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Archives of cardiovascular diseases
Volume 104, n° 3
pages 155-160 (mars 2011)
Doi : 10.1016/j.acvd.2010.12.006
Received : 13 October 2010 ;  accepted : 24 December 2010
Early single clinical experience with the new Figulla ASD Occluder for transcatheter closure of atrial septal defect in adults
Expérience préliminaire avec un nouveau dispositif d’occlusion (figulla) de la cloison interauriculaire pour fermeture percutanée des CIA chez l’adulte
 

Mehmet Cansel , Hasan Pekdemir, Julide Yağmur, Hakan Tasolar, Necip Ermis, Ertugrul Kurtoglu, Nusret Acıkgoz, Halil Atas, Ramazan Ozdemir
Faculty of Medicine, Inonu University, Malatya, Turkey 

Corresponding author. Inonu Universitesi Tıp Fakültesi, Turgut Ozal Tıp Merkezi Arastırma ve Uygulama Hastanesi, Kardiyoloji Anabilim Dalı, PK: 44100, Malatya/Turkey. Fax: +0090 422 3412708.
Summary
Background

Recently, the Occlutech Figulla ASD Occluder (FSO) has been introduced for transcatheter closure of atrial septal defects. This device can be used for transcatheter closure of small as well as large atrial septal defects.

Aims

To evaluate the feasibility and short-term results of transcatheter closure of secundum type atrial septal defects using the FSO device in adult patients.

Methods

Seventy-four consecutive adult patients were referred for transcatheter closure of secundum large atrial septal defects (“stretched” diameter>20mm and/or invasive pulmonary/systemic flow [Qp/Qs] ratio>1.5) using the FSO device.

Results

The FSO device was successfully implanted in 68 patients (mean±SD [range] age: 31.8±12.3 [17–64] years; weight: 71.5±18.4 [49–98]kg). All patients had right atrial and ventricular volume overload with a mean Qp/Qs ratio of 2.5±0.6 (range 1.5–3.8). Mean atrial septal defect diameter was 22.3±4.8 (range 12–33)mm and the size of the implanted FSO was 24.1±4.9 (range 12–36)mm. Two patients had trivial (jet width<1mm in diameter) residual shunts and one patient had a small (1–2mm) residual shunt. There were no moderate or severe residual shunts. No device embolization or other serious complication occurred during either the procedure or the follow-up.

Conclusion

The present study found that transcatheter closure of isolated secundum atrial septal defects using the novel design of the FSO device was safe, effective, and had an excellent outcome during the 6month follow-up period.

The full text of this article is available in PDF format.
Résumé
Justification

Le dispositif d’occludeur figulla (FSO) de fermeture percutanée des CIA a été introduit récemment pour la fermeture percutanée des CIA et constitue une alternative pour ces procédures, tant pour ce qui concerne les CIA de petites tailles, que les CIA larges.

Objectif

Nous avons évalué la faisabilité des résultats à court terme de la fermeture par cathéter transcutané de CIA ostium secondum en utilisant le dispositif d’occludeur figulla (FSO) chez des adultes.

Matériels et méthodes

Soixante-huit patients ont été adressés consécutivement pour fermeture percutanée de CIA ostium secondum large (diamètre étiré>20mm et/ou rapport QP/QS>1,5) en utilisant ce nouveau dispositif percutané. L’âge moyen était de 31,8+12,3 ans (extrême 17–63) et le poids moyen était de 71,5+18,4kg (extrêmes 49–98). Tous les patients présentaient une surcharge volumique auriculaire et ventriculaire droite avec un rapport QP/QS moyen à 2,5+0,6 (extrême 1,5–3,8).

Résultats

Le dispositif nouveau testé FSO a été implanté avec succès lors de 68 des 74 procédures (92 %). Le diamètre moyen de la CIA était de 22,3±4,8mm (extrêmes 12–33mm) et la taille moyenne du dispositif FSO implanté était de 24,1±4,9mm (extrêmes 12–36mm). Aucun patient n’a présenté de shunt résiduel significatif, deux avaient un shunt minime. Il n’y a pas eu d’embolisation du dispositif percutané ou d’autres complications sévères tant lors de la procédure que lors du suivi.

