1
Supplementary Information
Recent developments in next-generation occlusion devices
Chenglin1, Liwu Liu1,*, Yanju Liu1, Jinsong Leng2,*
Chenglin, Prof. Liwu Liu, Prof. Yanju Liu
1Department of Astronautical Science and Mechanics, Harbin Institute of Technology
(HIT), P.O. Box 301, No. 92 West Dazhi Street, Harbin 150001, People’s Republic of
China
Email: liuliwu_006@163.com
Prof. Jinsong Leng
2Center for Composite Materials and Structures, Harbin Institute of Technology
(HIT), P.O. Box 3011, No. 2 Yikuang Street, Harbin 150080, People’s Republic of
China
Email: lengjs@hit.edu.cn
Keywords: biodegradable occlusion devices, congenital heart defects, 3D printing,
shape memory polymer, biomedical devices
2
The non-degradable occlusion devices developed for ASD, PFO, PDA, VSD and
LAA closures since the late 1990s are provided in this Supplementary Information.
The materials for non-degradable occlusion devices are discussed in Section S1,
including frame materials and membrane materials. In Section S2.1-S2.4, various
non-degradable occlusion devices are systematically investigated and categorized into
four parts according to defect locations. Lastly, the complications associated with
non-degradable occlusion devices are pointed out in Section S3.
S1. Materials for non-degradable occlusion devices
S1.1. Frame materials for non-degradable occlusion devices
S1.1.1. Stainless steel
The first use of stainless steel in occlusion devices was the double umbrella
occluder reported by King and Mill in 1974 [1]. The modulus of stainless steel is
approximately 200 Gpa, and the tensile strength exceeds 500 Mpa [2]. However, due
to limited elasticity (elastic strain <1%), the implantation and deployment process is
extremely complicated, and a large-diameter sheath (approximately 23 F) is required
[3]. These drawbacks limit its further application in occlusion devices.
S1.1.2. Cobalt-based alloy
The application of cobalt-based alloy in occlusion devices includes MP35N as the
frame material of BioSTAR occluder (NMT Medical, Boston, MA, USA) and Phynox
as the frame material of Solysafe septal occluder (Swissimplant AG, Solothurn,
Switzerland) [4-6]. Compared with stainless steel, cobalt-based alloy possesses higher
strength, density, and Young’s modulus, allowing less frame material to provide
sufficient mechanical support. Additionally, the occluder has a lower profile and is
able to be transported through a smaller diameter catheter. The more stable
passivation film on the surface of the cobalt-based alloy leads to its stronger corrosion
resistance [7,8].
S1.1.3. Nitinol
Nitinol is a metal alloy of nickel and titanium, in which the atomic percentages of
the two elements are approximately equal. Due to its excellent shape memory
3
performance, acceptable biocompatibility, superelasticity and low fracture rate, most
commercially available metal occluder frames have been made of Nitinol since the
Amplatzer septal occluder (Abbott, Abbott Park, IL, USA) woven by Nitinol wires
was first developed in 1997 [9]. The long-term efficacy of Nitinol occluder is positive,
but there are also complications such as wear, erosion and nickel allergy [10-13].
Nickel is one of the common allergenic metals. The clinical manifestations of nickel
allergy are chest pain, palpitations, migraines, and pericardial effusion [12]. Excessive
nickel in the body is even associated with cancer. In addition, due to nondegradability,
the long-term contact between the Nitinol frame and blood leads to the release of
nickel ions. To reduce the release of nickel ions and further improve biocompatibility,
various coatings have been applied to the frame surface, such as titanium oxide
(Occlutech Figulla occluders), platinum/nano platinum (Cocoon occluders and Gore
Cardioform septal/ASD occluder), and titanium nitride (TiN, Lifetech Cera/CeraFlex
occluders) [14-18].
S1.2. Membrane materials for non-degradable occlusion devices
PET and PTFE/ePTEE are common materials used as membranes for
non-degradable occlusion devices. PET is a non-degradable polyester, and its fabric
form is commonly known as Dacron. PET possesses excellent mechanical properties,
chemical stability, and wear resistance. In addition, it has good biocompatibility and
has been approved by the FDA for the repair of soft tissues such as large blood vessels
[2]. PTFE is a linear thermoplastic polymer that can be stretched to obtain porous
ePTFE. Due to its high toughness, abrasion resistance, biocompatibility, non-adhesion,
and extremely strong hydrophobicity, PTFE, especially ePTFE, is extensively used in
the biological field, such as small-diameter vascular implants [19]. W. L. Gore &
Associates, Inc. has developed a range of medical implants based on ePTFE. As
membranes, both PET and PTFE/ePTEE exhibit good sealing performance and can be
completely covered by fibrous connective tissue within 1-3 months to achieve
endothelialization [3,20,21]. According to the characteristics of various defects,
different materials are selected as the occluder membranes. For example, PET
membrane is used in Lifetech Cera/CeraFlex ASD/PFO occluders (Lifetech Scientific,
Shenzhen, China) to close abnormal blood flow and reduce the possibility of blood
clot formation, while PTFE membrane with dense structure is used to close
4
high-pressure VSD and PDA to greatly improve the occlusion capability (e.g.,
Lifetech Cera/CeraFlex VSD/PDA occluders). Other membrane materials, such as
polypropylene (PP) and polyvinyl alcohol (PVA), are used in Cocoon family products
(Vascular Innovations Co., Nonthaburi, Thailand) and Ultrasept family products
(Cardia Inc., Eagan, MN, USA), respectively [14,22,23]. However, early malfunction
of PVA membrane due to perforation was reported in Ultrasept II device [24].
S2. Nondegradable occlusion devices
Most of the non-degradable occlusion devices consist of a self-expanding Nitinol
frame and polymer membranes. According to the device configuration, it can be
divided into the following four categories:
1) Double-disc devices. The left and right discs are connected by the waist, such as
Amplatzer septal occluder (Abbott, Abbott Park, IL, USA), Gore Cardioform
septal occluder (W. L. Gore & Associates, Inc., AZ, USA), Cera ASD/PFO
occluder (Lifetech Scientific, Shenzhen, China) and Cocoon ASD/PFO occluder
(Vascular Innovations Co., Nonthaburi, Thailand).
2) Single-disc devices/internal plug devices, such as Occlutech Duct occluder
(Occlutech International AB, Helsingborg, Sweden), Ultrasept ASD occluder
(Cardia Inc., Eagan, MN, USA), Amplatzer Duct occluder (Abbott, Abbott Park,
IL, USA), Watchman device (Boston Scientific, Marlborough, MA, USA) and
WaveCrest LAA occluder (Biosense Webster, CA, USA).
3) Coils, such as Nit-Occlud PDA occluder and Nit-Occlud Lê VSD occluder (PFM
Medical, Cologne, Germany).
4) Ligation devices, mainly for the exclusion of the LAA, including Lariat suture
delivery system (SentreHEART, Redwood City, CA, USA) and Sierra ligation
system (Aegis Medical Innovations, Vancouver, Canada).
These developed devices have undergone a series of updates and evolutions in
materials (various coating on Nitinol wires), configurations, and delivery systems to
meet the following ideal requirements: [25]
1) The size of the delivery sheath is small enough;
5
2) The device can be recaptured and repositioned multiple times;
3) Complete closure without residual shunt;
4) No tissue damage during deployment.
This section will systematically discuss five types of non-degradable occluders
developed since the late 1990s, including ASD occluders, PFO occluders, PDA
occluders, VSD occluders, and LAA occluders.
S2.1. Septal (ASD and PFO) occluders
The first percutaneous ASD closure was carried out by King and Mills in 1974 [1],
followed by Rashkind and Mullins in the early 1980s who developed the first
commercial occluder, Rashkind device [26]. Septal occluders have made considerable
progress, and percutaneous catheter occlusion of the septal defects has become an
ideal choice in clinical treatment [17,27-34]. Currently, Amplatzer septal occluder is
the most extensively used device in the world due to its highly operable deployment
technique, applicable device size range, and satisfactory closure rate [35-37]. Many
ASD occluders are also suitable for PFO closure, thus the occlusion devices
developed for ASD and PFO will be discussed together.
S2.1.1. Amplatzer septal occluders
Amplatzer septal occluder (ASO; Fig. S1a; Abbott, Abbott Park, IL, USA), the
leading device for ASD closure, is a self-expandable and self-centering double disc
device woven from Nitinol wires and connected through a waist [9]. ASO has a
distinctive waist that can be matched to fill defects according to the diameter of
defects. In addition, three layers of polyester patches woven from 200 wires are filled
in the double discs and waist to enhance occlusion capability [38]. ASO was approved
by the FDA in 2001. The innovative configuration and highly operable deployment
technique of ASO inspire the design of the subsequent occluders and provide a
reference prototype [39,40].
The initial clinical trial of ASO was conducted in 30 ASD patients, and the device
was successfully implanted in all patients. 57% (17/30) of the patients achieved
immediate closure, with mild and moderate residual shunts occurring in 10 and 3
patients, respectively. At 1-month follow-up, the complete closure rate increased to
6
97% [38]. Another human experience study using the ASO in 442 ASD patients
showed that the implantation success rate was 95.7%, the secondary efficacy success
rate (within 2 years) was 91.6%, and the incidence of complications was 7.2% [41].
As shown in Fig. S1b, Amplatzer Cribriform Multifenestrated septal occluder is
another transcatheter ASD closure device provided by Abbott, which is specifically
designed to close multifenestrated ASD. The device consists of double discs of the
same size connected through a narrow waist, which allows the device to be placed via
a central defect to cover a larger fenestrated area. The efficacy was assessed by
implanting the device in 16 patients with fenestrated ASD. The procedure was
successfully carried out in 13 patients, and 92% (12/13) of patients were completely
closed at 6 and 12 months of follow-up [42].
The Amplatzer PFO occluder evolved from ASO is a double-disc device that the
right atrial disc is larger than the left atrial disc (Fig. S1c). As one of the most widely
used PFO occluders worldwide, more than 100,000 devices have been implanted into
PFO patients. A large-scale comparative study (RESPECT trial) between Amplatzer
PFO occluder implantation and medical treatment alone in adults with cryptogenic
ischemic stroke showed that the former can significantly reduce the risk of stroke
recurrence [43]. Another multicenter clinical trial also showed that the use of
Amplatzer PFO occluder to close PFO is a safe and effective therapy in the prevention
of recurrent stroke and transient ischemic attack (TIA) [44].
S2.1.2. Occlutech Figulla septal occluders
The Occlutech Figulla ASD occluder (Occlutech International AB, Helsingborg,
Sweden), similar to ASO in structure and implantation method, is a double-disc
device woven from Nitinol wires with a diameter of 0.082 mm to 0.186 mm [40,45].
The two discs and waist are filled with PET membranes. The device can be
automatically centered and repositioned [46]. Compared with ASO, the device is
characterized by no stainless steel hub in the left atrium, which improves the
flexibility of the device [45,47]. The device obtained the CE mark in 2007.
The second-generation device, Occlutech Figulla Flex I (OFF I) ASD occluder,
has an optimized delivery system with a ball-socket connection that can be tilted to 45
degrees, thus improving the flexibility of the device implantation. It received the CE
7
mark in 2009 [32,48]. The third-generation device available since 2011 is Occlutech
Figulla Flex II (OFF II) ASD occluder (Fig. S1d), which has made further
improvements to the delivery system. The device is capable of performing a complete
circular motion and can be adjusted to the optimal angle during implantation [33,49].
A retrospective study of Occlutech Figulla septal occluders for ASD closure in
1315 patients showed that the device was successfully implanted in 1291 (98.2%)
patients. The occlusion rate was 78.6% immediately and 83.1% at discharge. The
successful closure rate was 96.4%, 97.3%, and 98% at 6 months, 12 months, and 5
years of follow-up, respectively [48]. Recently, a randomized, controlled, multicenter
trial was conducted to assess the efficacy of OFF II ASD occluder and ASO in closing
septal defects. The results showed that the effectiveness of OFF II ASD occluder was
no less than that of ASO [33].
Similar to the Flex II ASD occluder, the Flex II PFO occluder is a double disc
device woven from Nitinol wires, but with a lower profile (Fig. S1e). The ball-forceps
connection of the device allows a maximum rotation angle of 50 degrees. A
prospective registry (OPPOSE) of PFO closure using the Flex II PFO occluder was
carried out. A total of 100 patients underwent PFO closure and were followed up for 6
months, confirming the effectiveness of the Flex II PFO occluder [17].
S2.1.3. Gore septal occluders
The Gore Helex septal occluder (GSO; Fig. S1f; W. L. Gore & Associates, Inc.,
AZ, USA) for ASD and PFO occlusion is composed of a spiral single-stranded Nitinol
wire and ePTFE mesh. Unlike Amplatzer series, it is not self-centering and is suitable
for defects up to 18 mm in diameter [30,50].
The Gore Cardioform septal occluder (GCSO; Fig. S1g; W. L. Gore & Associates,
Inc., AZ, USA) is an upgrade of GSO. The double disc configuration formed by five
platinum-filled Nitinol wires improves the compliance of GCSO to cardiac anatomy
and the stability of GCSO. In addition, a new more porous ePTFE membrane is used
to promote autologous tissue growth [29,51]. The first clinical experience in both
children and adults showed that GCSO was effective for ASDs up to 15 mm and can
adapt to defects in different anatomical structures, including the deficient aortic rim,
aneurysm, and multifenestrated defect [29]. Another clinical experience involving
8
GCSO included 38 patients with septal defects (29 PFOs and 9 ASDs), and a 3-month
follow-up of 24 patients showed that 18 (75%) patients with PFO and 8 (88.8%)
patients with ASD were completely occluded without residual shunt [52]. GCSO
obtained FDA approval for PFO closure.
