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Case Reports Transcatheter Closure of Long Tubular Patent Arterial Ducts: The Amplatzer Duct Occluder II––A New and Valuable Tool Gareth Morgan, * MB BCh BaO MPhil MRCPCH, Andrew J. Tometzki, MB ChB FRCPCH, and Robin P. Martin MB ChB FRCPCH Despite the wide variety of occlusion devices available for closing the patent ductus arteriosus; some defects with unusual morphology still remain a challenge. The drive for increasingly user friendly and lower caliber delivery systems is also ongoing. The new amplatzer ductal occluder II may prove to be a useful additional tool in these circumstances. We describe our initial experiences with this new device in three patients with long tubular (Type C) ducts. ' 2009 Wiley-Liss, Inc. Key words: device; interventional; PDA INTRODUCTION Percutaneous closure of the patent ductus arterio- sus (PDA) has been safely practiced with an evolving range of devices for over 30 years [1]. Recently, the most widely used occluders have been detachable coils and the Amplatzer Ductal Occluder (ADO) [2– 4]. Using these occluders, the majority of PDA’s in children above 5 kg have been amenable to trans- catheter closure. The morphology of the PDA is vari- able, however, and some types of defect prove more of a challenge to the interventionalist than others [5,6]. Krichenko et al. in 1989 described the morpho- logical variations of the PDA and their relative fre- quency [7]. The subtype which most often causes a problem is the long tubular PDA (type C) accounting for 7.6% of defects [8,9]. Without constriction at the pulmonary or aortic end, this subtype lacks an an- chorage point for coil occlusion. The ADO is short and to close a long duct the aortic retention skirt may need to be deployed in the tubular section of the duct, to avoid embolization of the occluder. Pre- viously, hemodynamically significant PDA’s of this morphology have often been referred for surgical li- gation. A new occluder (Amplatzer ADO II) has recently been introduced onto the market. We describe our initial evaluation of this occluder in closing long tubular PDA’s. THE DEVICE The Amplatzer Duct Occluder II (ADOII) (AGA Medical Corporation, Golden Valley, MN) is a self expanding Nitinol occluder with a central waist with two retention discs. There is no fabric in the occluder (Fig. 1). The central waist is designed to fill the defect and the two retention discs are designed to be deployed on the aortic and pulmonary sides of the defect. The diameter is dictated by the diameter of the central waist and is avail- able from 3 to 6 mm in 1 mm increments. To allow for the variation in ductal length, each specified device di- ameter is available with either a 4 mm or 6 mm central waist length. The retention discs, which are symmetrical, have diameters 6 mm larger than the central waist size Conflict of interest: No conflicts of interest. Bristol Congenital Heart Centre, Bristol Royal Hospital For Children, Upper Maudlin Street, Bristol BS2 8BJ. *Correspondence to: Gareth Morgan, Bristol Congenital Heart Centre, Upper Maudlin Street, Bristol BS2 8BJ. E-mail: [email protected] Received 4 June 2008; Revision accepted 14 September 2008 DOI 10.1002/ccd.21841 Published online 23 February 2009 in Wiley InterScience (www. interscience.wiley.com). ' 2009 Wiley-Liss, Inc. Catheterization and Cardiovascular Interventions 73:576–580 (2009)

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Page 1: Transcatheter closure of long tubular patent arterial ducts: The Amplatzer Duct Occluder II—A new and valuable tool

Case Reports

Transcatheter Closure of Long Tubular PatentArterial Ducts: The Amplatzer Duct Occluder II––A New

and Valuable Tool

Gareth Morgan,* MB BCh BaO MPhil MRCPCH, Andrew J. Tometzki, MB ChB FRCPCH,and Robin P. Martin MB ChB FRCPCH

Despite the wide variety of occlusion devices available for closing the patent ductusarteriosus; some defects with unusual morphology still remain a challenge. The drivefor increasingly user friendly and lower caliber delivery systems is also ongoing. Thenew amplatzer ductal occluder II may prove to be a useful additional tool in thesecircumstances. We describe our initial experiences with this new device in threepatients with long tubular (Type C) ducts. ' 2009 Wiley-Liss, Inc.

Key words: device; interventional; PDA

INTRODUCTION

Percutaneous closure of the patent ductus arterio-sus (PDA) has been safely practiced with an evolvingrange of devices for over 30 years [1]. Recently, themost widely used occluders have been detachablecoils and the Amplatzer Ductal Occluder (ADO) [2–4]. Using these occluders, the majority of PDA’s inchildren above 5 kg have been amenable to trans-catheter closure. The morphology of the PDA is vari-able, however, and some types of defect prove moreof a challenge to the interventionalist than others[5,6]. Krichenko et al. in 1989 described the morpho-logical variations of the PDA and their relative fre-quency [7]. The subtype which most often causes aproblem is the long tubular PDA (type C) accountingfor 7.6% of defects [8,9]. Without constriction at thepulmonary or aortic end, this subtype lacks an an-chorage point for coil occlusion. The ADO is shortand to close a long duct the aortic retention skirtmay need to be deployed in the tubular section ofthe duct, to avoid embolization of the occluder. Pre-viously, hemodynamically significant PDA’s of thismorphology have often been referred for surgical li-gation. A new occluder (Amplatzer ADO II) hasrecently been introduced onto the market. Wedescribe our initial evaluation of this occluder inclosing long tubular PDA’s.

