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 Table of Contents  
ORIGINAL ARTICLE
Year : 2017  |  Volume : 15  |  Issue : 1  |  Page : 15-20

Transcatheter closure of atrial septal defect in children using the Occlutech Figulla occluder device


1 Department of Cardiology, Kasr Al Ainy Faculty of Medicine, Cairo University, Cairo, Egypt
2 Department of Pediatric Cardiology, Kasr Al Ainy Faculty of Medicine, Cairo University, Cairo, Egypt

Date of Submission04-Feb-2017
Date of Acceptance28-Mar-2017
Date of Web Publication23-Aug-2017

Correspondence Address:
Mahmoud Ali
Department of Cardiology, Kasr Al Ainy Faculty of Medicine, Cairo University, Kasr Al Ainy Street, PO Box 11562, Cairo
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/AZMJ.AZMJ_9_17

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  Abstract 


Background
Percutaneous transcatheter closure of atrial septal defect (ASD) among children using devices other than the Amplatzer septal occluder has not been extensively tested.
Objectives
We evaluated the efficiency and safety of secundum ASD closure using the Occlutech Figulla ASD occluder in children and the efficiency and safety of secundum ASD closure under transthoracic echocardiography (TTE) guidance in children with less than 12 kg body weight.
Patients and methods
Forty-two patients (19 girls and 23 boys; mean age 4.8±2.0 years) were enrolled in a prospective cohort study. All patients underwent TTE and transesophageal echocardiography (TEE) to assess the characteristics of the ASD before transcatheter closure. Procedures were performed under fluoroscopic and TTE or TEE guidance. Follow-up was done at 1, 3, and 6 months following the procedure by clinical and TTE examination.
Results
The mean defect size was 14.9±4.2 mm on TTE and 16.1±4.7 mm on TEE. The mean device size was 17.9±4.9 mm (range 10.5–27 mm). The mean procedure time was 59.6±19.5 min. Thirty-one cases were performed under general anesthesia and TEE guidance, whereas the other 11 cases were performed under general anesthesia and TTE guidance. The device was placed successfully in all 42 patients. A small residual flow was seen immediately after device placement in three (7.1%) patients, which disappeared at 6 months. No complications occurred during the procedure. All patients were asymptomatic during the follow-up period.
Conclusion
Transcatheter closure of secundum ASD is generally safe and efficient in children younger than 12 years old, and ASD closure under TTE guidance in children less than 12 kg body weight is considered safe and efficient when performed in a tertiary center in the presence of an expert echocardiographer and interventional cardiologist.

Keywords: atrial septal defect, Occlutech Figulla device, transcatheter ASD closure


How to cite this article:
Ali M, El-Sisi A, El-Din HS, Bakhoum S, Kandil H. Transcatheter closure of atrial septal defect in children using the Occlutech Figulla occluder device. Al-Azhar Assiut Med J 2017;15:15-20

How to cite this URL:
Ali M, El-Sisi A, El-Din HS, Bakhoum S, Kandil H. Transcatheter closure of atrial septal defect in children using the Occlutech Figulla occluder device. Al-Azhar Assiut Med J [serial online] 2017 [cited 2017 Nov 18];15:15-20. Available from: http://www.azmj.eg.net/text.asp?2017/15/1/15/213592




  Introduction Top


Atrial septal defect (ASD) is one of the most commonly encountered congenital heart diseases, with a birth prevalence of 1.6–1.8 per 1000 live births [1],[2].

With the advances in clinical evaluation and noninvasive imaging, most ASD cases are diagnosed during infancy and childhood. However, hemodynamically significant ASD might be diagnosed for the first time during adulthood in developing countries [3]. If left untreated, patients with such defects may develop many complications, including right ventricular (RV) failure, atrial arrhythmias, and systemic embolization [1]. Although the surgical closure of ASD is associated with a high success rate and a low rate of complications, percutaneous device closure is considered the current method of choice for the management of secundum ASD when applicable [1].

