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 > 20 mm 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 < 1 mm in diameter) residual shunts and one patient had a small (1–2 mm) 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 6 month follow-up period.
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 > 20 mm 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 + 18,4 kg (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 ± 4,8 mm (extrêmes 12–33 mm) et la taille moyenne du dispositif FSO implanté était de 24,1 ± 4,9 mm (extrêmes 12–36 mm). 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).
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. . 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 ( Figs. 1–3 ). To the best of our knowledge, there are very few data regarding TCC of secundum ASDs using FSO devices in adults . 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.
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 > 20 mm 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 > 35 mm or an insufficient septal tissue rim < 4 mm 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 .
Selection of patients suitable for TCC
TTE and TOE examinations were performed using an ATL HDI 5000 echocardiography machine (Bothell, WA, USA) and a 5.0 MHz 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 . 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 . 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 (100 IU/kg) was administered to keep the activated clotting time > 200 s. Also, 100 mg aspirin and 75 mg clopidogrel were given 1 day 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 .
FSO device
The FSO device is constructed from 0.082–0.186 mm nitinol wires that are tightly woven into two flat round discs with a 4 mm-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 30–45 μm) to enhance thrombogenicity. There is only one stainless steel hub (microscrew) at the right atrial disc for cable connection ( Figs. 1–3 ). The size of the required delivery sheaths are shown in Table 1 .
| Waist diameter (mm) | Left atrial disc (mm) | Right atrial disc (mm) | Delivery sheath (Fr) | ASD size (mm) |
|---|---|---|---|---|
| 6 | 18 | 14 | 7 | D ≤ 6 |
| 7.5 | 18 | 14 | 7 | 6 < D ≤ 7.5 |
| 9 | 21 | 17 | 7 | 7.5 < D ≤ 9 |
| 10.5 | 21 | 17 | 7 | 7 < D ≤ 10.5 |
| 12 | 26 | 22 | 10 | 10.5 < D ≤ 12 |
| 15 | 29 | 25 | 10 | 12.5 < D ≤ 15 |
| 18 | 32 | 28 | 12 | 15 < D ≤ 18 |
| 21 | 35 | 31 | 12 | 18 < D ≤ 21 |
| 24 | 39 | 35 | 12 | 21 < D ≤ 24 |
| 27 | 42 | 38 | 14 | 24 < D ≤ 27 |
| 30 | 45 | 41 | 14 | 30 < D ≤ 27 |
| 33 | 48 | 43 | 14 | 30 < D ≤ 33 |
| 36 | 52 | 46 | 14 | 33 < D ≤ 36 |
| 39 | 54 | 49 | 14 | 36 < D ≤ 39 |
| 40 | 55 | 50 | 14 | 39 < D ≤ 40 |
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