International Journal of Cardiology 177 (2014) 418–422

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Catheter closure of atrial septal defects using the Cocoon septal occluder: Preliminary results of a European multicenter study☆ Basil D. Thanopoulos a,⁎, Luigi Biasco b, Petros Dardas c, Ole De Backer b, Panayiotis Avraamides d, Dan Deleanou e, Vlassis Ninios c, Petros P. Mavrommatis d, Lars Soendergaard b a

Department of Pediatric Cardiology, Iatrikon Medical Center, Athens, Greece Department of Cardiology, Rigshospitalet, Copenhagen, Denmark Department of Interventional Cardiology, St. Luke Hospital, Thessaloniki, Greece d Department of Cardiology, Limassol General Hospital, Limassol, Cyprus e Department of Cardiac Interventions, Ares Medical Center, Bucharest, Romania b c

a r t i c l e

i n f o

Article history: Received 6 April 2014 Received in revised form 9 July 2014 Accepted 15 September 2014 Available online 11 October 2014 Keywords: Cocoon septal occluder Atrial septal defect Catheter closure

a b s t r a c t Despite its simplicity, device closure of atrial septal defects is still associated with rare but potentially lethal complications. In this prospective non-randomized multicenter study we investigated the safety and efficacy of the Cocoon septal occluder (CSO) for closure of atrial septal defects (ASDs) in 92 patients. Median age of the patients was 10.5 years (range 3–61 years) and median weight was 25 kg (range 13–65 kg). The device is an improved new generation double disc design made of Nitinol wire mesh that is coated with platinum using NanoFusion technology. The discs are connected by a waist with diameter ranging from 6 mm to 40 mm with 2 mm increments. All patients completed a 3-month follow-up. Mean ASD diameter was 21 ± 7 mm (range 10–35 mm), while the mean device diameter was 24 ± 8 mm (range 14–40 mm). The CSO was permanently implanted in all 92 patients. Complete echocardiographic closure of the defect immediately after the procedure or at the one month follow-up, was observed in all 92 patients (100%). No device-related complications were observed during the procedure or at short-term follow-up (range 3–12 months). Our preliminary results indicate that CSO is a promising device for transcatheter closure of ASDs. Further studies are required to document its efficacy, safety and long-term results in a larger patient population. © 2014 Elsevier Ireland Ltd. All rights reserved.

1. Introduction

of the recently developed Cocoon septal occluder (CSO) (Vascular Innovations Co., Nonthaburi, Thailand) device for catheter closure of ASD II. This occluder has certain design characteristics which could make it an attractive alternative to the other currently available double disc (DD) devices for catheter closure of defects in the atrial septum.

Transcatheter closure of secundum atrial septal defect (ASD II) using the Amplatzer septal occluder (ASO) (St. Jude Medical, St. Paul Minnesota, USA) has become the procedure of choice in most cardiac centers [1–4]. However, despite its technical simplicity the procedure is still associated with complications which, although very rare, are potentially lifethreatening [5]. In this study we report initial experience with the use

2. Methods

☆ This statement is to certify that all authors have seen and approved the manuscript being submitted, have contributed significantly to the work, attest to the validity and legitimacy of the data and its interpretation, and agree to its submission to the International Journal of Cardiology. We attest that the article is the authors' original work, has not received prior publication and is not under consideration for publication elsewhere. We adhere to the statement of ethical publishing as appears in IJC 2013.On behalf of all co-authors, the corresponding author shall bear full responsibility for the submission. ⁎ Corresponding author at: Department of Pediatric Cardiology, Iatrikon Medical Center, Distomou 5-7, 15125 Athens, Greece. Tel./fax: +30 210 6179839. E-mail addresses: [email protected], [email protected] (B.D. Thanopoulos).

A total of 92 consecutive patients, 50 children (median age 6.5 years, range 3–12 years) and 42 adults (median age 28 years, range 18–61 years), from 5 centers in Europe underwent attempted ASD II closure using the CSO. Six of the adult patients had nickel allergy documented with the TRUE (Allerdem, Phoenix, Arizona, 3 patients) or Tegaderm (3M, St. Paul, Minnesota, 2 patients) skin parch test [6]. Following these tests the patients (all females) had refused to consent catheter closure with the ASO or other Nitinol made occluders. All patients were selected according to a previously agreed protocol with full and informed consent. All devices were implanted in the context of a protocol approved by the Ethical Committees of the participating hospitals. Patients were selected according to the guidelines for ASD II closure of the American College of Cardiology/ American Heart Association [7,8]. The patients were informed that shortness of breath and/or chest pain are serious signs of an adverse event (device erosion) and that they should report to the emergency room. The author(s) of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology.

http://dx.doi.org/10.1016/j.ijcard.2014.09.006 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.

