2016, Wiley Periodicals, Inc.

DOI: 10.1111/joic.12284

STRUCTURAL HEART DISEASE

Mid-Term Outcomes after Percutaneous Closure of the Secundum Atrial

Septal Defect with the Figulla-Occlutech Device

CARLOS A. C. PEDRA, M.D., PH.D., F.A.C.C., F.S.C.A.I.,1,2 SIMONE F. PEDRA, M.D., PH.D.,1,2
RODRIGO N. COSTA, M.D., PH.D.,1,2 MARCELO S. RIBEIRO, M.D.,1,2 WANDA NASCIMENTO, M.D.,1,2


LUIS OTAVIO S. CAMPANHA, ~ M.D.,1,2 M. VIRGINIA T. SANTANA, M.D., PH.D.,1
IEDA B. JATENE, M.D., PH.D.,2 JORGE E. ASSEF, M.D., PH.D.,1 and VALMIR F. FONTES, M.D.1,2
ao Paulo, Brazil; and 2Hospital do CoraSc ~
From the 1Instituto Dante Pazzanese de Cardiologia, S~ ao da AssociaSc ~ orio S
rio, S~
ao Sanat
ao
Paulo, Brazil

Objectives: To evaluate the mid-term outcomes after percutaneous closure of the secundum atrial septal defects
(ASD) using the Figulla-Occlutech device (FOD).
Background: Transcatheter closure has become the method of choice for most patients with ASD. Although the
FOD may have some advantageous characteristics there is a paucity of data on later outcomes after the use of this
relatively new device.
Methods: Observational, single arm study including 200 non-consecutive patients who underwent ASD closure
between 04/09 and 07/15 in 2 centers. Device performance, deployment technique, and immediate and mid-term
outcomes were assessed.
Results: Median age and weight were 24 years (472) and 58 kg (1592), respectively. Single defects were observed
in 171 patients (median size of 19 mm). The remainder had multiple or multifenestrated defects. Implantation of
FOD (median size of 24 mm) was successful in all (99%), but 2 patients (1 with decient posteroinferior rim; 1
with a large ASD for the size of the child). Embolization with device retrieval occurred in 2 (1%). Median follow-up
of 36 months was obtained in 172 patients. Serial echocardiographic assessment showed complete closure in all but
2 patients, in whom an additional small non-signicant posterior defect was purposely left untouched. There have
been no episodes of late arrhythmias, device embolization, cardiac erosion, endocarditis, thromboembolism, wire
fracture, or death.
Conclusions: Transcatheter closure of ASDs in older children, adolescents, and adults using the FOD was highly
successful in a wide range of anatomical scenarios with high closure rates and no complications in mid-term
follow-up. (J Interven Cardiol 2016;29:208215)

Introduction

The secundum atrial septal defect (ASD) is a

Disclosure statement: Drs. Carlos A. C. Pedra, Rodrigo N. Costa,
and Marcelo S. Ribeiro are proctors for the Figulla devices and
receive honoraria in training sessions. The other authors do not
have any conflict of interests.
Authorship declaration: All authors listed met the authorship
criteria according to the latest guidelines of the International
Committee of Medical Journal Editors. All authors read the
manuscript and were in agreement with it.
Address for reprints: Carlos A. C. Pedra, Director, Catheterization
Laboratory for Congenital Heart Disease, Instituto Dante Pazza-
nese de Cardiologia, Av Dr Dante Pazzanese 500, 14o andar, CEP
04012-180, S~ao Paulo, SP, Brazil. Fax: 55-11-50854196; e-mail:
cacpedra@uol.com.br
common congenital heart defect (CHD), especially in
adults.1 Most of these defects are amenable for
transcatheter closure, which became the method of
choice to treat most patients due to its safety and efcacy
with excellent mid-to-long term outcomes.25 Although
cardiac erosions may occur after the use of the
Amplatzer Septal Occluder (ASO),6 this complication
is very rare. The Figulla-Occlutech device (FOD;
Occlutech, Jena, Germany) is relatively new, being a
nitinol double-disk occluder with a self-centering

