Rotarex mechanical debulking: The Leipzig experience in 1.200+ patients Dierk Scheinert, MD Division of Interventional Angiology University-Hospital Leipzig, Germany
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
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)
Thrombus-Containing Lesions Scenario 2: Embolic Occlusion Acute onset of pain Pale foot, sensory loss, motoric function intact
Thrombus-Containing Lesions Scenario 3: Subacute Occlusions Previous iliac-femoral endovascular revasc. Sub-acute in-stent occlusion (2 months)
Thrombus-Containing Lesions Scenario 4: Bypass reocclusion Right femoro-popliteal bypass Right iliaco-femoral bypass Femoro-popliteal bypass occlusion since 7 months
Thrombus-Containing Lesions Specific 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
Rotarex-Catheter (Straub-Medical) ROTAREX ROTAREX S Multilayer braided 40 000 rpm Removal Suction Fragmentation - Transport
Thrombus-Containing Lesions Scenario 1: Acute Occlusions
Thrombus-Containing Lesions Scenario 2: Embolic Occlusion
Thrombus-Containing Lesions Scenario 3: Subacute Occlusions Rotarex 8F + Fluency spot-stenting
Thrombus-Containing Lesions Scenario 4: Bypass reocclusion Right femoro-popliteal bypass Right iliaco-femoral bypass Femoro-popliteal bypass occlusion since 7 months
Scenario 4 Rotarex 6 F 3-vessel BTK run-off No distal protection Immediate proximal and distal anastomotic post-balooning
Scenario 4
Rotarex mechanical debulking: The Leipzig experience in 1.200+ patients - Single center registry: - Use of Thrombectomy device in OPAD 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 debulking: The Leipzig experience in 1.200+ patients Intervention Feature - Native virgin arteries - Surgical bypasses - Redo procedures - In-stent procedures 1203 Procedures
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
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)
Rotarex mechanical debulking in native arteries: Clinical status Rutherford class on admission Rutherford Score Patient with events, n(%) 0 0 1 17 (1.4) 2 188 (15.6) 3 363 (30.2) 4 452 (37.6) 5 134 (11.1) 6 49 (4.1) Total 1203 (100) Table 2. Baseline Rutherford scores among patients at enrollment Debulking Devices on native vessels
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) 6 844 (70.2) 8 359 (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.
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
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
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)
Rotarex mechanical debulking in native arteries: Acute results Stenting-rate: 29.2 % Full lesion stenting: 7.6 % Focal stenting: 21.6 %
Rotarex mechanical debulking 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 debulking in native arteries: Clinical Follow-up: 12 months results Major Adverse Events (MAE) to 12 month 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 debulking in native arteries: Clinical Follow-up: 12 months results 500 73.2% of claudicants with improvement of Rutherford class 400 300 Number of patients 200 Baseline Follow up 100 0 RF 0 RF 1 RF 2 RF 3 RF 4 RF 5 RF 6 Rutherford classes (RF)
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.
Rotarex mechanical debulking: The Leipzig experience in 1.200+ patients Dierk Scheinert, MD Division of Interventional Angiology University-Hospital Leipzig, Germany