Transcatheter closure of secundum atrial septal defects

10
Core Curriculum Transcatheter Closure of Secundum Atrial Septal Defects Zahid Amin, * MD, FSCAI, FAHA, FAAP Key words: pediatric interventions; congenital heart disease in adults; pediatric cath/ intervention complications; patent foramen ovale atrial septal defect INTRODUCTION The atrial septum is composed of septum primum and septum secundum. The septum primum, also known as the septum ovale, is the thin portion of the atrial sep- tum that is cradled by the septum secundum, also known as the thick portion of the atrial septum. Secun- dum atrial septal defect (ASD) is a defect in the septum primum. It is the most common type of ASD. These defects can range in size from a tiny perforation of the atrial septum (small ASD) to complete absence of the atrial septum (large ASD). Sometimes, in large defects, the septum secundum may also be deficient, making transcatheter closure of the ASD challenging. ATRIAL SEPTAL RIMS To close the ASD using the transcatheter techniques, it is important for the interventional cardiologist to have sound knowledge of the atrial septal rims and the structures that surround the ASD. In the past, the rims of the atrial septum have been named according to their physical location (anterior, inferior, etc.) in refer- ence to the patient. For example, the atrial septal rim that is close to the anterior chest wall was called ante- rior or anterior/superior rim. When the orientation of the patient changes (for example, from upright to lying down position) the description of the rims may become confusing. To avoid any confusion, I propose classifi- cation of the atrial septal rims based upon adjacent structures. This simplified classification was initially proposed by Shrivastava and Radhakrishnan [1]. With minor modification to their classification, I suggest the following: aortic rim, the atrial septal rim that is adja- cent to the aortic valve; superior vena cava (SVC) rim, the rim adjacent to the SVC; superior rim, the rim between the SVC rim and the aortic rim; posterior rim, the rim opposite to the aortic rim; inferior vena cava (IVC) rim, the rim adjacent to the IVC; atrio-ventricu- lar valve (AV) rim, the rim adjacent to the AV valve rim (Fig. 1). DEVICE CLOSURE OF ASD Since the Amplatzer septal occluder (ASO) (AGA Medical Corp., Golden Valley, MN) is the only device approved by the Food and Drug Administration (FDA) and the most widely used device, this review focuses on ASD closure with the ASO device (Fig. 2). There are, however, other available devices in the market [2– 7]. These are: Helex septal occluder device (W.L. Gore, Flagstaff, AZ); Sideris Buttoned device that has under- gone several modifications over the years; STARFlex (NMT, Boston, MA) device, which is a modification of the CardioSEAL device; Intrasept 1 PFO device that was modified for closure of ASD. The Babic’s ASDOS device and Das’s Angel wings were discontinued shortly after their introduction. Excluding the ASO, the above-mentioned devices can close defects that are 20 mm or smaller in diameter. The Helex septal oc- Joint Division of Pediatric Cardiology, University of Nebraska/ Creighton University, Children’s Hospital of Omaha, Nebraska *Correspondence to: Zahid Amin, MD, Children’s Hospital, 8200 Dodge Street, 4th Floor Health Care Pavilion, Omaha, NE 68114. E-mail: [email protected] Received 17 May 2006; Revision accepted 5 June 2006 DOI 10.1002/ccd.20872 Published online 12 October 2006 in Wiley InterScience (www. interscience.wiley.com). ' 2006 Wiley-Liss, Inc. Catheterization and Cardiovascular Interventions 68:778–787 (2006)

Transcript of Transcatheter closure of secundum atrial septal defects

Page 1: Transcatheter closure of secundum atrial septal defects

Core Curriculum

Transcatheter Closure of SecundumAtrial Septal Defects

Zahid Amin,* MD, FSCAI, FAHA, FAAP

Key words: pediatric interventions; congenital heart disease in adults; pediatric cath/intervention complications; patent foramen ovale atrial septal defect

INTRODUCTION

The atrial septum is composed of septum primumand septum secundum. The septum primum, also knownas the septum ovale, is the thin portion of the atrial sep-tum that is cradled by the septum secundum, alsoknown as the thick portion of the atrial septum. Secun-dum atrial septal defect (ASD) is a defect in the septumprimum. It is the most common type of ASD. Thesedefects can range in size from a tiny perforation of theatrial septum (small ASD) to complete absence of theatrial septum (large ASD). Sometimes, in large defects,the septum secundum may also be deficient, makingtranscatheter closure of the ASD challenging.

