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Procedural findings and early healing response after implantation of a self-apposing bioresorbable scaffold in coronary bifurcation lesions

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Abstract

We aimed to evaluate feasibility, early healing and self-correcting properties of the Desolve 150 bioresorbable scaffold (BRS) implanted in bifurcation lesions, using the simple, provisional side branch (SB) stenting technique. BIFSORB pilot was a proof-of-concept study enrolling 10 patients with stable angina pectoris and a bifurcation lesion with SB ≥ 2.5 mm and less than 50% diameter stenosis. Procedure and 1-month outcome was evaluated by optical coherence tomography (OCT) to assess scaffold performance and healing patterns. Nine patients were treated with Desolve 150 BRS and one delivery to the target bifurcation failed. Thrombus formation in the jailed SB ostium was seen in three cases, but was completely resolved at 1-month. OCT confirmed acute self-correcting properties. No clinical events were reported after six months. Scaffold diameter by OCT increased in the proximal main vessel from 3.09 ± 0.16 mm to 3.34 ± 0.18 mm (p = 0.01) and in distal main vessel from 2.82 ± 0.26 mm to 3.02 ± 0.29 mm (p < 0.01) at one-month follow-up. SB ostial diameter stenosis improved from 42 ± 15% to 34 ± 12% (p = 0.01). Malapposition was effectively reduced after 1 month from 4.1 (1.4; 6.1)% to 0.1 (0; 0.6)% (p = 0.002). Treatment of bifurcation lesions using Desolve 150 BRS was feasible except for a delivery failure and unsettling thrombus formation behind jailing SB struts, which was completely resolved at 1-month. Self-correcting and even self-expanding properties were confirmed.

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Funding

The study was an academic study funded entirely by Aarhus University Hospital, Skejby, Denmark.

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Authors and Affiliations

  1. Department of Cardiology, Aarhus University Hospital Skejby, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark

    Emil Nielsen Holck, Camilla Fox-Maule, Trine Ørhøj Barkholt, Lars Jakobsen, Michael Maeng, Evald Høj Christiansen & Niels Ramsing Holm

  2. Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Wenxuan Building, 800 Dongchuan RD, Minhang District, Shanghai, China

    Shengxian Tu

  3. Division of Image Processing, Department of Radiology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands

    Jouke Dijkstra

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  1. Emil Nielsen Holck
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  2. Camilla Fox-Maule
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  9. Niels Ramsing Holm
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Correspondence to Niels Ramsing Holm.

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Conflict of interest

Emil Nielsen Holck: travel grants from St. Jude Medical, Elixir and Reva Medical; Camilla Fox Maule: travel grants from St. Jude Medical, Boston Scientific; Trine Ørhøj Barkholt travel grants from St. Jude Medical, Terumo; Lars Jakobsen: none; Michael Maeng: none; Jouke Dijkstra: none; Shengxian Tu: research grant from Medis medical imaging; Evald Høj Christiansen: Institutional research grants from Abbott, Elixir, St. Jude Medical and Terumo. Speaker fees from St. Jude Medical, Edwards, Biotronik; Niels Ramsing Holm1: institutional research grants from Medis medical imaging, Abbott, Elixir, St. Jude Medical and Terumo. Speaker fees from St. Jude Medical, Terumo, Reva Medical.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Holck, E.N., Fox-Maule, C., Barkholt, T.Ø. et al. Procedural findings and early healing response after implantation of a self-apposing bioresorbable scaffold in coronary bifurcation lesions. Int J Cardiovasc Imaging 35, 1199–1210 (2019). https://doi.org/10.1007/s10554-019-01537-5

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