ISR-treatment The Leipzig experience with purely mechanical debulking. Sven Bräunlich Department for Angiology University-Hospital Leipzig, Germany

Transcription

1 ISR-treatment The Leipzig experience with purely mechanical debulking Sven Bräunlich Department for Angiology University-Hospital Leipzig, Germany

2 Disclosure Speaker name: Sven Bräunlich I have the following potential conflicts of interest to report: x Consulting (Abbott, Bard, Cook, Straub) 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 The Problem of In-stent Restenosis and Reocclusion Endovascular revascularization of long femoropopliteal lesions is well established today Stents improve patency What to do in case of restenosis or reocclusion?

4 The Problem of In-stent Restenosis and Reocclusion

5 The Problem of In-stent Restenosis and Reocclusion Classification of ISR In-Stent Occlusions are at high risk for recurrent ISR after re-intervention

6 The Problem of In-stent Restenosis and Reocclusion Specific endovascular strategies are needed to open the stent BEFORE angioplasty/ptx application

7 The Problem of In-stent Restenosis and Reocclusion Werner et al. JEVT 2012

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

9 Rotarex mechanical debulking: The Leipzig experience in patients - Single center registry: - Use of a debulking device (Rotarex) in PAOD patients - Safety and efficacy - Consecutive patient enrollment - Real world scenario patients treated (from 1/ /2013) patients were analyzable (86,9%)

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

11 Rotarex mechanical debulking: The Leipzig experience in patients Intervention Feature - Native virgin arteries - Surgical bypasses - Redo procedures - In-stent procedures 338 Procedures

12 Rotarex for chronic ISR In-stent occlusion right SFA and PA

13 Rotarex for chronic ISR Result after 3 Rotarex passages

14 Rotarex for chronic ISR Result after additional DCB angioplasty

15 Rotarex mechanical debulking in In-stent procedures: Demographic characteristics (n=338) Age, Mean ± SD (n) 68.1 ± 13.6 Male gender, n(%) 217 (64.2) Medical History, n(%) Obesity 113 (33.4) Smoking 166 (49.1) Dyslipidemia 263 (77.8) Diabetes 147 (43.5) Hypertension 275 (81.4) Coronary Artery Disease 110 (32.6) Cerebrovascular disease 41 (12.1) Renal Impairment 46 (13.6) Dialysis 5 (1.5) Previous anticoagulation 24 (7.2) Table 1. Clinical characteristics of 338 patients treated with mechanical debulking for in-stent procedures.

16 Rotarex mechanical debulking in In-stent procedures: Onset of symptoms (n=338) Acute ( <14 days ) 73 (21.6%) Subacute ( < 3 months ) 114 (33.7%) Chronic ( > 3 months ) 151 (44.6%)

17 Rotarex mechanical debulking in In-stent procedures: Clinical status Rutherford class on admission Rutherford Score Patient with events, n(%) (0.6) 2 58 (17.2) (62.7) 4 28 (8.3) 5 38 (11.2) 6 0 (0.0) Total 338 (100) Table 2. Baseline Rutherford scores among patients at enrollment Debulking for in-stent procedures

18 Rotarex mechanical debulking in In-stent procedures: Angiographic and procedural characteristics Total Vascular access sites 338 Antegrade 118 (34,9%) Crossover 176 (52.1%) Retrograde 44 (13%) Sheath diameter device (French) (40.2) (59.8) Mean lesion length (cm) 16.3 ( ) Intervention area Iliac 44 (13%) SFA 139 (41.1%) Popliteal 39 (11.5%) SFA + Popliteal 101 (29.9%) Proximal BTK 6 (1.8%) Other 9 (2.7%) Table 3. Overall Angiographic and procedural characteristics among 338 patients treated with mechanical debulking devices for in-stent procedures.

19 Rotarex mechanical debulking in In-stent procedures: Angiographic and procedural characteristics Type of lesion (complain symptoms) n (%) Calcification 327 * No/mild 72 (22%) Moderate 156 (46.2%) Severe 99 (31.8%) Intervention Feature 338 De-novo lesions 54 (15.9%) Previous Balloon Angioplasty 161 (47.6%) * Loss of 11 patients, due to inadequate images

20 Rotarex mechanical debulking in In-stent procedures: Acute results Procedural success rate: 326 (96.4% ) Main performed procedure Rotarex Debulking alone: 68 (20.9%) Rotarex Debulking + PTA: 195 (59.8%) Additional Stenting: 41 (12.6%) Additional Thrombolysis: 45 (13.8%) Associated BTK treatment: 75 (23.0%) Mean time follow-up: 12 ± 2.4 months

21 Rotarex mechanical debulking in In-stent procedures: Acute results - Complications Major Adverse Events (MAE) to 30 days post-intervention MAE All events n (%) Perforation 14 (4.1%) Bleeding 15 (4.4%) Dissection 10 (2.9%) Acute closure 7 (2.2%) Emboli 22 (6.5%) Infection 8 (2.1%)

22 Rotarex mechanical debulking in In-stent procedures: Clinical Follow-up: 30-day Results Major Adverse Events (MAE) to 30 postoperative day MAE Events (%) Death MI TLR TVR Major Amputation Total

23 Rotarex mechanical debulking in In-stent procedures: Clinical Follow-up: 12 months Results Major Adverse Events (MAE) after 12 month MAE Events (%) Death MI TLR TVR Major Amputation

24 Rotarex mechanical debulking in In-stent procedures: Clinical Follow-up: 12 months Results Major Adverse Events (MAE) after 12 month MAE Events (%) Death MI TLR TVR Major Amputation

25 Schmidt LINC 2013 Leipzig Rotarex + DCB Registry (39% ISR) Rotarex + DCB Freedom from restenosis DCB only Days follow-up

26 Rotarex mechanical debulking in In-stent procedures Summary Mechanical debulking with the Rotarex-catheter resulted in a high procedural success rate of 96.4% The low rate of procedural complications and 30 day clinical events supports the safety of the device The 12-months TLR rate of 12.7% in a real world scenario demonstrates the clinical effectiveness of Rotarex mechanical debulking for In-stent procedures

27 Rotarex mechanical debulking in In-stent procedures Summary The removal of stent-occluding material with the Rotarex before adjunctive therapy (DCB) appears to be a reasonable approach

28 Thank you!