ClotTriever System Research Articles

Rationale and Design of the DEFIANCE Study: A Randomized Controlled Trial of Mechanical Thrombectomy Versus Anticoagulation Alone for Iliofemoral Deep Vein Thrombosis

BackgroundDeep vein thrombosis (DVT) is a common medical condition that is associated with clinically significant sequelae, including postthrombotic syndrome (PTS). Anticoagulation alone remains the guideline-recommended treatment for many patients with iliofemoral DVT. Recent technological advances have led to an increase in the use of mechanical thrombectomy for DVT, but mechanical thrombectomy-based procedures have not yet been compared with standard-of-care anticoagulation therapy in randomized studies. MethodsThe DEFIANCE study (ClinicalTrials.gov: NCT05701917) is an international and actively enrolling randomized controlled trial (RCT) in lower extremity DVT assessing an interventional strategy that includes mechanical thrombectomy with the ClotTriever System (Inari Medical, Irvine, CA) versus anticoagulation alone. Approximately 300 patients with unilateral iliofemoral DVT and symptom duration ≤12 weeks will be randomized 1:1. Study conduct includes an independent core laboratory for duplex ultrasound assessment, an independent medical monitor for safety adjudication, and evaluation of PTS severity on the Villalta scale using best clinical practices. The primary endpoint is a composite outcome structured as a hierarchal win ratio of 1) the occurrence of treatment failure or therapy escalation as adjudicated by the medical monitor, with failure defined as amputation or gangrene of the target leg or venous thromboembolism-related mortality, and 2) the assessment of PTS severity at the 6-month follow-up visit. In addition to being a component of the primary endpoint, the severity of PTS at 6 months is also evaluated as a stand-alone secondary endpoint. An additional secondary endpoint is a composite of outcomes at the 10-day visit and is structured as a hierarchal win ratio of 1) vessel compressibility on duplex ultrasound, 2) patient-reported pain, and 3) improvement of edema. The safety endpoints are access site complications requiring endovascular or surgical repair and the occurrence through the 30-day visit of mortality, major bleeding, or new symptomatic pulmonary embolism. ConclusionsDEFIANCE will be the first RCT to evaluate a mechanical thrombectomy-based interventional approach versus anticoagulation therapy alone for DVT. The results will inform the treatment of patients with iliofemoral DVT and the prevention of PTS-associated morbidity. Trial RegistrationDEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis (DEFIANCE), ClinicalTrials.gov: NCT05701917, URL: https://clinicaltrials.gov/study/NCT05701917?cond=Deep%20Vein%20Thrombosis&term=defiance&rank=1

Protrieve Sheath embolic protection during venous thrombectomy: early experience in seventeen patients

