Comparison of Percutaneous Closure of Large PatentDuctus Arteriosus by Multiple Coils Versus the

Amplatzer Duct Occluder Device

Giuseppe Santoro, MD, Maurizio Cappelli Bigazzi, MD, Maria Teresa Palladino, MD,Maria Giovanna Russo, MD, Marianna Carrozza, MD, and Raffaele Calabro, MD

This study compared the efficacy and costs of the mostused approaches for percutaneous closure of largepatent ductus arteriosus, that is, multiple coils and theAmplatzer duct occluder (ADO) device. From April2000 to September 2003, 47 patients underwentclosure of large, symptomatic patent ductus arterio-sus (diameter 4.6 � 3.0 mm/m2; QP/QS 2.1 � 1.9)with multiple Cook detachable coils (n � 19) or theADO device (n � 28). The multiple coil approach wassignificantly cheaper (1,389 � 168 vs 3,811 � 38 €,p <0.0001) but as effective as the ADO device over amid-term follow-up (occlusion rate 89.5% vs 96.4%, p� NS). �2004 by Excerpta Medica, Inc.

(Am J Cardiol 2004;94:252–255)

Isolated patent ductus arteriosus (PDA) is a leadingcause of congestive heart failure in neonates and

infants, as well as chronic left ventricular volumeoverload in children and adults.1 Over time, transcath-eter closure became the first-choice therapeutic optionregardless of PDA diameter and patient size.2–6 How-ever, this approach is still considered challenging inlarge PDA, with a non-negligible procedural failurerate and residual shunt.2,5,7–10 In this setting, the mostfrequently used options are multiple coil implantationand the Amplatzer duct occluder (ADO) device (AGAMedical Corporation, Golden Valley, Minnesota).Both techniques have been proved to be effective andsafe in large clinical series.7–14 To date, no singlecenter study has been carried out to compare theefficacy and costs of these therapeutic options in pa-tients with large, clinically symptomatic PDAs.

• • •Between April 2000 and September 2003, 138

patients underwent elective transcatheter PDA closureat our institution. Based on clinical, noninvasive, andhemodynamic findings, 49 of them had large PDAs(minimal diameter �3 mm and/or QP/QS �1.5:1). Allpatients showed cardiomegaly at chest x-ray and leftchamber enlargement (�90° percentile for body sur-face area) at echocardiography. Thirteen patients(27.7%) were on pharmacologic therapy for conges-tive heart failure or recurrent pulmonary edema epi-

sodes. Based on patient size and/or PDA morphology,ductal occlusion was performed by multiple Cookdetachable coils (Cook, Bloomington, Indiana) (19patients, group I) or the ADO device (28 patients,group II). Our policy was to use the multiple coiloption in patients weighing �5 kg, in tubular orelongated PDAs, or whenever the aortic isthmus anat-omy precluded the use of the ADO device. Afterinformed consent from adult patients or children’sparents, cardiac catheterization was performed undergeneral anesthesia in pediatric patients or local anes-thesia in adults. The PDA closure protocol has beenextensively described.2,5,9,12,13 Briefly, after hemody-namic data recording, PDA shape and size were as-sessed from a descending aortogram in the right an-terior oblique and lateral views. PDA shape and sizewere classified according to Krichenko et al,15 ac-counting for the magnification factor. For the multiplecoil approach, the first coil was chosen to be 2.0 to 2.5times wider than the narrowest ductal diameter andlong enough to produce �3 loops inside the ductalampulla, to form a “nest” that retained the other coilsin place. Further coils were chosen; these were 1.5 to2.0 times wider than the narrowest ductal diameter.The multiple coil deployment was always performedsimultaneously from both the pulmonary and aorticsides, intertwining the coils to each other to fit nicelyinto the ductal ampulla before the final release (Figure1). For the ADO approach, the device size was chosento be �2 mm larger than the minimal ductal diameterand was deployed by the pulmonary artery route (Fig-ure 2). Control angiography was obtained 15 minutesafter device implantation. Procedural and fluoroscopytime were calculated at the end of the interventionalprocedure. Procedural costs were calculated only interms of disposable catheterization material and theoccluding device, because it is our policy not to per-form any interventional procedure on an outpatientbasis. Clinical and echocardiographic follow-up wereroutinely performed at discharge, after 1, 6, and 12months, and once a year thereafter if any residualshunt persisted. PDA was considered fully occluded ifno residual shunt was seen by echocardiography, andrecanalization was considered to have occurred if anyductal shunt was detected in a patient with a previ-ously documented complete occlusion.

