Polivinil Alkol Membranının Spontan Perforasyonu: Atriyal Septal Defekt Kapama Cihazı Disfonksiyonunun Nadir Bir Nedeni

Amaç: Atriyal septal defektin perkütan yolla kapatılması etkinliği kanıtlanmış bir prosedür olup birçok avantajı nedeniyle standart tedavi haline gelmiştir. Bununla birlikte, polivinil alkol membran ile kaplanmış Atriyal septal defektin kapama cihazları, spontan Polivinil Alkol membran perforasyonuna bağlı olarak tekrarlayan ciddi şantlara neden olabilir. Çalışmamızda, Polivinil Alkol membran ile kaplı CARDIA Ultrasept Atriyal septal defektin kapama cihazı (Eagan, Minnesota, ABD) implante edilen hastalarımızda, spontan polivinil alkol membran perforasyonu gelişip gelişmediğini araştırmayı amaçladık.Yöntem: CARDIA Ultrasept protezi ile perkütan kapama uygulanan sekundum tip Atriyal septal defektin tanılı tüm hastalarımızı retrospektif olarak gözden geçirdik.Bulgular: UItrasept cihazı ile atriyal septal defektin kapama işlemi uygulanan, 4 ila 56 yaşları arasında olan on hasta çalışmaya alındı. Medyan 26 aylık takip periyodu sırasında, dört hastada polivinil alkol membran sorunu saptandı. Üç hastada polivinil alkol membran perforasyonu tekrar girişim gerektiren ciddi soldan sağa şanta neden olurken, bir hastada minimal rezidü şanta neden oldu. Kullanılan cihazlar 14 mm (iki hasta), 16 mm (bir hasta) ve 30 mm (bir hasta) idi. İki hastada, sorunlu cihazın cerrahi olarak çıkarılması ve perikardiyal yama ile kapama işlemi uygulandı. Bir hastada ise perkütan ikinci atriyal septal defektin cihazı ile kapama işlemi uygulandı. İkinci prosedürler sonrası, bu üç hastada da rezidü şant tespit edilmedi.Sonuç: Polivinil alkol membran perforasyonu nadir görülür ve genellikle yeniden girişim gerektirir. Operatörler bu sorunun farkında olmalı ve polivinil alkol membran kaplı cihaz implante edilen tüm hastalarını tekrar gözden geçirmelidirler.

Anahtar Kelimeler:

Polivinil alkol membran, perforasyon, atriyal septal defekt kapama cihazı, rekkürren şant

Spontaneous Perforation of Polyvinyl Alcohol Membrane: A Rare Cause of Atrial Septal Occluder Failure

Objective: Percutaneous closure of atrial septal defect is a well-established procedure and has evolved to become the standard of care due to its many advantages. However, atrial septal defect closure devices covered with polyvinyl alcohol membrane could cause recurrent significant shunts due to a spontaneous polyvinyl alcohol membrane perforation. To investigate whether spontaneous polyvinyl alcohol membrane perforation developed in our patients who had implanted with CARDIA Ultrasept atrial septal defect occluder (Eagan, Minnesota, USA) that covered with Polyvinyl Alcohol membrane.Methods: We retrospectively rewieved all patients with a diagnosis of secundum type atrial septal defect who underwent percutanoues closure with CARDIA Ultrasept prosthesis.Results: Ten patients aged 4 to 56 years who underwent atrial septal defect closure with UItrasept device were included. During a median 26 months follow up period, we detected a four cases of polyvinyl alcohol membrane failure. In 3 patients, perforation of polyvinyl alcohol membrane caused significant left to right shunt that required re-intervention, while in one patient it caused minimal residual shunt. The devices were used were 14 mm (two patients), 16 mm (one patient) and 30 mm (one patient). Two patients underwent surgical device removal and pericardial patch closure. One patient underwent device in device procedure. Residual shunts were not occured in after reinterventions.Conclusion: Polyvinyl alcohol membrane perforation is rare and can require reintervention. Operators have to be aware of this malfunction.