208 Journal of Interventional Cardiology Vol. 29, No. 2, 2016

 OUTCOMES AFTER ASD CLOSURE WITH THE FIGULLA DEVICE
mechanism provided by a central connecting waist.
Although it was introduced in the mid-to-late 2000,
there is a paucity of data in the literature with regards to
the follow-up results after the use of such device.716 In
this manuscript, we report the acute and mid-term
outcomes in a large cohort of patients who underwent
ASD closure using the FOD in 2 institutions.
Methods
Study Design. This is an observational study of a
cohort of patients with secundum ASDs who under-
went transcatheter closure of the ASD in a non-
consecutive fashion using the Figulla-Occlutech
occluder (FOD) in 2 referral centers. Data were
collected retrospectively from the charts. Informed
consent was obtained from patients or guardians. This
study was approved by the local ethics committees.
Inclusion criteria included children, adolescents, and
adults with a clinical diagnosis of single or multiple
ASDs with left-to-right shunt and right ventricular
volume overload on echocardiography. Exclusion
criteria included other types of ASDs (sinus venosus,
ostium primum); associated cardiac diseases that
required surgical repair; pulmonary vascular resistance
of greater than 8 Woods Units X m
2; active infectious
diseases; allergy to nickel; contraindication to anti-
platelet therapy and refusal to sign the informed
consent. Also excluded were secundum ASDs that
were considered unsuitable for transcatheter closure
Figure 1. The Figulla-Occlutech Device.
A: Left atrial disc view. There is no pin on the
left disc. The number of nitinol wires is reduced
toward the center of the device. B: Pivoting
mechanism between the delivery cable and the
right atrial disc before detachment.
Vol. 29, No. 2, 2016 Journal of Interventional Cardiology
including too large defects in adults (generally over
36 mm); too large an ASD in relation to the size of the
patient, especially in small (1015 kg) children in whom
a large device could impair proper functioning of AV
valves, pulmonary veins and coronary sinus; and ASDs
with more than 1 decient rim, especially contralateral
rims. In patients >60 years, left ventricular diastolic
dysfunction was assessed by echo means pre- and
post-balloon occlusion of the defect, as reported
previously.17,18 Diuretics and/or vasodilators were
given before the procedure if judged necessary.
Transthoracic echocardiography (TTE) was employed
for children and transesophageal echocardiography
(TEE) for adolescents and adults to assess suitability
for transcatheter closure. Patients were started on aspirin
(35 mg/kg/day; max: 200 mg) a couple of days before
the procedure.
The Device. The FOD is made of a Nitinol wire
mesh with shape-memory properties.716 Two
self-expandable discs are connected by a exible
connecting central waist. Two ultrathin non-woven
fabrics made of PET help close the defect and provide
growth of the endothelium over the occluder after
placement (Fig. 1). They are individually braided using
very thin (40150 mm or 0.001570.00590 inches) and
numerous strands of Nitinol (80 in total), which are
covered by a biocompatible titanium oxide layer
giving the Figulla-Occlutech occluder a golden
appearance. All strands end proximally on a single
weld on the right side requiring no clamp on the left
disk (Fig. 1A).
209
 PEDRA, ET AL.

