Dierk Scheinert, MD

Division of Interventional Angiology

University-Hospital Leipzig, Germany

Rotarex mechanical debulking:

The Leipzig experience in 1.200+ patients

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)

Removal – Suction – Fragmentation - Transport

40 000 rpm

ROTAREX ROTAREX S Multilayer braided

Thrombus-Containing Lesions Scenario 1: Acute Occlusions

Thrombus-Containing Lesions Scenario 2: Embolic Occlusion

Rotarex 8F + Fluency spot-stenting

Thrombus-Containing Lesions Scenario 3: Subacute Occlusions

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%)

Intervention Feature

- Native „virgin“ arteries

- Surgical bypasses

- Redo procedures

- In-stent procedures

Rotarex mechanical debulking:

The Leipzig experience in 1.200+ patients

1203 Procedures

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:

Demographic characteristics (n=1203)

Acute ( 3 months) 678 (56.4)

Rotarex mechanical debulking in native arteries:

Onset of symptoms

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:

Clinical status – Rutherford class on admission

Table 3. Overall Angiographic and procedural characteristics among 1203 patients treated with Mechanical debulking devices for “plain” native arteries.

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%)

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:

Angiographic and procedural characteristics

• 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

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 - Complications

Stenting-rate: 29.2 %

Full lesion stenting: 7.6 %

Focal stenting: 21.6 %

Rotarex mechanical debulking in native arteries:

Acute 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: 30-day 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

0

100

200

300

400

500

RF 0 RF 1 RF 2 RF 3 RF 4 RF 5 RF 6

Number of patients

Rutherford classes (RF)

Baseline

Follow up

73.2% of claudicants with

improvement of Rutherford class

Rotarex mechanical debulking in native arteries:

Clinical Follow-up: 12 months results

• 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 in native arteries:

Summary

Dierk Scheinert, MD

Division of Interventional Angiology

University-Hospital Leipzig, Germany

Rotarex mechanical debulking:

The Leipzig experience in 1.200+ patients