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; Mæng, Michael; Dijkstra, Jouke; Christiansen, Evald Høj; Holm, Niels Ramsing

doi:10.1007/s10554-019-01537-5

Cited by 5 publications

(7 citation statements)

References 23 publications

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“…Implantation was feasible and there were no clinical events reported at 6 months. OCT showed improvement in SB ostial area and reduction in malapposition at follow‐up 28 …”

Section: Discussionmentioning

confidence: 89%

“…OCT showed improvement in SB ostial area and reduction in malapposition at follow-up. 28 Since the introduction of BRS, it has become evident that careful selection of lesions and meticulous implantation techniques are of utmost importance. In BIFSORB pilot II we followed present recommendations for BRS implantation with careful predilatation, meticulous sizing of the scaffold by OCT, and sensible care during implantation procedures with no expansion beyond the device limits.…”

Section: D Qca Resultsmentioning

confidence: 99%

“…This may have led to BRS under‐expansion and malapposition, which are known predictors of ST 27 . A small pilot study investigated the DESolve BRS for treatment of bifurcation lesions in 10 patients 28 . All procedures were OCT guided and 1 month OCT follow‐up was performed in all patients.…”

Section: Discussionmentioning

confidence: 99%

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Bioresorbable magnesium scaffold in the treatment of simple coronary bifurcation lesions: The BIFSORB pilot II study

Barkholt

Neghabat

Holck

et al. 2021

Cathet Cardio Intervent

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Objectives: To evaluate the feasibility, safety, and healing response of a magnesiumbased bioresorbable scaffold (BRS) in the treatment of simple bifurcation lesions using the single stent provisional technique.Background: BRS may hold potential advantages in the treatment of coronary bifurcation lesions, however low radial strength and expansion capacity has been an issue with polymer-based scaffolds. The magnesium BRS may prove suitable for bifurcation treatment as its mechanical properties are closer to those of permanent metallic drug-eluting stents. Methods:The study was a proof-of-concept study with planned inclusion of 20 patients with stable angina pectoris and a bifurcation lesion involving a large side branch (SB) > 2.5 mm with less than 50% diameter stenosis. Procedure and healing response were evaluated by optical coherence tomography (OCT). The main endpoints were a composite clinical safety endpoint and an OCT healing index at 1 month (range: 0-98).Results: Eleven patients were included in the study. The study was prematurely terminated due to scaffold fractures and embolization of scaffold fragments in three cases requiring bailout stenting with drug-eluting stents. One patient underwent bypass surgery at 3 months due to stenosis proximal to the study segment. All SB were patent for 1 month. One-month OCT evaluation showed strut coverage of 96.9% and no malapposition. Scaffold fractures and uncovered jailing struts resulted in a less favorable mean OCT healing index score of 10.4 ± 9.0.Conclusions: Implanting a magnesium scaffold by the provisional technique in nontrue bifurcation lesions was associated with scaffold fracture, embolization of scaffold fragments, and a high need for bailout stenting.

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“…Implantation was feasible and there were no clinical events reported at 6 months. OCT showed improvement in SB ostial area and reduction in malapposition at follow‐up 28 …”

Section: Discussionmentioning

confidence: 89%

Section: D Qca Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Bioresorbable magnesium scaffold in the treatment of simple coronary bifurcation lesions: The BIFSORB pilot II study

Barkholt

Neghabat

Holck

et al. 2021

Cathet Cardio Intervent

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“…Finally, 12 studies are included in the quantitative synthesis after excluding most unrelated studies (Fig. 1) [7,8,[17][18][19][20][21][22][23][24][25][26]. Among them, the Desolve 150 BRS (Elixir, US) was used in one study [23], while others used the second-generation everolimus-eluting bioresorbable vascular scaffolds (ABSORB; Abbott Vascular, Santa Clara, CA, USA).…”

Section: Search Results and Characteristicsmentioning

confidence: 99%

Efficacy and safety of bioresorbable scaffolds in patients with coronary bifurcation lesions: A systematic review and meta-analysis

Liang

Zhang

et al. 2022

Cardiol J.

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Background: Bioresorbable scaffolds (BRS) were considered to be beneficial for coronary bifurcation lesions regarding the avoidance of lateral branch opening incarceration after complete absorption. However, data is limited in this setting. The aim of this meta-analysis was to evaluate the short (6-month) and medium-term (1year) outcomes of BRS in patients with coronary bifurcation lesions.Methods: PubMed, EMBASE, Web of Science, Cochrane library databases were searched to find the studies of BRS implantation in patients with coronary bifurcation lesions. The effective outcome was target lesion revascularization. The safety outcomes included major adverse cardiovascular events, target vessel 2 revascularization, myocardial infarction, definite or probable scaffold thrombosis, and cardiac death.Results: A total of 1204 patients involved in 12 studies were included. The pooled estimate rate of target lesion revascularization as efficacy outcome was highly consistent between 6-month and 1-year follow-up, which was 4.74% (95% CI 2.36-9.54%, I 2 = 41.5%, p = 0.14) and 4.37% (95% CI 3.05-5.69%, I 2 = 4.6%, P = 0.39).The pooled estimated rate of major adverse cardiovascular events as safety outcome was 5.50% and 7.31% for both 6-month and 1-year follow-up. The pooled estimated rate of target vessel revascularization, myocardial infarction, definite or probable scaffold thrombosis, and cardiac death at 1-year follow-up was 5.92%, 2.52%, 1.69%, and 0.42%. Conclusions:The application of BRS for coronary bifurcation lesions is acceptable in efficacy outcome, but the high rate of scaffold thrombosis remains of concern (Registered by PROSPERO, CRD42019140341).

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“…Still in this topic, Holck et al [26] studied procedural findings and early healing response after implantation of a self-apposing BVS in coronary bifurcation lesions. They evaluated feasibility, early healing and self-correcting properties of the Desolve® 150 BVS implanted in bifurcation lesions, using the simple, provisional side branch (SB) stenting technique.…”

Section: Evaluation Of Bioresorbable Vascular Scaffolds (Bvs)mentioning

confidence: 99%

Cardiovascular imaging 2019 in the International Journal of Cardiovascular Imaging

Reiber

Pereira

Dallan

et al. 2020

Int J Cardiovasc Imaging

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

Cited by 5 publications

References 23 publications

Bioresorbable magnesium scaffold in the treatment of simple coronary bifurcation lesions: The BIFSORB pilot II study

Bioresorbable magnesium scaffold in the treatment of simple coronary bifurcation lesions: The BIFSORB pilot II study

Efficacy and safety of bioresorbable scaffolds in patients with coronary bifurcation lesions: A systematic review and meta-analysis

Cardiovascular imaging 2019 in the International Journal of Cardiovascular Imaging

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