ATRIAL SEPTAL RIMS

To close the ASD using the transcatheter techniques,it is important for the interventional cardiologist tohave sound knowledge of the atrial septal rims and thestructures that surround the ASD. In the past, the rimsof the atrial septum have been named according totheir physical location (anterior, inferior, etc.) in refer-ence to the patient. For example, the atrial septal rimthat is close to the anterior chest wall was called ante-rior or anterior/superior rim. When the orientation ofthe patient changes (for example, from upright to lyingdown position) the description of the rims may becomeconfusing. To avoid any confusion, I propose classifi-cation of the atrial septal rims based upon adjacentstructures. This simplified classification was initiallyproposed by Shrivastava and Radhakrishnan [1]. Withminor modification to their classification, I suggest thefollowing: aortic rim, the atrial septal rim that is adja-cent to the aortic valve; superior vena cava (SVC) rim,the rim adjacent to the SVC; superior rim, the rim

between the SVC rim and the aortic rim; posterior rim,the rim opposite to the aortic rim; inferior vena cava(IVC) rim, the rim adjacent to the IVC; atrio-ventricu-lar valve (AV) rim, the rim adjacent to the AV valverim (Fig. 1).

DEVICE CLOSURE OF ASD

Since the Amplatzer septal occluder (ASO) (AGAMedical Corp., Golden Valley, MN) is the only deviceapproved by the Food and Drug Administration (FDA)and the most widely used device, this review focuseson ASD closure with the ASO device (Fig. 2). Thereare, however, other available devices in the market [2–7]. These are: Helex septal occluder device (W.L. Gore,Flagstaff, AZ); Sideris Buttoned device that has under-gone several modifications over the years; STARFlex(NMT, Boston, MA) device, which is a modification ofthe CardioSEAL device; Intrasept1 PFO device thatwas modified for closure of ASD. The Babic’s ASDOSdevice and Das’s Angel wings were discontinuedshortly after their introduction. Excluding the ASO, theabove-mentioned devices can close defects that are20 mm or smaller in diameter. The Helex septal oc-

Joint Division of Pediatric Cardiology, University of Nebraska/Creighton University, Children’s Hospital of Omaha, Nebraska

*Correspondence to: Zahid Amin, MD, Children’s Hospital, 8200

Dodge Street, 4th Floor Health Care Pavilion, Omaha, NE 68114.

E-mail: [email protected]

Received 17 May 2006; Revision accepted 5 June 2006

DOI 10.1002/ccd.20872

Published online 12 October 2006 in Wiley InterScience (www.

interscience.wiley.com).

' 2006 Wiley-Liss, Inc.

Catheterization and Cardiovascular Interventions 68:778–787 (2006)

Page 2: Transcatheter closure of secundum atrial septal defects

cluder is awaiting approval by the FDA (Fig. 3), whichis expected in the first half of 2006.The Helex septal occluder study was carried out in

14 US sites from March 21 through April 2003. Of atotal of 321 subjects, 128 were in the surgical arm and193 in the device arm. Of the patients in the devicearm, 98.1% were determined to have successful closure(defined as complete closure or presence of less than3-mm shunt by transthoracic echocardiography and ab-solutely less than 4-mm shunt by color Doppler flowechocardiography). All in all, the device appears to besafe and effective in patients with small- to moderate-

sized ASD (personal communication, Larry Latson andWarren Cutright).

PROCEDURE

The procedure is performed under transesophageal(TEE) or intracardiac echocardiography (ICE) guid-ance. In rare cases, if the defect is small, and TEE iscontraindicated (for example, patients with repairedtracheoesophageal fistula), the procedure can be per-formed under transthoracic echocardiography guidance.Experimental work is also in progress to close ASDunder MRI guidance [8]. Right heart catheterizationmay be needed in cases where pulmonary hypertensionis suspected. In most children, however, pulmonaryhypertension is rare.

Echocardiography

Although the majority of ASDs are closed underTEE guidance, ICE is gaining popularity. Regardlessof the approach, a thorough anatomic understanding ofthe ASD is mandatory, and presence of an expertechocardiographer can therefore be very helpful duringthe procedure. The interventionalist should have asound knowledge of the different views that are uti-lized during device closure of the ASD.

TEE

The size of the defect should be measured in at leasttwo orthogonal views since many of the defects areoval in shape. Complete echocardiographic examina-

Fig. 1. Classification of atrial septal rims.

Fig. 2. Amplatzer atrial septal occluder device.

Fig. 3. Helex septal occluder device.

