Utility of a scoring balloon for a severely calcified lesion: bench test and finite element analysis
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We aimed to investigate the effectiveness of a scoring balloon catheter in expanding a circumferentially calcified lesion compared to a conventional balloon catheter using an in vitro experiment setting and elucidate the underlying mechanisms of this ability using a finite element analysis. True efficacy of the scoring device and the underlying mechanisms for heavily calcified coronary lesions are unclear. We employed a Scoreflex scoring balloon catheter (OrbusNeich, Hong Kong, China). The ability of Scoreflex to dilate a calcified lesion was compared with a conventional balloon catheter using 3 different sized calcium tubes. The thickness of the calcium tubes were 2.0, 2.25, and 2.5 mm. The primary endpoints were the successful induction of cracks in the calcium tubes and the inflation pressures required for inducing cracks. The inflation pressure required for cracking the calcium tubes were consistently lower with Scoreflex (p < 0.05, Student t test). The finite element analysis revealed that the first principal stress applied to the calcified plaque was higher by at least threefold when applying the balloon catheter with scoring elements. A scoring balloon catheter can expand a calcified lesion with lower pressure than that of a conventional balloon. The finite element analysis revealed that the concentration of the stress observed in the outside of the calcified plaque just opposite to the scoring element is the underlying mechanism of the increased ability of Scoreflex to dilate the calcified lesion.
KeywordsCalcified lesion Scoring balloon Finite element analysis Complex lesion Balloon angioplasty
The authors would like to thank Mr. Kenataro Takenaka and Prof. Taiji Adachi for their great advice and suggestions in the finite element analysis. Special thanks also go to Ms. Rika Sugiura, Ms. Hiromi Yoshida, and Ms. Yoko Shimizu for their secretarial supports.
Conflict of interest
The Scoreflex and Sapphire balloon catheters were supplied by OrbusNeich Japan. None of the authors have identified a conflict of interest.
Movie 1. The ultra-high-speed movie of 1,250,000 frames per seconds showing that the crack originated from the outside of the calcium tube. (AVI 212 kb)
- 1.Kyono H, Kozuma K, Shiratori Y, Maeno Y, Iino R, Takada K, et al. Angiographic and clinical outcomes of 100 consecutive severe calcified lesions requiring rotational atherectomy prior to sirolimus-eluting stent implantation in hemodialysis and non-hemodialysis patients. Cardiovasc. Interv. Ther. [Internet]. 2011 [cited 2013 Nov 22];26:98–103. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24122529.
- 2.Tan K, Sulke N, Taub N, Sowton E. Clinical and lesion morphologic determinants of coronary angioplasty success and complications: current experience. J. Am. Coll. Cardiol. [Internet]. 1995 [cited 2013 Jan 6];25:855–65. Available from: http://www.ncbi.nlm.nih.gov/pubmed/7884088.
- 3.Hoffmann R, Mintz GS, Popma JJ, Satler LF, Kent KM, Pichard AD, et al. Treatment of calcified coronary lesions with Palmaz-Schatz stents. An intravascular ultrasound study. Eur. Heart J. [Internet]. 1998 [cited 2013 Jan 6];19:1224–31. Available from: http://www.ncbi.nlm.nih.gov/pubmed/9740344.
- 4.Sonoda S, Morino Y, Ako J, Terashima M, Hassan AHM, Bonneau HN, et al. Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantation: serial intravascular ultrasound analysis from the sirius trial. J. Am. Coll. Cardiol. [Internet]. 2004 [cited 2013 Jan 6];43:1959–63. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15172398.
- 5.Fujii K, Carlier SG, Mintz GS, Yang Y, Moussa I, Weisz G, et al. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study. J. Am. Coll. Cardiol. [Internet]. 2005 [cited 2013 Jan 6];45:995–8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15808753.