The most commonly used device for ASD closure is the Amplatzer septal occluder (ASO). Many other devices are currently available and used in selected patients with suitable morphological and anatomical features, such as the Figulla ASD occluder, the Gore HELEX septal occluder, etc. [4],[5],[6],[7]. The Occlutech Figulla device is characterized by flexibility, easy application, ability to self-center in the shunt, and ability to be retrieved before disconnection from the delivery system [6]. In this study, we aimed to assess the safety and efficiency of ASD closure using the Occlutech Figulla ASD occluder in children with hemodynamically significant left-to-right shunting.


  Patients and methods Top


Forty-two patients (19 girls and 23 boys; mean age 4.8±2.0 years, range 3–10 years) with hemodynamically significant left-to-right secundum ASD suitable for device closure as assessed by transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) were enrolled in this prospective cohort study.

Patients with a hemodynamically significant shunt with right-sided volume overload were selected for elective closure. A hemodynamically significant shunt was evidenced by the presence of both the echocardiographic evidence of right-sided dilation and catheter-derived Qp/Qs ratio of at least 1.5. The Qp/Qs ratio was calculated by dividing the product of flow through the pulmonary artery, and the pulmonary arterial diameter by the product of flow through the aorta and aortic diameter. Patients with complex ASD lesions (primum or sinus venosus ASD), reversed right-to-left shunt, or left ventricular dysfunction were excluded from the study. Written informed consent was obtained from the parents of children, and the study was approved by the local ethical committee. All procedures performed on human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Echocardiography

Examination was performed using Philips IE-33 (Philips Medical Systems, Andover, Massachusetts, USA) and Esaote MyLab™ 70 XVision (Esaote Medical Systems, Genoa, Italy) with ECG monitoring. TTE and TEE examinations were performed in all patients to ensure the presence of a single secundum ASD with a left-to-right shunt with ASD diameter more than 6 mm but less than 36 mm with adequate septal rims of at least 5 mm, although a deficient aortic rim was allowed, and to assess RV size and function with estimation of pulmonary artery systolic pressure (PASP). The largest ASD diameter detected in any view in a given patient was chosen as the reference ASD diameter for selecting the optimal size of the device occluder ([Figure 1]).
Figure 1 TEE at 0 angle A. showing the atrial septal defect. B. color flow Doppler showing left to right shunt.

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Routine examination before catheterization included a standard 12-lead ECG and chest radiograph. Complete blood counts, prothrombin time, prothrombin concentration, and partial thromboplastin time were ascertained to exclude bleeding disorders.

Technique

All selected ASD cases were percutaneously closed using the Occlutech Figulla ASD occluder (Occlutech GmbH, Jena, Germany). The device consists of a nitinol mesh providing a smooth and flexible outer layer. The absence of a left atrial disc microscrew minimizes the amount of material on the left atrial aspect and reduces the possibility of thrombus formation [8]. All cases were performed under general anesthesia. The procedure was performed under fluoroscopic and TTE or TEE guidance. Intravenous heparin (50 IU/kg) was administered to maintain the activated clotting time of more than 200 s. The right femoral venous access was secured, and a soft-tipped 0.035-inch wire was advanced through the atrial defect and positioned within the left upper pulmonary vein in left anterior oblique/cranial view. The size of the defect was confirmed by TTE or TEE. An appropriate delivery sheath was advanced to the left atrial side over the guidewire. The occluder was subsequently loaded in a short Cook delivery sheath (Cook Inc., Bloomington, Indiana, USA) and advanced to the left atrial side. After opening the left atrial disc, the system was retracted until the left atrial disc was positioned opposite the left interatrial septum. The right atrial disc was deployed thereafter. Before device release, the cable was pushed forward and backward (Minnesota Wiggle), and correct positioning was confirmed by means of fluoroscopy and TEE or TTE. Adequate device position was determined by the lack of movement of the device in either direction. A residual shunt was ruled out by color Doppler flow imaging ([Figure 1]b). Once the occluder was positioned properly, it was released by opening the locking mechanism.