In its rst generation, the FOD was connected to the
delivery cable through a malefemale screwing
mechanism. Newer generations (Flex I available since
2010 and Flex II available since late 2014) do not have
any threaded hub or clamp. Instead, they have a rounded
pin (the connecting ball) at the center portion of the right
atrial (RA) disc, which connects to a newer delivery
system through a coupling mechanism, similar to a
bioptome. This allows a tilted angle of 3040 degrees
on the right disk before nal release (Fig. 1B). Both
generations of devices were used in this experience.
After connection to the delivery system, the device is
loaded and collapsed into a short sheath with the same
prole of a compatible long delivery sheath (714 Fr).
Once in a proper position, the occluder is released by
unscrewing the delivery cable (1st generation) or by
releasing the locking system (2nd generation).
The ASD device size is determined by the diameter of
its waist, which is 2.53.5 long. The FODs are available
in the following sizes: 4, 5, 7.5, 9, 10.5, 12, 13.5, 15,
16.5, 18, 21, 24, 27, 30, 33, 36, 39, and 40 mm. The LA
disc is 716 mm and the RA disk is 511 mm larger than
the waist depending on the size of the device.
In the occasional patient with a cribiform septum,
the Figulla-Occlutech PFO device was used. They are
available in 4 sizes: 16/18, 23/25, 27/30, and 31/35.
The numbers are related to the diameters of the left and
right discs, respectively.
Procedures. They were performed under general
endotracheal anesthesia and 2- (2D; Fig. 2) or 3-
dimensional (3D) TEE monitoring (Figs. 3 and 4). This
later technology was especially useful for evaluation of
complex defects (very large or multiple; Figs. 3 and 4).
The right femoral vein was cannulated using a 57 Fr
short sheath. The left femoral vein was also cannulated
when 2 different devices were required (Fig. 2).
Arterial access was obtained using 6 Fr sheaths solely
in patients >40 years of age to perform coronary
angiography. Heparin sulfate (100150 U/kg;
max: 10.000) was given to achieve an activated
clotting time >200 seconds. Cephalosporins were
given at the time of procedure followed by 2
subsequent doses 68 hours apart. Routine right heart
catheterization was carried out to rule out xed
pulmonary arterial hypertension.
Balloon interrogation of the defect was performed
in all cases early in our experience using the NuMED
sizing balloon (PTS1 balloon; Numed; Cornwall,
Canada). Recently, this has been applied only to
defects associated with a oppy or an aneurismal
posterior septum; a large anterior defect associated
with (a) smaller posteroinferior defect (s) when the
use of a single device was contemplated to close all
defects; 2 distant (>78 mm) defects requiring the
use of 2 different devices; and defects that may be to
large for the size of the patient, especially in young
children. An occluder that was 02 mm larger than
the stretched diameter was selected for implantation.
We slightly oversized the device (24 mm larger than
the stretched diameter) in cases with decient rims,
especially the retroaortic. Recently, in patients with a
single defect surrounded by a reasonably thick

Figure 2. Multiple atrial septal defect closure using 2-dimensional echocardiography monitoring. A: In 0 degrees view both defects (arrows) are
seen separated by a 68 mm rim of tissue. B: After release the larger posterior device (broad short arrow) is embracing the smaller and more
anterior one (long and thin arrow). LA, left atrium; RA, right atrium; Ao, aorta.

210 Journal of Interventional Cardiology Vol. 29, No. 2, 2016

 OUTCOMES AFTER ASD CLOSURE WITH THE FIGULLA DEVICE

Figure 3. Large atrial septal defect closure using 3-dimensional echocardiography monitoring. A: Left atrial view showing a large (33  30 mm)
ASD with sufcient rims all around. B: Left atrial view after device release displaying the left atrial disc well abutted onto the interatrial septum.
The left atrial disc surface has a somewhat concave shape and a smooth appearance with no central pins. SVC, superior vena cava; IVC, inferior
vena cava; ASD, atrial septal defect; Ao, aorta; MV, mitral valve.

septum we have simply taken into account the largest
measurement using several echo views and used a
device that was 2025% larger than the largest
diameter. This same guideline was applied for very
large defects (largest diameter >30 mm; Fig. 3).
Device implantation was performed using several
established techniques according to previously
published protocols.19,20
Patients recovered overnight and were dis-
charged home the following day. A TTE with
color Doppler was performed to assess device
position and the presence of residual shunt.
Routine recommendations19,20 with regards to
aspirin use, engagement in contact sports and
endocarditis prophylaxis were given. Clinical visits
were scheduled at 1, 3, 6, and 12 months and every
3 years thereafter.
Statistics. Values were expressed as absolute
numbers and frequencies, means and standard devia-
tions, or medians and range where applicable.