To address 1) GCSO is not suitable for ASDs with a diameter greater than 17 mm,
and 2) implantation of ASO in ASD patients with retro-aortic rim deficiency (< 5 mm)
may lead to device erosion, the Gore Cardioform ASD occluder (GCA; Fig. S1h; W. L.
Gore & Associates, Inc., AZ, USA) has been developed as the latest extension of Gore
family of septal defect occluders to allow the device to be applicable in a wider range
of ASD patients. GCA is comprised of the same frame and film materials as GSO. The
device with a diameter of 27 mm-37 mm is composed of a six-lobed spiral wireframe,
while the device with a diameter of 44 mm-48 mm consists of an eight-lobed spiral
wireframe to improve stability. GCA has an anatomically adaptable waist, which is a
significant improvement on GCSO. Therefore, GCA can accommodate defects with
different structural features and can occlude a wider range of ASDs (diameter: 8
mm-35 mm) [16,53].
The ASSURED clinical study enrolled 125 ASD patients and the GCA device
was successfully implanted in 120 (96%) cases. The 6-month follow-up of 112
patients showed that all ASDs were successfully closed. No residual shunt or device
dislocation occurred. 36% of wireframe fractures occurred, but there were no related
clinical sequelae. Overall, the ASSURED clinical study showed the effectiveness and
safety of GCA in occluding ASD. Based on this positive outcome, GCA was approved
by FDA in 2019 [53].
9
Fig. S1. Septal occluders. A) Amplatzer septal occluder; b) Amplatzer Cribriform
Multifenestrated septal occluder; c) Amplatzer PFO occluder. Occlutech Figulla d)
Flex II ASD occluder; e) Flex II PFO occluder. Gore septal occluders. F) Gore Helex
septal occluder; g) Gore Cardioform septal occluder; h) Gore Cardioform ASD
occluder.
S2.1.4. Lifetech HeartR/Cera/CeraFlex septal occluders
Lifetech Scientific (Shenzhen, China) has developed three generations
(HeartR/Cera/CeraFlex) of interventional closure devices. Fig. S2 displays the ASD
and PFO occluders. As one of the first-generation devices, the HeartRASD occluder is
woven from Nitinol wires and covered with PET membranes (Fig. S2a). The
second-generation (Cera) devices upgrade the Nitinol frame with TiN coating. This
bioceramic coating aims to reduce the dissolution of nickel ions and the formation of
thrombus, thus improving biocompatibility and accelerating endothelialization (Fig.
S2b-d) [18,39]. As shown in Fig. S2e, the CeraFlex ASD occluder (CFO) is a
third-generation device. As an upgraded version of Cera ASD occluder (CO), CFO
allows 360-degree flexible rotation, thus it can be accurately positioned and conform
to a variety of septal anatomical structures [15]. The implantation technique and
10
configuration of CFO are similar to ASO, except that there is no protruding hub on the
left disc of CFO to reduce the metal content. CFO received the CE mark in 2011. In
addition, Cera/CeraFlex Multifenestrated ASD occluder is specially designed for
closing multifenestrated ASD (Fig. S2c,f).
A multicenter study involving 405 ASD patients was carried out to assess the
efficacy of CO and ASO for ASD closure. The results showed that the implantation
success rate, complete closure rate, and safety were similar in the CO group and ASO
group when the ASD size, the incidence of complex lesions, the occluder size, and the
operation time were close to each other. However, the average cost of implanting a
CO is 37.5% less than that of implanting an ASO, thus CO can be considered as an
attractive alternative to ASO [54].
Fig. S2. Lifetech ASD and PFO occluders. A) HeartRASD occluder; b) Cera ASD
occluder; c) Cera Multifenestrated ASD occluder; d) Cera PFO occluder; e) CeraFlex
ASD occluder; f) CeraFlex Multifenestrated ASD occluder; g) CeraFlex PFO
occluder.
S2.1.5. CardioSEAL and STARFlex devices
The CardioSEAL device (Fig. S3a; NMT Medical, Boston, MA, USA), an
upgraded version of the original Clamshell device, is a double umbrella device with
four metal skeletons covered with Dacron mesh. Compared to Clamshell,
11
CardioSEAL is equipped with two joints on each arm, improving fatigue fracture
resistance and conformability with the atrium. In addition, the MP35N skeletons are
used instead of the stainless steel skeletons to improve the compatibility with
magnetic resonance imaging (MRI). The delivery system is improved and can be
delivered through 10 F sheath. The STARFlex device made by Nitinol is the latest
version of the CardioSEAL device (Fig. S3b). The Nitinol micro springs between the
umbrellas are modified to allow the device to self-center [55].
Clinical trials showed that fractures occurred in all three generations, less
frequently in newer generations. The fracture rates for Clamshell, CardioSEAL, and
STARFlex devices were 68%, 41%, and 34%, respectively. Besides, the improvement
of each generation of the device led to an increase in the closure rate. The success
rates of the three generations of devices were 79%, 93%, and 98%, respectively [56].
Another comparative analysis of Amplatzer and CardioSEAL/STARFlex devices used
to close PFO and ASD showed that Amplatzer devices were superior to
CardioSEAL/STARFlex devices in terms of efficacy, safety, and low incidence of
adverse events [57].
S2.1.6. Ultrasept ASD/PFO occluders
The 7th generation Ultrasept ASD and PFO occluders developed by Cardia Inc.
(Fig. S3c,d; Eagan, MN, USA) are the evolution and improvement of earlier versions
such as Atriasept I/II and Ultrasept I occluders [58]. Cardia devices have a low-profile
Nitinol mesh covered with PVA membrane to reduce material usage and improve
compliance. The double articulated sail and self-centering design allow the device to
be deployed easily and achieve an ultra-low profile in the atrium.
However, due to the perforation of the PVA membrane, significant and repeated
left-to-right shunts occurred not only in Atriasept I/II devices but also in Ultrasept I/II
devices [24,58-60]. More recently, a newly enhanced device has been developed,
which is expected to address the problem of membrane perforation by inserting
Goretex patches between the two Nitinol discs of the Ultrasept II device.
Transcatheter ASD closure was performed in 30 ASD patients using the new Ultrasept
II device with Goretex patches. Follow-up for 6 months revealed that no perforation
occurred in all devices [61].
12
S2.1.7. Cocoon ASD/PFO occluders
The Cocoon ASD occluder (Fig. S3e; Vascular Innovations Co., Nonthaburi,
Thailand) is a self-expandable double-disc device woven from Nitinol wires and
covered with PP fabrics. Platinum is coated on the Nitinol frame by nano fusion
technology to increase biocompatibility and smoothness, and to prevent nickel ion
precipitation. In addition, the device has the advantages of softness and lightness. It
has shown favorable results in clinical trials in the European Economic Area and was
approved by the CE mark. Two clinical trials involving 27 and 92 ASD patients
showed that the ASD closure rate was 100% in both groups at 1 month follow-up, and
no device-related complications occurred [14,22]. The configuration of the Cocoon
PFO occluder (Fig. S3f) is similar to that of Cocoon ASD occluder, and clinical trials
showed good outcomes [62]. Compared with Amplatzer and Occlutech occluders,
Cocoon occluders are more economical.
13
Fig. S3. Septal occluders. A) CardioSEAL device; b) STARFlex device; c) Ultrasept
ASD occluder; d) Ultrasept PFO occluder; e) Cocoon ASD occluder; f) Cocoon PFO
occluder; g) Nit-Occlud ASD-R occluder; h) Nit-Occlud PFO occluder [63]; i)
Solysafe septal occluder [64]; j) Premere PFO closure system [64]; k) SeptRx
Intrapocket PFO occluder [65]; l) SHSMA ASD occluder (Memopart); m) SHSMA
thin-waist, large-rim ASD occluder [66]; n) Cardi-O-Fix ASD occluder; o)
Cardi-O-Fix PFO occluder; p) PushMed ASD occluder; q) PushMed PFO occluder.
S2.1.8. Nit-Occlud ASD-R/PFO occluders
The Nit-Occlud ASD-R occluder (Fig. S3g; PFM Medical, Cologne, Germany) is
a dual-disc device woven by a single Nitinol wire without protruding fixing hubs. The
metal content in the left atrial disc decreased by about 50%, reducing the risk of
thromboembolism. Polyester membranes are sutured with PP thread to cover the two
discs, and two platinum markers are also fixed on the discs [34,67].
The clinical trial of the Nit-Occlud ASD-R device showed that ASDs were
successfully closed in 49 of 53 patients without significant complications. Device
embolism developed in 1 patient [67]. Another clinical trial included 25 ASD patients,
all of whom were successfully implanted with the devices. Release issues occurred in
3 patients, and 1 patient developed device-related erosion the day after the
implantation. During the 10-month follow-up, no further device-related complications
(e.g., erosion, embolism, or displacement) occurred. All patients were completely
occluded during follow-up. The clinical experience revealed that Nit-Occlud ASD-R
occluder can be used to occlude moderate to large ASDs [34].
The Nit-occlud PFO occluder (Fig. S3h) is a double-disc device made of
single-stranded Nitinol wire with Dacron coverage on the left and right discs. The left
atrial disc is a concave single-layer structure. The concave shape enables it to conform
to the left atrium with a low profile. The single-layer structure reduces the risk of
thromboembolism by decreasing the use of Nitinol [63]. 151 patients with cryptogenic
thromboembolism events underwent PFO closure using the Nit-Occlud PFO device
and the procedure success rate was 99.3% (150). Recurrence of stroke or TIA
occurred in 5 patients and device-related thrombosis occurred in 1 patient. No other
major complications occurred [68].
14
S2.1.9. Solysafe septal occluder
The Solysafe septal occluder (SSO; Fig. S3i; Swissimplant AG, Solothurn,
Switzerland) is developed for ASD and PFO closure, with double foldable polyester
membranes fixed on eight Phynox wires. Platinum-iridium (PT-IR) markers are used
for X-ray guidance [6,69]. A prospective multicenter pilot study using the SSO
showed excellent clinical results with an overall closure rate of 100% (44/44) [69].
However, it was reported that the high fracture rate of SSO cannot be ignored [70].
Another study showed that 22 out of 25 patients with septal defects underwent
successful SSO implantation, and there was 1 case of device embolization and 1 case
of hemiparesis. At 6 years of follow-up, wire fracture occurred in 1 patient and
residual shunt occurred in 1 patient [5].
S2.1.10. Premere PFO closure system
The Premere PFO closure system (Fig. S3j; Velocimed, Inc., acquired by St. Jude
Medical, Inc., now Abbott) consists of two crossed Nitinol anchors attached to a
polyester rope, with a woven polyester patch covering the right disc. Therefore, there
is very little material on the left side, and the amount of metal is approximately
1/15-1/20 of that of the Amplatzer PFO occluder of the same size. In addition, the
device is characterized by variable rope length to adapt to individual anatomical
structure. The clinical trial involving the Premere PFO closure system showed that the
procedure success rate and pre-discharge closure rate of 70 patients who underwent
percutaneous PFO closure were 100% and 95.7%, respectively. No complications
were reported [71].
S2.1.11. SeptRx Intrapocket PFO occluder
The SeptRx Intrapocket PFO occluder (Fig. S3k; SeptRx, Inc., Fremont, CA,
USA) is the first “in-tunnel” PFO occlusion device that can be placed directly in the
PFO pocket with only a small amount of foreign materials in the atrial septum. The
device has a laser-cut, electro-polished, self-expandable Nitinol frame, with a
filament-woven Nitinol mesh in the center to improve sealing performance. In
addition, there are two pairs of anchor struts connected to the frame, and the longer
pair is designed to conform to various PFO tunnel lengths by changing the shape. All
anchor struts are covered with tantalum coils for fluoroscopy guidance. The
15
first-in-man trial enrolled 13 patients with cryptogenic stroke or TIA, and the device
was successfully implanted in 11 patients. At 1 and 6 months of follow-up, 6 and 11
PFOs were closed, respectively. There were no adverse events [65].
S2.1.12. SHSMA ASD occluders
Two types of ASD occluders have been developed by SHSMA (Lepu Medical,
Beijing, China): Memopart and thin-waist large-edge occluders [66,72]. As shown in
Fig. S3l and m, the occluders consist of two discs woven from Nitinol wires, with a
self-centering waist in the middle. The thin-waist large-rim ASD occluder is specially
designed for small-sized ASD patients with atrial septal aneurysm and
multifenestrated ASD patients. 21 patients underwent percutaneous closure of ASD
using the Memopart device, and complete occlusion was achieved in all cases before
discharge. During an average follow-up of 10 months, no residual shunt or other
complications occurred [72].
Other septal occluders, such as Cardi-O-Fix ASD/PFO occluder (Starway
Medical Technology, Inc., Beijing, China) and PushMed ASD/PFO occluder
(Shanghai Push Medical Device Technology Co., Ltd, Shanghai, China), are also
double-disc devices woven from Nitinol wires and filled with polyester patches (Fig.
S3n-q). In addition, Starway Medical and Push Medical have developed occluders for
PDA and VSD, which are all composed of a woven Nitinol frame and polyester
membranes. Their configurations are illustrated in Fig. S4n,o, and Fig. S7g,h,
respectively [73].