Transcatheter Closure of Secundum ASD 779

Page 3: Transcatheter closure of secundum atrial septal defects

tion of an ASD includes measurement in three standar-dized views that are utilized during the procedure: (1)the aortic short axis view, to identify and evaluate theaortic rim and the posterior rim; (2) the bi-caval view,to evaluate the SVC and IVC rims; and (3) the four-chamber view, to evaluate the AV valve rim and thesuperior rim (Figs. 4 and 5). The probe is positioned inthe esophagus to image the atria and the aortic valve.Small adjustments in the position of the probe in theesophagus, the degree of rotation and flexion used onthe probe, and the precise angle of the plane are alwaysnecessary due to individual anatomic variability.For ICE, the readers are referred to excellent articles

that address the use of ICE to guide device closure ofASDs [9–11].

Balloon Sizing

There are two sizing balloons available that are usedfor the stationary method of assessing the \stretcheddiameter," the NuMED sizing balloon (NuMED, Hop-kington, NY) and the AGA sizing balloon (AGA Med-ical). Recently, a newer and improved version of theAGA sizing balloon has become available. The newAmplatzer sizing balloon II is available in three sizes(18, 24, and 34 mm). In contrast to the previouslyavailable AGA sizing balloons, the radio opaquemarkers bands are inside the balloon. Two markerbands are 0.4 mm apart for proper positioning of thecatheterization laboratory camera angle. The thirdmarker is 15 mm from the 2nd marker for measuringthe size of the defect. The balloon is made of softerand more compliant material. The distal tip is softer toprevent inadvertent injury to cardiac structures.Balloon sizing the defect is useful, since most of the

defects are somewhat oval in shape and choosing acorrect size device that is suitable for the defect mayotherwise be difficult. The most important point to

remember is that even these malleable balloons canstretch the ASD and falsely increase the size of thedefect. As discussed later, oversizing can be detrimen-tal and can lead to potential complications. In a recentreport [12], we recommended that stop-flow techniquebe used when balloon sizing of the ASD is performed.The stop-flow technique is described as follows: afterthe balloon is astride the ASD, inflate the balloon withsaline or saline/contrast mixture until no shunt is seenacross the ASD by color echocardiography, deflate theballoon until shunting reappears, then reinflate to elim-inate the shunt (stop-flow diameter of the ASD). A de-vice that is equal to or up to 2 mm larger than the flow-stop diameter usually works well. Oversizing should beavoided. It is not necessary to stretch the ASD diameter,and hence the term balloon-stretched diameter should beavoided. I would, however, like to concede that in somepatients who have thin, flailing septum primum, balloonsizing may not be easy because the septum is stretchedeven by gentle inflation of the balloon. Despite theseshortcomings that occur rarely in a few patients duringballoon sizing, it is possible to measure the stop-flow di-ameter. Patience is a virtue. Again, it is strongly recom-mended to adhere to stop-flow diameter of ASD.Another area where balloon sizing can be cumber-

some is in small patients with deficient rims. A goodexample is in a patient who weighs 15 kg and has a26 mm ASD. This patient is very likely to have defi-cient aortic, posterior, and/or IVC rims. Balloon sizingwith long balloons in such patients may lead toobstruction of the flow from the IVC, decrease inflowof circulation from the right and left atria into theventricles, leading to hemodynamic compromise (lowcardiac output and hypotension). In addition, duringballoon sizing, stop-flow diameter may not be ac-hieved; even a minor indentation may not be seen byfluoroscopy (Fig. 6). For such patients, balloon sizingmay not be performed; instead total atrial septal length

Fig. 4. ASD dimension in 4-chamber view. Fig. 5. ASD dimension in short-axis view.

780 Amin

Page 4: Transcatheter closure of secundum atrial septal defects

can be used to determine the size of the device. Thetotal atrial septal length, in our laboratory, is measuredin 4-chamber view by transthoracic echocardiographyand/or TEE. The AV valve rim (Fig. 7) plus the aver-age size of the ASD (measured at least in two orthogo-nal views) plus the superior rim equals total atrial sep-tal length (Fig. 8). A device where the left atrial discof the Amplatzer septal occluder is equal to or smallerthan the total atrial septal length can be used.