Conclusions

Notre étude a montré que la fermeture percutanée de CIA ostium secondum isolé utilisant un nouveau dispositif percutané (FSO) est sûr, efficace et est associé à un excellent pronostic lors de la période de suivi (six mois).

The full text of this article is available in PDF format.

Keywords : Atrial septal defects, Septal occluder device

Mots clés : Occludeur de CIA figulla, Fermeture par cathéter, Communication interauriculaire

Abbreviations : ASD, ASO, ECG, FSO, TCC, TOE, TTE


Background

The most common intervention for structural heart diseases across age groups is TCC of ASDs, which was first described in 1976 by King et al. [1]. Since then, very advanced techniques and devices for TCC have been developed, and TCC has been used with increasing frequency as an alternative to open-heart surgery. Today, the ASO (AGA Medical, Golden Valley, MN, USA) is the most widely used device worldwide for TCC of ASDs. Recently, the FSO (Occlutech GmbH., Jena, Germany) was introduced for TCC of secundum ASDs. This alternative device can be used for TCC of small as well as large ASDs. Construction and implantation procedures are similar to those of ASO. However, there are several major advantages of this novel device, including increased flexibility, minimized implanted material, and the absence of the left atrial clamp, which reduces trauma and clot formation risks on the left atrial disc [2] (Figure 1, Figure 2, Figure 3). To the best of our knowledge, there are very few data regarding TCC of secundum ASDs using FSO devices in adults [2, 3]. Here we present early clinical experience and short-term results from our centre on TCC of secundum type ASDs using FSO devices in 68 adult patients.



Figure 1


Figure 1. 

The Occlutech Figulla device. Note the absence of the microscrew hub at the left atrial disc.

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Figure 2


Figure 2. 

Angiographic view of the Occlutech Figulla device after release. Note the absence of the microscrew hub at the left atrial disc.

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Figure 3


Figure 3. 

Transoesophageal echocardiographic view of the Occlutech Figulla device after release.

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Materials and methods
Patient population

Between September 2007 and January 2010, 74 consecutive adult patients were referred for TCC of secundum large ASDs (“stretched” diameter >20mm and/or invasive pulmonary/systemic flow [Qp/Qs] ratio >1.5) for placement of the FSO device. Patients were recruited from Inonu University Cardiology Department, and written informed consent was obtained from all participating patients. All patients underwent a physical examination, standard 12-lead ECG, chest X-ray, TTE, and TOE. A complete blood count and several additional tests were performed to identify patients with coagulation disorders.

Exclusion criteria

Patients were excluded if their secundum ASDs were: accompanied with other complex congenital cardiac malformations; had a defect stretched diameter>35mm or an insufficient septal tissue rim<4mm from either atrioventricular valve, the coronary sinus, or the right pulmonary veins; multiple defects that could not be adequately covered by the device; angiographically confirmed acquired coronary artery disease; or severe mitral and/or tricuspid regurgitation. Patients diagnosed as having a bleeding disorder; untreated ulcer; any contraindication to aspirin; non-reactive elevated pulmonary vascular resistance; small ASDs with a Qp/Qs ratio<1.5; or no signs of right ventricular dilatation were also excluded [4].

Selection of patients suitable for TCC

TTE and TOE examinations were performed using an ATL HDI 5000 echocardiography machine (Bothell, WA, USA) and a 5.0MHz biplane transoesophageal probe in all patients. All echocardiographic measurements were obtained in three different frames recorded at the same phase of the cardiac cycle. TTE and TOE have been described in detail previously [5]. TCC of ASDs was performed under TOE monitoring using the FSO. Although the balloon sizing method has been accepted as the gold standard for the selection of device size, it is not necessary in all ASD patients [6, 7]. In this study, the stretched balloon diameter was measured under fluoroscopy when the balloon occluded the defect completely. Balloon sizing was used in 22/74 patients with ASDs (29.7%), usually in patients with a floppy septum. Before the procedure, intravenous heparin (100IU/kg) was administered to keep the activated clotting time>200s. Also, 100mg aspirin and 75mg clopidogrel were given 1day before the procedure. The FSO implantation procedure is analogous to the technique used for ASO implantation. The TCC of ASDs technique has been described previously [5, 8].

