Summary
Background
Transcatheter therapy is the first-line treatment for closure of patent ductus arteriosus (PDA). A range of different devices have been used.
Aim
To report our experience using the new Occlutech ® PDA occluder for closure of PDA.
Methods
All consecutive patients receiving an Occlutech ® PDA occluder for closure of PDA from March 2014 to May 2015 were included in the study. Occluders were implanted using a conventional technique. After cardiac catheterization, transthoracic echocardiography was performed sequentially. Residual shunting and procedural and mid-term complications, including embolization, device-induced left pulmonary artery stenosis and aortic coarctation, were systematically assessed and reported.
Results
Fifty-six patients (35 females) with a median age of 1 year (range: 29 days to 24 years) were included in the study. PDAs were closed successfully using device number 5/3.5 in 17 patients, 6/4 in 28 patients, 7/5 in four patients, 8/6 in six patients and 10/8 in one patient. Post-implantation angiography showed no residual shunt in 10 patients (17.8%), moderate intraprosthetic shunt in 43 patients (76.8%) and severe shunt in three patients (5.4%). One device embolized in the right pulmonary artery 1 hour after successful closure; the device was retrieved surgically after unsuccessful snaring. After a mean follow-up of 10 months (range: 3–17.8 months), no residual shunt or device-related complications were noted.
Conclusion
The new Occlutech ® PDA occluder allows safe and efficient PDA closure, similar to existing devices.
Résumé
Contexte
Le traitement percutané est le traitement de première ligne pour la fermeture d’un canal artériel persistant (PDA). Divers dispositifs sont utilisés.
Objectif
Nous rapportons les résultats de l’utilisation du nouveau système de fermeture Occlutech ® .
Méthodes
Tous les patients consécutifs ayant reçu ce dispositif de mars 2014 à mai 2015 ont été inclus dans cette étude. Les dispositifs ont été implantés selon la technique habituelle. Au décours, des contrôles échographiques ont été réalisées à intervalle régulier à la recherche de complications (shunt résiduel, embolisation, néocoarctation, sténose de l’artère pulmonaire gauche, etc.).
Résultats
Cinquante-six patients (35 filles) avec un âge médian d’un an (29 jours à 24 ans) ont été inclus. Les canaux artériels ont été occlus avec succès en utilisant des prothèses 5/3,5, 6/4, 7/5, 8/6 et 10/8 respectivement dans 17, 28, 4, 6 et 1 cas. Les angiographies post-procédurales ont montré l’absence de shunt chez 10 patients (17,8 %), la présence d’un shunt modérée intraprothétique chez 43 (76,8 %) et sévère chez 3 (5,4 %). Une embolisation dans l’artère pulmonaire droite a été déplorée une heure après son implantation. Le dispositif a été retiré chirurgicalement après échec du retrait percutané. Après un suivi moyen de 10 mois (3 à 17,8 mois), aucun shunt résiduel n’est à déplorer. Aucune complication secondaire n’a été retrouvée.
Conclusion
La nouvelle prothèse Occlutech ® de fermeture permet de fermer des canaux artériels avec une efficacité et un risque similaires aux prothèses existantes.
Background
Transcatheter therapy is now the first-line treatment for closure of patent ductus arteriosus (PDA). Since the first successful attempt at transcatheter closure by Porstmann et al. in 1967 , a range of different devices have been developed to simplify the procedure. Devices using coil- or nitinol-based technology [e.g. the AMPLATZER™ Duct Occluder (ADO); St. Jude Medical, St. Paul, MN, USA] have been used with success . Despite excellent results with very low risks, all available devices are mainly useful for conically shaped PDAs.
The Occlutech ® PDA occluder (Occlutech International AB, Helsingborg, Sweden) has recently been developed and introduced onto the market. At first sight, it is very similar to the ADO from St. Jude Medical. It is made of nitinol mesh, and consists of two parts ( Fig. 1 ): a retention disk on the aortic side of the device (with a D1 length), and a conical body in the form of a shank with tapered diameters (D2 and D3). D2, the part of the body proximal to the retention disk, is 1.5–2 mm smaller than D3, the distal part of the body (the pulmonary part). The aortic retention disk is 5–8 mm larger than the body. The device is manufactured in two lengths: short and long (labelled as L, long devices are 2.4–3.5 mm longer than the standard design), each coming in various sizes ( Table 1 ). Devices are labelled according to D2 and D3 as well as length (device numbers 5/3.5, 6/4, 7/5, 8/6, 10/8, 12/10, 15/12 and 18/14 for short lengths; and 5/3.5L, 6/4L, 7/5L, 8/6L and 10/8L for long lengths). Polytetrafluoroethylene (PTFE) patches are sutured into the device to facilitate sealing. This new design was made to configure better with the various PDA anatomies seen in our patients.
| Manufacturer | Device number | Retention skirt diameter D1 (mm) | Device diameter at descending aorta D2 (mm) | Device diameter at pulmonary artery D3 (mm) | Device length (mm) | Sheath size |
|---|---|---|---|---|---|---|
| St. Jude | 5/4 | 9 | 5 | 4 | 5 | 5 Fr |
| St. Jude | 6/4 | 10 | 6 | 4 | 7 | 5 Fr |
| St. Jude | 8/6 | 12 | 8 | 6 | 7 | 6 Fr |
| St. Jude | 10/8 | 16 | 10 | 8 | 8 | 6 Fr |
| St. Jude | 12/10 | 18 | 12 | 10 | 8 | 7 Fr |
| St. Jude | 14/12 | 20 | 14 | 12 | 8 | 7 Fr |
| St. Jude | 16/14 | 22 | 16 | 14 | 8 | 7 Fr |
| Manufacturer | Device number | Retention skirt diameter D1 (mm) | Device diameter at descending aorta D2 (mm) | Device diameter at pulmonary artery D3 (mm) | Device length (mm) | Sheath size | |
|---|---|---|---|---|---|---|---|
| With standard shank | With long shank | ||||||
| Occlutech | 5/3.5 | 9 | 3.5 | 5 | 4.25 | 7 | 6 Fr |
| Occlutech | 6/4 | 10 | 4 | 6 | 5 | 7.5 | 6 Fr |
| Occlutech | 7/5 | 11 | 5 | 7 | 6.05 | 8.5 | 6 Fr |
| Occlutech | 8/6 | 13 | 6 | 8 | 6.6 | 9 | 6 Fr |
| Occlutech | 10/8 | 16 | 8 | 10 | 7 | 10.5 | 7 Fr |
| Occlutech | 12/10 | 18 | 10 | 12 | 12 | NA | 7 Fr |
| Occlutech | 12/15 | 20 | 12 | 15 | 14 | NA | 8 Fr |
| Occlutech | 18/14 | 24 | 14 | 18 | 16 | NA | 9 Fr |
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