Results are expressed as mean � SD. Statisticalanalysis was performed using the unpaired Student’s ttest and the chi-square test. Significance was definedas a p value �0.05.

Transcatheter closure was effectively performed inall but 2 patients (95.9%). The first patient was a

From the Department of Pediatric Cardiology, 2nd University of Na-ples, “Monaldi” Hospital, Naples, Italy. Dr. Santoro’s address is: ViaVito Lembo, 14, Salerno 84131, Italy. E-mail: santoropino@tin.it.Manuscript received January 9, 2004; revised manuscript receivedand accepted March 19, 2004.

252 ©2004 by Excerpta Medica, Inc. All rights reserved. 0002-9149/04/$–see front matterThe American Journal of Cardiology Vol. 94 July 15, 2004 doi:10.1016/j.amjcard.2004.03.079

4.5-kg, 6-month-old baby in severe congestive heartfailure due to a supposed small ventricular septaldefect and a 5.5-mm conical PDA. She underwentPDA occlusion by multiple coil implantation withalmost complete shunt disappearance at angiographiccontrol. However, after the procedure, the ventricularseptal defect shunt was considered significant and thepatient underwent surgical repair. The second patientwas a 6-month-old infant with an 8-mm, pliable, con-ical PDA that was revealed as unsuitable for closurewith an 8/10-mm ADO device. The size of the aorticisthmus precluded further attempts with larger ADOdevices.

Clinical, hemodynamic, and angiographic data at

procedure of the remaining patients are listed in Table1. Patients’ data according to the therapeutic optionare reported in Table 2. In group I patients, 40 coilswere used in 19 patients (2 coils in 17 patients and 3coils in 2 patients). In group II patients, the mean sizeof the ADO device was 8.2 � 2.0 mm (range 6 to 14,median). Procedural time and fluoroscopic time were81 � 37 minutes (range 20 to 215) and 9.8 � 1.4minutes (range 3 to 20), respectively. PDA completeocclusion was achieved in 78.7% of patients at dis-charge, increasing to 91.5% at 1 month and to 93.6%at last follow-up control (16 � 10 months, range 1 to41). The multiple coil approach was significantlymore time-consuming than ADO implantation (96 �

FIGURE 1. PDA closure by simultaneous implantation of 2 Cook detachable coils. (A) Preclosure PDA angiographic appearance. (B)Simultaneous coil deployment from both the aortic and pulmonary sides. (C) Complete PDA occlusion at the angiographic control.

BRIEF REPORTS 253

46 vs 71 � 28 minutes, p �0.03) but without anysignificant difference in fluoroscopic time (8.9 � 2.4vs 10.2 � 2.1 minutes, p � NS). No significant

difference in terms of procedural efficacy (95% vs96.6%, p � NS), as well as occlusion rate at anyfollow-up time point (73.7% vs 78.6% at 24 hours;84.2% vs 96.4% at 1 month; 89.5% vs 96.4% at lastfollow-up control, p � NS) was observed between thegroups over a mid-term follow-up. PDA size andshape did not influence either the procedural efficacyor the residual shunt. Neither late complications norPDA recanalizations occurred during a mid-term fol-low-up in either group. In particular, no left pulmo-nary artery or aortic isthmus flow abnormalities wererecorded at follow-up Doppler analysis. Proceduralcost was lower in group I than in group II (1,389 �168 vs 3,811 � 38 €, p �0.0001).

• • •Over time, transcatheter PDA closure has been

shown to be safe and effective with different availabledevices.2–4,16 However, procedural failures and resid-ual shunt make it challenging in large PDA and/oryounger patients.4,5,7,11 In these settings, the mostcommonly used approaches are multiple coil implan-tation and the ADO device, although closure of largePDA has been sporadically performed with the Clam-shell device (NMT Inc., Boston, Massachusetts), theSideris buttoned device (Custom Medical Devices,Amarillo, Texas), or the Gianturco-Grifka VascularOcclusion device (Cook Inc., Bloomington, Indi-ana).17–19 The ADO device has been proved to behighly effective in large series,4,6,14 but its implanta-tion is quite troublesome in neonates and small in-fants, being indicated in patients weighing �5 kg.4Conversely, the multiple coil approach is suitable fora wider range of patients but is more technicallychallenging and presents a non-negligible incidence ofprocedural failures and residual shunt.6,8,9 The use ofcontrolled-release coils that can be easily intertwinedto each other during a multiple simultaneous deploy-ment could theoretically make the closure of largePDAs simpler, safer, and more effective than theclassic Gianturco coils, thus avoiding some technicalmodifications of the multiple coil delivery.8,10,12

