a PDF of this article. - Journal of Invasive Cardiology

Original Contribution
Review
Transcatheter Closure of Secundum Atrial Septal Defects
Suhaib Kazmouz, MD, Damien Kenny, MD, Qi-Ling Cao, MD, Clifford J. Kavinsky, MD, PhD,
Ziyad M. Hijazi, MD, MPH
Abstract: Atrial septal defect (ASD) is one of the most common congenital heart defects, accounting for 7%-10% of all congenital heart disease (CHD) in children and 30%-33% of defects
diagnosed in adults with CHD. This review highlights the evolution
of transcatheter ASD closure, indications, follow-up, outcomes, and
complications with a focus on the erosion issue with certain devices.
J INVASIVE CARDIOL 2013;25(5):257-264
Key words: atrial septal defect, transcatheter ASD closure
Figure 1. The Amplatzer septal occluder device.
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Atrial septal defect (ASD) is one of the most common congenital heart defects, accounting for 7%-10% of all congenital
heart disease (CHD) in children and 30%-33% of defects diagnosed in adults with CHD. If left untreated, there is significant
risk of atrial arrhythmias and late morbidity; therefore, closure
of hemodynamically significant defects (right ventricle volume
overload as evidenced by transthoracic echocardiography or
Qp:Qs >1:5:1) is advised in childhood.1 Historically, surgery has
been the gold standard; however, the initial description of transcatheter closure by King and Mills in 19762 laid the groundwork
for the development of refined and clinically acceptable transcatheter alternatives to surgery. This initial work by King and
Mills was truly revolutionary, and 25-year follow-up data on the
5 patients who underwent transcatheter closure were reported in
2003 with 4 of these patients alive and well.3 Unfortunately, following this huge step, work on transcatheter closure of ASD lay
fallow for a number of years until 1983, when Rashkind reported successful delivery of a single foam-covered six-ribbed device
with hooks at the ends of three of these ribs.4 Modifications of
this basic design led to the development of the Clamshell device,
a double-hinged paired umbrella with four arms that folded on
themselves.5 Clinical studies with this device were halted due to
concerns regarding device fracture and residual shunting.6-8
In 1993, Das et al reported on a new device called the Angel Wing, which was the first self-centering device and had two
Dacron-covered square disks and nitinol frames with midpoint
torsion spring eyelets.9 One of the authors of this paper (ZMH)
implanted the first Angel Wing device in June 7, 1995;10 however,
From the Rush Center for Congenital & Structural Heart Disease, Departments of
Medicine and Pediatrics, Rush University Medical Center, Chicago, Illinois.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure
of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the
content herein. Conflict of Interest: Dr Hijazi is a consultant for Occlutech.
Manuscript submitted December 26, 2012, provisional acceptance given January 28,
2013, final version accepted February 7, 2013.
Address for correspondence: Ziyad M. Hijazi MD, MPH, Rush Center for Congenital & Structural Heart Disease, Jones 770, 1653 W. Congress Parkway, Chicago, IL
60612. Email: Zhijazi@rush.edu
Vol. 25, No. 5, May 2013
Figure 2. The Helex septal occluder.
because of the relative stiffness of the frame and the design of the
attachment mechanism, it was not easy to retrieve by catheter
and due to 2 cases of device erosion, the device was redesigned
and named the Guardian Angel. However, that device was never
used in humans. The real breakthrough with transcatheter ASD
closure came with the development of the Amplatzer septal occluder in the mid 1990s (Figure 1). This device design consists
of a nitinol wire mesh that is tightly woven into two disks with
a connecting waist between the two disks corresponding to the
approximate thickness of the interatrial septum. The first clinical
report was published in 1997.11 United States Food and Drug
Administration (FDA) approval followed in 2001. Although
many other devices have been reported, the other mainstream
device in clinical use today in the United States is the Helex septal occluder (Figure 2). This device consists of a single nitinol
wire covered by an ultrathin membrane of expanded polytetrafluoroethylene. In its occlusive configuration, the device forms
two round flexible discs that straddle the septum.