PurposeThe Protrieve Sheath (Inari Medical; Irvine, CA) is designed for embolic protection during venous thrombectomy. This report describes experience with its use.Materials and methodsBetween November 2022 and December 2023 (13 months), seventeen patients, including nine (52.9%) females and eight (47.1%) males (mean age 58.8 ± 13.3 years, range 37–81 years), underwent deep venous thrombectomy following the Protrieve Sheath placement for embolic protection. Gender, age, presenting symptoms, procedural indications, obstructed venous segments, the Protrieve Sheath access and deployment sites, thrombectomy devices utilized, need for stent reconstruction, technical success, clinical success, adverse events (the Protrieve Sheath maldeployment or clinically significant embolic events), removed thrombi analyses, and mortality were recorded. Technical success was defined as successful deployment of the Protrieve Sheath funnel central to the thrombectomy site. Clinical success was defined as improvement in presenting venous occlusive symptoms without procedure-related venous thromboembolism.ResultsThe most common presenting symptom was extremity swelling (n = 15; 88.2%). Nine (52.9%) patients had malignant and eight (47.1%) had benign etiologies of venous obstruction. Obstructed venous segments included the inferior vena cava (IVC) and lower extremity (n = 9; 52.9%), isolated lower extremity (n = 4; 23.5%), isolated IVC (n = 2; 11.8%), thoracic central veins and superior vena cava (n = 1; 5.9%), and isolated thoracic central vein (n = 1; 5.9%). The Protrieve Sheath access sites included the right internal jugular vein (n = 15; 88.2%) for IVC and lower extremity obstructions and the right common femoral vein (n = 2; 11.8%) for thoracic central vein and superior vena cava obstructions. The Protrieve sheath funnel deployment locations included intrahepatic IVC in 13 patients (n = 13; 76.5%), suprarenal IVC in two (n = 2; 11.8%), and inferior cavoatrial junction in two (n = 2; 11.8%). Thrombectomy devices used included the ClotTriever System (Inari Medical) (n = 15; 88.2%), the InThrill Thrombectomy System (Inari Medical) (n = 4; 23.5%), the FlowTriever System (Inari Medical) (n = 2; 11.8%), the Lightning Flash 16 Aspiration System (Penumbra; Salt Lake City, UT) (n = 2; 11.8%), the Cleaner Rotational Thrombectomy System (Argon; Plano, TX) (n = 1; 5.9%), and the RevCore Thrombectomy System (Inari Medical) (n = 1; 5.9%). Ten (58.8%) patients required stent reconstruction following thrombectomy. Technical success was achieved in all patients. Clinical success was achieved in 16 (94.1%) patients. No immediate adverse events, including the Protrieve Sheath maldeployment or clinically significant embolic events, occurred.ConclusionUse of the Protrieve Sheath during large-bore venous mechanical thrombectomy resulted in favorable technical and clinical outcomes without device-related adverse events or clinically significant thromboembolic events.

Outcomes From Mechanical Thrombectomy for Deep Vein Thrombosis: Insights From the PINC AI Healthcare Database

BackgroundMechanical thrombectomy (MT) is playing an increasingly important role in treating deep vein thrombosis (DVT). Although degrees of safety and efficacy have been shown in independent studies, there remains a lack of comparative evidence between MT devices. To address this, we aimed to compare demographics, clinical outcomes, and resource metrics of patients receiving MT for DVT with 3 common devices using a real-world database. MethodsPatients receiving MT for DVT between January 2018 and March 2022 were identified from the PINC AI Healthcare Database and divided into analysis populations for the AngioJet ZelanteDVT (AJ), the ClotTriever system (CT), and the Indigo system (IN). Rates of in-hospital mortality, resource utilization, and 30-day readmission were compared. Regression modeling was performed to adjust for potential covariates and compare outcomes. ResultsA total of 4455 MT encounters were identified and met inclusion criteria (AJ, 1753; CT, 1344; IN, 1358). In-hospital mortality ranged from 1.0% (CT) to 2.9% (IN), with modeling predicting significantly higher odds for the AJ (odds ratio [OR], 3.42) and IN (OR, 3.38) groups. Similarly, higher rates of resource utilization were predicted in the AJ and IN groups when compared with the reference group (CT). Average costs ranged from $29,549 (CT: SD, $30,705) to $42,705 (IN: SD, $41,114). Thirty-day readmissions ranged from 10.0% (AJ) to 14.6% (IN), while modeling predicted significantly greater odds for the IN group (OR, 1.47). ConclusionsThese results suggest that all MT interventions may be unequal in terms of outcomes and resources, with the CT device associated with lower in-hospital mortality and resource burden.

Stripping the catheter: A new device for an old technique.

Fibroblastic sleeve is a common pathophysiological phenomenon characterized by the formation of a mixed fibrous-collagen tissue encasing the outside of venous access devices. Although it nearly always presents asymptomatically, this catheter-related complication represents one of the leading culprits of venous catheters malfunction. Several techniques have been described for the management of dysfunctional catheters secondary to fibroblastic sleeve, including medical therapy, catheter exchange, balloon angioplasty, and percutaneous stripping. However, there is no common consensus for the treatment management in patients who present contraindications to surgical port removal. This report illustrates the case of a port catheter malfunction due to a fibroblastic sleeve in an oncological patient with a high risk of bleeding. This was effectively treated with a minimally invasive stripping technique using an off-label device for mechanical thrombectomy, namely the ClotTriever system (Inari Medical, Irvine, CA).

