1-year outcomes of the Indigo thrombectomy catheter for ...€¦ · Introducer. Procedural steps...
Transcript of 1-year outcomes of the Indigo thrombectomy catheter for ...€¦ · Introducer. Procedural steps...
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1-year outcomes of the Indigo thrombectomy catheter for
deep vein thrombosis
Dr. Theodosios BisdasClinic of Vascular Surgery
Athens Medical Center, Greece
St. Franziskus Hospital, Muenster, Germany
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Different techniquesto remove the clot
Rheolyticpharmaco-mechanial
thrombectomy
Rotationalmechanical
thrombectomy
Ultrasound-enhanced
thrombolysis
Aspiration thrombectomy
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Aim of the study
Aim of our study was to evaluate the safety and efficacy of aspiration thrombectomy for the
treatment of acute lower limb DVT
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The Indigo thrombectomy system
MECHANICAL CLOT ENGAGEMENTProprietary Separator Technology
MAXIMISED ASPIRATION POWERLarge Lumen Aspiration
TIP DIRECTIONALITYFor Circumferential Aspiration
ADVANCED TRACKING TECHNOLOGYMultiple Materials Transitions
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Mechanism of actionIn vitro model
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CAT8 - tip shapes
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Procedural stepsIntroducer
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Procedural stepsSeparator
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Case presentation
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Case presentation
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In case of cava filterCapturex (Straub Medical)
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Case presentation
BEFORE AFTER
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Case 2(DVT, POD 4 post cholecystectomy)
FINAL
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Case 332y, female, acute TVT, left limb, transpopliteal access
CAT8 XTorq
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Case 332y, female, acute DVT, left limb, transpopliteal access
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Patients and Methods
• Retrospectively collected data• December 2015 – January 2018, St. Franziskus
Hospital, Muenster, GER• CAT XTORQ catheter (Penumbra Inc)• Consecutive patients with iliofemoral DVT up to 14
days• All but one patient Rivaroxaban for 1 year and
compression stockings for at least 6 months
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Key characteristics
Characteristics No of patients
Total 25
Median age (IQR) 51 (43-67)
Male 15 (60%)
Villalta Score > 10 17 (68%)
Paraneoplastic syndrome 1 (4%)
Previous DVT 4 (16%)
Previous symptomatic pulmonary embolism 2 (8%)
Median interval (days) between symptoms and treatment (IQR) 8 (2-10)
Involvement of CFV 19 (76%)
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Outcomes
• Maino Technical success: ≥ 90% thrombus removal with restoration of
flow postthrombectomy and < 50% diameter narrowing, no robust collateral filling, and/or mean pressure gradient < 2 mmHg after stenting (common femoral, extern iliac and common iliac vein)
o Technical success in patients with absolute contraindication for lytic agent
o Primary patency @ 12 months
• Secondaryo Postthrombotic syndromeo Major bleeding* o Symptomatic pulmonary embolismo Death
*if it was associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g., intracranial, intraspinal)
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Results
25 patients included
In 5 patients absolute contraindication for lysis
Mean lesion length: 190 mm
rtPA intraop6 cases
24%
rtPA postop7 cases
28%
Cava filter5 cases
20%
Stent deployment24 cases (Veniti, BSC), 1 case Obliqus (Optimed)
100%
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Short-term outcomes
• Technical success: 88% (22 out of 25 patients)• Pat 1: < 90% thrombus removal
• Pat 2: < 90% thrombus removal
• Pat 3: Aspirated volume > 1 L
• Technical success in patients with absolute contraindication for lysis: 100%
• No pulmonary embolism
• No major bleeding up to 30 days (median aspiratedvolume: 730 ml (610-1240)
• Mean hospital day: 1.5 days
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Long-term outcomes
• Primary patency: 96%
• Moderate to severe PTS: 2 (8%)
• Symptomatic pulmonary embolism: 1 (4%)*
• Death: 1 (4%)*
*1 patient with paraneoplastic syndrome
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Conclusions
• The Indigo thrombectomy system showedvery promising results in acute DVT cases
• Ideal for lysis-free indication (paraneoplastic, major surgery, intracranial bleeding etc)
• Very low rates of moderate or severe PTS
• After stenting, high primary patency at 1 year
• Learning curve
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1-year outcomes of the Indigo thrombectomy catheter for
deep vein thrombosis
Dr. Theodosios BisdasClinic of Vascular Surgery
Athens Medical Center, Greece
St. Franziskus Hospital, Muenster, Germany