Anatomy of the Atrial Septum
The atrial septum is formed by the septum primum, which
originates from the atrial roof and septum secundum. Formation of the septum occurs through several stages. The septum
primum grows as a crescenteric flap, leaving an opening between the left and right atria called the ostium primum. With
growth of the septum primum, the ostium primum narrows
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KAZMOUZ, et al.
Table 1. American Heart Association guidelines for closure
of atrial septal defects.
Class I
(1) Transcatheter secundum ASD closure is indicated in
patients with hemodynamically significant ASD with suitable
anatomic features (level of evidence: B).
Class IIa
(1) It is reasonable to perform transcatheter secundum ASD
closure in patients with transient right-to-left shunting at the atrial
level who have experienced sequelae of paradoxical emboli such as
stroke or recurrent transient ischemic attack (level of evidence: B).
(2) It is reasonable to perform transcatheter secundum ASD
closure in patients with transient right-to-left shunting at the atrial
level who are symptomatic because of cyanosis and who do not require such a communication to maintain adequate cardiac output
(level of evidence: B).
Class IIb
C
Class III
(1) Transcatheter secundum ASD closure is not indicated in
patients with a small secundum ASD of no hemodynamic significance and with no other risk factors (level of evidence: B).
(2) Transcatheter ASD closure should not be performed with
currently available devices in patients with ASDs other than
those of the secundum variety. This would include defects of
septum primum, sinus venosus defects, and unroofed coronary
sinus defects (level of evidence: C).
(3) Transcatheter ASD closure is contraindicated in the
management of patients with a secundum ASD and advanced
pulmonary vascular obstructive disease (level of evidence: C).
and a second opening (ostium secundum) is formed. As the
septum secundum grows anteriorly to meet the septum primum posteriorly, it leaves a small opening called the foramen
ovale (FO), providing a continuous pathway for shunting of
blood across the pulmonary vascular bed in fetal life. Thus, the
foramen ovale is not a true deficiency in the atrial septum. Following birth, and decrease in pulmonary vascular resistance,
the hooded morphology of the septum primum collapses over
the foramen ovale to provide functional closure. The muscular
rims of the foramen ovale are known as the limbus and form
the raised margin around the FO. Autopsy studies have showed
that FO is circular to elliptical in shape and represents a part
of the anterosuperior portion of the atrial septum, with a mean
diameter of 4.9 mm and mean length of 8 mm.12 Ostium secundum ASD is the most common form of atrial defect, and
mostly relates to deficiency in the septum primum or rarely
the septum secundum. Indeed, the vast majority of these defects reflect complete absence, deficiency, or multiple fenestrations of the septum primum. In the absence of the valve of the
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Indications for Closure
The indications for closure of an ASD in the pediatric population are outlined in Table 1. Under usual circumstances, flow
through an ASD occurs from left to right, but to a variable degree depending on the size of the ASD, the ventricular compliance, and the pulmonary vascular resistance (PVR). Excessive
flow through the defect will eventually lead to right atrial and
ventricular volume overload. If the shunt is large and results in
significant right heart volume loading, the patient may experience symptoms of shortness of breath, reduced exercise tolerance, or palpitations in the second or third decade of life.15 5%10% of patients who have large ASDs with right heart volume
overload evident by echocardiography will develop late complications, such as reduced exercise tolerance, atrial arrhythmia,
or elevated PVR.15 Intervention in older patients has also been
shown to be advantageous, with Konstantinides and colleagues
demonstrating significant improvement in the survival rate in
symptomatic patients older than 40 years undergoing surgical
ASD closure compared to those treated medically.16
Transcatheter ASD closure is deemed feasible if the balloonstretched diameter of the defect is less than 35 mm and the
defect has sufficient rims (>5 mm) of surrounding atrial tissues.