Follow-up

All patients were discharged on treatment with aspirin 5 mg/kg/day for 6 months. Prophylaxis for infective endocarditis was recommended during the first 6 months. At follow-up, all patients were examined by TTE at 1, 3, and 6 months to evaluate the presence of residual shunt, the position and stability of the device, and its relationship with adjacent anatomic structures and the presence of any thrombotic complication ([Figure 2]a and [Figure 2]b).
Figure 2 A. TTE apical four view showing ASD and right side dilatation B. TTE modified apical four view after device deployment; no residual by color.

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The residual shunt was considered trivial if the width of the color jet was less than 1 mm, small if it was at least 1 mm and less than 2 mm, moderate if it was at least 2 mm and less than 4 mm, and large if it was at least 4 mm. The procedure success was defined as no, trivial, or small residual shunt immediately after the procedure. Complications during and after transcatheter ASD closure were recorded.

The procedure was considered successful if no, trivial, or small residual shunt was present immediately after the procedure and in the absence of major complications such as death, stroke, device embolization, perforation, or pericardial effusion.

Statistical analysis

Data were analyzed using the statistical package for the social sciences, version 17.0 (SPSS Inc., Chicago, Illinois, USA). Numerical data were expressed as mean and SD or as median and range as appropriate. The paired t-test was used for comparison of variables. P values less than 0.05 were considered significant.


  Results Top


The study included 42 patients (19 girls and 23 boys; mean age 4.8±2.0 years, range 3–10 years). Thirty-two (76.2%) cases presented with shortness of breath, fatigue, or repeated chest infection, whereas the other 10 (23.8%) were accidentally discovered on routine clinical examination for other etiologies. The demographics and clinical data of the patients are illustrated in [Table 1].
Table 1 Demographic and procedural characteristics of the studied population

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Preprocedural TTE revealed an isolated secundum ASD in all patients with evidence of right atrial and RV dilatation. Mid-RV cavity size was 14.0±2.6 mm. Tricuspid valve regurgitation of moderate to severe degree was observed in all patients. Six (14.2%) cases had associated pulmonary stenosis; five cases had mild valvular pulmonary stenosis with a peak gradient of 30 mmHg most probably due to increased pulmonary flow; and one patient had moderate valvular pulmonary stenosis with a peak gradient of 50 mmHg. Twenty (47.6%) cases had mild-to-moderate mitral valve prolapse. Six (14.2%) cases had pulmonary hypertension with mean PASP of more than 40 mmHg; five cases had mild pulmonary hypertension; and one patient had severe pulmonary hypertension with mean PASP of 70 mmHg. The mean ASD size was 14.9±4.2 mm. The mean IAS length was 35.8±3.1 mm and the mean ASD size/IAS ratio was 0.41±0.09. The mean Qp/Qs was 2.0±0.2. All patients had adequate rims, except the aortic rim, which was deficient (<5 mm) in 30 (71.4%) cases ([Table 2]).
Table 2 Transthoracic echocardiography and transesophageal echocardiography findings in the studied population

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Preprocedural TEE confirmed the diagnosis of isolated ASD. The mean ASD size was 16.1±4.7 mm (median 16 mm). The mean IAS length was 36.7±2.8 mm.

Procedure

All cases were performed under general anesthesia and TTE or TEE guidance. Right femoral vein access was achieved in all cases. All cases received parenteral heparin at a dose of 50 IU/kg during the procedure, together with cefotaxime 100 mg/kg intravenously. The mean device size used was 17.9±4.9 mm (range 10.5–27 mm, median 18 mm). Long and short sheaths used ranged between 7 and 12 Fr. The mean procedure time was 59.6±19.5 min. The mean fluoroscopy time was 19.8±5.6 min. ASD was successfully closed in all cases, and no case of embolization was recorded. A small central residual flow was seen immediately after device placement in three (7.1%) cases, which disappeared by the end of 3-month follow-up.

