Abstract:Background and Aims Graft materials such as covered stents and artificial vascular grafts have been widely used to treat peripheral arterial disease (PAD). However, the increasing prevalence of chronic graft thrombosis and chronic lower limb arterial thrombosis has brought attention to the challenge of removing chronic thrombi. This study evaluated the feasibility of using the Rotarex mechanical thrombectomy system for treating chronic thrombosis formation in PAD patients.Methods A retrospective analysis was conducted on the clinical data of 10 PAD patients with chronic thrombosis admitted consecutively to the Department of Vascular Surgery, Hainan Provincial People's Hospital, from July 2023 to December 2023. All patients were male, with an average age of (70.4±8.6) years. The cohort included five synthetic graft cases, one with a covered stent and four with autologous arteries. The occlusion sites included the iliac artery (2 cases), superficial femoral artery (7 cases), and popliteal artery (4 cases), with a median occlusion duration of 5.5 (3-38) months. The Rotarex mechanical thrombectomy system was used in combination with balloon angioplasty or stent implantation to restore lower limb blood flow. The debulking success rate, procedural success rate, and changes in hemoglobin (Hb), and ankle-brachial index (ABI) were evaluated. Patients were followed up at 3 and 6 months after operation with ultrasound examination, Rutherford classification, and ABI assessment.Results The Rotarex mechanical thrombectomy achieved a 100% success rate in both debulking and procedural outcomes. The median operative time was 150 (120-270) min. All patients underwent percutaneous transluminal angioplasty (PTA) following thrombectomy. Nine stents were deployed in six patients: five in the distal segments of the occluded vessels, three in the proximal segments, and one fully covering the diseased segment. Preoperative Hb was (131.30±24.55) g/L, which decreased to (114.20±25.28) g/L postoperatively, showing a statistically significant difference (t=4.253, P=0.002). The preoperative ABI was 0.46±0.15, which improved to 0.95±0.19 postoperatively, also showing a significant difference (t=17.528, P<0.001). No perioperative complications, such as distal arterial embolism, arterial injury, or acute renal dysfunction, were observed. The follow-up rate was 100% at 3 months and 80% at 6 months. At 3 months, ultrasound examinations showed patent target vessels in all patients, with Rutherford classification of grade 0 in 8 cases and grade 1 in 2 cases and an ABI of 0.84±0.17. At 6 months, two patients were lost to follow-up. Among the remaining 8 patients, ultrasound revealed moderate stenosis in 2 cases and patent vessels in 6 cases, with Rutherford classification of grade 0 in 4 cases and grade 1 in 4 cases, and an ABI of 0.76±0.16.Conclusion The Rotarex mechanical thrombectomy system is a safe and feasible option for treating chronic thrombosis in PAD patients.