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Procedural findings and early healing response after implantation of a self-apposing bioresorbable scaffold in coronary bifurcation lesions. / Holck, Emil Nielsen; Fox-Maule, Camilla; Barkholt, Trine Ørhøj et al.
I: The international journal of cardiovascular imaging, Bind 35, Nr. 7, 07.2019, s. 1199-1210.Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review
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TY - JOUR
T1 - Procedural findings and early healing response after implantation of a self-apposing bioresorbable scaffold in coronary bifurcation lesions
AU - Holck, Emil Nielsen
AU - Fox-Maule, Camilla
AU - Barkholt, Trine Ørhøj
AU - Jakobsen, Lars
AU - Tu, Shengxian
AU - Maeng, Michael
AU - Dijkstra, Jouke
AU - Christiansen, Evald Høj
AU - Holm, Niels Ramsing
PY - 2019/7
Y1 - 2019/7
N2 - 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.
AB - 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.
KW - Absorbable Implants
KW - Aged
KW - Angina, Stable/diagnostic imaging
KW - Coronary Artery Disease/diagnostic imaging
KW - Coronary Stenosis/diagnostic imaging
KW - Coronary Vessels/diagnostic imaging
KW - Feasibility Studies
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Percutaneous Coronary Intervention/adverse effects
KW - Pilot Projects
KW - Proof of Concept Study
KW - Prospective Studies
KW - Prosthesis Design
KW - Risk Factors
KW - Time Factors
KW - Tomography, Optical Coherence
KW - Treatment Outcome
KW - Wound Healing
U2 - 10.1007/s10554-019-01537-5
DO - 10.1007/s10554-019-01537-5
M3 - Journal article
C2 - 31053981
VL - 35
SP - 1199
EP - 1210
JO - International Journal of Cardiovascular Imaging
JF - International Journal of Cardiovascular Imaging
SN - 1569-5794
IS - 7
ER -