Department of Vascular Surgery, Ludwig-Maximilians-University Hospital Munich, Munich, Germany.
Department of Vascular Surgery, St. Franziskus-Hospital GmbH, Münster, Germany.
J Endovasc Ther. 2024 Dec;31(6):1165-1172. doi: 10.1177/15266028231158313. Epub 2023 Mar 10.
Intravascular lithotripsy (IVL) followed by drug-coated balloon (DCB) angioplasty might be a valuable alternative to surgery for calcified common femoral artery (CFA) atherosclerotic disease. Nonetheless, the 12 months performance of this treatment strategy remains unknown. This study reports on the 12 months outcomes of IVL with adjunctive DCB angioplasty for calcified CFA lesions.
This is a retrospective single-center, single-arm study. Consecutive patients treated by IVL and DCB for calcified CFA disease between February 2017 and September 2020 were evaluated. The primary measure outcome of this analysis was primary patency. Procedural technical success (<30% stenosis), freedom from target lesion revascularization (TLR), secondary patency, and overall mortality were additionally analyzed.
Thirty-three (n=33) patients were included in this study. The majority presented with lifestyle limiting claudication (n=20, 61%), 52% (n=17) of the patients had chronic kidney disease (CKD) and 33% (n=11) had diabetes. The procedural technical success was 97% (n=32). A flow-limiting dissection post IVL was observed in 2 patients (6%) and a peripheral embolization in a single patient (3%), while the bail-out stenting rate amounted to 12% (n=4). No perforation was observed. The median length of hospital stay was 2 days (interquartile range 2-3). At 12 months, the primary patency was 72%. The freedom from TLR and the secondary patency rates were 94% and 88%, respectively. The 12-month survival amounted to 100% and 75% (n=25) of the patients were asymptomatic or presented with mild claudication. The presence of chronic limb-threatening ischemia (CLTI) (hazard ratio [HR], 0.92; confidence interval (CI); 0.18-4.8, p=0.7) or CKD (HR, 1.30; 95% CI, 0.29-5.8; p=0.72), as well as the use of a 7 mm IVL catheter (HR, 0.59; 95% CI, 0.13-2.63; p=0.49) or of high-dose DCB (HR, 0.68; 95% CI, 0.13-3.53; p=0.65) did not influence the primary patency.
In this study, the combination of IVL and DCB angioplasty for calcified CFA disease was associated with low risk for periprocedural complications, acceptable 12 months clinical outcomes, and low rates of reinterventions.
Intravascular lithotripsy in combination with DCB angioplasty can be an alternative to surgery in highly selected patients with CFA atherosclerotic disease. In this Cohort the combination therapy lead to acceptable clinical results and low reintervention rates at 12 months.
血管内碎石术（IVL）联合药物涂层球囊（DCB）血管成形术可能是治疗钙化性股总动脉（CFA）动脉粥样硬化疾病的一种有价值的替代手术方法。尽管如此，这种治疗策略的 12 个月疗效仍不清楚。本研究报告了 IVL 联合 DCB 血管成形术治疗钙化性 CFA 病变的 12 个月结果。
这是一项回顾性的单中心、单臂研究。连续评估了 2017 年 2 月至 2020 年 9 月期间因钙化性 CFA 疾病接受 IVL 和 DCB 治疗的患者。本分析的主要疗效终点是初始通畅率。此外还分析了手术技术成功率（<30%狭窄）、无靶病变血运重建（TLR）率、次级通畅率和总死亡率。
本研究共纳入 33 例患者。大多数患者表现为生活受限性跛行（n=20，61%），52%（n=17）的患者患有慢性肾脏病（CKD），33%（n=11）的患者患有糖尿病。手术技术成功率为 97%（n=32）。2 例患者（6%）在 IVL 后出现血流受限性夹层，1 例患者（3%）出现外周栓塞，紧急支架置入率为 12%（n=4）。未观察到穿孔。中位住院时间为 2 天（四分位距 2-3）。12 个月时，初始通畅率为 72%。无 TLR 率和次级通畅率分别为 94%和 88%。12 个月的生存率为 100%，75%（n=25）的患者无症状或仅有轻度跛行。慢性肢体威胁性缺血（CLTI）（风险比 [HR]，0.92；置信区间 [CI]，0.18-4.8，p=0.7）或 CKD（HR，1.30；95% CI，0.29-5.8；p=0.72）的存在，以及使用 7mm IVL 导管（HR，0.59；95% CI，0.13-2.63；p=0.49）或高剂量 DCB（HR，0.68；95% CI，0.13-3.53；p=0.65）均不影响初始通畅率。
在这项研究中，IVL 联合 DCB 血管成形术治疗钙化性 CFA 疾病的联合治疗具有围手术期并发症风险低、12 个月临床结果可接受、再干预率低的特点。
血管内碎石术联合 DCB 血管成形术可作为 CFA 动脉粥样硬化疾病高度选择患者的手术替代方法。在这个队列中，联合治疗在 12 个月时导致了可接受的临床结果和较低的再介入率。
