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Long-term safety and absorption assessment of a novel bioresorbable nitrided iron scaffold in porcine coronary artery.

ABSTRACT: This study aimed to investigate the long-term biocompatibility, safety, and degradation of the ultrathin nitrided iron bioresorbable scaffold (BRS) in vivo, encompassing the whole process of bioresorption in porcine coronary arteries. Fifty-two nitrided iron scaffolds (strut thickness of 70 μm) and 28 Vision Co-Cr stents were randomly implanted into coronary arteries of healthy mini-swine. The efficacy and safety of the nitrided iron scaffold were comparable with those of the Vision stentwithin 52 weeks after implantation. In addition, the long-term biocompatibility, safety, and bioresorption of the nitrided iron scaffold were evaluated by coronary angiography, optical coherence tomography, micro-computed tomography, scanning electron microscopy, energy dispersive spectrometry and histopathological evaluations at 4, 12, 26, 52 weeks and even at 7 years after implantation. In particular, a large number of struts were almost completely absorbed in situ at 7 years follow-up, which were first illustrated in this study. The lymphatic drainage pathway might serve as the potential clearance way of iron and its corrosion products.

SUBMITTER: Zheng JF

PROVIDER: S-EPMC8976101 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Long-term safety and absorption assessment of a novel bioresorbable nitrided iron scaffold in porcine coronary artery.

Zheng Jian-Feng JF Xi Zi-Wei ZW Li Yang Y Li Jia-Nan JN Qiu Hong H Hu Xiao-Ying XY Luo Tong T Wu Chao C Wang Xin X Song Lai-Feng LF Li Li L Qi Hai-Ping HP Zhang Gui G Qin Li L Zhang Wan-Qian WQ Shi Xiao-Li XL Wang Shu-Han SH Zhang De-Yuan DY Xu Bo B Gao Run-Lin RL

Bioactive materials 20220111

This study aimed to investigate the long-term biocompatibility, safety, and degradation of the ultrathin nitrided iron bioresorbable scaffold (BRS) in vivo, encompassing the whole process of bioresorption in porcine coronary arteries. Fifty-two nitrided iron scaffolds (strut thickness of 70 μm) and 28 Vision Co-Cr stents were randomly implanted into coronary arteries of healthy mini-swine. The efficacy and safety of the nitrided iron scaffold were comparable with those of the Vision stentwithin ...[more]

PMID: 35415293

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Project description:BackgroundCoronary artery perforation is a rare but potentially lethal complication of percutaneous coronary intervention (PCI) with an associated mortality of 7-17%. We report the case of coronary artery perforation complicating Absorb bioresorbable vascular scaffold (BVS) implantation and the associated technical challenges with managing this life-threatening complication.Case reportA 46-year-old male was referred to our institution and underwent PCI with an Absorb bioabsorbable vascular scaffold (BVS) to a proximal LAD long segment bifurcation lesion. Following pre-dilation and deployment of the 3.5 × 28 mm Absorb BVS, high pressure post-dilation of the distal scaffold was complicated by a large, Ellis type III coronary perforation with no flow to the distal LAD beyond the rupture, and associated with a large pericardial effusion confirmed on bedside transthoracic echocardiogram (TTE). The insult was temporised with prolonged balloon inflation within the Absorb BVS immediately proximal to the site of perforation, permitting urgent insertion of a pericardial drain. After deflation of the balloon, a 3.0 × 21 mm BeGraft covered stent was deployed across the perforation, restoring normal LAD flow and abolishing the perforation. Cardio-pulmonary resuscitation was not required and the patient remained conscious throughout the procedure. TTE demonstrated normal left ventricular function and the patient was discharged 3 days later. Repeat angiography at 3 months showed patent stents with TIMI III flow, and optical coherence tomography (OCT) showed good expansion and apposition of the proximal Absorb BVS and BeGraft. The patient has remained well 4 years after PCI with no major cardiovascular events.ConclusionThe utility of bioresorbable scaffold technology remains controversial although meticulous implantation techniques are associated with improved clinical outcomes. Adoption of the Pre-dilatation, Sizing and Post-dilatation ('PSP') method of BVS implantation with routine aggressive vessel preparation and scaffold optimization however may contribute to a higher risk of vessel perforation. The case emphasises the importance of accurate sizing of the vessel with intracoronary imaging and demonstrates the value of newer generation covered stents with single-layer design and slimmer crossing profile producing improved deliverability and procedural success.

Project description:BackgroundBioresorbable scaffolds (BRS) were developed to overcome limitations related to late stent failures of drug-eluting stents, but lumen reductions over time after implantation of BRS have been reported. This study aimed to investigate if lesion preparation with a scoring balloon compared with a standard noncompliant balloon minimizes lumen reduction after implantation of a Magmaris BRS assessed with optical coherence tomography and intravascular ultrasound.MethodsEighty-two patients with stable angina were randomized in a ratio of 1:1 to lesion preparation with a scoring balloon versus a standard noncompliant balloon before implantation of a Magmaris BRS. The primary end point was minimal lumen area at 6-month follow-up.ResultsFollowing Magmaris BRS implantation, minimal lumen area (6.4±1.6 versus 6.3±1.5 mm2; P=0.65), mean scaffold area (7.8±1.5 versus 7.5±1.7 mm2; P=0.37), and mean lumen area (8.0±1.6 versus 7.7±2.1 mm2; P=0.41) did not differ significantly in patients with lesions prepared with scoring versus standard noncompliant balloon, respectively. Six-month angiographic follow-up with optical coherence tomography and intravascular ultrasound was available in 74 patients. The primary end point, 6-month minimal lumen area, was significantly larger in lesions prepared with a scoring balloon compared with a standard noncompliant balloon (4.7±1.4 versus 3.9±1.9 mm2; P=0.04), whereas mean lumen area (7.2±1.4 versus 6.8±2.2 mm2; P=0.35) did not differ significantly. Intravascular ultrasound findings showed no difference in mean vessel area at the lesion site from baseline to follow-up in the scoring balloon group (16.8±2.9 versus 17.0±3.6 mm2; P=0.62), whereas mean vessel area (17.1±4.4 versus 15.7±4.9 mm2; P<0.001) was smaller in lesions prepared with a standard noncompliant balloon due to negative remodeling.ConclusionsLesion preparation with a scoring balloon before implantation of a Magmaris BRS resulted in a significantly larger minimal lumen area after 6 months due to less negative remodeling compared with lesion preparation with a standard noncompliant balloon.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT04666584.

Dataset Information

Long-term safety and absorption assessment of a novel bioresorbable nitrided iron scaffold in porcine coronary artery.

Publications

Long-term safety and absorption assessment of a novel bioresorbable nitrided iron scaffold in porcine coronary artery.

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