However, transcatheter closure has been routinely performed
in defects with deficient rims, particularly of the anterosuperior
atrial septum. Attempted closure in patients with 2 or more
deficient rims is not advised and device embolization is thought
to be higher in patients with significantly deficient posterior
and inferior rims. Weight restrictions have lessened over time
and multiple reports have demonstrated safe and effective closure in patients weighing less than 15 kg.17
The American Heart Association recommendations for closure in adults reflect those for children as well as documented
orthodeoxia-platypnea, and ASD with left-to-right shunt and
PVR less than two-thirds of the systemic vascular resistance.1,18
Contraindications for ASD device closure include elevated
PVR in excess of 7 Wood units (indexed), although closure in patients with secundum ASD and pulmonary arterial hypertension
can be successfully performed in selected subjects and is associated with good outcomes.19 Other contraindications include acute
or recent sepsis, or contraindications for antiplatelet therapy.
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(1) Transcatheter closure may be considered in patients with a
small secundum ASD who are believed to be at risk of thromboembolic events (eg, patients with a transvenous pacing
system or chronically indwelling intravenous catheters, patients
with hypercoagulable states) (level of evidence: C).
fossa ovalis, the ASD is usually elliptical in shape and located
centrally; however, ASD position, shape, and size vary widely
and defects may extend toward the vena cavae, right pulmonary
veins, coronary sinus, or atrioventricular valves. The relationship to these structures remains important when considering
device closure.13,14 Due to the anatomical limitations, effective
transcatheter closure of sinus venous, coronary sinus, or ostium
primum defects is not considered viable.
Procedure
Prior to defect closure, it is crucial to identify the number of
defects, defect size, location, morphology, and the surrounding
atrial septal tissue to determine whether the defect is amenable
to transcatheter closure or not. Baseline assessment of cardiac
structures that may be affected by the procedure should also
be carried out. Echocardiography remains the noninvasive gold
The Journal of Invasive Cardiology®
Transcatheter Closure of Secundum ASDs
Figure 3. Stepwise angiographic images of Helex septal occluder deployment. (A) The catheter is advanced in the right upper pulmonary vein. (B)
Defect balloon sizing. (C) Left atrial disk deployment. (D) Right atrial disk deployment. (E) The device is released.
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Figure 4. Stepwise intracardiac echocardiographic images of Helex septal occluder deployment. (A) Atrial septal defect. (B) Left-to-right shunt
through the atrial septal defect. (C) Balloon sizing of the defect. (D) The delivery system crossing the defect to the left atrium. (E) Device deployment. (F) The device is deployed with no residual shunt.
standard imaging tool for detecting an interatrial communication. Three-dimensional transthoracic and transesophageal and
intracardiac echocardiography have also been used.
Although transcatheter closure of small-to-moderate sized
defects with good rims is frequently straightforward, it should
be performed only in laboratories and by experienced operators
equipped to deal with complications and unexpected challenges of the procedure, and surgical back-up should be available.
Conscious sedation may be used if intracardiac echocardiography (ICE) is used to guide closure; however, general anesthesia
is preferred when TEE is used or with younger patients as they
may not be cooperative. Access is obtained usually in the right
femoral vein. If ICE is used, an additional sheath is needed in the
left or right femoral vein depending on the patient’s weight. If
Vol. 25, No. 5, May 2013
the weight is >35 kg, we access the femoral vein in the right using two separate punctures a few millimeters from each other;
however, if the weight is <35 kg, we access the contralateral
vein. The main advantages of ICE over TEE during this procedure include avoidance of anesthesia, better view of the left
atrium and the posteriorinferior rim of the septum, and need
for fewer personnel, because the interventional cardiologist will
be able to perform the interventional procedure independently
with the need for an anesthesiologist or echocardiographer.