Complications and follow-up

No complications were seen during the procedure. Follow-up transthoracic TTE was performed after 30, 60, and 180 days. At 6-month follow-up, all patients were asymptomatic. TTE showed securely closed and properly positioned devices. No related masses were seen. Patients with preprocedural echocardiographic evidence of elevated PASP showed normalization of the estimated PASP and regression of the tricuspid valve regurgitation severity with reduction of the RV end-diastolic dimensions by 2–3 mm. Only one patient with preprocedural PASP 70 mmHg showed a decline to 50 mmHg at 6-month follow-up.

Assessment of quality of life in patients before and after atrial septal defect device closure

The eight health concepts were assessed using the Arabic version of the RAND 36-Item Health Survey, which is a printed multiple questionnaire given to the parents of children to be filled before and 6 months after ASD device closure. The quality-of-life assessment was performed at a mean follow-up time of 6.0±8.0 months after the intervention. At 6 months, New York Heart Association functional class had improved, with noticeable decreased incidence of respiratory tract infection, mild body weight gain, and increased general and mental health.


  Discussion Top


The present study showed that secundum ASD can be safely and securely closed under TEE guidance and TTE guidance in children less than 12 kg body weight using devices other than the widely used ASO device. This requires, however, proper preprocedural TTE and TEE examinations and the presence of well-trained echocardiographers and interventional cardiologists in a tertiary center.

Although the surgical closure of ASD is an uncomplicated surgery with high success rate and low complication rate, percutaneous ASD closure (when suitable) is currently the recommended method for secundum defect closure [1]. The advantages of percutaneous ASD closure are preservation of the thoracic anatomy, shorter hospital stay, and absence of scars, which could cause psychological problems in female patients in whom the prevalence of ASD is higher.

The ASO is the most commonly used device worldwide, with excellent results in pediatric and adult patients, as demonstrated in several studies [8],[9]. In contrast, the Gore HELEX septal occluder has been approved by the FDA to close defects with a stretched ASD diameter of up to 18 mm [7].

The Occlutech Figulla ASD occluder was recently introduced and has been tested in previous studies, which have shown its safety and efficacy in ASD closure [6],[10]. The Occlutech Figulla device has been designed to close the whole range of defects suitable for percutaneous closure. Although the Occlutech device looks similar to the ASO device, there are two main differences between the two devices. The nitinol wires on the Occlutech Figulla device are braided to avoid a distal clamp, which offers potential benefits to decrease the chance of clot formation on the left atrial disc and to increase flexibility of the disc for better positioning on the interatrial septum. The Occlutech device is also characterized by more than 50% reduction of left atrial material in comparison with the ASO system [6].

In the present study, successful implantation with procedural success was achieved in all cases. This was achieved by proper defect size determination by means of TTE and TEE, which aided in accurate sizing of the implanted device. No in-hospital complications were recorded. At 6-month follow-up, no major complications were observed. Immediate, short, and mid-term clinical results and success rates are comparable to those obtained by the ASO device reported in previous published studies [9],[11].In the present study, the rate of residual shunt was 7.1%, which disappeared at 6-month follow-up. Krizanic et al. [6] reported a residual shunt rate of 9.1% for ASD cases at 60-day follow-up, which disappeared at 6-month follow-up. Çeliker et al. [12] reported a high immediate residual shunt rate of 43.8% in 80 children who underwent percutaneous ASD closure. Ammar and Hegazy [13] reported no residual shunt at the end of the procedure or through the follow-up period in 17 children under the age of 2 years. In the present study, there was no thrombus formation or major complication in any of the cases. Kaya et al. [14] reported no serious complications or thrombus formation in 12 patients using the ASO device for percutaneous ASD closure. Ammar and Hegazy [13] reported that the complication rate was 11.8%.


