Department of Surgery, Kyungpook National University Chilgok Hospital, Kyungpook National University School of Medicine, Daegu, South Korea.
Department of Surgery, Daegu-Catholic University of Medicine, Daegu, South Korea.
Ann Vasc Surg. 2023 Jul;93:291-299. doi: 10.1016/j.avsg.2023.01.048. Epub 2023 Feb 4.
Thrombi are common in steno-occlusive lesions of infrainguinal atherosclerotic diseases. Despite the easy passage of guidewires through these lesions, conventional ballooning or stenting cannot effectively treat them, and patients are at risk of distal embolization. This study aimed to investigate the clinical outcomes of using a rotational aspiration atherectomy system to treat infrainguinal atherosclerotic disease.
Patients underwent revascularization of target lesions using the Jetstream™ Atherectomy System. The primary endpoint was the freedom from clinically driven target lesion revascularization (CD-TLR) 12-month after the procedure. Outcomes were evaluated according to the clinical severity, lesion type, use of drug-coated balloons (DCBs), and lesion length, characteristics, and sites. Survival analysis for CD-TLR over time was plotted. All statistical analyses were performed using SPSS version 22 (IBM; Armonk, NY, USA). P-values <0.05 were considered statistically significant.
In total, 150 patients (91.2% male; mean age, 69.8 years; 66.2% with diabetes) with de novo or restenotic infrainguinal lesions were enrolled. The mean lesion length was 17.2 cm, 75.0% were occlusive, and 38.2% had severe calcification. The lesion types were sclerotic (64.7%), thrombosclerotic (20.6%), thrombotic (8.8%), and in-stent (5.9%). Adjunctive DCB was used in 86.8% of patients. The 12-month primary patency rate (PPR) and CD-TLR rates were 81.6% and 90.1%, respectively. The 12-month CD-TLR rate was significantly better in the sclerotic and thrombosclerotic groups than in the thrombotic group (100% and 100% vs. 66.7%; P = 0.001). The 12-month PPR was significant better in TransAtlantic Inter-Society Consensus (TASC) A and B groups than TASC C and D groups (P = 0.02). The 12-month PPR is significantly better after using a DCB or stent placement than after using a simple balloon (P = 0.01). There were no major adverse events, including procedure-related death, myocardial infarction, or major amputation.
The results of this study demonstrated the safety and effectiveness of the Jetstream atherectomy device for complex infrainguinal lesions. This system functions optimally with TASC A/B lesions and sclerotic or thrombosclerotic lesions.
血栓在下肢动脉粥样硬化狭窄闭塞性病变中很常见。尽管导丝很容易通过这些病变，但传统的球囊扩张或支架置入术不能有效地治疗这些病变，患者有远端栓塞的风险。本研究旨在探讨使用旋转抽吸动脉切除术系统治疗下肢动脉粥样硬化疾病的临床效果。
患者使用 Jetstream™动脉切除术系统对靶病变进行血运重建。主要终点是术后 12 个月时免于临床驱动的靶病变血运重建（CD-TLR）。根据临床严重程度、病变类型、使用药物涂层球囊（DCB）以及病变长度、特征和部位对结果进行评估。绘制 CD-TLR 随时间的生存分析曲线。所有统计分析均使用 SPSS 版本 22（IBM；Armonk，NY，USA）进行。P 值<0.05 被认为具有统计学意义。
共纳入 150 例初发或再狭窄的下肢动脉病变患者（91.2%为男性；平均年龄 69.8 岁；66.2%合并糖尿病）。平均病变长度为 17.2cm，75.0%为闭塞性病变，38.2%有严重钙化。病变类型为硬化性（64.7%）、血栓性（20.6%）、血栓形成性（8.8%）和支架内（5.9%）。86.8%的患者辅助使用了 DCB。12 个月时的主要通畅率（PPR）和 CD-TLR 率分别为 81.6%和 90.1%。硬化性和血栓性病变组的 12 个月 CD-TLR 率明显优于血栓形成性病变组（100%和 100%比 66.7%；P=0.001）。TASC A 和 B 组的 12 个月 PPR 明显优于 TASC C 和 D 组（P=0.02）。与单纯球囊扩张相比，使用 DCB 或支架置入后 12 个月 PPR 明显更好（P=0.01）。无主要不良事件，包括与手术相关的死亡、心肌梗死或主要截肢。
本研究结果表明 Jetstream 动脉切除术系统治疗复杂下肢动脉病变的安全性和有效性。该系统在 TASC A/B 病变和硬化性或血栓性病变中效果最佳。
