Wu Ridong, Yang Qingqi, Wang Mian, Li Zilun, Yao Chen, Chang Guangqi
Department of Vascular Surgery, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.
CVIR Endovasc. 2025 Jan 7;8(1):3. doi: 10.1186/s42155-024-00501-2.
To evaluate the safety and efficacy of chocolate balloons in patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, and compare them with conventional balloons.
This single-center retrospective study included 167 patients with CLTI and infrapopliteal who underwent endovascular intervention with or without chocolate balloons from September 1, 2019 to June 30, 2023. The primary endpoint was amputation-free survival (AFS). Secondary endpoints included major amputation, the absence of clinically driven target lesion revascularization (CD-TLR), the incidence of flow-limiting dissection, below-the-knee (BTK) stent implantation, change in Rutherford clinical grade, procedural success, and major adverse cardiovascular events (MACEs). Patients were followed at 30 days, 6 months, and 12 months to assess symptom improvement, vascular patency as determined by dual-function ultrasound or angiography, and survival.
At 12 months, AFS was noted in 78.1% of patients in chocolate balloon group and 70.7% of those in conventional balloon group (p = 0.37). The chocolate balloon group demonstrated a significantly higher rate of CD-TLR absence, with 84.0% compared to 69.4% in the conventional balloon group (p = 0.04). The chocolate balloon group had a major amputation-free rate of 92.8%, slightly better than the 89.5% in the conventional balloon group (p = 0.58). Notably, the chocolate balloon group significantly reduced flow-limiting dissection (p = 0.02) and BTK stent implantation (p = 0.03) compared to the conventional balloon group.
Chocolate balloon reduces the incidence of flow-limiting dissection and BTK stent implantation in patients with CLTI and infrapopliteal. Compared with conventional balloons, there was less lesion revascularization at 12 months, but no significant benefit was found in improving ASF and reducing major amputation of the affected limb.
评估巧克力球囊用于慢性肢体威胁性缺血（CLTI）和腘下动脉疾病患者的安全性和有效性，并与传统球囊进行比较。
这项单中心回顾性研究纳入了167例CLTI和腘下动脉疾病患者，这些患者在2019年9月1日至2023年6月30日期间接受了有或没有巧克力球囊的血管内介入治疗。主要终点是无截肢生存（AFS）。次要终点包括大截肢、无临床驱动的靶病变血运重建（CD-TLR）、限流性夹层的发生率、膝下（BTK）支架植入、卢瑟福临床分级的变化、手术成功率和主要不良心血管事件（MACE）。在30天、6个月和12个月时对患者进行随访，以评估症状改善情况、通过双功能超声或血管造影确定的血管通畅情况以及生存率。
在12个月时，巧克力球囊组78.1%的患者实现了AFS，传统球囊组为70.7%（p = 0.37）。巧克力球囊组CD-TLR缺失率显著更高，为84.0%，而传统球囊组为69.4%（p = 0.04）。巧克力球囊组的无大截肢率为92.8%，略高于传统球囊组的89.5%（p = 0.58）。值得注意的是，与传统球囊组相比，巧克力球囊组显著降低了限流性夹层（p = 0.02）和BTK支架植入（p = 0.03）的发生率。
巧克力球囊降低了CLTI和腘下动脉疾病患者限流性夹层和BTK支架植入的发生率。与传统球囊相比，12个月时病变血运重建较少，但在改善AFS和减少患侧肢体大截肢方面未发现显著益处。