  Conclusion Top


Transcatheter closure of secundum ASD is generally safe and efficient in children younger than 12 years old, and ASD closure under TTE guidance in children less than 12 kg body weight is considered safe and efficient when performed in a tertiary center in the presence of an expert echocardiographer and interventional cardiologist.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Warnes CA, Williams RG, Bashore TM, Child JS, Connolly HM, Dearani JA et al. ACC/AHA 2008 Guidelines for the Management of Adults with Congenital Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to develop guidelines on the management of adults with congenital heart disease). Circulation 2008; 118:e714–e833.  Back to cited text no. 1
    
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Van der Linde D, Konings EE, Slager MA, Witsenburg M, Helbing WA, Takkenberg JJ, Roos-Hesselink JW. Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J Am Coll Cardiol 2011; 58:2241.  Back to cited text no. 2
    
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Farouk H, Shaker A, El-Faramawy A, Mahrous A, Baghdady Y, Adel A et al. Adult congenital heart disease registry at Cairo University: a report of the first 100 patients. World J Pediatr Congenit Heart Surg 2015; 6:53–58.  Back to cited text no. 3
    
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Rao PS, Berger F, Rey C, Haddad J, Meier B, Walsh KP et al. Results of transvenous occlusion of secundum atrial septal defects with the fourth generation buttoned device: comparison with first, second and third generation devices. International Buttoned Device Trial Group. J Am Coll Cardiol 2000; 36:583–2.  Back to cited text no. 4
    
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Sah SP, Bartakian S, El-Said H, Molkara DP, Printz B, Moore JW. Preprocedural transthoracic echocardiography can predict Amplatzer septal occluder device size for transcatheter atrial septal defect closure. Congenit Heart Dis 2016; 11:656–662. doi:10.1111/chd.12365.  Back to cited text no. 5
    
6.
Krizanic F, Sievert H, Pfeiffer D, Konorza T, Ferrari M, Hijazi Z et al. The Occlutech Figulla PFO and ASD occluder: a new nitinol wire mesh device for closure of atrial septal defects. J Invasive Cardiol 2010; 22:182–187.  Back to cited text no. 6
    
7.
Jones TK, Latson LA, Zahn E, Fleishman CE, Jacobson J, Vincent R et al. 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 2007; 49:2215–2221.  Back to cited text no. 7
    
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Du ZD, Hijazi ZM, Kleinman CS, Silverman NH, Larntz K. Amplatzer Investigators. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol 2002; 39:1836.  Back to cited text no. 8
    
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Masura J, Gavora P, Podnar T. Long-term outcome of transcatheter secundum-type atrial septal defect closure using Amplatzer septal occluders. J Am Coll Cardiol 2005; 45:505–507.  Back to cited text no. 9
    
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Cansel M, Pekdemir H, Yağmur J, Tasolar H, Ermis N, Kurtoglu E et al. Early single clinical experience with the new Figulla ASD Occluder for transcatheter closure of atrial septal defect in adults. Arch Cardiovasc Dis 2011; 104:155–160.  Back to cited text no. 10
    
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Spies C, Timmermanns I, Schräder R. Transcatheter closure of secundum atrial septal defects in adults with the Amplatzer septal occluder: intermediate and long-term results. Clin Res Cardiol 2007; 96:340–346.  Back to cited text no. 11
    
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Çeliker A, Özkutlu S, Karagöz T, Ayabakan C, Bilgiç A. Transcatheter closure of interatrial communications with Amplatzer device: results, unfulfilled attempts and special considerations in children and adolescents. Anadolu Kardiyol Derg 2005; 5:159–164.  Back to cited text no. 12
    
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Ammar RI, Hegazy RA. Transcatheter closure of secundum ASD using Occlutech Figulla-N device in symptomatic children younger than 2 years of age. J Invasive Cardiol 2013; 25:76–79.  Back to cited text no. 13
    
14.
Kaya MG, Ozdoru I, Baykan A, Dogan A, Inanc T, Dogdu O et al. Transcatheter closure of secundum atrial septal defects using the Amplatzer septal occluder in adult patients: our first clinical experiences [in Turkish]. Türk Kardiyol Dern Ars 2008; 36:287–293.  Back to cited text no. 14
    


    Figures

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