The amplatzer vascular plug and amplatzer vascular plug II for vascular occlusion procedures in 50...

The Amplatzer Vascular Plug and AmplatzerVascular Plug II for Vascular Occlusion Procedures

in 50 Patients With CongenitalCardiovascular Disease

Matthew Schwartz,* MD, Andrew C. Glatz, MD, Jonathan J. Rome, MD,and Matthew J. Gillespie, MD

Objective: To describe the use of the amplatzer vascular plug (plug 1) and amplatzervascular plug II (plug 2) in patients with congenital cardiovascular disease (CCVD).Background: Plugs 1 and 2 have recently been made available. We report our experi-ence describing plugs 1 and 2 in patients with CCVD highlighting the versatility ofthese devices. Methods: All patients with CCVD who underwent a vascular occlusionprocedure at the Children’s Hospital of Philadelphia between August 1, 2004 and July30, 2009 with plug 1 or 2 were included. A retrospective review was performed.Results: Fifty patients underwent vascular occlusion procedure with plug 1 or 2 at amedian age of 2.0 years (range 1 day to 47 years) and median weight of 12.3 kg (range3.1–98 kg). Fifty-eight plugs (43% plug 1, 57% plug 2) were placed in 52 vessels. Ofthese vessels, 20 (38%) were patent ductus arteriosus (PDA), 14 (27%) venous collater-als, 5 (10%) aorto-pulmonary collaterals, 4 (8%) modified Blalock Taussig shunts, 3(5%) porto-systemic connections, and 6 (12%) miscellaneous structures. Excluding apatient who was lost to follow-up, complete occlusion was observed in 100% of ves-sels either at the time of the catheterization or at follow-up. There were two complica-tions (3.8%). Conclusions: Plugs 1 and 2 are safe and effective devices that can beused in a variety of blood vessels in patients with CCVD. Plug 2 is particularly useful inclosure of high-flow, tubular structures, especially type C PDA’s. VC 2010 Wiley-Liss, Inc.

Key words: pediatric interventions; collaterals; embolization; congenital heart diseasein adults; patent ductus arteriosus

INTRODUCTION

Transcatheter blood vessel closure was first reportedin 1967 when Portsmann described occlusion of a pat-ent ductus arteriosus with an Ivalon plug [1]. Sincethen, advances in technology have equipped interven-tionalists with a wide variety of devices. Closureprocedures for congenital defects have generally dicho-tomized into materials for embolization (i.e., coils) ordevices designed for closure of cardiac defects such asseptal occluders. The amplatzer vascular plug (plug 1,AGA Medical, Golden Valley, MN) and the amplatzervascular plug II (plug 2) are recent additions to theinterventional cardiology armamentarium. These devi-ces have features of both closure and embolizationdevices making them particularly versatile for closureof lesions not ideally treated by existing devices. Plug1 is a self-expanding, cylindrical device made of niti-nol wire mesh. The device contains platinum markerbands at both ends with a microscrew welded to theband on the proximal end to facilitate attachment to a

135 cm long delivery cable. Plug 1 is available in sizesranging from 4 to 16 mm in diameter in 2 mm incre-ments and ranges in length from 7 to 8 mm. Deliverycan be achieved using 5 Fr (sizes 4–8 mm), 6 Fr (sizes10–12 mm), or 8 Fr (sizes 14–16 mm) guide catheters[2,3].

The Children’s Hospital of Philadelphia, Division of Cardiology,Philadelphia, Pennsylvania

Conflict of interest: Nothing to report.

*Correspondence to: Matthew Schwartz, MD, The Children’s Hospi-

tal of Philadelphia, Division of Cardiology, Room 8NW 25, 34th and

Civic Center Blvd., Philadelphia, PA 19104.

E-mail: [email protected]

Received 23 September 2009; Revision accepted 2 November 2009

DOI 10.1002/ccd.22370

Published online 15 June 2010 in Wiley Online Library

(wileyonlinelibrary.com)

VC 2010 Wiley-Liss, Inc.