Device Closure

A 6 or 7-F wedge catheter or multipurpose (Cook,Bloomington, IN) or Goodale-Lubin (Bard, AZ) cathe-ter is used to cross the defect. Some operators prefer

an angiogram in the right upper pulmonary vein to bet-ter visualize the anatomy of the atrial septum and toexclude partial anomalous pulmonary venous return;but this is optional, because anomalous pulmonary ve-nous drainage and septal anatomy can be evaluated byTEE. The wedge catheter is advanced to the left upperpulmonary vein. The catheter is removed over anexchange length Amplatz extra stiff wire. The shortsheath is removed and an appropriate sized Amplatzerdelivery sheath is advanced over the wire into the leftupper pulmonary vein. The dilator and the wire areremoved slowly to ensure air does not get sucked intothe sheath. Another way of avoiding air introductioninto the sheath is to remove the dilator when the

Fig. 6. Balloon sizing of large ASD. No indentation is seen. See text for detailed description.

Fig. 7. AV valve rim measurement for measuring the totalatrial septal length.

Fig. 8. Superior rim measurement for calculation of the totalatrial septal length.

Transcatheter Closure of Secundum ASD 781

Page 5: Transcatheter closure of secundum atrial septal defects

sheath is in the IVC and flush the sheath before intro-ducing it into the left atrium. Alternatively, the sheathis advanced into the proximal left upper pulmonaryvein and then allowed to back bleed without aspiration.To aid back-bleed, the sheath is lowered below thelevel of the heart; once back-bleed is established, thesheath is flushed with saline thoroughly. If blood re-mains in the sheath, it tends to clot rather quickly,increasing risk of introducing clot in the left atrium.Some interventionalists remove the dilator and the wirewhile the sheath is immersed in the saline to avoid airbubbles from being aspirated into the sheath.The device is immersed in saline and examined

before screwing it to the delivery cable. Some physi-cians immerse the device in warm saline; this, how-ever, is not a routine practice of majority of the in-terventionalists. Nitinol, the material from which thedevice is manufactured, keeps its shape at body tem-perature; cold water may make the device soft, espe-cially if the device being used is large. The device isloaded into the loader, and the loader is attached tothe delivery sheath by clockwise rotation. Care shouldbe taken to ensure that the delivery cable rotates dur-ing attachment of the loader to the delivery sheath;otherwise, the cable will become partially unscrewedfrom the device, increasing the chance of inadvertentpremature device release and embolization. Once thedevice is at the tip of the delivery sheath, the sheath iswithdrawn in the mid left atrium to deploy the leftdisc, the sheath and the cable are retracted in unisonto approximate the left disc to the atrial septum, andthe waist and the right disc are then released by re-tracting the sheath over the cable. The device deploy-ment is usually performed under echocardiographicguidance. The device position is checked by echocardi-ography before releasing the device.In patients with deficient aortic and/or posterior rim,

device deployment is challenging. In these patients, af-ter the left disc is deployed and pulled to approximateit to the atrial septum, the superior/anterior part of thedevice (that is toward the aortic rim) protrudes in theright atrium. By echocardiography, the device appearsperpendicular to the atrial septum. This leads to multi-ple attempts of device deployment, recapturing forrepositioning, which in turn may lead to kinking of thedelivery sheath. These maneuvers increase the proce-dure time and the risk of device embolization.There are few techniques to circumvent this prob-

lem. In our experience, these techniques can be tai-lored to the type of rim deficiency.

Deficient Aortic Rim

For large ASDs with deficient aortic rims, the leftupper pulmonary vein technique works well. This tech-

nique has been used by several interventionalists withexcellent results (Figs. 9–12). The delivery sheath isplaced into the left upper pulmonary vein; the depth ofthe sheath should be enough to ensure that the devicewill temporarily stay in the pulmonary vein when thesheath is withdrawn. The sheath is then withdrawnswiftly all the way into the right atrium so as to de-ploy both discs simultaneously, while the deliverycable is kept taut and stable in one location. The de-vice resembles an American football at initial deploy-ment. The left disc springs out of the pulmonary veinand slaps onto the atrial septum. This maneuver keepsthe left disc parallel to the atrial septum which pre-vents the aortic edge of the device from protrudinginto the right atrium. If the device does not spring outof the pulmonary vein, a gentle traction on the cablehelps in withdrawing the device. Extreme care andcaution should be exercised to avoid advancing the de-vice deep into the pulmonary vein, as injury to thepulmonary vein can occur. Alternatively, some opera-tors choose to use Hausdorf sheath (see below). Thetip of the sheath is angled so that at the time of thedelivery of the device, the edge of the device towardsthe aortic rim is kept away from the aortic rim, keep-ing the device parallel to the ASD.

