ASD DEVICE

CLOSURE
Dr.S.R. Sruthi Meenaxshi
 Atrial septal defect (ASD) is the most common congenital lesion in adults after bicuspid aortic
valve.
 Although patients with this defect are often asymptomatic until adulthood, potential
complications of an untreated ASD include atrial arrhythmias, paradoxical embolization,
cerebral abscess, right ventricular failure, and pulmonary hypertension that can become
irreversible and lead to right-to-left shunting (Eisenmenger syndrome).
PREPROCEDURAL
ASSESSMENT
 Preprocedural assessment in patients with indications for ASD closure includes review of the
transthoracic echocardiogram (TTE).
 Some patients require additional testing such as transesophageal echocardiogram (TEE),
cardiovascular computerized tomography (CT), or cardiac magnetic resonance (CMR)
imaging to confirm the diagnosis and identify or exclude associated defects prior to surgical or
percutaneous closure.
 In patients with pulmonary hypertension, cardiac catheterization is usually recommended to
determine the best management strategy.
 Conditions that are likely to require surgical correction should be identified prior to intervention:

 Primum ASD, sinus venosus ASDs, and coronary sinus defects require surgical closure.

 Primum ASD is usually accompanied by a cleft mitral valve.

 A cleft mitral leaflet should be repaired at the time of ASD closure, even if associated mitral
regurgitation is not severe, to avoid the need for another operation since mitral regurgitation
usually progresses.

 Primum ASDs may also be associated with tricuspid valve abnormalities, left ventricular outflow
tract obstruction, ventricular septal defects, and a more extensive defect involving the
atrioventricular septum (atrioventricular septal defect).
 Sinus venosus ASDs are usually associated with one or more anomalous right-sided
pulmonary veins.
 Sinus venous ASDs and the associated anomalous veins are often missed on standard TTE.
 Agitated saline contrast administered during a TTE should demonstrate prompt filling of the
left heart chambers with bubbles in the presence of a sinus venosus atrial septal defect.
 Additional imaging options include TEE, CT, or CMR. However, these types of ASDs and
anomalous pulmonary veins can be missed even with advanced imaging techniques.
 These defects should be sought in patients with right heart enlargement.
 Our practice is to delineate the anatomy, including all of the anomalous pulmonary veins,
before the patient goes to the operating room for surgical intervention.
 Coronary sinus defects (also known as "unroofed coronary sinus") are often missed despite
echocardiography.
 They are often associated with left-sided superior vena cava and may accompany other
congenital anomalies including ostium primum or secundum ASDs.
 Observation of agitated saline in the left atrium initially, rather than the right atrium, after
injection into a left-sided arm vein suggests the presence of a coronary sinus defect and left-
sided superior vena cava.
 Multiple ASDs may be present (eg, concurrent secundum and primum ASDs).

 Some patients with multiple small secundum ASDs are amenable to percutaneous closure;
others require surgical closure.
 Some patients with ASDs have concomitant valve disease (in addition to cleft mitral valve
with primum ASD as discussed above).

 Moderate or more tricuspid regurgitation may persist after ASD closure in the adult.

 We favor surgical ASD closure when there is moderate or more tricuspid regurgitation to
facilitate both ASD closure and tricuspid repair at the time of operation
CHOICE OF CLOSURE
PROCEDURE
 Percutaneous transcatheter device closure is an alternative to surgical repair for the majority of
patients with secundum ASDs. Surgical closure is recommended for patients with secundum
ASD requiring closure when percutaneous repair is not feasible or appropriate .
 Anatomic requirements for percutaneous closure are discussed below.
 A secundum ASD with a large atrial septal aneurysm or a multifenestrated atrial septum
requires careful evaluation to determine whether percutaneous device closure is appropriate 
 Sinus venosus, coronary sinus, and ostium primum defects are preferably closed surgically, as
they are not generally amenable to percutaneous device closure (although there are case
reports of percutaneous closure of these defects).
 Percutaneous versus surgical closure for secundum ASD —

  Observational studies comparing surgical and percutaneous transcatheter closure of secundum

ASD suggest that mortality rates are similar, the rate of procedural success is comparable or
slightly better with surgery, and the rate of early complications and length of hospital stay are
reduced with the percutaneous approach.

 Differing types of complications occur following the two procedures as illustrated by the
following studies.
 An atrial septal aneurysm (ASA) is defined as redundant and mobile interatrial septal tissue in
the region of the fossa ovalis with phasic excursion of at least 10 to 15 mm during the
cardiorespiratory cycle.