Reverse sheathing technique for iliocaval thrombectomy in the setting of IVC filters

The Inari ClotTriever system (Inari Medical, Irvine, California) is safe and effective for the treatment of DVT. However, because it consists of a 31 cm coring device and collection bag that must be extended for use, application may be precluded by available intravascular “running room”, such as in the presence of an IVC filter. Here we present a technique for bypassing IVC filters via retrograde deployment of the ClotTriever within a sheath, as illustrated in three cases. This technique extends the applicability of the ClotTriever to locations in which its length would otherwise preclude use.

One-Year Clinical Outcomes Following Mechanical Thrombectomy for Deep Vein Thrombosis: A CLOUT Registry Analysis

BackgroundMechanical thrombectomy is a promising treatment option for deep vein thrombosis; however, long-term data are lacking. Here, we report for the first time the 1-year clinical outcomes from the completely enrolled ClotTriever Outcomes (CLOUT) registry evaluating mechanical thrombectomy with the ClotTriever System (Inari Medical). MethodsThe CLOUT registry (NCT03575364) is a prospective, multicenter, single-arm study that enrolled 500 patients with proximal lower extremity deep vein thrombosis. Prespecified 1-year outcomes include Villalta score and corresponding postthrombotic syndrome (PTS) severity, duplex ultrasound findings of patency (defined as the presence of flow with normal or partial compressibility), Revised Venous Clinical Severity Score, and quality of life (QoL). ResultsIn CLOUT, the median age was 61.9 years and 50.5% of patients were women. A total of 310 patients completed the 1-year visit. The 1-year PTS rate (Villalta score ≥ 5) was 19.3% and the moderate-to-severe PTS rate (Villalta score ≥ 10) was 8.8%. Median Villalta score decreased from 9.0 (IQR, 5.0-14.0) at baseline to 1.0 (IQR, 0.0-4.0) at 1 year (P < .0001). Similar rates of PTS and moderate-to-severe PTS were observed among limbs assessed at all study time points. Patency was observed in 94.2% of limbs. Median Revised Venous Clinical Severity Score was 6.0 (IQR, 3.0-9.0) at baseline and 3.0 (IQR, 1.0-4.0) at 1 year (P < .0001). Additionally, 90.4% of patients experienced improvements in QoL. ConclusionsOne-year outcomes from the CLOUT registry demonstrate low PTS rates and preserved patency accompanied by improved symptom relief and QoL. Study follow-up through 2 years is ongoing.

Single-center experience with the ClotTriever BOLD catheter for deep vein thrombosis percutaneous mechanical thrombectomy of the lower extremity.

The ClotTriever System is a percutaneous mechanical thrombectomy system used to treat deep vein thrombosis (DVT). The BOLD catheter is a newer compatible component with a modified coring element for which reported outcomes are limited. This retrospective study aims to assess the preliminary procedural safety and success data for patients treated with the BOLD catheter. All consecutive patients with symptomatic lower extremity DVT who underwent thrombectomy with the BOLD catheter between 23 November 2021 and 26 June 2022 at a single center were included. Baseline and procedural characteristics were reported. The primary outcome, intraprocedural safety, was assessed by a chart review of recorded intraprocedural adverse events (AEs) or device malfunction. The secondary outcome, procedural success, was defined as ≥75% reduction in the total occlusion across treated venous segments. This was assessed by an interventionalist review of pre- and postprocedural venograms. Additional outcomes included length of postprocedural hospital stay and assessment of AEs at discharge and a 30-day follow-up visit. Eleven patient cases were reviewed. The median patient age was 65 years, the majority were women, and all were treated unilaterally. All procedures were completed in a single session without intraprocedural AEs or device malfunction. The median procedural blood loss was 50 ml. A review of pre- and postprocedural venograms showed that 35 venous segments were treated, including the femoral (n = 9), common femoral (n = 9), external iliac (n = 10), and common iliac (n = 7) veins. Procedural success was achieved in 10 patients (90.9%), and the median reduction rate in venous occlusion was 100%. The median length of postprocedural hospital stay was 1 day, and no AEs were noted at discharge (N = 11). One adverse event occurred among the eight patients who completed their follow-up visit. A patient with advanced-stage cancer and medication failure had a recurrent DVT 13 days postprocedure, which was not related to the device or procedure. No safety concerns concerning the BOLD catheter were raised during the review of the cases included in this analysis, and the device was successful in reducing venous occlusion in patients with symptomatic proximal lower extremity DVT.