Deficient Posterior Rim

The left atrial roof technique works well in patientswith deficient posterior rim. In this scenario, the stand-ard device deployment technique is unsuccessful be-cause the posterior edge of the device protrudes intothe right atrium. Small patients, who have a deficientposterior rim, also have small left atrial cavity. Whenthe left disc is deployed, it cannot expand fully in theleft atrial cavity; hence, the posterior edge of the deviceprotrudes into the right atrial cavity. To avoid this, thedelivery sheath is placed near the orifice of the rightupper pulmonary vein (not inside the pulmonary vein).On fluoroscopy (antero-posterior view), the deliverysheath appears parallel to the spine. The device isadvanced and the left disc is deployed in the atrial roofwhile keeping the sheath stable. The deployed left discis perpendicular to the spine after it is deployed in theatrial roof. The right disc is deployed by withdrawingthe sheath (Figs. 13–15). This maneuver keeps the pos-terior edge of the device inside the left atrium andaway from the posterior rim of the defect, while the re-mainder of the device is deployed. This technique isalso applicable in patients who have combined defi-ciency of aortic and posterior rims.There are other techniques described in the literature

to avoid protrusion of the aortic edge of the device.These techniques, however, require an additional ve-

782 Amin

Page 6: Transcatheter closure of secundum atrial septal defects

nous access, dilator tips, and balloons to keep the ante-

rior edge from protruding into the right atrium [13,14].

The methods above earlier are simple and do not re-

quire additional venous access or sheaths etc.

Hausdorf Sheath

The late Dr. Hausdorf designed a delivery sheathwhose tip was angled to keep the aortic edge of thedisc posterior, hence parallel to the septum and away

Fig. 9–12. (9) Delivery sheath in the left upper pulmonary vein. (10) Delivery sheath withdrawnto deploy both discs simultaneously. (11) Once the left disc springs out of the pulmonary vein,the cable is pushed to form the right disc. (12) Deployed device, ready for release.

Transcatheter Closure of Secundum ASD 783

Page 7: Transcatheter closure of secundum atrial septal defects

Fig. 13–15. (13) The deliver sheath tip close to the left atrial roof. (14) The left disc is beingdeployed, the sheath is kept in one location by gently pushing inward. (15) A: Once the leftdisc has been deployed, the sheath is withdrawn and the right disc is deployed. B: The rightdisc is gently pushed so that it assumes its shape.

784 Amin

Page 8: Transcatheter closure of secundum atrial septal defects

from the aortic rim. The Hausdorf sheath (Cook) isavailable in sizes 10, 11, and 12 French. The Daigsheath (St. Jude Medical, MN) has somewhat similarconfiguration to the Hausdorf sheath and has been usedby some interventionalists with good success.

COMPLICATIONS

In addition to the usual potential complications asso-ciated with any cardiac catheterization and inter-vention, ASD closure carries the risk of thrombus for-mation, device embolization, infection, and erosion[12,15–27]. The risk of device embolization variesfrom institution to institution. In our personal experi-ence, it is about 0.5% and in the literature about 1%[25]. The exact overall incidence is, however, difficultto establish. The Amplatzer ASD device has a goodmargin of safety as the device size is based upon thewaist and not the discs. For devices that are 10 mm orsmaller, the left disc is 12 and the right disc is 8 mmlarger than the waist; for device sizes 11–32 mm, theleft disc is 14 mm and the right disc is 10 mm largerthan the waist; and for devices that are 34–40 mm(40 mm device is not approved by FDA for use in theUSA), the left disc is 16 mm and the right disc is10 mm larger than the waist. The self-centering designof the device also helps to keep the device in stableposition even when the rims are deficient. Given thiscomfortable margin of safety, it is likely that deviceembolization occurs because of significant but inad-vertent undersizing or improper deployment. As under-sizing is relatively uncommon, the main cause of de-vice embolization is inability to recognize deficiencyof atrial septal rims, especially the IVC rim. This rimis technically difficult to visualize by TEE. However,with experience, it is possible to evaluate this rim byTEE. In pediatric patients, the most ideal way to eval-uate the IVC rim is by Transthoracic echocardiography.A subcostal view in coronal plane will define the pres-ence or absence of the IVC rim. This rim is easily seenby ICE, although when closing large ASDs, ICE mayhave its own challenges. Deficient IVC rim should beconsidered a contraindication to device closure. A thor-ough evaluation of the atrial septal rims and gentle wig-gle (Minnesota wiggle) or constant pull and push areexcellent indicators of device stability. If the device isnot parallel to the atrial septum, it should be recapturedand redeployed. Rarely, device embolization may occurseveral days after the procedure. A chest X-ray 1 weekafter device deployment is recommended to evaluate thedevice position. There are a few case reports in the litera-ture where device embolization presumably occurredseveral weeks after the procedure [21–23]. In one pub-lished case report, the device embolized several weeks

after the procedure [21]. In this series, however, theauthors conceded that the device orientation was notproper during placement. In addition, no follow-upstudies (chest radiograph, echocardiogram) were per-formed. Although it is not impossible, it is improbablefor the device to embolize after 3–4 weeks. Patientsshould be strongly cautioned to avoid strenuous activ-ity for a minimum of 4 weeks. In an active teenagerpatient, it may be wise to recommend avoidance ofstrenuous activity for 8 weeks.