S2.2. PDA occluders
PDA was the earliest CHD treated by percutaneous intervention. Transcatheter
closure of PDA was first achieved by Porstmann in 1967 using an Ivalon plug through
an 18 F delivery sheath [74]. Since early PDA occlusion devices required very large
delivery sheaths, it was not until the 1990s that the transcatheter PDA occlusion was
widely used as an alternative to surgery [25]. In the past three decades, the most
commonly used PDA closure devices are coils and duct occluders. The coil is
represented by Nit-Occlud PDA occluder; duct occluders include Amplatzer Duct
occluders, Lifetech HeartR/Cera/CeraFlex PDA occluders, Occlutech Duct occluder,
Cocoon Duct occluder, SHSMA PDA occluder, etc. [14,75-78]. Coils are more
16
suitable for small-sized PDAs, and duct occluders are preferred for medium and
large-sized PDAs [79].
S2.2.1. Amplatzer Duct occluders
Abbott provides four different types of PDA occluders, as displayed in Fig. S4a-d,
including Amplatzer Duct occluder (ADO), Amplatzer Duct occluder II (ADO II),
Duct occluder II AS (additional size), and Amplatzer Piccolo occluder. Among them,
ADO and ADO II are widely used in the clinic. ADO is a tapered device made of
Nitinol, designed to close large-sized PDAs. ADO II is applicable for most PDAs,
especially small to medium-sized PDAs. Compared with ADO, the membrane-free,
symmetrical double-disc design of ADO II allows it to be delivered via an arterial or
venous route through a flexible 4-5 F catheter. In a clinical study of 192 patients with
PDA, the procedure success rate was 93%, and 98% of the patients with successful
implantation were completely closed [77].
In addition, ADO and ADO II are also used for VSD closure and have shown
favorable outcomes [80-82].
S2.2.2. Occlutech Duct occluder
The Occlutech Duct occluder (ODO; Fig. S4e; Occlutech International AB,
Helsingborg, Sweden) is a PDA occlusion device with unique braided Nitinol
structure. It is composed of a tapered shank and a fixed disc located near the distal end
of the aorta after implantation. The shank is supposed to be placed at the narrowest
part of the duct [78]. ODO provides two options for shank length (standard and long).
The absence of a distal protruding hub reduces the profile of the device. The Nitinol
frame is coated with titanium oxide and shows a specific yellow color. In addition, the
pulmonary artery side of ODO is wider than the aortic side, which helps to lower the
risk of protrusion and embolism to the aortic side. Compared with ADO, ODO is
slightly less opaque [79,83]. The ODO was used to close PDA in 71 patients and
procedural success was achieved in all patients. Postoperative angiography showed
that complete closure was achieved in 47 patients (66.2%). Mild residual shunts
occurred in 13 patients, and trivial shunts occurred in 11 patients. Postoperative
angiography showed that 47 patients (66.2%) were completely closed, 13 cases
developed mild residual shunts and 11 cases developed trivial shunts. At 24 h after
17
procedure, the complete closure rate was 91.5%, and mild residual shunts occurred in
6 cases. 1-month follow-up showed that all patients were completely closed [79].
S2.2.3. Nit-Occlud PDA/ PDA-R occluders
The Nit-Occlud PDA occluder (Fig. S4f; PFM Medical, Cologne, Germany) is an
inverted cone device that consists of multiple spiral Nitinol coils with various
diameters and stiffness for closing PDAs with a maximum diameter of 6 mm. The
increased stiffness gradient of the device from the lung side to the aortic side
facilitates the device to better adapt to the anatomical structure of PDA. Additionally,
the device can be repositioned and retracted if required [84,85]. In a prospective
postapproval study of 184 PDA patients, 97.8% of patients were successfully
implanted with the devices. 1 year follow-up showed that minimal or no residual
shunts occurred in 98.7% (150/152) patients, while minor residual shunts occurred in
2 patients. There were 3 cases of device embolization [86]. Another clinical trial
involving 541 patients showed a 94.4% complete success rate without death or severe
device-related adverse events. More recently, 268 patients received Nit-Occlud PDA
coils for PDA closure, and all devices were successfully implanted. The immediate
closure rate after surgery and the closure rate at 6 months follow-up were 62% and
98.5%, respectively. There were 12 cases of residual shunts, 1 case of a minor
thromboembolic event, and no other procedure-associated complications occurred
[87].
Another PDA occlusion device developed by PFM Medical is Nit-Occlud PDA-R
occluder, which is also braided from one Nitinol wire without protruding clamps. It is
a self-expanding, mushroom-shaped device with three polyester membranes for
sealing PDAs with diameters between 2 mm and 8 mm. Its radial force is only 9 N,
which is 30% lower than that of ADO, allowing less trauma during implantation. As
shown in Fig. S4g, the larger distal disc (retention disc) with a special reverse
structure is used for anchoring in the aortic ampulla. Two platinum markers are fixed
on the device for X-ray positioning [88,89]. The clinical experience showed favorable
procedural and 6-month outcomes. The procedure success rate was 100%. The
incidence of trivial residual shunts was 42%, 28%, 12.1%, and 0% at surgery
completion, 1 day, 1 week, and 12 weeks, respectively. There was 1 case of
embolization without other significant short-term or long-term complications [88].
18
S2.2.4. Lifetech HeartR/Cera/ CeraFlex PDA occluders
As described in Section S2.1.4, Lifetech Scientific has developed three
generations of occlusion devices, including the HeartR, Cera, and CeraFlex product
families. The upgrade process of the PDA occluder is similar to that of the ASD/PFO
occluder, except that the PTFE membranes are used for the PDA device rather than
the PET membranes. The configurations of HeartRPDA occluder, Cera PDA occluder,
and CeraFlex PDA occluders are illustrated in Fig. S4h-j. Cera PDA occluder consists
of a mushroom-shaped Nitinol frame with TiN coating and PTFE membranes. The
device was successfully implanted in 18 PDA patients, and the postoperative residual
shunt was observed in 1 patient. The first follow-up of transthoracic echocardiography
(TEE) showed that all patients were completely occluded without death or
complications [90].
S2.2.5. Cocoon Duct occluder
The Cocoon Duct occluder (Fig. S4k; Vascular Innovations Co., Nonthaburi,
Thailand) is a self-expandable and self-centering occlusion device for PDA closure,
including a cylinder and a fixed disc for positioning. The frame is woven from
platinum-coated Nitinol wires and filled with PP fabrics. A clinical trial involving 57
patients showed that the procedural success rate was 100%. 85.9% of patients
achieved immediate complete closure, while 14.1% of patients experienced residual
shunts. Follow-up at 1 and 6 months showed that all patients were completely closed
and no other complications occurred during the follow-up period [91].
S2.2.6. SHSMA PDA occluders
Two kinds of PDA occluders are developed by SHSMA, one is regular PDA
occluder, which has a similar structure with ADO; the other is a specially designed
curved eccentric PDA occluder (Fig. S4l, m). 40 patients with PDA underwent
transcatheter closure using the regular SHSMA PDA occluder. The successful closure
rate was 100%, and the sequelae rate was 2.5% [66].
19
Fig. S4. PDA occluders. A) Amplatzer Duct occluder; b) Amplatzer Duct occluder II;
c) Amplatzer Duct Occluder II AS; d) Amplatzer Piccolo occluder; e) Occlutech Duct
occluder; f) Nit-Occlud PDA occluder; g) Nit-Occlud PDA-R occluder; h) HeartR
PDA occluder; i) Cera PDA occluder; j) CeraFlex PDA occluder; k) Cocoon Duct
occluder; l) SHSMA PDA occluder; m) SHSMA bent, eccentric PDA occluder [66]; n)
Cardi-O-Fix PDA occluder; and o) PushMed PDA occluder.
S2.3. VSD occluders
Transcatheter closure of VSD began in the late 1980s and devices that were
originally used to close PDA or ASD were used to close VSD [81,92]. Currently,
transcatheter closure of VSD is an emerging alternative to high-risk open-heart
surgery [93-95]. Amplatzer VSD occluder is the first device specifically developed for
VSD closure. However, due to the high incidence of AV block, Amplatzer
membranous VSD occluder is no longer clinically available. Amplatzer muscular
VSD occluder is still available on the market and was approved by the FDA in 2007.
20
In addition, many other devices have been developed by different companies for VSD
closure, including Occlutech mVSD/pmVSD occluders, Nit-Occlud Lê VSD occluder,
Lifetech HeartR/KONAR-MF/Cera VSD occluders, Cocoon VSD occluders, and
SHSMA VSD occluders. Details of various VSD occluders will be discussed below.
S2.3.1. Amplatzer VSD occluders
Three types of VSD occluder have been developed by Abbott, including
Amplatzer muscular VSD occluder, Amplatzer PI muscular VSD occluder, and
Amplatzer membranous VSD occluder (Fig. S5a-c). Similar to other Amplatzer series
occluders, these Amplatzer VSD occluders are self-expanding double-disc devices
woven with Nitinol wires and can be repositioned. Amplatzer muscular VSD occluder
is developed for high-risk patients with standard surgical repair; Amplatzer PI
muscular VSD occluder is suitable for the damaged muscular tissue of the septum in
patients with myocardial infarction. The two muscular VSD occluders are designed
with different waist diameters to accommodate different anatomical structures of the
septal wall. The Amplatzer membranous VSD occluder is designed to close the
hemodynamically significant pmVSD. However, it is no longer clinically available
due to the high risk of AV block, and there is currently no FDA approved (peri)
membranous VSD occluder [96].
S2.3.2. Occlutech mVSD/pmVSD occluders
Occlutech offers two kinds of VSD closure devices: mVSD occluder and pmVSD
occluder, which are respectively used to occlude mVSD and pmVSD with significant
hemodynamics. The mVSD occluder is a symmetrical double-disc device, and its
short disc margin reduces the pressure on surrounding tissues (Fig. S5d). The pmVSD
occluder is composed of a wide shank and a disc, of which the wide shank is designed
for firm anchoring (Fig. S5e). Both devices are fabricated by unique braiding
technology using titanium oxide-coated Nitinol wires. There is no distal hub on the
device, minimizing the use of materials. In addition, the devices can be completely
retrieved and repositioned.
21
Fig. S5. VSD occluders. A) Amplatzer muscular VSD occluder, b) Amplatzer PI
muscular VSD occluder; c) Amplatzer membranous VSD occluder; d) Occlutech
mVSD occluder; e) Occlutech pmVSD occluder; f) Nit-Occlud Lê VSD occluder.
S2.3.3. Nit-Occlud Lê VSD occluder
The cone-shaped Nit-Occlud Lê VSD occluder (Fig. S5f; PFM Medical, Cologne,
Germany) consists of Nitinol coil for supporting and polyester fibers for improving
sealing performance [97,98]. It has good adaptability and can conform to the
anatomical structures of both pmVSD and mVSD. A comparative study of the
Amplatzer VSD occluders and the Nit-occlud Lê VSD occluder for VSD closure
showed that the incidence of residual shunts was similar in the two groups at 6 months
follow-up. The Amplatzer VSD occluders were able to close large defects, but 5 AV
block occurred, 4 of which required additional pacemakers. The advantage of
Nit-occlud Lê VSD occluder was that it was suitable for both types of VSDs, and only
1 transient AV block occurred [99].
In a recent clinical study, the Nit-Occlud Lê VSD occluder was successfully
implanted in 40 of 46 patients. Major complications were observed in 6 patients,
including residual shunt, multiple outlet VSD, etc. 40% of patients showed residual
shunts shortly after occlusion, and 15% of patients showed residual shunts at 27
months of follow-up. No device embolization or complete AV block occurred. As the
residual shunt may cause hemolysis, the use of Nit-Occlud Lê VSD device for
22
pmVSD closure is still controversial, thus careful selection of qualified patients is
necessary [100].
S2.3.4. Lifetech HeartR/KONAR-MF/Cera VSD occluders
There are three types of VSD occluders provided by Lifetech Scientific: HeartR
VSD occluder, KONAR-MF VSD occluder, and Cera VSD occluder (Fig. S6). As
mentioned above, HeartRseries products are the first-generation occlusion devices
developed by Lifetech (Fig. S6a,b). The HeartRVSD occluder is a double-disc device
woven by Nitinol wires and covered with PTFE membranes. It is fatigue-resistance,
recapturable and repositionable. A clinical trial showed that the HeartRVSD occluder
was successfully implanted in 871 of 890 patients (97.9%), and significant
complications occurred in 1.12% (10/890) of patients [101,102].
The KONAR-MF VSD occluder (MFO, Fig. S6c) is a soft, self-expandable,
double-disc device, which is woven by 144 threads of 0.002-inch Nitinol wires. The
two discs are connected by an articulated conical waist. MFO comes in eight sizes
from 5/3 mm to 14/12 mm. Four larger devices are covered with PTFE membranes,
while four smaller devices have no membrane inside. It was approved by the CE mark
in 2018 [96,103]. Recently, a clinical study showed that 98% (96/98) of VSD patients
successfully received MFO device implantation. Major complications occurred in 4
cases, including 2 cases of device embolization, 1 case of complete heart block, and 1
case of device displacement. An average follow-up of 7-12 months revealed 8 cases of
mild residual shunts, 8 cases of mild rhythm disturbance, 1 case of tricuspid
insufficiency, and 1 case of aortic valve insufficiency [96].
