Bioresorbable Polymeric Vascular Scaffolds

Ormiston, John A.; Vroey, Frederic De; Serruys, Patrick W.; Webster, Mark

doi:10.1161/circinterventions.111.963710

Cited by 76 publications

(45 citation statements)

References 3 publications

(4 reference statements)

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“…5,31,32 The morphological description of the OCT signs of discontinuity immediately postprocedure has been previously reported, and 3 cases were observed in the present series. One of them was diagnosed by the operator and treated by implantation of a metallic stent at 42 days 5,31 ; 2 other cases were retrospectively diagnosed by the core laboratory. At follow-up, persistent or acquired signs of discontinuity on OCT are reported in Table 6.…”

Section: Strut Discontinuity At 2 Years a Common Sign Of Bioresorptionsupporting

confidence: 65%

“…Angiography revealed a nonsignificant stenosis of 23% DS, with OCT documentation of strut discontinuity happening at the index procedure. 5,31,32 In 1 patient, the planned angiography at 6 months disclosed a significant proximal edge restenosis (QCA, 64%; FFR, 0.72) of presumably iatrogenic origin because of the deep engagement of a left Amplatz catheter up to the mid portion of the right coronary artery at the index procedure. 5 At 12 months, 1 patient presented with recurrent angina, and angiography demonstrated a proximal edge restenosis, presumably because of angiographic miss of the balloon predilation at the index procedure.…”

Section: Cohort With Serial Imaging At 6 and 24 Monthsmentioning

confidence: 99%

“…5 One case of periprocedural strut discontinuity caused by overstretching of a scaffold has been previously reported. 31 One baseline OCT was not available but strut discontinuity was detected at 6 months and persisted at 2 years. Two cases had no discontinuities at baseline but showed signs of discontinuity at 6 months: one persisted and the other resolved at 2 years.…”

Section: Optical Coherence Tomographymentioning

confidence: 99%

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First Serial Assessment at 6 Months and 2 Years of the Second Generation of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold

Ormiston

Serruys

Onuma

et al. 2012

Circ: Cardiovascular Interventions

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194

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Background-Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confirm the absence of late restenosis or unfavorable imaging outcomes. Methods and Results-The ABSORB trial is a multicenter single-arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm 2 on optical coherence tomography and 0.17±0.26 mm 2 on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm 2 on intravascular ultrasound, P=0.003 and 0.77±1.33 m 2 on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis. Key Words: coronary artery disease ◼ coronary intervention and bioresorbable scaffold Conclusions-This

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Section: Strut Discontinuity At 2 Years a Common Sign Of Bioresorptionsupporting

confidence: 65%

Section: Cohort With Serial Imaging At 6 and 24 Monthsmentioning

confidence: 99%

Section: Optical Coherence Tomographymentioning

confidence: 99%

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First Serial Assessment at 6 Months and 2 Years of the Second Generation of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold

Ormiston

Serruys

Onuma

et al. 2012

Circ: Cardiovascular Interventions

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194

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“…They proposed this complication was related to over -expansion of the device [14]. Going along with this theory, in 2011 Ormiston et al [15] reported a case of strut disruption in a second generation BVS: an Absorb 1.1 scaffold which had been postdilatated for two times at 24 atm and 16 atm. Further studies with second generation BVS also show low rates of strut disruption but only in OCT analyses, not on IVUS ones [2,3].…”

Section: Discussionmentioning

confidence: 99%

“…This external layer is the one which supports and controls the everolimus eluting process. The scaffold is available in different diameters (2.5, 3.0, 3.5 mm) and lengths (15,18, 23 and 28 mm), and we have chosen the most appropriate ones according to each lesion characteristics. Radial tension of this bioresorbable device is comparable to previously described radial tension in most bare metal stents.…”

Section: Devices and Optical Coherence Tomographymentioning

confidence: 99%

“Assessment of effectiveness and security in high pressure postdilatation of bioresorbable vascular scaffolds during percutaneous coronary intervention. Study in a contemporary, non-selected cohort of Spanish patients”

Abellás-Sequeiros¹,

Ocaranza-Sánchez²,

Braga

et al. 2016

International Journal of Cardiology

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Objectives: To determine security and benefits of high pressure postdilatation (HPP) of bioresorbable vascular scaffolds (BVS) in percutaneous coronary intervention (PCI) of complex lesions whatever its indication is. Background: Acute scaffold disruption has been proposed as the main limitation of BVS when they are overexpanded. However, clinical implications of this disarray are not yet clear and more evidence is needed. Methods: A total of 25 BVS were deployed during PCI of 14 complex lesions after mandatory predilatation. In all cases HPP was performed with NC balloon in a 1:1 relation to the artery. After that, optical coherence tomography (OCT) analyses were performed. Results: Mean and maximal postdilatation pressure were 17 ± 3.80 and 20 atmospheres (atm) respectively. Postdilatation balloon/scaffold diameter ratio was 1.01. A total of 39,590 struts were analyzed. Mean, minimal and maximal scaffold diameter were respectively: 3.09 ± 0.34 mm, 2.88 ± 0.31 mm and 3.31 ± 0.40 mm. Mean eccentricity index was 0.13 ± 0.05. ISA percentage was 1.42% with a total of 564 malapposed struts. 89 struts were identified as disrupted, which represents a percentage of disrupted struts of 0.22%. At 30 days, none of our patients died, suffered from stroke, stent thrombosis or needed target lesion revascularization (TLR). Conclusions: NC balloon HPP of BVS at more than 17 atm (up to 20 atm) is safe during PCI and allows to achieve better angiographic and clinical results.

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Expansion and malapposition characteristics after bioresorbable vascular scaffold implantation

Brown

McCormick

Braganza

et al. 2014

Cathet Cardio Intervent

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Bioresorbable Polymeric Vascular Scaffolds

Cited by 76 publications

References 3 publications

First Serial Assessment at 6 Months and 2 Years of the Second Generation of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold

First Serial Assessment at 6 Months and 2 Years of the Second Generation of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold

“Assessment of effectiveness and security in high pressure postdilatation of bioresorbable vascular scaffolds during percutaneous coronary intervention. Study in a contemporary, non-selected cohort of Spanish patients”

Expansion and malapposition characteristics after bioresorbable vascular scaffold implantation

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