Rotarex mechanical debulking: The Leipzig experience in patients
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1 Rotarex mechanical debulking: The Leipzig experience in patients Dierk Scheinert, MD Division of Interventional Angiology University-Hospital Leipzig, Germany
2 Disclosure Speaker name: Dierk Scheinert I have the following potential conflicts of interest to report: Consulting: Abbott, Angioslide, Atheromed, Biotronik, Boston Scientific, Cook Medical, Cordis, Covidien, CR Bard, Gardia Medical, Hemoteq,Intact Vascular Inc., Medtronic, Ostial Inc, TriReme Medical, Trivascular, Upstream Peripheral Technologies
3 Thrombus-Containing Lesions Scenario 1: Acute Occlusions Chronic calf claudicant, boths sides Sudden hip and thigh pain with descompensation on the right side (4 days)
4 Thrombus-Containing Lesions Scenario 2: Embolic Occlusion Acute onset of pain Pale foot, sensory loss, motoric function intact
5 Thrombus-Containing Lesions Scenario 3: Subacute Occlusions Previous iliac-femoral endovascular revasc. Sub-acute in-stent occlusion (2 months)
6 Thrombus-Containing Lesions Scenario 4: Bypass reocclusion Right femoro-popliteal bypass Right iliaco-femoral bypass Femoro-popliteal bypass occlusion since 7 months
7 Thrombus-Containing Lesions Specific strategies are needed to open the vessel and to avoid distal embolization: - Thrombus aspiration - Thrombolysis - Mechanical thrombectomy (Rotarex)
8 Local bleeding after 12h low-dose thrombolysis
9 Rotarex-Catheter (Straub-Medical) ROTAREX ROTAREX S Multilayer braided rpm Removal Suction Fragmentation - Transport
10 Thrombus-Containing Lesions Scenario 1: Acute Occlusions
11 Thrombus-Containing Lesions Scenario 2: Embolic Occlusion
12 Thrombus-Containing Lesions Scenario 3: Subacute Occlusions Rotarex 8F + Fluency spot-stenting
13 Thrombus-Containing Lesions Scenario 4: Bypass reocclusion Right femoro-popliteal bypass Right iliaco-femoral bypass Femoro-popliteal bypass occlusion since 7 months
14 Scenario 4 Rotarex 6 F 3-vessel BTK run-off No distal protection Immediate proximal and distal anastomotic post-balooning
15 Scenario 4
16 Rotarex mechanical debulking: The Leipzig experience in patients - Single center registry: - Use of Thrombectomy device in OPAD patients - Safety and efficacy - Consecutive patient enrollment - Real world scenario patients treated (from 1/ /2013) patients were analyzable (86,9%)
17 Rotarex mechanical debulking: The Leipzig experience in patients Intervention Feature - Native virgin arteries - Surgical bypasses - Redo procedures - In-stent procedures 1203 Procedures
18 Rotarex mechanical debulking in native arteries: Demographic characteristics (n=1203) Age, Mean ± SD (n) 66.7 ± 12.1 (1203) Male gender, n(%) 805 (66.9) Medical History, n(%) Obesity 396 (32.9) Smoking 573 (47.6) Dyslipidemia 795 (66.1) Diabetes 482 (40.1) Insulin-dependent DM 85 (17.6*) Hypertension 957 (79.6) Coronary Artery Disease 360 (29.9) Cerebrovascular disease 122 (10.1) Renal Impairment 146 (12.1) Dialysis 18 (1.5) Previous anticoagulation 87 (7.2) Table 1. Clinical characteristics of 1203 patients treated with Mechanical Debulking for plain native arteries. * among diabetic patients
19 Rotarex mechanical debulking in native arteries: Onset of symptoms Acute (<14 days) 211 (17.5) Subacute (< 3 months) 314 (26.1) Chronic (> 3 months) 678 (56.4)
20 Rotarex mechanical debulking in native arteries: Clinical status Rutherford class on admission Rutherford Score Patient with events, n(%) (1.4) (15.6) (30.2) (37.6) (11.1) 6 49 (4.1) Total 1203 (100) Table 2. Baseline Rutherford scores among patients at enrollment Debulking Devices on native vessels
21 Rotarex mechanical debulking in native arteries: Angiographic and procedural characteristics Total Vascular access sites 1203 Antegrade 739 (61.5%) Crossover 413 (34.3%) Retrograde 51 (4.2%) Sheath diameter device (French) (70.2) (29.8) Mean lesion lenght (cm) 11.7 (2-24.8) Intervention area AIC 13 (1.1%) SFA 835 (69.4%) Popliteal 114 (9.5%) SFA + Popliteal 169 (14.0%) Proximal BTK 49 (4.1%) Other 23 (1.9%) Table 3. Overall Angiographic and procedural characteristics among 1203 patients treated with Mechanical debulking devices for plain native arteries.
22 Rotarex mechanical debulking in native arteries: Angiographic and procedural characteristics Type of lesion (complain symptoms) n(%) Calcification 1169 * No/mild 396 (33.9) Moderate 464 (39.7) Severe 309 (26.4) Intervention Feature 1203 De-novo lesions 789 (65.6) Previous Balloon Angioplasty 414 (34.4) * Loss of 34 patients, due to inadequate images
23 Rotarex mechanical debulking 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
24 Rotarex mechanical debulking in native arteries: Acute results - Complications Table 6. Major Adverse Events (MAE) to 12-months post-intervention 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)
25 Rotarex mechanical debulking in native arteries: Acute results Stenting-rate: 29.2 % Full lesion stenting: 7.6 % Focal stenting: 21.6 %
26 Rotarex mechanical debulking in native arteries: Clinical Follow-up: 30-day results Major Adverse Events (MAE) to 30 postoperative day MAE Events (%) Death MI * TLR ** TVR *** Major Amputation Total Table 4. Major Adverse Events (MAE) to 30 postoperative day. Values are rate numbers (%) of observations Myocardial infarction ** Target-lesion revascularization *** Target-vessel revascularization
27 Rotarex mechanical debulking in native arteries: Clinical Follow-up: 12 months results Major Adverse Events (MAE) to 12 month MAE Events (%) Death MI * TLR ** TVR *** Major Amputation
28 Rotarex mechanical debulking in native arteries: Clinical Follow-up: 12 months results % of claudicants with improvement of Rutherford class Number of patients 200 Baseline Follow up RF 0 RF 1 RF 2 RF 3 RF 4 RF 5 RF 6 Rutherford classes (RF)
29 Rotarex mechanical debulking in native arteries: Summary The use of the Rotarex-catheter in native peripheral arteries with acute, subacute and chronic lesions resulted in a high procedural success rate of 94.7% The low rate of procedural complications and 30 day clinical events supports the safety of the device in a broad range of lesions The 12-months TLR rate of 10.6% together with a marked improvement of the clinical status demonstrates the clinal effectivness at 1 year.
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