FSO device

The FSO device is constructed from 0.082–0.186mm nitinol wires that are tightly woven into two flat round discs with a 4mm-long connecting waist. The size of the device is determined by the diameter of the waist, and is available in the sizes shown in Table 1, which also shows the corresponding sizes of the left and right atrial discs. The prosthesis is filled with a polyester patch (thickness 30–45μm) to enhance thrombogenicity. There is only one stainless steel hub (microscrew) at the right atrial disc for cable connection (Figure 1, Figure 2, Figure 3). The size of the required delivery sheaths are shown in Table 1.

Follow-up

Immediately after the release of the FSO, a precise TOE examination was performed to evaluate the shape of the occluder and search for thrombus formation on the device. A detailed colour Doppler interrogation of the interatrial septum was performed, mainly to detect and quantify any residual shunts. Residual shunts were graded as: trivial (jet width<1mm in diameter), small (1–2mm), moderate (>2 but <4mm), or severe (≥4mm) [9]. The relationship between the occluder and the atrioventricular valves was evaluated. Drainage of the vena cava superior/vena cava inferior, right pulmonary veins and coronary sinus were evaluated for obstruction.

At 24-hour follow-up, ECG, chest radiograph, and TTE were performed. The presence of a thrombus on both discs of the FSO was searched for using TTE. Residual shunts were looked for and quantified using colour Doppler. The relationship of both atrioventricular valves towards the FSO was assessed. Drainage of the caval veins, right pulmonary veins and coronary sinus were evaluated for obstruction. Thereafter, ECG and TTE were scheduled at 1month, 6 months, 1 year and then annually after the procedure. The same TTE examination protocol was used throughout the follow-up period as was performed 24hours after the procedure.

The patient was discharged with the following medical recommendations/advice: dual platelet inhibition was continued with 100mg aspirin for 6months and 75mg clopidogrel for 1–3months; and standard antibiotic prophylaxis for endocarditis (dental, gastroenterological, and gynaecological procedures) for 180days.

Statistical analysis

Statistical analysis was performed using SPSS for Windows version 17.0 software (SPSS Inc, Chicago, IL, USA). Continuous variables are expressed as mean±SD. Categorical variables are expressed as numbers and percentages. The paired t -test was used for comparison of variables studied at baseline and 6 months after TCC of ASD. P <0.05 was considered significant.

Results

The FSO device was successfully implanted during 68 of 74 procedures (91.9%). Patient demographics of those successfully implanted are shown in Table 2. The remaining six patients were excluded prior to attempted implantation as per the protocol: in three, the ASD was too large (>35mm) after TOE and catheter assessment with the balloon sizing method; and in the other three, TOE demonstrated a septal tissue rim<4mm from the atrioventricular valves. Before the TCC of ASD, one patient had atrial fibrillation, and oral anticoagulation therapy was initiated after the procedure for this patient. Two patients had atrial arrhythmias: supraventricular tachycardia resolved after using antiarrhythmic therapy; and frequent atrial extrasystoles disappeared spontaneously 24hours after the procedure. The mean ASD diameter was 22.3mm; and the mean size of the implanted FSO was 24.1mm (Table 2).

Immediately after the procedure, as documented by colour Doppler echocardiography (TOE in all patients), two patients had trivial residual shunts, and one had a small residual shunt. There were no moderate or severe residual shunts. At 6month follow-up by TTE, one patient had a small residual shunt.

There were no serious complications (e.g. aortic regurgitation; narrowing of coronary sinus, pulmonary vein, inferior or superior vena cava; obstruction of intracardiac structures; attacks of infective endocarditis; thromboembolism; cardiac perforation; aorta-to-right-atrial fistulae; pericardial effusion; device wire fracture; deformation of implanted device; or whole-device embolization) both during the procedure and 6 months after TCC of ASDs. The mitral and tricuspid valves were not encroached upon by the FSO device in any of the patients enrolled in the study.