Figure 4. Multiple atrial septal defects and complex interatrial septum anatomy as assessed by 3-dimensional echocardiography. A: Right atrial
view showing multiple atrial septal defects (marked by asterisks) in multiple locations of the interatrial septum near the SVC, IVC, behind the
aorta and in the more posterior portion of the interatrial septum (arrow). B: Right atrial view after implantation of 2 devices. The smaller one was
implanted in the superior defect and the larger one in the more inferior defect. The tiny posterior defect (arrow) was not covered by any of the
devices and was left untouched. SVC, superior vena cava; IVC, inferior vena cava; Ao, aorta; SD, smaller device; LD, larger device.

Vol. 29, No. 2, 2016 Journal of Interventional Cardiology 211

 PEDRA, ET AL.

Results posteroinferior rim. Two devices were sequentially

and successfully implanted. However, after releasing
Patients. From April 2008 to July 2015, trans- both devices, the inferior one (Flex I15 mm) started
catheter ASD closure with the FOD was attempted in to tilt and was considered to be in an unstable position,
200 patients. Patient demographics are displayed in which prompted device removal. It was partially
Table 1. All patients had normal or slightly elevated retrieved with some difculty using a snare that
pulmonary arterial pressures. Five elderly patients brought the right disc into a 12 Fr sheath followed by
were in atrial brillation prior to the procedure that complete removal using a 6 Fr bioptome that
remained unchanged after implantation. grabbed the proximal pin inside the sheath. This patient
Procedures. Seventy-ve procedures were per- was sent to surgery the following day with
formed using the rst generation device while the uneventful recovery. In a 10-year-old girl weighing
Figulla Flex I and II were used in the remainder. 30 kg with a large ASD (2627 mm), a well-positioned
Defect and device characteristics are displayed in 30 mm device abutted the anterior leaet of the mitral
Table 2. In 52 patients, balloon interrogation of valve resulting in mitral insufciency, prompting
the defect was not performed. Successful implanta- device removal. The procedure was abandoned
tion was achieved in all but 2 patients. One patient and a recommendation for elective surgical repair
had 2 distant defects and a decient (<5 mm) was made. In the remaining patients with decient
rims device were implanted successfully with no
complications.
There were 2 instances of device embolization to the
Table 1. Patient Demographics
aorta. In both cases, the devices (12 mm 1st generation
Variable with a screwing female pin and a 10.5 mm Flex II)
were retrieved using a snare followed by successful
Number of patients (n) 200 closure of the defect using a larger device. In 1 patient,
Gender (F/M) 125/75 there was thrombus formation within the sheath that
NYHA class I or II 200 resolved with judicious aspiration and anticoagulation
Median age in years (range) 24 (472) optimization. In 4 patients, the initial selected device
Patients >18 years 122/200 was changed to a larger (in 3) or a smaller (in 1) one
Patients <10 years 32/200 because it was felt to be too small or large after
Median weight in kg (range) 58 (1592) echocardiographic evaluation or embolization (see
above). No patient experienced signicant and
F, female; M, male. prolonged arrhythmias. We observe a cobra-formation
during deployment in 1 device, which was replaced.
Occasionally, especially when using larger devices
Table 2. Defect and Device Characteristics
(>30 mm), the LA disk of the FOD did not recongure
Variable n 200 (100%) entirely, remaining with a globe appearance. This was
managed by gently pushing the left disc against the
Single defect 171 (85.5%) roof of the LA to at the disc out. Also, the tip of the
Multiple defects (1 device) 20 (10%) delivery system of the Figulla Flex I and II
Multiple defects (2 devices) 7 (3.5%) occasionally got entangled with the wire mesh of the
Multifenestrated septum 2 (1%) device after release. Slight rotation of the cable freed
Deficient rim 93 (46.5%) the system uneventfully.
Anterosuperior 88 (44%) One patient with a very large defect (33  36 mm) in
Posteroinferior 3 (1.5%) whom a 40 mm device was implanted remained with a
Posterosuperior 2 (1%) small residual leak (2 mm) at the posteroinferior aspect
Floppy/Aneurysmal septum 45 (22.5%) (near the inferior vena cava) of the atrial septum. Out
Median ASD size in mm (range) 19 (6.536) of the 6 remaining patients with multiple defects that
Median device size in mm (range) 24 (940) required 2 devices, 2 remained with a 2 mm postero
inferior defect that was left uncovered after implanta-
ASD, atrial septal defect. tion of 2 devices (Fig. 4) and 1 had a residual defect