Hemodynamic Compromise

Development of pericardial effusion causing hemo-dynamic compromise has been reported in the litera-ture [12,15]. The incidence of this rare complicationhas declined sharply over the last 2 years, as the causeof erosions has been thoroughly investigated andphysicians have been updated about ways to preventthe complication. Pericardial effusion that causes peri-cardial tamponade results in hemodynamic compro-mise. During the FDA approved trials in the US, peri-cardial effusion developed in one patient after devicedeployment. The effusion was drained and the devicewas left in place. After the device approval, the reportedincidence rose rather sharply. The company took a pro-active approach and convened a board composed of in-terventionalists and an echocardiographer. After severalboard meetings and review of all the reported cases,the most common denominator that appeared to havecaused pericardial effusion with hemodynamic compro-mise was device oversizing. Again, as in the case of de-vice embolization, the exact incidence of hemodynamiccompromise from pericardial effusion is difficult to esti-mate, as all cases of compromise may not have been re-ported to the company. It is, however, mandatory to re-port any hemodynamic compromise to the company ifthe event occurred in the US. Hence, US data is accu-rate. The incidence of hemodynamic compromise in theUS is about 1/1,000 implants. Since the recognition ofthis phenomenon and publication (12), the incidence hasdecreased significantly. For example, the incidence ofhemodynamic compromise decreased from 0.24% in2002–2003 to 0.02% in 2004–2005 (personal communi-cations, AGA Medical Corp.). The decrease in the inci-dence is a direct effect of the awareness of the compli-cation, and the development of ways to minimize suchcomplications with open discussion in several meetingsover the last 3 years.Hemodynamic compromise occurred when the devi-

ces were significantly oversized compared to the sizeof the ASD, when there was deficiency of the aorticand/or the superior rim. All documented erosionsoccurred when the edge of the right or the left atrialdisc eroded through the atrial free wall into the peri-

Transcatheter Closure of Secundum ASD 785

Page 9: Transcatheter closure of secundum atrial septal defects

cardial cavity. If the erosion extended into the aorta,pericardial tamponade occurred rapidly. When the de-vice was oversized, the discs extended beyond theatrial septum and tented the atrial free wall. Anatomi-cally, anterior-superior free wall of the atria (adjacentto the aortic rim) is most vulnerable when the aortic orsuperior rim is deficient and the waist of the devicetouches the aorta. If the device is not oversized, thedevice adjusts because of the self-centering nature ofthe device. When oversized, the disc is wedged be-tween the bulging and pulsating aorta anteriorly andthe posterior septal rim. This causes the anterior/supe-rior edge of the device to tent the atrial free wall.To avoid device erosion, balloon sizing should be

performed using the stop-flow diameter and the deviceshould be equal to or 2 mm larger than the diameter(as stated earlier). The majority (nearly 75%) of theerosions occurred within the first 5 days [12]. Allpatients should be kept in the hospital overnight. Ifthere is any evidence of pericardial effusion, serialechocardiograms should be performed to ensure thatthe effusion is not increasing in volume. With neces-sary precautions, the risk of hemodynamic compromiseshould decrease further.Another rare complication of device placement is the

formation of a fistula between the aorta and the right orleft atrium [19,20]. This is a rare complication that isnot immediately life threatening and is usually diagnosedduring a follow-up examination when continuous mur-mur is heard over the precordium. The communicationhas been repaired with surgery during which time thedevice was removed, the ASD was closed with a patch,and the fistula repaired. I am aware of one case, wherethe fistula was closed with a device. I believe that thesecommunications are best repaired surgically. The com-munication is in close proximity of the aortic valve andplacement of another device may not be prudent.

Cobra Head Malformation of the ASO

During device advancement through the deliverysheath, the left disc may twist, and when the device ispushed out of the sheath, it assumes the form of cobrahead [26,27]. The best way to avoid this complicationis to ensure that the cable is not rotated during advance-ment of the device. If cobra head malformation is seen,recapture and removal of the device should be under-taken. Usually, a gentle twist helps to untangle the leftdisc and the device assumes its normal shape. If this isnot successful, replacement of the device is recom-mended.

