ROTAREXS for Subacute and Chronic Arterial Occlusions INTRODUCTION

ROTAREX®S for Subacute and Chronic Arterial Occlusions

INTRODUCTION Endovascular therapy has gained acceptance as a valuable alternative to the surgical treatment of occluded SFA and PA. Because of the high initial restenosis rates various methods have been developed to increase the patency – drug eluting balloons and stents, as well as different athero- and thrombectomy devices (Silverhawk, Rotarex, Laser, Pathway).

ROTAREX®S (Straub Medical AG, Switzerland) Ø 0. 018" guidewire Ø 6 F (110 cm. and 135 cm. ) – 3 -5 mm. Ø 8 F (85 cm. and 110 cm. ) – 5 -8 mm.

The outer part of the cutting head is driven at 40 000 rpm by the internal spiral and thus produces a permanent vacuum within the catheter which sucks detached thrombotic material.

MATHERIALS AND METHODS 25 pts subacute and CTO of the native SFA and PA Mean duration of symptoms – 75 days (15 -150) Rutherford class 3 – 13 pts, Rutherford class 4 – 8 pts, Rutherford class 5 – 4 pts Mean initial ABI – 0, 41 (0 -0, 58) Mean lesion length – 69 mm. (30 -180 mm. )

Occluded segment – SFA (11 pts), PA (6 pts), SFA+PA (8 pts) Ipsilateral access in 9 pts, contralateral - in 16 pts Guidewires – 0, 018" from set, 0, 035" stiff, 0, 014" 6 F device in 11 pts, 8 F device in 14 pts Mean activation time 4, 4 min. (2 -8 min. ), mean 3 passages (1 -5), mean aspirated volume 190 ml. (70 -350 ml. ) Stents implanted in 14 pts (56%) – Protégé Ever. Flex

Premedication ◦ 100 mg ASS daily ◦ 2500 U heparin i. a. bolus Post interventional therapy ◦ 100 mg ASS daily unlimited ◦ Stent - clopidogrel 300 mg loading dose and 75 mg daily for 6 months

FOLLOW UP Clinical exam and ABI at discharge and 1, 6, 12 m. } Mean ABI increase at discharge – 0, 43, 1 y. – 0, 28 } Mean downgrade of Rutherford class at 1 y. – 2, 4 (3 healed ulcerations of 4 pts in Rutherford 5) } Complications – 1 SFA rupture, 2 false aneurysms } Reocclusions at 1 y. – 8 pts (32%) } Only 1 pt (4%) required major amputation at 1 y. } No deaths at 1 y.

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PTA + stent SFA PA SFA+PA 13 5 ROTAREX®S 7 11 6 ~ ABI 0, 48 0, 43 ~ Rutherford class 3, 34 3, 64 ~ length of occlusion 63 mm. 69 mm. ~ stents implanted 1, 16 0, 56 ~ length of stents 76, 4 mm. 56, 2 mm. Primary patency 1, 6, 12 m. 80% 64% 44% 88% 72% 8 68%

CONCLUSION Advantages of the Rotarex®S device: Easy to handle, shortens intervention time No potential risk of bleeding when administring thrombolytics Removes atherothrombotic matherials Less stent placement and shorter when needed Higher primary patency (less elastic recoil? )

CONCLUSION Disadvantages of the Rotarex®S device: Relatively large diameter – cannot be used in middle and distal segments of tibial arteries Not recommended in heavily calcified lesions Cost not covered by NHIF Despite the small number of pts our results are acceptable. Would they be even better if we used drug eluting balloons and stents?

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