212 Journal of Interventional Cardiology Vol. 29, No. 2, 2016

 OUTCOMES AFTER ASD CLOSURE WITH THE FIGULLA DEVICE

between both devices implanted. The remainder had the occurrence of erosion6 has been a reason for
complete immediate closure of the defect. All, except 3 concern. A post-market study to determine the real
patients were discharged home the following day. incidence of this complication and its impact on
Follow-Up. Follow-up time was a median of clinical care is being conducted at the time of this
3 years in 172 patients. All were in NYHA functional writing. Also, thrombus formation on the left sided
class I. Two patients (with 2 devices) remained with a disc has been described, albeit being a rare occur-
small (<2 mm) residual leak through an additional rence.28,29 As such, it seems worth exploring the role
defect during follow-up despite having normal right and clinical safety and efcacy of other devices
ventricular size on TTE. In only 11 patients (all >40 available for ASD closure.
years of age), right ventricular size did not return to This article reports the mid-term outcomes after the
normal size despite complete closure of the defect. All use of the FOD to close the secundum ASD in a large
patients remained in sinus rhythm except for those who cohort of patients with a broad anatomical variety of
had had atrial brillation prior to the intervention. defects.13,16 Although we have used this device mainly
There was no late embolization (even in patients with for adults, it was also safe and effective for older
decient rims), erosion, wire fracture on chest X-ray, children and adolescents. Because of the higher prole
thrombus formation on TTE, endocarditis, or AV valve of the sheaths required for implantation of the 1st and
dysfunction. Immediate and follow-up results are 2nd generation devices we preferentially avoided their
summarized in Table 3. use in smaller children. When compared to the ASOs,
the FOD usually require sheaths 23 Fr larger for the
same size of device. The 3rd generation of the device
Discussion (Figulla Flex II) has a lower prole, which was useful to
expand the indications for smaller children, as already
Transcatheter closure has become the method of reported in the literature.30 Also, the pivoting system
choice to manage most patients with secundum between the RA disc ball and the delivery cable was
ASDs,2124 with the ASO (St. Jude Medical, St. further improved allowing for a 5060 degrees rotation.
Paul, MN) probably being the gold-standard device for This further decreased the tension before device release
closure. Although excellent mid-to-long term out- allowing a better assessment of device position,
comes have been published with this device,25,2527 especially the RA disc.
A wide range of underlying anatomies including
single small to very large defects; multiple and
Table 3. Immediate and Follow-Up Outcomes multifenestrated defects; ASDs associated with aneur-
ismal, oppy or standard septae; and defects in
Variable different locations with sometimes decient surround-
Successful implantation: n (%) 198/200
ing rims could all be addressed using the FOD. All
(99%)
these observations attest to its versatility. The 2 failed
Two devices: n (%) 7/198
implantations observed in this experience seem to be
(3.4%)
due to inappropriate patient selection instead of limited
Embolization with retrieval and new 2/198
device performance. The mid-term outcomes encoun-
implantation: n (%) (<1%)
tered in this experience were encouraging. There was a
Mean fluoroscopic time in minutes 8.5  3.7
high rate of complete closure and no complications.
Mean procedure time in minutes 89  21
This is in line with previously published reports.716
Immediate closure rate: n (%) 196/198
Advantageous characteristics of this device include no
(>99%)
clamp and less amount of uncovered metallic material on
Lost to follow-up: n (%) 26/198
the left disk, which may facilitate endothelialization and
(<13%)
avoid thrombus formation. Although the lack of the
Median follow-up in months (range) 36 (172)
distal clamp may partially explain the globe appearance
Late closure rate: n (%) 170/172
of the LA disk that is occasionally observed when
(>99%)
deploying larger devices, it minimizes the risks of
Early or late erosions: n (%) 0 (0%)
inadvertent trauma to the adjacent cardiac structures.
More importantly, enhanced exibility results from a

