Virmani Renu, Finn Aloke V, Kutyna Matthew, Sato Yu, Meess Karen, Smith Cody, Chisena Robert S, Gurm Hitinder S, George Jon C
CVPath Institute, Gaithersburg, MD, USA.
The Jacobs Institute, Buffalo, NY, USA.
Cardiovasc Revasc Med. 2023 May;50:43-53. doi: 10.1016/j.carrev.2023.01.003. Epub 2023 Jan 10.
To assess the feasibility and treatment effect of pulsatile intravascular lithotripsy (PIVL) on calcified lesions in a cadaveric model of peripheral artery disease.
PIVL represents a novel potential approach to intravascular lithotripsy for the treatment of vascular calcification.
In this preclinical device-feasibility study, technical success, calcium morphology and luminal expansion before and after PIVL treatment were evaluated in surgically isolated, perfused atherosclerotic lower-leg arteries and in perfused whole cadaveric lower legs. Analytical methods included micro-computed tomography (μCT), intravascular optical coherence tomography, digital subtraction angiography, and quantitative coronary analysis.
Treatment delivery was successful in all whole-leg specimens (N = 6; mean age 74.2, 66 % female) and in the 8 excised vessels with diameter appropriate to the PIVL balloon (2 vessels exceeding diameter specifications were excluded). There were no vessel perforations. After PIVL, excised vessels showed extensive evidence of new, full-thickness fractures in lesions with calcium arc exceeding 152° and with calcium wall thickness between 0.24 mm and 1.42 mm. PIVL fractures were observed in intimal nodules, sheets, shingles, and medial plates. Vessels within whole-leg specimens also showed full-thickness fracturing and a mean of 1.9 ± 0.9 mm in acute luminal gain, 101.6 ± 99.5 % gain in total minimum cross-sectional area, and a 31.7 ± 13.4 % relative reduction in stenosis (P < 0.001 for all analyses).
In a cadaveric model, PIVL treatment was technically feasible, fractured both circumferential and eccentric calcium lesions, and resulted in acute luminal gain. A clinical feasibility study of PIVL is currently enrolling.
在周围动脉疾病的尸体模型中评估脉冲式血管内碎石术（PIVL）治疗钙化病变的可行性和治疗效果。
PIVL是一种用于血管内碎石术治疗血管钙化的新型潜在方法。
在这项临床前设备可行性研究中，对手术分离并灌注的动脉粥样硬化小腿动脉以及灌注的完整尸体小腿进行PIVL治疗前后的技术成功率、钙形态和管腔扩张情况进行评估。分析方法包括微计算机断层扫描（μCT）、血管内光学相干断层扫描、数字减影血管造影和定量冠状动脉分析。
治疗在所有全腿标本（N = 6；平均年龄74.2岁，66%为女性）以及8条直径适合PIVL球囊的切除血管中成功实施（排除2条超过直径规格的血管）。未发生血管穿孔。PIVL治疗后，切除的血管显示，在钙弧超过152°且钙壁厚度在0.24毫米至1.42毫米之间的病变中，有广泛的新的全层骨折迹象。在内膜结节、片状、带状和中层板中观察到PIVL骨折。全腿标本中的血管也显示出全层骨折，急性管腔增益平均为1.9±0.9毫米，总最小横截面积增益为101.6±99.5%，狭窄相对降低31.7±13.4%（所有分析P<0.001）。
在尸体模型中，PIVL治疗在技术上是可行的，可使圆周形和偏心性钙病变骨折，并导致急性管腔增益。目前正在进行PIVL的临床可行性研究。
