Trine Ørhøj Barkholt

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

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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; Jakobsen, Lars; Tu, Shengxian; Maeng, Michael; Dijkstra, Jouke; Christiansen, Evald Høj; Holm, Niels Ramsing.

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 avisTidsskriftartikelForskningpeer review

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@article{6d767322a1dd416ba0eb21a6d5329e30,
title = "Procedural findings and early healing response after implantation of a self-apposing bioresorbable scaffold in coronary bifurcation lesions",
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.",
keywords = "Absorbable Implants, Aged, Angina, Stable/diagnostic imaging, Coronary Artery Disease/diagnostic imaging, Coronary Stenosis/diagnostic imaging, Coronary Vessels/diagnostic imaging, Feasibility Studies, Female, Humans, Male, Middle Aged, Percutaneous Coronary Intervention/adverse effects, Pilot Projects, Proof of Concept Study, Prospective Studies, Prosthesis Design, Risk Factors, Time Factors, Tomography, Optical Coherence, Treatment Outcome, Wound Healing",
author = "Holck, {Emil Nielsen} and Camilla Fox-Maule and Barkholt, {Trine {\O}rh{\o}j} and Lars Jakobsen and Shengxian Tu and Michael Maeng and Jouke Dijkstra and Christiansen, {Evald H{\o}j} and Holm, {Niels Ramsing}",
year = "2019",
month = jul,
doi = "10.1007/s10554-019-01537-5",
language = "English",
volume = "35",
pages = "1199--1210",
journal = "International Journal of Cardiovascular Imaging",
issn = "1569-5794",
publisher = "Springer",
number = "7",

}

RIS

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 -