The foremost disadvantage is the additional cost of the imaging catheter.20 Intravenous heparin should be given to keep an
activated clotting time >200 seconds throughout the procedure as the risk of thrombus in the left atrium will predispose
the patient to stroke.21 A thorough hemodynamic evaluation
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Figure 5. Stepwise angiographic images of Amplatzer septal occluder deployment. (A) The wire crossing to the right upper pulmonary vein. (B)
Balloon sizing of the defect (arrows refer to the waist of the balloon). (C) Deployment of the left and right disk of the device (arrow L refers to the
left disk, arrow R refers to the right disk). (D) An angiogram in the right atrium showing the contrast covering the right disk of the device. (E) An
angiogram in the left atrium showing the contrast covering the left disk of the device. (F) The device after the release.
should be carried out before device deployment and special
attention should be given to the pulmonary artery pressures,
PVR, Qp:Qs, left atrial pressure, and the left ventricular enddiastolic pressure. Right upper pulmonary venous angiography
may be performed, since it profiles the atrial septum and the
defect size and may serve as a roadmap during device deployment. This view is obtained with 35° left anterior oblique and
35° cranial angulation. Intraprocedural echocardiography is
used to assess the size of the defect and the septal rims in multiple planes, with confirmation of pulmonary venous drainage
(particularly right-sided) to the left atrium and the degree of
atrioventricular valve regurgitation. Balloon sizing of the defect is recommended in all ASD device closure cases; however,
some operators may choose not to balloon-size based on the
size and location of the defect. Once the defect is crossed and
a catheter advanced into the left upper pulmonary vein, a stiff
exchange-length guidewire is positioned in that vein. Following
this, an appropriate-sized sizing balloon (St Jude Medical or
NuMED, Inc) is advanced across the defect. The balloon is inflated under echocardiography guidance until no residual shunt
through the defect is seen (stop-flow technique). At this stage,
260
the diameter of the balloon is measured by cine recording and
echocardiography. In the case of the Amplatzer devices, a device
approximately no more than 2 mm greater than the stop-flow
diameter is usually chosen. The Helex device is usually not recommended for defects greater than 18 mm in diameter and a
device:balloon size ratio of 2:1 is chosen for best results. The
delivery sheath is then advanced over the wire and once the
tip of the dilator crosses the defect, the dilator is held and the
sheath advanced over the dilator into the left upper pulmonary
vein. The wire and the dilator are then slowly withdrawn and
the sheath held below the level of the heart to allow back-bleed
to eliminate any possibility of air embolism. The device is then
loaded and advanced to the tip of the sheath (Figures 3-6).
The delivery sheath is pulled out of the pulmonary vein
into the left atrium, and at this point the delivery cable is fixed
firmly while retracting the sheath over the cable and deploying
the left atrial disc in the left atrium. Then, the entire assembly
(sheath/cable) is withdrawn toward the septum. Once the left
disc is within a few millimeters of the septum, the connecting waist is deployed partially in the left atrium with continuous traction toward the defect. The purpose is to “stent” the
The Journal of Invasive Cardiology®
Transcatheter Closure of Secundum ASDs
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Figure 6. Stepwise intracardiac echocardiographic images of Amplatzer septal occluder deployment. (A) Atrial septal defect (ASD). (B) Left-toright shunt through the ASD. (C) The deflated balloon across the ASD. (D) Balloon sizing of the defect. (E) The delivery system crossing the defect
to the left atrium. (F) Deployment of the left disc of the device. (G) Deployment of the right disc of the device. (H) The device is deployed with no
residual shunt.
defect with the waist. Then, with continuous traction toward
the right atrium, the right atrial disc is deployed in the right
atrium. Once the entire disc is deployed, the delivery cable is
then pushed toward the septum to approximate the two discs
of the device to each other.
The mechanism for deployment of the Helex device is outlined in Figures 3 and 4. Echocardiography and cine fluoroscopy should be used to document and monitor all stages of
device deployment with full assessment prior to device release.