In agreement with the literature, a high rate of pro-cedural success was recorded in ourseries, regardless of the therapeutic op-tion, patient age, and ductal size. Over-all, the PDA occlusion rate was as highas 91.5% after 1 month and nearly94% over a mid-term follow-up. Ourpolicy of “tailoring” the interventionalapproach to patient size and PDA mor-phology certainly caused a selectionbias toward smaller patients and PDAsin the multiple coil group, but neitherthe indexed PDA size nor its hemody-namic burden significantly differed be-tween the groups. According to oth-ers,20 our first-choice option inpercutaneous closure of large PDAs isthe ADO device, whenever the local

anatomy and PDA shape allow its use. However, neitherof these factors should be considered an obstacle topercutaneous treatment of a large PDA, because the

FIGURE 2. (A) Closure of a 3.5-mm, conical PDA by implantationof a 6/8 mm ADO device, (B) without any residual shunt at theangiographic control.

TABLE 1 Patients’ Data at Patent Ductus Arteriosus (PDA) Closure

Age (yrs) 10.3 � 14.9 (range 4 mos–66 yrs, median 3.5 yrs)Weight (kg) 30 � 27 (range 4.5–90, median 17)Body surface area (m2) 0.9 � 0.6PDA diameter (mm) 3.3 � 1.3 (range 1.8–9.0)PDA indexed diameter (mm/m2) 4.6 � 3.0 (range 1.5–17.7)QP/QS 2.1 � 1.9 (range 1.8–5.0; median 1.6)Mean pulmonary artery pressure (mm Hg) 24 � 7 (range 15–49)Mean aortic pressure (mm Hg) 63 � 17 (range 60–119)PDA shape

Conical 65.9%Tubular 27.7%Window-like 4.3%

254 THE AMERICAN JOURNAL OF CARDIOLOGY� VOL. 94 JULY 15, 2004

multiple coil approach is as effective in patients unsuit-able for the ADO device implantation. In our series,albeit more time-consuming than the ADO implantation,the multiple coil approach was not significantly differentin terms of fluoroscopic time, procedural efficacy, andshunt disappearance. After the procedure, a trend towardan earlier complete PDA closure after the ADO deviceimplantation was recorded (Figure 3), but no significantdifference between the groups was found at any timepoint of the follow-up. Finally, despite the use of themore expensive controlled-release coils, the multiple coilapproach was still significantly cheaper than the ADOdevice approach.

1. Heymann MA. Patent ductus arteriosus. In: AdamsFH, Emmanoulides GC, Reimenscheider TA, eds.Heart Disease in Infants, Children and Adolescents.Baltimore, MD: Williams & Wilkins, 1994:209 –223.2. Hijazi ZM, Geggel RL. Results of anterograde trans-catheter closure of patent ductus arteriosus using singleor multiple Gianturco coils. Am J Cardiol 1994;74:925–929.3. Bermudez-Canete R, Santoro G, Bialkowsky J,Herraiz I, Salgado A, Gonzalez C, Formigari R,Skutnik M, Ballerini L. Patent ductus arteriosus oc-clusion with detachable coils. Am J Cardiol 1998;82:1547–1549.4. Bilkis AA, Alwi M, Hasri S, Haifa AL, Geetha K,Rehman MA, Hasanah I. The Amplatzer Duct Oc-cluder: experience in 209 patients. J Am Coll Cardiol2001;37:258–261.5. Wang JK, Liau CS, Huang JJ, Hsu KL, Lo PH, HungJS, Wu MH, Lee YT. Transcatheter closure of patentductus arteriosus using Gianturco coils in adolescentsand adults. Catheter Cardiovasc Interv 2002;55:513–518.6. Faella HJ, Hijazi ZM. Closure of the patent ductusarteriosus with the Amplatzer PDA device: immediateresults of the international clinical trial. Catheter Car-diovasc Interv 2000;51:50–54.7. Owada CY, Teitel DF, Moore P. Evaluation of Giant-urco coils for closure of large (�3.5 mm) patent ductus