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2.1. Device The CSO is an improved new generation ASO-like double disc occluder constructed from Nitinol wires that are woven into two low profile self-expandable discs with a connecting waist (Fig. 1A, B). The diameter of the left disk is 6 mm larger than the waist for devices up to 10 mm, 7 mm larger for devices up to 32 mm, and 8 mm larger for devices up to 40 mm. The diameter of the right disk is 4 mm and 5 mm larger than the waist for the small (up to 10 mm) and large devices, respectively. Waist diameters range from 8 to 40 mm in increments of 2 mm. Similarly to ASO the CSO is screwed on a delivery cable and withdrawn into a plastic loader for introduction into a radiopaque 7 to 14 F Mullins type delivery sheath with no metal rings at its distal end. The device is covered with platinum using NanoFusion technology. This prevents nickel leaking into the blood stream in the heart, the corrosion of Nitinol wire frame in long term implants, and eliminates irregularities of the Nitinol wires resulting in a smooth device surface (Fig. 2A, B). In addition, the CSO is the softest and lightest currently available device with a less metal to septum ratio than the other DD occluders. This is due to the removal of the oxide of the Nitinol and the coating of the wire mesh with a very soft metal like the platinum. A bubble removing system with a backup valve is also provided (Fig. 3). The most important features of CSO are summarized in Table 1. 2.2. Procedure The procedure of closing ASDs with the CSO is similar to that of using the ASO [1–4]. All patients underwent diagnostic right heart catheterization and angiography under general anesthesia and at the same time were studied by two and three dimensional (2D, 3D) transesophageal echocardiography (TEE). The patients were heparinized to achieve an activated clotting time of more than 200 s at the time of device implantation. Rim adequacy was evaluated in 4 planes, short axis view (0°), 4-chamber view (45°), and long axis view (90° and 120°). The size of CSO was selected according to a) the measured maximal transesophageal echocardiographic (2D–3D) diameter of defect, and b) the anatomic characteristics of the atrial septum. A 3–4 mm and 6–8 mm larger CSO than the measured diameter of the ASD was used in patients with normal atrial septal thickness and very thin (floppy membrane-like) aneurysmal septum, respectively. Balloon ASD sizing was not used as it tends to oversize the defects [9,10]. When its position was optimal the device was released by a counterclockwise rotation of the delivery cable with a plastic pin vice (Fig 4A, B). Residual shunts were graded as foaming, trivial, small, moderate and large as previously described [1]. Patients were discharged the day after the procedure and taking aspirin 3 to 5 mg/kg daily for six months. Before discharge an electrocardiogram, a biplane chest X-ray, and a transthoracic echocardiographic study were performed. The follow-up of the patients included a chest X-ray, an electrocardiogram, and complete transthoracic two-dimensional and color-Doppler echocardiographic studies at 1 week, one month, 3 months and 6 months after the procedure and then serially every 6 months. A 2D or 3D transesophageal echocardiographic study and a 24-hour Holter electrocardiogram recording was scheduled for the six-month follow-up. 2.3. Statistical analysis Results were expressed as mean value ± SD, with confidence intervals given were applicable.

3. Results The mean ASD diameter was 18 ± 6 mm (range 10–27) and 20 ± 7 mm (range 14–35 mm) in pediatric and adult patients respectively.

Fig. 2. Ultra magnified (A) and magnified (B) Nitinol wire frame of CSO after the application of platinum coating showing a very smooth device surface.

Mean device diameter was 20 ± 5 mm (range 14–30 mm) and 24 ± 8 mm (range 18–40 mm) in the pediatric and adult population of the study respectively. Twenty-four (26%) and 12 (11%) patients had a deficient (3–4 mm) aortic or posterior rim, respectively. No patient had complete absence of the aortic rim. The CSO was successfully implanted in all patients. After release of the device color Doppler echocardiography revealed no residual shunt in 88 of the 92 patients (96% closure rate) (Fig. 5A, B, C, D). Foaming (trace central residual shunt and no contrast jet) through the device was present in 28 patients but disappeared

Fig. 1. Side (A) and anterior (B) view of the Cocoon septal occluder.