Vol. 29, No. 2, 2016 Journal of Interventional Cardiology 213

 PEDRA, ET AL.
single weld on the right side and the use of thinner and
more numerous strands of nitinol. Whether this
characteristic may be associated with better intra-atrial
conduction and P wave dispersion after device ASD
closure when compared to the ASO31 remains to be seen
with larger number of patients and longer follow-up.
Additionally, the Flex I and II delivery systems have a
pivoting mechanism that minimizes the amount of
tension between the RA disk and the delivery cable
before release.
On the other hand, the smaller and rounded pin on
the right disc of the Figulla Flex I proved to be more
difcult to be snared and pulled into the sheath in a
patient with a mal-positioned device in this experience.
After partial recapture, a bioptome had to be used to
completely remove the device. This was not observed
in a patient in whom de Flex II device was retrieved
using a small snare. Similar techniques for retrieval
have been described.32 Additionally, the absence of a
pin on the LA disc impairs grabbing the device from
both sides, which may be useful in some situations for
complete stretching before removal through a small
vessel or into a sheath. Conversely, due to its enhanced
exibility it may be easier to drag it in a partially
collapsed form. In order to avoid entanglement of the
tip of the delivery cable within the wire mesh, the
coupling pin should be brought into the distal pod
before bringing the delivery cable into the long sheath.
If there is still some resistance, the cable should be
rotated slightly to free the system.
6pt?>Although the lack of reports of cardiac erosion
or perforation after the use of the FOD is encouraging,
this must be interpreted with caution. If the estimated
incidence of erosion of 0.1% as published by Amin
et al.6 after the use of the ASO was observed with the
FOD, we would expect at least 20 cases out of 20,000
implants performed worldwide until 2013 (according
to the company track record). This has not been
observed and might be due to a variety of reasons. The
denominator may be overestimated since the company
tracks shipped devices and not necessarily implanted
ones. It is possible that this complication might be
under-reported in the literature. On the other hand, it
may have been possible that operators implanting the
Figulla device have learned with the previously
accumulated experience with the ASO and have
avoided the use of oversized devices in high-risk
situations, eventually decreasing the rate of erosions.
Finally, the FOD may as well be less traumatic to the
anterosuperior atrial wall and adjacent aorta due to its
214 Journal of Interventional Cardiology
enhanced exibility, although this physical property
has not been proved in experimental studies. With such
a low estimate of the incidence of erosions, only a very
large number of patients (maybe those specically at a
higher risk) followed for a long period of time will
determine the real incidence of this complication with
this device.
This study is limited by its observational non-
randomized design. Also, we did not employ detailed
uoroscopic assessment to look for wire fractures
during follow-up. Additionally, minor residual leaks
and/or small thrombus on the device might have been
overlooked using TTE and not TEE for serial follow-
up evaluations. Finally, some patients were lost to
follow-up.
Conclusions
Transcatheter closure of ASDs using the FOD was
operator friendly, safe, and effective in this large
experience in older children, adolescents, and adults.
The device performed as well as the ASO in a wide
range of anatomical scenarios resulting in excellent
mid-term outcomes. Much larger number of patients
and longer follow-up are needed to determine whether
this device is associated with a decreased risk of
erosion.
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