Catheterization and Cardiovascular Interventions 76:411–417 (2010)

Plug 2 was designed to improve the occlusive prop-erties of the original device. It contains a finer, moredensely woven nitinol braided in two layers in thesmaller devices and three layers in devices bigger than10 mm. It is available in diameters starting at 3 mm,ranging from 4 to 22 mm in 2 mm increments. It isavailable in lengths ranging from 6 to 18 mm and isdeployed through 4–7-Fr guide catheters [4].

While the use of plug 1 in patients with congenitalcardiovascular disease has been reported [2], there islittle information on the application of plug 2 topatients with congenital heart defects [4–6]. The pur-pose of this report is to describe our experience withplug 1 and 2 in patients with congenital cardiovasculardisease at the Children’s Hospital of Philadelphiaemphasizing lesions where these devices seem particu-larly advantageous.

MATERIALS AND METHODS

Following approval from the Institutional ReviewBoard, a retrospective chart review of all patients withcongenital cardiovascular disease who underwent avascular occlusion procedure with a plug 1 or 2 in thecardiac catheterization laboratory at the Children’sHospital of Philadelphia between August 1, 2004 andJuly 30, 2009 was performed. Demographic informa-tion was recorded, and target blood vessels were char-acterized by reviewing the original angiograms. Thediameter of each vessel was measured to the closest0.5 mm. For patent ductus arteriosus (PDA’s), fourseparate measurements were made including the length,aortic, pulmonary, and the ‘‘mid-segment’’ diameterwas measured. The size and number of implanted devi-ces (plug 1 and 2) were recorded along with the angio-graphic result following implantation. The ratio ofdevice to blood vessel diameter for all patients wascalculated. For PDA closures, the ratio was calculatedusing the ‘‘mid-segment’’ diameter. For all other ves-sels, the ratio was calculated using the diameter of thevessel segment into which the device was deployed.Summary statistics are reported as mean þ standarddeviation for normally distributed continuous variablesand median with range for continuous variables with askewed distribution.

Technical success was defined as complete occlusionat the time of the procedure or appropriate device posi-tioning with a reduction in flow through the target ves-sel, consistent with thrombus organization in the de-vice. A vessel was considered completely occluded ifangiography showed no residual flow at the time of theprocedure, or if subsequent imaging documented theabsence of residual flow. The median time between theinterventional procedure and most recent follow-up

imaging study (echocardiogram, CT scan, or catheteri-zation) was calculated. For PDA occlusion procedures,residual pulmonary artery or aortic obstruction wasruled out angiographically and/or by pressure pullbackwhen indicated.

Periprocedural complications including bleedingrequiring transfusion, device malposition/embolization,arrhythmia requiring intervention, stroke, death, or anycomplication requiring subsequent procedure or hospi-talization were recorded.

RESULTS

Patients underwent general anesthesia or conscioussedation for all procedures. The vascular plugs werechosen based on target vessel diameter, and deployedusing standard techniques as previously described [2–4,7]. Both devices were delivered through a variety ofguide catheters without difficulty.

Fifty patients met inclusion criteria (five of thesecases have been previously reported) [7–9]. Fifty-eightvascular plugs consisting of 25 plug 1 (43%) and 33plug 2 (57%) devices were used in 52 blood vessels.The median age of the patients was 2.0 years (range 1day to 47 years) and median weight 12.3 kg (range2.8–98 kg). The mean device to blood vessel ratio forplug 1 was 1.61 (SD � 0.32) and for plug 2 was 1.47(SD � 0.29).

A wide variety of blood vessels were addressed aslisted in Table I. Of the 52 vessels occluded, 20 (38%)were PDA’s, 14 (27%) were venous collaterals, 5(10%) aorto-pulmonary collaterals, 4 (8%) modifiedBlalock Taussig shunts (BT Shunt), 3 (5%) porto-systemic connections, and 6 (12%) miscellaneousstructures.