THE DEVICE

The Amplatzer Duct Occluder II (ADOII) (AGAMedical Corporation, Golden Valley, MN) is a selfexpanding Nitinol occluder with a central waist with tworetention discs. There is no fabric in the occluder (Fig.1). The central waist is designed to fill the defect and thetwo retention discs are designed to be deployed on theaortic and pulmonary sides of the defect. The diameter isdictated by the diameter of the central waist and is avail-able from 3 to 6 mm in 1 mm increments. To allow forthe variation in ductal length, each specified device di-ameter is available with either a 4 mm or 6 mm centralwaist length. The retention discs, which are symmetrical,have diameters 6 mm larger than the central waist size

Conflict of interest: No conflicts of interest.

Bristol Congenital Heart Centre, Bristol Royal Hospital ForChildren, Upper Maudlin Street, Bristol BS2 8BJ.

*Correspondence to: Gareth Morgan, Bristol Congenital Heart

Centre, Upper Maudlin Street, Bristol BS2 8BJ.

E-mail: [email protected]

Received 4 June 2008; Revision accepted 14 September 2008

DOI 10.1002/ccd.21841

Published online 23 February 2009 in Wiley InterScience (www.

interscience.wiley.com).

' 2009 Wiley-Liss, Inc.

Catheterization and Cardiovascular Interventions 73:576–580 (2009)

Page 2: Transcatheter closure of long tubular patent arterial ducts: The Amplatzer Duct Occluder II—A new and valuable tool

(Table I). The device has the same screw attachment forthe delivery wire as found with other Amplatzer occlu-sion devices and there are radio-opaque markers on each

retention disc. The delivery catheter required is 4F forwaist size 3–4 mm and 5F for waist size 5–6mm (Fig. 1).The important features of this occluder are its mechani-

Fig. 1. (A) The 4F or 5F delivery catheter structure. (B) Schematic displaying the deploymentconfiguration and sizing measurements. (C) The unloaded device and delivery wire. Repro-duced courtesy of AGA medical corporation, Golden Valley, MN.

TABLE I. Amplatzer Duct Occluder II

Device

description

Waist

diameter (mm)

Disc

diameter (mm)

Device

length (mm)

Min delivery

catheter size

3/4 3 9 4 4F

3/6 3 9 6 4F

4/4 4 10 4 4F

4/6 4 10 6 4F

5/4 5 11 4 5F

5/6 5 11 6 5F

6/4 6 12 4 5F

6/6 6 12 6 5F

‘‘Out of the box’’ sizes and specification. Data reproduced courtesy of AGA medical corporation,

Golden valley, MN.

Transcatheter Closure of Long Tubular PDA 577

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

Page 3: Transcatheter closure of long tubular patent arterial ducts: The Amplatzer Duct Occluder II—A new and valuable tool

TABLE II. Basic Characteristics of Each Patient

Case

Age

(months)

Weight

(kg) Qp:Qs

Duct

diameter (mm)

Aortic

diameter (mm)

Duct length

(mm)

Device

size

Sheath

size

Procedure

time (min)

Fluoro

time (min)

24 hr

Echo

1 16 8.9 2.9 3 10.5 19.3 4/6 5F 56 6 No leak

2 18 7.6 2.2 4 14.4 19.7 5/6 5F 56 8 No leak

3 23 11.4 1.8 4 15.2 21.7 5/6 5F 58 6 No leak

Duct diameter and length are both measured angiographically and are marked with white lines in Fig. 2. The aortic diameter was measured at the

point immediately inferior to the ampulla on the lateral angiogram.

Fig. 2. Angiography and fluoroscopy showing preclosure (i),deployment (ii), and postclosure (iii) images for each case.Panel 2(iii) illustrates protrusion of the aortic disc into theaorta following device release, attributable to the patientsvery shallow aortic ampulla combined with the concave profile

of the ADO II retention skirt (in contrast to the flat retentionskirt characterizing the original ADO) There was no associatedpullback gradient and no velocity increase on post catheterechocardiography.

578 Morgan et al.

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

Page 4: Transcatheter closure of long tubular patent arterial ducts: The Amplatzer Duct Occluder II—A new and valuable tool

cal flexibility, the symmetrical retention discs, and theabsence of fabric from the device. The delivery system iscatheter-based rather than sheath-based system, and thusis potentially suitable for use in smaller children [10].

