Hostname: page-component-8448b6f56d-tj2md Total loading time: 0 Render date: 2024-04-23T13:21:03.567Z Has data issue: false hasContentIssue false
  • English
  • Français

A word of caution: diabolic behaviour of AndraStents®: inflation of supporting balloon leads to “diabolo”-misconfiguration of the stent

Published online by Cambridge University Press:  20 June 2019

Christoph M. Happel Open the ORCID record for Christoph M. Happel [Opens in a new window] ,
Jose L. Zunzunegui Martínez ,
María Jesús del Cerro ,
Dietmar Schranz ,
Markus Khalil ,
Fernando Ballesteros ,
César Abelleira Pardeiro ,
Harald Bertram ,
Philipp Beerbaum  and
Nikolaus A. Haas
Christoph M. Happel*
Affiliation:
Pediatric Cardiology & Intensive Care Medicine, Department for Pediatric Cardiology and Intensive Care Medicine, Hannover Medical School, Hannover, Lower Saxony, Germany
Jose L. Zunzunegui Martínez
Affiliation:
Unidad de Cardiología Infantil, Department for Pediatric Cardiology, Hospital Universitario Gregorio Marañón, Madrid, Madrid, Spain
María Jesús del Cerro
Affiliation:
Servicio de Cardiología Infantil, Department for Pediatric Cardiology, Hospital Universitario Ramón y Cajal, Madrid, Spain
Dietmar Schranz
Affiliation:
Pediatric Heart Center Hesse, Department for Pediatric Cardiology, University Hospital Giessen and Marburg, Giessen, Hesse, Germany
Markus Khalil
Affiliation:
Pediatric Heart Center Hesse, Department for Pediatric Cardiology, University Hospital Giessen and Marburg, Giessen, Hesse, Germany
Fernando Ballesteros
Affiliation:
Unidad de Cardiología Infantil, Department for Pediatric Cardiology, Hospital Universitario Gregorio Marañón, Madrid, Madrid, Spain
César Abelleira Pardeiro
Affiliation:
Servicio de Cardiología Infantil, Department for Pediatric Cardiology, Hospital Universitario Ramón y Cajal, Madrid, Spain
Harald Bertram
Affiliation:
Pediatric Cardiology & Intensive Care Medicine, Department for Pediatric Cardiology and Intensive Care Medicine, Hannover Medical School, Hannover, Lower Saxony, Germany
Philipp Beerbaum
Affiliation:
Pediatric Cardiology & Intensive Care Medicine, Department for Pediatric Cardiology and Intensive Care Medicine, Hannover Medical School, Hannover, Lower Saxony, Germany
Nikolaus A. Haas
Affiliation:
Department for Pediatric Cardiology and Pediatric Intensive Care, Ludwig Maximilians University, Medical Hospital of the University of Munich, Campus Grosshadern, Munich, Bavaria, Germany
*
Author for correspondence: C. M. Happel, MD PhD, Pediatric Cardiology & Intensive Care Medicine, University Children’s Hospital, Medical School Hannover, Carl-Neuberg-Str. 1, 30659 Hannover, Germany. Tel: +49 511 532 6751; E-mail: cmh@gmx.net
Get access Rights & Permissions [Opens in a new window]

Abstract

Aims:

Transcatheter implantation of pulmonary balloon-expandable stent-valves requires pre-stenting of the right ventricular outflow tract with large calibre stents. To increase awareness of the associated risks of this part of transcatheter pulmonary valve replacement therapy, we report potential fatal complications during the implantation of AndraStents® in the right ventricular outflow tract in six cases from five different European institutions and their management.

Method and result:

We present a retrospective case series analysis looking at the time period from 2013 to 2018. Of 127 AndraStents® implanted in the right ventricular outflow tract, in six patients, age from 13 to 71 years, a misconfiguration of the AndraStent® occurred forming a “diabolo”-configuration. During inflation of the balloon, the stent showed extreme “dog-boning”, an expansion of the stent at both ends with the middle part remaining unexpanded. This led to rupture of the balloon and loss of manoeuvrability in four patients. Out of the total six cases, in four patients the stent was eventually expanded with high-pressure balloons, and in one case the stent was surgically retrieved. In one patient, in whom a percutaneous retrieval of the embolised stent was attempted, a fatal bleeding occurred.

Conclusions:

Pre-stenting of the right ventricular outflow tract by AndraStents® can lead to misconfiguration of the stent with potentially fatal complications. Rescue strategies of misconfigured stents include stent inflation and placement with high pressure non-compliant balloons or surgical backup. Interventional retrieval measures of AndraStents® cannot be advised.

Keywords

Percutaneous pulmonary valve implantationpre-stentingstent misconfigurationcomplication
Type
Original Article
Information
Cardiology in the Young , Volume 29 , Issue 7 , July 2019 , pp. 972 - 976
Copyright
© Cambridge University Press 2019 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Ansari, MM, Cardoso, R, Garcia, D, et al. Percutaneous pulmonary valve implantation: present status and evolving future. J Am Coll Cardiol 2015; 66: 2246–2255. doi: 10.1016/j.jacc.2015.09.055.CrossRefGoogle ScholarPubMed
Cardoso, R, Ansari, M, Garcia, D, et al. Prestenting for prevention of melody valve stent fractures: a systematic review and meta-analysis. Catheter Cardiovasc Interv 2016; 87: 534–539.CrossRefGoogle ScholarPubMed
Eicken, A, Ewert, P, Hager, A, et al. Percutaneous pulmonary valve implantation: two-centre experience with more than 100 patients. Eur Heart J 2011; 32: 1260–1265.CrossRefGoogle ScholarPubMed
Haas, NA, Carere, RG, Kretschmar, O, et al. Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system. Int J Cardiol 2018; 250: 86–91. doi: 10.1016/j.ijcard.2017.10.015.CrossRefGoogle ScholarPubMed
Esmaeili, A, Bollmann, S, Khalil, M, et al. Percutaneous pulmonary valve implantation for reconstruction of a patch-repaired right ventricular outflow tract. J Interven Cardiol 2017; 31: 106–111.CrossRefGoogle ScholarPubMed
Stümper, O, Gewillig, M, Vettukattil, J, et al. Modified technique of stent fenestration of the atrial septum. Heart 2003; 89: 1227–1230.CrossRefGoogle ScholarPubMed
Rupp, S, Schieke, C, Kerst, G, et al. Creation of a transcatheter fenestration in children with failure of Fontan circulation: focus on extracardiac conduit connection. Catheter Cardiovasc Interv 2015; 86: 1189–1194. doi: 10.1002/ccd.26042CrossRefGoogle ScholarPubMed
Bukala, J, Kwiatkowski, P, Malachowski, J. Numerical analysis of crimping and inflation process of balloon-expandable coronary stent using implicit solution. Int J Numer Method Biomed Eng 2017; 33: e2890. doi: 10.1002/cnm.2890CrossRefGoogle ScholarPubMed
Mortier, P, De Beule, M, Carlier, SG, et al. Numerical study of the uniformity of balloon-expandable stent deployment. J Biomech Eng 2008; 130: 021018. doi: 10.1115/1.2904467.CrossRefGoogle ScholarPubMed
Cui, FS, Lee, HP, Lu, C, Chai, P. Effects of balloon length and compliance on vascular stent expansion. Int J App Mech 2010; 2: 681–697.CrossRefGoogle Scholar