open access
The potential hazard of a non-slip element balloon causing distal longitudinal stent deformation: the first clinical experience and in vitro assessment


- Division of Cardiology, Osaka Saiseikai Izuo Hospital, Osaka, Japan
open access
Abstract
Background: A new complication, longitudinal stent deformation (LSD), is increasingly reported with
recent intracoronary stent designs. There have been experiences of unusual cases of distal LSD caused
by entrapment of a Lacrosse® non-slip element (NSE) balloon (Goodman Co., Ltd., Nagoya, Japan),
which has three flexible nylon elements to prevent slippage. Accordingly, the aim of this study is to report
the clinical experience of distal LSD caused by the NSE in the documented center and to investigate the
incidence and mechanisms involved.
Methods: Coronary intervention cases were retrospectively reviewed using the NSE balloon in hospital
between May 2014 and June 2017. In bench testing, distal LSD was reproduced in a silicon tube model
to identify its mechanism.
Results: A total of 95 patients with 107 lesions underwent coronary interventions with NSE. Of these,
72 lesions (12 de-novo lesions and 60 in-stent restenosis) were treated using in-stent dilatation. Two
distal LSD cases occurred, representing an incidence of 2.78% (2/72) among all procedures; 16.7%
(2/12) of the de-novo lesions developed LSD. In vitro experimentation allowed indentification of the
mechanisms involved and bailout strategies.
Conclusions: This is the first study to evaluate NSE balloon catheter entrapment complicated by distal
LSD in which reconstruction of the deformed stent and retrieval of the NSE could be achieved successfully.
There is a potential hazard for distal LSD during post-dilatation using the NSE balloon due to its
structural characteristics. Careful assessment is needed to prevent this complication.
Abstract
Background: A new complication, longitudinal stent deformation (LSD), is increasingly reported with
recent intracoronary stent designs. There have been experiences of unusual cases of distal LSD caused
by entrapment of a Lacrosse® non-slip element (NSE) balloon (Goodman Co., Ltd., Nagoya, Japan),
which has three flexible nylon elements to prevent slippage. Accordingly, the aim of this study is to report
the clinical experience of distal LSD caused by the NSE in the documented center and to investigate the
incidence and mechanisms involved.
Methods: Coronary intervention cases were retrospectively reviewed using the NSE balloon in hospital
between May 2014 and June 2017. In bench testing, distal LSD was reproduced in a silicon tube model
to identify its mechanism.
Results: A total of 95 patients with 107 lesions underwent coronary interventions with NSE. Of these,
72 lesions (12 de-novo lesions and 60 in-stent restenosis) were treated using in-stent dilatation. Two
distal LSD cases occurred, representing an incidence of 2.78% (2/72) among all procedures; 16.7%
(2/12) of the de-novo lesions developed LSD. In vitro experimentation allowed indentification of the
mechanisms involved and bailout strategies.
Conclusions: This is the first study to evaluate NSE balloon catheter entrapment complicated by distal
LSD in which reconstruction of the deformed stent and retrieval of the NSE could be achieved successfully.
There is a potential hazard for distal LSD during post-dilatation using the NSE balloon due to its
structural characteristics. Careful assessment is needed to prevent this complication.
Keywords
coronary artery disease, balloon angioplasty, complication, drug eluting stent


Title
The potential hazard of a non-slip element balloon causing distal longitudinal stent deformation: the first clinical experience and in vitro assessment
Journal
Issue
Pages
645-652
Published online
2018-06-14
Page views
3406
Article views/downloads
895
DOI
10.5603/CJ.a2018.0065
Pubmed
Bibliographic record
Cardiol J 2019;26(6):645-652.
Keywords
coronary artery disease
balloon angioplasty
complication
drug eluting stent
Authors
Hiroki Shibutani
Yuzo Akita
Yohei Oishi
Hiroyuki Sueyoshi
Yu Mukai
Kotaro Yutaka
Yumie Matsui
Masahiro Yoshinaga
Masahiro Karakawa


- Hanratty CG, Walsh SJ. Longitudinal compression: a "new" complication with modern coronary stent platforms--time to think beyond deliverability? EuroIntervention. 2011; 7(7): 872–877.
- Mamas MA, Williams PD. Longitudinal stent deformation: insights on mechanisms, treatments and outcomes from the Food and Drug Administration Manufacturer and User Facility Device Experience database. EuroIntervention. 2012; 8(2): 196–204.
- Williams PD, Mamas MA, Morgan KP, et al. Longitudinal stent deformation: a retrospective analysis of frequency and mechanisms. EuroIntervention. 2012; 8(2): 267–274.
- Janakiraman E, Subban V, Victor SM, et al. Longitudinal deformation - price we pay for better deliverability of coronary stent platforms. Indian Heart J. 2012; 64(5): 518–520.
- Inaba S, Weisz G, Kobayashi N, et al. Prevalence and anatomical features of acute longitudinal stent deformation: An intravascular ultrasound study. Catheter Cardiovasc Interv. 2014; 84(3): 388–396.
- Guler A, Guler Y, Acar E, et al. Clinical, angiographic and procedural characteristics of longitudinal stent deformation. Int J Cardiovasc Imaging. 2016; 32(8): 1163–1170.
- Arnous S, Shakhshir N, Wiper A, et al. Incidence and mechanisms of longitudinal stent deformation associated with Biomatrix, Resolute, Element, and Xience stents: Angiographic and case-by-case review of 1,800 PCIs. Catheter Cardiovasc Interv. 2015; 86(6): 1002–1011.
- Taguchi I, Kageyama M, Kanaya T, et al. Clinical significance of non-slip element balloon angioplasty for patients of coronary artery disease: a preliminary report. J Cardiol. 2014; 63(1): 19–23.
- Prabhu S, Schikorr T, Mahmoud T, et al. Engineering assessment of the longitudinal compression behaviour of contemporary coronary stents. EuroIntervention. 2012; 8(2): 275–281.
- Ormiston JA, Webber B, Webster MWI. Stent longitudinal integrity bench insights into a clinical problem. JACC Cardiovasc Interv. 2011; 4(12): 1310–1317.
- Ormiston JA, Webber B, Ubod B, et al. Stent longitudinal strength assessed using point compression: insights from a second-generation, clinically related bench test. Circ Cardiovasc Interv. 2014; 7(1): 62–69.
- Barragan P, Garitey V, Mouneimne K, et al. Longitudinal compression behaviour of coronary stents: a bench-top comparative study. EuroIntervention. 2014; 9(12): 1454–1462.
- Abdel-Wahab M, Sulimov DS, Kassner G, et al. Longitudinal deformation of contemporary coronary stents: an integrated analysis of clinical experience and observations from the bench. J Interv Cardiol. 2012; 25(6): 576–585.