Rotarex mechanical thrombectomythe first line option for thrombotic occlusions?

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Rotarex mechanical thrombectomythe first line option for thrombotic occlusions? Dierk Scheinert, MD Division of Interventional Angiology University Hospital Leipzig, Germany

Disclosure Advisory Board /Consultant: Abbott, Biotronik, Boston Scientific, Cook Medical, Cordis, CR Bard, Gardia Medical, Medtronic/Covidien, TriReme Medical, Trivascular, Upstream Peripheral Technologies

Risk of Thrombus... and embolization Concentric stenoses CTO lesions Acute occlusions

Thrombus-Containing Lesions Specific endovascular strategies are needed to open the vessel AND to avoid distal embolization: - Thrombus aspiration - Thrombolysis - Mechanical thrombectomy (Rotarex)

Local bleeding after 12h low-dose thrombolysis

Thrombus-Containing Lesions Specific endovascular strategies are needed to open the vessel AND to avoid distal embolization: - Thrombus aspiration - Thrombolysis - Mechanical thrombectomy (Rotarex)

Rotarex S Catheter (Straub-Medical) 40 000 rpm Detachment (up to 1 cm/s) Suction Fragmentation Transport

Thrombus aspiration in P3 and TPT Rotarex Thrombectomycatheter 6F Short activation time

Rotarex for Acute Occlusions Proglide-closure left groin and puncture right CFA 2 passages Rotarex 8F short activation-time

CTO of the left SFA, 8 Fr Rotarex First pass Several passes

Rotarex for Chronic SFA-CTOs 2 x 5.0/120 In.Pact Pacific 12 months results

Rotarex + DEB Registry Femoropopliteal Lesions Clinically chronic Apop-occlusion 6 Fr Rotarex After DEB

Rotarex mechanical thrombectomy: The Leipzig experience in 1.200+ patients - Single center registry: - Use of Thrombectomy device in PAOD patients - Safety and efficacy - Consecutive patient enrollment - Real world scenario - 1.809 patients treated (from 1/2005 11/2013) - 1.572 patients were analyzable (86,9%)

Rotarex mechanical thrombectomy: The Leipzig experience in 1.200+ patients Intervention Feature - Native virgin arteries - Surgical bypasses - Redo procedures - In-stent procedures 1203 Procedures

Rotarex mechanical thrombectomy in native arteries: Acute results Procedural success rate: 1139 (94.7% ) Main performed procedure Rotational Thrombectomy alone: 255 (21.2%) Rotational Thrombectomy + PTA: 597 (49.6%) Additional Stenting: 251 (29.2%) Additional Thrombolysis: 113 (9.4%) Mean time follow-up: 12 ± 2.4 months

Rotarex mechanical thrombectomy in native arteries: Acute results - Complications Major Adverse Events (MAE) to 30 postoperative day MAE All events n (%) Perforation 22 (1.8) Bleeding 29 (2.4) Dissection 108 (9) Acute closure 27 (2.2) Emboli 87 (7.2) Infection 14 (1.2)

Rotarex mechanical thrombectomy in native arteries: Acute results Stenting-rate: 29.2 % Full lesion stenting: 7.6 % Focal stenting: 21.6 %

Rotarex mechanical thrombectomy in native arteries: Clinical Follow-up: 30-day results Major Adverse Events (MAE) to 30 postoperative day MAE Events (%) Death 19 1.6 MI * 13 1.1 TLR ** 25 2.1 TVR *** 7 0.6 Major Amputation 17 1.4 Total 81 6.7 Table 4. Major Adverse Events (MAE) to 30 postoperative day. Values are rate numbers (%) of observations Myocardial infarction ** Target-lesion revascularization *** Target-vessel revascularization

Rotarex mechanical thrombectomy in native arteries: Clinical Follow-up: 12 months results Major Adverse Events (MAE) to 12-months post-intervention MAE Events (%) Death 101 8.4 MI * 28 2.3 TLR ** 127 10.6 TVR *** 41 3.4 Major Amputation 47 3.9

Rotarex mechanical thrombectomy in ISR Subacute in-stent occlusion right SFA and PA

Rotarex mechanical thrombectomy in ISR Result after Rotarex-thrombectomy

Rotarex mechanical thrombectomy in ISR Result after additional balloon angioplasty

Rotarex for Bypass Occlusion - Iliaco-fem Bypass right -Fem-pop Bypass right, now occluded - Severe claudication since 6 month

Rotarex for Bypass Occlusion Recanalization with 8F Rotarex

Rotarex for Bypass Occlusion Rotarex demasks the culprit lesion

Rotarex for Bypass Occlusion Result after PTA of the anastomoses

When to use a protection device? Recommended only in case of - necessity for additional ballooning - one-vessel run-off - contraindication for thrombolysis Intensive thrombectomy of the proximal part before passing the last cm of the occlusion also helps to avoid embolization.

Conclusion Particular endovascular techniques are available to treat thrombus containing lesions without the harm of distal embolization Mechanical thrombectomy with the Rotarex device is safe and effective Sophisticated embolic protection systems are available to improve our results in selected cases

Rotarex mechanical thrombectomythe first line option for thrombotic occlusions? Dierk Scheinert, MD Division of Interventional Angiology University Hospital Leipzig, Germany