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posterior rim [9]. The Greek maneuver is applied when protrusion of the aortic edge of the deployed left disk of the device in to the right atrium is detected by echo. To circumvent this, the left disk is recaptured and the whole delivery system is pushed inward and leftward into the left atrium where the left disk and the 2/3 of right disk are simultaneously released. This maneuver forces the left disk to become parallel to the septum preventing the protrusion of the device into the right atrium. Atrial fibrillation of short duration in 4 patients and 7 small groin hematomas were the only procedural complications. No acute allergic reactions to nickel were observed. 4. Follow-up

Fig. 3. Cocoon bubble removing system (black arrow) attached to the loader (yellow arrow) in preparation for removal of air bubbles from a collapsed device.

Table 1 Most important characteristics of the Cocoon septal occluder. Device Nanoplatinum coating. Provides: 1. Superior bio-compatible properties compared to Nitinol preventing nickel leaking into the blood steam in the heart, 2. Very smooth surface minimizing the risk of adjacent cardiac structures. Softest currently available ASD occluder confirms to the anatomy of the atria. Metal to septal ratio less to other currently available devices. MRI compatible Ability to recapture and reposition Self-centering Filled with polypropylene woven fabric which is better to polyester with respect to thrombogenicity CE approved Delivery system Radiopaque: Obviates the need for placement of metal rings for opacification of its distal end. Bubble removing system Back-up valve: avoids bleeding through the delivery sheath during the delivery process. ASD = atrial septal defect; MRI = magnetic resonance imaging.

within 10 to 15 min. The mean fluoroscopy time was 8 ± 3 s (range 6–14 s). The Greek maneuver was used to facilitate closure in 12 patients with large (≥30 mm) atrial septal defects and deficient aortic or

Follow-up of the patients ranged from 3 to 12 months. Follow-up data were available in all 92 patients at 24 h, one and 3 months after the procedure. At one and 3-month follow-up, 2D echocardiographic evaluation with color Doppler flow mapping revealed complete closure in all 92 patients (100%). All devices were appropriately placed across the atrial septum with no evidence of interference with the adjacent cardiac structures. Sixty-six of the 92 (71%) patients, including all those with a known nickel allergy, had completed a 6-month followup and underwent a complete TEE evaluation. The device was in appropriate position with no evidence of wire fractures and thrombus formation. No patient developed any allergic reaction to nickel, thromboembolism, endocarditis or hemolysis. 5. Discussion Transcatheter closure using double disc occluders is currently the preferred method for the majority of patients with ASD II in most centers [1–4]. Early and long-term results are excellent and comparable to surgery, with a high closure rate and few major complications [11]. At present, there are two occluders that have been approved for catheter closure of ASD II by the US Food and Drug Administration (FDA). The Amplatzer septal occluder (ASO) (Saint Jude Medical) and the Gore septal occluder (Helex) (W. L. Gore and Associates, Flagstaff, Arizona). The Helex is a non-self-centering device with no known recommendations for deficiency of atrial septal rims and is used for closure of small to moderate sized ASDs. The ASO is the most widely used device (approximately 240,000 implantations until recently), as it can close successfully defects up to 40 mm [7]. However, despite the simplicity of its implantation, this device has been rarely associated with lifethreatening aortic erosions which occur with an incidence of 0.001% and severe allergic reactions due to nickel leakage into the blood stream.

Fig. 4. A, B. Oblique (cranial 30°-LAO 30°) (A) and lateral (B) view fluoroscopic image showing an appropriately placed CSO across the atrial septum immediate after its release.

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Fig. 5. A, B, C, and D. A. 2D TEE image in short axis view showing a large secundum ASD with a maximal diameter of 2.8 cm. B. Fluoroscopic oblique view of a released 32 mm CSO that was used for defect closure. C. D. 2D and 3D echocardiographic images with color Doppler after release of the device demonstrating appropriate device position and complete closure (arrows).