 ASA is commonly associated with patent foramen ovale or one or more ASDs
 A perforated aneurysm may be associated with a significant left-to-right shunt and present
with clinical and hemodynamic features of an ASD.

 Perforated aneurysms can be closed surgically or percutaneously, depending upon their

morphology.

 In a retrospective review of 50 patients, perforated aneurysms were classified as follows

ATRIAL SEPTAL ANEURYSM
 Type A - aneurysm with persistent foramen ovale
 Type B - aneurysm with single ASD
 Type C - aneurysm with two perforations
 Type D - aneurysm with multiple perforations
PERCUTANEOUS CLOSURE
OF SECUNDUM ASD
 Percutaneous device closure is an alternative to surgical closure in patients with secundum
ASDs who have appropriate anatomic characteristics.
 Two devices have both US Food and Drug Administration approval and CE-mark and are
commercially available in the United States and Europe for percutaneous ASD closure the
Amplatzer Septal Occluder and the Gore CARDIOFORM Septal Occluder.
 The Occlutech ASD Occluder, the Ceraflex ASD Occluder, and the Nit-Occlud ASD-R have
received CE-mark and are in clinical use in Europe 
 Of note, the Gore CARDIOFORM Septal Occluder does not have self-centering properties,
which limits its use for larger defects and it is used mostly for patent foramen ovale closure.
 However, in selected patients with centrally located ASDs or multiperforated atrial septum,
the CARDIOFORM Septal Occluder is a valid alternative device with less foreign material
and excellent occlusion properties.
 The Amplatzer septal occluder and the CARDIOFORM device are characterized by relatively
stiff delivery mechanisms, so the angulation of the device changes after device release.
 In contrast to these occluders, the Occlutech and Ceraflex occluders have more flexible
delivery mechanisms, which enable optimal septal alignment prior to device release.
 The device remains in its final configuration and does not change its angulation at release.
 An additional advantage of the flexible properties of the Occlutech and Ceraflex occluders is
that the left atrial disc has less of a tendency to slip along the aortic root into the right atrium
during device placement, and hence, fewer adjunctive procedures (eg, device deployment with
an additional balloon) are needed.
 A few other devices that had been approved and were previously used for ASD closure are no
longer available, including the CardioSEAL Septal Occlusion System, the STARFlex device (a
next-generation version of the CardioSEAL device), and the Gore HELEX (a predecessor of
the CARDIOFORM device).
 The following discussion will review the efficacy and complications associated with
percutaneous device closure of secundum ASD.
CONTRAINDICATIONS AND CAUTIONS