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

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. 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 6months were analyzed. Adverse events were identified and independently adjudicated. All-cause mortality at 30days was 0.9%, and 8.6% of subjects experienced a serious adverse event (SAE) within the first 30days, 1 of which (0.2%) was device related. SAE rethrombosis/residual thrombus incidence was 4.8% at 30days and 8.0% at 6months. Between baseline and 6months, 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 6months (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. 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 6months. Level of Evidence 3: Non-randomized controlled cohort/follow-up study.

Successful endovascular thrombectomy with the ClotTriever System for acute subclavian vein thrombosis in venous thoracic outlet syndrome

BackgroundThe case describes a successful endovascular thrombectomy using the ClotTriever System for an acute subclavian thrombosis in venous thoracic outlet syndrome. To the best of our knowledge, this is the first case report on use of Inari ClotTriever for acute upper extremity deep venous thrombosis due to venous thoracic outlet syndrome. The rapid technical and clinical success of our intervention may be an interesting cue for interventional radiologist colleagues.Case presentationUpper extremity deep vein thrombosis in the setting of venous thoracic outlet syndrome generally occurs in young adults after excessive arm activity and can sometimes be managed with anticoagulation. In this case, a 29-year-old male diagnosed with acute effort-induced thrombosis of the left subclavian vein and persistent symptoms following low-molecular-weight heparin therapy underwent mechanical thrombectomy. Successful thrombectomy was completed with > 90% thrombus burden reduction and no complication. The patient experienced immediate symptom relief and vein patency was confirmed via imaging 3 months post procedure.ConclusionsMechanical thrombectomy is a promising treatment technique for thrombosis associated with venous thoracic outlet syndrome.

Percutaneous mechanical thrombectomy to remove post-thrombotic obstructions and manage post-thrombotic syndrome-associated venous leg ulceration

BackgroundUp to one half of patients with a diagnosis of deep vein thrombosis will develop post-thrombotic syndrome (PTS). Patients with PTS can develop venous leg ulcers (VLUs) due to post-thrombotic obstructions (PTOs) that contribute to prolonged ambulatory venous hypertension. The current treatments for PTS, which include chronic thrombus, synechiae, trabeculations, and inflow lesions, do not target PTOs, and such obstructions can affect stenting success. The aim of the present study was to determine whether removal of chronic PTOs using percutaneous mechanical thrombectomy would promote VLU resolution and positive outcomes. MethodsIn this retrospective analysis, the characteristics and outcomes for patients with VLUs secondary to chronic PTO who were treated using the ClotTriever System (Inari Medical) between August 2021 and May 2022 were assessed. Technical success was considered the ability to cross a lesion and introduce the thrombectomy device. Clinical success was defined as a decrease of ≥1 in the severity category for the ulcer diameter using the revised venous clinical severity score (score 0, no VLU; score 1, mild VLU [size <2 cm]; score 2, moderate VLU [size 2-6 cm]; score 3, severe VLU [size >6 cm]) at the latest follow-up visit. ResultsA total of 11 patients with 15 VLUs on 14 limbs were identified. Their mean age was 59.7 ± 11.8 years, and four patients (36.4%) were women. The median VLU duration was 11.0 months (interquartile range [IQR], 6.0-17.0 months), and 2 patients had VLUs secondary to a deep vein thrombosis event >40 years previously. All treatments were performed in a single session, with technical success achieved in 100% of the 14 limbs. A median of five passes (IQR, four to six passes) with the ClotTriever catheter were performed per limb. Chronic PTOs were successfully extirpated, and intraprocedural intravascular ultrasound showed effective disruption of venous synechiae and trabeculations. Stents were placed in 10 limbs (71.4%). The time to VLU resolution or the latest follow-up was 12.8 ± 10.5 weeks, and clinical success was achieved for all 15 VLUs (100%), with the revised venous clinical severity score for the ulcer diameter improving from a median of 2 (IQR, 2-2) at baseline to a median score of 0 (IQR, 0-0) at last follow-up. The VLU area had decreased by 96.6% ± 8.7%. Of the 15 VLUs, 12 (80.0%) had resolved completely, and 3 had demonstrated near-complete healing. ConclusionsAll patients showed complete or near-complete VLU healing within a few months after mechanical thrombectomy. Mechanical extirpation and interruption of chronic PTOs allowed for luminal gain and restoration of cephalad inflow. With additional investigation, mechanical thrombectomy with the study device could prove a vital component to the treatment of VLUs secondary to PTOs.

Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry

PurposeTo analyze the first 250 patients from the prospective, multicenter, industry-sponsored ClotTriever Outcomes (CLOUT) registry, assessing the safety and effectiveness of mechanical thrombectomy for acute, subacute, and chronic deep vein thrombosis (DVT). Materials and MethodsReal-world patients with lower extremity DVT were treated with the ClotTriever System (Inari Medical, Irvine, California). Adjuvant venoplasty, stent placement, or both were performed at the physician’s discretion. Thrombus chronicity was determined by visual inspection of removed thrombus, categorizing patients into acute, subacute, and chronic subgroups. Serious adverse events (SAEs) were assessed through 30 days. Clinical and quality-of-life (QoL) outcomes are reported through 6 months. ResultsThrombus chronicity was designated for 244 of the 250 patients (acute, 32.8%; subacute, 34.8%; chronic, 32.4%) encompassing 254 treated limbs. Complete or near-complete (≥75%) thrombus removal was achieved in 90.8%, 81.9%, and 83.8% of the limbs with acute, subacute, and chronic thrombus, respectively. No fibrinolytics were administered, and 243 (99.6%) procedures were single sessions. One (0.4%) patient in the subacute group experienced a device-related SAE, a fatal pulmonary embolism. On comparing baseline and 6-month data, improvements were demonstrated in median Villalta scores (acute, from 10 to 1; subacute, from 9 to 1; chronic, from 10 to 3; for all, P < .0001) and mean EuroQol group 5-dimension (EQ-5D) self-report questionnaire scores (acute, 0.58 to 0.89; subacute, 0.65 to 0.87; chronic, 0.58 to 0.88; for all, P < .0001). There were no significant differences in outcomes across the subgroups. ConclusionsMechanical thrombectomy using the ClotTriever System with adjunctive venoplasty and stent placement is safe and similarly effective for acute, subacute, and chronic DVT.

Percutaneous thrombectomy of upper extremity and thoracic central veins using Inari ClotTriever System: Experience in 14 patients.

In the present report, we have described the technical and clinical outcomes of percutaneous thrombectomy in the deep veins of the upper extremity and thorax using the ClotTriever system (Inari Medical, Irvine, CA). Fourteen patients with symptomatic deep venous occlusive disease in the upper extremity deep veins and thoracic central veins who had undergone thrombectomy using the ClotTriever system between October 2020 and January 2022 were reviewed. The technical results, adverse events, imaging follow-up data, and clinical outcomes were recorded. Fourteen patients (seven men and seven women; mean age, 53.6± 13.3years) constituted the study cohort. Of the 14 patients, 9 (64.3%) had had DVT due to intravascular invasion or external compression from known malignancy, 2 (14.3%) had had infected thrombi and/or vegetation due to Staphylococcus aureus refractory to intravenous antibiotic therapy, and 3 (21.4%) had had a benign etiology for thrombus formation. The presenting symptoms included upper extremity and/or facial swelling (n= 14), upper extremity pain (n= 6), fever (n= 2), and dyspnea (n= 1). Thrombectomy with the ClotTriever system was successfully completed in all 14 patients. Seven patients (50.0%) had required additional venous stent reconstruction after thrombectomy to address the underlying stenosis. No major adverse events were noted. All the patients had experienced resolution of the presenting symptoms. For the management of symptomatic deep venous occlusive disease of the upper extremity deep veins and thoracic central veins, thrombectomy using the ClotTriever system was feasible with excellent technical and clinical success.

Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry.

We report in-hospital outcomes from the multicenter, prospective, single-arm ClotTriever Outcomes (CLOUT) registry, which enrolled up to 500 patients with proximal lower extremity deep vein thrombosis (DVT) treated with percutaneous mechanical thrombectomy using the ClotTriever System (Inari Medical). The CLOUT registry enrolled all-comer patients with DVT, irrespective of symptom duration, thrombus age, prior treatment of the current DVT, or bilateral thrombus. The primary effectiveness end point was defined as complete or near complete (≥75%) reduction in Marder score. Thrombus burden was assessed by an independent core laboratory. Mortality and serious adverse events, including device-relatedness, were adjudicated by an independent medical monitor. Here, safety and outcomes are evaluated through discharge. The median age was 61.9 years (IQR, 48.0-70.8), 50.5% were women, 24.9% had a history of DVT, and 23.2% had previously failed treatment of the current DVT. Nearly all procedures (99.4%) were performed in a single session with negligible procedural blood loss (median 40.0 mL; IQR, 20.0-50.0), and most patients (97.8%) required no subsequent intensive care unit monitoring. The primary effectiveness end point was achieved in 91.2% of limbs. Through discharge, 1 device-related serious adverse event (0.2%) occurred. Health status, as assessed by self-reported pain and circumferential measurements of limb edema, were significantly improved at discharge. Thrombectomy with the ClotTriever System is a safe and effective treatment for proximal lower extremity DVT, while also avoiding the need of intensive care. Early patient improvements are demonstrated, and follow-up is ongoing to 2 years.

Abstract No. 22 ▪ FEATURED ABSTRACT Safety and Effectiveness of the ClotTriever System for Treating Deep Vein Thrombosis: Six-Month Outcomes of the Fully Enrolled CLOUT Registry

Abstract No. 22 ▪ FEATURED ABSTRACT Safety and Effectiveness of the ClotTriever System for Treating Deep Vein Thrombosis: Six-Month Outcomes of the Fully Enrolled CLOUT Registry

ClotTriever system for mechanical thrombectomy of deep vein thrombosis.

There is increasing evidence that early and comprehensive removal of thrombus in deep vein thrombosis is associated with improved outcomes, including decreased incidence of post-thrombotic syndrome and debilitating long-term symptoms. Catheter-directed thrombolysis is effective for the rapid removal of clot, but it is associated with high bleeding risk. Percutaneous mechanical thrombectomy is a highly effective method for the removal of clot without the use of systemic or catheter-directed thrombolytic therapy. The Inari ClotTriever system (Inari Medical Inc., CA, USA) is a thrombectomy device, which is approved for deep vein thrombosis by the US FDA in 2017. Herein we review the current treatment strategies using the ClotTriever system, its specifications, indications and current state of literature.

Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity: Presented at Eastern Vascular Society meeting, September 23-26, 2021, Charleston, SC.

Objective: The all-comer ClotTriever Outcomes registry assessed indicators of thrombus chronicity in patients with acute, subacute, and chronic lower extremity deep vein thrombosis (DVT). The effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) by chronicity subgroup was also assessed and reported here in this subanalysis.

Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry: Presented at the Thirty-fifth Annual Eastern Vascular Symposium of Twenty-second Annual New Cardiovascular Horizons, New Orleans, Louisiana, June 1-4, 2021, and the Eastern Vascular Society, Charleston, South Carolina, September 23-23, 2021.

Objectives: The multicenter, prospective, single arm CLOUT registry assesses the safety and effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) for the treatment of acute and nonacute lower extremity deep vein thrombosis (DVT) in all-comer patients. Reported here are the outcomes of the first 250 patients.

Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity

ObjectiveThe all-comer ClotTriever Outcomes registry assessed indicators of thrombus chronicity in patients with acute, subacute, and chronic lower extremity deep vein thrombosis (DVT). The effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) by chronicity subgroup was also assessed and reported here in this subanalysis. MethodsAll-comer patients with lower extremity DVT were enrolled, with no limitation based on the patients’ symptom duration. Chronicity was assessed three times and compared: before the procedure based on symptom duration, during the procedure based on available pre-thrombectomy imaging, and visual inspection of the extracted thrombus morphology after thrombectomy. Patients were grouped into acute, subacute, and chronic subgroups according to their post-thrombectomy thrombus chronicity based on thrombus morphology. Analyses on baseline and procedural characteristics along with thrombus removal were performed across subgroups. The effectiveness of thrombus removal was determined by Marder scores adjudicated by an independent core laboratory, with a prespecified primary effectiveness end point of complete or near-complete (≥75%) thrombus removal. ResultsOf the 260 treated limbs from 250 patients, using symptom duration alone, 70.7% were considered acute, 20.9% subacute, and 8.4% chronic. Upon visual inspection, the extracted thrombus chronicity was approximately one-third in each subgroup: 32.7% had acute thrombus, 35.4% subacute thrombus, and 31.9% chronic thrombus. Chronicity assessed using symptom duration alone mismatched the post-thrombectomy chronicity in 55.1% of limbs (P < .0001) with 49.0% being more chronic than suggested by the patients’ duration of symptoms. Chronicity assessed using pre-thrombectomy imaging mismatched the post-thrombectomy chronicity in 17.5% of limbs (P < .0001). No patients received thrombolytics and 99.6% were treated in a single session. Complete or near-complete thrombus removal was achieved in a high percentage of limbs regardless of thrombus chronicity: 90.8%, 81.9%, and 83.8% in limbs with acute, subacute, and chronic thrombus, respectively. ConclusionsThis subanalysis from the all-comer ClotTriever Outcomes registry demonstrates that extracted thrombus in DVT may be more chronic than suggested by the patients’ duration of symptoms. The addition of imaging is helpful to determine the ability of thrombus to respond to therapy. Irrespective of thrombus chronicity, the ClotTriever system can be effective at removing acute, subacute, and chronic thrombus in a single-session procedure without the need for thrombolytics.

Abstract No. 153 ▪ FEATURED ABSTRACT Safety and effectiveness of the ClotTriever system for treating deep vein thrombosis of all chronicities: CLOUT registry six-month outcomes

The ClotTriever System (Inari Medical, Irvine, CA) is a mechanical thrombectomy device used to treat deep vein thrombosis (DVT). This sub-analysis of the prospective, multi-center CLOUT registry (NCT03575364) assesses ClotTriever System outcomes for lower extremity DVT based on thrombus chronicity.

Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry

ObjectivesThe multicenter, prospective, single arm CLOUT registry assesses the safety and effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) for the treatment of acute and nonacute lower extremity deep vein thrombosis (DVT) in all-comer patients. Reported here are the outcomes of the first 250 patients. MethodsAll-comer patients with lower extremity DVT were enrolled, including those with bilateral DVT, those with previously failed DVT treatment, and regardless of symptom duration. The primary effectiveness end point is complete or near-complete (≥75%) thrombus removal determined by independent core laboratory-adjudicated Marder scores. Safety outcomes include serious adverse events through 30 days and clinical outcomes include post-thrombotic syndrome severity, symptoms, pain, and quality of life through 6 months. ResultsThe median age was 62 years and 40% of patients had contraindications to thrombolytics. A range of thrombus chronicity (33% acute, 35% subacute, 32% chronic) was observed. No patients received thrombolytics and 99.6% were treated in a single session. The median thrombectomy time was 28 minutes. The primary effectiveness end point was achieved in 86% of limbs. Through 30 days, one device-related serious adverse event occurred. At 6 months, 24% of patients had post-thrombotic syndrome. Significant and sustained improvements were observed in all clinical outcomes, including the Revised Venous Clinical Severity Score, the numeric pain rating scale, and the EuroQol Group 5-Dimension Self-Report Questionnaire. ConclusionsThe 6-month outcomes from the all-comer CLOUT registry with a range of thrombus chronicities demonstrate favorable effectiveness, safety, and sustained clinical improvements.