Selman Vefa YILDIRIM, Taliha ÖNER, Barış GÜVEN, Timur MEŞE, Vedide TAVLI, Rahmi ÖZDEMİR, Savaş DEMİRPENÇE, Murat Muhtar YILMAZER

Perkütan olarak Solysafe® septal tıkayıcı ile sekundum atriyal septal defektlerin kapatılmasının orta dönem sonuçları

Amaç: Bu makalede perkütan olarak Solysafe® septal tıkayıcı ile sekundum atriyal septal defektlerin kapatılmasının orta dönem takip sonuçları sunuldu. Çalışma planı: Bu çalışmaya Temmuz 2008 - Haziran 2010 tarihleri arasında sekundum atriyal septal defektin perkütan olarak kapatıldığı toplam 25 hasta (8 erkek, 17 kız; ort. yaş 8.4±3.6 yıl; dağılım 5-12 yıl) alındı. Bulgular: Ortalama takip süresi 6.1±0.5 (dağılım 5.2-7.2) yıldı. Cihaz 25 hastanın 22’sine başarılı bir şekilde yerleştirildi. Balon ölçümü ile yapılan değerlendirmede gerilmiş atriyal septal defect çapı ortalama 13.6±4.4 (dağılım 8-26) mm idi. 15 mm’lik dokuz, 20 mm’lik sekiz, 25 mm’lik altı ve 35 mm’lik iki cihaz kullanıldı. Üç hastada 20 mm’lik bir ve 35 mm’lik iki cihaz kullanıldı ve bu hastalarda işlem başarısız oldu. Geriye kalan 22 hastada işlem sırasında veya sonrasında perikard efüzyonu, endokardit, hemoliz, elektrokardiyografik değişiklikleri, kapak problemleri veya şüpheli ekokardiyografik bulgulara rastlanmadı. Yalnızca bir hastada altıncı yılda tel kırılması ve bir diğer hastada altı yıllık takip süresince rezidüel şant görüldü. Cihaz embolizasyonu (n=1) ve hemiparezi (n=1) işlem ile ilişkili erken dönem majör komplikasyonlardı. Sonuç: Sekundum atriyal septal defektlerin perkütan kapatılması başarılı olmakla birlikte, tel kırılmalarına bağlı olarak üretimden kaldırılması nedeniyle, cihazın en az yılda bir kere olmak üzere belirli aralıklarla kontrol edilmesinin daha uygun olacağı düşünüldü.

Mid-term results of Solysafe® septal occluder for percutaneous closure of secundum atrial septal defects

Background: In this article, we report mid-term follow-up results of the Solysafe® septal occluder for percutaneous closure of secundum atrial septal defects.Methods: A total of 25 patients (8 males, 17 females; mean age 8.4±3.6 years; range 5 to 12 years) who underwent percutaneous closure of secundum atrial septal defect between July 2008 and June 2010 were included in this study.Results: The mean follow-up was 6.1±0.5 (range, 5.2 to 7.2) years. The device was successfully implanted in 22 of 25 patients. The mean stretched diameter of the atrial septal defect as assessed by balloon sizing was 13.6±4.4 (range, 8 to 26) mm. Nine 15-mm devices, eight 20-mm devices, six 25-mm devices, and two 35-mm devices were used. A 20-mm and two 35-mm devices were used in three patients and the procedure failed in these patients. Among the remaining 22 patients, no pericardial effusion, endocarditis, hemolysis, electrocardiographic changes, valvular problems, or suspicious echocardiographic findings were observed during or after the procedure. Only in one patient, a wire fraction was seen at six years, while another patient had a residual shunt during a six-year follow-up. Device embolization (n=1) and hemiparesis (n=1) were the early major complications related to the procedure.Conclusion: Although percutaneous closure of secundum atrial septal defects is successful, it would be wiser to check the device regularly, at least once a year, as the manufacturing of the device has been discontinued due to wire fractions.

PDF

___

14. Cabrera M, Contreras A, Peirone A. Late cardiac perforation following percutaneous atrial septal defect closure using the Solysafe device. J Invasive Cardiol 2011;23:E139-41.
13. Knirsch W, Quandt D, Dave H, Prêtre R, Kretschmar O. Mid-term follow-up of interventional closure of atrial septal defect using Solysafe™ Septal Occluder - impact of standardized fluoroscopy for complication detection. Int J Cardiol 2011;152:127-8.
12. Gielen S, Riede FT, Schuler G, Dähnert I. Wire fractures in Solysafe septal occluders: a single center experience. Catheter Cardiovasc Interv 2012;79:1161-8.
11. Hein R, Bayard Y, Taaffe M, Büscheck F, Ostermayer S, Billinger K, et al. Patent foramen ovale and left atrial appendage: new devices and methods for closure. Pediatr Cardiol 2005;26:234-40.
10. Ewert P. The Solysafe septal occluder for the closure of ASDs and PFOs. In: Hijazi ZM, Feldman T, Al-Qbandi MHA, Sievert H editors. Transcatheter Closure of ASDs and PFOs. A comprehensive Assessment. 1st ed. Minneapolis: Cardiotext Publishing; 2010. p. 417-3.
9. Kretschmar O, Sglimbea A, Daehnert I, Riede FT, Weiss M, Knirsch W. Interventional closure of atrial septal defects with the Solysafe Septal Occluder--preliminary results in children. Int J Cardiol 2010;143:373-7.
8. Nişli K, Oner N, Aydoğan U, Ertugrul T. Atrial septal defect closure with Solysafe device: first experience in Turkey. Transcatheter Derg 2007;7:451–2.
7. Ewert P, Söderberg B, Dähnert I, Hess O, Schuler G, Bussmann C, et al. ASD and PFO closure with the Solysafe septal occluder - results of a prospective multicenter pilot study. Catheter Cardiovasc Interv 2008;71:398-402.
6. Yılmazer MM, Güven B, Vupa-Çilengiroğlu Ö, Öner T, Demirpençe S, Meşe T, et al. Improvement in cardiac structure and functions early after transcatheter closure of secundum atrial septal defect in children and adolescents. Turk J Pediatr 2013;55:401-10.
5. Salehian O, Horlick E, Schwerzmann M, Haberer K, McLaughlin P, Siu SC, et al. Improvements in cardiac form and function after transcatheter closure of secundum atrial septal defects. J Am Coll Cardiol 2005;45:499-504.
4. Du ZD, Hijazi ZM, Kleinman CS, Silverman NH, Larntz K. 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;39:1836-44.
3. King TD, Thompson SL, Steiner C, Mills NL. Secundum atrial septal defect. Nonoperative closure during cardiac catheterization. JAMA 1976;235:2506-9.
2. Meier B. Patent foramen ovale-amplatzer PFO occluders. In: Sievert H, Shakeel QA, Wilson N, Hijazi ZM editors. Percutaneous Interventions for Congenital Heart Disease, 1st ed. Abingdon: Informa UK Ltd.,; 2007. p. 289-309.
1. Masura J, Gavora P, Formanek A, Hijazi ZM. Transcatheter closure of secundum atrial septal defects using the new self-centering amplatzer septal occluder: initial human experience. Cathet Cardiovasc Diagn 1997;42:388-93.