To adapt to various defect anatomical structures, Cera series VSD occluders
include four different types, as shown in Fig. S6d-g, three of which are used for
pmVSD and one for mVSD. The Nitinol frame is covered with TiN bioceramic
coating to reduce nickel ion precipitation and improve biocompatibility. Dense PTFE
membranes are filled in the device for better sealing performance. In a clinical study,
55 patients were implanted with the Cera VSD occluders for pmVSD closure, and
procedure success was achieved in 51 patients. There were 5 cases of minor residual
shunts and 5 cases of moderate residual shunts. During approximately 10 months of
follow-up, no residual shunt was observed in 91% of patients. AV block and serious
23
aortic regurgitation occurred in 1 patient [104].
Fig. S6. Lifetech VSD occluders. a) HeartRmVSD occluder; b) HeartRpmVSD
occluder; c) KONAR-MF VSD occluder; d) Cera mVSD occluder; e) Cera symmetric
pmVSD occluder; f) Cera asymmetric pmVSD occluder; g) Cera eccentric pmVSD
occluder.
S2.3.5. Cocoon VSD occluders
The Cocoon VSD occluders (Vascular Innovations Co., Nonthaburi, Thailand) are
self-expanding double-disc occlusion devices, braided with platinum-coated Nitinol
wires and connected through the waist. PP fabrics were sewn with polyester thread on
both discs and waist. As shown in Fig. S7a-c, Cocoon VSD occluders are available in
three types (pmVSD occluder, mVSD occluder, and aneurysmal VSD occluder) to
occlude different VSDs. The waist height of the three occluders increases in turn,
which are 4 mm, 7 mm, and 10 mm, respectively. The occluders are currently
available in Korea. Clinical experience involving Cocoon VSD occluders showed that
residual shunts and conduction abnormalities may be observed in the early
postoperative period, especially in pmVSD patients [105].
S2.3.6. SHSMA VSD occluders
There are three kinds of VSD occluders designed by SHSMA, including
symmetric VSD occluder, thin-waist occluder, and (zero) asymmetric eccentric VSD
occluder, which is respectively suitable for defects more than 2 mm/more than 4
24
mm/less than 2 mm from the aortic valve (Fig. S7d-f) [66,92,95,106-109]. The
asymmetric eccentric VSD occluder was approved by the CFDA in 2003 and CE mark
in 2008 [95]. A large-scale clinical study of VSD closure using the SHSMA VSD
occluder showed that 17 (1.63%) of 1046 pmVSD patients developed complete AV
block after surgery, and 8 (0.8%) patients received permanent pacemaker implantation.
In addition, complete AV block occurred in 14 cases within 1 month and decreased to
3 cases 1 year later [108].
Due to the complexity of VSD and the limited types of VSD occluders available
for clinical use, alternative devices are used for VSD closure, such as ADO, ADO II,
and Amplatzer Vascular Plug II (AVP II) [80-82,93]. The soft Amplatzer devices have
shown positive clinical outcomes in VSD occlusion. ADO, ADO II, and AVP II
devices were implanted in 119 patients for pmVSD closure. During the follow-up
period, 3 cases of residual shunts and 1 case of embolism were observed. The success
closure rate was 98.3%, and no complete AV block was reported [82].
Fig. S7. VSD occluders. Cocoon VSD occluders [105]. a) Cocoon pmVSD occluder;
b) Cocoon mVSD occluder; c) Cocoon aneurysmal VSD occluder. SHSMA VSD
occluders [108]. d) Symmetric VSD occluder; e) thin-waist occluder; f) (zero)
asymmetric eccentric VSD occluder; g) Cardi-O-Fix VSD occluder; h) PushMed VSD
occluder
25
S2.4. LAA occluders
In recent years, transcatheter closure of LAA has achieved encouraging results in
preventing stroke in AF patients [110-112]. With the Watchman device and Amplatzer
Amulet device as leading devices, a variety of occluders have been developed for
LAA closure. According to the method of exclusion, it can be divided into two types:
plug closure and ligation (Fig. S8). Devices for LAA exclusion using the ligation
method include Lariat suture delivery system and Sierra ligation system. Plug closure
devices can be divided into two subtypes: disc plug device and internal plug device.
Disc plug devices include Amplatzer Cardiac Plug, Amplatzer Amulet device,
LAmbre device, LACbes device, Ultrasept LAA device, SeaLA device, and Omega
LAA occluder. Internal plug devices include PLAATO device, Watchman devices,
Occlutech LAA occluders, and WaveCrest LAA occluder [113-122]. In addition,
according to the procedure route, there are three approaches: endocardial approach,
epicardial approach, and hybrid approach. The endocardial approach is to puncture the
interatrial septum before releasing the device to close the LAA. The epicardial
approach is to puncture epicardium and ligate the neck of LAA. The hybrid approach
involves both endocardial and epicardial approaches [123-125]. The procedure route
is related to the exclusion method, and the endocardial approach is used in all plug
closure devices. Sierra ligation system is an epicardial LAA occlusion device, while
the Lariat suture delivery system is a hybrid LAA occlusion device [126,127].
Fig. S8. Classification of LAA exclusion methods
S2.4.1. PLAATO device
The first transcatheter LAA occluder was PLAATO (Fig. S9a; Appriva Medical,
26
CA, USA), consisting of a self-expandable Nitinol cage and ePTFE membranes.
PLAATO was first implanted into the human body in 2001, with occlusion success
rates of 97.3% and 90% respectively in two clinical trials with 111 and 180 AF
patients [117,122]. However, PLAATO device also exposed some limitations,
including device embolization, peripheral leakage/incomplete closure, LAA damage
(leading to pericardial tamponade), etc. Even with these deficiencies, the emergence
of PLAATO still demonstrates LAA closure may provide an alternative for AF
patients who are unsuitable for anticoagulant therapy, facilitating the development of
LAA occluders [128]. PLAATO was discontinued in 2006 due to economic shortages
[126,129].
Fig. S9. LAA occluders. a) PLAATO device; b) Watchman device; c) Watchman FLX
device; d) Amplatzer Cardiac Plug; e) Amplatzer Amulet device; f) LAmbre device; g)
Occlutech LAA occluder; h) New version of Occlutech LAA occluder
S2.4.2. Watchman and Watchman FLX devices
As one of the leading LAA occluders in the current market, Watchman device
(Boston Scientific, Marlborough, MA, USA) was developed after PLAATO device
[130]. As displayed in Fig. S9b, it consists of an expandable “jellyfish” shaped single
lobe Nitinol frame with fixed barbs and a PET membrane. Compared with the
PLAATO device, the Watchman device is released at the distal end of the LAA orifice
[129]. Watchman device is the first CE marked and FDA approved endocardial LAA
27
occluder. Two clinical trials (PROTECT-AF and PREVAIL) were conducted to
compare the efficacy of transcatheter LAA closure and warfarin therapy for stroke
prevention. The results showed that the Watchman device was no less effective in
stroke prevention than warfarin, and confirmed the feasibility as well as safety of
LAA closure in nonvalvular AF patients [119,131].
The latest version is Watchman FLX device, which consists of a Nitinol frame
with 18 struts and a PET membrane (Fig. S9c). 18 “J” shaped struts are staggered in
two rows to ensure the stability of positioning. Compared with the previous
generation of the Watchman device, the length of the Watchman FLX device is
shortened to facilitate the deployment in shallow LAA. Watchman FLX device
received the CE mark in 2019. 12 patients with high-risk nonvalvular AF underwent
transcatheter LAA occlusion treatment using the Watchman FLX device and were
followed up for 6 months. All devices were successfully implanted, of which 6 cases
(50%) required partial recapture and 1 case (8.3%) required full recapture. During the
follow-up of 1 month, displacement occurred in 2 cases, embolism occurred in 1 case
and thrombosis occurred in 1 case [132].
S2.4.3. Amplatzer Cardiac Plug and Amplatzer Amulet device
The Amplatzer Cardiac Plug (ACP) and Amplatzer Amulet device (the latest
version of ACP, also know as ACP 2) developed by Abbott, are self-expanding
double-disc Nitinol cages optimized on the basis of ASO. Both ACP and ACP 2 (Fig.
S9d, e) are characterized by a complete sealing of the LAA at the orifice. Compared
with ACP, ACP 2 has been greatly optimized. To simplify the implantation process
and ensure the device stability, the lobes and waist of ACP 2 are lengthened; the
stiffness of the hooks is increased; and the number of stabilizing wires is increased
from 6 to 10 pairs. In addition, the diameter of the proximal disc is increased to
improve the sealing performance. ACP 2 offers a wider range of device sizes
compared to Watchman devices. It is available in eight sizes with lobe diameters
ranging from 16 mm to 34 mm [133]. ACP 2 is fully retrievable and repositionable
[134,135]. ACP and ACP 2 were approved by the CE mark in 2008 and 2013,
respectively. Recently, clinical experience showed that the ACP was successfully
implanted in 97.3% (1,019/1,047) of patients, with significant intraoperative adverse
events occurring in 52 (4.97%) cases. 1001 patients were followed up for an average
28
of 13 months, during which 9 strokes (0.9%), 9 transient ischemic attacks (0.9%), and
15 major bleeding (1.5%) occurred [112].
S2.4.4. LAmbre device
The Lambre device (Fig. S9f; Lifetech Scientific, Shenzhen, China) is composed
of an umbrella-shaped self-expanding Nitinol frame and PET membranes. The frame
includes eight independent stabilizing hooks for securing to the LAA wall [120,136].
Lambre device is an improvement based on Watchman device and ACP device, and is
specifically designed for complete recapturing and repositioning [131]. The first
multicenter clinical trial of the LAmbre device showed that the occlusion success rate
was 99.4% (152 of 153) and periprocedural adverse events occurred in 3.3%. During
the 12-month follow-up, 99% (120/121) of the LAAs were completely closed [120].
S2.4.5. Occlutech LAA occluder
The Occlutech LAA occluder (Fig. S9g; Occlutech International AB, Helsingborg,
Sweden) is composed of a self-expanding cylindrical Nitinol frame and a fibrous poly
(carbonate) carbamate membrane. The controllable delivery sheath can be rotated to
180 degrees to position the device [116,137]. In the first clinical study of 30 patients,
the success rate of LAA closure was 93% [115]. The device was approved by the CE
mark but was withdrawn because of device embolization. In addition, some devices
were recalled due to the risk of dislodgement. Fig. S9h shows the upgraded version of
the Occlutech LAA occluder. Eight pairs of anchors are designed in the middle of the
new version device to increase stability, and an improved nanostructured impermeable
membrane is used to improve sealing performance [123]. The clinical trial of the new
version device was launched in 2018.
S2.4.6. LACbes device
The LACbes device (Fig. S10a; Shanghai Push Medical Device Technology,
Shanghai, China) consists of two parts: an anchor cylinder with integrated micro barbs
and a sealing disc. Both parts are filled with polyester membranes and are connected
by a thin waist [114]. Additionally, the device can be fully retrieved. The clinical
study involving the LACbes device enrolled 175 patients. All cases were completely
closed at 12 months of follow-up, and the incidence of ischemic stroke was 0.59%.
Recently, 22 patients with nonvalvular AF underwent LAA closure using the device
29
under the guidance of real-time 3D TEE. There was no perioperative stroke or death,
no device displacement, and no closure-related complications during an average
follow-up of 1 year [138].
S2.4.7. WaveCrest LAA occluder
The WaveCrest LAA occluder (Fig. S10b; Biosense Webster, CA, USA) is a
single-lobe Nitinol frame covered with ePTFE membrane to reduce thrombosis and
achieve rapid endothelialization. The device has the most anchor points (20 points) to
reduce the risk of embolism. The clinical study showed that 93% (68/73) of patients
were successfully implanted with the Wavecrest devices. At 1.5 months of follow-up,
92% of the LAAs were completely closed. 2 patients experienced pericardial effusion,
and no other severe complications were observed [125].
S2.4.8. Ultrasept LAA device
The Ultrasept LAA device (Fig. S10c; Cardia Inc., Eagan, MN, USA) is a flexible
cylindrical self-expanding Nitinol cage that includes a bulb with 12 securing hooks
and a sail. The dual-articulated joint connecting the bulb and sail allows the device to
adapt to different LAA anatomical structures. The device is retrievable and
repositionable. The first multicenter experience of the Ultraseal LAA device showed
that 122 of 126 patients (97%) were fully isolated, and the remaining 4 patients failed
to close due to the challenging LAA anatomy. Major complications were observed in
2.4% of the patients [111].
30
Fig. S10. LAA devices. a) LACbes device [114]; b) WaveCrest LAA occluder; c)
Ultrasept LAA device; d) CLAAS device; e) SeaLA device; f) Omega LAA occluder;
g) Lariat suture delivery system; h) Sierra ligation system.
S2.4.9. CLAAS device
The CLAAS device (Conformal Medical, Inc., Nashua, NH, USA) consists of a
foam cup and a nitinol endoskeleton, with an ePTFE membrane covering the upper
surface of the device. The device is self-adaptive, available in only two sizes but
adaptable to a wide range of LAA anatomies. 18 of the 22 patients receiving CLAAS
device implantation were successfully implanted. At 45 days of follow-up,1 patient
showed inadequate sealing and 1 patient showed laminated thrombus (no
complications). Besides, 3 patients with 1-year follow-up showed good sealing [147].
S2.4.10. SeaLA device
The SeaLA device (Fig. S10e; DiNova Medical, Hangzhou, China) is a fully
recapturable self-expanding Nitinol cage consisting of a distal anchoring plate with
nine hooks and a proximal sealing plate. The latest clinical study involving the SeaLA
device showed that all 8 AF patients achieved complete LAA occlusion without
adverse events. No device displacement, device thrombosis, or other complications
occurred during the 45 days of follow-up.
