Purpose: To assess the efficacy and safety of the Rotarex rotational thrombectomy catheter in treating occlusions of the femoropopliteal arteries.
Methods: The Rotarex catheter (Straub Medical, Switzerland) is a rotational thrombectomy device which is supposed to be able to remove fresh and partially organized clot material from an acutely or subacutely occluded vessel. Nineteen limbs of 18 patients (10 women, 8 men; mean age 72.9 +/- 7.3 years) with acute or subacute (23 +/- 16 days) occlusions of the middle or distal third of the superficial femoral artery or the popliteal artery were treated. The occlusions were 3-20 cm long.
Results: Thrombectomy was technically successful in 15 of 19 vessels (79%). The primary procedural success including additional procedures such as angioplasty and/or stent-graft placement in 17 limbs was 94%. The mean ankle-brachial index improved from 0.36 +/- 0.26 (before thrombectomy) to 0.81 +/- 0.21 (2 days after the procedure) (p = 0.012). Clinical symptoms shifted to at least one Fontaine stage lower in 13 limbs. As complications we observed two perforations (arteries showing heavily calcified plaques), one arteriovenous fistula and three distal embolizations. One perforation, the fistula and one intimal tear after percutaneous transluminal angioplasty were treated with covered stents; the three distal embolizations were treated successfully with aspiration or Rotarex thrombectomy. In the other perforation the intervention was terminated. None of the complications needed surgical treatment. The complication rate was 31.5%. Follow-up studies showed three early (4-11 days) and six late (1-6 months) reocclusions. The cumulative primary patency rate was 68 +/- 12% at 3 months, and 39 +/- 13% at 6, 12 and 19 months; the secondary patency rate was 68 +/- 12% at 3 months and 53 +/- 13% at 6, 12 and 20 months.
Conclusion: The Rotarex thrombectomy catheter is effective and quick in treating acute and subacute occlusions of the superficial femoral and popliteal arteries. It should not be used in arteries with heavily calcified plaques because of the risk of perforation. Limited long-term patency is mainly due to the complexity of the underlying lesion. Our results suggest that the Rotarex mechanical thrombectomy catheter is effective and might serve as an alternative treatment modality to intra-arterial lysis.