■据估计,在30%至50%的外周动脉疾病(PAD)患者中存在血管钙化,并且是血管内治疗的主要挑战之一。与其他动脉相比,the动脉是独特的,因为它在膝盖运动过程中暴露于显着的变形和生物力学应力。血管内碎石术(IVL)是一种新颖的技术,使用声压波来引起内膜和内壁钙化内的微骨折。血管内碎石术是安全的股骨和膝下病变,但缺乏后续研究。因此,这项研究的目的是描述IVL在the和the下动脉疾病中的首次随访结局。
■这个前景,多中心队列研究包括在4个部位的pop动脉和pop下动脉接受IVL治疗的所有患者。预定在6至8周和12个月进行双工超声检查的标准化随访。主要安全终点是30天主要不良事件(MAE)的复合。主要疗效终点是主要通畅,肢体抢救,12个月时无截肢生存期(AFS)。次要终点为原发辅助通畅性和无靶病变血运重建(TLR)。对患有慢性威胁肢体缺血(CLTI)和间歇性跛行(IC)的患者进行终点分布,并使用Kaplan-Meier方法进行估算。
■在2021年4月至2023年3月之间,对29例30肢的患者进行了治疗。62.1%和80.0%的患者存在糖尿病(DM)和CLTI,分别。在32个治疗的病变中,84.4%的患者出现严重钙化,12.5%的患者需要支架置入.30天内发生4次MAE:1次关闭装置故障,1大截肢,2人死亡,两者均与研究设备无关。主要的通畅性,初级辅助通畅,免于TLR,肢体抢救,12个月的AFS为68.8%,90.0%,93.3%,83.9%,CLTI患者为57.1%,分别。再狭窄无事件发生,重新遮挡,TLR,严重截肢,或IC患者的死亡率。
■这项首次分析显示了静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内静脉内
结论:血管钙化是外周动脉疾病(PAD)的共同特征,是血管内治疗的主要挑战之一。在膝关节运动过程中,the动脉受到生物力学应力,这使得支架置入术没有吸引力,并且经常导致更差的临床结果。这项研究旨在描述IVL在the和the下动脉疾病中的首次随访结果。与以前的研究一样,未发现相关的手术并发症,支架的纾困率仅为12.5%.此外,在复杂的患者群体中,这项研究显示了有希望的安全性和有效性结局.有必要将IVL与单独的血管成形术或其他血管准备装置进行比较,以治疗the和the下动脉疾病。
UNASSIGNED: Vessel calcification is estimated to be present in 30% to 50% of patients with peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The
popliteal artery is unique compared with other arteries due to its exposure to significant deformation and biomechanical stress during knee motion. Intravascular lithotripsy (IVL) is a novel technique that uses acoustic pressure waves to cause microfractures within the intimal and medial wall calcification. Intravascular lithotripsy is safe in femoropopliteal and infrapopliteal lesions, but follow-up studies are lacking. Therefore, the purpose of this study was to describe the first follow-up outcomes of IVL in
popliteal and infrapopliteal arterial disease.
UNASSIGNED: This prospective, multicenter cohort study included all patients treated with IVL in the
popliteal and infrapopliteal arteries at 4 sites. Standardized follow-up with duplex ultrasonography was scheduled at 6 to 8 weeks and 12 months. The primary safety endpoint was a composite of major adverse events (MAEs) at 30 days. Primary efficacy endpoints were primary patency, limb salvage, and amputation-free survival (AFS) at 12 months. Secondary endpoints were primary-assisted patency and freedom from target lesion revascularization (TLR). Endpoints were distributed for patients with chronic limb-threatening ischemia (CLTI) and intermittent claudication (IC) and estimated using the Kaplan-Meier method.
UNASSIGNED: Between April 2021 and March 2023, 29 patients with 30 limbs were treated. Diabetes mellitus (DM) and CLTI were present in 62.1% and 80.0% of patients, respectively. Within the 32 treated lesions, severe calcification was present in 84.4% and bailout stenting was necessary in 12.5% of the lesions. Four MAEs occurred within 30 days: 1 closure device failure, 1 major amputation, and 2 deaths, neither of which was related to the study device. The primary patency, primary-assisted patency, freedom from TLR, limb salvage, and AFS at 12 months were 68.8%, 90.0%, 93.3%, 83.9%, and 57.1% for CLTI patients, respectively. No events occurred in restenosis, re-occlusion, TLR, major amputation, or mortality in patients with IC.
UNASSIGNED: This first-ever analysis on follow-up outcomes of IVL in the popliteal and infrapopliteal arteries demonstrated promising safety and efficacy outcomes with a low rate of bailout stenting.
CONCLUSIONS: Vessel calcification is a common feature in peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The
popliteal artery is subjected to biomechanical stress during knee motion, which makes stenting unappealing and often leads to worse clinical outcomes. This study aimed to describe the first follow-up outcomes of IVL in
popliteal and infrapopliteal arterial disease. As in line with previous studies, no relevant procedural complications were found and the rate of bail-out stenting was only 12.5%. Moreover, in a complex patient population, this study demonstrated promising safety and efficacy outcomes. The comparison of IVL with angioplasty alone or other vessel preparation devices for popliteal and infrapopliteal arterial disease is warranted.