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. 2023 Nov;46(11):1571-1580.
doi: 10.1007/s00270-023-03509-8. Epub 2023 Aug 14.

Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry

Abdullah Shaikh  1 , Adam Zybulewski  2 , Joseph Paulisin  3 , Mohannad Bisharat  4 , Nicolas J Mouawad  5 , Adam Raskin  6 , Eugene Ichinose  7 , Steven Abramowitz  8 , Jonathan Lindquist  9 , Ezana Azene  10 , Neil Shah  11 , James Nguyen  12 , Josh Cockrell  13 , Bhavraj Khalsa  14 , Vipul Khetarpaul  15 , Douglas A Murrey Jr  16 , Kalyan Veerina  17 , Edvard Skripochnik  18 , Thomas S Maldonado  19 , Matthew C Bunte  20 , Suman Annambhotla  21 , Jonathan Schor  22 , Herman Kado  23 , Hamid Mojibian  24 , David Dexter  25 ; CLOUT Investigators
Affiliations

Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry

Abdullah Shaikh et al. Cardiovasc Intervent Radiol. 2023 Nov.

Abstract

Purpose: Mechanical thrombectomy for the treatment of deep vein thrombosis (DVT) is being increasingly utilized to reduce symptoms and prevent postthrombotic syndrome (PTS), but more data on clinical outcomes are needed. Mechanical thrombectomy was studied in the ClotTriever Outcomes (CLOUT) registry with 6-month full analysis outcomes reported herein.

Materials and methods: The CLOUT registry is a prospective, all-comer study that enrolled 500 lower extremity DVT patients across 43 US sites treated with mechanical thrombectomy using the ClotTriever System. Core-lab assessed Marder scores and physician-assessed venous patency by duplex ultrasound, PTS assessment using Villalta score, venous symptom severity, pain, and quality of life scores through 6 months were analyzed. Adverse events were identified and independently adjudicated.

Results: All-cause mortality at 30 days was 0.9%, and 8.6% of subjects experienced a serious adverse event (SAE) within the first 30 days, 1 of which (0.2%) was device related. SAE rethrombosis/residual thrombus incidence was 4.8% at 30 days and 8.0% at 6 months. Between baseline and 6 months, venous flow increased from 27.2% to 92.5% of limbs (P < 0.0001), and venous compressibility improved from 28.0% to 91.8% (P < 0.0001), while median Villalta scores improved from 9.0 at baseline to 1.0 at 6 months (P < 0.0001). Significant improvements in venous symptom severity, pain, and quality of life were also demonstrated. Outcomes from iliofemoral and isolated femoral-popliteal segments showed similar improvements.

Conclusion: Outcomes from the CLOUT study, a large prospective registry for DVT, indicate that mechanical thrombectomy is safe and demonstrates significant improvement in symptoms and health status through 6 months. Level of Evidence 3: Non-randomized controlled cohort/follow-up study.

Keywords: Deep vein thrombosis; Mechanical thrombectomy; Postthrombotic syndrome.

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Conflict of interest statement

Abdullah Shaikh, MD, is a speaker for Inari Medical. Mohannad Bisharat, MD, is a consultant for Inari Medical. Nicolas J. Mouawad, MD, MPH, MBA, is a consultant for Inari Medical and Boston Scientific. Eugene Ichinose, MD, is a consultant for Inari Medical, Penumbra, and Angiodynamics, and is a speaker for Pfizer and Bristol Meyers Squib. Steven Abramowitz, MD is a speaker for Inari Medical. Jonathan Lindquist, MD, receives grant support from Inari Medical, Boston Scientific, Sirtex Medical, Philips, is a consultant for Inari Medical, Boston Scientific, Avantec Vascular, Endoshape, Inc., Philips, and Trisalu Life Sciences; and is on the advisory board of Avantec Vascular. Bhavraj Khalsa, MD, is a consultant for Inari Medical. Kalyan Veerina, MD is a speaker for Inari Medical. Thomas S. Maldonado, MD, is a consultant for Inari Medical. Matthew C. Bunte, MD, MS, receives grant support from Inari Medical, and is a consultant for Abbott, Shockwave Medical, and Inari Medical.

Adam Zybulewski, MD, Joseph Paulisin, DO, Adam Raskin, MD, Ezana Azene, MD, PhD, Neil Shah, MD, James Nguyen, MD, Josh Cockrell, MD, Vipul Khetarpaul, MD, Douglas A. Murrey Jr., MS, MD, Edvard Skripochnik, MD, Suman Annambhotla, MD, report no conflicts of interest.

Figures

Fig. 1
Fig. 1
Kaplan–Meier Analysis of Rethrombosis/Residual Thrombus of Treated Vein Segment. Kaplan–Meier analysis of the freedom from rethrombosis events through 180 days is presented, with an abbreviated y-axis (90–100%) shown in the inset. The total number of events and # of patients at risk every 30 days is shown in the chart at the bottom of the figure
Fig. 2
Fig. 2
Duplex Ultrasound Outcomes at Baseline, 30 days, and 6 Months A. Percent of limbs with flow present. B. Percent of limbs with normal or partial compressibility. C. Percent of limbs with patency, defined as the presence of flow and normal/partial compressibility
Fig. 3
Fig. 3
PTS Severity Scores at Baseline to 6 Months. A. Box and half-violin plot of Villalta scores at baseline, 30 days, and 6 months post-procedure. Median is represented by black line; mean is represented by red dot. Black dots are outliers B. Percent of limbs in Villalta score/PTS severity groups at baseline and 6 months post-procedure. Villalta Score/PTS severity categories: No PTS: 0–4; Mild PTS: 5–9; Moderate PTS: 10–14; Severe PTS: ≥ 15. C. Percent of limbs with a change in Villalta score/PTS severity category at 6 months compared to baseline for paired values
Fig. 4
Fig. 4
Venous Clinical Severity Score, Pain Score, and Quality of Life Score from Baseline through 6 Months. Clinical outcomes were assessed at baseline, then at 30 days and 6 months post-procedure. Median is represented by a black line; mean is represented by a red dot. A: Revised venous clinical severity score (rVCSS, 0–30 scale); B: Numerical pain rating scale (NPRS, 0–10 scale); C: EuroQoL group 5-D (EQ-5D) quality of life measurement (1 = highest quality)
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