen, and itwas often easily pulled in to the pulmonary artery leav-ing only the aortic disc to anchor and occlude. Thisposition was considered less stable and effective, andrecrossing and redeployment were more cumbersomefrom the pulmonary side.

On the basis of the above, our primary approach fortranscatheter PDA closure developed as follows: mea-sure the diameter of the narrowed ductal segment,choose a device whose central portion is 2–2.5 timesthat diameter, position the device so the length of thedevice will lie well in the ductal lumen, and deliverfrom the aortic side. In cases where the narrowing wasvery mild or dynamic, we chose a device to match thelength of the ductus so that the aortic disc would sit inthe ampulla for better anchoring. [Figs. 1 and 2.]

In four cases, we failed to close the PDA with theADOIIAS device. In three cases, failure was due to de-vice instability. The ADOIIAS device was exchanged

Fig. 1. Device implanted at pulmonary end of PDA: Descend-ing aortogram in RAO [A] and lateral projections [B] demon-strate a tubular ductus arteriosus with a distal narrowing atthe pulmonary end of 2.8 mm. The PDA is closed by a 5-4ADOIIAS which has been implanted with one disc in the pul-monary end across the narrowing, while the central segmentand the other disc are wedged deep within the ductal lumen,completely obstructing flow ([C] and [D]).

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

for an Amplatzer Vascular Plug II in one, and anADOII device in another. In one patient earlier on inour experience, we had attempted closure from the pul-monary side. We were not able to stabilize the devicewell, and therefore closed it with an ADOII device. Inretrospect, this PDA could probably have been closedfrom the aortic side with an ADOIIAS. In the fourthcase of a tortuous tubular duct with a diameter of 2.5mm, the device was felt to be stable on the push-pullmaneuver, but then embolized to the right pulmonaryartery after release. A long 6 Fr venous sheath wasadvanced to the right pulmonary artery, and the embo-lized device was retrieved with a 5 mm Snare cathetercapturing the screw attachment. The device wasremoved and the ductus was successfully closed withan Amplatzer Vascular Plug II. On review of theangiogram, it became apparent that the area of narrow-ing was in fact dynamic and changed in diameter from2.5 to 3.5 mm and that although initially the placementof the pulmonary disk was appropriate, the device had"milked" in to the pulmonary lumen prior to release.The ADOIIAS device was not the appropriate choicefor the anatomy of that duct, emphasizing again theimportance of careful selection of the correct devicefor each duct.

The use of coils, as opposed to devices, for ductalclosure is potentially cheaper. However, the proceduremay be complicated by a significant residual leak rate,which may require a second procedure [15], althoughthis may be less likely with the smaller ductus [16]. Inaddition, larger ducti often require additional coils withincreased procedure time, complexity, and radiation ex-posure [17,18].

CONCLUSIONS

In summary, in our experience the ADOIIAS de-vice is safe and effective for transcatheter closure ofsmall to moderate ducti with a narrowing at the

pulmonary end of less than 3 mm and is best deliv-ered from the retrograde aortic route in a similarfashion to a coil. As with any intervention, the selec-tion of the correct device for the specific lesion iscrucial. Further studies are required to elucidate theoptimal case definition for its deployment, as well asreports of long-term follow up to rule out late-onsetcomplications.

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