Intravascular treatment of long segments of experimental peripheral arteries with multiple, serial, balloon-expandable, resorbable scaffolds.
Intravascular treatment of long segments of experimental peripheral arteries with multiple, serial, balloon-expandable, resorbable scaffolds.
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DOI：
10.1016/j.jvssci.2022.03.002
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发表时间：
2022
期刊：
影响因子：
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通讯作者：
Schwartz, Lewis B
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作者：
El Khoury, Rym;Tzvetanov, Ivan;Estrada, Edward A;McCarroll, Edward;Michal, Eugene;Blumeyer, Jack;Guy, Louis-Georges;Laflamme, Martin;Schwartz, Lewis B
有症状的股腘动脉闭塞性疾病越来越多地使用血管内方法治疗。然而，再狭窄，特别是植入永久性金属支架后，仍然很常见。迄今为止，可吸收支架未能达到足够的径向强度，无法成功治疗长而可移动的外周动脉。在目前的非存活大型动物实验中，一种新型装置由多个，短的，连续的，气球可膨胀的，生物可吸收的支架组成，用于遭受超生理变形的动脉。与天然血管相比，支架动脉继续弯曲（113°±19°vs 110°±20°，P = 0.10）和缩短（15%±15% vs 20%±14%,P = 0.16），而不受放置研究装置的影响。支架动脉的平均管腔直径在过度屈曲时保持不变，无扭结或闭塞（4.7±0.7 vs 4.7±0.5 mm; P = 0.80）。动脉变形是由支架间隙缩短（伸展和屈曲分别为2.2±0.8 mm和1.9±0.7 mm, P < 0.01）和支架本身缩短（伸展和屈曲分别为10.7±1.4 mm和9.9±1.1 mm, P < 0.01）造成的。本研究的结果挑战了植入外周活动动脉的球囊可膨胀装置的局限性。我们提出了一种生物可吸收的支架，它结合了足够的径向强度，以保持平均腔直径与运动和灵活性，以适应股腘变形。在目前的研究中，我们描述了一种使用生物可吸收支架治疗股腘动脉闭塞性疾病的新治疗模式。聚乳酸基支架的球囊膨胀性和材料特性与短节段结构相结合，提供了径向力来抵抗下肢动脉的生理性机械变形，同时伴随其自然运动。在本研究中，对急性动物模型进行了测试，该实验装置目前正在进行首次人体临床试验（ClinicalTrials.gov识别符，NCT04584632）。
Symptomatic femoropopliteal occlusive disease has been increasingly treated using endovascular methods. However, restenosis, especially after implantation of permanent metallic stents, has remained common. To date, resorbable scaffolds have failed to achieve sufficient radial strength to enable the successful treatment of long, mobile, peripheral arteries. In the present nonsurvival, large animal experiment, a novel device consisting of multiple, short, serial, balloon-expandable, bioresorbable scaffolds was deployed in arteries subjected to supraphysiologic deformation. Compared with native vessels, the scaffolded arteries continued to bend (113° ± 19° vs 110° ± 20°; P = .10) and shorten (15% ± 15% vs 20% ± 14%; P = .16), unencumbered by the placement of the investigational device. The mean luminal diameter of the scaffolded arteries was preserved without kinks or occlusions in exaggerated flexion (4.7 ± 0.7 vs 4.7 ± 0.5 mm in extension vs flexion; P = .80). Arterial deformation was borne by shortening of the interscaffold spaces (2.2 ± 0.8 mm vs 1.9 ± 0.7 mm in extension vs flexion; P < .01) and the scaffolds themselves (10.7 ± 1.4 mm vs 9.9 ± 1.1 mm in extension vs flexion; P < .01). The results from the present study challenge the perceived limitations of balloon-expandable devices implanted in peripheral mobile arteries. We have presented a bioresorbable scaffold that combines sufficient radial strength to preserve the mean luminal diameter with movement and the flexibility to accommodate femoropopliteal deformation. In the present study, we have described a novel treatment paradigm for femoropopliteal arterial occlusive disease using bioresorbable scaffolds. The balloon-expandable nature and material properties of the polylactide-based scaffolds combined with the short and segmented configuration provided the radial force to resist the physiologic mechanical deformation of the lower extremity artery while accompanying its natural motion. In the present study an acute animal model was tested, and the experimental device is now undergoing a first-in-human clinical trial (ClinicalTrials.gov identifier, NCT04584632).