CASES

Angiographic measurements of the ductal length anddiameter were made. The length of the duct was mea-sured as a straight line from an extrapolated line acrossthe mouth of the aortic ampulla to an extrapolated lineacross the pulmonary arterial entrance of the duct. All ofthe ducts were tortuous and the lateral plane measure-ments will have foreshortened the true length to a vari-able degree. The ductal width was measured as the nar-rowest point along the entire length. Details of the threecases are given in Table II. All were young childrenwith a history of premature birth. Patient 2 had symp-toms associated with significant chronic lung disease andwas on home oxygen. The other two were asymptom-atic. All had signs of left heart volume overload on pre-procedural transthoracic echocardiogram (TTE) and allhad moderate/large PDA’s with continuous murmurs andcontinuous left to right flow on echocardiography.Patient 3 had previously undergone attempted PDA clo-sure using a 5/5 detachable coil, but this was abandoneddue to poor conformation of the device and significantresidual shunting after deployment.Each procedure was performed under general anes-

thetic with 100 U/kg of heparin given IV followinginsertion of the venous and arterial sheaths. Vascularaccess was via the femoral vein and femoral artery. Ineach case, the right heart pressures were measured andthe pulmonary to systemic flow ratio was calculated. An-giography was performed in the descending aorta inposteroanterior (PA) and lateral views and right anterioroblique (RAO) 208/left anterior oblique (LAO) 608 ifnecessary to open up the length of the duct. In thesethree patients the ADOII occluder was selected based ontype C ductal morphology. The defect was crossed fromthe venous side using a 5F multipurpose catheter. Anoccluder was selected according to the sizing chart (Ta-ble I), prepared and loaded into the catheter deliverysystem for which the multipurpose catheter wasexchanged over a standard exchange wire. Because ofthe long tubular nature of these three PDA’s the longerdevice was selected in each case. The process of deploy-ment is similar to that of the original ADO [4]. Fluoro-scopic images of deployment (ii) are displayed in Fig. 2along with descending aortic angiography before deploy-ment (i) and 5 min after release (iii) for each case. Themean procedure time was 56 min and the mean fluoros-copy time was 6 min. In each case there was no angio-graphic leak 5 min after release. TTE and Chest X-Ray

(CxR) were performed the following day and in eachcase showed complete occlusion with no aortic orbranch PA stenosis. The patients were all discharged 24hr after the procedure with no complications.In case two, initial deployment resulted in the aortic

disc opening within the ductus and a consequent sig-nificant leak on prerelease angiography. Prior torelease, therefore, the device was recaptured and rede-ployed, this time with the aortic disc in the aorticampulla, resulting in complete occlusion.

DISCUSSION

Transcatheter closure of PDA’s with detachable coilsand using the first generation ADO is well establishedand yields excellent results. Some PDA’s, however, donot lend themselves to the shape of the ADO and mayrequire multiple coils with suboptimal results. Othernovel device designs, such as the Nit-Occlud1 (pfmAG, Germany), have recently become available. Itsdesign does not suit tubular type C PDA’s, lacking asignificant aortic ampulla.The ADOII can be delivered transvenous or transarte-

rially because of its symmetrical design and requires amaximum 5F delivery catheter. Part of the reason forthis is the lack of fabric within the device, allowing it tofit into a smaller delivery system. The thrombogenic fab-ric is supplanted by having a much tighter nitinol weaveand six planes of occlusion, which will hopefully giveequivalent complete occlusion rates, however, long-termocclusion rates with this device are unknown.The deployment technique is similar to that for the

original ADO but attention needs to be focused on thecorrect configuration of the two discs. In tubular (typeC) ducts, the position of the central waist is not impor-tant, unlike in funnel shaped (type A) ducts where thewaist is best placed on the aortic side or across thenarrowest part of the duct. Unlike the ADO, theADOII can be elongated to accommodate the anatomyof the long duct because of the presence of two sym-metrical discs to anchor the occluder at either end.This elongation of a relatively short device in a rela-tively long duct decreases the diameter of the centralwaist. The correct occluder size may, therefore need tobe larger than the measured diameter of the duct. Thepotential for protrusion particularly of the aortic reten-tion skirt needs to be considered carefully given thedevices more concave profile.Our additional observations were that the device

was malleable and easy to reposition prior to release.Despite this, however, we have not noticed any tend-ency to easily ‘‘pull-through’’ as one might expectwith such a flexible occluder.

Transcatheter Closure of Long Tubular PDA 579

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

Page 5: Transcatheter closure of long tubular patent arterial ducts: The Amplatzer Duct Occluder II—A new and valuable tool

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10. Product specifications courtesy of AGA medical corporation,

Golden Valley Minnesota, MN 55442.

580 Morgan et al.

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