Various strategies have been described to promote stability of
the device in the setting of a deficient anterosuperior rim, including use of the Hausdorf sheath, the pulmonary vein deployment
technique, use of the dilator to maintain the left atrial disc on the
left atrial aspect of the septum during deployment, and use of a
balloon across the defect to maintain the device in a stable position.22-24 Recently, the manufacturer of the Amplatzer device (St
Jude Medical) introduced a new delivery system (TorqView FX)
that has an inner softer cable that does not produce much tension
on the device. Once the right atrial disc is deployed, the stiffer
cable is retracted and the softer inside cable is pushed; this allows
better alignment of two discs with the atrial septum.
Follow-up
Within 24 hours of device implantation, an echocardiogram
should be done on all patients to evaluate the device position
and any residual shunt and to look for any potential complications (device erosion, embolization, etc). Twelve-lead electrocardiogram should also be performed, since rare cases of heart
block have been reported with large devices.25 Hill and colleagues reported an increased incidence of atrial arrhythmias
Vol. 25, No. 5, May 2013
and conduction abnormalities early after device closure.26 Postprocedure follow-up visits for all patients should be done at 6
months, 1 year, and then every 1-2 years thereafter. At each
visit, physical exam, electrocardiogram, and echocardiography
should be performed. If complete closure is documented at the
6-month follow-up visit, aspirin and SBE prophylaxis may be
discontinued. It has been well documented that right ventricular size will improve rapidly in the first month; however, longstanding right ventricular dilation may improve more slowly
and may not normalize completely.27
Clinical Outcomes
In 2002, a trial comparing surgical closure and transcatheter closure with the Amplatzer septal occluder demonstrated
comparable closure rates.28 However, complication rates in the
surgical group were significantly higher than the device closure
group (24% vs 7%, respectively), and the length of the procedure and the hospital stay were shorter in the patients who
underwent transcatheter closure.
Furthermore, in 2007 a multicenter pivotal study compared
transcatheter ASD closure with the Helex device to surgical closure.29 There was no significant difference in the efficacy and
safety between the two groups; however, the length of sedation
and the hospital stay were longer in the surgically treated group.
Patel et al studied 113 patients >40 years old and demonstrated that ASD closure using the Amplatzer septal occluder
in these patients was safe and effective with minimal complications.28 They reported a remarkable decrease in symptoms,
which included fatigue, dyspnea, exercise intolerance, and
palpitations, as well as decrease in the right ventricle size.30 In
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Table 2. Reported complications.
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in adult patients.32 In the majority of cases, this
complication improves with time. Device erosion
Spies41
Authors
Chan38 Waight39 Massimo40
into the aortic root or the roof of the left or right
Year
1999
2000
2002
2007
atrium is one of the most serious complications;
Patient number
100
77
417
170
however, it is rare with an approximate incidence
of 0.1% in the United States.33
Used devices
ASO
ASO
SF/ASO/CS
ASO
In a recent presentation at the April 2012 PediOverall complication rate
5%
3.9%
8.6%
17%
atric Interventional Cardiac Symposium (PICS),
Major complications
0%
3.9%
2.6%
7%
data review from multiple databases suggested an
Atrial fibrillation
8
6
incidence of erosion to be 0.07%-0.11% in the
United States and 0.04%-0.17% worldwide.34 All
Supraventricular tachycardia
2
erosion cases except two had either a deficient anComplete heart block
1
1
1
terior superior rim or were oversized.35 Device eroDevice embolization
1
2
15
4
sion symptoms typically include chest pain, dizziness, shortness of breath, hemodynamic collapse,
Pericardial effusion
2
1
or sudden death, but patients can also be totally
Thrombus formation
1
asymptomatic.35 Pericardial effusion/tamponade,
Iliac vein dissection
1
hemopericardium, and aortic to atrial fistula have
Hematoma
1
been associated with erosion of the device after
closure. Furthermore, the mortality rate due to
Retropharynx hemorrhage
1
device erosion is very rare, ranging from 0.004%Sizing balloon rupture
1
0.015% for the worldwide experience and from
Malposition
3
12
0.008%-0.016% in the United States. Such rare
Transient ST elevation
1
3
rates compare very well with those of surgical repair of ASD. The Amplatzer device is not the only
Transient ischemic attack
1
1
device that has been linked to erosion, but other
Deep venous thrombosis
1
devices with two flat discs have also been linked
Hemoptysis
1
(Starflex; CardioSeal).32 Most erosions occurred at
Left atrial appendage perforation
1
the roof of the atria, near the aortic root, and in
most cases symptoms developed within 72 hours
after the procedure. A small number have been reanother study, percutaneous ASD closure was found to result ported from 8 months to 6 years after closure.34 Some of the
in early and remarkable cardiac geometric improvements that factors that may increase the risk of the erosion are deficient
nearly reverted the right-to-left volumetric imbalance com- aortic rim with or without deficient superior rim and the use of
pletely. Most of this remodeling occurs within a few weeks after an over-sized device. The United States FDA held a panel meetASD closure. Even in patients >60 years old, transcatheter ASD ing in May 2012 to examine the issue of device erosions. The
closure is safe and effective, and right ventricle remodeling is final recommendations of the FDA Circulatory Device System
still reported.31
are still pending at the time of this writing.