S2.4.10. Omega LAA occluder
The Omega LAA occluder (Fig. S10f; Vascular Innovations, Nonthaburi,
Thailand) is a two-layer “disc-and-cup” cage woven from self-expanding
platinum-coated Nitinol wires. The PP membrane is filled into the cage to enhance the
occlusion capacity, and the flexible waist can adapt to the complex LAA anatomy. In
addition, the self-fixing inverted cup has eight hooks to improve stability.
S2.4.11. Lariat suture delivery system
Different from the conventional LAA exclusion method, the Lariat suture
delivery system (Fig. S10g; SentreHEART, Redwood City, CA, USA) occludes LAA
by suture ligation [126]. The system is composed of a balloon catheter, magnetic
guidewires, and an epicardial suture device [125]. The epicardial suture device
features an easy-to-use 50 mm loop that is compatible with 5 mm access. The LAA
31
exclusion process of the Lariat suture delivery system is a hybrid process involving
both endocardial and epicardial approaches. The unique method of closing LAA
brings some advantages and disadvantages. Lariat is compatible with various
anatomical shapes and sizes, and the maximum dimensions that can be adapted are
40mm in width, 20mm in height, and 70mm in length; Lariat only leaves a small
fraction of the “0” braided polyester suture outside the LAA, and no foreign body in
contact with blood is left. However, the complex closure process may lead to a high
risk of procedure-related complications, such as pericardial effusion (8 of 41 patients,
20%) [131].
S2.4.12. Sierra ligation system
The Sierra ligation system (Fig. S10h; Aegis Medical Innovations, Vancouver,
Canada) is an epicardial LAA occlusion device consisting of an LAA stabilizer and a
ligator. Compared with Lariat suture delivery system, there is no need for additional
septal puncture. The stabilizer with electrodes can identify the position of LAA
through electronic signal navigation. Once the position of the LAA is determined, the
stabilizer guides the hollow suture-like ligator to LAA, and then the ligator is
tightened to close LAA. Sierra ligation system is a research device and has not been
approved for commercial use. Initial clinical experience of the device enrolled 7
patients and all cases underwent successful LAA closure. Transient ventricular
tachycardia and extrinsic right-sided chamber compression occurred in 1 case. No
complications related to the device or operation were encountered [127].
Other devices such as PFM LAA occluder (PFM Medical, Cologne, Germany),
Lefort LAA occluder (Lepu Medical, Beijing, China), and Epitek LAA occluder
(Medford, NJ, USA) are also developed for LAA closure, all of which are woven from
Nitinol wires.
S3. Complications of non-degradable occlusion devices
With the improvement of interventional techniques and the development of
various metal occluders, percutaneous catheter occlusion of heart defects has been
considered as an efficient alternative. However, there are rare but potentially
life-threatening complications associated with implanted metal occluders. As a
leading occlusion device, the most severe complication of ASO is erosion. FDA
32
received over 100 erosion reports related to ASO from 2002 to 2011 [13,22]. The
incidence of ASO migration and aortic erosion is approximately 1 in 1000, occurring
in 18 of 15,900 cases (0.12%) in the United States and 37 of 35,000 cases (0.11%)
worldwide [50]. FDA reported that improper device size selection may cause the
device to rub against the heart wall and corrode the tissue. If the scraping causes holes
in the aortic root, blood may accumulate in the sac (i.e., tamponade), which is
life-threatening. The mortality rate due to device erosion is extremely rare, ranging
from 0.004% to 0.015% worldwide [139]. No erosion of GSO has been reported,
possibly due to the small surface area of the Nitinol frame and the fact that the frame
has little direct contact with the tissue. To summarize, erosion is related to the device
scratching the heart tissue caused by the inappropriate size of the device. Covering the
Nitinol frame with a polymer membrane and reducing the amount of Nitinol material
may help reduce erosion. In fact, the difference in stiffness between the Nitinol frame
and the human tissue is a more essential reason [140]. Therefore, it is a better choice
to use low-rigidity biopolymers to prepare the occluder frame.
In addition to erosion, device-related complications include nickel allergy, device
dislodgement/embolization, thrombosis, wire fracture, heart block, pericardial
tamponade, and residual shunt [10-13,22,70,128,141-146]. Adverse events associated
with nickel allergy (e.g., chest pain, palpitation, and migraine) have been reported in
patients receiving Nitinol occluders [12]. Device displacement/embolization is the
most common complication, which may be associated with inadequate rim,
inappropriate deployment location, or improper device size selection. A clinical study
reported that among 258 patients with the ASOs, 3 patients developed device
embolization and 2 patients developed migration. Of the 159 patients implanted with
the CardioSEAL/STARFlex devices, 4 cases experienced embolization, and 1 case
experienced migration [143]. It has been reported that devices migrated to the
pulmonary artery and the lateral wall of the right atrium 2 or even 13 years after the
procedure. Therefore, the implantation of bioabsorbable occluders is an ideal way to
address this issue [11,142].
The wire frame fracture rate of GSO is about 5%-7% and larger size device is
more prone to fracture [141]. Generally, fractures cause clinical sequelae only in rare
cases. A report showed that the rupture of the wire of the Atriasept device caused
33
aortic perforation and severe tamponade [146]. Another study reported that device
rupture occurred after ASD closure with Atriasept II occluder nearly for 4 years,
resulting in mitral valve perforation [145]. Again, the late-stage complications that
occur several years after implantation of metal occluders can be fully avoided by
implanting biodegradable occlusion devices.
References
[1] T.D. King, and N.L. Mills, Nonoperative closure of atrial septal defects.
Surgery 75 (1974) 383-8.
[2] S. Samavedi, L.K. Poindexter, M. Van Dyke, and A.S. Goldstein, Chapter 7-
Synthetic Biomaterials for Regenerative Medicine Applications. in: G. Orlando, J.
Lerut, S. Soker, and R.J. Stratta, (Eds.), Regenerative Medicine Applications in Organ
Transplantation, Academic Press, Boston, 2014, pp. 81-99.
[3] Y. Huang, J.F. Kong, and S.S. Venkatraman, Biomaterials and design in
occlusion devices for cardiac defects: A review. Acta Biomaterialia 10 (2014)
1088-1101.
[4] C. Jux, H. Bertram, P. Wohlsein, M. Bruegmann, and T. Paul, Interventional
Atrial Septal Defect Closure Using a Totally Bioresorbable Occluder Matrix:
Development and Preclinical Evaluation of the BioSTAR Device. Journal of the
American College of Cardiology 48 (2006) 161-169.
[5] M.M. Yilmazer, S.V. Yildirim, T. Mese, B. Guven, S. Demirpence, R. Ozdemir,
T. Oner, and V. Tavli, Mid-term results of Solysafe(R) septal occluder for
percutaneous closure of secundum atrial septal defects. Turk Gogus Kalp Damar
Cerrahisi Derg 26 (2018) 58-64.
[6] O. Kretschmar, A. Sglimbea, I. Daehnert, F.T. Riede, M. Weiss, and W.
Knirsch, Interventional closure of atrial septal defects with the Solysafe Septal
Occluder — Preliminary results in children. International Journal of Cardiology 143
(2010) 373-377.
[7] S. Hiromoto, E. Onodera, A. Chiba, K. Asami, and T. Hanawa, Microstructure
and corrosion behaviour in biological environments of the new forged low-Ni
Co–Cr–Mo alloys. Biomaterials 26 (2005) 4912-4923.
[8] A. Nagai, Y. Tsutsumi, Y. Suzuki, K. Katayama, T. Hanawa, and K. Yamashita,
Characterization of air-formed surface oxide film on a Co–Ni–Cr–Mo alloy (MP35N)
and its change in Hanks’ solution. Applied Surface Science 258 (2012) 5490-5498.
[9] N. MAJUNKE, and H. SIEVERT, ASD/PFO Devices: What Is in the Pipeline?
Journal of Interventional Cardiology 20 (2007) 517-523.
[10] O. Elkiran, C. Karakurt, G. Kocak, and C. Taskapan, Serum Nickel and
Titanium Levels after Transcatheter Closure of Atrial Septal Defects with Amplatzer
Septal Occluder. Cardiol Res Pract 2019 (2019) 7891746.
[11] D.N. Lysitsas, B. Wrigley, P. Banerjee, P.E. Glennon, J.M. Parmar, M.F. Shiu,
and M. Been, Presentation of an embolised Amplatzer septal occluder to the main
pulmonary artery 2 years after implantation. International Journal of Cardiology 131
(2009) e106-e107.
[12] B. Wertman, B. Azarbal, M. Riedl, and J. Tobis, Adverse Events Associated
With Nickel Allergy in Patients Undergoing Percutaneous Atrial Septal Defect or
34
Patent Foramen Ovale Closure. Journal of the American College of Cardiology 47
(2006) 1226-1227.
[13] Z. Amin, Z.M. Hijazi, J.L. Bass, J.P. Cheatham, W.E. Hellenbrand, and C.S.
Kleinman, Erosion of Amplatzer septal occluder device after closure of secundum
atrial septal defects: review of registry of complications and recommendations to
minimize future risk. Catheter Cardiovasc Interv 63 (2004) 496-502.
[14] H. Mahmoud, A. Nicolescu, C. Filip, G. Duica, G. Nicolae, and E.E. Cinteza,
Cocoon devices for transcatheter closure of atrial septal defect and patent ductus
arteriosus in children: Single center experience. Medicine (Baltimore) 98 (2019)
e14684.
[15] S.C. Apostolopoulou, A. Tsoutsinos, C. Laskari, M. Kiaffas, and S. Rammos,
Large single centre experience with the Cera™ and CeraFlex™ occluders for closure
of interatrial communications: usefulness of the flexible rotation feature.
Cardiovascular Intervention and Therapeutics 33 (2018) 70-76.
[16] Q. de Hemptinne, E.M. Horlick, M.D. Osten, X. Millan, V.X. Tadros, M. Pighi,
B.F. Gonzalez, S.M. Alnasser, J. Miro, A.W. Asgar, and R. Ibrahim, Initial clinical
experience with the GORE((R)) CARDIOFORM ASD occluder for transcatheter
atrial septal defect closure. Catheter Cardiovasc Interv 90 (2017) 495-503.
[17] D. Hildick-Smith, T. Williams, P. MacCarthy, N. Melikian, M. Monaghan, M.
Spence, S.T. MacDonald, A. Duke, J. Kovac, A. McGregor, R. Hilling-Smith, A.
Gomes, C. Thomson, M. Mullen, and L. Morrison, Occlutech percutaneous patent
foramen ovale closure: Safety and efficacy registry (OPPOSE). International Journal
of Cardiology 245 (2017) 99-104.
[18] D. Zhang, Z. Zhang, Z. Zi, Y. Zhang, W. Zeng, and P.K. Chu, Fabrication of
graded TiN coatings on nitinol occluders and effects on in vivo nickel release.
Bio-medical materials and engineering 18 (2008) 387-393.
[19] A.I. Cassady, N.M. Hidzir, and L. Grøndahl, Enhancing expanded
poly(tetrafluoroethylene) (ePTFE) for biomaterials applications. Journal of Applied
Polymer Science 131 (2014) 40533.
[20] M. Sigler, and C. Jux, Biocompatibility of septal defect closure devices. Heart
93 (2007) 444-449.
[21] E.M. Zahn, N. Wilson, W. Cutright, and L.A. Latson, Development and testing
of the Helex septal occluder, a new expanded polytetrafluoroethylene atrial septal
defect occlusion system. Circulation 104 (2001) 711-6.
[22] B.D. Thanopoulos, L. Biasco, P. Dardas, O. De Backer, P. Avraamides, D.
Deleanou, V. Ninios, P.P. Mavrommatis, and L. Soendergaard, Catheter closure of
atrial septal defects using the Cocoon septal occluder: Preliminary results of a
European multicenter study. International Journal of Cardiology 177 (2014) 418-422.
[23] F. Chamié, L.C.D. Nascimento Simões, R. Mattos, D. Chamié, J. Carlos Tress,
and M. Otero Lacoste, Early Experience with the New CARDIA Ultrasept™ Device
for Patent Foramen Ovale Occlusion: Still a Good Option. Revista Brasileira de
Cardiologia Invasiva (English Edition) 20 (2012) 309-314.
[24] P. Aubry, E. Brochet, X.H.D. Fretay, S. Bouton-Brochet, H. Ibrahim, X. Arrault,
U. Hvass, and J. Juliard, Early Malfunction of Polyvinyl Alcohol Membrane–Covered
Atrial Septal Defect Closure Devices. Circulation: Cardiovascular Interventions 7
(2014) 721-722.
[25] A. Baruteau, S. Hascoët, J. Baruteau, Y. Boudjemline, V. Lambert, C. Angel, E.
Belli, J. Petit, and R. Pass, Transcatheter closure of patent ductus arteriosus: Past,
present and future. Archives of Cardiovascular Diseases 107 (2014) 122-132.
35
[26] W.J. Rashkind, Transcatheter treatment of congenital heart disease. Circulation
67 (1983) 711-6.
[27] F. Godart, A. Houeijeh, M. Recher, C. Francart, A. Polge, M. Richardson, M.
Cajot, and A. Duhamel, Transcatheter closure of atrial septal defect with the Figulla®
ASD Occluder: A comparative study with the Amplatzer® Septal Occluder. Archives
of Cardiovascular Diseases 108 (2015) 57-63.
[28] R. Correa, E. Zahn, and D. Khan, Mid-term outcomes of the Helex septal
occluder for percutaneous closure of secundum atrial septal defects. Congenit Heart
Dis 8 (2013) 428-33.