Technical success was obtained in all patients.Forty-five (87%) vessels showed evidence of completeocclusion at the time of the catheterization. Seven

TABLE I. Sites of Vascular Occlusion

Sites Number of vessels (% total)

PDA 20 (38%)

Venous collateral 14 (27%)

Veno-venous 7 (13.5%)

Veno-atrial 7 (13.5%)

Aorto-pulmonary collateral 5 (10%)

Modified BT shunt 4 (8%)

Porto-systemic connection 3 (5%)

Miscellaneous 6 (12%)

Pulmonary AVM 2 (4%)

Fontan fenestration 1 (2%)

Fontan fenestration stent 1 (2%)

Coronary fistula 1 (2%)

Conduit aneurysm 1 (2%)

412 Schwartz et al.

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

(13%) vessels showed residual flow, with completeocclusion demonstrated in five of these at a medianfollow-up time of 1 week (range 3 days to 11 months).Thus, 50 vessels (96%) showed evidence of completeocclusion either at the time of the catheterization or onsubsequent imaging.

Two of the vessels (4%) with residual flow at thetime of the catheterization were not subsequentlyimaged. One of these was a left superior vena cava ina 27-year-old male with tricuspid atresia and an atrio-pulmonary Fontan who presented with anasarca. Hewas found to have elevated Fontan pressures due to aleft superior vena cava that drained to a coronary sinuswith an atretic ostium. A communication between thecoronary sinus and left atrium was established, and theleft superior vena cava was occluded with two plug 1devices (12 and 10 mm). Angiography showed persis-tent flow through the LSVC, but the patient was fullyheparnized. One year later, the patient’s oxygen satura-tion was 96%, consistent with complete left superiorvena cava occlusion [8].

The second vessel was a decompressing right azy-gous vein in a 4-year-old with an unbalanced completeatrioventricular canal status post right bidirectionalGlenn. The vein was occluded with an 8 mm plug 2that was well positioned; however, residual flow waspresent on angiography. No follow-up imaging or sub-sequent clinic visits were available for review. If thispatient, who was lost-to-follow-up, is excluded, 51(100%) vessels demonstrated complete occlusion either

at the time of the catheterization (n ¼ 45), on subse-quent imaging (n ¼ 5), or per clinical course (n ¼ 1).

Follow-up imaging was available for review on 27treated vessels (52%) with a median follow-up time of2 months (range 3 days to 36 months). All blood ves-sels remained completely occluded with stable deviceposition.

PDA Occlusion

Twenty patients underwent PDA occlusion(Table II). The median age was 1.6 years (range 3months to 4 years) and median weight 10.7 kg (range2.8–17.7 kg). All of the PDA’s treated were tubular inshape with absent aortic ampulla (Krichenko type C,D, and E) [10]. Plug 1 was used in six patients (30%).The mean plug 1 to vessel diameter ratio was 1.93 �0.48. Plug 2 was used in 14 (70%) patients and themean plug 2 to vessel diameter ratio was 1.46 � 0.42.In four patients treated with plug 1, the device waspreloaded with embolization coils to promote thrombo-sis [7]. Complete occlusion was documented in allpatients either at the time of catheterization (n ¼ 19)or on follow-up echocardiogram (n ¼ 1, follow-upecho at 1 month). No patients had left pulmonary ar-tery or aortic obstruction. Figure 1A shows a tubularPDA in a 17-month-old female prior to intervention.Figure 1B shows complete vascular occlusion follow-ing placement of a 6 mm plug 2 device.

TABLE II. Vascular Closures in 50 Patients

Site of intervention

No. of

vessels No. of devices Agea wt.a (kg)

Vessel

diametera

(mm)

Device

diametera

(mm)

CO on Angio

or F/U (%)

PDA 20 Plug 1 n ¼ 6 1.6 yrs 10.7 3.75b 6 20 (100)

Plug 2 n ¼ 14 (3 mos–4 yrs) (2.8–17.7) (2–6) (3–10)

Venous Collateral 14 Plug 1 n ¼ 9 11.9 yrs 36.9 6 10 13 (93)c

Plug 2 n ¼ 10 (10 mos–47 yrs) (7.4–98) (4–12) (6–16)