All echocardiographic findings of the ASD patients before and 6 months after TCC are presented in Table 3. Left ventricular ejection fraction (LVEF) and left ventricular end-diastolic diameter (LVEDD) had increased significantly 6 months after TCC (Table 3), but there were no significant changes in left ventricular end-systolic diameter (LVESD), interventricular septal thickness, or left ventricular posterior wall (PW) thickness (Table 3). Right ventricular end-diastolic diameter (RVEDD), right ventricular outflow tract (RVOT), and left and right atrial diameters had all decreased significantly 6 months after TCC (Table 3). Systolic pulmonary artery pressure had also decreased significantly 6 months after TCC (39.3±6.9 to 32.1±4.4mmHg; P <0.0001).

Discussion

Since the introduction of the ASD Occluder devices [1], many such devices have been developed for TCC with variable degrees of success [1, 10, 11, 12, 13, 14, 15, 16]. In the present study, we used a new ASD occluder, the FSO, in patients with isolated secundum type ASD. To date, there is a paucity of short-term data and experience regarding TCC of secundum ASDs using the FSO devices in adults [2, 3], and there are no long-term data. In the present study, complete occlusion was achieved in 68/74 patients (91.9%), with no mortality or significant complications during a short-term follow-up period (up to 6 months). Therefore, our study demonstrates and confirms the safety and the excellent outcome of TCC of ASDs using the novel design of the FSO device.

The construction of the FSO is similar to that of the ASO. However, there are some important structural innovations in favour of the novel FSO. The ASO device is made up of a nitinol wire tube that is clamped in two stainless steel hubs, one on each side of the disc. In contrast, the FSO device is individually braided, avoiding a distal clamp (Figure 1, Figure 2, Figure 3). The potential benefits of this are a decreased risk of thrombus formation on the left atrial disc and increased the flexibility of the device [2]. Sigler and Jux have demonstrated that protruding metal parts, like the microscrew of the ASO and the spring arms of the CardioSEAL/STARflex devices, were the last parts of the septal occluders to endothelialize [17]. Thus, the surfaces of these parts carry the risk of device-related thrombus formation at an early stage.

Previous studies have demonstrated that the incidence of thrombus formation in TTC of ASD, particularly with the ASO device, was lower the than other devices, such as CardioSEAL, StarFLEX, and PFO-Star [18, 19, 20]. Similarly, in the present study, we detected no thrombus formation or systemic thromboembolism in the patients during the procedure or the follow-up. However, long-term prospective studies are needed to determine whether the reduction of material in the left atrial disc can reduce the thromboembolic complications, following TCS of ASD with the FSO.

Even though the implantation technique of the FSO is similar to that of the ASO, the increased flexibility and reduced amount of material implanted in the left atrial disc make the FSO devices safer and more comfortable during implantation than other devices [21]. This device is very easy to handle, and can be recaptured after deployment of both discs, thus making it quite easy to reposition [3, 22]. Additionally, the delivery system allows improvements in product handling because of its final positioning without any adverse tension [23].

Major disadvantages of the FSO device are the requirements of a two Fr [7–14 in Table 1] size sheath and a larger delivery system than the ASO device. It is well known that complications of femoral vein access may be slightly increased with larger venous sheaths [24]. However, we do not think that this is too concerning, as the access is from the venous system in adults, and there were no complications (e.g. right iliac vein dissection, groin haematoma or retroperitoneal haemorrhage [18]) during TCC of ASD using the FSO in our study. However, additional care should be taken when using the FSO device in childhood. Furthermore, this device should be carefully evaluated in further studies.

After the ASO device implantation, new-onset arrhythmias are the most common early complication [25], but significant arrhythmias (e.g. persistent or transient complete atrioventricular block) have only rarely been reported [9, 11]. In this study, we noted that two patients had atrial arrhythmias: supraventricular tachycardia resolved after using antiarrhythmic therapy and frequent atrial extrasystoles disappeared spontaneously 24hours after the procedure. Also, there was no significant or persistent atrial or ventricular arrhythmia in our patients during the follow-up after the FSO device implantation.

Conclusions

The present study shows that TCC of isolated secundum ASD using the novel design of the FSO device is safe and effective. We had a high success rate, and immediate and short-term results were encouraging. However, in the present study, we only had a short follow-up time (6 months). As long-term follow-up is currently not available for this device, these initial short-term findings should be evaluated in further long-term prospective studies including larger numbers of patients.

Disclosure of Interest

None.

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