[29] C. Nyboe, V.E. Hjortdal, and J.E. Nielsen-Kudsk, First experiences with the
GORE(R) Septal Occluder in children and adults with atrial septal defects. Catheter
Cardiovasc Interv 82 (2013) 929-34.
[30] T.K. Jones, L.A. Latson, E. Zahn, C.E. Fleishman, J. Jacobson, R. Vincent, and
K. Kanter, Results of the U.S. multicenter pivotal study of the HELEX septal occluder
for percutaneous closure of secundum atrial septal defects. J Am Coll Cardiol 49
(2007) 2215-21.
[31] S.E. Hardt, A. Eicken, F. Berger, S. Schubert, M. Carminati, G. Butera, J.
Grohmann, R. Höhn, J.E. Nielsen-Kudsk, D. Hildick-Smith, M. Settergren, J.D.
Thomson, N. Geis, and L. Søndergaard, Closure of patent foramen ovale defects using
GORE® CARDIOFORM septal occluder: Results from a prospective European
multicenter study. Catheterization and Cardiovascular Interventions 90 (2017)
824-829.
[32] N.A. Haas, C.M. Happel, D.B. Soetemann, A. Hanslik, A. Moysich, D.
Kececioglu, and K.T. Laser, Optimal septum alignment of the Figulla Flex occluder to
the atrial septum in patients with secundum atrial septal defects. EuroIntervention 11
(2016) 1153-60.
[33] D. Kenny, A. Eicken, I. Dahnert, Y. Boudjemline, H. Sievert, M.B. Schneider,
T. Gori, and Z.M. Hijazi, A randomized, controlled, multi-center trial of the efficacy
and safety of the Occlutech Figulla Flex-II Occluder compared to the Amplatzer
Septal Occluder for transcatheter closure of secundum atrial septal defects. Catheter
Cardiovasc Interv 93 (2019) 316-321.
[34] M.O. Bulut, I.K. Yucel, M. Kucuk, S. Balli, E.Z. Basar, and A. Celebi, Initial
Experience with the Nit-Occlud ASD-R: Short-Term Results. Pediatr Cardiol 37
(2016) 1258-65.
[35] A.D. Everett, J. Jennings, E. Sibinga, C. Owada, D.S. Lim, J. Cheatham, R.
Holzer, J. Ringewald, R. Bandisode, and R. Ringel, Community use of the amplatzer
atrial septal defect occluder: results of the multicenter MAGIC atrial septal defect
study. Pediatr Cardiol 30 (2009) 240-7.
[36] Z. Jalal, S. Hascoët, C. Gronier, F. Godart, L. Mauri, C. Dauphin, B. Lefort, M.
Lachaud, D. Piot, M. Dinet, Y. Levy, A. Fraisse, C. Ovaert, X. Pillois, J. Lusson, J.
Petit, A. Baruteau, and J. Thambo, Long-Term Outcomes After Percutaneous Closure
of Ostium Secundum Atrial Septal Defect in the Young: A Nationwide Cohort Study.
JACC: Cardiovascular Interventions 11 (2018) 795-804.
[37] J.W. Moore, R.N. Vincent, R.H. Beekman, L. Benson, L. Bergersen, R. Holzer,
N. Jayaram, K. Jenkins, Y. Li, R. Ringel, J. Rome, and G.R. Martin, Procedural
Results and Safety of Common Interventional Procedures in Congenital Heart Disease:
Initial Report From the National Cardiovascular Data Registry. Journal of the
American College of Cardiology 64 (2014) 2439-2451.
36
[38] J. Masura, P. Gavora, A. Formanek, and Z.M. Hijazi, Transcatheter closure of
secundum atrial septal defects using the new self-centering amplatzer septal occluder:
initial human experience. Cathet Cardiovasc Diagn 42 (1997) 388-93.
[39] M.A. Astarcioglu, M. Kalcik, T. Sen, A.C. Aykan, T. Gokdeniz, O.M. Gursoy,
S. Karakoyun, S. Kulahcioglu, S. Gunduz, C. Kilit, M. Oylumlu, and B. Amasyali,
Ceraflex versus Amplatzer occluder for secundum atrial septal defect closure.
Multicenter clinical experience. Herz 40 Suppl 2 (2015) 146-50.
[40] K. AYTEMIR, A. OTO, S. ÖZKUTLU, E.B. KAYA, U. CANPOLAT, H.
YORGUN, L. ŞAHINER, and G. KABAKÇI, Early-Mid Term Follow-Up Results of
Percutaneous Closure of the Interatrial Septal Defects with Occlutech Figulla Devices:
A Single Center Experience. Journal of Interventional Cardiology 25 (2012) 375-381.
[41] Z. Du, Z.M. Hijazi, C.S. Kleinman, N.H. Silverman, and K. Larntz, Comparison
between transcatheter and surgical closure of secundum atrial septal defect in children
and adults: Results of a multicenter nonrandomized trial. Journal of the American
College of Cardiology 39 (2002) 1836-1844.
[42] M. Numan, S.A. El, M. Tofeig, S. Gendi, T. Tohami, and H.G. El-Said,
Cribriform amplatzer device closure of fenestrated atrial septal defects: feasibility and
technical aspects. Pediatr Cardiol 29 (2008) 530-5.
[43] J.L. Saver, J.D. Carroll, D.E. Thaler, R.W. Smalling, L.A. MacDonald, D.S.
Marks, D.L. Tirschwell, and I. RESPECT, Long-Term Outcomes of Patent Foramen
Ovale Closure or Medical Therapy after Stroke, Massachusetts Medical Society,
United States, 2017, pp. 1022-1032.
[44] T.E. Hong, D. Thaler, J. Brorson, M. Heitschmidt, and Z.M. Hijazi,
Transcatheter closure of patent foramen ovale associated with paradoxical embolism
using the amplatzer PFO occluder: Initial and intermediate-term results of the U.S.
multicenter clinical trial. Catheterization and Cardiovascular Interventions 60 (2003)
524-528.
[45] A. Halabi, and Z.M. Hijazi, A new device to close secundum atrial septal
defects: First clinical use to close multiple defects in a child. Catheterization and
Cardiovascular Interventions 71 (2008) 853-856.
[46] M. Ali, H. Salah El-Din, S. Bakhoum, A. El-Sisi, K. Mahmood, H. Farouk, and
H. Kandil, Feasibility of percutaneous closure of atrial septal defects in adults under
transthoracic echocardiography guidance using the Figulla atrial septal defect
occluder device. Journal of the Saudi Heart Association 30 (2018) 21-27.
[47] F. Krizanic, H. Sievert, D. Pfeiffer, T. Konorza, M. Ferrari, Z. Hijazi, C. Jung,
A. Lauten, and H.R. Figulla, The Occlutech Figulla PFO and ASD occluder: a new
nitinol wire mesh device for closure of atrial septal defects. The Journal of invasive
cardiology 22 (2010) 182.
[48] N.A. Haas, D.B. Soetemann, I. Ates, O. Baspinar, I. Ditkivskyy, C. Duke, F.
Godart, A. Lorber, E. Oliveira, E. Onorato, F. Pac, W. Promphan, F.T. Riede, S.
Roymanee, R. Sabiniewicz, S.O. Shebani, H. Sievert, D. Tin, and C.M. Happel,
Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices
in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series.
Catheter Cardiovasc Interv 88 (2016) 571-581.
[49] J. Neuser, M. Akin, U. Bavendiek, T. Kempf, J. Bauersachs, and J.D. Widder,
Mid-term results of interventional closure of patent foramen ovale with the Occlutech
Figulla ® Flex II Occluder. BMC cardiovascular disorders 16 (2016) 217.
[50] P.S. Rao, and A.D. Harris, Recent advances in managing septal defects: atrial
septal defects. F1000Res 6 (2017) 2042.
37
[51] N. Bissessor, Current perspectives in percutaneous atrial septal defect closure
devices. Med Devices (Auckl) 8 (2015) 297-303.
[52] X. Freixa, R. Ibrahim, J. Chan, P. Garceau, A. Dore, F. Marcotte, L. Mercier, F.
Mongeon, A. Basmadjian, P. Khairy, and A.W. Asgar, Initial clinical experience with
the GORE septal occluder for the treatment of atrial septal defects and patent foramen
ovale. EuroIntervention : journal of EuroPCR in collaboration with the Working
Group on Interventional Cardiology of the European Society of Cardiology 9 (2013)
629-635.
[53] R.J. Sommer, B.A. Love, J.A. Paolillo, R.G. Gray, B.H. Goldstein, G.J. Morgan,
M.J. Gillespie, I. ASSURED, and T.A.I. For, ASSURED clinical study: New GORE®
CARDIOFORM ASD occluder for transcatheter closure of atrial septal defect.
Catheterization and cardiovascular interventions : official journal of the Society for
Cardiac Angiography & Interventions (2020).
[54] M.G. Kaya, M. Akpek, A. Celebi, T. Saritas, M. Meric, K. Soylu, H. Karapinar,
and Y.Y. Lam, A multicentre, comparative study of Cera septal occluder versus
AMPLATZER Septal Occluder in transcatheter closure of secundum atrial septal
defects. EuroIntervention 10 (2014) 626-31.
[55] M.J. Landzberg, CardioSEAL-STARFlex®, and PFO-Star® Closure of PFO. In:
Herrmann H.C. (eds) Interventional Cardiology. Contemporary Cardiology., Humana
Press, 2005.
[56] A.W. Nugent, A. Britt, K. Gauvreau, G.E. Piercey, J.E. Lock, and K.J. Jenkins,
Device Closure Rates of Simple Atrial Septal Defects Optimized by the STARFlex
Device. Journal of the American College of Cardiology 48 (2006) 538-544.
[57] Y. Li, K. Zhou, Y. Hua, C. Wang, L. Xie, J. Fang, X. Rong, and J. Shen,
Amplatzer occluder versus CardioSEAL/STARFlex occluder: a meta-analysis of the
efficacy and safety of transcatheter occlusion for patent foramen ovale and atrial
septal defect. Cardiol Young 23 (2013) 582-96.
[58] M. Nassif, M. Abdelghani, B.J. Bouma, B. Straver, N.A. Blom, K.T. Koch, J.G.
Tijssen, B.J. Mulder, and R.J. de Winter, Historical developments of atrial septal
defect closure devices: what we learn from the past. Expert Rev Med Devices 13
(2016) 555-68.
[59] M.G. Ramoglu, T. Ucar, and E. Tutar, Early malfunction of polyvinyl alcohol
membrane of septal occluder. Catheter Cardiovasc Interv 87 (2016) E151-3.
[60] B.S. Parlar H, Spontaneous Perforation of Polyvinyl Alcohol Membrane A Rare
Cause of Atrial Septal Occluder Failure. 3 (2019) 125-128.
[61] A.G.E.S. Roberto M-V, Atrial septal defect closure with the new Cardia
Ultrasept II device with interposed Goretex patch Mexican experience-has the
perforation of Ivalon's membrane been solved. Cardiology in the Young 28 (2018)
709–714.
[62] S. Srimahachota, N. Sansanayudh, V. Lertsuwunseri, J. Cholteesupachai, and P.
Lertsapcharoen, New PFO device for closure of patent foramen ovale in patients who
had a history of cryptogenic stroke; a report of 14 cases. Journal of the Medical
Association of Thailand = Chotmaihet thangphaet 98 Suppl 1 (2015) S107.
[63] D.H. Steinberg, S.C. Bertog, J. Momberger, J. Franke, I. Hofmann, K. Renkhoff,
S. Joy, L. Vaskelyte, and H. Sievert, Initial experience with the novel patent foramen
ovale occlusion device Nit‐Occlud® in patients with stroke or transient ischemic
attack. Catheterization and Cardiovascular Interventions 85 (2015) 1262-1267.
[64] S.J.D. Brecker, Percutaneous Device Closure of the Atrial Septum, Informa
Healthcare, 2006.
38
[65] W.J. Zimmermann, C. Heinisch, N. Majunke, S. Staubach, S. Russell, N.
Wunderlich, and H. Sievert, Patent Foramen Ovale Closure With the SeptRx Device:
Initial Experience With the First “In-Tunnel” Device. JACC: Cardiovascular
Interventions 3 (2010) 963-967.
[66] W.F. Sun, Z.F. Dong, K. Gong, G.P. Zhang, T. Cui, Y.D. Xia, J. Dong, and Y.
Shen, Transcatheter closure with use of the SHSMA occluder in 180 patients with
congenital heart defects: preliminary results. Tex Heart Inst J 37 (2010) 531-7.
[67] A. Heath, I.V. Alvensleben, J. Navarro, G. Echazú, R. Kozlik-Feldmann, and F.
Freudenthal, Developing High Medical Technology, a Challenge for Developing
Countries: The Percutaneous Closure of Atrial Septal Defects Using Nit-Occlud
ASD-R: Early and Mid-term Results. World Journal for Pediatric and Congenital
Heart Surgery 10 (2019) 433-439.
[68] A. Araszkiewicz, S. Sławek, O. Trojnarska, M. Lesiak, and M. Grygier,
Interventional closure of patent foramen ovale with Nit‐occlud® device in prevention
of recurrent neurologic events-Long‐term results. Catheterization and Cardiovascular
Interventions 92 (2018) 159-164.
[69] P. Ewert, B. Soderberg, I. Dahnert, O. Hess, G. Schuler, C. Bussmann, J.
Bernhard, and P. Sick, ASD and PFO closure with the Solysafe septal occluder -
results of a prospective multicenter pilot study. Catheter Cardiovasc Interv 71 (2008)
398-402.