Between 2002 and 2011, the FDA received more than 100 reports of erosions associated with the St. Jude Amplatzer ASO [12]. There is currently a debate regarding the implication of a deficient aortic rim in the pathogenesis of aortic erosions following the placement of an ASO and whether its presence is a contraindication for catheter closure. Although it has been reported that 90% of erosions have occurred in cases with deficiency of the aortic rim, according to FDA [12] there are no solid data that could precisely relate aortic rim deficiency with an increased risk for adverse events. It should be also noted, that the extent of rim deficiency that may increase the risk

for device-related aortic erosions remains unknown. Apart from rim deficiency, another important factor is the operator factor (training and credentialing of the individuals performing these procedures, use of oversized devices) which may be more important than the ASD device used per se. According to the American Heart Association [12] and latest FDA [13] guidelines, the ASO should remain in clinical use as it is safe and effective in the great majority of cases. In addition, the FDA recommends that all candidates for catheter ASD closure using the ASO (particularly, those with an associated deficient aortic rim), the individual operators and the centers performing these

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procedures should be informed about the possibility of serious device related complications and the necessity of a closed early and longterm follow-up. The CSO was designed in an attempt to satisfy rational demands for reduction of the morbidity and mortality rates of device ASD closure to as much low as possible [8]. When compared to the ASO and the other non-coated nickel containing DD occluders, the most important properties of CSO are the nanoplatinum coating and its softness resulting predominantly from the removal of the oxide of Nitinol during its preparation process. The nanoplatinum coating prevents nickel leaking into the blood stream in the heart and development of immune system mediated systemic or localized allergic reactions. As these allergic manifestations may be quite severe, rendering necessary the surgical removal of the occluder [6,14], despite their rarity, it is recommended that all patients should be questioned specifically for potential nickel allergy before device ASD occlusion [6]. It should be noted that no patient in this study, included the 6 patients with documented allergy to nickel, developed any allergic reaction early after the procedure or during follow-up. The device softness and its smooth surface (does not erode into the adjacent cardiac structures and minimizes the risk for thrombus formation) that is obtained with the nanoplatinum cover may potentially reduce the incidence of device related aortic erosions in patients having increased risk for adverse events. However, given the relative small number of patients in this study, the rare incidence of erosion and the short-term follow-up, it would be difficult to comment on the safety of the CSO compared to the ASO regarding erosion risk. Finally, the excellent radiopacity of the delivery sheath obviates the need for placement of metal rings at its distal end that may embolize into the systemic or pulmonary circulation [15]. For preventing nickel leaking into the blood stream two other occluders have a special coating over the Nitinol wires. The Lifetech (Lifetech Scientific, Shenzhen, China) device is using a relatively thick ceramic coating which, however, renders its surface rough potentially facilitating tissue erosion when oversized. The Occlutech (Occlutech Figulla, Occlutech GmbH, Jena, Germany) occluder is using gold coating which has not fulfilled its objectives in coronary stents. The CSO is covered by a thin layer of platinum (nanoplatinum) which belongs to the noble metal group that is very malleable and has the highest biocompatibility of all Nobel metals. In the present study, transcatheter closure with the CSO was carried out in 92 patients, aged from 3 to 61 years with ASD II ranging from 10 to 35 mm in diameter. Complete closure of the defect was obtained in all patients with no allergic reactions to nickel or device related complications during the procedure or at a short term follow-up. In addition, as opposed to the other currently available ASD occluders, no device deformations or fractures were observed in our patient population [16–18]. It appears, therefore, that CSO it is an effective and safe double disc ASD occluder that has certain design features which make it potentially attractive for catheter closure of secundum ASDs. There are limitations in our study. The main limitation is the short term follow-up as the data are limited to the 3–12 months postprocedural period. This reflects the fact that the CSO is a novel recently available device. Another limitation is the lack of a comparative group treated with ASO or the other currently available double-disk occluders using a randomized long-term follow-up protocol.

6. Conclusions Our preliminary data show that the CSO with its design characteristics is a useful addition to our armamentarium for catheter closure of atrial septal defects in children and adults. However, further studies are required to document its efficacy, safety and long-term results in a larger patient population.

Conflict of interest There is no conflict of interest and there were no sources of financial support.

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Catheter closure of atrial septal defects using the Cocoon septal occluder: preliminary results of a European multicenter study.

Despite its simplicity, device closure of atrial septal defects is still associated with rare but potentially lethal complications. In this prospectiv...
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