AP Collateral 5 Plug 1 n ¼ 1 2.0 yrs 9.7 3.5 7 5 (100)

Plug 2 n ¼ 5 (2 mos–21 yrs) (3.8–76) (3–12) (4–18)

Modified BT Shunt 4 Plug 1 n ¼ 2 2.5 yrs 15.9 2.75 4 4 (100)

Plug 2 n ¼ 2 (14 mos–4 yrs) (10.7–18.7) (2.5–4) (4–6)

Porto-systemic

Communication

3 Plug 1 n ¼ 3 8 mos 5.5 5 8 3 (100)

Plug 2 n ¼ 0 (1–8 mos) (3.5–7.4) (5–7) (8–10)

Miscellaneous 6 Plug 1 n ¼ 4 4.3 mos 14.8 5 8 6 (100)

Plug 2 n ¼ 2 (1 day–21 yrs) (3.1–76) (4.5–10) (6–14)

Total 52 58 2.0 yrs 12.3 4.3 6 51 (98)d

Angio, angiography; AP, aorto-pulmonary; BT, blalock taussig; CO, complete occlusion; F/U, follow-up imaging; kg, kilogram; mos, months; PDA,

patent ductus arteriosus; Wt, weight; yrs, years.aMedian values with range reported.bMid PDA diameter.cIncludes one patient with occlusion of veno-atrial collateral and residual flow on angiography whose subsequent saturations suggest complete

occlusion of vessel.dThe single patient without complete occlusion had residual flow on angiography and was lost to follow-up.

Amplatzer Vascular Plug in CCVD 413


Venous Collateral Occlusion

Fourteen patients had occlusion of venous collaterals(Table II). A total of 19 devices (plug 1 ¼ 9, plug 2 ¼10) were placed in 14 vessels. The collaterals includedseven veno-venous and seven veno-atrial vessels. Allexcept two of the devices were placed in patients withsingle ventricle physiology. Twelve patients had com-plete occlusion demonstrated either at the time of thecatheterization (n ¼ 11) or at a follow-up procedure(n ¼ 1, 11 months later). Two patients with residualflow at the time of the catheterization had no subse-quent imaging available for review as discussed above.

Figure 2A and B show occlusion of a large decom-pressing vein in a 24-year-old male with Fontan circu-lation.

Aorto-Pulmonary Collateral Occlusion

Four patients had occlusion of aorto-pulmonary col-laterals (Table II). A total of six devices (plug 1 ¼ 1,plug 2 ¼ 5) were placed in five vessels. Two patientshad Tetralogy of Fallot with pulmonary atresia, onepatient had normal intracardiac anatomy, and onepatient had Scimitar Syndrome. All five vessels werecompletely occluded on angiography.

Modified BT Shunt Occlusion

Four patients underwent occlusion of modified BTshunts (Table II). A total of four devices were placed(plug 1 ¼ 2, plug 2 ¼ 2) and all four resulted in com-plete occlusion.

Porto-Systemic Connections

Three patients had occlusion of porto-systemic con-nections (Table II). A total of three plug 1 deviceswere placed. Two of the patients were twins whounderwent ductus venosus closure (previously reported)[9]. The third patient had a large porto-hepatic fistula.Angiography at the time of the catheterization showedcomplete occlusion in all patients.

Miscellaneous Structures

Six patients underwent closure of miscellaneous vas-cular structures including two pulmonary arteriovenousmalformations (AVM’s), a Fontan fenestration stent, atubular Fontan fenestration, a coronary-cameral fistula,and a right ventricle-to-pulmonary artery conduit aneu-rysm (Table II). The pulmonary AVMs were occludedin the newborn period. The first Fontan fenestrationclosure was in a 5-year-old girl with hypoplastic leftheart syndrome who had previously undergone fenes-tration enlargement and stenting at age of 3 years. Atthat time, a 5 mm stent was used to open the fenestra-tion. This was subsequently occluded with an 8 mmplug 1 device with good result. A second fenestrationwas closed in a 6-year-old girl with tricuspid atresiawho presented with profound cyanosis. She had previ-ously undergone an extracardic Fontan that was fenes-trated by sewing a tube graft from the conduit to theright atrium. A 14 mm plug 1 device was placed intothis large ‘‘tubular’’ fenestration. Residual flow wasseen on angiography, but echocardiogram 3 days latershowed complete occlusion. In addition, a 3-year-oldgirl underwent coronary-cameral fistula occlusion withgood result and a 21-year-old male underwent