[70] S. Gielen, F.T. Riede, G. Schuler, and I. Dahnert, Wire fractures in Solysafe
septal occluders: a single center experience. Catheter Cardiovasc Interv 79 (2012)
1161-8.
[71] G. Rigatelli, P. Cardaioli, F. Dell'Avvocata, M. Giordan, and M. Chinaglia,
Premere occlusion system for transcatheter patent foramen ovale closure: Mid‐term
results of a single‐center registry. Catheterization and Cardiovascular Interventions 77
(2011) 564-569.
[72] J.L. Haddad, G.C. Novaes, R.B. Pavão, A.V. Badran, D.C. Lemos, I.M. Lago,
M. de Oliveira Lima-Filho, G.L. de Figueiredo, P.H. Manso, W.V. de Andrade
Vicente, L.G. Gali, M.M.D. Romano, and J. Antonio Marin-Neto, Percutaneous
Closure of Ostium Secundum Atrial Septal Defect Using the Memopart™ Occlusion
Device. Revista Brasileira de Cardiologia Invasiva (English Edition) 21 (2013)
384-389.
[73] J.M. Wang, J.M. Zuo, S.M.P. Yu, D.M.P. Yi, X.M. Yang, X.M.P. Zhu, J.M.P.
Li, L.M.P. Yang, L.M.P. Xiong, S.M.P. Ge, J.M.P. Ren, and J.M.P. Yang,
Effectiveness and Safety of Transcatheter Closure of Perimembranous Ventricular
Septal Defects in Adults. American Journal of Cardiology, The 117 (2016) 980-987.
[74] W. Porstmann, L. Wierny, and H. Warnke, Closure of persistent ductus
arteriosus without thoracotomy. Ger Med Mon 12 (1967) 259-61.
[75] R. Fiszer, M. Szkutnik, B. Chodor, and J. Bialkowski, Preliminary Experience
in the Use of CERA Occluders for Closure of Different Intracardiac and Extracardiac
Shunts. Journal of Invasive Cardiology 26 (2014) 385-388.
[76] S. Sinha, D. Levi, A. Peirone, and C. Pedra, Techniques for trans‐catheter
retrieval of embolized Nit‐Occlud® PDA‐R and ASD‐R devices. Catheterization and
Cardiovascular Interventions 91 (2018) 478-484.
[77] D.H. Gruenstein, M. Ebeid, W. Radtke, P. Moore, R. Holzer, and H. Justino,
Transcatheter closure of patent ductus arteriosus using the AMPLATZER™ duct
occluder II (ADO II). Catheterization and Cardiovascular Interventions 89 (2017)
1118-1128.
39
[78] F. Godart, A. Houeijeh, O. Domanski, M. Guillaume, M. Brard, and H. Lucron,
Is the new Occlutech duct occluder an appropriate device for transcatheter closure of
patent ductus arteriosus? International Journal of Cardiology 261 (2018) 54-57.
[79] M. Bilici, F. Demir, A. Akın, M. Türe, H. Balık, and M. Kuyumcu,
Transcatheter Closure of Patent Ductus Arteriosus in Children with the Occlutech
Duct Occluder. Pediatric Cardiology 38 (2017) 1598-1605.
[80] L.J. Zhao, B. Han, J.J. Zhang, Y.C. Yi, D.D. Jiang, and J.L. Lyu, Transcatheter
closure of congenital perimembranous ventricular septal defect using the Amplatzer
duct occluder 2. Cardiol Young 28 (2018) 447-453.
[81] M. Kanaan, P. Ewert, F. Berger, S. Assa, and S. Schubert, Follow-up of patients
with interventional closure of ventricular septal defects with Amplatzer Duct
Occluder II. Pediatr Cardiol 36 (2015) 379-85.
[82] R. Mijangos-Vazquez, A. El-Sisi, J.J. Sandoval, J.A. Garcia-Montes, R.
Hernandez-Reyes, R. Sobhy, A. Abdelmassih, M.M. Soliman, S. Ali, T.
Molina-Sanchez, and C. Zabal, Transcatheter Closure of Perimembranous Ventricular
Septal Defects Using Different Generations of Amplatzer Devices: Multicenter
Experience. J Interv Cardiol 2020 (2020) 8948249.
[83] M.A.E. Abdelbasit, M. Alwi, G. Kandavello, M. Che Mood, H. Samion, and
Z.M. Hijazi, The new Occlutech® PDA occluder: Initial human experience.
Catheterization and Cardiovascular Interventions 86 (2015) 94-99.
[84] A. Celiker, E. Aypar, T. Karagoz, E. Dilber, and N. Ceviz, Transcatheter
closure of patent ductus arteriosus with Nit-Occlud coils. Catheter Cardiovasc Interv
65 (2005) 569-76.
[85] J.W. Moore, J. Greene, S. Palomares, A. Javois, C.Y. Owada, J.P. Cheatham,
M.H. Hoyer, T.K. Jones, and D.S. Levi, Results of the combined U.S. Multicenter
Pivotal Study and the Continuing Access Study of the Nit-Occlud PDA device for
percutaneous closure of patent ductus arteriosus. JACC Cardiovasc Interv 7 (2014)
1430-6.
[86] Results of the combined U.S. multicenter postapproval studyof the Nit-Occlud
PDA device for percutaneous closure of patent ductus arteriosus. Catheter
Cardiovascular Intervention (2019) 645-651.
[87] A. Maksymenko, Y. Kuzmenko, A. Dovhaliuk, O. Motrechko, F. Herrmann, N.
Haas, and A. Lehner, Percutaneous closure of patent ductus arteriosus with the
Nit-Occlud® patent ductus arteriosus device in 268 consecutive cases. Annals of
Pediatric Cardiology 12 (2019) 206.
[88] A. Peirone, J. Diaz, A. Contreras, E. Banille, M. Cabrera, A. Spillmann, N.
Bueno, and E. Juaneda, Percutaneous closure of the patent ductus arteriosus using the
Nit-Occlud PDA-R (reverse) device: initial experience reporting immediate and
short-term results. The Journal of invasive cardiology 23 (2011) 513.
[89] M.A. Granja, L. Trentacoste, M. Rivarola, J.D. Barbosa, V. Lucini, A. Peirone,
and A. Spillman, Multicenter nit-occlud(R) PDA-R patent. Ductus arteriosus
occlusion device trial: initial and six-month results. Catheter Cardiovasc Interv 86
(2015) 258-63.
[90] F. Chamié, L.C. Simões, D.S.C. de Queiroz, and R. Mattos, Percutaneous
Closure of a Patent Ductus Arteriosus with the Cera™ PDA Occluder: Another Good
Option in the Toolbox. Revista Brasileira de Cardiologia Invasiva (English Edition)
20 (2012) 77-81.
[91] S. Sinha, M. Razi, M. Jha, V. Mishra, P. Aggarwal, L. Rekwal, and A. Singh,
TCT-854 Prospective Evaluation of Feasibility, Safety, and Efficacy of Cocoon Duct
40
Occluder for Transcatheter Closure of Large Patent Ductus Arteriosus: A
Single-Centre Study with Short- and Medium-Term Follow-up Results. Journal of the
American College of Cardiology 70 (2017) B272.
[92] Y. Qin, J. Chen, X. Zhao, D. Liao, R. Mu, S. Wang, H. Wu, and H. Guo,
Transcatheter Closure of Perimembranous Ventricular Septal Defect Using a
Modified Double-Disk Occluder. The American Journal of Cardiology 101 (2008)
1781-1786.
[93] M. Shrestha, W. Promphan, T. Layangool, S. Roymanee, K.
Wongwaitaweewong, P. Prachasilchai, T. Kirawittaya, C. Sangtawesin, and P.
Pattarakunwiwat, Feasibility and 1‐year outcome of transcatheter closure of
perimembranous ventricular septal defects with different devices. Catheterization and
Cardiovascular Interventions 93 (2019) E30-E37.
[94] Q.M. Xing, Q.M. Wu, L.M. Shi, Y.M. Xing, and G.M. Yu, Minimally invasive
transthoracic device closure of isolated ventricular septal defects without
cardiopulmonary bypass: Long-term follow-up results. Journal of Thoracic and
Cardiovascular Surgery, The 149 (2015) 257-265.
[95] F. Chen, P. Li, S. Liu, Du H, B. Zhang, X. Jin, X. Zheng, H. Wu, S. Chen, L.
Han, Y. Qin, and X. Zhao, Transcatheter Closure of Intracristal Ventricular Septal
Defect With Mild Aortic Cusp Prolapse Using Zero Eccentricity Ventricular Septal
Defect Occluder. Circ J 79 (2015) 2162-8.
[96] I.C. Tanidir, O. Baspinar, M. Saygi, M. Kervancioglu, A. Guzeltas, and E.
Odemis, Use of Lifetech™ Konar-MF, a device for both perimembranous and
muscular ventricular septal defects: A multicentre study. International Journal of
Cardiology (2020).
[97] N.A. Haas, N.A. Haas, L. Kock, L. Kock, H. Bertram, H. Bertram, R.
Boekenkamp, R. Boekenkamp, D. De Wolf, D. De Wolf, I. Ditkivskyy, I. Ditkivskyy,
M.W. Freund, M.W. Freund, M. Gewillig, M. Gewillig, C.M. Happel, C.M. Happel,
U. Herberg, U. Herberg, E. Karthasyan, E. Karthasyan, R. Kozlik-Feldmann, R.
Kozlik-Feldmann, O. Kretschmar, O. Kretschmar, Y. Kuzmenko, Y. Kuzmenko, O.
Milanesi, O. Milanesi, G. Mueller, G. Mueller, G. Pongiglione, G. Pongiglione, S.
Schubert, S. Schubert, G. Tarusinov, G. Tarusinov, C. Kampmann, and C. Kampmann,
Interventional VSD-Closure with the Nit-Occlud® Lê VSD-Coil in 110 Patients:
Early and Midterm Results of the EUREVECO-Registry. Pediatric Cardiology 38
(2017) 215-227.
[98] E. Odemis, M. Saygi, A. Guzeltas, I.C. Tanidir, Y. Ergul, I. Ozyilmaz, and I.
Bakir, Transcatheter Closure of Perimembranous Ventricular Septal Defects using
Nit-Occlud® Lê VSD Coil: Early and Mid-Term Results. Pediatric Cardiology 35
(2014) 817-823.
[99] P. Chungsomprasong, K. Durongpisitkul, C. Vijarnsorn, J. Soongswang, and
T.P. Lê, The results of transcatheter closure of VSD using amplatzer® device and nit
occlud® Lê coil. Catheterization and Cardiovascular Interventions 78 (2011)
1032-1040.
[100] A. Houeijeh, F. Godart, Z. Jalal, C. Ovaert, F. Heitz, P. Mauran, A. Baruteau, L.
Guirguis, K. Hadeed, J. Baudelet, X. Iriart, P. Aldebert, P. Acar, A. Fraisse, E.
Odemis, C. Karsenty, J.B. Thambo, and S. Hascoët, Transcatheter closure of a
perimembranous ventricular septal defect with Nit-Occlud Lê VSD Coil: A French
multicentre study. Archives of Cardiovascular Diseases 113 (2020) 104-112.
[101] J. Liu, Z. Wang, L. Gao, H. Tan, Q. Zheng, and M. Zhang, A Large Institutional
Study on Outcomes and Complications after Transcatheter Closure of a
41
Perimembranous-Type Ventricular Septal Defect in 890 Cases. Acta Cardiologica
Sinica 29 (2013) 271-276.
[102] K.D. Mandal, D. Su, and Y. Pang, Long-Term Outcome of Transcatheter
Device Closure of Perimembranous Ventricular Septal Defects. Frontiers in pediatrics
6 (2018) 128.
[103] R.N. Haddad, L.S. Daou, and Z.S. Saliba, Percutaneous closure of
restrictive-type perimembranous ventricular septal defect using the new KONAR
multifunctional occluder: Midterm outcomes of the first middle-eastern experience.
Catheterization and cardiovascular interventions : official journal of the Society for
Cardiac Angiography & Interventions (2019).
[104] C.A. Esteves, L.A. Solarewicz, R. Cassar, J.R. Neves, V. Esteves, and R.
Arrieta, Occlusion of the perimembranous ventricular septal defect using CERA(R)
devices. Catheter Cardiovasc Interv 80 (2012) 182-7.
[105] H.S.J.K. Park, Early Experiences Using Cocoon Occluders for Closure of a
Ventricular Septal Defect. Journal of cardiovascular imaging 3 (2018) 165–174.
[106] Y. Zhou, F. Chen, X. Huang, X. Zhao, H. Wu, Y. Bai, and Y. Qin, A new
coated nitinol occluder for transcatheter closure of ventricular septal defects in a
canine model. BioMed research international 2013 (2013) 507919-7.
[107] T. Cui, W. Sun, Y. He, G. Zhang, D. Wang, Y. Xia, F. Wang, and M. Zhu, The
Feasibility and Safety of Interventional Occlusion Treatment of Intracristal
Ventricular Septal Defects: Clinical Report of 56 Cases. Cardiology 137 (2017)
218-224.
[108] Y.M. Bai, X.M. Xu, C.M. Li, J.M. Zhu, H.M. Wu, S.M. Chen, F.M. Chen, X.M.
You, X.M. Zhao, and Y.M. Qin, Complete atrioventricular block after percutaneous
device closure of perimembranous ventricular septal defect: A single-center
experience on 1046 cases. Heart Rhythm 12 (2015) 2132-2140.
[109] Q. Wang, X. Zhu, Z. Duanzhen, P. Zhang, H. Chen, X. Han, X. Sheng, and L.