Anticoagulation

During the FDA-approved trials, patients were startedon aspirin therapy 2 days before the procedure. A dose of

5 mg/kg for children is recommended. It is recom-mended that all patients should continue to take aspirinfor a period of 6 months after the device implantation.If for some reason aspirin is contraindicated, clopidrogelcan be used. The adult dose is 75 mg/day. At the cur-rent time, no pediatric dose has been established.During device closure of the ASD, 100 units/kg of

heparin is given intravenously, after obtaining a base-line activated clotting time (ACT). The ACT is main-tained around 250 sec throughout the procedure. If theprocedure is not completed within 30 min, it is recom-mended to check the ACT and administer heparinaccordingly. We do not recommend protamine at theconclusion of the procedure.

SBE Prophylaxis

After device closure of the ASD, SBE prophylaxis isrecommended for a period of 6 months to prevent endo-carditis. Usually, we recommend avoiding routine dentalcleaning or other routine procedures for 6 months.Amoxicillin (50 mg/kg; maximum 2,000 mg) or clinda-mycin (20 mg/kg; 600 mg maximum) 1 hr before theprocedure can be used for adequate coverage.

SUMMARY

In summary, device closure of the ASD has becomestandard of care for secundum ASD. ASDs as large as40 mm diameter can be closed using the ASO devices[28]. Midterm and long-term results are excellent [29].However, as the experience with device closure andfollow-up increases, we will undoubtedly becomeaware of other potential issues and ways to circumventthem, just like the surgeons did early in the experiencewith operative ASD repair.

REFERENCES

1. Shrivastava S, Radhakrishnan S. Echocardiographic anatomy of

the atrial septal defect: \Nomenclature of the rims." Indian Heart

J 2003;55:88,89.

2. Bjornstad G. Is interventional closure the current treatment of

choice for selected patients with deficient atrial septation? Car-

diol Young 2006;16:3–10.

3. Rao PS, Berger F, Rey C, Haddad J, Meier B, Walsh K, Chandar

J, Lloyd T, de Lezo JS, Zamora R, Sideris E. Results of transve-

nous occlusion of secundum atrial septal defects with the fourth

generation buttoned device: Comparison with first, second and

third generation devices. J Am Coll Cardiol 2000;36:583–592.

4. Zahn E, Wilson N, Cutright W, Latson L. Development and test-

ing of the Helex septal occluder, a new expanded polytetrafluor-

ethylene atrial septal defect occlusion system. Circulation 2001;

104:711–716.

5. Horst S, Babic U, Hausdorf G, Schneider M, Hopp H, Pfeiffer D,

Pfisterer M, Friedli B, Urban P. Transcatheter closure of atrial

defect and patent foramen ovale with the ASDOS device (a multi-

institutional European trial). Am J Cardiol 1998;82:1405–1413.

786 Amin

Page 10: Transcatheter closure of secundum atrial septal defects

6. Rickers C, Hamm C, Stern H, Hofmann T, Franzen O, Schrader R,

Sievert H, Schranz D, Michel-Behnke I, Vogt J, Kececioglu D,

Sebening W, Eicken A, Meyer H, Matthies W, Kleber F, Hug J,

Weil J. Percutaneous closure of secundum atrial septal defect with

a new self centering device (\angel wings"). Heart 1998;80:517–521.

7. Goy J, Stauffer J, Yusoff Z, Wong A, Owlya R, Perret F, Sie-

genthaler M, Savcic M, Menetrey R, Seydoux C. Percutaneous

closure of atrial septal defect type ostium secundum using the

new intrasept occluder: Initial experience. Catheter Cardiovasc

Interv 2006;67:265–267.

8. Rickers C, Jerosch-Herald M, Hu J, Murthy N, Wang X, et al.

Magnetic resonance image-guided transcatheter closure of atrial

septal defects. Circulation 2003;107:132–138.

9. Hijazi ZM, Wang Z, Cao Q, Koenig P, Waight D, Lang R.

Transcatheter closure of atrial septal defects and patent foramen

ovale under intracardiac echocardiographic guidance: Feasibility

and comparison with transesophageal echocardiography. Cathe-

ter Cardiovasc Interv 2001;52:194–199.

10. Bartel T, Konorza T, Arjumand J, Ebradlidze T, Eggebrecht H,

Caspari G, Neudorf U, Erbel R. Intracardiac echocardiography is

superior to conventional monitoring for guiding device closure

of interatrial communications. Circulation 2003;107:795–797.