 Pulmonary hypertension — Severe fixed pulmonary hypertension is considered a

contraindication to ASD closure.
 However, advances in the medical management of patients with pulmonary vascular disease
together with the development of novel percutaneous closure techniques may make ASD
closure feasible in this setting.
 It has been suggested that patients with a net left-to-right shunt, a pulmonary vascular
resistance less than 800 to 960 dyne sec cm (-5) m2 (10 to 12 Wood units), and a resting
systemic arterial oxygen saturation ≥90 percent might benefit from ASD closure
 The potential efficacy of percutaneous closure was demonstrated in a report of 29 patients
with a secundum ASD and a baseline peak pulmonary artery pressure >40 mmHg (mean 65
mmHg) in whom an Amplatzer device was implanted .
 Complete ASD occlusion was achieved in 28 patients (97 percent). Immediately after the
procedure, the mean peak pulmonary artery pressure decreased to 54 mmHg; at a mean of 21
months, it decreased further to 31 mmHg.
 There were no procedural complications. Functional status was improved after the procedure
and was maintained at a mean of 21 months.
 Six of 12 patients who had AF at baseline recovered sinus rhythm by discharge.
DIASTOLIC DYSFUNCTION
  Unrecognized left ventricular diastolic dysfunction may be present in older patients with ASDs.
 The presence of the left-to-right shunt at the atrial level may function to "offload" the stiff left
ventricle in these patients.
 One series demonstrated that temporary test occlusion of the ASD with a soft balloon catheter in
adult patients may help identify individuals whose left heart filling pressures will worsen if
device closure is performed .
 Our practice is to generally perform ASD test occlusion in patients 40 years old or older.
 If the mean left atrial or pulmonary capillary wedge pressure or left ventricular end-diastolic
pressure increases significantly with test occlusion, then we forego device closure in most cases.
 Further research needs to be conducted to identify a threshold increase in filling pressures, above
which ASD closure may be detrimental.
ASD RIMS
 Anatomic requirements — Percutaneous device closure is generally applicable only
to secundum ASDs .
 Sinus venosus, primum, and coronary sinus defects are not often amenable to percutaneous
repair, although cases of percutaneous repair of these defects have been reported 
 The ideal lesion for percutaneous closure is a secundum defect ≤38 mm in diameter with a rim
of tissue around the defect of at least 5 mm to prevent obstruction of the coronary sinus, right
pulmonary veins, venae cavae, or atrioventricular valves.
 The presence of a "retroaortic" superior-anterior atrial septal rim is favorable for device
closure, but septal deficiency in this region is common and not necessarily a contraindication
to percutaneous closure.
 Retroaortic rim deficiency has been associated with risk of erosion, as discussed below.
 Approximately one-half to two-thirds of secundum ASDs in adults meet these criteria .
 While smaller defects are often more amenable to device closure, larger defects can also
be closed percutaneously.
 The Amplatzer device is available in sizes ranging from 4 to 38 mm, reflecting the
diameter of the central device of the waist and generally correlating with the size of the
ASD to be closed.
 By comparison, the CARDIOFORM device comes in only three sizes (20, 25, and 30
mm), reflecting the diameter of the device disk at full deployment.
 The CARDIOFORM device can be used to close defects up to approximately 18 mm in
diameter.
 Closure of multiple ASDs has been performed using one or more closure devices,
including use of an Amplatzer multifenestrated "cribriform" septal occluder device or one
or more CARDIOFORM device .
 Rarely, secundum ASD is associated with a partial anomalous pulmonary venous connection
that should generally be managed with surgical ASD closure and concomitant baffling of the
anomalous pulmonary venous return.
 Thus, prior to percutaneous closure, a search for anomalous pulmonary veins or other
concurrent lesions that might require surgery should be undertaken, particularly if right heart
chamber enlargement is out of proportion to the size of the ASD.
ECHOCARDIOGRAPHIC
MONITORING
 The use of transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) can facilitate the
deployment of percutaneous ASD closure devices.

 Measurement of the size and location of the ASD by TEE can help select the appropriate device.

 In addition, TEE and ICE can be used to guide the procedure in real time, an approach that may eliminate the need
for fluoroscopy.

 Two- and three-dimensional (3D) TEE is particularly helpful when multiple devices are inserted to close multiple
ASDs .

 TEE during the procedure can also determine whether disruption of systemic or pulmonary venous inflow or valve
function occurs with device placement.
 In one series, 94 patients underwent ICE during percutaneous closure of an ASD or patent foramen ovale
(PFO) .
 All devices were deployed successfully. During the procedure, ICE identified a previously unrecognized
anatomical diagnosis in 32 patients (an additional ASD or PFO, a redundant atrial septum, or an atrial septal
aneurysm).
 Procedural complications occurred in four patients: atrial fibrillation (AF) in three and supraventricular
tachycardia in one. Two of the arrhythmias resolved spontaneously and two required cardioversion with no
recurrence.
 3D echocardiography enables direct and complete visualization of the ASD, so that the area of the defect can
be estimated and the anatomy of the entire interatrial septum can be defined.
 This 3D information facilitates optimal deployment and positioning of all types of interatrial closure devices.
 Clinical series suggest that percutaneous ASD closure can be safely and effectively be performed using only
echocardiographic guidance without fluoroscopy 
OUTCOMES OF
PERCUTANEOUS CLOSURE 
Observational studies of percutaneous closure have generally reported efficacy rates similar to
surgical closure with shorter hospital stays and lower rates of complications .

Defect closure is associated with a reduction in left atrial volume and improvements in right and
left ventricular function and functional capacity even in adults who were asymptomatic at
baseline. 
COMPLICATIONS 
 Complications associated with transcatheter closure of a secundum ASD include device
embolization or malposition, access site complications, atrial arrhythmias, atrioventricular
conduction block (often transient), erosion/perforation, and sudden death (in at least some
cases related to erosion) 
 Early — The type and frequency of early complications were evaluated in a report of 417
patients (mean age 27 years) who underwent secundum ASD closure with the AMPLATZER
or CardioSEAL/STARFlex device .
 Thirty-four patients (8.6 percent) experienced a complication during hospitalization:

●Device embolization or malposition requiring surgery in 2.4 percent and managed

percutaneously in 1 percent.
●AF or supraventricular tachycardia in 2.4 percent.
●Other complications (heart block, pericardial effusion, thrombus formation on the left
atrial portion of the device, iliac vein dissection, groin hematoma) in 2.2 percent.
 A similar rate of early complications (11.5 percent) and no mortality were reported in a multi-center study of 688
patients undergoing ASD closure with the Amplatzer, CardioSEAL/STARflex, or HELEX septal occluder .
 Device embolization occurred in 1.4 percent of patients with 0.4 percent of cases requiring surgical device
removal.
 In contrast, in another series of 124 patients, 6.5 percent required surgery for device malposition or embolization .
 Embolized Amplatzer ASD occluders may be removed relatively safely by snaring the detachment hub and
withdrawing through an adequately sized sheath.
 The Occlutech and Ceraflex occluders, especially the larger sizes, are more difficult to be removed since a snare
may slip off the detachment hub. The additional use of a dedicated biotome can be very helpful in these rare
cases .
 Transient atrioventricular block has been described with a frequency ranging from 1 to 6 percent .
 Atrioventricular block may be more common with larger devices and smaller patients. This problem appears to
resolve or improve spontaneously in most cases.
 Thrombus formation — Antiplatelet therapy (aspirin and clopidogrel) is given for at least six
months to all patients receiving a percutaneous closure device to protect against thrombus formation .
 Thrombus formation can occur in the left and/or right atrium .
 Anticoagulation is used in patients with ASD closure devices who have another indication for
anticoagulation therapy, such as AF.
 The frequency with which thrombus formation occurs was evaluated in a review of 407 consecutive
patients with an ASD and 593 consecutive patients with a PFO who were treated with a variety of
devices . The following findings were noted:
●Thrombus on the device was detected by TEE at four weeks in 14 patients (1.4 percent) and at six
months in six patients (0.6 percent).
The overall rate of thrombus formation was 1.2 percent in patients with an ASD and 2.5 percent in
patients with a PFO.
 After the investigators discontinued use of heparin therapy after implantation, thrombus
occurred in only 1 of 183 patients (0.5 percent) treated with aspirin and clopidogrel.
●Thrombus formation was significantly more common with the CardioSEAL and STARFlex
devices than with the Amplatzer device (5.9 versus 0 percent).
An intermediate rate of 3.6 percent was noted with the Atrial-Septal-Defect-Occlusion-System
(ASDOS) device.
●The thrombus resolved in 17 of 20 patients after anticoagulation with heparin and/or warfarin;
in the remaining three patients, the thrombus was removed surgically. Four of the 20 patients
suffered embolic events (strokes in three and a transient ischemic attack in one).
 Left atrial thrombus formation with transient ischemic attacks has been described as late as
three years after implantation 
EFFECT OF DEFECT CLOSURE ON
RISK OF ATRIAL ARRHYTHMIAS
 Atrial arrhythmias, primarily atrial fibrillation and atrial flutter, occur in approximately 20 percent of adult patients with an ASD and
are often the presenting symptom.
 The risk of these arrhythmias increases with patient age (especially over age 40) and with higher pulmonary artery pressures .
 In a report of 211 adults, for example, the incidence of AF or atrial flutter prior to surgery was 1 percent for those aged 18 to 40, 30
percent for those aged 40 to 60, and 80 percent in those over the age of 60.
 Observational data suggest that ASD closure may reduce but does not eliminate the risk of atrial tachyarrhythmias.
 The effect of surgical or percutaneous defect closure on the prevalence of atrial arrhythmias was evaluated by a systematic review,
including 26 studies in which a total of 1841 patients (with median or mean age at least 18 years prior to intervention) underwent
surgical closure and 945 patients underwent percutaneous closure .
 Meta-analysis demonstrated a reduction in the prevalence of atrial tachyarrhythmias after ASD closure (odds ratio [OR] = 0.66, 95%
CI 0.57-0.77).
 This effect was found after both surgical closure (OR = 0.72, 95% CI 0.60-0.87) and percutaneous closure (OR = 0.49, 95% CI
0.32-0.76). A significant decline in atrial tachyarrhythmias was seen both at <30 days and midterm (30 days to five years) follow-up.
 Limitations of the analysis include differences in methods for monitoring arrhythmias before and after closure in most of the studies.
 The risk of AF after ASD closure is presumably primarily related to irreversible factors, such
as incomplete atrial remodeling, that predispose to the arrhythmia.
 Surgical techniques, such the Maze procedure performed at the time of surgical ASD closure,
decrease the long-term incidence of AF in selected patients.
 This procedure involves the placement of incisions or cryolesions in the atria to interrupt the
macroreentrant circuits that sustain atrial flutter and AF .
 The use of radiofrequency ablation to create endocardial lesions is also effective in preventing
recurrences of AF, although data are limited in the patients with ASD 
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