- 6.Karvouni E, Stankovic G, Albiero R, Takagi T, Corvaja N, Vaghetti M, et al. Cutting balloon angioplasty for treatment of calcified coronary lesions. Catheter. Cardiovasc. Interv. [Internet]. 2001 [cited 2013 Feb 26];54:473–81. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11747183.
- 7.Kato R, Ashikaga T, Sakurai K, Ito J, Ogawa T, Tahara T, et al. Influence of additional ballooning with a dual wire balloon after a rotational atherectomy to expand drug-eluting stent for calcified lesions. Cardiovasc. Interv. Ther. [Internet]. 2012 [cited 2013 Nov 22];27:155–60. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22477064.
- 8.Kanai T, Hiro T, Takayama T, Fukamachi D, Watanabe Y, Ichikawa M, et al. Three-dimensional visualization of scoring mechanism of “AngioSculpt” balloon for calcified coronary lesions using optical coherence tomography. J. Cardiol. Cases [Internet]. Elsevier Ltd; 2012 [cited 2012 Dec 22];5:e16–e19. Available from: http://linkinghub.elsevier.com/retrieve/pii/S1878540911000855.
- 9.Martín-Reyes R, Jiménez-Valero S, Moreno R. Effectiveness of cutting balloon angioplasty for a calcified coronary lesion. evaluation by optical coherence tomography and intravascular ultrasound. Rev. Port. Cardiol. [Internet]. 2010;29:1889–90. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21428144.
- 10.Meerkin D, Tardif J-C, Bertrand OF, Bonan R. Cutting and stenting in a heavily calcified left anterior descending artery lesion. J. Invasive Cardiol. [Internet]. 2002 [cited 2013 Jan 4];14:547–51. Available from: http://www.ncbi.nlm.nih.gov/pubmed/12205357.
- 11.Cui FS, Lee HP, Lu C, Chai P. Effects of Balloon Length and Compliance on Vascular Stent Expansion. Int. J. Appl. Mech. [Internet]. 2010 [cited 2012 Nov 2];02:681–97. Available from: http://www.worldscientific.com/doi/abs/10.1142/S1758825110000718.
- 12.Capelli C, Nordmeyer J, Schievano S, Lurz P, Khambadkone S, Lattanzio S, et al. How do angioplasty balloons work: a computational study on balloon expansion forces. EuroIntervention [Internet]. 2010;6:638–42. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21044919.
- 13.Walraevens J, Willaert B, De Win G, Ranftl A, De Schutter J, Sloten J Vander. Correlation between compression, tensile and tearing tests on healthy and calcified aortic tissues. Med. Eng. Phys. [Internet]. 2008 [cited 2013 Feb 26];30:1098–104. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18342563.
- 14.Hillegass WB. Rotational atherectomy for heavily calcified unprotected left main disease: proceed with caution. Catheter. Cardiovasc. Interv. [Internet]. 2012 [cited 2013 Jan 6];80:221. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22825985.
- 15.Garcia-Lara J, Pinar E, Valdesuso R, Lacunza J, Gimeno JR, Hurtado JA, et al. Percutaneous coronary intervention with rotational atherectomy for severely calcified unprotected left main: immediate and two-years follow-up results. Catheter. Cardiovasc. Interv. [Internet]. 2012 [cited 2013 Jan 6];80:215–20. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22121088.
- 16.Nii H, Wagatsuma K, Nakanishi R, Uchida Y, Amano H, Toda M, et al. Clinical outcomes of the placement of a drug-eluting stent with the use of RotablatorTM in dialytic patients: in comparison with non-dialytic patients. Cardiovasc. Interv. Ther. [Internet]. 2011 [cited 2013 Nov 22];26:246–51. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24122591.
- 17.Mintz GS, Kovach JA, Javier SP, Pichard AD, Kent KM, Popma JJ, et al. Mechanisms of lumen enlargement after excimer laser coronary angioplasty. An intravascular ultrasound study. Circulation [Internet]. 1995 [cited 2013 Jan 6];92:3408–14. Available from: http://www.ncbi.nlm.nih.gov/pubmed/8521561.