11. Mullen M, Dias B, Walker F, Siu S, Benson L, McLaughlin P.

Intracardiac echocardiography guided device closure of atrial

septal defects. J Am Coll Cardiol 2003;41:285–292.

12. Amin Z, Hijazi ZM, Bass JL, Cheatham JP, Hellenbrand W,

Kleinman C. Erosion of Amplatzer septal occluder device after

closure of atrial septal defects: Review of registry of complica-

tions and recommendations to minimize future risk. Catheter

Cardiovasc Interv 2004;63:496–502.

13. Wahab HA, Bairam AR, Cao QL, Hijazi ZM. Novel technique

to prevent prolapse of the Amplatzer septal occluder through

large atrial septal defect. Catheter Cardiovasc Interv 2003;60:

543–545.

14. Dalvi B, Pinto R, Gupta A. New technique for device closure of

large atrial septal defects. Catheter Cardiovasc Interv 2005;64:

102–107.

15. Chessa M, Carminati M, Butera G, Bini MR, Drago M, et al.

Early and late complications associated with transcatheter occlu-

sion of secundum atrial septal defects. J Am Coll Cardiol 2002;

39:1061–1064.

16. Divekar A, Gaamangwe T, Shaikh N, Raabe M, Ducas J.

Cardiac perforation after device closure of atrial septal defects

with the Amplatzer septal occluder. J Am Coll Cardiol 2005;45:

1213–1218.

17. Stangl V, Stangl K, Bohm J, Felix S. Thrombus formation after

catheter closure of an atrial septal defect with a clamshell de-

vice. Ann Thorac Surg 2000;69:1956.

18. Grayburn P, Schwartz B, Anwar A, Hebeler R. Migration of an

Amplatzer septal occluder device for closure of atrial septal

defect into the ascending aorta with formation of an aorta-to-

right atrial fistula. Am J Cardiol 2005;96:1607–1609.

19. Chun DS, Turrentine MWE, Moustapha A, Hoyed MH. Deve-

lopment of aorta-to-right atrial fistula following closure of

secundum atrial septal defects using Amplatzer septal occluder.

Catheter Cardiovasc Interv 2003;58:246–251.

20. Jang G, Lee J, Kim S, Shim W, Lee C. Aorta to right atrial fis-

tula following transcatheter closure of an atrial septal defect.

Am J Cardiol 2005;96:1605,1606.

21. Mashman W, King S, Jacobs W, Ballard W. Two cases of late

embolization of Amplatzer septal occluder devices to the pulmo-

nary artery following closure of secundum atrial defects. Cathe-

ter Cardiovasc Interv 2005;65:588–592.

22. Teoh K, Wilton E, Brecker S, Jahangiri M. Simultaneous re-

moval of an Amplatzer device from an atrial septal defect and

the descending aorta. J Thorac Cardiovasc Surg 2006;131:909,

910.

23. Tsilimingas N, Reiter B, Kodolitsch Y, Munzel T, Meinertz T,

Hofmann T. Surgical revision of an uncommonly dislocated

self-expanding Amplatzer septal occluder device. Ann Thorac

Surg 2004;78:686,687.

24. Balasundaram R, Anandaraja S, Juneja R, Choudhary S. Infec-

tive endocarditis following implantation of Amplatzer atrial sep-

tal occluder. Indian Heart J 2005;57:167–169.

25. Du ZD, Hijazi ZM, Kleinman CS, Silverman NH, Larntz K.

Comparison between transcatheter and surgical closure of secundum

atrial septal defect in children and adults: Results of a multicenter

non-randomized trial. J Am Coll Cardiol 2002;39:1836–1844.

26. Cooke JC, Gelman JS, Harper RW. Cobra head malformation of

the Amplatzer septal occluder device: An avoidable complication

of percutaneous ASD closure. Catheter Cardiovasc Interv 2001;52:

83–85.

27. Waight DJ, Hijazi ZM. Amplatzer devices: Benign cobra head

malformation. Catheter Cardiovasc Interv 2001;52:86,87.

28. Lopez K, Dalvi B, Balzer D, Bass JL, Momenah T, et al. Trans-

catheter closure of large secundum atrial septal defects using the

40 mm Amplatzer septal occluder: Results of an international

registry. Catheter Cardiovasc Interv 2005;66:580–584.

29. Masura J, Gavora P, Podnar T. Long-term outcome of transcath-

eter secundum-type atrial septal defect closure using Amplatzer

septal occluder device. J Am Coll Cardiol 2005;45:505–507.

Transcatheter Closure of Secundum ASD 787