Complications
The most common complications are outlined in Table 2.
Complications that relate to the procedure and the device are
rare. The following complications may occur during transcatheter ASD closure: device migration; device malposition; cardiac
erosion/perforation leading to tamponade and death; atrioventricular block; bacterial endocarditis; and the complications
encountered from cardiac catheterization, including air embolism, infection, and hematomas. The Helex device has not
been associated with device erosion; however, there have been
numerous cases of wire-frame fracture, with a quoted incidence
between 5% and 7%, particularly with the larger (35 mm) device. Although these fractures typically cause no clinical sequelae, rare cases of damage to the mitral valve have been reported.29 Device embolization is the most commonly encountered
complication, which may relate to inadequate rims, improper
sizing, or placement of the device.32 Arrhythmia is the second
most common complication and it tends to be more common
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ASD Closure Devices
Many devices have been developed, with only two devices
receiving FDA approval in the United States. These are the Amplatzer septal occluder and the Helex septal occluder.
1. The Amplatzer septal occluder. The Amplatzer septal
occluder is one of two closure devices being used in the United
States manufactured by St Jude Medical. It is a self-centering device that consists of two circular retaining discs made of nitinol
wire mesh and linked together by a short connecting waist. While
the waist centers the device in the defect and occludes it, the retaining discs provide stability on opposite sides of the defect. The
size is determined by the size of the waist and ranges from 4-40
mm; however, the 40 mm device is not approved in the United
States. It is delivered by a long sheath available in different sizes.
2. The Gore Helex septal occluder. The Gore Helex is
the second device approved for use in the United States and is
manufactured by WL Gore & Associates. No cases of migration
or erosion have been reported for this device. The occluder is
The Journal of Invasive Cardiology®
Transcatheter Closure of Secundum ASDs
Figure 7. Gore septal occluder.
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Figure 8. The Occlutech device.
Figure 9. Loading the Occlutech device on the delivery system.
composed of an expanded polytetrafluoroethylene material with
hydrophilic coating, which is supported by a nitinol frame. The
occluder has a double disc shape that bridges the defect. A 2:1
ratio between the device size and the defect size “balloon-stretched
diameter” should be used for optimal results, and the device diameter should not exceed 90% of the measured septal length. The
septal tissue margins should be sufficient in size and integrity to
prevent device embolization, and residual leaks are more common
when the defect size is measured to be more than 18 mm.
In one large study, 87% of 342 patients had the Helex device implanted successfully. There were significant adverse events
(mostly device removal for different reasons) in 5.8%.36 Overall
composite success was seen in 91.5%. Significant residual shunt
and frame fracture were reported; however, no device erosion or
cardiac perforation have been reported thus far with the Helex.