Keywords:

polyvinyl alcohol membrane, perforation, atrial septal defect occluder, recurrent shunt,

PDF

___

Du ZD, Hijazi ZM, Kleinman CS, The 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: 1836–1844.
Visconti KJ, Bichell DP, Jonas RA et al. Developmental outcome after surgical versus interventional closure of secundum atrial septal defect in children. Circulation 1999; 100 (Suppl):II145–II150.
King TD, Thompson SL, Steiner C, et al. Secundum atrial septal defect: non operative closure during cardiac catheterization. J Am Med Assoc 1976; 235: 2506–2509.
Alexandre N, Ribeiro J, Gärtner A et al. Biocompatibility and hemocompatibility of polyvinyl alcohol hydrogel used for vascular grafting-In vitro and in vivo studies. J Biomed Mater Res Part A. 2014 [published online ahead of print January 31, 2014], doi:10.1002/jbm.a.35098.
Huang Y, Kong JF, Venkatraman SS. Biomaterials and design in occlusion devices for cardiac defects: A review. Acta Biomater 2014;10:1088–1101.
Nassif M, Abdelghani M, Bouma BJ et al. (2016): Historical developments of atrial septal defect closure devices: what we learn from the past, Expert Review of Medical Devices, DOI: 10.1080/17434440.2016.1182860.
Bartel T, Bonaros N, Muller S. Device failure weeks to months after transcatheter closure of secundum type atrial septal defects. Heart 2010;96,1603.
Bhattacharyya S, Ilsley CD, Baltabaeva A. Disintegration of polyvinyl alcohol membrane covering atrial septal defect closure device. Eur Heart J Cardiovasc Imaging 2015;16:1153.
Labombarda F, Roule V, Beygui F. Delayed spontaneous perforation of polyvinyl alcohol membrane—covered atrial septal defect closure devices. Catheter Cardiovasc Interv 2016 Aug 18. doi: 10.1002/ccd.26704.
Ramoglu MG, Ucar T, Tutar E. Early malfunction of polyvinyl alcohol membrane of septal occluder. Catheter Cardiovasc Interv 2016;87:E151–3.
Chamié F, Maia J, Giuliano LC. Device-in-device: A transcatheter alternative to surgical explantation of a failing atrial septal defect intracardiac prosthesis. Catheter Cardiovasc Interv. 2016 Aug;88(2):239-43. doi: 10.1002/ccd.26456.
Bozyel S, Şahin T, Dervis E et al. A massive left-to-right shunt due to delayed spontaneous perforation of polyvinyl alcohol membrane of atrial septal occluder. Turk Kardiyol Dern Ars. 2017; 45(6): 541-544
Rosa SA, Ferreira F, Sousa L, et al. Successful percutaneous closure of a residual atrial septal defect due to device failure. Rev Port Cardiol. 2017;36, 475.e1-475.e3.
Bozyel S, Sahin T. Residual shunt due to spontaneous perforation of polyvinyl alcohol membrane of ASD Occluder; what about after diagnosis? Rev Port Cardiol. 2018. https://doi.org/10.1016/j.repc.2017.11.012
Chen F, Zhao X, Zheng X et al. Incomplete endothelialization and late dislocation after implantation of an Amplatzer septal occluder device. Circulation. 2011;124:e188---9.
Vogt MO, Kühn A, Hörer J et al. Clinical, echocardiographic and histopathologic findings in nine patients with surgically explanted ASD/PFO devices: do we know enough about the healing process in humans? Int J Cardiol. 2011;147:398---404.
Roberto M-V, Antonio G-MJ, Elena S-LM et al. Atrial septal defect closure with the new Cardia Ultrasept II™ device with interposed Goretex patch: Mexican experience – has the perforation of Ivalon’s membrane been solved? Cardiol Young. 2018 May;28(5):709-714. doi: 10.1017/S1047951118000100. Epub 2018 Feb 27.