Fig. 1. A: Type C PDA. A shows a lateral view of an aortagramin a 17-month-old female showing a large, type C PDA. B: TypeC PDA occlusion. B shows a repeat angiogram followingdeployment of a 6 mm amplatzer vascular plug II. The device iswell seated, completely within the ductus when compared tothe baseline angiogram and there is no residual flow.

414 Schwartz et al.


successful occlusion of a right ventricle-pulmonary ar-tery conduit aneurysm as show in Fig. 3A and B.

COMPLICATIONS

Two patients experienced complications in our se-ries. The first was a 7-month-old male with Trisomy

21 who, following successful PDA closure with a modi-fied plug 1, required transfusion due to bleeding fromthe venous access site. He was discharged from the hos-pital on the following day with no sequelae. The secondwas a 4-month-old female with Trisomy 21 who under-went uncomplicated PDA occlusion with a 4 mm plug 2device and developed a femoral arteriovenous fistula. A5-Fr sheath was placed in the right femoral vein fordevice delivery. Attempts to access the right femoralartery were unsuccessful and a 4-Fr pigtail catheter wasplaced in the left femoral artery for the procedure. Fivemonths following the catheterization, she presented withright leg swelling and a right femoral bruit. Ultrasoundshowed an arteriovenous fistula between the right super-ficial femoral artery and superficial femoral vein. Shesubsequently underwent fistula ligation and has sufferedno vascular issues since.

DISCUSSION

The FDA approved the amplatzer vascular plug 1and 2 for use in May 2004, and September 2007,respectively. Since that time, there have been numerouspublished reports describing their utility for vascularocclusion procedures in a variety of clinical settings,including the peripheral vasculature [3], pulmonaryAVMs [11–13], venous collaterals [14], aorto-pulmo-nary collaterals [15], coronary fistulae [16–18], patentductus ateriosus [7,19], modified Blalock-Taussigshunts [20], Fontan fenestrations [21], ventriculo-pul-monary connections [22], vena cava aneurysms [23],perivalvular leaks [24], and porto-systemic connections[9,25]. The majority of these reports are small seriesthat describe the original plug 1 device, with fewreports describing plug 2 [4–6].

The largest published report by Hill et al. describedthe experience with plug 1 use in patients with congen-ital heart disease at 11 centers across the United States[2]. Fifty-two patients with a median age of 9.2 years(range 0.2–68.7 years) and median weight of 20 kg(range 4.7–104.2 kg) were included in that series. The

Fig. 2. A: Decompressing Vein. A shows an AP view of ahand injection into a large tortuous, hemorrhoidal venous col-lateral which originates from the innominate vein and drainsinto the left pulmonary vein causing hypoxemia in a 24-year-old patient status post Fontan. The delivery sheath is insertedtranshepatically, crosses the Fontan baffle, and is loopedbroadly within the left atrium to allow access to the pulmo-nary venous end of the large decompressing vein. TwoAmplatzer Vascular plug 2 devices (16 and 12 mm) were easilyadvanced along the tortuous course of the delivery sheath,and deployed within the collateral. B: Decompressing veinocclusion. B shows the follow-up angiogram demonstratingocclusion of the decompressing venous collateral.



most commonly occluded vessels were aortopulmonarycollaterals (42%) and pulmonary AVM’s (32%). Ve-nous collateral vessels, transhepatic tracts, surgicalshunts, PDA’s, and coronary artery fistulae were alsotreated. The plug 1 device proved highly effective in avariety of settings, with 94% complete occlusion dem-onstrated at the time of catheterization. Their seriesincluded no major complications, but one device was

electively removed from a PDA due to significant re-sidual flow. Plug 2 was not yet available for use at thetime of their report.