Meng, Simultaneous transcatheter therapy for perimembranous ventricular septal
defect combined with patent ductus arteriosus. Journal of Cardiac Surgery 32 (2017)
370-375.
[110] V.Y. Reddy, H. Sievert, J. Halperin, S.K. Doshi, M. Buchbinder, P. Neuzil, K.
Huber, B. Whisenant, S. Kar, V. Swarup, N. Gordon, and D. Holmes, Percutaneous
left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical
trial. JAMA 312 (2014) 1988-98.
[111] L. Asmarats, J. Masson, P.A. Pagnotta, S. Cook, M. Foresti, R. Ibrahim, A.
Sukiennik, R. Sabiniewicz, D. Maffeo, J. Carballo, I. Cruz-González, C. Grasso, F.
Pisano, G. Senatore, G. Tarantini, A. Kasongo, M. Chiarito, S. Puricel, N. Messas, J.C.
Moreno-Samos, G. O Hara, and J. Rodés-Cabau, Percutaneous Left Atrial Appendage
Closure With the Ultraseal Device: Insights From the Initial Multicenter Experience.
JACC: Cardiovascular Interventions 11 (2018) 1932-1941.
[112] A. Tzikas, S. Shakir, S. Gafoor, H. Omran, S. Berti, G. Santoro, J. Kefer, U.
Landmesser, J.E. Nielsen-Kudsk, I. Cruz-Gonzalez, H. Sievert, T. Tichelbacker, P.
Kanagaratnam, F. Nietlispach, A. Aminian, F. Kasch, X. Freixa, P. Danna, M.
Rezzaghi, P. Vermeersch, F. Stock, M. Stolcova, M. Costa, R. Ibrahim, W.
Schillinger, B. Meier, and J.W. Park, Left atrial appendage occlusion for stroke
prevention in atrial fibrillation: multicentre experience with the AMPLATZER
Cardiac Plug. EuroIntervention 11 (2016) 1170-9.
[113] M. Grygier, A. Markiewicz, A. Araszkiewicz, A. Babicz-Sadowska, R. Plaksej,
A. Komosa, O. Trojnarska, and M. Lesiak, Watchman FLX: the initial Polish
42
experience with a new device for left atrial appendage occlusion. Kardiol Pol 78
(2020) 240-242.
[114] X. Tang, Z. Zhang, F. Wang, Y. Bai, X. Xu, X. Huang, X. Zhao, S. Gong, and
Y. Qin, Percutaneous Left Atrial Appendage Closure With LACBES((R)) Occluder-
A Preclinical Feasibility Study. Circ J 82 (2017) 87-92.
[115] B. Bellmann, S. Schnupp, P. Kuhnlein, C. Javernik, C. Kleinecke, A. Rillig, U.
Landmesser, J. Brachmann, and J.W. Park, Left Atrial Appendage Closure With the
New Occlutech(R) Device: First in Man Experience and Neurological Outcome. J
Cardiovasc Electrophysiol 28 (2017) 315-320.
[116] J. Park, M.A. Sherif, K. Zintl, Y. Lam, M. Goedde, T. Scharnweber, F. Jung,
R.P. Franke, and J. Brachmann, Percutaneous left atrial appendage closure with a
novel self-modelizing device: A pre-clinical feasibility study. International Journal of
Cardiology 177 (2014) 957-963.
[117] Y. Bayard, H. Omran, P. Neuzil, L. Thuesen, M. Pichler, E. Rowland, A.
Ramondo, W. Ruzyllo, W. Budts, G. Montalescot, P. Brugada, P.W. Serruys, A.
Vahanian, J. Piéchaud, A. Bartorelli, J. Marco, P. Probst, K. Kuck, S.H. Ostermayer,
F. Büscheck, E. Fischer, M. Leetz, and H. Sievert, PLAATO (Percutaneous Left
Atrial Appendage Transcatheter Occlusion) for prevention of cardioembolic stroke in
non-anticoagulation eligible atrial fibrillation patients: results from the European
PLAATO study. EuroIntervention : journal of EuroPCR in collaboration with the
Working Group on Interventional Cardiology of the European Society of Cardiology
6 (2010) 220-226.
[118] B. Schneider, J. Finsterer, and C. Stollberger, Effects of percutaneous left atrial
appendage transcatheter occlusion (PLAATO) on left atrial structure and function. J
Am Coll Cardiol 45 (2005) 634-5; author reply 635.
[119] D.R. Holmes, V.Y. Reddy, Z.G. Turi, S.K. Doshi, H. Sievert, M. Buchbinder,
C.M. Mullin, and P. Sick, Percutaneous closure of the left atrial appendage versus
warfarin therapy for prevention of stroke in patients with atrial fibrillation: a
randomised non-inferiority trial. The Lancet 374 (2009) 534-542.
[120] H. Huang, Y. Liu, Y. Xu, Z. Wang, Y. Li, K. Cao, S. Zhang, Y. Yang, X. Yang,
D. Huang, B. Yu, X. Su, L. Wu, and C. Huang, Percutaneous Left Atrial Appendage
Closure With the LAmbre Device for Stroke Prevention in Atrial Fibrillation: A
Prospective, Multicenter Clinical Study. JACC: Cardiovascular Interventions 10
(2017) 2188-2194.
[121] M.W. Bergmann, LAA occluder device for stroke prevention: Data on
WATCHMAN and other LAA occluders. Trends in Cardiovascular Medicine 27
(2017) 435-446.
[122] S.H. Ostermayer, M. Reisman, P.H. Kramer, R.V. Matthews, W.A. Gray, P.C.
Block, H. Omran, A.L. Bartorelli, P. Della Bella, C. Di Mario, C. Pappone, P.N.
Casale, J.W. Moses, A. Poppas, D.O. Williams, B. Meier, A. Skanes, P.S. Teirstein,
M.D. Lesh, T. Nakai, Y. Bayard, K. Billinger, T. Trepels, U. Krumsdorf, and H.
Sievert, Percutaneous left atrial appendage transcatheter occlusion (PLAATO system)
to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation - Results
from the international multi-center feasibility trials. JOURNAL OF THE
AMERICAN COLLEGE OF CARDIOLOGY 46 (2005) 9-14.
[123] D.H.F. Chow, Y. Wong, J. Park, Y. Lam, T. De Potter, J. Rodés-Cabau, L.
Asmarats, M. Sandri, E. Sideris, T. McCaw, R.J. Lee, H. Sievert, L. Søndergaard, and
O. De Backer, An overview of current and emerging devices for percutaneous left
atrial appendage closure. Trends in Cardiovascular Medicine 29 (2019) 228-236.
43
[124] M.K. Turagam, P. Velagapudi, S. Kar, D. Holmes, V.Y. Reddy, M.M. Refaat, L.
Di Biase, A. Al-Ahmed, M.K. Chung, T. Lewalter, J. Edgerton, J. Cox, J. Fisher, A.
Natale, and D.R. Lakkireddy, Cardiovascular Therapies Targeting Left Atrial
Appendage. Journal of the American College of Cardiology 72 (2018) 448-463.
[125] J.M. Romero, A.M.F.F. Natale, K.M. Engstrom, and L.M.P.F. Di Biase, Left
atrial appendage isolation using percutaneous (endocardial/epicardial) devices:
Pre-clinical and clinical experience. Trends in Cardiovascular Medicine 26 (2016)
182-199.
[126] C.M. Yu, A.A. Khattab, S.C. Bertog, A.P. Lee, J.S. Kwong, H. Sievert, and B.
Meier, Mechanical antithrombotic intervention by LAA occlusion in atrial fibrillation.
Nat Rev Cardiol 10 (2013) 707-22.
[127] C.J. Bruce, S.J. Asirvatham, T. McCaw, E. Hong, S. Berhow, N.M. Ammash,
and P.A. Friedman, Novel percutaneous left atrial appendage closure. Cardiovascular
Revascularization Medicine 14 (2013) 164-167.
[128] B. Kong, Y. Liu, H. Huang, H. Jiang, and C. Huang, Left atrial appendage
closure for thromboembolism prevention in patients with atrial fibrillation: advances
and perspectives. Journal of thoracic disease 7 (2015) 199-203.
[129] M. Schmid, A.A. Khattab, S. Gloekler, and B. Meier, Future epidemic impact of
atrial fibrillation and a new interventional strategy for stroke prophylaxis. Future
Cardiol 7 (2011) 219-26.
[130] J. Saw, Editorial commentary: Percutaneous left atrial appendage closure for
stroke prevention. Trends in Cardiovascular Medicine 26 (2016) 200-201.
[131] W. Khawar, N. Smith, and S. Masroor, Managing the Left Atrial Appendage in
Atrial Fibrillation: Current State of the Art. The Annals of Thoracic Surgery 104
(2017) 2111-2119.
[132] J. Seeger, R. Birkemeyer, W. Rottbauer, and J. Wohrle, First experience with
the Watchman FLX occluder for percutaneous left atrial appendage closure.
Cardiovasc Revasc Med 18 (2017) 512-516.
[133] J. Saw, and M. Lempereur, Percutaneous Left Atrial Appendage Closure:
Procedural Techniques and Outcomes. JACC: Cardiovascular Interventions 7 (2014)
1205-1220.
[134] I. Cruz-Gonzalez, J.C. Rama-Merchan, J. Rodriguez-Collado, J.
Martin-Moreiras, A. Diego-Nieto, A. Arribas-Jimenez, and P.L. Sanchez-Fernandez,
Left atrial appendage closure devices for cardiovascular risk reduction in atrial
fibrillation patients. Research Reports in Clinical Cardiology 6 (2015) 47.
[135] X. Freixa, J.L.K. Chan, A. Tzikas, P. Garceau, A. Basmadjian, and R. Ibrahim,
The Amplatzer™ Cardiac Plug 2 for left atrial appendage occlusion: novel features
and first-in-man experience. EuroIntervention : journal of EuroPCR in collaboration
with the Working Group on Interventional Cardiology of the European Society of
Cardiology 8 (2013) 1094-1098.
[136] Y. Lam, A new left atrial appendage occluder (Lifetech LAmbreTM Device) for
stroke prevention in atrial fibrillation. Cardiovascular Revascularization Medicine 14
(2013) 134-136.
[137] J. Kim, S. Lee, S. Bong, S. Park, S. Hong, S. Shin, C.Y. Shim, G. Hong, D.
Choi, Y. Jang, and J. Park, Preclinical assessment of a modified Occlutech left atrial
appendage closure device in a canine model. International Journal of Cardiology 221
(2016) 413-418.
44
[138] H. Zhang, Z. Tang, Z. Han, L. Zeng, and C. Wang, Role of real time-three
dimensional transesophageal echocardiography in left atrial appendage closure with
LACBES ® devices. Experimental and therapeutic medicine 17 (2019) 1456-1462.
[139] S. Kazmouz, D. Kenny, Q. Cao, C.J. Kavinsky, and Z.M. Hijazi, Transcatheter
closure of secundum atrial septal defects. The Journal of invasive cardiology 25 (2013)
257.
[140] D. Shi, Y. Kang, G. Zhang, C. Gao, W. Lu, H. Zou, and H. Jiang,
Biodegradable atrial septal defect occluders: A current review. Acta Biomater 96
(2019) 68-80.
[141] T.K. Jones, L.A. Latson, E. Zahn, C.E. Fleishman, J. Jacobson, R. Vincent, and
K. Kanter, Results of the U.S. Multicenter Pivotal Study of the HELEX Septal
Occluder for Percutaneous Closure of Secundum Atrial Septal Defects. Journal of the
American College of Cardiology 49 (2007) 2215-2221.
[142] T. Cotts, P.J. Strouse, and J.N. Graziano, Late migration of a Sideris buttoned
device for occlusion of atrial septal defect. Catheterization and Cardiovascular
Interventions 68 (2006) 754-757.
[143] M. Chessa, M. Carminati, G. Butera, R.M. Bini, M. Drago, L. Rosti, A.
Giamberti, G. Pome, E. Bossone, and A. Frigiola, Early and late complications
associated with transcatheter occlusion of secundum atrial septal defect. J Am Coll
Cardiol 39 (2002) 1061-5.
[144] M. Sigler, A. Horke, T. Paul, and F. Uhlemann, Solysafe Device Pushed Away
by Amplatzer Septal Occluder After Closure of a Residual Atrial Septal Defect. JACC:
Cardiovascular Interventions 12 (2019) e95-e96.
[145] R.S. Werner, R. Prêtre, F. Maisano, and M.J. Wilhelm, Fracture of a
Transcatheter Atrial Septal Defect Occluder Device Causing Mitral Valve Perforation.
The Annals of Thoracic Surgery 108 (2019) e29-e30.
[146] F.J. Hernández Pérez, J.A. Fernández Díaz, C. García Montero, A. García
Touchard, J.F. Oteo Domínguez, J.R. Domínguez Puente, and J. Goicolea Ruigómez,
Late aortic perforation with a fractured ATRIASEPT II device resulting in
life-threatening tamponade. EuroIntervention: journal of EuroPCR in collaboration
with the Working Group on Interventional Cardiology of the European Society of
Cardiology 9 (2013) 532.
[147] R. Sommer, J. Kim, M. Szerlip, M. Dohadwala, S. Chandhok, L. Sugeng, C.
Cain, A. Kaplan, and W. Gray, TCT CONNECT-451 Novel Conformable Foam-Based
Implant for Left Atrial Appendage Closure: Conformal EFS Experience. Journal of
the American College of Cardiology 76 (2020) B193.