arteriosus. J Am Coll Cardiol 1997;30:1856–1862.8. Ing FF, Sommer RJ. The snare-assisted technique for transcatheter coilocclusion of moderate-to-large patent ductus arteriosus: immediate and interme-diate results. J Am Coll Cardiol 1999;33:1710–1718.9. Akagi T, Iemura M, Tananari Y, Ishii M, Yoshizawa S, Kato H. Simultaneousdouble or triple coil technique for closure of moderate sized (�3.0 mm) patentductus arteriosus. J Interv Cardiol 2001;14:91–96.10. Kumar RK, Krishnan MN, Venugopal K, Sivakumar K, Anil SR. Bioptome-assisted simultaneous delivery of multiple coils for occlusion of the large patentductus arteriosus. Catheter Cardiovasc Interv 2001;54:95–100.11. Hijazi ZM, Geggel RL. Transcatheter closure of large patent ductus arteriosus(�4 mm) with multiple Gianturco coils: immediate and mid-term results. Heart1996;76:536–540.12. Grifka MD RG, Jones TK. Transcatheter closure of large PDA using 0.052“Gianturco coils: controlled delivery using a bioptome catheter through a 4 Frenchsheath. Catheter Cardiovasc Interv 2000;49:301–306.13. Huang TC, Hsieh KS, Lee CL, Lin CC. Safety and efficacy of using0.052-inch Gianturco coil for closure of large (�4 mm) patent ductus arteriosus.J Invasive Cardiol 2002;14:173–177.14. Masura J, Walsh KP, Thanopoulos B, Chan C, Bass J, Goussous Y, GavoraP, Hijazi ZM. Catheter closure of moderate-to large-sized patent ductus arteriosususing the new Amplatzer Duct Occluder: immediate and short-term results. J AmColl Cardiol 1998;31:878–882.15. Krichenko A, Benson LN, Burrows P, Moes CAF, McLaughlin P, FreedomRM. Angiographic classification of the isolated, persistently patent ductus arte-riosus and implications for percutaneous catheter occlusion. Am J Cardiol 1989;63:877–880.16. Formigari R, Toscano A, Herraiz I, Bialkowski J, Donti A, Picchio FM,Bermudez-Canete R, Ballerini L. Late follow-up of occlusion of the patent ductusarteriosus with the Rashkind device with emphasis on long-term efficacy and riskfor infections. Am J Cardiol 2001;88:586–588.17. Bridges ND, Perry SB, Parness I, Keane JF, Lock JE. Transcatheter closureof a large patent ductus arteriosus with the clamshell septal umbrella. J Am CollCardiol 1991;18:1297–1302.18. Sideris EB, Rao PS, Zamora R. The Sideris buttoned devices for transcatheterclosure of patent ductus arteriosus. J Interv Cardiol 2001;14:239–246.19. Grifka RG, Vincent JA, Nihill MR, Ing FF, Mullins CE. Transcatheter patentductus arteriosus closure in an infant using the Gianturco-Grifka Vascular Oc-clusion Device. Am J Cardiol 1996;78:721–723.20. Hijazi ZM. Catheter closure of ductus arteriosus in adolescents and adults:what to use? Catheter Cardiovasc Interv 2002;55:519–520.

TABLE 2 Patients’ Clinical and Hemodynamic Data According to the TherapeuticOption

Variable Group I (n � 19) Group II (n � 28)

Age (yrs) 5.8 � 8.6 (median 3.1) 13.3 � 17.0 (median 4.5)Weight (kg) 21 � 18 (median 15) 36 � 30 (median 18.5)QP/QS 1.8 � 1.0 2.3 � 0.8Mean pulmonary artery

pressure (mm Hg)22 � 6 25 � 1

Mean aortic pressure (mm Hg) 65 � 13 75 � 30PDA diameter 2.8 � 0.8 3.7 � 1.5*PDA diameter/body surface

area (mm/m2)5.0 � 3.8 4.3 � 2.4

ShapeConical 52.7% 75%Tubular 42% 17.8%Window-like 5.3% 3.5%

Follow-up (mos) 18 � 9 15 � 11Costs (Euros) 1389 � 168 3811 � 38†

*p �0.01; †p �0.0001.

FIGURE 3. Time course of the shunt disappearance over a mid-term follow-up (F-U), according to the PDA occluding device.

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