Vol. 25, No. 5, May 2013
A newer modification of this device, the Gore septal occluder
(GSO) just received United States FDA approval for initiation
of an IDE clinical trial. It is also comprised of a nitinol wire
frame covered with expanded polytetrafluoroethylene (ePTFE).
The wire frame is formed from five wires shaped into the right
and left atrial discs, the eyelets, and the lock loop. The five-wire
design provides conformability, allowing each individual wire
within a right or left atrial disc to conform to the heart anatomy.
The ePTFE includes a hydrophilic surface treatment to facilitate
echocardiographic imaging of the occluder and surrounding tissue during implantation. Figure 7 depicts this new device.
3. The Occlutech Figulla Flex II device. The Occlutech
Figulla Flex II (Occlutech gmbH) is a self-expanding nitinol
wire mesh, very similar to the Amplatzer device in shape, but
with a different design that eliminates the left atrial microscrew.
This is fully recapturable and repositionable, and allows 50% reduction of meshwork material on the left atrial side with greater
flexibility compared with Amplatzer device. Furthermore, the
delivery cable mechanism is different and allows pivoting of
the device, which facilitates positioning across the septum, an
advantageous feature especially in large defects. Figures 8 and 9
depict the device and its delivery cable.
4. Transcatheter Patch device. The Transcatheter Patch
utilizes a balloon-mounted, porous, polyurethane patch in
combination with a defect bridging system for device apposition and immobilization until patch integration into adjacent
tissue occurs. This device is flexible, biodegrades in situ and
eventually will be replaced with native tissue. It is manufactured by Custom Medical Devices.
5. Cardioseal/Starflex. The Cardioseal/Starflex family of
devices consists of two square patches of polyster fabric handsewn to a stainless-steel skeleton. Usually, it is used to close
defects <16 mm. The manufacturer of these devices (Nitinol
Medical Technologies) ceased to exist due to financial problems
and the technology was sold to WL Gore & Associates.
6. Bioabsorbable devices (Biostar, Biotrek). Biostar and
Biotrek are unique in using bioabsorbable materials to optimize
the biological response of the defect closure and reduce the burden of prosthetic material that remains in the heart once the
closure is achieved. The Biostar has an engineered porcine intestinal collagen layer scaffold, while the Biotrek uses the synthetic
polymer poly-4-hydroxybutyrate. The manufacturer of these two
devices is the same as the CardioSeal and ceased to exist.
7. Cardia devices. There are multiple generations of Cardia
occluders (manufactured by Cardia Inc). Overall, the device
has a double umbrella, with a frame of four arms. These devices have evolved and improved remarkably over the last 1-2
decades. There is a plan for a clinical trial in the United States.
8. Solysafe septal occluder. The Solysafe septal occluder
consists of a self-centering device with two foldable polyester
patches attached to eight metal wires made of phynox, which
has been used in surgical implants for years. The course of the
wires and the device’s patch enable the device to self-center in
defects of variable diameters, with a maximum diameter given
by the distance between the wires. With five device sizes, defects
with stretched diameter up to 30 mm can be effectively closed.
Gielen et al37 reported a very high incidence of device fracture
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in their most recent study. The incidence of device fracture was
82.3% after 5 years of implantation. The device was also associated with erosions and was therefore discontinued by the
manufacturer (Swissimplant AG).
9. PFM device (ASD-R). Manufactured by PFM gmbH,
the PFM is a double-disc device made of nitinol wire, which
is woven tightly in a single piece without welding or hubs on
either side, which may reduce the risk of clot on the disc. A
self-centering waist is achieved by reverse configuration of the
left atrial disc.
Conclusion
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References
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Despite the recent concern about device erosions associated
with some devices, albeit very rare, transcatheter ASD closure
has continued to be a very safe procedure with comparable results to surgical closure, and long-term follow up studies have
shown that the overall outcomes remain excellent. Device closure of the appropriate defect is an attractive alternative option
to open surgical techniques. The United States FDA Circulatory Device System recommendations regarding device erosions are still pending and perhaps will shape the future of ASD
device closure in the United States.
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