How do I use mechanical debulking for the treatment of arterial occlusions
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1 How do I use mechanical debulking for the treatment of arterial occlusions Sven Bräunlich, MD Division of Interventional Angiology University-Hospital Leipzig, Germany
2 Disclosure Speaker name: Sven Bräunlich I have the following potential conflicts of interest to report: x Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest
3 Mechanical debulking Specific endovascular strategies are needed to open the artery AND to avoid distal embolization
4 Rotarex S Catheter (Straub-Medical) Detachment (up to 1 cm/s) Suction Fragmentation Transport
5 Thrombus-Containing Lesions Acute Occlusions 82 year, female, acute onset of pain right leg, Atrial Fibrillation 2 passages Rotarex 8F activation-time 45 sec.
6 Rotarex for CHRONIC occlusions 6 Fr Rotarex DCB Result
7 Rotarex for chronic occlusions Clinically chronic Apop-occlusion 6 Fr Rotarex After DCB
8 Rotarex for chronic ISR In-stent occlusion right SFA and PA
9 Rotarex for chronic ISR Result after Rotarex-thrombectomy
10 Rotarex for chronic ISR Result after additional DCB angioplasty
11 Rotarex for chronic SFA-CTO CTO of the left SFA, 8 Fr Rotarex First pass Several passes
12 Rotarex for Chronic SFA-CTO 2 x 5.0/120 mm DCB 12 months FU results
13 Rotarex mechanical debulking: The Leipzig experience in patients - Single center registry: - Use of Debulking device in PAOD patients - Safety and efficacy - Consecutive patient enrollment - Real world scenario patients treated (from 1/ /2013) patients were analyzable (86,9%)
14 Rotarex mechanical debulking: The Leipzig experience in patients Intervention Feature - Native virgin arteries - Surgical bypasses - Redo procedures - In-stent procedures 1203 Procedures
15 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
16 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)
17 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 Iliac 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.
18 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
19 Rotarex mechanical debulking in native arteries: Acute results Procedural success rate: 1139 (94.7% ) Main performed procedure Rotarex Debulking alone: 255 (21.2%) Rotarex Debulking + PTA: 597 (49.6%) Additional Stenting: 251 (29.2%) Additional Thrombolysis: 113 (9.4%) Mean time follow-up: 12 ± 2.4 months
20 Rotarex mechanical debulking in native arteries: Acute results - Complications Table 6. 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)
21 Rotarex mechanical debulking in native arteries: Results Procedural success rate 94.7% Stenting-rate: 29.2 % Full lesion stenting: 7.6 % Focal stenting: 21.6 % Clinical follow-up: 12 months TLR 10.6%
22 Rotarex mechanical debulking Summary Mechanical debulking with the Rotarex-catheter resulted in a high procedural success rate of 94.7% The Rotarex device is safe and effective in a broad range of lesions, including CTO The 12-months TLR rate of 10.6% in a real world scenario demonstrates the clinical effectiveness of Rotarex mechanical debulking in arteries
23 Thank you!
24 How do I use mechanical debulking for the treatment of arterial occlusions Sven Bräunlich, MD Division of Interventional Angiology University-Hospital Leipzig, Germany
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