We report this large single center experiencedescribing both plug 1 and 2 use in patients with con-genital cardiovascular disease. Both devices proved tobe effective in a wide variety of vascular structures.Patent ductus arteriosus (38%) and venous collaterals(27%) were the most common sites of intervention inour cohort. Complete occlusion was achieved in 87%of vessels at the time of the catheterization increasingto 100% occlusion at follow-up. This excludes onepatient whose subsequent clinical course and imagingwere unavailable for review. We do not necessarilyperform repeat angiography to demonstrate completeocclusion of the target blood vessel at the time of cath-eterization. If there is evidence for thrombus organiza-tion within the implanted plug and a significant flowreduction through the vessel, the presumption is madethat complete occlusion will develop as the activatedclotting time (ACT) normalizes. This may explain whyour complete occlusion rate at the time of catheteriza-tion—87%, is lower than the 94% rate of occlusionreported by Hill et al. As stated above, all of thevessels with significant residual flow at the end of theprocedure in our cohort were completely occluded onfollow-up.

We found the plugs, particularly plug 2, especiallyuseful for occlusion of tubular PDA’s (Type C–E perKrichenko classification) not well suited to closurewith existing devices such as Gianturco coils or theAmplazter Ductal Occluder (ADO, AGA Medical,Golden Valley, MN) [10]. Coil embolization of high-flow, tubular PDAs is well established, however itoften requires multiple coils, and malposition, emboli-zation, and recanalization can occur. The ADO aorticretention disc makes centering the device in tubularPDAs difficult. If the aortic ampulla is inadequate, thedevice may be at risk for embolization to the descend-ing aorta, or can cause coarctation, especially in smallchildren [26]. In comparison, when using plug 2, wefound that the device was easily delivered throughsmall catheters into the center of the ductus leading tocomplete occlusion without obstruction of the aorta orof the left pulmonary artery in all cases. Furthermore,neither device malposition nor embolization occurred.Our approach to plug 2 delivery was to have all threediscs contained within the ductus when possible, or tohave two discs within the duct and one disc opened inthe pulmonary artery when a pulmonary ampulla waspresent. Both approaches were equally effective. All 14PDA’s closed with plug 2 showed complete occlusionon angiography and many of these were large. Plug 1was also effective for PDA closure, but in our

Fig. 3. A: Right ventricle-pulmonary artery conduit aneurysm.A shows an AP view of a delivery sheath positioned in ananeurysm at the proximal end of a right ventricle-pulmonaryartery conduit in a 21-year-old male with Tetralogy of Fallotand pulmonary atresia. The aneurysm measures 16 mm 3 21mm with neck measuring 8 mm. B: RV-PA conduit aneurysmocclusion. B shows a 14 mm amplatzer vascular plug II posi-tioned within the conduit aneurysm. Two of the three discsare within the aneurysm, and the third is lying flush againstthe wall of the conduit, effectively sealing off the mouth of theaneurysm.

416 Schwartz et al.


experience required modification to increase thrombo-genicity in four of the six patients treated [7].

In most cases, plug 1 and 2 devices were chosen tohave a diameter that was roughly 1.5 times that of thetarget vessel, consistent with other reports [2]. Twocomplications occurred, yielding a complication rate of3.8% comparable to previous large series describingtranscatheter vascular occlusion procedures [27,28].Both complications were related to vascular access,and not specific to the use of plug 1 or 2.

CONCLUSIONS

In summary, we found plug 1 and 2 are versatile,and highly effective devices for occlusion of a varietyof lesions in congenital heart disease. Given its supe-rior occlusive properties and lower profile design, plug2 has supplanted plug 1 at our institution for occlusionprocedures. The device is particularly useful for occlu-sion of high-flow tubular lesions (type C–E PDA’s,aorto-pulmonary collaterals, AVMs) not ideally treatedwith existing tools and constitutes a useful addition tothe armamentarium of the pediatric interventionalist.

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